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NOT PEER REVIEWED
Mr. Clive Bates’ response to our article, the Foundation for a Smoke-Free World and healthy Indigenous futures: an oxymoron?, indicates the need to clarify several issues. In this response, we emphasise two key issues:
1. Organisations claiming to serve the good of the public, but who receive direct or third-party funding from the tobacco industry, are faced with serious conflicts of interest (COI); and
2. harm reduction is only part of a comprehensive approach to reducing commercial tobacco use.
As Indigenous peoples, we have an inherent responsibility to protect the health and wellbeing of Indigenous peoples now and for our future generations. The tobacco industry poses, and has posed in the past, a significant threat to our health and wellbeing. Therefore, we are deeply concerned about the Philip Morris-funded Foundation focusing on Indigenous peoples.
Philip Morris International, the Philip Morris Funded-Foundation and the Centre for Research Excellence: Indigenous Sovereignty and Smoking
Mr. Bates states that “There is no credible analysis (anywhere) of the actual, rather than the imagined, relationship between PMI and the Foundation for a Smokefree World”. This is incorrect 1-5. Researchers in journals such as The Lancet and Tobacco Control have analyzed key documents from the Foundation, including tax returns and bylaws that highlighted numerous relationship issues and conflicts of interest 1-5.
NOT PEER REVIEWED
Mr. Clive Bates’ response to our article, the Foundation for a Smoke-Free World and healthy Indigenous futures: an oxymoron?, indicates the need to clarify several issues. In this response, we emphasise two key issues:
1. Organisations claiming to serve the good of the public, but who receive direct or third-party funding from the tobacco industry, are faced with serious conflicts of interest (COI); and
2. harm reduction is only part of a comprehensive approach to reducing commercial tobacco use.
As Indigenous peoples, we have an inherent responsibility to protect the health and wellbeing of Indigenous peoples now and for our future generations. The tobacco industry poses, and has posed in the past, a significant threat to our health and wellbeing. Therefore, we are deeply concerned about the Philip Morris-funded Foundation focusing on Indigenous peoples.
Philip Morris International, the Philip Morris Funded-Foundation and the Centre for Research Excellence: Indigenous Sovereignty and Smoking
Mr. Bates states that “There is no credible analysis (anywhere) of the actual, rather than the imagined, relationship between PMI and the Foundation for a Smokefree World”. This is incorrect 1-5. Researchers in journals such as The Lancet and Tobacco Control have analyzed key documents from the Foundation, including tax returns and bylaws that highlighted numerous relationship issues and conflicts of interest 1-5.
Addressing conflicts of interest is fundamentally important for ethical practice. Conflicts of interest are commonly described in ethical principles, including specific Indigenous codes 6-8. The Tri-Council Policy Statement describes a COI as:
“when activities or situations place an individual or institution in a real, potential or perceived conflict between the duties or responsibilities related to research, and personal, institutional or other interest. These interests include, but are not limited to, business, commercial or financial interests pertaining to the institution and/or the individual, their family members, friends, or their former, current or prospective professional associates.” 6, page 93
A clear COI is created when the tobacco industry’s role is purported to support health research, while also profiting from the sale and promotion of tobacco products–all while smoking continues to be identified as the single greatest avoidable cause of death and disease worldwide 9 10. In other words, there is a COI when health professionals accept funding from the tobacco industry 9 10. This COI was also identified in the United Nations General Assembly, when they recognised the “fundamental conflict of interest between the tobacco industry and public health” 11, page 5. The Foundation was launched with a 12-year funding commitment from PMI of $1 billion 12. There has been financial dependence on PMI as well as conflicting commercial and business interests 2-4 12. Further, analysis of the Foundation’s tax return indicated that the Foundation remains solely funded by PMI. 3 The Foundation and subsequently the Centre have received PMI funding. As Yach and Bettcher stated in an earlier time, “tobacco is at the centre of the contradictions... …It is where the goals of a set of multinationals are clearly in conflict with public health and welfare.” 13, page 6
The COI, actual and perceived, and the inherent conflict of duty can manifest in additional ways:
1) the PMI-funded Foundation’s harm reduction role serves PMI’s agenda of moving into the Alternative Nicotine Devices market, while PMI continues to promote and sell tobacco 14. Therefore, the Foundation serves PMI’s Alternative Nicotine Devices market aspirations 14-16.
2) The Foundation serves a public relations role for PMI. The PMI-funded Foundation’s mission of progressing toward ending smoking through health, science, and technology for smoking cessation and tobacco harm reduction tools, supports PMI’s corporate responsibility agenda. Therefore, it could be argued that the Foundation contributes a veneer of credibility to PMI. This veneer provides public relations opportunities for PMI to frame themselves as “good” global corporate citizens 17-19. Further, Legg et al. 3 provide additional analysis of the relationship between PMI and the Foundation, highlighting that the Foundation’s expenditure on public relations was more than their expenditures on research, challenging the Foundation’s purported image as a “scientific body” and supporting the growing consensus that they serve as a PMI public relations function 3 20.
As Mr. Bates highlights, the tobacco industry continues to directly and indirectly fund foundations, centers, and researchers. Funding foundations, centers, and researchers can be used in its effort to gain credibility 3 21. The tobacco industry has marketed global corporate responsibility with attractive research funding and courted prominent scientists. This has included epidemiologists including Dr. Ernst Wynder, an early proponent of tobacco harm reduction 17, and Dr. Alvan R. Feinstein, editor of the Journal of Clinical Epidemiology 18. Feinstein critiqued the “atmosphere [in which a tobacco industry] consultant’s stature, credibility, and integrity become instantly impugned and tarnished by the depravity of associating with the tobacco ‘bad guy’” 18. However, Feinstein failed to declare that he, too, was a tobacco industry consultant 22-24. The Foundation’s director has also previously detailed such industry strategies as “buying scientists” to serve commercial objectives and undermine effective tobacco control 25. In 2007, Yach and Bettcher stated, “As the vector of the tobacco epidemic, the tobacco industry's actions fall far outside of the boundaries of global corporate responsibility” 13, page 207.
The tobacco industry has a long and productive history of colluding in covering up, denying, confusing, and questioning the science on smoking and smoking-related morbidity and mortality 26. Given the long and comprehensive history of the tobacco industry using public relations firms and scientists in its manipulation of research 27 28, the connections between the Foundation and bodies with long-standing tobacco industry links continues to raise significant concerns about the legitimacy of the PMI-funded Foundation, the Centre, and their research messages.
3) the Foundation and its protagonists create divisions both real and perceived. For example, the Foundation and its protagonists can frame institutions and various peoples as “for” or “against” harm reduction in a binary fashion, but in fact there are many aspects and diverse views on harm reduction 29-32. The arguments about who to trust and who researchers should accept funding from can dilute the health sectors’ efforts, sow confusion and doubt, and generate opportunities to promote the tobacco industry agenda 16 33. As outlined, this echoes a common colonisation tool - divide and conquer. 10 34 This credibility dilemma over who the public should engage with, believe, and trust creates a false dichotomy of “us vs. them”. In reality, views lie on a diverse continuum. Such divisions, real or perceived, do not help progress constructive debate about reducing tobacco use or tobacco related harms, and disrupt knowledge production processes in public health and medicine. 28 Indigenous processes are about inclusivity and our right to the enjoyment of the highest attainable standard of health. 35 We want to have fora that promote that standard, where different perspectives can be heard and discussed free from externally imposed agendas. 32 35
Harm reduction and a comprehensive approach to reducing tobacco use among Indigenous peoples
The World Health Organization (WHO) Framework Convention on Tobacco Control (FCTC) 32, and others 29-31, have outlined the need for a comprehensive and multifaceted systems approach to reducing commercial tobacco use, including preventing tobacco uptake. 29-32 A comprehensive systems approach emphasises that there is no single solution to addressing smoking disparities; by definition, the solutions are complex. 9 30-32 In addition, the FCTC guiding principles recognize the particular needs and challenges experienced by Indigenous peoples, and the importance of facilitating Indigenous participation in developing, implementing, and evaluating tobacco control. 32 Indigenous peoples should be able to engage in tobacco reduction debates, including about forms of harm reduction, free from external or tobacco industry agendas. 32 35 While Mr. Bates states, “There is a far more imaginative way to see the Centre, the Foundation and PMI”, our interests are clear. We are interested in reducing tobacco use, and consequently tobacco-related death and disease. We are interested in improving our health and wellbeing. “For the tobacco epidemic, the vector is not a virus, bacterium, or other microorganism – it is an industry and its business strategy.” 36, page 71
Conclusion
There is a need for evidence-based debate to reduce tobacco-related death and disease, and we encourage constructive debate that strengthens and advances tobacco control programs and policies. But this science must be ethical and independent from the tobacco industry. 2 5 25 27 28 32 37 We must reinforce the calls from WHO, the public health community, and Indigenous peoples to reject collaborations with the Foundation 3 10 20 32 38. We encourage centers and researchers not to accept Foundation funds, and we urge the Foundation to return its funding to PMI. Tobacco-related death and disease is completely preventable 9, and the “health and well-being of Indigenous peoples is too critical, the promise of future Indigenous generations too important.” 10, page 3
References
1. Chapman S. Tobacco giant wants to eliminate smoking: British Medical Journal Publishing Group, 2017.
2. Daube M, Moodie R, McKee M. Towards a smoke-free world? Philip Morris International’s new Foundation is not credible. The Lancet 2017;390(10104):1722-24.
3. Legg T, Peeters S, Chamberlain P, et al. The Philip Morris-funded Foundation for a Smoke-Free World: tax return sheds light on funding activities. The Lancet doi: 10.1016/S0140-6736(19)31347-9
4. van der Eijk Y, Bero LA, Malone RE. Philip Morris International-funded ‘Foundation for a Smoke-Free World’: analysing its claims of independence. Tobacco Control 2018 doi: 10.1136/tobaccocontrol-2018-054278
5. J. Liberman. The new Philip Morris-funded Foundation for a Smoke-Free World: independent or not?, McCabe Centre for Law & Cancer, 30 January 2018, accessed June 2019 2018 [
6. Canadian Tri-Council. Tri-Council Policy Statement: Ethical Conduct for Research Involving Humans (TCPS2): Ottawa, ON: Canadian Institutes of Health Research, Natural Sciences and …, 2010.
7. Hudson M, Milne M, Reynolds P, et al. Te ara tika. Guidelines for Māori research ethics: a framework for researchers and ethics committee members 2010
8. Ermine W, Sinclair R, Jeffery B. The ethics of research involving Indigenous peoples: Indigenous Peoples' Health Research Centre Saskatoon, Saskatchewan 2004.
9. Health UDo, Services H. The health consequences of smoking—50 years of progress: a report of the Surgeon General: Atlanta, GA: US Department of Health and Human Services, Centers for Disease …, 2014.
10. Waa A, Robson B, Gifford H, et al. Foundation for a Smoke-Free World and healthy Indigenous futures: an oxymoron? Tobacco Control 2019:tobaccocontrol-2018-054792. doi: 10.1136/tobaccocontrol-2018-054792
11. Political Declaration of the High-level Meeting of the General Assembly on the Prevention and Control of Non-communicable Diseases, A/RES/66/2 (24 January 2012), para. 38; 2012.
12. Foundation for a Smoke-Free World. Media advisory: Foundation forming to eliminate smoking worldwide, 2017.
13. Yach D, Bettcher D. Globalisation of tobacco industry influence and new global responses. Tobacco Control 2000;9(2):206-16. doi: 10.1136/tc.9.2.206
14. Philip Morris International. Philip Morris International, 2018 Annual Report, 2018.
15. Foundation for a Smoke-Free World. Our Vision: Foundation for a Smoke-Free World; 2018 [Available from: https://www.smokefreeworld.org/our-vision accessed 18 September 2018.
16. Foundation for a Smoke-Free World. Strategic Plan 2019-2021 The Foundation for a Smoke-Free World: Foundation for a Smoke-Free World, 2018.
17. Fields N, Chapman S. Chasing Ernst L Wynder: 40 years of Philip Morris’ efforts to influence a leading scientist. Journal of Epidemiology & Community Health 2003;57(8):571-78.
18. Mukherjee A, Ekanayake E. Epistemic communities and the global alliance against tobacco marketing. Thunderbird International Business Review 2009;51(3):207-18.
19. Malone RE. On tobacco industry cultural appropriation. Tobacco Control 2009;18(6):425-26. doi: 10.1136/tc.2009.034488
20. Global Center for Good Governance in Tobacco Control. An open letter to the Director General and Executive Board of the World Health Organization, 2019.
21. Smith KE, Fooks G, Collin J, et al. “Working the system”—British American tobacco's influence on the European union treaty and its implications for policy: an analysis of internal tobacco industry documents. PLoS Medicine 2010;7(1):e1000202.
22. Nixon L, Mejia P, Cheyne A, et al. Big Soda’s long shadow: news coverage of local proposals to tax sugar-sweetened beverages in Richmond, El Monte and Telluride. Critical Public Health 2015;25(3):333-47.
23. Etter JF. Secondhand smoke in Geneva, 1996–2006: changes in exposure, opinions, and workplace smoking bans in the absence of national legislation. International journal of occupational and environmental health 2009;15(2):159-65.
24. Dockrell M. Eye and heart at mortal war: coronaries and controversy in a smoke-free Scotland. Expert review of pharmacoeconomics & outcomes research 2009;9(1):23-27.
25. Yach D, Bialous SA. Junking science to promote tobacco. American journal of public health 2001;91(11):1745-48.
26. Francey N, Chapman S. “Operation Berkshire”: the international tobacco companies' conspiracy. BMJ: British Medical Journal 2000;321(7257):371.
27. Bero LA. Tobacco industry manipulation of research. Public health reports 2005;120(2):200.
28. Brandt AM. Inventing conflicts of interest: a history of tobacco industry tactics. American journal of public health 2012;102(1):63-71.
29. Carson KV, Brinn MP, Labiszewski NA, et al. Interventions for tobacco use prevention in Indigenous youth. Cochrane Database of Systematic Reviews 2012(8)
30. Chamberlain C, Perlen S, Brennan S, et al. Evidence for a comprehensive approach to Aboriginal tobacco control to maintain the decline in smoking: an overview of reviews among Indigenous peoples. Systematic reviews 2017;6(1):135.
31. Minichiello A, Lefkowitz AR, Firestone M, et al. Effective strategies to reduce commercial tobacco use in Indigenous communities globally: a systematic review. BMC Public Health 2015;16(1):21.
32. World Health Organization. WHO Framework Convention on Tobacco Control. Geneva: WHO Document Production Services, 2003:44.
33. Friedman LC, Cheyne A, D G, et al. Tobacco Industry Use of Personal Responsibility Rhetoric in Public Relations and Litigation: Disguising Freedom to Blame as Freedom of Choice. American Journal of Public Health 2015;105(2):250-60.
34. Banerjee SB. The Practice of Stakeholder Colonialism: National Interest and Colonial Discourses in the Management of Indigenous Stakeholders. In: Prasad A, ed. Postcolonial Theory and Organization Analysis: A Critical Engagement. New York: Palgrave Macmillan 2003:255-82.
35. UN General Assembly. United Nations Declaration on the Rights of Indigenous peoples. UN Wash 2007;12:1-18.
36. Leung CM-K, Leung AKC, Hon K-LE, et al. Fighting tobacco smoking--a difficult but not impossible battle. International journal of environmental research and public health 2009;6(1):69-83. doi: 10.3390/ijerph6010069 [published Online First: 2009/01/05]
37. Cohen JE, Zeller M, Eissenberg T, et al. Criteria for evaluating tobacco control research funding programs and their application to models that include financial support from the tobacco industry. Tobacco control 2009;18(3):228-34.
38. World Health Organization. WHO Statement on Philip Morris funded Foundation for a Smoke-Free World: WHO Geneva, 2017.
NOT PEER REVIEWED
I hope that Tobacco Control will offer a right of reply to the target of this one-sided criticism. In the meantime, let me put a few points to the authors:
1. There is no credible analysis (anywhere) of the actual, rather than the imagined, relationship between PMI and the Foundation for a Smokefree World (FSFW - ‘the Foundation’) that suggests PMI exerts material control over the Foundation. Its basic legal documents suggest otherwise. Nor have the authors explained why the Foundation's goal of ending smoking within a generation is somehow a bad thing or insincere.
2. Nor is there a credible assessment of the relationship between the Foundation and the new Centre for Research Excellence: Indigenous Sovereignty and Smoking (the Centre) that is the subject of criticism in this paper. There are two degrees of separation between the Centre and PMI, and the philosophy of the Foundation is to support centres of excellence and to leave them to get on with their work. The Centre has an excellent (Māori) leader and is quite capable of asserting its independence. How it would somehow do the bidding of PMI is not explained by the authors.
3. The authors dismiss the Centre’s focus on ‘harm reduction’ and instead emphasise: “the need to shift attention away from individuals to the true source of the problem: commercial tobacco and the companies that sell and promote it.”. While I share the sentiment about individual smoking cessat...
NOT PEER REVIEWED
I hope that Tobacco Control will offer a right of reply to the target of this one-sided criticism. In the meantime, let me put a few points to the authors:
1. There is no credible analysis (anywhere) of the actual, rather than the imagined, relationship between PMI and the Foundation for a Smokefree World (FSFW - ‘the Foundation’) that suggests PMI exerts material control over the Foundation. Its basic legal documents suggest otherwise. Nor have the authors explained why the Foundation's goal of ending smoking within a generation is somehow a bad thing or insincere.
2. Nor is there a credible assessment of the relationship between the Foundation and the new Centre for Research Excellence: Indigenous Sovereignty and Smoking (the Centre) that is the subject of criticism in this paper. There are two degrees of separation between the Centre and PMI, and the philosophy of the Foundation is to support centres of excellence and to leave them to get on with their work. The Centre has an excellent (Māori) leader and is quite capable of asserting its independence. How it would somehow do the bidding of PMI is not explained by the authors.
3. The authors dismiss the Centre’s focus on ‘harm reduction’ and instead emphasise: “the need to shift attention away from individuals to the true source of the problem: commercial tobacco and the companies that sell and promote it.”. While I share the sentiment about individual smoking cessation, I believe their proposed alternative problem-definition is overly simplistic and that it will not serve smokers of any ethnicity well. The appropriate approach is to take a ‘system view’, in which the system includes individuals, community, tobacco industry and supply chain, technology and innovation, information, regulation, taxation and enforcement - and to recognise this system is undergoing a significant disruption. A focus on ‘harm reduction’ should not be misunderstood as an individualist perspective. It requires careful engineering of incentives through ‘risk-proportionate’ policies that bear down hard on the cigarette trade but encourage smokers to switch to lower risk products. It is not an alternative to conventional MPOWER techniques, but a way of widening and improving the responses available to smokers.
4. No analysis is provided of the Centre's mission or work programme and how this will, somehow, harm the interests of indigenous people. No consideration is given to the implications of NOT having the Centre, of NOT doing its work and NOT producing its intellectual property. What is gained by NOT trying to reduce the smoking-related harms among indigenous people? Why is it better for this money to be spent elsewhere or returned to PMI's shareholders than spent on improving the life-chances of New Zealand’s indigenous populations?
5. Instead of dispassionate analysis of the Centre's work programme and the Foundation's aims, an array of irrelevant arguments and innuendo about the original funder is deployed in an effort to discredit the Centre and its work. It amounts to a superficial analysis of business motivations and the incentives of tobacco firms and fails to grasp how these have been fundamentally changed by the ongoing technology disruption created by new forms of non-combustible products. Yet, that is precisely why such a centre has such an important role in the rapidly evolving environment.
6. Indigenous people's smoking rates in New Zealand remain far higher than the European origin population (daily smoking prevalence was 31.2% among Māoris compared to 13.5% among the European population in 2018). Clearly, the standard tobacco control playbook has not been a conspicuous success in this population, yet Māoris suffer a disproportionate burden from the key tobacco policy: tobacco taxes set at a high level. Māoris account for 26% of national expenditure on tobacco, but only account for 15% of the adult population and around 70% of their expenditure is tax (approximately $NZ 700m). The harm reduction approach should also be seen as a way to mitigate the economic inequities that arise from tobacco use and tobacco taxation - there are large savings to smokers who switch from smoking to vaping.
7. Given the relative failure of conventional tobacco control in reducing smoking prevalence in indigenous populations, surely it makes sense to try new approaches - including the 'harm reduction' approach that aims help smokers switch from combustible to non-combustible nicotine products. For many, this will be an easier transition than complete cessation because it involves giving up less (i.e. it does not involve giving up nicotine, sensory impacts, behavioural ritual etc) but for almost the same health gain.
8. There is some support for this in New Zealand’s parliament. A joint House of Representatives Māori Affairs and Health Committee inquiry noted in December 2018 that New Zealand was off-track to meet the Aotearoa 2025 goal and that regularising the market for vaping products should be recognised as part of the policy response:
"We recommend that legislation be enacted to recognise and regulate vaping and e-cigarettes as a pathway to help smokers to quit".
9. Emotive rhetoric about a 'new colonisation' may help to fire up activists but it adds little of practical value to the debate. Nicotine is one of several drugs in widespread and longstanding use in most societies. As a drug, nicotine is relatively benign and does not cause intoxication, overdose, violence, accidents, sexual vulnerability, job losses, family breakdown etc. We now have an opportunity to address its ‘dirty’ delivery system, the inhalation of tobacco smoke, and so to reduce the great harm that arises from how nicotine is administered. How does a Centre trying to reduce smoking-related harm among indigenous people colonise anyone?
10. There is a far more imaginative way to see the Centre, the Foundation and PMI. This is how I see it: due to a major technology disruption in the consumer nicotine marketplace, some tobacco companies are now repositioning themselves in a way that will be beneficial for public health despite their ongoing participation in the cigarette business. A valuable by-product of that has been the release of $1 billion to support research and programmes that reduce smoking and related harms and facilitate a transition from combustible nicotine products to non-combustible. Committed public health advocates and academics should at least keep an open mind about this, while others seize the opportunity to do good and reduce harm with these funds, especially in disadvantaged communities. In this case, the Centre and its leadership have done exactly that and, in my view, they should be given time and some encouragement to prove their worth to indigenous communities.
Note: I have no relationship with the Centre, the Foundation or PMI, and I do not speak on their behalf or at their behest. The views stated here are my own. I have been a public health advocate for tobacco harm reduction since 1998.
We read with interest a recent publication by Li, et. al, entitled Association of smoking and electronic cigarette use with wheezing and related respiratory problems in adults: cross-sectional results from the Population Assessment of Tobacco and Health (PATH) study, wave 2. The primary finding, reported in the abstract, was that risk of wheezing and related respiratory symptoms was significantly increased in current exclusive e-cigarette users compared to never users, with an adjusted odds ratio of 1.67 (1.23, 2.15). We think the report is misleading for several reasons.
First, the main multivariable analysis (Table 2) did not adequately adjust for important confounders that impact wheeze, most importantly, cigarette smoking history. In most analyses of medical outcomes in adults, pack-years of smoking has a strong relation to smoking-related diseases, over-and-above current smoking status. Since three quarters of vapers in the main model were ex-smokers, cigarette smoking history is almost certainly contributing to the size and significance of the main reported finding. Other combustible tobacco use and current marijuana smoking would also be expected to exacerbate cough and wheeze. Our bet is that large numbers of e-cigarette users also use marijuana.
The authors partially addressed smoking history with a secondary analysis (Table 3), in which they stratified by former smoking status. In that analysis, vaping was not significantl...
We read with interest a recent publication by Li, et. al, entitled Association of smoking and electronic cigarette use with wheezing and related respiratory problems in adults: cross-sectional results from the Population Assessment of Tobacco and Health (PATH) study, wave 2. The primary finding, reported in the abstract, was that risk of wheezing and related respiratory symptoms was significantly increased in current exclusive e-cigarette users compared to never users, with an adjusted odds ratio of 1.67 (1.23, 2.15). We think the report is misleading for several reasons.
First, the main multivariable analysis (Table 2) did not adequately adjust for important confounders that impact wheeze, most importantly, cigarette smoking history. In most analyses of medical outcomes in adults, pack-years of smoking has a strong relation to smoking-related diseases, over-and-above current smoking status. Since three quarters of vapers in the main model were ex-smokers, cigarette smoking history is almost certainly contributing to the size and significance of the main reported finding. Other combustible tobacco use and current marijuana smoking would also be expected to exacerbate cough and wheeze. Our bet is that large numbers of e-cigarette users also use marijuana.
The authors partially addressed smoking history with a secondary analysis (Table 3), in which they stratified by former smoking status. In that analysis, vaping was not significantly associated with any respiratory symptom among persons with no previous cigarette smoking history. The secondary analysis strongly suggests that if a measure capturing extent of former smoking was entered as a covariate in the main model, the primary reported finding of an association between e-cigarette use and pulmonary symptoms would have been null.
Second, the analyses did not adjust for conditions that exacerbate wheeze (chronic obstructive pulmonary disease, congestive heart failure and certain cardiac medications), another potential source of residual confounding. These conditions may also cause declining health, prompting the person to quit smoking or switch from smoking to vaping, adding to a cross sectional association through reverse causality.
While addressing this last issue requires longitudinal data, we believe adding former smoking status and marijuana smoking to the main analysis should be done. The inclusion of these covariates would provide a less biased estimate of the cross-sectional association between vaping and respiratory symptoms and perhaps reach entirely different conclusions. We hope the authors will publish updated results in their response to this comment.
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A key finding of this paper does not find its way into the abstract namely, "no significant differences in wheezing and related respiratory symptoms was found when comparing current vapers who never smoked with never smokers. " This tends to suggest, unsurprisingly, that it is the prior smoking history that is the critical factor in current wheeze. The paper supports the harm reduction hypothesis for switching to vaping completely from smoking as per the conclusion. But the conclusion also states in the first line, "Vaping was associated with increased risk of wheezing and related respiratory symptoms, " which is incorrect without adding "in current smokers." Vapers who previously smoked have lower risk than those who continue to smoke, including dual users, and those who never smoked have no increased risk.
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We would like to clear up some misconceptions in Dr. Glantz’s reply to our recent article (1). First, our analytic approach did not assume linearity as the title of Dr. Glantz’s response implies. On the contrary, we applied a log linear form, which not only better fit the data, but also incorporates non-linearities. Additionally, we also conducted and provided results using a linear form in the supplementary material, which yielded similar results.
In his reply to our paper, Dr. Glantz claims that we should have started the vaping period in 2009 rather than in 2014 or 2013. However, we feel this criticism is wrong since we provided extensive data in the paper showing that vaping among youth was minimal until at least 2013.
Consequently, we focused on when vaping became more widespread and, by most accounts, became a concern. Further, we conducted analyses that considered changes in trend for other years and obtained qualitatively similar results when the transition was specified as dating back to 2013 or 2012. We also conducted analyses which allowed for changes in trend in both 2009 and 2014 and found no change in trend from 2009 onward, whereas the change in trend from 2014 onward continued to hold. We understand that Dr. Glantz and colleagues in another paper (2) used 2009 as a base year for vaping. However, we feel this choice was a poor one since virtually no students were using e-cigarettes in 2009, and hence vaping would not be...
NOT PEER REVIEWED
We would like to clear up some misconceptions in Dr. Glantz’s reply to our recent article (1). First, our analytic approach did not assume linearity as the title of Dr. Glantz’s response implies. On the contrary, we applied a log linear form, which not only better fit the data, but also incorporates non-linearities. Additionally, we also conducted and provided results using a linear form in the supplementary material, which yielded similar results.
In his reply to our paper, Dr. Glantz claims that we should have started the vaping period in 2009 rather than in 2014 or 2013. However, we feel this criticism is wrong since we provided extensive data in the paper showing that vaping among youth was minimal until at least 2013.
Consequently, we focused on when vaping became more widespread and, by most accounts, became a concern. Further, we conducted analyses that considered changes in trend for other years and obtained qualitatively similar results when the transition was specified as dating back to 2013 or 2012. We also conducted analyses which allowed for changes in trend in both 2009 and 2014 and found no change in trend from 2009 onward, whereas the change in trend from 2014 onward continued to hold. We understand that Dr. Glantz and colleagues in another paper (2) used 2009 as a base year for vaping. However, we feel this choice was a poor one since virtually no students were using e-cigarettes in 2009, and hence vaping would not be a factor influencing adolescent smoking.
Dr. Glantz also criticizes our study by pointing out several years during the vaping period when smoking prevalence did not decline. While it is true that smoking did not decline in some years during the vaping period, exceptions do not prove the rule. Indeed, the point of statistical analysis is to distinguish salient trends. Our aim was to provide straightforward analyses of the trends in cigarette smoking replicated across six different surveys. We estimated equations which allowed for long-term trends and changes in trend, and corrected for autocorrelation in the error terms where tests indicated a problem. Across six separate surveys, we obtained remarkably consistent results showing that the downward trend in smoking rates were greatly accelerated since vaping became more widespread.
In his criticism of our study Dr. Glantz focused particular attention on our results from the NYTS. We began our analysis of these data in 2011 because data became publicly available on an annual basis beginning in that year. Further, these data show that, while high school smoking rates fell from 15.8% to 12.7% between 2011 and 2013, representing a 20% drop in that three-year period, smoking rates declined to 9.8% in 2014 representing a 25% decline in just one year. Smoking prevalence further declined to 7.6% in 2017, representing a 40% drop since 2013. Nonetheless, the NYTS data provides the weakest indication of the change in trend during the vaping period due to the limited ability to detect pre-vaping trends.
Since our study was completed, more recent data have been published on youth and young adult smoking and vaping. In particular, the just released Monitoring the Future data indicate that last 30 day prevalence of smoking by 12th graders fell from 9.7% in 2017 to 7.6% in 2018, a 22% drop in just one year. In addition, NHIS data indicate that smoking prevalence for 18-24 year olds (both genders) fell from 13.1% in 2016 to 10.4% in 2017, a 21% drop in one year. These new data are consistent with the trends we describe in our paper.
Finally, we disagree in three ways with Dr. Glantz’s criticism that our paper only narrowly focused on cigarette use while ignoring total tobacco product use, including e-cigarettes. First, our decision to focus on the associations between e-cigarettes and cigarettes was based on concerns that e-cigarette use leads to increased smoking (3). Second, we think it is inappropriate to combine e-cigarettes and cigarettes in the same category of health risk, since virtually all scholarly evidence reviews have concluded that e-cigarettes are likely substantially less harmful than cigarettes and other combustible tobacco products, including the NASEM (3), PHE (4), and RCP (5) reports. Third, despite FDA’s legal classification of e-cigarettes as tobacco products, a strong argument can be made that e-cigarettes are not tobacco products at all, but rather a specific type of nicotine delivery product, just as nicotine patches, gum, and lozenges are also nicotine delivery products. No one would classify nicotine patches, gum, and lozenges as tobacco products. Indeed, classifying e-cigarettes as tobacco is the reason that Dr. Glantz can make his final claim that total tobacco use has risen with the introduction of e-cigarettes. While this conclusion is true under the classification scheme that Dr. Glantz uses, it is irrelevant to the arguments we made. Our arguments hinge on whether the increase in vaping is offset by a greater decrease in smoking (and other tobacco use) than would be expected in a world without e-cigarettes. We have never suggested better than one for one substitution, and would agree that vaping has substantially increased.
The data presented by Dr. Glantz on e-cigarette use are based on any last 30 day use. An important advance in our study over prior analyses, including the earlier study by Dr. Glantz and colleagues (2), was that we also considered measures of more established use, such as having smoked 100 cigarettes, daily smoking and smoking half a pack a day. These are more valid measures of regular smoking and are thus more directly related to public health impacts. Our study found that the conclusions about trends in vaping and smoking were robust across different measures of smoking. Indeed, we considered the ratio of daily to last 30 day smoking as an indicator of transitions from experimental to more regular cigarette smoking. We again found more rapidly declining rates during the period after vaping became more widespread.
It will be important to carefully monitor trends in the use of cigarettes, e-cigarettes and other nicotine delivery products to inform the kinds of policies that are likely to yield beneficial health outcomes for the population.
References
(1) Levy DT, Warner KE, Cummings KM, et al., Examining the relationship of vaping to smoking initiation among US youth and young adults: a reality check. Tob Control. 2018 Nov 20. pii: tobaccocontrol-2018-054446. doi: 10.1136/tobaccocontrol-2018-054446. [Epub ahead of print]
(2) Dutra L, Glantz S. E-cigarettes and national adolescent cigarette use: 2004-2014. Pediatrics. 2017 Feb;139(2). pii: e20162450. doi: 10.1542/peds.2016-2450.
(3) National Academy of Sciences Engineering and Medicine. Public health consequences of e-cigarettes. Washington, DC: The National Academies Press, 2018.
(4) Public Health England. E-cigarettes and vaping: policy, regulation and guidance. London: PHE;2018.
(5) Royal College of Physicians. Nicotine without smoke: Tobacco harm reduction. London: RCP;2016.
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PMI finally responded to my paper in Tobacco Control1 showing that the data submitted in their MRTP application to the FDA to market IQOS with reduced risk claims did not actually support claims of reduced risks.
Specifically, PMI’s MRTP application included their 3-month study of 24 non-cancer biomarkers of potential harm (which PMI calls “clinical risk endpoints,” CRE) in humans using IQOS compared to conventional cigarettes. These biomarkers include measures of inflammation, oxidative stress, lipids, blood pressure, and lung function. (PMI did separate studies of biomarkers of exposure, several of which are carcinogens.) While PMI’s application emphasizes that these biomarkers generally changed in positive directions, my examination of the data revealed no statistically detectable difference between IQOS and conventional cigarettes for 23 of the 24 BOPH in Americans and 10 of 13 in Japanese. Moreover, it is likely that the few significant differences were false positives. Thus, despite delivering lower levels of some toxicants, PMI’s own data failed to show consistently lower risks of harm in humans using IQOS compared to conventional cigarettes.
Their undated response, “The Difference between IQOS and Continued Smoking,”2 presents two arguments:
• The original study submitted to FDA was “NOT DESIGNED to serve as the sole pivotal evidence with regards to CRE’s and to show statistically significant changes in the CREs.”...
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PMI finally responded to my paper in Tobacco Control1 showing that the data submitted in their MRTP application to the FDA to market IQOS with reduced risk claims did not actually support claims of reduced risks.
Specifically, PMI’s MRTP application included their 3-month study of 24 non-cancer biomarkers of potential harm (which PMI calls “clinical risk endpoints,” CRE) in humans using IQOS compared to conventional cigarettes. These biomarkers include measures of inflammation, oxidative stress, lipids, blood pressure, and lung function. (PMI did separate studies of biomarkers of exposure, several of which are carcinogens.) While PMI’s application emphasizes that these biomarkers generally changed in positive directions, my examination of the data revealed no statistically detectable difference between IQOS and conventional cigarettes for 23 of the 24 BOPH in Americans and 10 of 13 in Japanese. Moreover, it is likely that the few significant differences were false positives. Thus, despite delivering lower levels of some toxicants, PMI’s own data failed to show consistently lower risks of harm in humans using IQOS compared to conventional cigarettes.
Their undated response, “The Difference between IQOS and Continued Smoking,”2 presents two arguments:
• The original study submitted to FDA was “NOT DESIGNED to serve as the sole pivotal evidence with regards to CRE’s and to show statistically significant changes in the CREs.”
• PMI has a new, larger study 6-month human study comparing IQOS with conventional cigarettes that concluded that IQOS is less risky than conventional cigarettes.3
With regard to the first point, one is left with the question of why PMI submitted and represented data in the original MRTP application, when it now admits that the study was not designed to provide key evidence. They did not question the specific conclusions that I drew in my paper.
The new 6-month study differs from the study presented in the original MRTP application in several important ways.
First, it is much larger (984 people in the new study compared to 79 in the US study and 112 in the Japanese study cited in the MRTP application). Making the study larger increases statistical power and makes it more likely to declare a difference statistically significant. This is a good thing.
Second, and of greater concern, the new study only considers 6 of the 24 non-cancer biomarkers in the earlier study, leaving the question of why PMI did not measure the other 18. (The 2 other biomarkers in the new study are biomarkers of exposure [CO and NNAL], which were not included in the earlier study and are not at issue in my paper.) Most of the things that they leave out are determined from blood tests, but they had to draw blood to measure the biomarkers they do report. The others are more detailed measures of lung function than the one reported in the new study and easily measured measures of blood pressure.
PMI should be expanding, not dropping, clinical endpoints because of evidence that IQOS is different from cigarettes.4,5 Indeed, the data they presented in the MRTP application suggested that IQOS may be causing liver damage not observed in cigarettes.6
Given the millions of dollars PMI’s application represents, cost does not justify dropping these routine clinical measures. Their detailed presentation on the new study3 does not address this question.
Third, PMI uses an arcane, little-used statistical method, the Hailperin-Rüger method, that was developed to confirm earlier studies.7 (Neither I nor two biostatistics colleagues have seen this used in any recent clinical trials. A PubMed search with the keyword “Hailperin-Rüger” conducted on December 19, 2018, resulted in just one study.8 The basic argument of the Hailperin-Rüger method is that it is overly cautious to require that all observed changes be statistically significant in order to confirm that a therapy works, and that if some lesser number of the variables change significantly, that should be good enough for a global test. The number of significant changes is specified in advance and the probability of a chance finding is adjusted.
PMI decided that if 5 of the 8 biomarkers (6 clinical risk and 2 exposure) changed in the direction of less risk, that would be enough to conclude that IQOS was less risky than conventional cigarettes. They do not provide a clear explanation of why they used 5, other than it was “more than half.”
PMI justified using Hailperin-Rüger because “the probability of finding five significant tests (p<0.05) by chance alone is extremely low (0.006%).” This is a misleading statement because this low probability would only be the case a chance finding if none of the five variables actually changed. The probabilities are much higher when there are real changes.
So, in the new study, PMI went from considering changes in 24 clinical risk biomarkers in the original study to 8 in the new study to only requiring 5 to be statistically significant.
That is a pretty major drop in the level of evidence PMI now suggests is sufficient to demonstrate that IQOS is less risky than cigarettes.
In the new study 5 of the changes were statistically significant, so PMI concluded that, overall, IQOS was better. Had they picked 6 in their plan, the overall results would not have been significant, even under the Hailperin-Rüger method’s relaxed standards.
There are other problems with using the Hailperin-Rüger method. First, it is designed to confirm results of earlier studies. The earlier study did not convincingly show that IQOS was better than conventional cigarettes. Second, the usual way that Hailperin-Rüger is used is when you have several measures of the same thing. (For example, the one paper8 located in PubMed that used Hailperin-Rüger assessed 10 different measures of neurological function and pre-specified that if 5 of the 10 were statistically significant, the global test would be considered statistically significant.) The idea is that requiring all of them to change significantly is being too stringent a requirement to identify a change in lung function. In this case, PMI mixed apples and oranges by applying the text to a set of 6 clinical variables and 2 exposure that were measuring different underlying physiological processes.
PMI also used a one-tail test that assumes that one only need worry above improvements in the biomarkers without any concern for the possibility that they might worsen the biomarkers. (As noted above, PMI presented – but did not emphasize – other evidence in their MRTP application showing that IQOS caused problems not observed in cigarettes.6) I tell my students that, with rare exceptions, one should always do two-tail tests. Two-tail tests require larger differences to reach statistical significance, so by using a one-tail test, PMI made it easier to conclude changes were statistically significant. In this case the overall conclusion would have been the same with a two-tail test, so this bias did not make any practical difference, but they should have not used a one-tail test.
PMI’s use of a one-tailed test was especially hypocritical since back in the early 1990’s the tobacco companies sued the US EPA for using a one-tail test in their risk assessment that concluded that secondhand smoke caused lung cancer.9 EPA used a one-tail test because they said it was inconceivable that secondhand smoke exposure would protect against lung cancer (the other tail). The irony there was that EPA would have reached the same conclusion using a two-tailed test.
All this raises the question of whether PMI manipulated the experimental design and analysis to get the desired conclusion, as they have done in the past.10
The law requires the MRTP applicant PMI to demonstrate, among other things, that IQOS, as it is actually used by consumers, will “significantly reduce harm and the risk of tobacco-related disease to individual tobacco users.” Neither the original 3 month study nor the newer 6 month study meet this standard.
The bottom line: FDA and other regulatory agencies should not rely on PMI’s new study to support a conclusion that IQOS is less risky than conventional cigarettes.
As slightly reformatted version of this post has been submitted to the IQOS MRTP docket at FDA with tracking number 1k2-978f-eqmr. A PDF of the comment is available here.
References
1. Glantz S. PMI’s Own in vivo Clinical Data on Biomarkers of Potential Harm in Americans Show that IQOS is Not Detectably Different from Conventional Cigarettes. Tob Control. 2018;27(Suppl 1):s9-s12. doi: 10.1136/tobaccocontrol-2018-054413. Epub 052018 Aug 054421.
2. Baker G, Harris C, Hankins M, et al. The Difference between IQOS and Continued Smoking. 2018; https://www.pmiscience.com/resources/docs/default-source/news-documents/.... Accessed 19 Dec 2018.
3. PMI Research & Development. Study Results Overview: ZRHR-ERS-09 US (Evaluation of Biological and Functional Changes in Healthy Smokers After Switching to THS 2.2 for 26 Weeks. In PMI IQOS MRTP June 8, 2018 Amendment: Additional Information and Data from a Recently Completed Clinical Study (.zip – 1.3 GB) (added November 29, 2018). 2018; https://digitalmedia.hhs.gov/tobacco/static/mrtpa/PMP/June%208%2C%202018.... Accessed 18 Dec 2018.
4. Glantz S. Heated tobacco products: The example of IQOS. Tobacco Control. 2018;27(Suppl 1):s1-s6; DOI: 10.1136/tobaccocontrol-2018-054601.
5. St. Helen G, Jacob P, Nardone N, Benowitz N. IQOS: Examination of Philip Morris International’s claim of reduced exposure. Tob Control. 2018;27(Suppl 1):s30-s36. doi: 10.1136/tobaccocontrol-2018-054321. Epub 052018 Aug 054329.
6. Chun L, Moazed F, Matthay M, Calfee C, Gotts J. Possible Hepatotoxicity of IQOS. Tob Control. 2018;27(Suppl 1):s39-s40. doi: 10.1136/tobaccocontrol-2018-054320. Epub 052018 Aug 054321.
7. Koch GG, Gansky SA. Statistical Considerations for Multiplicity in Confirmatory Protocols. Drug Information Journal. 1996;30(2):523-534.
8. Schellenberg R, Todorova A, Wedekind W, Schober F, Dimpfel W. Pathophysiology and psychopharmacology of dementia--a new study design. 2. Cyclandelate treatment--a placebo-controlled double-blind clinical trial. Neuropsychobiology. 1997;35(3):132-142.
9. Schachtman NA. EPA Post Hoc Statistical Tests – One Tail vs Two. 2012; http://schachtmanlaw.com/epa-post-hoc-statistical-tests-one-tail-vs-two/. Accessed 19 Dec 2018.
10. Wertz MS, Kyriss T, Paranjape S, Glantz SA. The toxic effects of cigarette additives. Philip Morris' project mix reconsidered: an analysis of documents released through litigation. PLoS medicine. 2011;8(12):e1001145.
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David Levy and colleagues’ paper “Examining the relationship of vaping to smoking initiation among US youth and young adults: a reality check” used data from all the surveys over time that measured youth and young adult e-cigarette use and smoking and concluded there was a substantial increase in youth vaping prevalence beginning in about 2014. Time trend analyses showed that the decline in past 30-day smoking prevalence accelerated by two to four times after 2014. Indicators of more established smoking rates, including the proportion of daily smokers among past 30-day smokers, also decreased more rapidly as vaping became more prevalent.
The inverse relationship between vaping and smoking was robust across different data sets for both youth and young adults and for current and more established smoking. While trying electronic cigarettes may causally increase smoking among some youth, the aggregate effect at the population level appears to be negligible given the reduction in smoking initiation during the period of vaping's ascendance.
The good news is that Levy and colleagues are finally accepting the overwhelming evidence that kids who start with e-cigarettes are more likely to end up smoking cigarettes, the so-called “gateway effect.”
Now they have fallen back to arguing that the gateway effect is not big enough to overcome the benefits of e-cigs as substitutes for cigarettes.
NOT PEER REVIEWED
David Levy and colleagues’ paper “Examining the relationship of vaping to smoking initiation among US youth and young adults: a reality check” used data from all the surveys over time that measured youth and young adult e-cigarette use and smoking and concluded there was a substantial increase in youth vaping prevalence beginning in about 2014. Time trend analyses showed that the decline in past 30-day smoking prevalence accelerated by two to four times after 2014. Indicators of more established smoking rates, including the proportion of daily smokers among past 30-day smokers, also decreased more rapidly as vaping became more prevalent.
The inverse relationship between vaping and smoking was robust across different data sets for both youth and young adults and for current and more established smoking. While trying electronic cigarettes may causally increase smoking among some youth, the aggregate effect at the population level appears to be negligible given the reduction in smoking initiation during the period of vaping's ascendance.
The good news is that Levy and colleagues are finally accepting the overwhelming evidence that kids who start with e-cigarettes are more likely to end up smoking cigarettes, the so-called “gateway effect.”
Now they have fallen back to arguing that the gateway effect is not big enough to overcome the benefits of e-cigs as substitutes for cigarettes.
The approach they used, interrupted time series analysis, estimates the declining trend in cigarette use over time, then tests whether this trend changes (in this case, they generally tested for a slope change) after the advent of e-cigarettes.
Interrupted time series is a well-established method for analyzing changes in trends. Indeed Lauren Dutra and I (1) used interrupted time series to do a similar analysis of the effect that the advent of e-cigarettes had on cigarette smoking among youth using the National Youth Tobacco Survey from 2004 to 2014. Based on data over that time, we found that the advent of e-cigarettes (using a start date of 2009 for e-cigs) did not affect the declining trend in cigarette smoking, but led to an increase in total tobacco product use (Figure 1 in our paper).
Lauren and I also used individual-level data (something Levy and colleagues did not consider in their analysis) and found that about one-third of the kids using e-cigarettes had risk profiles that made them unlikely to start using nicotine with conventional cigarettes. Thus, e-cigarettes are expanding the tobacco market.
Levy and colleagues expand the time period of analysis up to 2016 or 2017 (depending on the data source). This is an important addition because, as they note, e-cigarette use has continued to grow since 2014 (their Figure 1).
I have several concerns about the analysis and interpretation of the data that Levy and colleagues present.
The assumption in interrupted time series analysis as they (and we) do it is that the underlying trend is linear (a straight line). The figures in the supplementary file suggest that many of the time histories are curved. Failing to account for this curvature can distort the results and also make the results highly sensitive to the break year (i.e., where the line bends) in the analysis.
A related concern because of the curvature in the data is that the break year they use in their analysis is 2014. They justify this by arguing that 2014 is when e-cigarette use took off. But, if you look at their Figure 1, you could also argue for using 2009 as the break year because that is where the data they have on e-cig use extrapolated back to zero. While e-cig use was lower before 2014, an increasing effect of e-cigs would be captured in the slope change in an interrupted time series model (assuming that the linear assumption is met).
The specific shape of the data curve is especially important in most recent years where e-cigarette use has increased so much among youth and young adults. This fact, combined with the gateway effect, would lead one to predict that historical drops in cigarette smoking would stop or even reverse. Indeed, looking at the detailed data in the supplementary figures shows this in several (but not all) cases:
• The Monitoring the Future (MTF) data showed increases in 10th grade 30 day and daily cigarette smoking (Supplementary Figures 1 and 8) and essentially flat 12th grade smoking between 2016 and 2017 (Supplementary Figure 2).
• The National Youth Tobacco Survey showed flat 30 day cigarette smoking from 2014 to 2017 (Supplementary Figure 3), the first time that there was not a drop in cigarette smoking since NYTS started in 2004. (I also do not understand why Levy and colleagues did not use the NYTS back to 2004; they started in 2011.)
• The National Health Interview Survey showed flat young adult smoking prevalence from 2015 to 2016 for both males and females (Supplementary Figures 13 and 14).
Another important omission in Levy and colleagues’ paper is that they only present data on cigarette smoking rather than total tobacco product use. This is an exceptionally important variable because if e-cigarettes are increasing nicotine use among youth, that is a bad thing.
And that is what Lauren Dutra and I found through 2014 (figure above). The rapid increase in e -cigarette use after 2014 in Levy’s Figure 1 reinforces this concern.
New data for 2018 released by the CDC in the November 16, 2018 MMWR (2) reinforces how serious this problem is. They documented continuing increases in e-cigarette use through 2018 (figure in MMWR) and, more important, increases in any tobacco use.
That is the real reality.
REFERENCES
(1) Dutra L, Glantz S. E-cigarettes and National Adolescent Cigarette Use: 2004-2014. Pediatrics. 2017 Feb;139(2). pii: e20162450. doi: 10.1542/peds.2016-2450.
(2) Cullen KA, Ambrose BK, Gentzke AS, Apelberg BJ, Jamal A, King BA. Notes from the Field: Use of Electronic Cigarettes and Any Tobacco Product Among Middle and High School Students — United States, 2011–2018. MMWR Morb Mortal Wkly Rep 2018;67:1276–1277. DOI: http://dx.doi.org/10.15585/mmwr.mm6745a5
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In view of the rising prevalence of adolescent smoking worldwide, it makes a lot of sense to strictly limit cigarette sales only to alcohol licensed premises, particularly, in countries where there are minimum age requirements for buying alcohol. In a previous letter (1) to Lancet Global Health we had argued in favor of the same as we believe that restricting sale of cigarettes or other tobacco products will bring about a decrease in consumption by adolescents.
Smoking addictions are usually acquired during adolescence and this usually happens due to an apparently unregulated sale of tobacco products. Regulation is difficult when the number of tobacco selling establishments far exceeds the managing capacity of local administration. In India, adolescents have unrestricted access to tobacco products as small vendors, whose only source of income is by selling tobacco products, tend not to compromise on any business opportunity.
Although there is a positive association between alcohol and smoking, as the authors have pointed out “tobacco sales are not financially important for the majority of alcohol-licensed tobacco retailers”, so it is a win-win situation for preventing initiation of cigarette smoking by adolescents as alcohol vendors will have no incentive to bypass regulations by selling tobacco products to those who do not qualify as per legal age restrictions. In India, smoking and consumption of alcohol are also social taboos and th...
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In view of the rising prevalence of adolescent smoking worldwide, it makes a lot of sense to strictly limit cigarette sales only to alcohol licensed premises, particularly, in countries where there are minimum age requirements for buying alcohol. In a previous letter (1) to Lancet Global Health we had argued in favor of the same as we believe that restricting sale of cigarettes or other tobacco products will bring about a decrease in consumption by adolescents.
Smoking addictions are usually acquired during adolescence and this usually happens due to an apparently unregulated sale of tobacco products. Regulation is difficult when the number of tobacco selling establishments far exceeds the managing capacity of local administration. In India, adolescents have unrestricted access to tobacco products as small vendors, whose only source of income is by selling tobacco products, tend not to compromise on any business opportunity.
Although there is a positive association between alcohol and smoking, as the authors have pointed out “tobacco sales are not financially important for the majority of alcohol-licensed tobacco retailers”, so it is a win-win situation for preventing initiation of cigarette smoking by adolescents as alcohol vendors will have no incentive to bypass regulations by selling tobacco products to those who do not qualify as per legal age restrictions. In India, smoking and consumption of alcohol are also social taboos and this particular factor in itself might deter adolescents from buying tobacco products. We feel that limiting sale of tobacco products to alcohol-licensed premises will surely prevent initiation of cigarette by adolescents.
References:
1. Barua MP, Mishra V, Kumar S. Reducing adolescent smoking in India. Lancet Glob Health. 2017 Mar;5(3): e266. doi: 10.1016/S2214-109X(17)30036-0. PubMed PMID: 28193389
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More than 1,000 participants were exposed to IQOS in our clinical studies. The authors of the letter “Possible hepatotoxicity of IQOS" based their analysis on approximatively 10% of the data instead of examining the data as a whole. For example, for the five-day exposure studies in confinement, they stated that the percentage of participants with elevated bilirubin in IQOS arm was more than three times higher than that observed in the smoking abstinence (SA) arm in the European study (8.8% [7 participants] in IQOS arm, 2.6% [1 participant] in SA arm). However, they missed reporting that this percentage was lower in the IQOS arm than in the cigarette smoking (CC) arm in the Japanese study (10% [8 participants] in IQOS arm, 15% [6 participants] in CC arm). They also stated that the mean increase in alanine aminotransferase (ALT) was higher with IQOS than with CC or SA in the Japanese study but did not report that in the European study, the mean increase in ALT was lower in the IQOS arm than in the CC or SA arm.
Similarly, for the 90-day exposure studies in an ambulatory setting, they mentioned that the percentage of participants with increased ALT levels after 60 days of exposure was higher within the IQOS arm (6.3% [5 participants] in IQOS arm, 0% in CC arm, 2.6% [1 participant] in SA arm) in the U.S. study. However they omitted to mention that in the Japanese study, this percentage was lower in IQOS arm compared with CC or SA arms after 3...
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More than 1,000 participants were exposed to IQOS in our clinical studies. The authors of the letter “Possible hepatotoxicity of IQOS" based their analysis on approximatively 10% of the data instead of examining the data as a whole. For example, for the five-day exposure studies in confinement, they stated that the percentage of participants with elevated bilirubin in IQOS arm was more than three times higher than that observed in the smoking abstinence (SA) arm in the European study (8.8% [7 participants] in IQOS arm, 2.6% [1 participant] in SA arm). However, they missed reporting that this percentage was lower in the IQOS arm than in the cigarette smoking (CC) arm in the Japanese study (10% [8 participants] in IQOS arm, 15% [6 participants] in CC arm). They also stated that the mean increase in alanine aminotransferase (ALT) was higher with IQOS than with CC or SA in the Japanese study but did not report that in the European study, the mean increase in ALT was lower in the IQOS arm than in the CC or SA arm.
Similarly, for the 90-day exposure studies in an ambulatory setting, they mentioned that the percentage of participants with increased ALT levels after 60 days of exposure was higher within the IQOS arm (6.3% [5 participants] in IQOS arm, 0% in CC arm, 2.6% [1 participant] in SA arm) in the U.S. study. However they omitted to mention that in the Japanese study, this percentage was lower in IQOS arm compared with CC or SA arms after 30 days of exposure (1.3% [1 participant] in IQOS arm, 4.8% [2 participants] in CC arm, 7.5% [3 participants] in SA arm).
Taken together, the changes reported by the authors concern a small number of participants across all arms and most likely represent normal fluctuations of these parameters.
Finally, the grade 2 ALT increase in IQOS arm that was mentioned in the letter corresponds to a participant with an isolated increase at Day 30, which is explained by the use of concomitant medication. This information was also part of the publicly available information but was not taken into account by the authors.
In conclusion, the data submitted to the FDA as well as the data gathered in the context of our post-market safety surveillance system, based on pharmaceutical industry best practices, show unquestionably that there is no increased risk of developing hepatotoxicity after switching to IQOS.
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This study has some important findings that could, if replicated, guide FDA decision making on applications from manufacturers to make modified risk tobacco product claims. However, while it does not detract from the study’s findings, the article does not accurately describe the standards FDA must apply when evaluating those applications. The abstract inaccurately suggests that tobacco products in the U.S. may make reduced-risk or reduced-exposure claims so long as they are not misleading, and does not mention that any explicit or implicit reduced-exposure or reduced-risk claims may not be legally made without first submitting an application to FDA and receiving a permissive order, which considers various other factors, as well.
The introduction of the paper does a bit better, accurately stating that the Tobacco Control Act requires prior review by FDA before making lower-exposure or lower-risk claims. But it then suggests that manufacturers can receive that permission if they either demonstrate that the product lowers harm or risk compared with other tobacco products or if they demonstrate that the product is free of or contains reduced levels of harmful chemicals and the related claims don’t mislead consumers to believe that the reduced-exposure means lower risk. While that description is accurate as far as it goes, it leaves off the enormously important requirement, in both cases, that a manufacturer’s application for permission to...
NOT PEER REVIEWED
This study has some important findings that could, if replicated, guide FDA decision making on applications from manufacturers to make modified risk tobacco product claims. However, while it does not detract from the study’s findings, the article does not accurately describe the standards FDA must apply when evaluating those applications. The abstract inaccurately suggests that tobacco products in the U.S. may make reduced-risk or reduced-exposure claims so long as they are not misleading, and does not mention that any explicit or implicit reduced-exposure or reduced-risk claims may not be legally made without first submitting an application to FDA and receiving a permissive order, which considers various other factors, as well.
The introduction of the paper does a bit better, accurately stating that the Tobacco Control Act requires prior review by FDA before making lower-exposure or lower-risk claims. But it then suggests that manufacturers can receive that permission if they either demonstrate that the product lowers harm or risk compared with other tobacco products or if they demonstrate that the product is free of or contains reduced levels of harmful chemicals and the related claims don’t mislead consumers to believe that the reduced-exposure means lower risk. While that description is accurate as far as it goes, it leaves off the enormously important requirement, in both cases, that a manufacturer’s application for permission to make a modified-risk claim must also show that the proposed claim will benefit the health of the population as a whole (taking into consideration impacts of the product and its marketing with the modified-risk claim on implementation, cessation, relapse, etc.).
This study’s findings could have been presented even more powerfully if the article had also discussed their relevance to FDA’s consideration of how reduced-risk or reduced-exposure claims would impact the public health based on the claims likely influence on youth and adult consumer behaviors.
The "serious criticism" that Mr. Bates refers to is from him (on another website).
In order for the FDA to issue an order allowing Philip Morris International to market IQOS in the United States as a reduced risk tobacco product, the law required that, among other things, FDA "determines that the applicant [PMI] has demonstrated that such product [IQOS], as it is actually used by consumers will significantly reduce harm and the risk of tobacco- related disease to individual tobacco users."
That is why PMI provided the information of biomarkers of potential harm to the FDA. and how they compare to values observed in smokers. My paper shows that, using PMI's own data, IQOS will not significantly reduce risk to consumers compared with cigarettes.
Bates ignores this reality and instead talks about biomarkers of exposure, which is a different question.
NOT PEER REVIEWED The main problem with the claim of equivalence between smoking and switching to iQOS is that some biomarkers of potential harm change over a much longer timeframe than the 90-day duration of the trials. Biomarkers of potential harm can reflect years of accumulated physical changes arising from smoking and only improve slowly after smoking cessation. The trial did, of course, pick up very substantial reductions in biomarkers of exposure, which would, over time, emerge as reductions in biomarkers of potential harm.
This would have been apparent and obvious to readers if the paper had also shown the results for the third arm of the trial, smoking abstinence. The biomarkers of potential harm for smoking abstinence and for switching to iQOS are quite similar in this trial. This is a curious omission. Furthermore, biomarkers of exposure turned quite similar for both switching to iQOS and smoking abstinence - both are greatly reduced, which is an encouraging finding about the iQOS product.
It is unlikely that anyone would argue against smoking abstinence on the basis of the biomarkers of potential harm in the original PMI study. However, the author has selectively used the iQOS data from these trials without the context of the smoking abstinence data to oppose the Modified Tobacco Product Application that PMI made to the U.S. FDA - the author's attempt to block this reduced-risk product from entering the US market. ...
NOT PEER REVIEWED The main problem with the claim of equivalence between smoking and switching to iQOS is that some biomarkers of potential harm change over a much longer timeframe than the 90-day duration of the trials. Biomarkers of potential harm can reflect years of accumulated physical changes arising from smoking and only improve slowly after smoking cessation. The trial did, of course, pick up very substantial reductions in biomarkers of exposure, which would, over time, emerge as reductions in biomarkers of potential harm.
This would have been apparent and obvious to readers if the paper had also shown the results for the third arm of the trial, smoking abstinence. The biomarkers of potential harm for smoking abstinence and for switching to iQOS are quite similar in this trial. This is a curious omission. Furthermore, biomarkers of exposure turned quite similar for both switching to iQOS and smoking abstinence - both are greatly reduced, which is an encouraging finding about the iQOS product.
It is unlikely that anyone would argue against smoking abstinence on the basis of the biomarkers of potential harm in the original PMI study. However, the author has selectively used the iQOS data from these trials without the context of the smoking abstinence data to oppose the Modified Tobacco Product Application that PMI made to the U.S. FDA - the author's attempt to block this reduced-risk product from entering the US market. https://tobacco.ucsf.edu/pmi’s-own-data-biomarkers-potential-harm-americans-show-iqos-not-detectably-different-conventional-cigs
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The potential presence of formaldehyde cyanohydrin in the polylactic acid (PLA) filter of Marlboro Heatstick when heated was reported by Davis and al. PLA is a biodegradable thermoplastic derived from renewable resources such as corn starch. This tentative identification is based on the GC-MS analysis of the headspace of a heated piece of PLA, and the subsequent compound identification by mass spectra matching (acceptance criteria >85%) with the spectra library of the National Institute of Standard and Technology (NIST). However, this was not confirmed by injecting a purchased analytical grade reference standard, in order to unambiguously prove the presence of formaldehyde cyanohydrin. Therefore, we decided to repeat the experiment using headspace injection gas chromatography coupled to high resolution mass spectrometry under similar conditions as described in the publication. Our headspace GC-HR-MS analyses showed four peaks, at retention times of 16.38, 16.47, 17.14, and 18.58 min, in good agreement with the reported data reported (figure 4).
From the analysis of reference standards, we have confirmed the presence of both e-caprolactone (CAS# 502-44-3) and (S,S)-lactide (CAS# 4511-42-6) eluting at 16.47 and 17.14 min, respectively. We identified triacetin (CAS# 102-76-1) at 18.58 min, based on the reference standard, instead of 1,2-diacetin (their EI mass spectra are very similar).
However, we have demonstrated unambiguously the a...
NOT PEER REVIEWED
The potential presence of formaldehyde cyanohydrin in the polylactic acid (PLA) filter of Marlboro Heatstick when heated was reported by Davis and al. PLA is a biodegradable thermoplastic derived from renewable resources such as corn starch. This tentative identification is based on the GC-MS analysis of the headspace of a heated piece of PLA, and the subsequent compound identification by mass spectra matching (acceptance criteria >85%) with the spectra library of the National Institute of Standard and Technology (NIST). However, this was not confirmed by injecting a purchased analytical grade reference standard, in order to unambiguously prove the presence of formaldehyde cyanohydrin. Therefore, we decided to repeat the experiment using headspace injection gas chromatography coupled to high resolution mass spectrometry under similar conditions as described in the publication. Our headspace GC-HR-MS analyses showed four peaks, at retention times of 16.38, 16.47, 17.14, and 18.58 min, in good agreement with the reported data reported (figure 4).
From the analysis of reference standards, we have confirmed the presence of both e-caprolactone (CAS# 502-44-3) and (S,S)-lactide (CAS# 4511-42-6) eluting at 16.47 and 17.14 min, respectively. We identified triacetin (CAS# 102-76-1) at 18.58 min, based on the reference standard, instead of 1,2-diacetin (their EI mass spectra are very similar).
However, we have demonstrated unambiguously the absence of formaldehyde cyanohydrin by injecting the reference standard (Sigma, CAS# 107-16-4, ref. 50640). The formaldehyde cyanohydrin is eluting at 11.53 min and does not correspond to the peak eluting just before e-caprolactone that the authors tentatively identified as formaldehyde cyanohydrin (17.97 min under their conditions). This peak has been confirmed, using the purchased reference standard (NatureWorks, CAS # 13076-19-2), to be meso-lactide, the third isomers of lactide. The experimental details are available on PMIScience.com (https://www.pmiscience.com/library/publication/analysis-of-polylactic-ac...).
It is well known among analytical chemists that unit mass matching with a single data base is insufficient to prove the identity of a compound. Therefore, we typically use commercially available reference standards to verify our findings. This is important to us, as we are focused on developing reduced risk alternatives to combustible cigarettes. In this context, it is key that our science is always verified to the highest possible standards.
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Euromonitor International is a privately held, independent provider of strategic market research with no agenda other than to present the most realistic illicit trade data impartially and within its wider industry context. Subscribers to Euromonitor’s Passport Tobacco database are varied and include tobacco control/ public health groups, academia, retailers, manufacturers of raw materials as well as tobacco brand owners and banks/ consultancies, amongst others.
These same stakeholders are approached by Euromonitor for comment on industry trends, including those of illicit sales. Euromonitor’s stated sources for illicit cigarettes sales thus include trade press, customs offices, interviews with manufacturers and retailers, government and academic organisations. This is reconciled against local knowledge of the market and illicit trade’s wider context – eg national economic performance, trends in taxation, unit prices and duty paid sales, porosity of borders, law enforcement efforts, and so on. There is no reliance on any one source.
By its very nature, illicit trade in tobacco products is a contentious area and one that is difficult to quantify – there are often wide discrepancies between various sources on illicit trade, reflecting vested interests in either deflating or inflating figures. In these circumstances, Euromonitor strives to present the most widely accepted and realistic estimate of the illicit market, based on a holistic...
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Euromonitor International is a privately held, independent provider of strategic market research with no agenda other than to present the most realistic illicit trade data impartially and within its wider industry context. Subscribers to Euromonitor’s Passport Tobacco database are varied and include tobacco control/ public health groups, academia, retailers, manufacturers of raw materials as well as tobacco brand owners and banks/ consultancies, amongst others.
These same stakeholders are approached by Euromonitor for comment on industry trends, including those of illicit sales. Euromonitor’s stated sources for illicit cigarettes sales thus include trade press, customs offices, interviews with manufacturers and retailers, government and academic organisations. This is reconciled against local knowledge of the market and illicit trade’s wider context – eg national economic performance, trends in taxation, unit prices and duty paid sales, porosity of borders, law enforcement efforts, and so on. There is no reliance on any one source.
By its very nature, illicit trade in tobacco products is a contentious area and one that is difficult to quantify – there are often wide discrepancies between various sources on illicit trade, reflecting vested interests in either deflating or inflating figures. In these circumstances, Euromonitor strives to present the most widely accepted and realistic estimate of the illicit market, based on a holistic view of the wider national context and the factors that contribute towards it (as described above) – no single source or figure is taken as definitive and all figures undergo this wider review. Furthermore, this wider context is discussed at length in the attendant analysis in each country report where the trends behind the figures are laid out.
Given Euromonitor’s exhaustive geographic coverage of this dataset – at 100 markets researched in-field for illicit trade, there is no other source like it – as well as our annual revisiting of this dataset, it is inevitable that some changes between editions will be necessary. Euromonitor is transparent about its reasons for change and welcomes any discussion on what can be a opaque area - we are always happy to engage with all concerned stakeholders and review their own sources, on a country-by-country basis, should they exist.
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Coleman et al’s important report [1] on transitions in the vaping and smoking status of a nationally representative cohort of American 18+ adults who use electronic cigarettes (EC) from the PATH study provides rich data that can greatly advance our understanding of the natural history of EC use and their potential in harm reduction.
However, we were struck by the absence of emphasis in the report of what is perhaps its most important finding. If we examine the report’s data and consider the net impact of vaping on the critical goals of having vapers stopping smoking and vaping non-smokers not starting to smoke, the findings are very disturbing and should strong reason for pause among those advocating e-cigarettes as a game-changing way of stopping smoking.
At Wave 2, 12 months on from Wave 1, of the cohort of 2036 dual users (EC + smoking) only 104 (5.1%) had transitioned to using only EC and another 143 (7%) had quit both EC and smoking for a combined total of 247 or 12.1%. Of the 896 exclusive EC users at Wave 1, 277 (30.9%) had stopped vaping at Wave 2. Together, 524 out of the 2932 EC users (17.9%) followed from Wave 1 might be considered to have had positive outcomes at Wave 2.
The other side of the coin however, shows that of the 2036 dual users at Wave 1, 886 (43.5%) relapsed to using cigarettes exclusively. In addition, among the 896 exclusive EC users from Wave 1, 109 (12.2%) had stopped vaping and were now smoking, wit...
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Coleman et al’s important report [1] on transitions in the vaping and smoking status of a nationally representative cohort of American 18+ adults who use electronic cigarettes (EC) from the PATH study provides rich data that can greatly advance our understanding of the natural history of EC use and their potential in harm reduction.
However, we were struck by the absence of emphasis in the report of what is perhaps its most important finding. If we examine the report’s data and consider the net impact of vaping on the critical goals of having vapers stopping smoking and vaping non-smokers not starting to smoke, the findings are very disturbing and should strong reason for pause among those advocating e-cigarettes as a game-changing way of stopping smoking.
At Wave 2, 12 months on from Wave 1, of the cohort of 2036 dual users (EC + smoking) only 104 (5.1%) had transitioned to using only EC and another 143 (7%) had quit both EC and smoking for a combined total of 247 or 12.1%. Of the 896 exclusive EC users at Wave 1, 277 (30.9%) had stopped vaping at Wave 2. Together, 524 out of the 2932 EC users (17.9%) followed from Wave 1 might be considered to have had positive outcomes at Wave 2.
The other side of the coin however, shows that of the 2036 dual users at Wave 1, 886 (43.5%) relapsed to using cigarettes exclusively. In addition, among the 896 exclusive EC users from Wave 1, 109 (12.2%) had stopped vaping and were now smoking, with another 121 having resumed smoking as well as using EC (i.e. became dual users). Importantly, 502 of 896 (56%) exclusive e-cigarette users were those who had never been established smokers prior to using e-cigarettes. Alarmingly, of these 502 adults, 120 (23.9%) progressed from using only e-cigarettes to either dual use (54 or 10.8%) or smoking only (66 or 13.2%).
Taken together, 886 dual users in Wave 1 relapsed to become exclusive cigarette smokers in Wave 2, and 230 exclusive vapers in Wave 1 took up cigarette smoking in Wave 2 (dual use or exclusively cigarettes). Undoubtedly, these should be considered as negative outcomes.
The table below shows that for every person vaping at Wave 1 who benefited across 12 months by quitting smoking, there are 2.1 who either relapsed to or took-up smoking. Most disturbingly, in this adult cohort nearly one in four of those who had never been established smokers took up smoking after first using EC. Concern about putative gateway effects of ECs to smoking have been dominated by concerns about youth. These data showing transitions from EC to smoking in nearly a quarter of exclusive adult EC users with no histories of established smoking should widen this debate to consider adult gateway effects too.
By far the largest proportion of those with negative outcomes are those dual users who relapsed to smoking (886 or 43.5% of dual users). As the authors note in their discussion, many of these were infrequent EC users, possibly involved in transitory experimentation at Wave 1. If we add the 902 who were still dual using at Wave 2, then 1788 of 2036 dual users (87.8%) in this sample might be said to have been held in smoking (dual using or exclusive smoking) 12 months later compared to 12.1% dual users who may have benefitted by using ECs.
We would expect commercial interests in both the tobacco and EC industries would be more than delighted with these findings. However, from a public health harm reduction perspective these results argue against EC being an effective harm reduction strategy, and point to their far stronger potential to both recruit smokers and hold many smokers in smoking.
Reference
1. Coleman B et al Transitions in electronic cigarette use among adults in the Population Assessment of Tobacco and Health (PATH) Study, Waves 1 and 2 (2013-2105). Tobacco Control 2018; doi:10.1136/tobaccocontrol-2017-054174
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The potential presence of formaldehyde cyanohydrin in the polylactic acid (PLA) filter of Marlboro Heatstick when heated was reported by Davis and al. PLA is a biodegradable thermoplastic derived from renewable resources such as corn starch. This tentative identification is based on the GC-MS analysis of the headspace of a heated piece of PLA, and the subsequent compound identification by mass spectra matching (acceptance criteria >85%) with the spectra library of the National Institute of Standard and Technology (NIST). However, this was not confirmed by injecting a purchased analytical grade reference standard, in order to unambiguously prove the presence of formaldehyde cyanohydrin. Therefore, we decided to repeat the experiment using headspace injection gas chromatography coupled to high resolution mass spectrometry under similar conditions as described in the publication. Our headspace GC-HR-MS analyses showed four peaks, at retention times of 16.38, 16.47, 17.14, and 18.58 min, in good agreement with the reported data reported (figure 4).
From the analysis of reference standards, we have confirmed the presence of both e-caprolactone (CAS# 502-44-3) and (S,S)-lactide (CAS# 4511-42-6) eluting at 16.47 and 17.14 min, respectively. We identified triacetin (CAS# 102-76-1) at 18.58 min, based on the reference standard, instead of 1,2-diacetin (their EI mass spectra are very similar).
However, we have demonstrated unambiguously the a...
NOT PEER REVIEWED
The potential presence of formaldehyde cyanohydrin in the polylactic acid (PLA) filter of Marlboro Heatstick when heated was reported by Davis and al. PLA is a biodegradable thermoplastic derived from renewable resources such as corn starch. This tentative identification is based on the GC-MS analysis of the headspace of a heated piece of PLA, and the subsequent compound identification by mass spectra matching (acceptance criteria >85%) with the spectra library of the National Institute of Standard and Technology (NIST). However, this was not confirmed by injecting a purchased analytical grade reference standard, in order to unambiguously prove the presence of formaldehyde cyanohydrin. Therefore, we decided to repeat the experiment using headspace injection gas chromatography coupled to high resolution mass spectrometry under similar conditions as described in the publication. Our headspace GC-HR-MS analyses showed four peaks, at retention times of 16.38, 16.47, 17.14, and 18.58 min, in good agreement with the reported data reported (figure 4).
From the analysis of reference standards, we have confirmed the presence of both e-caprolactone (CAS# 502-44-3) and (S,S)-lactide (CAS# 4511-42-6) eluting at 16.47 and 17.14 min, respectively. We identified triacetin (CAS# 102-76-1) at 18.58 min, based on the reference standard, instead of 1,2-diacetin (their EI mass spectra are very similar).
However, we have demonstrated unambiguously the absence of formaldehyde cyanohydrin by injecting the reference standard (Sigma, CAS# 107-16-4, ref. 50640). The formaldehyde cyanohydrin is eluting at 11.53 min and does not correspond to the peak eluting just before e-caprolactone that the authors tentatively identified as formaldehyde cyanohydrin (17.97 min under their conditions). This peak, based on existing literature [1] and high resolution mass spectra, is highly likely to be meso-lactide, the third isomers of lactide. The experimental details are available on PMIScience.com (https://www.pmiscience.com/library/publication/analysis-of-polylactic-ac...)
It is well known among analytical chemists that unit mass matching with a single data base is insufficient to prove the identity of a compound. Therefore, we typically use commercially available reference standards to verify our findings. This is important to us, as we are focused on developing reduced risk alternatives to combustible cigarettes. In this context, it is key that our science is always verified to the highest possible standards.
[1] Arrieta MP, Parres-Garcia F, Lopez-Martinez J et al. Pirólisis de residuo de bioplásticos : Productos obtenidos del ácido poliláctico (PLA). Dyna Ingenieria e Industria, 2012 ; 87(4):395-399. doi:10.6036/4673
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The reporting of the results of this study is far from complete, which is concerning given the highly politicised controversy that surrounds this product. I hope the authors should respond to this comment by publishing supplementary material with all the data they collected in a an accessible form such a CSV file and summarised in tables in a supplementary memo.
In particular, the authors should provide all data on the following:
+ Vaping and JUUL current use (used in past 30-days) prevalence stratified by age, clearly differentiating between 18 and over and under-18s
+ Frequency of use of vaping products and JUUL within the 30 days among current (past-30 days) users, ideally using the same frequency breakdown used in the National Youth Tobacco Survey
+ Breakdown of vaping status by smoking status and frequency of vaping and JUUL use - to help determine the extent to which regular JUUL use is concentrated among smokers
+ Smoking prevalence and frequency
There is a rare opportunity to gain insights into a live controversy, yet the reporting of the survey is so incomplete it is difficult to draw any serious conclusions from it about the overall effect. For example, JUUL maybe displacing other vaping products used by youth as it is in the market overall. JUUL may be functioning as an alternative to smoking in both adolescents and adults and contributing to achieving smoke-free public health objectives.
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The reporting of the results of this study is far from complete, which is concerning given the highly politicised controversy that surrounds this product. I hope the authors should respond to this comment by publishing supplementary material with all the data they collected in a an accessible form such a CSV file and summarised in tables in a supplementary memo.
In particular, the authors should provide all data on the following:
+ Vaping and JUUL current use (used in past 30-days) prevalence stratified by age, clearly differentiating between 18 and over and under-18s
+ Frequency of use of vaping products and JUUL within the 30 days among current (past-30 days) users, ideally using the same frequency breakdown used in the National Youth Tobacco Survey
+ Breakdown of vaping status by smoking status and frequency of vaping and JUUL use - to help determine the extent to which regular JUUL use is concentrated among smokers
+ Smoking prevalence and frequency
There is a rare opportunity to gain insights into a live controversy, yet the reporting of the survey is so incomplete it is difficult to draw any serious conclusions from it about the overall effect. For example, JUUL maybe displacing other vaping products used by youth as it is in the market overall. JUUL may be functioning as an alternative to smoking in both adolescents and adults and contributing to achieving smoke-free public health objectives.
The Truth Initiative is proud of its advocacy for young people, but as far as presentation and interpretation of data are concerned, such activist commitment amounts to a competing interest. For that reason, everyone, including Truth, is served by full disclosure of the survey data in an appropriate and accessible form and answers to key data questions that would help understand the JUUL phenomenon.
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The authors state "These stores have largely stopped carrying e-cigarettes at the same time as starting to stock IQOS HEETS (HEATSTICKS), the cigarette-like component that is smoked in the IQOS device,..." but provide no insight into why that is. Are these retailers being incentivised to stop selling e-cigs by PMI?
While the risk profile of IQOS is uncertain, the product is highly likely to be much more harmful than vaping e-cigs. Commercial tactics that promote IQOS over vaping devices, excluding the latter from retail chains, would be of major concern for tobacco control.
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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...
NOT PEER REVIEWED
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.
Berry et al (1) report an analysis of two waves of the Population Assessment of Tobacco and Health (PATH) study focused on the association between the initiation of e-cigarette use by Wave 2 and cigarette abstinence/reduction assessed at Wave 2. They conclude that daily e-cigarette use is associated with both cigarette abstinence and reduced consumption among continuing smokers. While this addresses an important question, we argue that such analyses should be adjusted for the reason e-cigarettes are being used.
From Wave 1 of PATH (2), we know that ~75% of smokers agreed that e-cigarettes were useful to help people quit. However, ~80% agreed that e-cigarettes allowed someone to replace a cigarette where smoking was prohibited. From the first reason, we can hypothesize that e-cigarette use might be associated with cigarette abstinence/reduction. However, from the second reason, we can also hypothesize that e-cigarettes would be associated with neither cigarette abstinence nor reduction. The recent National Academies report (3) recommended that any assessment of the role of e-cigarettes in cigarette cessation/reduction should focus on smokers who used e-cigarettes to help them quit.
PATH Wave 2 data does include information on whether smokers tried to quit in the previous year, as well as whether they used e-cigarettes to aid the last quit attempt. Previous research (4) has shown that over half of the smoking population will not ha...
Berry et al (1) report an analysis of two waves of the Population Assessment of Tobacco and Health (PATH) study focused on the association between the initiation of e-cigarette use by Wave 2 and cigarette abstinence/reduction assessed at Wave 2. They conclude that daily e-cigarette use is associated with both cigarette abstinence and reduced consumption among continuing smokers. While this addresses an important question, we argue that such analyses should be adjusted for the reason e-cigarettes are being used.
From Wave 1 of PATH (2), we know that ~75% of smokers agreed that e-cigarettes were useful to help people quit. However, ~80% agreed that e-cigarettes allowed someone to replace a cigarette where smoking was prohibited. From the first reason, we can hypothesize that e-cigarette use might be associated with cigarette abstinence/reduction. However, from the second reason, we can also hypothesize that e-cigarettes would be associated with neither cigarette abstinence nor reduction. The recent National Academies report (3) recommended that any assessment of the role of e-cigarettes in cigarette cessation/reduction should focus on smokers who used e-cigarettes to help them quit.
PATH Wave 2 data does include information on whether smokers tried to quit in the previous year, as well as whether they used e-cigarettes to aid the last quit attempt. Previous research (4) has shown that over half of the smoking population will not have tried to quit in the previous year. By including these non-attempters, who by definition cannot have quit, Berry et al (1) may have introduced an important bias toward finding a higher daily e-cigarette effect on abstinence. We expect that daily e-cigarette use at Wave 2 will be much higher among those who made a recent quit attempt than in those who did not.
In their supplement tables (TableS3), they include an analysis of those who made a quit attempt prior to Wave 1(rather than between Waves 1 and 2). Using this analysis, there is a drastic reduction in the effect size amplitude and in the absolute number of involved smokers. We would expect similar, or even larger, reduction in effect estimates were they to have restricted their analysis to those who made a quit attempt in the year prior to Wave 2 and included reason for using e-cigarettes.
In order to know the effect of e-cigarettes on cessation, those who used an e-cigarette to help them to quit should be contrasted with comparable non-users: those who used other aids to quit as well as to those who quit unaided. There are numerous important potential confounders for these comparisons as it is well known that those who are least likely to be successful in the quit attempt are the most likely to use an aid. (5) For unbiased analyses, the exposure of interest needs to be isolated and covariate balance achieved between exposed and unexposed. There is a role for methodological approaches that help achieve covariate balance, such as propensity score matching, in deciding whether e –cigarettes improve population smoking cessation.
References:
1. Berry KM, Reynolds LM, Collins JM, Siegel MB, Fetterman JL, Hamburg NM, Bhatnagar A, Benjamin EJ, Stokes A. E-cigarette initiation and associated changes in smoking cessation and reduction: the Population Assessment of Tobacco and Health Study, 2013-2015.Tob Control. 2018 Mar 24. pii: tobaccocontrol-2017-054108. doi: 10.1136/tobaccocontrol-2017-054108.
2. Coleman BN, Rostron B, Johnson SE, Ambrose BK, Pearson J, Stanton CA, et al. Electronic cigarette use among US adults in the Population Assessment of Tobacco and Health (PATH) Study, 2013–2014. Tobacco Control. 2017. doi: 10.1136/tobaccocontrol-2016-053462.
3. National Academies of Sciences Engineering, and Medicine,. Public Health Consequences of E-Cigarettes. Washington, DC: Health and Medicine Division, National Academies of Sciences, Engineering, and Medicine, 2018
4. Zhu S-H, Lee M, Zhuang Y, Gamst A, Wolfson T. Interventions to increase smoking cessation at the population level: How much progress has been made in the last two decades? Tob Control. 2012;212:110–118
5. Leas EC, Pierce JP, Benmarhnia T, White MM, Noble ML, Trinidad DR, Strong DR. Effectiveness of Pharmaceutical Smoking Cessation Aids in a Nationally Representative Cohort of American Smokers. J Natl Cancer Inst. 2017 Dec 21. doi: 10.1093/jnci/djx240
Feliu et al’s conclusion “in the European Union countries with the higher scores in the Tobacco Control Scale, which indicates higher tobacco control efforts, have lower prevalence of smokers, higher quit ratios and higher relative decreases in their prevalence rates of smokers.” deserved comment.
First, it seems a tautology. Tobacco control policies are robustly evidence based. Accordingly, more efforts, less smokers.
Second, a PubMed search with “"tobacco control scale" only retrieved 27 articles since 2006 and no validation published yet. Obviously, the Scale poorly correlated with smoking rate: r2 being .58 in 2002/3, .15 in 2006/7 and .06 in 2010/11.(From table 3 in 2; n= 11 European countries).
Third, why make simple stuff complex? This surrogate is complex to calculate and its items are subjective because issuing a decree is useless if no implementation were enforced. In contrast, the smoking rate and its evolution are simple and reliable! How France can be ranked 4th among 28 countries with a 57/100 score (1) while smoking prevalence has been plateauing for so long at more than 30%? In France, from 2004 to 2017 no relevant increase in tobacco taxes, no implementation of the legal smoking ban in cafés or of the ban of sale to minors despite sting operations by NGO showing evidence of serious breaches.(3)
Fourth, claiming “the European Union should continue implementing comprehensive tobacco control pol...
Feliu et al’s conclusion “in the European Union countries with the higher scores in the Tobacco Control Scale, which indicates higher tobacco control efforts, have lower prevalence of smokers, higher quit ratios and higher relative decreases in their prevalence rates of smokers.” deserved comment.
First, it seems a tautology. Tobacco control policies are robustly evidence based. Accordingly, more efforts, less smokers.
Second, a PubMed search with “"tobacco control scale" only retrieved 27 articles since 2006 and no validation published yet. Obviously, the Scale poorly correlated with smoking rate: r2 being .58 in 2002/3, .15 in 2006/7 and .06 in 2010/11.(From table 3 in 2; n= 11 European countries).
Third, why make simple stuff complex? This surrogate is complex to calculate and its items are subjective because issuing a decree is useless if no implementation were enforced. In contrast, the smoking rate and its evolution are simple and reliable! How France can be ranked 4th among 28 countries with a 57/100 score (1) while smoking prevalence has been plateauing for so long at more than 30%? In France, from 2004 to 2017 no relevant increase in tobacco taxes, no implementation of the legal smoking ban in cafés or of the ban of sale to minors despite sting operations by NGO showing evidence of serious breaches.(3)
Fourth, claiming “the European Union should continue implementing comprehensive tobacco control policies in Europe.”(1) is optimistic, at best. The European Union is the chimney of rich countries: smoking prevalence in Italy, France and Germany is almost twice that in Australia and 1.5 fold that in the US. Almost no tobacco control in the European Union but Finland! The Scale is a smokescreen for tricky politicians cherry picking the weakest measures without even providing tools for implementation or monitoring.
Last, I am not aware that a critical assessment of the Eurobarometer method is available, and the limitations of such surveys cannot be overlooked. This deserves scrutiny as other data from the European Union on such a topic are a cause for concern: eg. the European School Project on Alcohol and other Drugs estimates smoking prevalence only on a declarative basis, roughly 10% of the data are missing despite only recruiting those attending school and only 80 % of the students said that they thought that their classmates had answered the questions honestly.(4)
1 Feliu A, Filippidis FT, Joossens L et al. Impact of tobacco control policies on smoking prevalence and quit ratios in 27 European Union countries from 2006 to 2014. Online Feb 22.
2 Kuipers MA, Monshouwer K, van Laar M, Kunst AE. Tobacco control and socioeconomic inequalities in adolescent smoking in Europe. Am J Prev Med 2015;49:e64-e72.
3 Braillon A, Mereau AS, Dubois G. [Tobacco control in France: effects of public policy on mortality]. Presse Med 2012;41:679-81.
4 Hibell B, Molinaro S, Siciliano V, Kraus L. The 2013 ESPAD validity study. European Monitoring Centre for Drugs and Drug Addiction. Publications Office of the European Union. Luxembourg. 2015.
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This paper’s core findings are quite helpful: (1) Tax/price increases for non-cigarette tobacco products can effectively reduce their use; and (2) Tax/price increases for non-cigarette tobacco products could prompt some users to increase their cigarette smoking if comparable tax/price increases for cigarettes are not done at the same time. But the paper’s related analysis is incomplete, producing misleading conclusions, largely because the paper focuses on cigarettes versus non-cigarette tobacco products without also considering the more important distinction for health-directed tobacco tax strategies between smoked tobacco products and non-combustible tobacco products.
In its abstract, the paper concludes that the “positive substitutability between cigarettes and non-cigarette tobacco products suggest that tax and price increases need to be simultaneous and comparable across all tobacco products.” But the paper does not appear to consider that the only substitutions that could significantly increase public health harms would be if the tax increases prompted some non-combusted tobacco product users to move to more-harmful smoking or prompted some smokers who would otherwise do so not to move to less-harmful non-combusted tobacco products. As a result, the paper fails to acknowledge that significant tax/price increases for only combusted tobacco products would not prompt any harm-increasing substitution and would directly secure desirable...
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This paper’s core findings are quite helpful: (1) Tax/price increases for non-cigarette tobacco products can effectively reduce their use; and (2) Tax/price increases for non-cigarette tobacco products could prompt some users to increase their cigarette smoking if comparable tax/price increases for cigarettes are not done at the same time. But the paper’s related analysis is incomplete, producing misleading conclusions, largely because the paper focuses on cigarettes versus non-cigarette tobacco products without also considering the more important distinction for health-directed tobacco tax strategies between smoked tobacco products and non-combustible tobacco products.
In its abstract, the paper concludes that the “positive substitutability between cigarettes and non-cigarette tobacco products suggest that tax and price increases need to be simultaneous and comparable across all tobacco products.” But the paper does not appear to consider that the only substitutions that could significantly increase public health harms would be if the tax increases prompted some non-combusted tobacco product users to move to more-harmful smoking or prompted some smokers who would otherwise do so not to move to less-harmful non-combusted tobacco products. As a result, the paper fails to acknowledge that significant tax/price increases for only combusted tobacco products would not prompt any harm-increasing substitution and would directly secure desirable public health gains by directly reducing smoking. It would be foolish for the public health community to reject or not support such a tax increase because it did not also increase taxes on non-combustible tobacco products. But the paper suggests otherwise.
A tobacco tax increase on cigarettes and all other combustibles would secure even larger public health gains if it also used different sized tax increases on different combustible products in order to raise the prices of all smoked tobacco products to the same level as cigarettes (typically the most highly taxed tobacco products), thereby making it more likely that cigarette smokers would respond to the tax increases by cutting back their smoking or quitting altogether, rather than by switching to less-taxed and less-expensive smoked tobacco products, such as little cigars or RYO. But the paper does not consider this option, and its support for comparable tax increases for all tobacco products argues against it.
A tax increase for combusted tobacco products could secure even larger public health gains if it also increased non-combustible tobacco product taxes and prices. But only if the increases to the combusted and non-combusted tobacco product taxes did not make the non-combustibles significantly more expensive relative to cigarettes and other smoked tobacco products, either relatively or in real terms, that they dampened moves from smoking to e-cigarettes or other non-combustibles or prompted some non-combustible users to increase their smoking. But that, also, is not discussed in the paper.
Instead, the main text of the paper talks about taxes to produce equal price increases for each type of tobacco product and concludes by offering the overly broad and potentially misleading recommendation that countries with tobacco-diverse markets “should raise taxes on non-cigarette tobacco products to prevent premature death.”
Perhaps all the additional policy analysis suggested here is too much to expect from a study with the rather simple stated objective of just systematically reviewing the price elasticity of demand of non-cigarette tobacco products. But the paper goes well beyond providing that information and also encourages tax increases for non-cigarette tobacco products, either on their own or along with comparable increases for cigarettes. Given that the paper has decided to make policy recommendations, it should do so more thoughtfully, with more explanation and more detailed guidance.
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The paper by Filippidis et al [1] provides data re-confirming the well-known fact that most ex-smokers attempt to quit without using any form of assistance, whether pharmaceutical, professional or via e-cigarettes. Moreover, the proportion of ex-smokers trying to quit unaided increased substantially in Europe between 2012-17 (ex-smokers using no assistance increased from 73.9% to 80.7%), a period where e-cigarette use accelerated in some nations.
Regrettably however, this study does not permit any comparison of success rates by method, as no data are reported on which method of cessation (assisted v unassisted) was used by ex-smokers on their last, final (and so successful) quit attempt.
The authors report that those “who successfully quit reported much lower use of cessation assistance compared with smokers who had tried to quit without success” and suggest that this might reflect indication bias, whereby those who find it harder to quit self-select to use assistance, leaving the low hanging fruit of non- or less addicted smokers to fall off the smoking tree using their own determination.
While this will be true for some, there are many former heavy smokers who quit without assistance. This argument also borrows assumptions from the discredited hardening hypothesis [2], which holds, in the face of evidence to the contrary, that as smoking prevalence falls the concentration of hardened, more deeply addicted smokers increase...
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The paper by Filippidis et al [1] provides data re-confirming the well-known fact that most ex-smokers attempt to quit without using any form of assistance, whether pharmaceutical, professional or via e-cigarettes. Moreover, the proportion of ex-smokers trying to quit unaided increased substantially in Europe between 2012-17 (ex-smokers using no assistance increased from 73.9% to 80.7%), a period where e-cigarette use accelerated in some nations.
Regrettably however, this study does not permit any comparison of success rates by method, as no data are reported on which method of cessation (assisted v unassisted) was used by ex-smokers on their last, final (and so successful) quit attempt.
The authors report that those “who successfully quit reported much lower use of cessation assistance compared with smokers who had tried to quit without success” and suggest that this might reflect indication bias, whereby those who find it harder to quit self-select to use assistance, leaving the low hanging fruit of non- or less addicted smokers to fall off the smoking tree using their own determination.
While this will be true for some, there are many former heavy smokers who quit without assistance. This argument also borrows assumptions from the discredited hardening hypothesis [2], which holds, in the face of evidence to the contrary, that as smoking prevalence falls the concentration of hardened, more deeply addicted smokers increases.
If our concern is (as it should be) to better understand the means of quitting that produce the largest net volume of ex-smokers across whole populations, studying the methods these former smokers used when they succeeded is critical. Yet the “inverse impact law of smoking cessation [3] shows that unassisted cessation, which undisputedly delivers more ex-smokers than any other method, is hugely neglected in smoking cessation research [4].
It is almost as if researchers want to turn away from learning more about the most successful route that has always delivered the largest number of successful quits. [5]
Rather than seeing the increase in unassisted quitting as something to be highlighted as a positive, motivating celebration of agency that could be megaphoned in campaigns to smokers imbued with pessimistic messages about how hard quitting is going to be, the authors conclude that their findings ”highlight the need for approaches to ensure that smokers get support”.
In 40 years of tobacco control, I cannot ever recall attending a meeting or conference on cessation where those whose living depended on them selling smoking cessation aids or providing professional cessation services did not reach similar conclusions. Yet 40 years on, the same cracked record is being played: we need to convince more smokers that they should not try foolishly to quit alone and that they need our help!
Analysis at the level of the success of quit “attempts” often shows that head-to-head, unassisted cessation attempts are less successful than those using assistance. But many so-called cessation attempts are empty gestures akin to those who attempt to get fit by buying an exercise bike, use it once or twice and then consign it to the corner. West and Sohal’s work on catastrophe theory noted that many who were not planning to quit at time 1, had succeeded at time 2. They suggested that “smokers have varying levels of motivational “tension” to stop and then “triggers” in the environment result in a switch in motivational state. If that switch involves immediate renunciation of cigarettes, this can signal a more complete transformation than if it involves a plan to quit at some future point.” [6]
The importance of continually stimulating the motivational tension to stop smoking and providing both informational and policy triggers for quitting cannot be over-emphasised.
It is long overdue that we gave far more attention to the net contribution of unassisted cessation at the population level. [7 ] Many smokers have little interest in being helped to quit. In this, they are very aware of many friends and acquaintances who quit alone when they were sufficiently motivated to do so. Over 40 years of professional hand-wringing, research and campaigning about how to undermine unaided quitting and sell more drugs and clinic appointments have thankfully done little to erode this.
References
1. Filippidis FT, Mons U, Jiminez-Ruiz C, Vardavas CI. Changes in smoking cessation assistance in the European Union between 2012 and 2017: pharmacotherapy versus counselling versus e-cigarettes. Tobacco Control http://dx.doi.org/10.1136/tobaccocontrol-2017-054117
2. Cohen JE, McDonald PW, Selby P. Softening up on the hardening hypothesis. Tobacco Control ttp://dx.doi.org/10.1136/tobaccocontrol-2011-050381
3. Chapman S. The Inverse Impact Law of Smoking Cessation. Lancet 2009; 373(9665):701-3.
4. Chapman S, Mackenzie R. The global research neglect of unassisted smoking cessation: causes and consequences. PLoS Medicine 2010; 7(2): e1000216. doi:10.1371/journal.pmed.1000216.
5. Smith A, Chapman S. Quitting unassisted: the 50 year neglect of a major health phenomenon. JAMA 2014;311(2):137-138. doi:10.1001/jama.2013.282618.
3. West R, Sohal T. “Catastrophic” pathways to smoking cessation: findings from national survey. BMJ. 2006 Feb 25; 332(7539): 458–460.
doi: 10.1136/bmj.38723.573866.AE
4. Smith A, Carter SM, Chapman S, Dunlop S, Freeman B. Why do smokers try to quit without medication or counseling? A qualitative study with ex-smokers. BMJ Open 5:e007301 doi:10.1136/bmjopen-2014-007301
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.
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.
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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...
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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 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
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Elias & Ling throw useful light on the slow-motion disaster that was the series of voluntary agreements begun in the 1970s between government and the tobacco industry in the UK, overseen by the Independent Scientific Committee on Smoking and Health (ISCSH). These had as their aim to address the issue of tobacco product modification to reduce the health risks of smoking. Industry produced new smoking materials with the aim of reducing the biological activity of the tar fraction of smoke from cigarettes, and agreed to a programme of gradual tar yield reduction across the years. The novel products failed because consumers rejected them (there were too few users even to recruit for trials to examine their potential benefits), and the reductions in machine-smoked tar yields were achieved largely through increasing filter ventilation. The material cited shows that the low tar programme fiasco was characterized by undue influence from tobacco industry and a complete lack of understanding of the dynamics of smoking behaviour on the part of the scientific experts charged by government with supervision of the programme.
This is a sorry tale from the early days of tobacco control, and Elias & Ling tell it well. So far so good. But in framing and interpreting their material they go well beyond the data they cite, and draw quite unwarranted conclusions about what they see as the deficiencies of the current UK harm reduction policy. Indeed, tak...
NOT PEER REVIEWED
Elias & Ling throw useful light on the slow-motion disaster that was the series of voluntary agreements begun in the 1970s between government and the tobacco industry in the UK, overseen by the Independent Scientific Committee on Smoking and Health (ISCSH). These had as their aim to address the issue of tobacco product modification to reduce the health risks of smoking. Industry produced new smoking materials with the aim of reducing the biological activity of the tar fraction of smoke from cigarettes, and agreed to a programme of gradual tar yield reduction across the years. The novel products failed because consumers rejected them (there were too few users even to recruit for trials to examine their potential benefits), and the reductions in machine-smoked tar yields were achieved largely through increasing filter ventilation. The material cited shows that the low tar programme fiasco was characterized by undue influence from tobacco industry and a complete lack of understanding of the dynamics of smoking behaviour on the part of the scientific experts charged by government with supervision of the programme.
This is a sorry tale from the early days of tobacco control, and Elias & Ling tell it well. So far so good. But in framing and interpreting their material they go well beyond the data they cite, and draw quite unwarranted conclusions about what they see as the deficiencies of the current UK harm reduction policy. Indeed, taken as a whole, their paper reads more as an attack on current UK policy than as a scholarly contribution to the history of tobacco control. Current policy, which had its beginnings some 20 years or more later, is painted as being an outgrowth of the low tar programme and as being similarly tainted with industry influence. It reflects no credit on the editorial processes and decision making of Tobacco Control that authors were permitted to get away with such unsupported conclusions in their published paper.
The idea that reduction in tar yield of cigarettes could be an effective way of reducing the health risks of smoking goes back to the 1960s at least. It was supported by many distinguished epidemiologists, including Doll, Peto, and Wynder. See for example this 1979 statement by Ernst Wynder: ““One of the things that has always appealed to me about science is that if I find something that makes biological sense, then I feel reassured. Thirty years ago, when we had a 40mg tar cigarette, if you smoked 30 cigarettes a day you were exposed to about 1200 mg tar a day. Today’s cigarettes have 20 mg tar, so you are exposed to 600 mg daily. If there’s one thing everybody can agree on, it is that all tobacco-related cancers are dose related.” (1)
What was lacking in this formulation was an understanding that the risk from products is not simply determined by their composition, but resides in the interaction between the user and the product – as Michael Russell pointed out, if tar yield was everything, the most dangerous product would be the large Cuban cigar (1).
Russell was an outspoken critic of the ISCSH’s record. In a 1980 comment on the committee’s second report (2) he noted “Most of all it [the report] is remarkable for the stunning naivety of its implicit model of smoking behaviour”. He pointed out that: “Lower risk cigarettes are equated with cigarettes with lower tar and nicotine yields. If people smoked cigarettes in the same way that smoking machines do, this would indeed be the case. But there is much evidence that they do not….The tendency for smokers to regulate their smoke intake has been ignored by the Hunter Committee”.
Russell was not a member of the ISCSH (indeed, the membership of the committee was heavily tilted towards epidemiology and toxicology, and included no behavioural science expertise). It is in Russell’s insights and policy prescriptions that we can see the real intellectual underpinnings of UK policy on harm reduction in recent years.
Russell had a number of key insights, the most fundamental of which is that people smoke for nicotine (3). This coupled with the observation that the harms of smoking come not from the drug people are seeking, but from contaminants of the delivery system used to obtain it, led to his dictum “People smoke for the nicotine, but die from the tar”. As early as the mid-1970s he began to advocate an approach to tobacco harm reduction that was based on an appreciation of nicotine’s role (4, 5). He was the first to expose the fallacy of low tar cigarettes (6) and the first to explore the potential of non-combustible nicotine products for harm reduction (7-9). His 1991 paper in the British Journal of Addiction (10) and editorial in The Lancet (11) set out a vision for a transformed nicotine market: “If a strategy were adopted to sanction and encourage the use of purified nicotine products as substitutes for smoking, and at the same time impose stringent regulations on permissible constituents of cigarette smoke …….. the virtual elimination of smoking could become a more realistic health promotion target” (11). This represents a paradigm shift from the failed approach adopted in the 1970s. How it, or something springing from it, became a part of UK tobacco control policy in recent years, is a story for others to tell. But it did not happen through tobacco industry influence.
References
1. Gori GB, Bock FG. Banbury Report 3: A Safe Cigarette? Cold Spring Harbor Laboratory; 1980.
2. Jarvis MJ, Russell MAH. Comment on the Hunter Committee's second report. British Medical Journal. 1980;5; 280(6219):994-5.
3. Russell MA. Cigarette smoking: natural history of a dependence disorder. Br-J-Med-Psychol. 1971;44(1):1-16.
4. Russell MA. Realistic goals for smoking and health. A case for safer smoking. Lancet. 1974;16; 1(851):254-8.
5. Russell MA. Low-tar medium-nicotine cigarettes: a new approach to safer smoking. Br-Med-J. 1976;12; 1(6023):1430-3.
6. Russell MAH, Jarvis M, Iyer R, Feyerabend C. Relation of nicotine yield of cigarettes to blood nicotine concentrations in smokers. British Medical Journal. 1980;280(6219):972-6.
7. Russell MAH, Jarvis MJ, Feyerabend C. A new age for snuff? Lancet. 1980;1; 1(8166):474-5.
8. Russell MAH, Jarvis MJ, Devitt G, Feyerabend C. Nicotine intake by snuff users. Br Med J. 1981;26; 283(6295):814-7.
9. Russell MAH, Jarvis MJ, West RJ, Feyerabend C. Buccal absorption of nicotine from smokeless tobacco sachets. Lancet. 1985;2(8468):1370.
10. Russell MAH. The future of nicotine replacement. Br-J-Addict. 1991;86(5):653-8.
11. Russell MAH. Nicotine use after the year 2000. The Lancet. 1991;337:1191-2.
NOT PEER REVIEWED Elias and Ling conclude that ‘Regulatory bodies should consider toxin exposure, and new products’ actual use, abuse potential and population health effects before endorsing them as safer’. We agree, and that is exactly what Public Health England and the Royal College of Physicians have done [1-4].
NOT PEER REVIEWED Elias and Ling conclude that ‘Regulatory bodies should consider toxin exposure, and new products’ actual use, abuse potential and population health effects before endorsing them as safer’. We agree, and that is exactly what Public Health England and the Royal College of Physicians have done [1-4].
NOT PEER REVIEWED The results provided by Stephens [1] may suggest to readers that since the concentrations of carcinogens are lower in vapourised nicotine products (VNPs), the risks of cancer are smaller compared to conventional cigarettes. The article uses the linear non-threshold model for risk assessment (a uniform cancer risk per unit dose from higher to lower doses), which is also used by most regulatory agencies. This model is considered to have a high degree of uncertainty; nevertheless, it implies that any dose of carcinogens increases the risk of cancer. Accordingly, the primary conclusion of Stephens and other’s[2] findings of the presence of carcinogens, particularly in heat-not-burn cigarettes (HNB) is that HNB poses a significant risk of cancer. In addition:
1) The article highlights a summation approach of overall cancer risk for each product, yet the individual concentrations of human carcinogens (for example, formaldehyde [3]) are still at risk level.
2) The assessment of carcinogenesis of low-level exposure to a mixture of chemicals is challenging [4]. Stephens’s summation model assumes that the effect of chemicals is independent. Even if we assume that for an individual chemical a lower concentration lowers carcinogenicity, we cannot rule out the potential effects of interactions among chemicals.
3) The analysis relies on holding consumption constant. However, manufacturer studies have suggested that consumption increases after a swi...
NOT PEER REVIEWED The results provided by Stephens [1] may suggest to readers that since the concentrations of carcinogens are lower in vapourised nicotine products (VNPs), the risks of cancer are smaller compared to conventional cigarettes. The article uses the linear non-threshold model for risk assessment (a uniform cancer risk per unit dose from higher to lower doses), which is also used by most regulatory agencies. This model is considered to have a high degree of uncertainty; nevertheless, it implies that any dose of carcinogens increases the risk of cancer. Accordingly, the primary conclusion of Stephens and other’s[2] findings of the presence of carcinogens, particularly in heat-not-burn cigarettes (HNB) is that HNB poses a significant risk of cancer. In addition:
1) The article highlights a summation approach of overall cancer risk for each product, yet the individual concentrations of human carcinogens (for example, formaldehyde [3]) are still at risk level.
2) The assessment of carcinogenesis of low-level exposure to a mixture of chemicals is challenging [4]. Stephens’s summation model assumes that the effect of chemicals is independent. Even if we assume that for an individual chemical a lower concentration lowers carcinogenicity, we cannot rule out the potential effects of interactions among chemicals.
3) The analysis relies on holding consumption constant. However, manufacturer studies have suggested that consumption increases after a switch to HNB devices [5]. For non-smokers or occasional smokers to whom HNBs are introduced as a safe product, any additional burden of toxicants increases the risk of cancer.
4) The conclusion concentrates on reduced risk of VNPs compared to the most harmful product (i.e tobacco smoke) and should also calculate elevated risk of using VNPs compared to background concentration.
In summary, smoking imposes exposure to a variety of toxicants with known and/or unknown health effect regardless of name, shape and means of use. These findings suggest that HNB cigarettes should be subject to the same regulations as tobacco cigarettes. The tobacco control community should communicate the absolute risks associated with these products. In particular, there is an urgent need for tobacco control policy actors to understand the potential absolute harms of heat-not-burn (HNB) cigarettes that PMI is pushing as ‘less harmful alternatives to smoking’ in their declared movement toward a smoke-free world (https://www.pmi.com/sustainability).
References:
[1] Stephens WE. Comparing the cancer potencies of emissions from vapourised nicotine products including e-cigarettes with those of tobacco smoke. Tobacco Control 2017.
[2] Auer R, Concha-Lozano N, Jacot-Sadowski I, et al. Heat-not-burn tobacco cigarettes: Smoke by any other name. JAMA Internal Medicine 2017.
[3] Cogliano VJ, Grosse Y, Baan RA, et al. Meeting report: summary of IARC monographs on formaldehyde, 2-butoxyethanol, and 1-tert-butoxy-2-propanol. Environmental health perspectives 2005:1205-1208.
[4] Goodson III WH, Lowe L, Carpenter DO, et al. Assessing the carcinogenic potential of low-dose exposures to chemical mixtures in the environment: the challenge ahead. Carcinogenesis 2015;36(Suppl_1):S254-S296.
[5] Lüdicke F, Baker G, Magnette J, et al. Reduced Exposure to Harmful and Potentially Harmful Smoke Constituents With the Tobacco Heating System 2.1. Nicotine & Tobacco Research 2017;19(2):168-175.
NOT PEER REVIEWED An often overlooked limitation in smoking-related studies based on surveys conducted by health institutions is the pressure on respondents to provide "the right answer." Especially in this area, where this population has been subjected to high intensity tobacco control policies and messages, sample representativeness cannot be established with certainty when those asking the questions are the originators and/or pursuers of these policies and messages and, undeniably, describing the effort as "denormalization" and seeking to form a stigma around smoking and smokers.
Furthering this theory is the strongly implied factor contained in this study's "Limitations" section that the respondents have been plucked from prior tobacco research, thereby affording them even more knowledge about the opinions of the researchers. Those who volunteer for smoking-related studies -- perhaps even receiving incentive payments? -- cannot be dismissed as the type who will lean toward providing expected answers in order to please, are indicative of the type who already agree with the perceived direction of the study, or, as already stated, fear telling the truth to those they know hold a general disapproving attitude toward the subject at hand.
Right now the sample representativeness is skewed because of this. By how much remains the question. But one should not discount wondering what the responses would be and how different...
NOT PEER REVIEWED An often overlooked limitation in smoking-related studies based on surveys conducted by health institutions is the pressure on respondents to provide "the right answer." Especially in this area, where this population has been subjected to high intensity tobacco control policies and messages, sample representativeness cannot be established with certainty when those asking the questions are the originators and/or pursuers of these policies and messages and, undeniably, describing the effort as "denormalization" and seeking to form a stigma around smoking and smokers.
Furthering this theory is the strongly implied factor contained in this study's "Limitations" section that the respondents have been plucked from prior tobacco research, thereby affording them even more knowledge about the opinions of the researchers. Those who volunteer for smoking-related studies -- perhaps even receiving incentive payments? -- cannot be dismissed as the type who will lean toward providing expected answers in order to please, are indicative of the type who already agree with the perceived direction of the study, or, as already stated, fear telling the truth to those they know hold a general disapproving attitude toward the subject at hand.
Right now the sample representativeness is skewed because of this. By how much remains the question. But one should not discount wondering what the responses would be and how different the outcome if administered by an organization such as my own where the respondents would likely be more at ease. And while if started from scratch with recruitment it might also attract other-thinking smokers that could skew it the other way (but also then questioning this study's sample at the same time), it need not be necessary in regard to the study limitation present here today.
NOT PEER REVIEWED This paper is part of the ongoing discussion about saving lives from tobacco use. As a practicing oncologist and part-time Hospice physician, I have seen real benefit from "vaping". First, many Hospice patients, who have smoked for decades and are actively dying put themselves at real risk if they smoke real cigarettes while dying. Taking away cigarettes during the terminal illness just causes antagonism and much distress for the patient, their family, and the Hospice staff. Vaping at the end of life does prevent burns, suffering, and psychological distress.
For my oncology patients, I recommend vaping as an alternative to cigarettes for the many cigarette smokers who cannot "quit", despite real effort attempts with nicotine patches, gum, Wellbutrin, or Chantix. I do see lives improving, pulmonary function improving, and less stress in the exam setting, trying to convince the patient to quit yet another time.
We do need more research about cigarette alternatives for the existing nicotine addicts. There is, most definitely a role for these products, but also a need for researching the safety, efficacy, and best application of these products as an alternative for active adult smokers with health issues.
NOT PEER REVIEWED The 2014 Surgeon Generals Report (p. 875) stated ““The burden of death and disease from tobacco use in the U.S. is overwhelmingly caused by cigarettes and more must be done to end the deaths from combustible tobacco.” The aim of our study was to show the potential of policies to encourage cigarette smokers to switch to e-cigarettes as a way to reach or at least get closer to that goal. Indeed, FDA Commissioner Gottlieb and Director, Center for Tobacco Products Zeller in a July commentary in NEJM set out a two-pronged approach to the endgame of 1) policies making cigarettes less desirable and 2) policies making e-cigarettes a better substitute for cigarettes. We feel that Dr. Peters misses the point of the article, that the article is an exploratory exercise, and compounds his misunderstanding with unsubstantiated claims.
First, while Dr. Peters criticizes the 5% excess total mortality risk estimate for e-cigarettes relative to cigarettes and the pessimistic estimate, he does not make a coherent argument as to why we might expect worse outcomes, even though he is a respiratory physician and might be expected to point out specific scientific evidence vaping might approach smoking in harmfulness for respiratory illness at least. Indeed, we have seen no coherent argument for an alternative to the 5% estimate. We note that the UK Royal College of Physicians argued that it was likely to be less, while accepting the 5% as a likely upper bound (not the mos...
NOT PEER REVIEWED The 2014 Surgeon Generals Report (p. 875) stated ““The burden of death and disease from tobacco use in the U.S. is overwhelmingly caused by cigarettes and more must be done to end the deaths from combustible tobacco.” The aim of our study was to show the potential of policies to encourage cigarette smokers to switch to e-cigarettes as a way to reach or at least get closer to that goal. Indeed, FDA Commissioner Gottlieb and Director, Center for Tobacco Products Zeller in a July commentary in NEJM set out a two-pronged approach to the endgame of 1) policies making cigarettes less desirable and 2) policies making e-cigarettes a better substitute for cigarettes. We feel that Dr. Peters misses the point of the article, that the article is an exploratory exercise, and compounds his misunderstanding with unsubstantiated claims.
First, while Dr. Peters criticizes the 5% excess total mortality risk estimate for e-cigarettes relative to cigarettes and the pessimistic estimate, he does not make a coherent argument as to why we might expect worse outcomes, even though he is a respiratory physician and might be expected to point out specific scientific evidence vaping might approach smoking in harmfulness for respiratory illness at least. Indeed, we have seen no coherent argument for an alternative to the 5% estimate. We note that the UK Royal College of Physicians argued that it was likely to be less, while accepting the 5% as a likely upper bound (not the most pessimistic possible). Studies support the Royal College that non-combustible nicotine use is substantially less harmful than the smoke from combustion in clinical studies that smokers who switched to e-cigarettes reduced symptoms of pulmonary disease and cancer biomarkers (Shahib et al., Ann. Internal Med 2017; Glasser et al., AJPM, 2017; Benowitz and Fraiman, Nat Rev Cardiol. 2017).
Second, Dr. Peters clearly misunderstands the limitations of the longitudinal youth research. The studies to date cannot rule out confounders based on a shared liability model and, consequently, others suggest that fears of a gateway are overblown (Kozlowski & Warner, Drug & Alc Dep, 2017). These studies were conducted in a period when smoking and vaping rates were going in opposite directions or when smoking rates were continuing to decline more rapidly in the presence of reduced vaping (2013-16), and are based on very low levels of use (ever use or any monthly use, not regular use). The gateway theory is about population level relationships, and it cannot account for the two behaviours, cigarette use and e-cigarette use, going in opposite directions.
Third, Dr. Peters mischaracterizes the use of vaping. Where it is regularly available, vaping is the most used form of smoking cessation help, and, while the current evidence indicates it is at least as effective as nicotine replacement therapy (NRT’s) and possibly more so, as e-cigarettes are used by more smokers in quit attempts than NRT’s (Hartman-Boyce, Cochrane Reviews, 2016), and therefore will be having a larger net population effect. The recent population level analysis of Zhu et al (BMJ, 2017) shows an acceleration of the reduction in smoking prevalence in a period where the rapid uptake of vaping was the most notable change in the tobacco control environment and Levy et al (NTR, 2017) show a strong relationship between vaping, especially when done regularly, and both previous year quit attempts and quit success. A recent review confirms that e-cigarettes help smokers to quit and that studies of negative correlations between e-cigarette use and smoking cessation fail to meet reasonable but rigorous standards of scientific evidence (Villanti et al., Addiction, 2017).
Fourth, Dr. Peters claims that we underestimate the declining prevalence from 2009 to 2015, but does not point out the plausibility of a significant proportion of this change being due to the introduction of vaping. Indeed, this is precisely why we made the starting point for our projections (2012) when we did, at the point when the level of vaping was so small as to not have any appreciable possible impact on smoking rates.
As we indicated in our reply to Dr. Glantz, our goal in this study is not to predict the future, but to suggest a course for reaching an endgame of eliminating cigarettes tobacco use. Our hope is for tobacco control advocates to keep an open mind about the possibilities. Having smokers switch to e-cigarettes may not be the ideal outcome, but do we want to let the perfect continue to be the enemy of the possible?
NOT PEER REVIEWED In his critique, Stan Glantz, PhD interprets and presents our study as doing something we explicitly warned readers it was not intended to do. He argues that “the model is based on a series of assumptions that are inconsistent with empirical evidence.” However, we explicitly state and he reiterates, that the model is not meant to be predictive. In our previous work (Addiction 2017: NTR 2017), we presented a framework to help better understand the effects of e-cigarettes and argued that we need better information before we rush to judgement about the actual impact of e-cigarette use.
Our goal in writing this paper was simply to show that e-cigarettes could help us reach a real smoking and tobacco control endgame. In the US, we have made great progress applying traditional policies, such as tax increases, smoke-free air laws and media campaigns. However, SimSmoke models for the US and other countries indicate that traditional tobacco control policies can only get us partially to the endgame. We think that we can achieve more. Many countries have complied fully or near fully with the FCTC and still have unacceptably high rates of smoking prevalence. The point of our paper is to show that strategies shifting smokers to e-cigarettes can play a role in achieving the endgame.
While Glantz recognizes that we provide a “pessimistic” as well as an “optimistic” scenario, he dwells on the optimistic scenario. Many in the public health community see...
NOT PEER REVIEWED In his critique, Stan Glantz, PhD interprets and presents our study as doing something we explicitly warned readers it was not intended to do. He argues that “the model is based on a series of assumptions that are inconsistent with empirical evidence.” However, we explicitly state and he reiterates, that the model is not meant to be predictive. In our previous work (Addiction 2017: NTR 2017), we presented a framework to help better understand the effects of e-cigarettes and argued that we need better information before we rush to judgement about the actual impact of e-cigarette use.
Our goal in writing this paper was simply to show that e-cigarettes could help us reach a real smoking and tobacco control endgame. In the US, we have made great progress applying traditional policies, such as tax increases, smoke-free air laws and media campaigns. However, SimSmoke models for the US and other countries indicate that traditional tobacco control policies can only get us partially to the endgame. We think that we can achieve more. Many countries have complied fully or near fully with the FCTC and still have unacceptably high rates of smoking prevalence. The point of our paper is to show that strategies shifting smokers to e-cigarettes can play a role in achieving the endgame.
While Glantz recognizes that we provide a “pessimistic” as well as an “optimistic” scenario, he dwells on the optimistic scenario. Many in the public health community seem to think that supporting a thoughtful e-cigarette based harm reduction strategy could have horrible public health consequences. We included a pessimistic scenario with major differences from the optimistic scenario to incorporate the concerns of those most skeptical of e-cigarettes as a harm reduction tool. One of the main findings of this study was to show that even if a strategy that secured large shifts away from smoking sharply increased e-cigarette use among those who would otherwise quit all tobacco use and otherwise nonsmoking youth – and even if e-cigarettes also turned out to be much more harmful than currently available research indicates – an aggressive switching strategy would still secure large net public health benefits. Again, we are not claiming that we know the answer, but we are asking that tobacco control advocates keep an open mind towards strategies encouraging cigarette smokers to switch to e-cigarettes.
Glantz has indicated that he believes that there are alternative ways to achieve endgame goals in regard to smoking without prompting any large shifts from smoking to e-cigarettes. We would encourage Glantz to publish his ideas and estimates of a set of policies that could possibly move us to such an endgame without prompting shifts to e-cigarette use. Cigarette tax increases, graphic health warnings on cigarettes, more aggressive anti-smoking public education campaigns, and even much more novel and aggressive strategies such as minimizing nicotine levels or banning menthol will all directly reduce smoking. But they will also likely move many smokers to e-cigarette use. Among other things, our study shows that securing large smoking declines through such measures will secure large public health gains even if they do so primarily by shifting smokers first to e-cigarettes.
It is interesting that Glantz has ended with a quote from our article, “tobacco industry documents reveal an industry strategy of ‘divide and conquer’ focused primarily on fostering divisions within the tobacco control community regarding modified risk products.” It is important that we in tobacco control do not stray into pointless, divisive stances. We have made great progress in reducing cigarette use, but much more can be done, and we’ll get there faster if we work together.
NOT PEER REVIEWED The data, interpretations and implications of the data modelling exercise conducted by Levy et al(1) should not go unchallenged. Regardless of the number and confidence of the opinions voiced, and the observation of lower levels of selected toxicants in e-cigarette users that are alluded to, there is great uncertainty about the extent to which harm might be reduced by the exclusive use of electronic cigarette rather than combustible tobacco. On this background, to describe one of two models, a 95% harm reduction as optimistic and the second, still a substantial, hopeful estimate of 60% reduction as pessimistic betrays a bias at the outset. The use of this “pessimistic” descriptor would to a casual reader imply that the truth lay, inevitably, somewhere between the two estimates.
Then there is the detail of the model. Firstly, the use of Holford projections(2) overestimated 2015 smoking rates in the US by at least 10% compared to CDC data(3) - underestimating the recent rate of decline in smoking prevalence in men and women between 2005 and 2015 by one-third. A higher base rate and slower rate of decline exaggerate tobacco-related harms in the status quo – naturally favouring each of the modelled scenarios. Starting with lower, more accurate estimates of current smoking and rates of decline would also increase the counterbalancing harms from initiation in non-smokers.
There are other obvious problems. In the status quo, 20% of boys and 14...
NOT PEER REVIEWED The data, interpretations and implications of the data modelling exercise conducted by Levy et al(1) should not go unchallenged. Regardless of the number and confidence of the opinions voiced, and the observation of lower levels of selected toxicants in e-cigarette users that are alluded to, there is great uncertainty about the extent to which harm might be reduced by the exclusive use of electronic cigarette rather than combustible tobacco. On this background, to describe one of two models, a 95% harm reduction as optimistic and the second, still a substantial, hopeful estimate of 60% reduction as pessimistic betrays a bias at the outset. The use of this “pessimistic” descriptor would to a casual reader imply that the truth lay, inevitably, somewhere between the two estimates.
Then there is the detail of the model. Firstly, the use of Holford projections(2) overestimated 2015 smoking rates in the US by at least 10% compared to CDC data(3) - underestimating the recent rate of decline in smoking prevalence in men and women between 2005 and 2015 by one-third. A higher base rate and slower rate of decline exaggerate tobacco-related harms in the status quo – naturally favouring each of the modelled scenarios. Starting with lower, more accurate estimates of current smoking and rates of decline would also increase the counterbalancing harms from initiation in non-smokers.
There are other obvious problems. In the status quo, 20% of boys and 14.8% of girls would commence smoking between ages 15 and 25. To achieve the effects modelled, 83% of the 15 year olds boys who would have commenced smoking and 70% of the pre-destined female smokers would have to be diverted to exclusive e-cigarette use. In the optimistic target, requiring the most complete diversion, there is no allowance for harms of “off target” initiation of e-cigarette use i.e. initiation in a young person otherwise destined not to smoke. This is irrational given that e-cigarette use in young people trebles smoking rates after allowance for predictors of smoking uptake(4). The harder e-cigarette use is pushed the more off-target use is likely unless magic is in operation. This detail is critical. Under the published “pessimistic” model for 15 year old girls, there is already a negative effect in terms of years of life lost; not a benefit.
It goes on. Ten years after the commencement of the model in 15 year olds, no individual appears to have ceased the use of e-cigarettes. In the real world, discontinuation is the norm, rather than the exception. Even in England, with ready availability and a favourable public discourse, a minority of smokers choose e-cigarettes to aid smoking cessation(5) . Assumed smoking cessation rates with e-cigarettes are greatly in excess of what is achieved in clinical trials and standard clinical practice. How an intervention that is rejected longer-term in most smokers and ineffective in short-term use will achieve the 5%/10% smoking rates as modelled is unclear but it does not affect the calculations in the model as under both scenarios the outcome in smoking rates is predetermined. The viability of the steps needed to achieve this outcome are not questioned.
It is not difficult to see where this is heading. The purported benefits could only ever be achieved if electronic cigarettes or other novel products were freely available, including to adolescents at or before the typical age of initiation of combustible tobacco use, and had low pricing/taxation amidst a generally liberal approach to their use in public places. This would need to be supported by strong and effective marketing, attractive packaging and advertising standards that permitted uncertain/unproven claims about long-term safety and health benefits. Products would need to be researched and designed that were more rewarding/addictive than combustible tobacco to prevent switch and interchange with smoking. One wonders what responsible corporate entity would develop such a product, potentially harming many of its consumers whilst removing their easy and free choice to cease its use.
References:
1. Levy DT, Borland R, Lindblom EN, et al. Potential deaths averted in USA by replacing cigarettes with e-cigarettes. Tobacco Control (online first; doi: 10.1136/tobaccocontrol-2017-053759)
2. Holford TR, Levy DT, McKay LA, et al. Patterns of birth cohort-specific smoking histories, 1965-2009. Am J Prev Med 2014;46:e31–7.
3. Jamal A, King BA, Neff LJ, Whitmill J, Babb SD, Graffunder CM. Current Cigarette Smoking Among Adults — United States, 2005–2015. MMWR Morb Mortal Wkly Rep 2016;65:1205–1211.
4. Soneji S, Barrington-Trimis JL, Wills TA et al. Association Between Initial Use of e-Cigarettes and Subsequent Cigarette Smoking Among Adolescents and Young Adults. A Systematic Review and Meta-analysis. JAMA Pediatr 2017; 171:788-797.
NOT PEER REVIEWED
The paper, “Potential deaths averted in USA by replacing cigarettes with e-cigarettes” by David Levy et al. published in Tobacco Control on October 2, 2017, attracted a moderate amount of attention with its conclusion that “Compared with the Status Quo, replacement of cigarette by e-cigarette use over a 10-year period yields 6.6 million fewer premature deaths with 86.7 million fewer life years lost in the Optimistic Scenario. … Our projections show that a strategy of replacing cigarette smoking with vaping would yield substantial life year gains, …”
This is a pretty impressive result until you consider that the Optimistic Scenario is based on a series of assumptions that are of which are inconsistent with empirical evidence to date:
Cigarette smoking prevalence drops from 17% to 5% in 10 years (from 19.3% to 4.6% in men and from $14.1% to 4.6% in women between 2016 and 2026).
The existence of e-cigarettes does not, on average, depress quitting cigarettes.
There is no relapse from e-cigarette use to cigarette smoking.
No youth who initiate with e-cigarettes progress to cigarette use.
No dual use of cigarettes and e-cigarettes.
The evidence free claim that e-cigarettes are 5% as dangerous as cigarettes.
(These assumptions were not clearly stated in the main paper; we figured them out based on the appendix and by examining the Excel spreadsheet of the model that the authors s...
NOT PEER REVIEWED
The paper, “Potential deaths averted in USA by replacing cigarettes with e-cigarettes” by David Levy et al. published in Tobacco Control on October 2, 2017, attracted a moderate amount of attention with its conclusion that “Compared with the Status Quo, replacement of cigarette by e-cigarette use over a 10-year period yields 6.6 million fewer premature deaths with 86.7 million fewer life years lost in the Optimistic Scenario. … Our projections show that a strategy of replacing cigarette smoking with vaping would yield substantial life year gains, …”
This is a pretty impressive result until you consider that the Optimistic Scenario is based on a series of assumptions that are of which are inconsistent with empirical evidence to date:
Cigarette smoking prevalence drops from 17% to 5% in 10 years (from 19.3% to 4.6% in men and from $14.1% to 4.6% in women between 2016 and 2026).
The existence of e-cigarettes does not, on average, depress quitting cigarettes.
There is no relapse from e-cigarette use to cigarette smoking.
No youth who initiate with e-cigarettes progress to cigarette use.
No dual use of cigarettes and e-cigarettes.
The evidence free claim that e-cigarettes are 5% as dangerous as cigarettes.
(These assumptions were not clearly stated in the main paper; we figured them out based on the appendix and by examining the Excel spreadsheet of the model that the authors shared with us in response to an email. Their Pessimistic Scenario is based on similar assumptions, albeit with a higher e-cig risk.)
It is important to recognize that the authors don’t even pretend that their estimates are based on reality. In their Discussion they state: “Unlike previous models of e-cigarette use, our model was not developed to predict future e-cigarette and cigarette use based on past trends. Rather the aim was to examine a hypothetical endgame strategy of reducing cigarette use through switching to e-cigarettes. ”
I used their model to investigate the lives saved if cigarette use dropped along the same trajectory that the authors assumed because of increased smokefree laws, anti-smoking media, higher taxes and achieving smokefree movies without anyone even using an e-cigarette. Doing so (without e-cigarettes) would have saved even more lives – 7.0 million fewer lives lost and 91.4 million fewer life years lost.
The centrality of the first assumption is demonstrated by the fact that, using the Levy et al model (which they provided me as a spreadsheet) requires that e-cigarettes be more dangerous than cigarettes (about 120-130% more dangerous) to end up having a net negative population health impact. This is because they assume huge drops in smoking cigarettes.
In other words, all that this paper shows is that if a lot fewer people smoke, there will be a lot fewer premature deaths from smoking. It contributes absolutely nothing to the discussion of the efficacy of e-cigarettes for harm reduction.
It would be like someone asking what would happen to melting ice sheets if we were to be able to bring greenhouse gasses back to pre-industrial levels in 10 years. The calculation is possible but the results would not contribute anything to public policy because, like the Levy paper, the assumptions are discordant with reality.
Finally, in the Conclusion of their paper Levy et al state that “tobacco industry documents reveal an industry strategy of ‘divide and conquer’ focused primarily on fostering divisions within the tobacco control community regarding modified risk products. Indeed, the tobacco control community has had divided approaches to e-cigarettes, and in the process may have lost focus on cigarettes, the most deadly form of nicotine delivery ... Most important, an e-cigarette substitution strategy provides the justification to redouble efforts to target cigarette use, as called for by the WHO Framework Convention for Tobacco Control.” The authors are, of course, welcome to their opinion. But nothing in this paper provides an empirical support for this argument.
NOT PEER REVIEWED It is disappointing that Robert Proctor’s advocacy for tobacco abolition, so clearly expressed in his magisterial ‘Golden Holocaust’ (2011) and, indeed, in Tobacco Control (1), appears to have been diluted to the same degree that he now seems in favour of diluting the concentration of nicotine in cigarettes. And this in spite of the various potential difficulties he points out in implementing the proposal to reduce nicotine in cigarettes to sub-addictive levels, not least that it could well result in decades-long delays before such cigarettes might eventually replace conventional ones.
I also have argued that the only realistic way to deal with the tobacco problem is through abolition (2). This is easier than it might seem, because, as Robert Proctor himself has said (1):
‘[S]moking is not a recreational drug; most smokers do not like the fact they smoke and wish they could quit.’
Is it not time for tobacco abolition, rather than ‘control’, to become part of the debate?
NOT PEER REVIEWED 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.
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 In the second column of this article, the author describes findings from a survey in Japan (Tabuchi et al, 2016, reference 15). However, there is a misinterpretation of Tabuchi et al’s table 2 which leads to wrong percentages for having tried heat not burn products in Caputi’s article. The figures 8.4% and 7.8% are not the percentages who had ever tried these products in the population but instead percentages out of those respondents who had ever tried an e-cigarette or a heat not burn product.
The actual figures for the population are therefore about 0.6% for iQOS (8.4% of 6.6%) and 0.5% for Ploom (7.8% of 6.6%).
Further information on the ever use of different products by age, gender and smoking status (about 1% of 15-19 year olds had tried each of the two heat not burn products), is found in supplementary table 3 of Tabuchi et al.
NOT PEER REVIEWED
Without citing any sources or providing any related analysis or explanation, this paper makes several sloppy and misleading statements about the scope and impact of federal preemption relating to state and local restrictions of flavored tobacco products.
We know from the preemption provisions in the federal Tobacco Control Act that state and local governments may not regulate the ingredients or characteristics of a tobacco product if the state or local regulation is “different from, or in addition to” an FDA tobacco product standard. [Sec. 916(a)(2)] But we do not yet know how FDA or the courts will interpret or apply that “different from, or in addition to” phrase. For example, it could mean that state and local governments are free to prohibit or limit the use of certain flavorings in certain types of tobacco products unless or until FDA prohibits or limits flavorings for those same types of tobacco products. To assert and publish a more restrictive interpretation of federal preemption with no qualification or clarification is not only misleading but promotes a more restrictive interpretation than necessary or desirable.
The paper also fails to note that the courts have ruled that the Tobacco Control Act’s preemption provisions leave state and local governments free to restrict the sale of flavored tobacco products within their boundaries. [See, e.g., U.S. Smokeless Tobacco v. City of New York, 708 F.3d 428 (2nd Cir., 2013).] The...
NOT PEER REVIEWED
Without citing any sources or providing any related analysis or explanation, this paper makes several sloppy and misleading statements about the scope and impact of federal preemption relating to state and local restrictions of flavored tobacco products.
We know from the preemption provisions in the federal Tobacco Control Act that state and local governments may not regulate the ingredients or characteristics of a tobacco product if the state or local regulation is “different from, or in addition to” an FDA tobacco product standard. [Sec. 916(a)(2)] But we do not yet know how FDA or the courts will interpret or apply that “different from, or in addition to” phrase. For example, it could mean that state and local governments are free to prohibit or limit the use of certain flavorings in certain types of tobacco products unless or until FDA prohibits or limits flavorings for those same types of tobacco products. To assert and publish a more restrictive interpretation of federal preemption with no qualification or clarification is not only misleading but promotes a more restrictive interpretation than necessary or desirable.
The paper also fails to note that the courts have ruled that the Tobacco Control Act’s preemption provisions leave state and local governments free to restrict the sale of flavored tobacco products within their boundaries. [See, e.g., U.S. Smokeless Tobacco v. City of New York, 708 F.3d 428 (2nd Cir., 2013).] 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
Background
E-cigarette is a delusive name for what the product actually is; an electronic vaporization device. Basic parts of an e-cigarette include: a tank containing the liquid to be vaporized, some sort of heating element, a battery to power the device, and a mouth piece. The liquid, often referred to as e-liquid, usually contains a base (for production of thick vapor) and flavor. E-liquid may or may not contain nicotine. The heating element converts the e-liquid into aerosol, which is then inhaled by the user. While many models resemble a conventional cigarette, others look nothing alike. Colloquially referred to vaporizers, such models have become more common in the recent years.
In the western world e cigarettes proposed as a tobacco control strategy for possible nicotine reduction and stressed on policy appraisals of harm and safety on regulation of other ingredients of the products. The related conflicts and controversies of e cigarettes as a contemporary tobacco control are discussed (1).
E-cigarettes began to appear in the Indian market around 2010. Today, E-cigarettes pose a complex challenge for the tobacco stricken country. According to Global Adult Tobacco Survey (GATS) 2010, 34.6% of the Indian adults were current tobacco users with 14% of adults indulging in current tobacco smoking (5.7% current cigarette smokers, 9.2% current bidi smokers) (2). Global Youth Tobacco Survey (GYTS) 2009 estimated current toba...
NOT PEER REVIEWED
Background
E-cigarette is a delusive name for what the product actually is; an electronic vaporization device. Basic parts of an e-cigarette include: a tank containing the liquid to be vaporized, some sort of heating element, a battery to power the device, and a mouth piece. The liquid, often referred to as e-liquid, usually contains a base (for production of thick vapor) and flavor. E-liquid may or may not contain nicotine. The heating element converts the e-liquid into aerosol, which is then inhaled by the user. While many models resemble a conventional cigarette, others look nothing alike. Colloquially referred to vaporizers, such models have become more common in the recent years.
In the western world e cigarettes proposed as a tobacco control strategy for possible nicotine reduction and stressed on policy appraisals of harm and safety on regulation of other ingredients of the products. The related conflicts and controversies of e cigarettes as a contemporary tobacco control are discussed (1).
E-cigarettes began to appear in the Indian market around 2010. Today, E-cigarettes pose a complex challenge for the tobacco stricken country. According to Global Adult Tobacco Survey (GATS) 2010, 34.6% of the Indian adults were current tobacco users with 14% of adults indulging in current tobacco smoking (5.7% current cigarette smokers, 9.2% current bidi smokers) (2). Global Youth Tobacco Survey (GYTS) 2009 estimated current tobacco use among Indian students at 14.6%, with 4.4% students reported to be current cigarette smokers (3). Alarmingly, the survey revealed that 56.2% of students who bought cigarettes in a store were not refused purchase because of their age. Allowing e-cigarettes to remain unregulated in such a setting is assumed by many to be be a recipe for disaster. However, a blanket ban without considering any potential health benefits also not without its cons. The smoking community is likely to feel further marginalized, deprived of what is perceived as an alternative with lower risk profile. (4–6)
E cigarettes in India
Initially, E-cigarettes were available only in a select smoke shops in metropolitan cities. They were generic, low quality models mostly imported from China, where the production had first begun in 2003. Over the years, a wide variety e-cigarettes and vaporizers have become available in many shops across urban areas. It isn’t uncommon to see a couple of low end models stocked in the neighborhood smoke shop.
Internet are rife with e-cigarette listings as well. The price ranges anywhere from 200 INR (~ 3 USD) for disposable models to 10,000 INR (~150 USD) for rechargeable imported ones. The price of entry level models doesn’t pose a significant barrier for adults or for students. A google search yielded more than 20 websites within first 5 pages of results, catering to sale of e-cigarettes and vaporizers, as well as related paraphernalia (7). These are not including the major online marketplaces like Amazon.in and Flipkart.com that too contain a number of listings for e-cigarettes. They can also be easily imported from other countries.
When ITC, the major tobacco player in India, released its first e-cigarette products (under ION brand) in 2014, it did so without seeking any prior approval (8). Earlier during the same year, India’s national carrier, Air India faced an inquiry for advertisement and sale of e-cigarettes to airline customers (9).
Legal Status in India
Under Poisons act, 1919, Nicotine is classified as a poisonous substance. In the form of Tobacco products, its sale is regulated under Cigarette and Other Tobacco Products Act (COTPA, 2003). Sale of Nicotine gums as a method of cessation is regulated under Drugs & Cosmetics Act, 1940. Since COTPA deals exclusively with Tobacco Products, and D&C Act doesn’t explicitly mention electronic Nicotine delivery devices, there exists an unregulated gray space for both the sale and advertisement of e-cigarettes in India.
Several State governments (Punjab, Chandigarh, Karnataka, Kerala and Maharashtra) have since issued a ban against the sale/intent of sale of e-cigarettes (10,11). Impact of these bans remains questionable despite the initial conviction receiving considerable media coverage (11). This is in part due to extensive availability of vaping products in online marketplaces.
When marketed as only flavor delivery devices, containing no nicotine whatsoever, there exists no regulation for manufacture/sale/possession/advertisement of e-cigarettes. This is often used by manufacturers/sellers to circumvent the rudimentary regulations that do exist to restrict sale of nicotine containing products, while offering an end-product with unknown risk profile and no health benefits. Popular online marketplaces like Amazon and Flipkart are flooded with such products.
The Dilemma
A balanced approach into this matter is warranted. COTPA should be appropriately revised to include e-cigarettes. Increasing delay is likely to lead to establishment of a more robust supply chain and consumer base. Furthermore, relevant inquiries must be made to assess the public and individual health impact of e-cigarettes in India.
As of now, it would be imprudent to classify it as anything more than a nicotine and/or delivery product. If anything, such a clean starting position allows us to adequately examine what this product means to different populations, and how closely do these images correlate with the reality.
References
1. Malone RE. Tob Control 2017;26:e1–e2
2.Global Adult Tobacco Survey (GATS) India: 2009-2010. [Last accessed on 20117 Mar 29]. available from: http://www.searo.who.int/LinkFiles/Regional_Tobacco_Surveillance_System_.... published by IIPS, Mumbai and funded by the Ministry of Health and Family Welfare, GOI 2010 .
3. Gajalakshmi V, Kanimozhi CV. A Survey of 24,000 Students Aged 13–15 Years in India: Global Youth Tobacco Survey 2006 and 2009. Tobacco Use Insights. 2010;3:23–3.
4. Berg CJ, Stratton E, Schauer GL, Lewis M, Wang Y, Windle M, et al. Perceived Harm, Addictiveness, and Social Acceptability of Tobacco Products and Marijuana Among Young Adults: Marijuana, Hookah, and Electronic Cigarettes Win. Subst Use Misuse [Internet]. 2015 Jan;50(1):79–89. Available from: http://www.pubmedcentral.nih.gov/articlerender.fcgi?artid=4302728&tool=p...
5. Brose LS, Brown J, Hitchman SC, McNeill A. Perceived relative harm of electronic cigarettes over time and impact on subsequent use. A survey with 1-year and 2-year follow-ups. Drug Alcohol Depend. 2015 Dec;157:106–11.
6. Tomashefski A. The perceived effects of electronic cigarettes on health by adult users: A state of the science systematic literature review. J Am Assoc Nurse Pract. 2016 Sep;28(9):510–5.
7.Google.Lovelites.in, littlegoa.com, vapeadda.com, vapourindia.com, litejoy.co.in, ecigindia.com, purevapors.in, evolvevapors.com, smokefree.in, planetion.in, indiabongs.com, evapeshop.in, esutta.com, ivape.in, vapecircle.com, tygrtygr.in, greenvapo.com, indianvapegarage.in, ecigarettecart.com, vape.co.in, vapin.in, epuff.in, ivapeindia.com, beyondvapeindia.com
[Retrieved 2017 Apr 1]
8.http://www.business-standard.com/article/companies/itcs-e-cigarettes-lik... Business Standard. 2014. [Retrieved 2017 Apr 1]
9.http://timesofindia.indiatimes.com/india/E-cigarette-sale-on-Air-India-f... Times of India. 2014 [Retrieved 2017 Apr 1]
NOT PEER REVIEWED
The editors of this journal, Tobacco Control, and specifically the authors of the editorial “Blog fog? Using rapid response to advance science and promote debate” [1] highlight the need - or requirement, depending on the viewpoint - of utilising a specified platform to debate the finer points of an article.
From an academic standpoint, individuals that have an interest in a specific field of study - such as Tobacco Control - will see, and respond to, such articles in the appropriate manner. However, one of the pitfalls prevalent in any rapid response platform, and this isn’t limited to the journal Tobacco Control, is the necessity of the journal’s guidelines to adhere to a specific writing format. This does have some advantages in keeping the debate over an article related exclusively to the article. However, there are some respondents that prefer to write an unabridged version of a critique lest the comment not pass the rapid response system for publication.
There are several advantages to publishing a critique of an article outside the rapid response system [2] that allows for a broader audience to read and respond to both the article content and the critique.
Personal blogs often reflect the style of the author, and also allow for greater freedom of expression including the use of imagery to illustrate vital points that many readers find both enjoyable and informative.
Providing a platform within the journal must allo...
NOT PEER REVIEWED
The editors of this journal, Tobacco Control, and specifically the authors of the editorial “Blog fog? Using rapid response to advance science and promote debate” [1] highlight the need - or requirement, depending on the viewpoint - of utilising a specified platform to debate the finer points of an article.
From an academic standpoint, individuals that have an interest in a specific field of study - such as Tobacco Control - will see, and respond to, such articles in the appropriate manner. However, one of the pitfalls prevalent in any rapid response platform, and this isn’t limited to the journal Tobacco Control, is the necessity of the journal’s guidelines to adhere to a specific writing format. This does have some advantages in keeping the debate over an article related exclusively to the article. However, there are some respondents that prefer to write an unabridged version of a critique lest the comment not pass the rapid response system for publication.
There are several advantages to publishing a critique of an article outside the rapid response system [2] that allows for a broader audience to read and respond to both the article content and the critique.
Personal blogs often reflect the style of the author, and also allow for greater freedom of expression including the use of imagery to illustrate vital points that many readers find both enjoyable and informative.
Providing a platform within the journal must allow for reasoned debate, including contrary opinions. It is widely regarded within non-academic circles that some responses don’t get published due in large part to the contrary nature of the response. Would the editors of the journal be comfortable with constructive guidance for non-academic parties to respond to articles published?
This seems to be an unlikely proposition and will only serve to reinforce a lack of trust and transparency in the journal. Blogging is a good practice at writing in an accessible way, academic publications should be accessible too.
References:
[1] O’Connor R, Gartner C, Henriksen L, et al Blog fog? Using rapid response to advance science and promote debate Tobacco Control 2017;26:121 - http://tobaccocontrol.bmj.com/content/26/2/121
NOT PEER REVIEWED This seems a good case for encouraging rechargeable cigalikes and 3rd generation refillable systems in the locations that charge a low cigarette tax.
This is a test message to ascertain if BMJ and Tobacco Control have gotten the rapid response feature up and running. If so this message should appear and those scientists globally wanting to file responses will be immediately alerted that this is now possible. The essence of any critique I personally may have with the BlogFog article is summarized in my declarations of intellectual COI. Submitted March 2nd, 2017.
NOT PEER REVIEWED
The editors of this journal, Tobacco Control, argue in their blog that debate about published articles should be concentrated on their rapid reaction facility. It is possible that they are making a constructive invitation to their critics to join a debating platform they might otherwise be wary of. However, the blog has been widely read as disparagement of other forms of engagement, notably social media and blogs. It is possible that the editors do not fully appreciate why people use blogs and social media to respond to papers they find problematic, and not Tobacco Control's rapid response feature. Here are several reasons:
1. Trust
Critics may consider, rightly or wrongly, that Tobacco Control has a track record of publishing papers that have dubious scientific merit, overconfident conclusions and policy recommendations that cannot be supported by the paper - almost always reinforcing a particular (abstinence-only) perspective. Critics may be concerned that their work will be treated unfairly or sidelined, or that they will be judged or ridiculed. They may distrust the editors, believe the journal is not impartial, or hold it in low esteem.
2. Conflict of interest and incentives
Not everyone is content to have their reactions edited or approved by the same people whose work they are criticising. Once a journal has published an article that is open to criticism, it develops a conflict of interest between its own r...
NOT PEER REVIEWED
The editors of this journal, Tobacco Control, argue in their blog that debate about published articles should be concentrated on their rapid reaction facility. It is possible that they are making a constructive invitation to their critics to join a debating platform they might otherwise be wary of. However, the blog has been widely read as disparagement of other forms of engagement, notably social media and blogs. It is possible that the editors do not fully appreciate why people use blogs and social media to respond to papers they find problematic, and not Tobacco Control's rapid response feature. Here are several reasons:
1. Trust
Critics may consider, rightly or wrongly, that Tobacco Control has a track record of publishing papers that have dubious scientific merit, overconfident conclusions and policy recommendations that cannot be supported by the paper - almost always reinforcing a particular (abstinence-only) perspective. Critics may be concerned that their work will be treated unfairly or sidelined, or that they will be judged or ridiculed. They may distrust the editors, believe the journal is not impartial, or hold it in low esteem.
2. Conflict of interest and incentives
Not everyone is content to have their reactions edited or approved by the same people whose work they are criticising. Once a journal has published an article that is open to criticism, it develops a conflict of interest between its own reputation and the pursuit of truth. Editors have personal and professional incentives not to look foolish or be shown up for the failure of peer review or editorial quality control. Critics may suspect that in the moderation process, editorial judgements of criticisms will be pedantic and be more concerned with the reputation of authors and the journal and be less concerned with an accurate reflection of the views of critics.
3. Style and expression
Many people prefer to communicate in their own style and not adopt the convoluted and opaque vernacular of science journal writing. They may have different types of knowledge and experience and wish to communicate in their own way. They may wish to adopt a more journalistic style or write in a way that encourages understanding. They may wish to be funny, satirical and engaging as well as rigorous. It may be a false perception that their voice is unwelcome, but it is not a surprising one. They may have their own audience which follows their commentaries, and they may wish to write for that audience.
4. Substantive reactions
Critics may wish to write at greater length and with more sophistication than a rapid response allows for, but not submit a paper for publication and wait months and spend many hours responding to poorly conceived or tactically obstructive questions from reviewers. They may not wish to have their work locked behind a paywall. They may wish to include graphics or formatting. In my own case, I wrote a comprehensive critique on my blog of the ['tobacco endgame' proposals published in 2013. There is no way I could spend months writing that up for publication in Tobacco Control, and the end result would have been a pale imitation of the original had I done so.
5. Responsiveness
Critics may be responding to 'moral panics' or media frenzies created by over-hyped science published in the journal. In this case, they need to respond rapidly and have the means to compose and publish according to their own timetable. They may wish to provide an initial reaction and then update it or add in other reactions. The "within 7-14 days" response time promised for publishing 'rapid reactions' is not consistent with the way news is consumed and commentary produced in the present era.
Other concerns include the following:
1. Wrong criteria for assessing the value of challenge
The dismissal of media other than the one preferred by and controlled by the journal's editors is disappointing. Surely, in public health, it should be the 'public' that decides where the debate is held? If criticism or insight is serious and thoughtful, then academics or editors should engage, because that's where the discussion is taking place. The journal has applied the wrong criteria by picking what sort of platform it is prepared to engage on. The decision should be based on the quality and seriousness of the criticism, not where it is produced or who produces it.
2. Self-limiting access to knowledge and insight
There is much high quality and readable analysis that is at least as valuable in intellectual depth, insight and accessibility as much formal publishing in this field [1] below. There are also trenchant and valid criticisms about motivation, ethics, intellectual quality, framing, inexperience etc on many other blogs that are well worth engaging with for anyone who wishes to - often these are opinion-formers. It is a mistake to believe that the real debate takes place in journals and everything else is just ignorant noise - it is a place to look for different insights. A bigger mistake is to disengage from 21st-century ways of communicating and sharing public knowledge. In other fields, this type of discourse is flourishing.
3. Where is the driven curiosity?
This is a critical field in which hundreds of millions of lives are at stake, and the pursuit of insight and the right thing to do should be relentless. I find it inexplicable that anyone involved should wish to shut themselves off from any form of engagement that that offers any useful insight. Where is the hunger for knowledge, the curiosity, the willingness to understand the views of people who are often the subject of study and often know far more than those doing the studying? Why would editors not want to be exposed to the feelings and adverse reactions to the research that is published in this journal? Why would they not engage more, instead of withdrawing?
Personally, I am committed challenging poor quality papers in whatever forum I can. I will continue to blog about them and expand my use of PubMed Commons, a neutral space for informed criticism. If Tobacco Control's rapid response platform provides a richer exchange, then I will try that.
NOT PEER REVIEWED The authors of this editorial assert that a journal article’s authors are “entitled to be aware of and respond to critiques”, and imply that this is only possible if critiques appear in a forum attached to the journal. Setting aside the fact that authors can easily become aware of and respond to critiques on other forums, I am curious if the authors could offer some basis for claiming such an entitlement? It seems quite contrary to all existing laws, principles of ethics, cultural norms, and standard practices that relate to commentary about published work. Moreover the behavior of many of these very authors suggests they are willing to go to great lengths to avoid being made aware of critiques.
It seems safe interpret the statement as saying that at least these particular authors would like responses to their work to appear on this page. And so, I am fulfilling their request. (Assuming this is allowed to appear, that is. I say that not because I believe there is anything in this comment that would warrant censorship, but to emphasize the blindness of this process. That is, the commentator really has no idea what will be allowed to appear.) I call the authors’ attention to two blog posts I have written critiquing this editorial to ensure they have the requested opportunity to be aware: https://antithrlies.com/2017/02/20/editors-of-t...
NOT PEER REVIEWED The authors of this editorial assert that a journal article’s authors are “entitled to be aware of and respond to critiques”, and imply that this is only possible if critiques appear in a forum attached to the journal. Setting aside the fact that authors can easily become aware of and respond to critiques on other forums, I am curious if the authors could offer some basis for claiming such an entitlement? It seems quite contrary to all existing laws, principles of ethics, cultural norms, and standard practices that relate to commentary about published work. Moreover the behavior of many of these very authors suggests they are willing to go to great lengths to avoid being made aware of critiques.
It seems safe interpret the statement as saying that at least these particular authors would like responses to their work to appear on this page. And so, I am fulfilling their request. (Assuming this is allowed to appear, that is. I say that not because I believe there is anything in this comment that would warrant censorship, but to emphasize the blindness of this process. That is, the commentator really has no idea what will be allowed to appear.) I call the authors’ attention to two blog posts I have written critiquing this editorial to ensure they have the requested opportunity to be aware: https://antithrlies.com/2017/02/20/editors-of-tobacco-control-admit-they...https://antithrlies.com/2017/02/22/more-on-tobacco-controls-stop-talking... . In those posts I expand a bit on what appears in this submission. I welcome responses to anything in them, either here, in the blog’s comments sections (I promise their comments will not be censored), or wherever else. However, no familiarity with those posts is necessary to respond to the following questions.
The authors declare “a policy that editors will not respond to external blog posts or social media messages about specific studies.” This statement implies that in the past they have provided such responses. However, I am quite familiar with the scholarly blogs (my own and others’) that often criticize papers that appear in Tobacco Control, and cannot recall a single occasion in which an editor of this journal responded. With the exception of the editorial’s last author occasionally engaging in Twitter conversations about articles — a format which precludes serious debate — I am not aware of any social media engagement. Thus I would like to ask the authors to support their implication by characterizing how often actions that are precluded by this policy actually occurred in the past, and to provide a few examples.
The authors state, “Occasionally, an individual who has written a postpublication critique has declined invitations to review similar papers prepublication.” I am one author of such critiques, and highly qualified to review research papers, but have never once been invited to review for Tobacco Control. I am in close communication with other such individuals, and would be surprised to learn that they have received any such invitation. So I would like to ask for clarification: Is the claim here that on a single occasion, Tobacco Control asked someone to review a paper, but s/he declined, and then wrote a critique after it was published? Or did that happen twice, three times, or more? Or does this merely mean that someone who was once invited to review *some* paper at the journal, and declined, later write a critique of another paper the journal published (thus the use of the word “similar”)?
The authors state: “As noted above, the Rapid Response process provides a forum for exploring such issues. In contrast, placing personal blog posts or social media messages complaining about a study, alleging flaws in the review process, or making ad hominem attacks on authors or editors do not advance the field or allow an appropriate scientific dialogue and debate.” I have several questions about this:
Should we interpret this to mean that the Rapid Response process will censor any attempt to post something that “complains” about a paper or identifies flaws in the review process? Taken on its face, this seems to preclude literally any important criticism. If a commenter observed, say, that a causal inference suffers from enormous residual confounding, which was not acknowledged by the authors, and which renders the conclusions in the paper unsupported, how is that not a “complaint” about the paper? If the identified flaw is apparent to the reader, how is that not also an allegation of a flaw in the review process that allowed the paper to be published with that flaw? Some clarification is needed.
Are the authors of the editorial simply saying they object to *explicit* statements about the failures of the review process, and are saying that these are forbidden from this page? And thus the implicit indictment of the review process from noting there is a major flaw in a paper is acceptable? But would noting a major flaw still constitute a “complaint”? If not, what does?
I am also curious about what ad hominem attacks the authors are referring to. Those of us who criticize tobacco control are quite familiar with the experience ad hominem attacks on our analyses (or, more often, as rationalizations for simply ignoring our analyses). Indeed, such attacks are far more common than substantive criticisms of our work. By contrast, I cannot recall any cases of scholarly blogging critics of a paper in Tobacco Control or other tobacco control papers who have descended to ad hominem attacks. I would like to ask the authors to provide examples to support this allegation. (I will offer the reminder that drawing conclusions about an author or journal based on a paper is, roughly speaking, the opposite of an ad hominem attack. An ad hominem attack would consist of criticizing or dismissing a paper based on the identity or characteristics of the authors or journal.)
Finally, the authors state: “Our role is to facilitate the processes of peer review, transparency and accountability which underpin the legitimacy and independence of academic research.” I am curious about what transparency they are claiming. It appears to me that the journal (in keeping with common practice in this field) sends out papers to reviewers who are chosen based on a non-transparent basis, keeps those reviewers anonymous and the reviews secret, and then makes a decision to publish based on non-transparent criteria. Yes, there are some published statements about what is considered in this process, but they are sufficiently vague that they seem to preclude or guarantee nothing. Am I wrong about this? If not, what transparency is the editorial referring to?
More immediately relevant, there is no apparent transparency in the decision about whether to publish a particular Rapid Response submission. Again, there are guidelines which seem sufficient vague that they would allow an ad hoc decision in either direction about most any submission. It seems rather unreasonable to ask commentators to take the time and effort to submit to a system with vague requirements, particularly given the suggestion that merely “complaining” about a paper is grounds for censorship. Again, clarification is needed if, as the editorial claims, this page is a legitimate forum for serious debate.
I will suggest that a genuinely transparent rule would take a form like the following: Should a reader wish to post a comment on my blog, it will appear, unedited, so long as it is on topic. I suppose I would refuse to post a comment that was utterly outlandish — that, say, ranted about the sexuality of a paper’s author, or alleged criminal behavior — but I have never been forced to make such a decision. I will further note (as I have stated previously) that if authors or editors of a paper that I am criticizing wish to comment, I will allow them to say literally anything they want. I suspect the same transparent rules apply to my fellow scholarly bloggers.
NOT PEER REVIEWED
While I would agree that comments that are directly applied to the article in question are better than blogs scattered across the internet, this policy is entirely dependent on the willingness of editors to publish critical comments that may not be formatted or composed in a style that they are entirely comfortable with. Will editors provide feedback to, for example, citizen activists on why their comments were not published, and how they could change them to make them more acceptable? This seems unlikely, and will only reinforce the perceived inequality of position.
I would also be moved to wonder how editors will deal with rapid responses that link to lengthier works elsewhere? For example, the format of the rapid response does not lend itself well to appending images, which can often be useful to highlight problems.much more effectively than text.
A more likely outcome of this policy is, I fear, an increasing separation into two echo chambers with no overlap, and with far too little exchange of thoughts between the proponents and opponents of vaping, to the detriment of the vast majority who are neither,
NOT PEER REVIEWED This ad watch shows an interesting example of illegal marketing
activity of an e-cigarette company in Korea. However, the description of the trend of
e-cigarette prevalence among Korean adolescents is not correct. According
to the national annual surveys that the author quoted (reference 4),
prevalence of current (30-day) e-cigarette use among Korean adolescents was
4.7% in 2011 and 5.0% in 2014. It decre...
NOT PEER REVIEWED This ad watch shows an interesting example of illegal marketing
activity of an e-cigarette company in Korea. However, the description of the trend of
e-cigarette prevalence among Korean adolescents is not correct. According
to the national annual surveys that the author quoted (reference 4),
prevalence of current (30-day) e-cigarette use among Korean adolescents was
4.7% in 2011 and 5.0% in 2014. It decreased continuously after then, and it
was 4.0% in 2015 and 2.5% in 2016. Even though there have been active
marketing activities by e-cigarette companies, strict regulations on e-
cigarettes enacted by the Korean government (i.e. tax levy, ban on sales to minors,
restriction of use in public places, and restriction of advertisement,
promotion and sponsorship) hindered increase of or even reduced e-
cigarette prevalence among Korean adolescents.
NOT PEER REVIEWED Back when I used to own property with several hundred feet highway
frontage, I was distressed to find and pick up an average of 50 or more
butts along my property every time I walked the perimeter.
I thought about the bottle deposit idea as a solution, but many
simply won't care and the unrefunded deposits end up as an added profit
for the manufacturer.
NOT PEER REVIEWED Back when I used to own property with several hundred feet highway
frontage, I was distressed to find and pick up an average of 50 or more
butts along my property every time I walked the perimeter.
I thought about the bottle deposit idea as a solution, but many
simply won't care and the unrefunded deposits end up as an added profit
for the manufacturer.
Why not mandate a special plastic baggy inserted in every pack for
returning the butts directly back to the manufacturer?
The smoker must return a bag of 25 butts for every pack of 20
cigarettes purchased.
Sized to specifically hold 25 butts with a zip seal end.
The retailer does not have to handle the butts, but at a mere glance can
see that it holds 25 butts when full. The retailer can reject any pack
that is not filled correctly.
The retailer can just toss the collected bags in a container picked
up by the wholesaler.
The wholesaler must collect a butt pack for every pack they sell to
the retailer.
The wholesaler must return a butt pack to the manufacturer for every
pack they buy to distribute.
There is no added profit to leave behind for those uncollected
deposits.
The manufacturer is held directly responsible for disposing of the
butts.
The smoker is forced to go out and collect 5 more butts than they get
in a pack.
This means the smokers clean up their own mess and the manufacturer
is forced to pay for the disposals.
NOT PEER REVIEWED Why is the LGBT at greater health risk?? and why was it necessary to
even add that?? This makes me very upset that we are "targeted" as such!
How is this.. or was this part of the study?
NOT PEER REVIEWED David Bareham cites 'Rip Tripper' as evidence that e-cigarette users
report experiences of allergies being exacerbated in non users by vapour
and describes Mr Tripper's subsequent rather mangled argument that the
devices should not be used in enclosed public spaces as "eloquent".
Perhaps Mr Bareham is unaware that Mr Tripper has also claimed that
vaping causes limb cramps and dry knuckles which...
NOT PEER REVIEWED David Bareham cites 'Rip Tripper' as evidence that e-cigarette users
report experiences of allergies being exacerbated in non users by vapour
and describes Mr Tripper's subsequent rather mangled argument that the
devices should not be used in enclosed public spaces as "eloquent".
Perhaps Mr Bareham is unaware that Mr Tripper has also claimed that
vaping causes limb cramps and dry knuckles which was a surprise to most
vapers, until they spotted the affiliate link to where they could purchase
electrolytes and a lotion to 'cure' them (1).
(1) 'Rip Trippers exposed as a sellout' Jh Reviews
https://youtu.be/F1EJkbM0m7g (contains profanity)
Conflict of Interest:
I am a trustee of NNA(UK) which is a consumer driven charity which aims to improve health by increasing awareness and understanding of reduced risk alternatives to smoked tobacco.
NOT PEER REVIEWED I would like to point out a few disturbing inaccuracies in the methodology and interpretation.
Since the health variable is binary, the authors apply "Wagstaff's correction" to the Concentration Index. This is a perfectly legitimate decision, but the authors mistakenly suggest that this correction can be applied to both the relative and the absolute version of the index, yielding two normalized indices. In fact,...
NOT PEER REVIEWED I would like to point out a few disturbing inaccuracies in the methodology and interpretation.
Since the health variable is binary, the authors apply "Wagstaff's correction" to the Concentration Index. This is a perfectly legitimate decision, but the authors mistakenly suggest that this correction can be applied to both the relative and the absolute version of the index, yielding two normalized indices. In fact, there is only one Wagstaff index, which can be expressed as W = RC/(1-m) = AC/[m(1-m)], with m = prevalence. All the results which are presented under the heading "Absolute concentration index" in Table 2 and as "AC" in Table 3 are therefore irrelevant. These results refer to the index mW which nobody has ever used in the literature. It follows that the decomposition formula (6) of the paper is redundant.
Similar remarks hold for the application of the alternative "Erreygers correction". The correction leads to one index, not two as suggested by the authors. The index can be written as E = 4mRC = 4AC. As a consequence, the results presented under the heading "Absolute concentration index" in Table A.1 of the supplementary online material are irrelevant. They refer to the index mE, which is not the one defined by Erreygers.
After a brief comparison of the Wagstaff and Erreygers indices the authors conclude that "the calculated RC and AC informed qualitatively similar inference" (p. 9). Since E = 4m(1-m)W, the values of E and W clearly will be positively correlated, and the more strongly so if the variation in prevalence is limited. For the whole population, the (unweighted) average of m is 0.28, and the standard deviation 0.19. As expected, the correlation of E and W is high, but not perfect: the coefficient of correlation is 0.8815, and the rank correlation coefficient 0.8726. Nevertheless, countries such as Liberia, Bangladesh and Benin, make large jumps in the rankings if inequality is measured by one index rather than the other. At least for these countries, it may be doubted whether the results are "qualitatively similar".
When it comes to the calculation of the between-group and within-group shares, it makes no difference whether the Wagstaff or Erreygers index is used. The main problem here is that any rank-dependent index is not subgroup decomposable. There is always a residual term, which may be quite large. Because of this, the decomposition results presented in the paper are unreliable.
NOT PEER REVIEWED When it comes to vaping my knowledge is somewhat advanced, in the
hardware aspect I am in the forefront of technology, I test prototypes and
beta models for manufacturers all around the globe, I also have acquired
quite a bit of knowledge when it comes to the creation of flavors.
There's a big difference between something you like and what is
referred to an "All Day Vape" or ADV and the impact t...
NOT PEER REVIEWED When it comes to vaping my knowledge is somewhat advanced, in the
hardware aspect I am in the forefront of technology, I test prototypes and
beta models for manufacturers all around the globe, I also have acquired
quite a bit of knowledge when it comes to the creation of flavors.
There's a big difference between something you like and what is
referred to an "All Day Vape" or ADV and the impact that has on quitting
successfully is quite dramatic.
I have this one flavor I make that I absolutely love, it's Caramel
Apple Crumble with a bit of Creamy Custard, but like many other vapes it's
just too decadent for anyone to vape all day much like chocolate flavors
generally are. Just because you enjoy it doesn't mean you can tolerate it
all day and that can determine your chances at a successful quit attempt.
The flavors used in the study appear to be much generic to yield
results that would reflect the current market as most of it is filled with
much more complex mixes and many variations of each flavor..
There are many variations of flavors that taste like different brands
of cigarettes or candy and fruits, if a smoker were to try a tobacco blend
that tasted like their brand of cigarette their chances at a successful
quit attempt would be much higher than if they tried another variation.
Flavor is by far the most important aspect of a successful quit
attempt when it comes to vaping, once a person finds 1 or 2 flavors they
can enjoy all day they then need to find a device with the vapor
production they are looking for and the appropriate nicotine level to suit
it.
Personally when I first decided to give vaping a shot I tried over
twenty flavors many of which I thought I would enjoy but didn't, I ended
up with two flavors Strawberry Creme and Skittles, SBC all day and Sk
when I felt like something a little more sweet...
The ability to allow people to sample flavors is very much the key to
their success, if I were not allowed and went with what I thought sounded
good I would still be smoking today.
NOT PEER REVIEWED
This is not a particularly well constructed argument. In particular, the paragraph that states:
"If ENDS emissions were really benign, indoor vaping advocates should take courage and call for it to be allowed in classrooms, crèches, hospitals and neonatal wards. That they do not rather suggests that they know well that such a position would be irresponsible."
is possibly the worst excuse for a genuine point of debate it has ever been my misfortune to encounter. it is not even a particularly well constructed straw man.
Many things are considered normal and appropriate for the general population that would not be considered appropriate for a crèche, classroom or neonatal ward.
To use merely the first two examples that sprang to mind (and the list is almost endless):
Incense sticks are widely used, and despite the clear emission of smoke, they are are not banned, or the subject of proposed bans, in most jurisdictions. Many people use them, but I doubt that any would do so in a crèche or neonatal ward. Yet, if we follow the same logic proposed here, this means that they are dangerous, and should be banned almost universally.
Similarly, fog machines are widely used in stage shows, nightclubs and even teenage discos. Despite the extremely strong similarity with vaping, both in chemical composition and particle size, there are not widespread calls for fog machines to be banned (I'm certainly not aware of...
NOT PEER REVIEWED
This is not a particularly well constructed argument. In particular, the paragraph that states:
"If ENDS emissions were really benign, indoor vaping advocates should take courage and call for it to be allowed in classrooms, crèches, hospitals and neonatal wards. That they do not rather suggests that they know well that such a position would be irresponsible."
is possibly the worst excuse for a genuine point of debate it has ever been my misfortune to encounter. it is not even a particularly well constructed straw man.
Many things are considered normal and appropriate for the general population that would not be considered appropriate for a crèche, classroom or neonatal ward.
To use merely the first two examples that sprang to mind (and the list is almost endless):
Incense sticks are widely used, and despite the clear emission of smoke, they are are not banned, or the subject of proposed bans, in most jurisdictions. Many people use them, but I doubt that any would do so in a crèche or neonatal ward. Yet, if we follow the same logic proposed here, this means that they are dangerous, and should be banned almost universally.
Similarly, fog machines are widely used in stage shows, nightclubs and even teenage discos. Despite the extremely strong similarity with vaping, both in chemical composition and particle size, there are not widespread calls for fog machines to be banned (I'm certainly not aware of any such calls by the authors of this article).
Does this mean that they would support the use of fog machines or incense stick in crèches and neonatal wards?
Somehow, I strongly doubt it.
Does this mean that they would support a ban on fog machines in smoke free public places? It doesn't seem particularly likely.
Logic does not easily allow us to conclude that because we feel something is not appropriate for places occupied by the most vulnerable of populations it should be more universally prohibited, nor that something we do not feel should be so prohibited is suitable for such populations.
Nor is it the case that any rational advocate for electronic cigarettes would claim that they are "benign". Every exposure has a risk attached to it. Some, like smoking, are massive risks while others, like a bacon sandwich, are not. Yet, in a debate as facile as this one, both can be stated to be carcinogenic. While this is indeed true in an absolute sense, equating the two would not be responsible risk communication, nor should it be an acceptable message to communicate to the public. It is not sufficient to identify a risk - some indication of the magnitude of it is also required.
So it is with the use of electronic cigarettes. Are they entirely, absolutely, risk free? Of course not. Do they have a good evidence base for positive risk/benefit? Yes.
One of the key benefits of electronic cigarettes is that vaping has been embraced and promoted by former smokers to their peers. No comparable culture exists for NRT products or unassisted quitting. Yet far from being encouraged, or even merely ignored, scorn is poured on these evangelical ex-smokers, notably by one of the authors of this article.
Some perspective is much needed, but this article will not provide it. It is, perhaps, telling that I feel my pre-existing view on harm reduction is an ideological COI, which it certainly is, and have listed it as such. The authors did not feel similarly inclined to declare theirs.
Positions are becoming increasingly entrenched, but a bastion of ideology makes it hard to change position when the evidence indicates a change is justified. There is much common ground between the two sides, yet increasingly it is a shell scarred no-mans land where people are afraid to stick their head above the parapet for fear of being attacked. Bitterness and mistrust is being generated by, and on, both sides of the debate, but who benefits from this hostility? It's not current or former smokers, it is neither Public Health or the health of the public. The only winners are likely to be the equally entrenched and embattled tobacco industry. Nobody wants that.
We need to move beyond facile arguments and veiled hostility to a sensible and rational debate. We all want less people to smoke, and less lives to be lost or marred. Articles like this do not - cannot - help.
NOT PEER REVIEWED The American Indoor Hygiene Association (AIHA) i.e. Experts in in
this particular field on passive exposure, have, previously, concluded
conversely to Bauld et al (1). As they state:
"If the only individual affected by using e-cigarettes were the
vaper, the discussion could end here. That is not, however, the case.
Similar to secondhand smoke, the ingredients exhaled by the vaper include
nicot...
NOT PEER REVIEWED The American Indoor Hygiene Association (AIHA) i.e. Experts in in
this particular field on passive exposure, have, previously, concluded
conversely to Bauld et al (1). As they state:
"If the only individual affected by using e-cigarettes were the
vaper, the discussion could end here. That is not, however, the case.
Similar to secondhand smoke, the ingredients exhaled by the vaper include
nicotine, metals, flavorings, and glycol that accumulate in the ambient
air. Recipients of secondhand vapor have not chosen to - many, in fact,
have explicitly chosen not to - use e-cigarettes. The exposure to
secondhand vapor, just like secondhand smoke, raises issues of involuntary
exposure and competing rights. This is even more critical for groups that
may be, and probably are, more susceptible to adverse effects of
secondhand vapor, including children, pregnant women, and people with
already compromised health, some of whom may have limited ability to leave
the spaces in which vaping occurs or has occurred."
This scientific postulation of second-hand inhalation of e-cigarette
aerosol and subsequent adverse health effects has been further
substantiated: via users of e-cigarettes, in their own personal, real-
world experiences (2). They subsequently, and eloquently argue, that the
devices should not be utilised in enclosed public spaces, due to these
events occurring.
Linda Bauld has previously argued in an extended article that:
". . . there is no good evidence that [second hand] exposure is
harmful to bystanders . . . To argue otherwise is just factually
incorrect." (3)
However, the phrase "harmful to bystanders" provides a hyperlink to a
review paper (4) of the potential for second hand exposures that,
incongruently to Professor Bauld's claim, concludes that e-cigarettes:
". . . impart a LOWER potential disease burden than conventional TCs"
(my emphasis)
I.E. therefore, NOT zero potential disease burden.
It is to be commended that Bauld et al wish to enhance the potential
for adult smoking cessation maximally, however, in this case, there IS
evidence that such a policy of non-restricted use potentially infringes
the rights of non-users to avoid passive inhalation and subsequent adverse
health effects, as the AIHA postulate, and as users of e-cigarettes have
confirmed in real-world conditions.
1) American Industrial Hygiene Association:
https://www.aiha.org/government-
affairs/Documents/Electronc%20Cig%20Document_Final.pdf
2) "Vaping e-cigs in public" Available at:
https://www.youtube.com/watch?v=6c5Ln69hWUc
3) Linda Bauld (2015). Available at:
https://www.theguardian.com/science/sifting-the-
evidence/2015/feb/23/theres-no-evidence-e-cigarettes-are-as-harmful-as-
smoking
4) Oh, A. & Kacker, A. 2014 Do electronic cigarettes impart a
lower potential disease burden than conventional tobacco cigarettes?
Review on E-cigarette vapor versus tobacco smoke. Laryngoscope
124(12):2702-6. doi: 10.1002/lary.24750. Epub 2014 Oct 9.
David Bareham
"All views are my own and do not necessarily reflect those of my
employer"
Conflict of Interest:
I have 3 presentations to local clinicians in Lincolnshire within the last 18 months entitled:
"E-cigarettes: update on evidence", organised by GlaxoSmithKline. No payment was requested nor provided for this work.
NOT PEER REVIEWED Bauld et al [1] draw an analogy between indoor vaping and the use of
bronchodilators for asthma ("if and when vapour products with a medicinal
license become available, it will be important to allow their use indoors,
just as asthma inhalers, which dispense a drug and propellants into the
atmosphere, can be used indoors.")
NOT PEER REVIEWED Bauld et al [1] draw an analogy between indoor vaping and the use of
bronchodilators for asthma ("if and when vapour products with a medicinal
license become available, it will be important to allow their use indoors,
just as asthma inhalers, which dispense a drug and propellants into the
atmosphere, can be used indoors.")
Surely, they cannot be serious here?
Newman et al showed the amount of dosed drug exhaled by asthmatics
ranged from just 0.2%-1.7% across different puffing behaviours [2]. A
typical person who uses an asthma puffer would be unwise to use it more
than 4-6 times a day [3] whereas vapers can take up to 610 puffs a day,
with an average of around 200 [4].
Conversely, the objective of many ENDS users is the absolute
opposite. As this article puts it "At the end of the day, Sub Ohm vaping
comes down to three words: big ass clouds" [5] Etter [6] notes that
"These newer devices deliver more power, more cloud density, [my emphasis]
more intense flavors and a better 'throat hit' than older models."
With this generation of ENDS becoming more popular, we would expect
to see clouding increase. As we know [7], many vapers in a room can send
particle counts above those recorded in room where smoking is allowed.
There is simply no comparison between the asthma medication and
propellant a few asthmatics might exhale into (for example) a crowded bar
over a few hours and what potentially dozens of vapers could generate in
the sort of exuberant clouding sessions that vaping in bars can entail.
And unlike vapers, asthmatics do not participate in asthma puffer social
events.
This vaper puts things plainly
https://www.youtube.com/watch?v=6c5Ln69hWUc
References
1. Bauld L, McNeill A, Hajek P, Britton J, Dockrell M. E-cigarette
use in public places: striking the right balance. Tob Control 2016;
doi:10.1136/tobaccocontrol-2016-053357
2. Newman SP, Weisz AWB, Talaee N, Clarke SW. Improvement of drug
delivery with a breath actuated pressurised aerosol for patients with poor
inhaler technique. Thorax 1991; 46:712-16.
3. Partners Healthcare. Asthma Center. Chapter 33: How many times a
day can I safely use my bronchodilator inhaler?
http://www.asthma.partners.org/NewFiles/BoFAChapter33.html
4. Martin E, Clapp PW, Rebuli ME et al . E-cigarette use results in
suppression of immune and inflammatory-response genes in nasal epithelial
cells similar to cigarette smoke. merican Journal of Physiology - Lung
Cellular and Molecular Physiology Published 10 June 2016 Vol. no. , DOI:
10.1152/ajplung.00170.2016
5. Kriegel D. What is sub ohm vaping? Our sub ohm vaping guide &
tips http://vaping360.com/what-is-sub-ohm-vaping-and-the-dangers-of-sub-
ohm-vapes/ 2015;May 26.
6. Etter J-F. A longitudinal study of cotinine in long-term users of
e-cigarettes. Drug and Alcohol Dependence 2016;160:218-221.
7. Soule EK, Maloney SF, Spindle TR, et al. Electronic cigarette use
and indoor air quality in a natural setting. Tob Control 2016;???.
doi:10.1136/tobaccocontrol-2015-052772
NOT PEER REVIEWED The Internet is widely used source for purchasing and selling products.
However,purchasing tobacco products online is a new trend. The internet
vendors are often exempted from taxes leading to lowering the cost of cigarettes
in certain countries.This is a really alarming situation as it would lead to
increase in sales of tobacco products due to lower prices. Countries need
to check this trend otherwise al...
NOT PEER REVIEWED The Internet is widely used source for purchasing and selling products.
However,purchasing tobacco products online is a new trend. The internet
vendors are often exempted from taxes leading to lowering the cost of cigarettes
in certain countries.This is a really alarming situation as it would lead to
increase in sales of tobacco products due to lower prices. Countries need
to check this trend otherwise all the gain achieved till now through
legislation and commitments to reduce tobacco consumption could be lost.
NOT PEER REVIEWED
In the last decade, electronic cigarettes (EC) have become
increasingly popular in particular among smokers. Most EC users choose to
use nicotine containing liquids (electronic nicotine delivery system,
ENDS); these ENDS can be considered as similar to nicotine replacement
therapies. Among the several questions EC use raises, one is of major
importance: Are EC a smoking cessation aid and if yes to...
NOT PEER REVIEWED
In the last decade, electronic cigarettes (EC) have become
increasingly popular in particular among smokers. Most EC users choose to
use nicotine containing liquids (electronic nicotine delivery system,
ENDS); these ENDS can be considered as similar to nicotine replacement
therapies. Among the several questions EC use raises, one is of major
importance: Are EC a smoking cessation aid and if yes to what extent
compared to existing pharmacotherapies such as nicotine replacement
therapies, varenicline or bupropion?
Several systematic reviews tried to approach the role of EC as a smoking
cessation aid. As of today, only two randomized trials assessed the
efficacy of EC with controversial results (1,2). As an editorial (3) and
the last systematic review (4) concluded, because of the absence of well-
designed and sufficiently powered randomized, controlled, head-to-head
therapeutic trials the current accumulation of data originating
essentially from observational studies does not allow us to make any
conclusion as to EC's therapeutic efficacy in smoking cessation.
Manzoli et al. (5, 6) assessed abstinence from tobacco cigarettes or
tobacco and electronic cigarettes ('any product') in a prospective
cohort study. They included at baseline EC only users, individuals using
tobacco cigarettes and EC (dual use) and those using only tobacco
cigarettes. They reported the 12-month (5) and 24-month (6) results in
two separate papers the latter published online in the June 2016 issue of
Tobacco Control. For both papers, the analyses were restricted to
individuals whose data were available at 12 or 24 months (completers).
This study raises the question whether observational studies assessing
efficacy should be analyzed similarly to randomized efficacy trials for
which the gold standard approach is the intent-to treat-analysis (ITT)
(7) which defines the population submitted to the main data analysis.
Table 1.
https://docs.google.com/document/d/1RM5mvK1s85N1iZZ_kKiHkKiMsS1SVl4YMPTj6ALHvS8/edit?usp=sharing
compares Manzoli et al. results for the 12-month and 24-month abstinence
outcomes (5,6). For all baseline categories, completers' abstinence rates
are higher than abstinence rates of the baseline population that we can
call here as the "ITT" population i.e. of all individuals included. Of
particular interest is that EC only users had higher tobacco cigarettes
but not 'any product' abstinence rates both at 12 and 24 months than the
two other groups. The (unadjusted) "ITT" tobacco cigarettes abstinence
rates are 42% and 40.8 % versus the completers abstinence rates of
61.9% and 61.1 % at 12 and 24 months, respectively; all higher than among
dual users or tobacco cigarette only users suggesting that EC can be an
aid to quit smoking. Unfortunately, both papers report only confounder
adjusted odds ratios for completers and not for the "ITT" population.
Observational studies looking for treatment efficacy could be analyzed
like randomized efficacy trials (8,9) to narrow the gap between randomized
clinical trials and observational data (8). Non-ITT, usually completer
analyses, aim to estimate the effect of treatments received as opposed
to treatments assigned under the ITT approach and by this exclude all
factors contributing to non-completion of the trial (lost to follow up,
adverse events, discontinuation for any reasons). The advantage of the ITT
analysis is that it evaluates the true treatment effect which is the sum
of the biological effects, positive or negative such as adverse events,
and study adherence. The limitation of the ITT analysis of randomized
efficacy trials is the underestimation of efficacy because of non-
treatment related confounders (e.g. lost to follow-up for moving to
another city). On the other hand, completer analysis overestimates
efficacy by ignoring e.g. discontinuation because of adverse events and
cannot, therefore, help to assess the benefit/risk ratio of a given
intervention.
Until results of high-quality, large-scale, comparative, randomized trials
of EC' efficacy will be available, data of well conducted prospective
observational studies as that of Manzoli at al. (5,6) could estimate EC's
efficacy by analyzing "ITT" data and not completers' data while adjusting
for all available and potential confounders. Thus, in the Manzoli et
al. study (5,6) adjusted "ITT" population abstinence rates would have
provided more convincing results about EC's efficacy as an aid for
smoking cessation than completers' adjusted abstinence rates.
REFERENCES
1. Caponnetto P, Campagna D, Cibella F, et al. EffiCiency and Safety of an
eLectronic cigAreTte (ECLAT) as tobacco cigarettes substitute: a
prospective 12-month randomized control design study. PLoS One. 2013 Jun
24;8(6):e66317. doi: 10.1371/journal.pone.0066317. Print 2013.
2. Bullen C, Howe C, Laugesen M, et al. Electronic cigarettes for smoking
cessation: a randomised controlled trial. Lancet. 2013 Nov
16;382(9905):1629-37. doi: 10.1016/S0140-6736(13)61842-5. Epub 2013 Sep 9.
3. Bernstein SL. Electronic cigarettes: more light, less heat needed.
Lancet Respir Med. 2016; Feb;4(2):85-7. doi: 10.1016/S2213-2600(16)00010-
2. Epub 2016 Jan 14
4. Malas M, van der Tempel J, Schwartz R, et al. Electronic Cigarettes for
Smoking Cessation: A Systematic Review. Nicotine Tob Res. 2016 Apr 25.
pii: ntw119. [Epub ahead of print] Review.
5. Manzoli L, Flacco ME, Fiore M, et al. , Electronic cigarettes efficacy
and safety at 12 months: Cohort Study. PLoS One. 2015 Jun
10;10(6):e0129443. doi: 10.1371/journal.pone.0129443. eCollection 2015.
6. Manzoli L, Flacco ME, Ferrante M, et al. Cohort study of electronic
cigarette use: effectiveness and safety at 24 months. Tob Control. 2016
Jun 6. pii: tobaccocontrol-2015-052822. doi: 10.1136/tobaccocontrol-2015-
052822. [Epub ahead of print]
7. Detry MA, Lewis RJ. The Intention-to Treat principle. How to assess the
true effect of choosing a medical treatment. JAMA 2014; 312:85-86.
8.Wilcox A, Wacholder S. Observational data and clinical trials. Narrowing
the gap? Editorial. Epidemiology 2008;19: 765.
9. Herna?n MA, Alonso A, Logan R, et al. Observational studies analyzed
like randomized experiments: an application to postmenopausal hormone
therapy and coronary heart disease. Epidemiology. 2008;19:766-779.
NOT PEER REVIEWED
The study conducted in England by Petrescu and colleagues [1]
concludes that there is a "potential for e-cigarette adverts to
undermine tobacco control efforts by reducing a potential barrier (i.e.
beliefs about harm) to occasional smoking".
Clearly it is important to keep monitoring the impact of advertising,
particularly on children, and this research paper is a welcome
contribution. However, i...
NOT PEER REVIEWED
The study conducted in England by Petrescu and colleagues [1]
concludes that there is a "potential for e-cigarette adverts to
undermine tobacco control efforts by reducing a potential barrier (i.e.
beliefs about harm) to occasional smoking".
Clearly it is important to keep monitoring the impact of advertising,
particularly on children, and this research paper is a welcome
contribution. However, it is important to put this in context.
The most recent survey of smoking among children in England found the
lowest recorded smoking rates among youth aged 11-15 since records began
in 1982.[2] It's worth noting that rates have continued to fall since e-
cigarette use and marketing of products began to take off in Great Britain
after 2010.[3][4] In 2010, 5% of 11-15 year olds were regular smokers
falling to 3% in 2014. Also, in 2010 27% had ever tried smoking, falling
to 18% in 2014.
So it doesn't appear that e-cigarette advertising in England has had
an impact so far on the number of children trying smoking, or becoming
regular smokers. Furthermore from May 2016 all cross border advertising
including TV, radio, internet and newspaper advertising has been banned
throughout the European Union, thereby limiting advertising to that with
local impact.
It should also be noted that in the UK e-cigarette manufacturers are
required to adhere to strict rules on advertising content.[5] These rules
specify in particular that advertisers must ensure ads do not target,
feature or appeal to children; that they do not confuse e-cigarettes with
tobacco products; that they do not mislead with regard to product
ingredients.
In jurisdictions where e-cigarette ads are unregulated and resemble
tobacco promotion, it's reasonable to assume that they could affect
children's perceptions of both e-cigarettes and smoking. This study
underlines the need to monitor e-cigarette marketing but the potential
risks that e-cigarette advertisements are undermining tobacco control
efforts in England are likely to be over-stated.
[1] D C Petrescu, M Vasiljevic, J K Pepper, K M Ribisl, T M Marteau.
What is the impact of adverts on children's perceptions of tobacco
smoking? Tobacco Control published online 6 Sept. 2016. Doi:
10.1136/tobaccocontrol-2016-052940
[2] Smoking, drinking and drug use among young people in England in
2014. Health & Social Care Information Centre, 2015.
[3] ASH Fact sheet. Use of electronic cigarettes (vapourisers) among
adults in Great Britain. ASH, 2016
[4] De Andrade M et al. The marketing of e-cigarettes in the UK.
Cancer Research UK, 2013.
https://www.cancerresearchuk.org/sites/default/files/cruk_marketing_of_electronic_cigs_nov_2013.pdf
[5] Committee on Advertising Practice.
https://www.cap.org.uk/Advice-Training-on-the-rules/Advice-Online-
Database/Electronic-cigarettes.aspx#.V86Snf_6uvE
NOT PEER REVIEWED.
The authors rightly point out that loopholes exist in some smoke-free air laws, exempting smoking of ???tobacco-free or herbal hookah products??? in public places.
In New York City, where this study took place, the governing laws are: (1) New York State Clean Indoor Air Act, and (2) New York City Smoke Free Air Act.[1] Between 2002-2003, both laws were amended to "prohibit smoking in virtually all in...
NOT PEER REVIEWED.
The authors rightly point out that loopholes exist in some smoke-free air laws, exempting smoking of ???tobacco-free or herbal hookah products??? in public places.
In New York City, where this study took place, the governing laws are: (1) New York State Clean Indoor Air Act, and (2) New York City Smoke Free Air Act.[1] Between 2002-2003, both laws were amended to "prohibit smoking in virtually all indoor places in New York State where people work or socialize.???[2] The changes were made "in response to mounting scientific evidence that links exposure to the airborne smoke that is a by-product of smoking . . . to serious health risks to non-smokers.???[3] Unfortunately, smoking was narrowly defined as "the burning of a lighted cigar, cigarette, pipe or any other matter or substance which contains tobacco.???[4] Thus, giving rise to New York???s loophole allowing non-tobacco hookah smoking.
By comparison, the situation is different in neighboring New Jersey. In 2006, the state legislature enacted the New Jersey Smoke-Free Air Act prohibiting smoking in public places.[5] In the Act, smoking is defined as "the burning of, inhaling from, exhaling the smoke from, or the possession of a lighted cigar, cigarette, pipe or any other matter or substance which contains tobacco or any other matter that can be smoked.???[6] New Jersey courts have interpreted the Act to include regulation of hookah bars???even when non-tobacco products are used in these devices. [7] Constitutional challenges to overturn this statute have failed underscoring its strength.
Weakly worded "smoking" definitions are a chief source of statutory loopholes allowing public use of hookahs, as well as electronic cigarettes. Advocates for stronger clean indoor air laws should consider developing a model rule with commentary containing explanations and examples. This lays a foundation to assist legislators in statutory creation and helps judges with interpretation. Such model rules exist for many other areas of the law. States are free to adopt model rules in whole or in part.
Smoking in the "new age" encompasses modalities not in existence when many smoking prohibitions were enacted. Vigilance is needed to ensure anti-smoking laws keep pace with the times.
References
[1] New York City C.L.A.S.H. v. City of New York, 315 F. Supp. 2d 461, 465 (2004).
[2] Id. at 466.
[3] Id. at 466-67.
[4] N.Y. Pub Health Law ?? 1399n(8) (Consol. 2003) (emphasis added).
[5] N.J. Stat. ???? 26:3D-55-64.
[6] N.J.S.A. 26:3D-57
[7] See State v. Badr, 415 N.J. Super 455 (2009).
NOT PEER REVIEWED In June 2015 we published our paper "The smoking population in the
USA and EU is softening not hardening" in the journal Tobacco Control. We
showed that as smoking prevalence has declined over time, quit attempts
increased in the USA and remained stable in Europe, US quit ratios
increased (no data for EU), and consumption dropped in the USA and Europe.
These results contradict the hardening hypothesis whi...
NOT PEER REVIEWED In June 2015 we published our paper "The smoking population in the
USA and EU is softening not hardening" in the journal Tobacco Control. We
showed that as smoking prevalence has declined over time, quit attempts
increased in the USA and remained stable in Europe, US quit ratios
increased (no data for EU), and consumption dropped in the USA and Europe.
These results contradict the hardening hypothesis which is often used as
part of the tobacco industry's strategy to avoid meaningful regulation and
protect its political agenda and markets, claiming that there is a need
for harm reduction among those smokers who "cannot or will not quit."
Indeed, rather than "hardening" the remaining smoking population is
"softening."
In February 2016 we received an email from Robert West, editor of the
journal Addiction, informing us that Addiction was about to publish an
article by Plurphanswat and Rodu entitled "A Critique of Kulik and Glantz:
Is the smoking population in the US really softening?" whose sole purpose
was to critique our Tobacco Control paper, and offered to let us respond to
the criticism. (The full collection of emails is available at
https://tobacco.ucsf.edu/addiction-refuses-allow-discussion-industry-ties-
criticism-our-%E2%80%9Csoftening-paper%E2%80%9D)
The fact that Plurphanswat and Rodu sent their paper to Addiction was
unusual because normal scientific procedure would have had them sending a
letter to the editor of the journal that originally published the work
(Tobacco Control).
As detailed below, we did respond, noting that Plurphanswat and
Rodu's paper fits into a well-established pattern of tobacco industry-
funded researchers trying, without any proper scientific justification, to
create controversy about research inconsistent with industry interests,
the fact that Rodu had understated his financial ties to the industry,
and, of course, showing how their criticism was based on statistical error
that they made.
Addiction rejected our response because we would not delete the first
two points and limit our response only to the statistical issue. Here is
our full response:
THE REJECTED RESPONSE
Consider the Source
"Harm reduction" is a key part of the tobacco industry's strategy to
avoid meaningful regulation and protect its political agenda and
markets.[1] This agenda is premised on the existence of "hard core"
smokers who "cannot or will not" quit.[2-4] Our paper, "The smoking
population in the USA and EU is softening not hardening",[5] undermined
this agenda because it showed that, contrary to the hardening hypothesis,
as smoking prevalence has declined over time, quit attempts increased in
the USA and remained stable in Europe, US quit ratios increased (no data
for EU), and consumption dropped in the USA and Europe.
There is a longstanding pattern of tobacco industry-funded experts
writing letters criticizing work that threatens the industry's position,
first described in 1993 by then-JAMA Deputy Editor Drummond Rennie.[6]
Rodu and various co-authors have written several such letters.[7-10]
Another similarity to past efforts is industry-linked experts submitting
critiques of a paper published in one journal to another,[11-15] which is
also the case here, with this critique of our paper published in Tobacco
Control being published in Addiction. One would have expected any
criticism to have been published as a letter in Tobacco Control.
Addiction requires "full disclosure of potential conflicts of
interest, including any fees, expenses, funding or other benefits received
from any interested party or organisation connected with that party,
whether or not connected with the letter or the article that is the
subject of discussion." As with another investigator supported by the
tobacco industry,[16] the conflict of interest statement Plurphanswat and
Rodu provide may not truly reflect the extent of Rodu's involvement with
the tobacco industry. For example:
* Rodu's Endowed Chair in Tobacco Harm Reduction Research at the
University of Louisville is funded by the U.S. Smokeless Tobacco Company
(US Tobacco) and Swedish Match North America, Inc.[17]
* Rodu is a Senior Fellow at the Heartland Institute, which has
received tobacco industry funding.[18-20]
* Rodu is a Member and Contributor to the R Street Institute, which
has received tobacco industry funding.[19,21]
* Before moving to Louisville, Dr. Rodu was supported in part by an
unrestricted gift from the United States Smokeless Tobacco Company to the
Tobacco Research Fund of the University of Alabama at Birmingham.[8]
* Rodu was a keynote speaker at the 2013 Tobacco Plus Expo
International, a tobacco industry trade fair to discuss "How has the
tobacco retail business evolved; where was it fifteen years ago, where is
it today and where is it going".[22]
* Rodu has worked with RJ Reynolds executives between at least 2000
and 2009 to help promote industry positions on harm reduction, including
specific products.[23-26]
The substance of Plurphanswat and Rodu's criticism is that the
statistically significant negative association between smoking prevalence
and quit attempts and the positive association between prevalence and
cigarettes smoked per day both become non-significant when more tobacco
control variables are included in the model (state fixed effects,
cigarette excise taxes, workplace smoking bans and home smoking bans). The
problem with including all these variables is that it results in a
seriously overspecified model, which splits any actual effects between so
many variables that all the results become nonsignificant. The regression
diagnostic for this multicollinearity is the Variance Inflation Factor
(VIF); values of the VIF above 4 indicate serious multicollinearity. For
the United States, adding all the other variables increases the VIF for
the effect of changes in smoking prevalence from 1.8 in our model for quit
attempts to 16.7, and from 1.8 in our model to 17.9 for cigarettes per
day, respectively. Plurphanswat and Rodu's model is a textbook case of why
one has to be careful not to put too many variables in a multiple
regression.
The Plurphanswat and Rodu criticism misrepresents our conclusions. We
did not argue that drops in prevalence caused increased quit attempts and
reduced consumption; we simply present the observation that, as prevalence
falls, quit attempts increase or remain constant and consumption falls,
which is the exact opposite of what the hardening hypothesis predicts.
Funding
This work was supported by National Cancer Institute Grants CA-61021
and CA-113710. The sponsor played no role in the conduct of the research
or preparation of the manuscript.
REFERENCES
1. Peeters S, Gilmore AB (2015) Understanding the emergence of the
tobacco industry's use of the term tobacco harm reduction in order to
inform public health policy. Tob Control 24: 182-189.
2. Abrams DB (2014) Promise and peril of e-cigarettes: can disruptive
technology make cigarettes obsolete? JAMA 311: 135-136.
3. Polosa R, Rodu B, Caponnetto P, Maglia M, Raciti C (2013) A fresh
look at tobacco harm reduction: the case for the electronic cigarette.
Harm Reduct J 10: 19.
4. Nitzkin JL (2014) The case in favor of E-cigarettes for tobacco
harm reduction. Int J Environ Res Public Health 11: 6459-6471.
5. Kulik MC, Glantz SA (2015) The smoking population in the USA and
EU is softening not hardening. Tob Control doi:10.1136/tobaccocontrol-2015
-052329 Published online 24 June 2015.
6. Rennie D (1993) Smoke and letters. JAMA 270: 1742-1743.
7. Rodu B, Phillips CV (2015) Letter by Rodu and Phillips regarding
article, "Discontinuation of smokeless tobacco and mortality risk after
myocardial infarction". Circulation 131: e422.
8. Rodu B, Cole P (2006) A deficient study of smokeless tobacco use
and cancer. Int J Cancer 118: 1585; author reply 1586-1587.
9. Rodu B, Plurphanswat N, Phillips CV (2015) Discrepant results for
smoking and cessation among electronic cigarette users. Cancer.
121(13):2286-7. doi: 10.1002/cncr.29307. Epub 2015 Mar 4.
10. Rodu B, Heavner KK (2009) Errors and omissions in the study of
snuff use and hypertension. J Intern Med 265: 507-508; author reply 509-
510.
11. Glantz SA, Parmley WW (1992) Passive smoking causes heart disease
and lung cancer. J Clin
Epidemiol 45: 815-819.
12. Mantel N (1992) Dubious evidence of heart and cancer deaths due
to passive smoking. J Clin
Epidemiol 45: 809-813.
13. Glantz SA, Parmley WW (1991) Passive smoking and heart disease.
Epidemiology, physiology, and biochemistry. Circulation 83: 1-12.
14. Jensen RP, Luo W, Pankow JF, Strongin RM, Peyton DH (2015) Hidden
formaldehyde in e-cigarette aerosols. N Engl J Med 372: 392-394.
15. Bates CD, Farsalinos KE (2015) Research letter on e-cigarette
cancer risk was so misleading it should be retracted. Addiction 110: 1686-
1687.
16. Bero LA, Glantz S, Hong MK (2005) The limits of competing
interest disclosures. Tob Control 14: 118-126.
17. University of Louisville. Available at
http://louisville.edu/bucksforbrains/descriptions/tobaccoharmreduction/,
accessed February
2016.
18. The Heartland Institute. Available at
https://www.heartland.org/dr-brad-rodu, accessed February 2016.
19. Nitzkin email string "Dialogue with Tobacco Industry re 3d Party
Research". Available at
https://tobacco.ucsf.edu/sites/tobacco.ucsf.edu/files/u9/Nitzkin-email-
s..., accessed
February 2016.
20. The Center for Media and Democracy. Available at
http://www.prwatch.org/news/2012/07/11671/tobacco-can-cure-smoking-and-
o...
alecs-annual-meeting-salt-lake, accessed February 2016.
21. The R Street Institute. Avaliable at
http://www.rstreet.org/people/brad-rodu/, accessed February 2016.
22. Tobacco Plus Expo 2013. Available at
https://web.archive.org/web/20121219001140/http://tobaccoplusexpo.com/tp...,
accessed February 2016.
23. University of Alabama, Debethizy JD, Doolittle DJ, Rodu B.
Followup from Brad Rodu. 2000 April 26. RJ
Reynolds.https://industrydocuments.library.ucsf.edu/tobacco/docs/hklw0187.
24. RJR, University of Alabama, Burger GT, Lyalls TM, Doolittle D,
Moskowitz SW, Rodu B, Smith C, Williard S. ECLIPSE and Dr. Brad Rodu. 2000
April 20; 2000 April 26. RJ Reynolds.
https://industrydocuments.library.ucsf.edu/tobacco/docs/lklw0187.
25. Hawkins SC. TTM - Brad Rodu for 122006 (20061200).PPT. 2008
December 01. RJ Reynolds.
https://industrydocuments.library.ucsf.edu/tobacco/docs/xrvm0222.
26. Reynolds American, Payne TJ, Rodu B. Thanks. The following
studies (attached) provide almost identical evidence that appropriate
marketing of smokeless products would result in a 10% drop in smoking
prevalence. 2009 February 27; 2009 March 02. RJ Reynolds.
https://industrydocuments.library.ucsf.edu/tobacco/docs/yjpl0222.
NOT PEER REVIEWED
I am writing in response to sight of an article published by you about my work for the International Tax and Investment Center (ITIC).
The ITIC guidebook
published in 2011 "The Illicit Trade in Tobacco Products and How to Tackle
it" makes it clear in the Executive
Summary that it is "a compilation of facts and views from a wide range of
sources including respected academics, private sector consultants,...
NOT PEER REVIEWED
I am writing in response to sight of an article published by you about my work for the International Tax and Investment Center (ITIC).
The ITIC guidebook
published in 2011 "The Illicit Trade in Tobacco Products and How to Tackle
it" makes it clear in the Executive
Summary that it is "a compilation of facts and views from a wide range of
sources including respected academics, private sector consultants,
journalists, international enforcement organizations, government revenue
authorities and industry". It also states in the very first footnote that
the case studies were provided by industry, consultants and academics and
other references include the Framework Convention Alliance, the World Bank
Economic of Tobacco Toolkit, ASH Action on Smoking and Health and the WHO
and Framework Convention Alliance are listed under "Interesting Links". I
wrote this guidebook for ITIC as an independent consultant with academic
freedom to ensure it presented a balanced picture of the issues and
attributed input to the appropriate sources. I have never lobbied on
behalf of an industry or individual company.
As the former UK senior civil servant in a revenue authority who
was privileged to lead the first UK Alcohol and Tobacco Fraud Review in
1997, my motivation in writing this guidebook has been to pass on my
knowledge and experience of the illegal tobacco trade to assist officials
in developing countries in improving their administration of excise
taxation and anti-smuggling controls. I do not work for the tobacco
industry and I have never smoked - in fact, I have suffered from asthma
all my life and was delighted to see workplace smoking bans in the UK. I
have never sought to undermine tobacco control policies. Rather, I have
sought to help the tax and enforcement authorities to reduce opportunities
for illegal trade, reduce demand and detect and prosecute the criminals
and terrorists who profit from illegal trade drawing heavily on the UK
experience in successfully reducing illegal trade in tobacco products from
over 20% in 2000 to around 10% currently whilst maintaining one of the
highest tax rates in the world.
It is undeniable that products that are light, portable and subject to
high levels of tax attract criminals. The guidebook (and the second
edition published in 2013) makes it clear that there are, however, several
drivers and facilitators of illegal trade in tobacco products including
tobacco taxation policy, corruption, protectionist measures, inadequate
legislation such as penalties, inadequate enforcement and public tolerance
though it is my personal view that the economic drivers of supply and
demand are the most important. Whilst advocating balanced tax policies in
the guidebook, I went on to explain that sustaining high tax rates and
maintaining manageable rates of illegal trade can only be achieved through
a comprehensive strategic approach encompassing all legitimate
stakeholders both public and private sector, national and international -
as in the various refreshed versions of the UK Tobacco Strategy. As a
former administrator I was trained and required to treat all taxpayers
fairly without favouring one industry or one company over another. This
has to be a key feature of effective tax and customs administration all
over the world. The tobacco industry is a significant payer of excise
revenue - second only to the hydrocarbon oil industry - and as long as it
sells legal products and complies with legislative requirements it
deserves the same treatment as any other industry. It is a feature of good
tax administration to have dialogue with taxpayers and their
representative associations and I have no hesitation in recommending this
way of working to senior officials in Ministries of Finance and Revenue
Authorities/Customs around the world. Indeed, the UK has long had and
published Memoranda of Agreement with the tobacco industry as well as with
other excise industries.
I am puzzled by the article's criticism of a reference to Codentify in the
2011 edition of the guidebook as I do not see any such reference. The case
study box on page 28 refers to International Track and Trace Standards and
the information attributed to the four major international tobacco
companies but Codentify is not mentioned as this is merely an illustration
of the standards in place among key players in the industry. It is placed
after a much more lengthy page on Article 15 of the WHO Framework
Convention on Tobacco Control which the conclusions in para. 7.5 fully
support but point out that rigorous enforcement, international cooperation
and cooperation with the private sector are essential as legislation alone
cannot eliminate illicit trade. With trillions of movements of tobacco
products across the world daily there are never going to be sufficient
enforcement resources to detect all illicit movements. Seizure rates, even
in those countries that pride themselves on top class enforcement, do not
exceed 20% to 23% and in the EU (see page 9 of the 2013 edition of the
guidebook) were around 7% in 2011. Seizure rates can be expected to be
considerably less in relation to illicit trade in most developing
countries. So, enforcement authorities need all the help they can get
from others in the public sector. This includes health and education
authorities who are best placed to provide awareness campaigns and develop
strategies to reduce demand and it includes help from legitimate industry
who can provide additional intelligence on the markets, trends and those
suspected of undermining their legal sales in the marketplace i.e. the
international criminal organizations and terrorists.
Moving on to the criticism of the WCO for allowing me to present a two day
course on excise taxation policy, administration and enforcement, I
would challenge anyone to present a meaningful course on excise taxation,
administration and enforcement without referring to tobacco taxation or to
illicit trade in excise products. The course included material on alcohol
with input from the Spirits industry and the Beer industry and material on
fuel taxation with input from the Oils industry as well as input on
tobacco taxation from a representative of the tobacco industry. Customs
officials have to deal with numerous products and legislation and their
national training rarely provides them with material on excise taxes which
they are tasked with protecting on imports, exports and transit shipments.
Providing customs officials with basic broad awareness of the key excise
taxes, how they work, good administrative and enforcement practices as
well as stakeholder perspectives is really important in improving the
performance of customs officials around the world. All the course material
was thoroughly vetted by the WCO before the course so delegates were
assured of receiving balanced and useful material.
Any cooperation of municipalities with the tobacco industry is problematic. In Vienna, the capital of Austria, the department responsible for waste made a deal with the tobacco industry. This resulted in the installation of metal tubes for cigarette butts at every tram station, resembling huge cigarettes. Now there are still butts on the floor (usually extinguished by foot), but in addition, smoke is escaping from many of these as...
Any cooperation of municipalities with the tobacco industry is problematic. In Vienna, the capital of Austria, the department responsible for waste made a deal with the tobacco industry. This resulted in the installation of metal tubes for cigarette butts at every tram station, resembling huge cigarettes. Now there are still butts on the floor (usually extinguished by foot), but in addition, smoke is escaping from many of these ash cylinders, contaminating sheltered waiting space for passengers. Because the ash tubes look like an oversize cigarette, they remind smokers waiting for a tram or bus to light up. So the main benefit of this deal was for the tobacco industry an additional form of advertising without warnings.
Conflict of Interest:
unpaid board member of www.aerzteinitiative.at, www.gamed.at, www.oeaw.ac.at/krl/ and www.oeghmp.at
NOT PEER REVIEWED Thanks for Mr. Middleton's information that there are local tobacco
manufacturers in Hong Kong. I made a mistake when reading the materials. I
have amended this in the updated version.
It does not affect the analysis as the government taxes based on
number of cigarettes sold rather than manufactured, but I sincerely
appreciate your valuable advice.
NOT PEER REVIEWED Thanks for Mr. Middleton's information that there are local tobacco
manufacturers in Hong Kong. I made a mistake when reading the materials. I
have amended this in the updated version.
It does not affect the analysis as the government taxes based on
number of cigarettes sold rather than manufactured, but I sincerely
appreciate your valuable advice.
For the analysis part, it is not easy to have an "official figure" of
illicit cigarette consumption. During the peer review stage, I indeed have
discussed with the reviewers which source is preferable. I adopt the
figures provided by the tobacco sellers, but also list the Euromonitor a
reviewer suggested for readers' reference. Noted that these figures lead
to the same result, as the total tobacco consumption (tax + illicit) drops
after the tax increasing, which rebuts the traditional economic view that
tobacco duty is not an effective method because of smuggling.
It is also not an easy job to determine how much price is affordable
for people esp youngsters. However when we find out that smuggling shall
not be a concern when the government increases the tax rate, it is clear that
tobacco duty is a powerful tool to control cigarette consumption.
NOT PEER REVIEWED Pressure the CDC and FDA to pressure state legislatures to outlaw the
sale of filtered cigarettes. As I see it, this is the only viable solution
for ending this litter problem. Cigarette smoking should be made as
unappealing as possible to all concerned.
NOT PEER REVIEWED The author appears to believe that the main problem with the FDA is that it is not doing enough to prevent new niche cigarette products reaching the market. This focus of concern is misplaced, given several thousand cigarette products are readily available and smokers are spoilt for choice with or without these new products. I have no great desire to see new cigarette products coming on the market, but is this...
NOT PEER REVIEWED The author appears to believe that the main problem with the FDA is that it is not doing enough to prevent new niche cigarette products reaching the market. This focus of concern is misplaced, given several thousand cigarette products are readily available and smokers are spoilt for choice with or without these new products. I have no great desire to see new cigarette products coming on the market, but is this really the most pressing agenda?
There are important issues for FDA and Congress to address, but on which the author did not comment. Allow me to suggest five:
1. FDA's governing framework for tobacco, the Tobacco Control Act, is unfit for the purpose of managing reduced risk products. It is designed to raise a high regulatory barrier to entry to a market dominated by worst products and to suppress innovation in better products. At the same time, it has protected the existing cigarette trade by 'grandfathering' the thousands of products that were on the market at 17 Feb 2007 and offering them an easy ride for subsequent modifications. A new legislative framework for recreational nicotine products is required.
2. FDA regulation is unlikely to offer a feasible route to market for most vapour products. ?Its approach will cause chaos in the marketplace, even though these products are helping many to quit smoking. The vapour category would be largely wiped out and confined to the tobacco industry's high volume commodity products if FDA proceeds on its present course. That would provide further protection for the cigarette trade and stimulate a black market. Workarounds, a change in the predicate date or simply doing nothing would be an improvement.
3. FDA's approach does little that supports and a lot that suppresses innovation, regardless of whether particular innovations are desirable for consumers. For example, under the proposed framework for vapour products to access the market, a third generation e-cigarette manufacturer would likely need to go through a new and hugely burdensome authorisation (PMTA) to introduce new safety features like temperature control or to improve nicotine delivery through better aerosol science. A notification regime with an FDA right to intervene if the evidence justifies it would be preferable to a cumbersome authorisation regime.
4. FDA applies a bizarre approach to communicating the far lower risk of products like snus to consumers. This starts with a default FDA-imposed warning that is technically correct but not truthful because it is highly misleading ("this product is not a safe alternative to smoking"). It then requires tobacco companies to calculate if they are rich enough, the data extensive enough and whether it is sufficiently in their commercial interest to go through an arduous process to convince the FDA to allow them to change the warning to something more truthful ("No tobacco product is safe, but this product presents substantially lower risks to health than cigarettes") - and face hostile resistance from tobacco control campaigner such as the author. FDA and CDC should be assessing the relative risks of these products, and communicating them clearly - so that public risk perceptions become, as far as possible, aligned with scientific reality.
5. FDA suffers from mission creep - a regulator should not be involved in campaigning. FDA should function, and be seen to function, as a neutral technocratic regulatory agency, leaving the hype to public health bodies like the CDC. In this case, there is a further problem - the scientific foundations of the new smokeless campaign are very poor and undermine FDA's credibility more generally. FDA should stick to its core mission and do it better.
Matthew L. Myers and his campaign would do better to consider the important issues in nicotine regulation, not expend time, money and credibility on marginal issues with negligible public health value.
Conflict of Interest:
I am a long-standing advocate for tobacco harm reduction and run the Counterfactual blog. I have no competing interests with respect to any relevant industry.
In a smaller sample of older teenagers, I recently extended and
replicated some of Vasiljevic and colleagues' findings [1]. In line with
their results, I found that e-cigarette advertisements did not increase
interest in tobacco smoking, interest in using e-cigarettes or
susceptibility to either behaviour.
In this experimental study, 65 UK non-smokers aged 16-19 years were
randomised to viewing either six e-ci...
In a smaller sample of older teenagers, I recently extended and
replicated some of Vasiljevic and colleagues' findings [1]. In line with
their results, I found that e-cigarette advertisements did not increase
interest in tobacco smoking, interest in using e-cigarettes or
susceptibility to either behaviour.
In this experimental study, 65 UK non-smokers aged 16-19 years were
randomised to viewing either six e-cigarette advertisements cleared for
television broadcast in the UK in 2014/15 or recent nicotine replacement
therapy (NRT) adverts. The e-cigarette adverts featured five different
brands and varied in content, setting, people portrayed, type of e-
cigarette and whether flavours were a focus. Participant completed a
baseline survey, watched the three-minute videos and completed a
distractor task and a post-exposure survey in their own time on individual
computers using headphones.
The main outcome measures were interest in using e-cigarettes and
interest in smoking tobacco cigarettes measured using visual analogue
scales from 0 'no interest at all' to 100 'most interest ever' completed
at baseline and post-exposure [2]. Additionally, at both time-points, four
items measured susceptibility to use e-cigarettes/smoke cigarettes by
asking participants if they would use an e-cigarette/smoke a cigarette if
offered one by a friend and if they thought they would use/smoke in the
next month [3]. Those ticking anything other than 'definitely not' on a 4-
point scale were considered susceptible to e-cigarette use or smoking,
respectively.
Ethical approval was granted from a Research Ethics Subcommittee at
King's College London (PNM 1415 61).
The majority of participants were female (63%), British (83%), and of
non-white ethnicities (65%). The NRT group was on average a few months
older than the e-cigarette group (p=0.02) and the e-cigarette group
indicated higher baseline interest in using e-cigarettes than the NRT
group (p=0.04). Mixed two-way analyses of variance therefore adjusted for
baseline differences between groups.
There was no significant group by time interaction for interest in
using e-cigarettes [F(1,62)=0.81, p=0.372, partial eta-squared=0.013] or
smoking tobacco cigarettes [F(1, 61)=0.30, p=0.86, partial eta-squared
<0.001], indicating that interest was not affected by exposure to the
adverts. Non-parametric tests showed no significant change in the
proportion susceptible to using e-cigarettes or smoking (all p>0.1),
any small changes were towards a reduction in susceptibility.
In conclusion, these results from an older age group of adolescents
and using a different control condition corroborate Vasiljevic and
colleagues' finding that there is no evidence of renormalisation of
smoking due to e-cigarette advertising.
References
1. Vasiljevic M, Petrescu DC, Marteau TM. Impact of advertisements
promoting candy-like flavoured e-cigarettes on appeal of tobacco smoking
among children: an experimental study. Tobacco control 2016 doi:
10.1136/tobaccocontrol-2015-052593.
2. King AC, Smith LJ, McNamara PJ, Matthews AK, Fridberg DJ. Passive
exposure to electronic cigarette (e-cigarette) use increases desire for
combustible and e-cigarettes in young adult smokers. Tobacco control
2015;24(5):501-4 doi: 10.1136/tobaccocontrol-2014-051563.
3. Bogdanovica I, Szatkowski L, McNeill A, Spanopoulos D, Britton J.
Exposure to point-of-sale displays and changes in susceptibility to
smoking: findings from a cohort study of school students. Addiction
(Abingdon, England) 2014 doi: 10.1111/add.12826.
It is enormously helpful when researchers consider new, not-yet-tried
tobacco control interventions (such as this study's consideration of
warning messages on cigarette sticks), especially when researchers figure
out effective ways to evaluate the not-yet-tried interventions.
Some additional possibilities related to new warnings or pack changes
that might be considered:
It is enormously helpful when researchers consider new, not-yet-tried
tobacco control interventions (such as this study's consideration of
warning messages on cigarette sticks), especially when researchers figure
out effective ways to evaluate the not-yet-tried interventions.
Some additional possibilities related to new warnings or pack changes
that might be considered:
(1) Put instructions for use in all cigarette packs that instruct
smokers (with explanations) about how they can minimize the harms and
risks to themselves and to others from their consumption of the
cigarettes, such as:
-- Do not smoke the cigarettes
-- Do not smoke near anyone else
-- Do not smoke in enclosed spaces
-- Do not smoke by inhaling
-- If inhaled, inhale as shallowly as possible
-- Do not smoke more than a few puffs of each cigarette (or do not
smoke more than halfway)
-- Do not smoke in bed or when tired
-- Make sure all smoked cigarettes are fully extinguished before
discarding
-- Discard of all cigarettes carefully (do not litter, do not discard
in waterways, do not leave where children or pets might consume).
(2) Make one cigarette in each pack a rolled-up scroll of information
or instructions for use for smokers (which would also reduce the number of
cigarettes that could be smoked in each pack, perhaps reducing
consumption).
(3) Audio warnings that play each time a pack is opened or a
cigarette is extracted (now possible with available technologies).
NOT PEER REVIEWED This article is manifestly wrong in material content.
Hong Kong has in fact, two current large domestic manufacturers of tobacco products, Hong Kong Tobacco Co Ltd and Nanyang Brothers Tobacco Co Ltd.
Moreover the HK Customs Dept are all over the local dial-up-delivery smuggling syndicates to the extent that the tobacco funded front groups ITIC and Oxford Economics had to produce wildly false and flawed
Inform...
NOT PEER REVIEWED This article is manifestly wrong in material content.
Hong Kong has in fact, two current large domestic manufacturers of tobacco products, Hong Kong Tobacco Co Ltd and Nanyang Brothers Tobacco Co Ltd.
Moreover the HK Customs Dept are all over the local dial-up-delivery smuggling syndicates to the extent that the tobacco funded front groups ITIC and Oxford Economics had to produce wildly false and flawed
Information on the supposed level of illicit product availability (suitably decimated by the following reports).
The HK Government gauges smoking prevalence from its Thematic Household survey reports; what is lacking in Hong Kong is the absence of questions in these Thematic Household Surveys seeking information
on how many interviewees had purchased and / or used illicit tobacco in the previous year, the price they paid for it and the frequency of such DNP usage and whether they were concerned that the ingredients / nicotine/tar levels would most likely be far more toxic than the excise DP cancer sticks. Only with the incorporation of this relevant data could the claimed 10.7% prevalence levels be accurately gauged.
In Singapore which has a lower cost of living than Hong Kong, a DP packet of Marlboro retails at HK$ 76 whereas the same DP packet in Hong Kong costs only HK$ 50, meaning tobacco remains affordable and available to HKG youth and there is no tobacco retailer license system, no POS display legislation and no onus on liquor /mahjong / sauna licensees to enforce the anti smoking legislation in their premises. The Health Department Policy Bureau failed to seek an excise increase in the last Budget, according to the Financial Secretary in an RTHK radio interview in Feb 2015. The Tobacco Control Office has just over 100 'enforcement' officers to cover Hong Kong, Kowloon, the New Territories and the Islands area over two shifts meaning they have insufficient manpower to patrol.
http://seatca.org/dmdocuments/Asia%2014%20Critique_Final_20May2015.pdf
http://tobaccocontrol.bmj.com/content/early/2015/01/05/tobaccocontrol-2014-051937.full
http://www.legco.gov.hk/yr11-12/english/counmtg/hansard/cm0322-translate-e.pdf
page 7400
http://www.customs.gov.hk/en/publication_press/press/index_current.html
Shows the multiple seizures and arrests.
Hong Kong Tobacco Company Ltd
Address : 3/F Paramount Building, Hong Kong
Tel 25618111
Owner Charles HO Tsu Kwok
https://webb-site.com/dbpub/positions.asp?p=4462
http://www.bloomberg.com/research/stocks/people/person.asp?personId=8075652&ticker=1105:HK
https://webb-site.com/articles/bauhiniafound.asp
Nanyang Brothers Tobacco Co Ltd
http://www.nbt-hk.com/
Location: Tuen Mun Hong Kong
http://www.zigsam.at/B_Peel.htm
http://www.scmp.com/news/hong-kong/law-crime/article/1846318/tobacco-worker-43-dies-industrial-accident-hong-kong
Nan Yang also manufacture flavored tobaccos (PEEL)which are sold in the local market
http://english.caijing.com.cn/2004-03-20/110030213.html
Smuggling arrests
http://www.siic.com/en_service_4.html
Nanyang owners
Nanyang Brothers Tobacco Co., Ltd.
Nanyang Brothers Tobacco (short for "NBT")is the largest cigarette manufacturer in Hong Kong, of which main brand is "Double Happiness " and has a history of more than 100 years. At present, "Double Happiness" has been one of the most valuable trademarks in the tobacco industry. The production base of NBT is located in Tuen Mun, Hong Kong. NBT owns advanced manufacturing techniques, and its process of production is completely under computer control and management in order to guarantee the quality of products. The product of NBT is not only sold to China Mainland, Taiwan, Hong Kong and Macao, but also sold to Singapore, Thailand and Korea and so on. In 2011, its sales revenue and net profit reached 2,473 million HK dollars and 610 million HK dollars respectively.
Cigarettes manufactured by Nanyang Brothers Tobacco
Nanyang Brothers Tobacco Co. Ltd., located at Tuen Mun, New Territories, Hong Kong, China
Nanyang Brothers Tobacco Co. Ltd., located at 9 Tsing Yeung Circuit, Hong Kong, China
Founded in 1906. NANYANG means SOUTH PACIFIC.
Current PRODUCTS:
Alain Delon, Centori, Chunghwa, DJ Mix, Just Above, Peel, Polar Bear, Shuang Xi, Texas 5, (The Globe), Wealth
NOT PEER REVIEWED
The recent endgame review by McDaniel et al1 demonstrates a major
flaw in thinking within the tobacco control community. The industry is
seen as dominated by the "big tobacco" cigarette companies. The real life
industry is intensely competitive and highly fragmented. There are, within
the industry, many who could effectively partner with the public health
community, if given the opportunity to do so. Bec...
NOT PEER REVIEWED
The recent endgame review by McDaniel et al1 demonstrates a major
flaw in thinking within the tobacco control community. The industry is
seen as dominated by the "big tobacco" cigarette companies. The real life
industry is intensely competitive and highly fragmented. There are, within
the industry, many who could effectively partner with the public health
community, if given the opportunity to do so. Because of this flaw in
thinking, the tobacco control community has been unwilling to consider any
role for tobacco harm reduction or electronic cigarettes in any public
health initiative. E-cigarettes have the potential to substantially reduce
smoking-related illness and death and do so without recruiting significant
numbers teens or other non-smokers to nicotine use. .2-5
The McDaniel paper1 lists sixteen end-game proposals, fourteen of
which consist of partial or total bans on aspects of the manufacture or
sale of non-pharmaceutical nicotine delivery products. Only two, one
referencing e-cigarettes and another "advantage cleaner nicotine products
over combustibles" make any reference to tobacco industry participation in
pursuit of tobacco control objectives. Both are discouraged as unproven
and impractical despite substantial scientific evidence to the contrary.
The time has come for the public health community to engage in
dialogue with those stakeholders in tobacco-related industries who are
ready, willing and able to partner with public health in pursuit of shared
public health objectives. The purpose of this dialogue would be to help
secure reductions in tobacco-related illness and death not likely
achievable by other means.
Experience to date with e-cigarettes gives us grounds for optimism
that this could easily be done without recruitment of teens and other non-
users to nicotine use. .2-4
A world in which tobacco-related addiction, illness and death have
been reduced to trivial public health problems could be achieved within our
lifetimes. Achieving this goal will require re-orienting tobacco control
from a crusade against all things "tobacco," to a public health initiative
considering all options for the prevention of addiction, illness and
death. This is a goal not likely achievable by any other means. A
seemingly small change in the wording of our tobacco control goal from "a
tobacco-free society" to "a smoke-free society" would get us most of the
way there.
References
1. McDaniel PA, Smith EA, Malone RE. The tobacco endgame: A
qualitative review and synthesis. Tob Control 2015 28 August; Special
Communication Published On Line:1-11.
2. Nitzkin JL. The case in favor of e-cigarettes for tobacco harm
reduction. International Journal of Environmental Research and Public
Health 2014;11:6459-71.
3. Nitzkin JL. E-cigarettes: A life-saving technology or a way for tobacco
companies to re-normalize smoking in American society? FDLI's Food and
Drug Policy Forum 2014 30 June;4(6):1-17.
4. McNeill A, Brose L, Calder R, Hitchman S. E-cigarettes: An evidence
update. A report commissioned by Public Health England
[https://www.gov.uk/government/publications/e-cigarettes-an-evidence-
update]. A an Evidence Update Plus Policy Implications. London, England,
August, 2015. 19 August 2015.
5. Farsalinos K, Polosa R. Safety evaluation and risk assessment of
electronic cigarettes as tobacco cigarette substitutes: A systematic
review. Therapeutic Advances in Drug Safety 2014;5(20):67-86
Conflict of Interest:
I currently serve as Senior Fellow for Tobacco Policy for the R Street Insitute
Despite the seemingly decline in tobacco use, the habit is picked up
by youths on a daily basis. According to the CDC fact sheet, tobacco use
is established primarily during adolescence where 9 out of 10 cigarette
smokers first initiate smoking by age 18. In the United States, more than
3,800 youths aged 18 years or younger try their first cigarette every day
[1]. If the trend continues, about 5....
Despite the seemingly decline in tobacco use, the habit is picked up
by youths on a daily basis. According to the CDC fact sheet, tobacco use
is established primarily during adolescence where 9 out of 10 cigarette
smokers first initiate smoking by age 18. In the United States, more than
3,800 youths aged 18 years or younger try their first cigarette every day
[1]. If the trend continues, about 5.6 million Americans that are less
than 18 years will die early from a smoking-related illness i.e. 1 of
every 13 young Americans will lose their lives to tobacco use [1]. These
figures are disturbing, and though tobacco control is at the forefront in
trying to reduce these mortalities from tobacco use, the road ahead seems
long and weary.
In 2007, a study using modelling techniques showed that increasing
the smoking age would lead to a drop in youth smoking prevalence from 22%
to under 9% for the 15- 17 year old age [2]. Another study done in
England, also found that increasing the age for legal purchase of tobacco
was associated with reduction in smoking [3]. According to a study done in
1996, "adopting the tobacco policy of raising the legal age would delaying
the initiation of smoking if it succeeds"[4]. And that it might also
contribute to the reduction of smoking-related mortality and morbidity in
the youth[4].
In this current study, the authors showed that the Needham community
in Massachusetts has achieved success with this policy by comparing the
youth smoking trends in this community with surrounding nearby communities
that have not raised the legal age for tobacco purchase [5]. Their results
showed that there was a greater decline in youth smoking in Needham due to
an increase in the legal smoking age relative to the other communities.
Although this study shows promising results for the immediate effects of
decline in tobacco use, it should be noted that present day youths now
have the leisure of purchasing alternative tobacco products in the form of
e-cigarettes, hookahs and smokeless tobacco. It is reported that nearly 4
of every 100 middle school students in 2014 use e-cigarettes, 3 in 100 had
used hookah and more than 5 in 100 currently use smokeless tobacco [1].
Enacting the policy on increasing the legal age to purchase tobacco
should be thoroughly comprehensive to include alternative tobacco products
as well. Though, the future of tobacco control seems daunting, it is still
worth a try to raise the legal age of tobacco purchase in order to curb
the sequelae of a lifelong addiction that has deleterious health effects.
2. Ahmad. (2007). Limiting youth access to tobacco: Comparing the
long-term health impacts of increasing cigarette excise taxes and raising
the legal smoking age to 21 in the united states. Health Policy
(Amsterdam), 80(3), 378; 378-391; 391.
3. Millett, C., Lee, J. T., Gibbons, D. C., & Glantz, S. A.
(2011). Increasing the age for the
legal purchase of tobacco in England: Impacts on socio-economic
disparities in youth smoking. Thorax, 66(10), 862-865.
4. Breslau, N. (1996). Smoking cessation in young adults: Age at
initiation of cigarette smoking and other suspected influences. American
Journal of Public Health (1971), 86(2), 214.
5. Schneider, S. K., Buka, S. L., Dash, K., Winickoff, J.P.,
O'Donell, L. (2015). Community reductions in youth smoking after raising
the minimum tobacco sales age to 21. Tobacco Control
doi:10.1136/tobaccocontrol-2014-052207
NOT PEER REVIEWED To the Editors,
In the article entitled, "Weight control belief and its impact on the
effectiveness of tobacco control policies on quit attempts: findings from
the ITC 4 Country Project" I noticed a problem regarding the measurement
of weight control beliefs. This variable (weight control beliefs
associated with tobacco use) is measured using only one question. The
researchers indicate, "In order to iden...
NOT PEER REVIEWED To the Editors,
In the article entitled, "Weight control belief and its impact on the
effectiveness of tobacco control policies on quit attempts: findings from
the ITC 4 Country Project" I noticed a problem regarding the measurement
of weight control beliefs. This variable (weight control beliefs
associated with tobacco use) is measured using only one question. The
researchers indicate, "In order to identify weight concerns related to
smoking, we exploit a question that measures smokers' level of agreement
with the following statement using a 5-point scale (strongly agree, agree,
neither agree nor disagree, disagree and strongly disagree): Smoking helps
weight control" (Shang et. al, p.2, 2015). This statement illustrates the
limited manner in which the aforementioned variable was measured. While
the limitation of weight control beliefs being analyzed using self-
reporting was addressed, the limitation of using only one question to
measure this variable was not. In the study entitled, "Smoking
Expectancies, Weight Concerns, and Dietary Behaviors in Adolescence" the
authors noted that they used the appetite control factor of the Smoking
Consequences Questionnaire (SCQ) to determine weight control beliefs. The
author of "Smoking Expectancies, Weight Concerns, and Dietary Behaviors in
Adolescence indicates, "Participants who endorsed smoking were given 5
possible consequences of smoking and were asked to rate the likelihood of
each consequence on a 10-point scale from 'completely unlikely' to
'completely likely.' The statements included, 'Smoking controls my
appetite,' 'Smoking keeps my weight down,' 'Cigarettes keep me from
overeating,' 'Cigarettes keep me from eating more than I should,' and,
'Smoking helps me control my weight.' Scores were an average across all
items" (Cavallo et. al., p. 68, 2010). This multifaceted approach to
measuring a variable is a more thorough and a more accurate measure of the
weight control variable. This more detailed measure, as indicted by the
author, has been measured by three different criteria: internal
consistence, degree of factor loading, and coefficient significance (.72
to .97). This measure starkly compares to the measure used in the article,
"Weight control belief and its impact on the effectiveness of tobacco
control policies on quit attempts: findings from the ITC 4 Country
Project", which was only measured in its degree of sensitivity.
References
Cavallo, D. A., Smith, A. E., Schepis, T. S., Desai, R., Potenza, M.
N., & Krishnan-Sarin, S.
(2010). Smoking expectancies, weight concerns, and dietary behaviors in
adolescence. Pediatrics, 126(1), e66-e72.
Shang, C., Chaloupka, F. J., Fong, G. T., Thompson, M., Siahpush, M.,
& Ridgeway, W. (2015). Weight control belief and its impact on the
effectiveness of tobacco control policies on quit attempts: findings from
the ITC 4 Country Project. Tobacco control. doi:10.1136/tobaccocontrol-
2014-051886
Beyond the plea to divest from funding tobacco companies,
shareholders need to consider the adverse impact of investing in
industries and resource extraction that worsen eco-degradation.
At a group level, the impetus for environmentally accountable
investing by colleges and universities can be better maintained by
teaching every student the practical ways to minimize th...
Beyond the plea to divest from funding tobacco companies,
shareholders need to consider the adverse impact of investing in
industries and resource extraction that worsen eco-degradation.
At a group level, the impetus for environmentally accountable
investing by colleges and universities can be better maintained by
teaching every student the practical ways to minimize their community's
ecological footprint. Mandatory ecology courses delivered to young minds
could incite a life-long pledge to heightened civic responsibility. It
holds potential to cultivate future leaders that will cogitate for not
just sustainable investment in centres of higher learning but become
strong advocates for environmentally friendly policy and industry in the
wider world. Students' concerted demands for sustainable investment on
campus are a positive, but only a first step.
The long-term commitment to lessening ecological degradation through
informed protest, "maintaining the rage," policy debate and green
innovation comprise better imprinted values that can be passed on to
children and grandchildren. The latter is best achieved through formal
education on humanity's impact on the natural world.
NOT PEER REVIEWED
Cavazos-Rehg et al. compared the results of Google Trends relative
search volume (RSV) data for non-cigarette tobacco use with data from
state- and national-level youth surveys.[1] Given the authors' findings of
positive correlations with Google Trends and survey data, we agree with
the conclusion that Google Trends may be a potential tool to provide real-
time monitoring for non-cigarette tobacco use. T...
NOT PEER REVIEWED
Cavazos-Rehg et al. compared the results of Google Trends relative
search volume (RSV) data for non-cigarette tobacco use with data from
state- and national-level youth surveys.[1] Given the authors' findings of
positive correlations with Google Trends and survey data, we agree with
the conclusion that Google Trends may be a potential tool to provide real-
time monitoring for non-cigarette tobacco use. The 2014 National Youth
Tobacco Survey indicates that electronic nicotine delivery system (ENDS)
use has tripled by middle and high school students from 2013-2014.[2] We
have conducted a preliminary review of Google Trends RSV data for ENDS to
detect if there were trends that may mirror acquisition patterns of ENDS
within and outside of the US.
The methods we used were similar to Ayers et al., who conducted a
data analysis from Google search engines from January 2008 through
September 2010.[3] We compiled a list of search terms in singular and
plural forms that reflected the most commonly used search terms for ENDS
including "e cig," "e cigarette," "electronic cigarette," and popular name
brands. To continue building the list, we added popular "related terms" as
indicated by Google Trends searches. When search terms exceeded the 30-
word limit, we compared RSV for individual terms and removed those with
the lowest RSV. Irrelevant (non-ENDS) results were excluded.[1] Results
were limited to October 2011 to May 2015 and included all countries.
Search queries range from 0-100 in volume, with the highest RSV assigned a
100.[4]
Similar to prior work,[3] ENDS emerged in all markets and RSV trends
have slowly increased since 2011, peaking in January each year. This
suggests that interest in information on ENDS is growing, and that there
has been a recent shift in interest by country compared to prior
findings.[3] The greatest RSV of ENDS is in the United Kingdom (100),
followed by the United States (84), Ireland (63), Cyprus (46), Malta (42),
Canada (41), Trinidad and Tobago (35), Australia (33), Philippines (29),
and New Zealand (29).
Web search data can help fill gaps by providing a timely
understanding of real-world activity and good temporal and spatial
resolution.[5] It is unclear how these search patterns reflect use
patterns in youth. Future investigations with comparisons to youth
surveillance datasets and population-level efforts using real-time
monitoring of youth interest,[6] and tracking of use patterns may help to
inform timely prevention programs and policies for ENDS, other non-
tobacco, and tobacco products.
References
1. Cavazos-Rehg PA, Krauss MJ, Spitznagel EL, et al. Monitoring of
non-cigarette tobacco use using Google trends. Tob Control. 2015;24(3):249
-255.
2. Centers for Disease Control and Prevention. E-cigarette use
triples among middle and high school students in just one year. Centers
for Disease Control and Prevention Newsroom. 2015.
http://www.cdc.gov/media/releases/2015/p0416-e-cigarette-use.html
(accessed 01 Jun 2015).
3. Ayers JW, Ribisl KM, Brownstein JS. Tracking the rise in
popularity of electronic nicotine delivery systems (electronic cigarettes)
using search query surveillance. Am J Prev Med. 2011;40(4):448-453.
4. Google Trends. About Google Trends. Google. 2015.
https://support.google.com/trends/answer/4355164?hl=en&ref_topic=4365531
(accessed 05 Jun 2015).
5. Mohebbi M, Dan Vanderkam JK, Kodysh J, et al. Google correlate
whitepaper. Google. 2011:1-6.
https://www.google.com/trends/correlate/whitepaper.pdf (accessed 01 Jun
2015).
6. Goel S, Hofman JM, Lahaie S, et al. Predicting consumer behavior
with web search. Proc Natl Acad Sci U S A. 2010;107(41):17486-17490.
NOT PEER REVIEWED
I read the research paper (other authors Ashvin, Emmanuel, Frank and
Prabhat) with interest.
Quite a few new points have been brought out. One of the important
political reasons for resistance is that hand made ones are done in rural
areas where alternate means of employment are hard to come by. This
results in the local political representative arguing against tax.
NOT PEER REVIEWED
I read the research paper (other authors Ashvin, Emmanuel, Frank and
Prabhat) with interest.
Quite a few new points have been brought out. One of the important
political reasons for resistance is that hand made ones are done in rural
areas where alternate means of employment are hard to come by. This
results in the local political representative arguing against tax.
Alternatives such as Agarbathi (insense stick) manufacturing, Coir
weaving or other rural handicrafts - must be suggested to make the
argument for higher taxation on Bidi. In all these cases the raw material
supply and picking up the finished products remains the responsibility of
the manufacturer (similar to the operation of making Bidi, but with no ill
effects on society).
Also, the higher probability of cancer in cigarette smoking must be
countered with the argument that larger number of Bidis are smoked per
person per day (since it is considerably cheaper).
Without such specific suggestions - this will remain a research paper
of analysis but not directive. Without a clear directive, no government
(much less the local politician) can act to change the situation. Also,
advertising of tobacco products is banned in India. So, that channel is
not an option.
How could the top manufacturer "Mangalore Ganesha Bidi" regain market
share in a matter of 1-2 years? They continue to supply 3.5 million small
packets every day (25 bidi in each packet). They have been the biggest
manufacturer for over five decades now. Their industry was
built on the fact that it is all hand made and provides employment in
rural areas.
Therefore, alternatives that provide credible means of livelihood in the
rural area, are essential in order to make any progress.
NOT PEER REVIEWED
We explicitly did not do a systematic review, which would have
included things such as assessing articles for quality and assessing for
presence of publication bias. Instead we opted for a narrative review.
This decision was made given the limited time available for the authors to
complete the supplement prior to the World Conference on Tobacco or Health
and the small number of available articles after ou...
NOT PEER REVIEWED
We explicitly did not do a systematic review, which would have
included things such as assessing articles for quality and assessing for
presence of publication bias. Instead we opted for a narrative review.
This decision was made given the limited time available for the authors to
complete the supplement prior to the World Conference on Tobacco or Health
and the small number of available articles after our literature search.
Our exclusion and inclusion criteria were also stated (see Figure 1).
Lastly, our search was up until September 9, 2014, therefore any articles
published afterwards were not included in the publication. We believe that
this paper represents a significant contribution concerning a newly
emerging threat to the health of the public.
NOT PEER REVIEWED "The GC temperature programme for all analyses was: 35C hold for 5???min; 10C/min to 300C; then hold for 3.5???min at 300C."
Water is not dangerous. Yet, if I submerge a human test subject in a container of water for 3.5 minutes, then this water becomes quite lethal. No vaping device is intended to run continuously for longer than a few seconds.
Furthermore, 300C is far too high a temperature for any vaping de...
NOT PEER REVIEWED "The GC temperature programme for all analyses was: 35C hold for 5???min; 10C/min to 300C; then hold for 3.5???min at 300C."
Water is not dangerous. Yet, if I submerge a human test subject in a container of water for 3.5 minutes, then this water becomes quite lethal. No vaping device is intended to run continuously for longer than a few seconds.
Furthermore, 300C is far too high a temperature for any vaping device. If I force a human test subject to drink a large cup of coffee heated to 300C, they will suffer severe injuries, possibly fatal. This does not make coffee consumed at an appropriate temperature and at an appropriate pace dangerous.
This letter responds to misrepresentations in a recent article by
Daniel Stevens and Stanton Glantz (1). In the article, Stevens and Glantz
question my integrity based on some questions during a 4-day deposition
which I gave in 2014 in a legal proceeding against my employer. These
writers cite snippets from the 1,000+-page transcript of that deposition,
relating the text of a facetious note that I h...
This letter responds to misrepresentations in a recent article by
Daniel Stevens and Stanton Glantz (1). In the article, Stevens and Glantz
question my integrity based on some questions during a 4-day deposition
which I gave in 2014 in a legal proceeding against my employer. These
writers cite snippets from the 1,000+-page transcript of that deposition,
relating the text of a facetious note that I had sent to my boss almost 20
years ago in 1996. The writers use a small portion of that note, together
with my answers to other deposition questions, taken out of context, to
infer that I gave questions from the open-book examination for
recertification to my co-workers to answer for me.
It is well-understood that recertification candidates must complete
the self-assessment examination themselves (2), which is precisely what I
did in both 1992 and 1996. Period. I stand by my sworn testimony that I
did not provide questions from either my 1992 or 1996 recertification
examinations to anyone to answer for me, and that my examination responses
were my own work. This is made clear in the deposition transcript and I
refute this attempt by Stevens and Glantz to suggest otherwise.
I am taken aback by the willingness of Tobacco Control to accept the
sort of "scholarship" pursued by Stevens and Glantz. These authors advise
special scrutiny of my work, with specific mention of my lead authorship
of the Industry Menthol Report that was written at the request of the FDA
(3). I stand by the scientific integrity of and conclusions in that
report, as well as by the comments provided to FDA on the recently-voided
TPSAC menthol report (4), and on FDA's own Preliminary Scientific
Evaluation of menthol (5).
Jonathan Daniel Heck, Ph.D., DABT, ATS
References
1. Stevens D, Glantz S. Tob Control Published Online First: May 12,
2015, doi:10.1136/
tobaccocontrol-2015-052271.
2.http://www.abtox.org/Candidates/ABOT_recertification/ABOT_recertification_policy.aspx
(accessed May 19, 2015)
3
http://www.fda.gov/downloads/AdvisoryCommittees/CommitteesMeetingMaterials/TobaccoProductsScientificAdvisoryCommittee/UCM249320.pdf
(accessed May 19, 2015).
4
http://www.lorillard.com/pdf/fda/Comments_to_FDA_on_TPSAC_Report.pdf
(accessed May 19, 2015)
5. http://www.lorillard.com/wp-content/uploads/2013/11/PSE-
Response_Lorillard_Final.pdf (accessed May 19, 2015)
Conflict of Interest:
I am a full-time employee of the Lorillard Tobacco Company. I have been asked on occasion to provide testimony in litigation involving my employer. I have done so from time to time, and receive no payment for this beyond the normal salary and benefits of my employment
NOT PEER REVIEWED This comment summarizes, but mischaracterizes the
findings and conclusions of our study. Our analyses and interpretation are
based strictly on the letter of the Family Smoking Prevention and Tobacco
Control Act (FSPTCA) and its requirements, including Section
911(b)(2)(ii), which bans "the use of explicit or implicit descriptors
that convey messages of reduced risk including 'light', 'mild' and 'low',
o...
NOT PEER REVIEWED This comment summarizes, but mischaracterizes the
findings and conclusions of our study. Our analyses and interpretation are
based strictly on the letter of the Family Smoking Prevention and Tobacco
Control Act (FSPTCA) and its requirements, including Section
911(b)(2)(ii), which bans "the use of explicit or implicit descriptors
that convey messages of reduced risk including 'light', 'mild' and 'low',
or similar descriptions in a tobacco product, label, labeling or
advertising".
The findings demonstrated that manufacturers did not simply remove
descriptors, to be in compliance with the law, but introduced new color-
coded brand name descriptors which smokers were able to recognize and
easily identify the formerly labeled "lights" brands. We did not examine
the use of colors themselves, which may be protected by the First
Amendment, but rather the use of color terms.
The marketing materials examined make explicit the fact that the use of
substituted color terms in brand names is similar to the dropped
"descriptors, so that consumers will continue to recognize these brands as
"lights". The National Cancer Institute previously found that filter
ventilation has been used by manufacturers to delineate the misleading
"lights" categories, which are now color-coded, and which conveyed
messages of reduced risk resulting in increased initiation and reduced
cessation.
Our conclusions are stated in conservative terms that manufacturers appear
to have evaded this critical element of the FSPTCA, which is intended to
protect the public health.
Research on waterpipe smoking, also called hookah, is still emerging,
and research on second-hand hookah exposure is still in its nascent
stages. However, after reading the review on the various effects of second
-hand waterpipe smoke exposure by Kumar et al recently published in
Tobacco Control1, we noted several major issues in its execution and have
serious reservations about th...
Research on waterpipe smoking, also called hookah, is still emerging,
and research on second-hand hookah exposure is still in its nascent
stages. However, after reading the review on the various effects of second
-hand waterpipe smoke exposure by Kumar et al recently published in
Tobacco Control1, we noted several major issues in its execution and have
serious reservations about the potential of this review as a tool in the
development of public health policy.
First, the authors failed to synthesize all available research on the
topic into their review, by utilizing only two electronic search
databases. When a search was conducted in CINAHL, we found one more
relevant article that could have been included in this review2. However,
we are unable to judge as the authors don't present the inclusion criteria
for the review. Furthermore, we found another systematic review on this
topic and found that the amount of nicotine absorption resulting from
daily hookah use was similar to that of daily cigarette use3. This is
concerning because the authors did not include the older systematic review
in the narrative nor did they derive information from it; consequently,
calling into question the relevance of the current review. In addition,
the authors were unclear regarding their methodology. They only provided a
list of search terms and failed to specify any inclusion criteria, making
it impossible for anyone to replicate their review.
Second, the authors did not seem to have assessed the scientific quality
of the included studies, negatively affecting the transparency of the
review process. Thus, readers cannot properly assess its quality as a
comprehensive review of the current body of literature or assess the
validity of the findings that were included in the review. They also
failed to assess publication bias, which would have been a relevant issue
as they only included published studies. Given that a number of reporting
guidelines for reviews have been produced, these issues are almost
unjustifiable.
Although the authors examined an important, often overlooked public health
issue, their review suffered from major methodological flaws that could
not be ignored. Unfortunately, the review's weaknesses prevent it from
being a proper synthesis of the current body of research on the effects of
second-hand exposure to hookah smoke and a useful tool for assisting
decision-making in public health policy.
REFERENCES
1 Kumar SR, Davies S, Weitzman M, Sherman S. A review of air quality,
biological indicators and health effects of second-hand waterpipe smoke
exposure. Tob Control. 2015; 24: i54-i59. doi: 10.1136/tobaccocontrol-2014
-052038
2 Aydin A, Kiter G, Durak H, Ucan ES, Kaya GC, Ceylan E. Water-pipe
smoking effects on pulmonary permeability using technetium-99m DTPA
inhalation scintigraphy. Ann Nucl Med. 2004; 18(4): 285-289. doi:
10.1007/BF02984465
3 Neergaard J, Singh P, Job J, Montgomery S. Waterpipe smoking and
nicotine exposure: a review of the current evidence. Nicotine Tob Res.
2007; 9(10): 987-994. doi: 10.1080/14622200701591591
Frederieke S. van der Deen and Nick Wilson (on behalf of the other
authors; both from the University of Otago, Wellington, New Zealand)
This electronic letter aims to give readers an update on the smoking
prevalence projections to 2025 and beyond in New Zealand (NZ) that were
provided in the paper by Ikeda et al. NZ is now one of four nations with
an official smokefree goal (others are: Fin...
Frederieke S. van der Deen and Nick Wilson (on behalf of the other
authors; both from the University of Otago, Wellington, New Zealand)
This electronic letter aims to give readers an update on the smoking
prevalence projections to 2025 and beyond in New Zealand (NZ) that were
provided in the paper by Ikeda et al. NZ is now one of four nations with
an official smokefree goal (others are: Finland, Scotland, and Ireland).
In NZ, this goal is generally interpreted as achieving a smoking
prevalence under 5% by the year 2025.
The modelling work by Ikeda et al aimed to explore the feasibility of
achieving this goal under current annual trends in smoking uptake and
cessation (ie, business-as-usual (BAU)). Smoking prevalence data from a
regularly conducted NZ health-related survey between 2002 and 2011 were
used to provide information on recent annual trends in smoking uptake and
cessation as input for future BAU smoking prevalence projections. However,
since this modelling work was first published (as an e-publication in
2013), smoking prevalence data from the 2013 Census has become available.
A larger than expected fall in smoking rates in the general NZ adult
population, but especially in Maori (indigenous population), was observed.
It was therefore decided to update the future BAU smoking prevalence
projections that were provided in the Ikeda et al paper by using smoking
prevalence data from the 2013 Census.
The updated future BAU projected smoking prevalence in 2025 was 8.3%
and 6.4% for non-Maori (Ikeda et al: 10.7% and 8.8%), and 18.7% and 19.3%
for Maori men and women, respectively (Ikeda et al: 30.0% and 37.3%).
Although the updated projections are more favourable from a public health
perspective (especially for Maori) than the previous modelling work, a
smoking prevalence below 5% by 2025 is still not attained by any
demographic group. Achieving the 2025 smokefree goal will most likely
require implementation of more intense existing tobacco control strategies
or potentially even entirely novel measures (eg, major changes in the
tobacco retail environment as per the Tobacco Control themed supplement
for March 2015 'The Pack and the Retail Environment').
Updating the previously published smoking prevalence projections
proved to be a feasible and relatively easy exercise. Projecting and
regularly updating future BAU smoking prevalence projections with most up-
to-date smoking prevalence data, in NZ and in other nations, may assist
policy makers in planning how much more intense tobacco control measures
may need to be to achieve smokefree goals. For more detail around the
methods of updating the previous modelling work by Ikeda et al, we would
refer readers to the recently published paper that describes this work
[1].
Reference
1. van der Deen FS, Ikeda T, Cobiac L, Wilson N, Blakely T (2014)
Projecting future smoking prevalence to 2025 and beyond in New Zealand
using smoking prevalence data from the 2013 census. N Z Med J 127 (1406):
71-79. http://www.otago.ac.nz/wellington/otago083774.pdf
We refer to the article, "Did the tobacco industry inflate estimates
of illicit cigarette consumption in Asia? An empirical analysis" Chen J,
et al. published in Tobacco Control on November 25, 2014 (Tob Control
2015;0:1-7) and concur with the important points raised in this article.
While the article focuses on Hong Kong, other countries in South East Asia
also faced a similar experience.
The...
We refer to the article, "Did the tobacco industry inflate estimates
of illicit cigarette consumption in Asia? An empirical analysis" Chen J,
et al. published in Tobacco Control on November 25, 2014 (Tob Control
2015;0:1-7) and concur with the important points raised in this article.
While the article focuses on Hong Kong, other countries in South East Asia
also faced a similar experience.
The authors revealed that the tobacco industry-funded study on the illicit
trade of cigarettes in Asia, "Asia-11 Illicit Tobacco Indicator 2012" by
the International Tax and Investment Center (ITIC) and Oxford Economics
(OE) inflated the extent of illicit consumption in Hong Kong by 133-337
percent. Similarly, other scholars have also questioned the methodology
applied in this report. For example, Dr. Frank Chaloupka, Distinguished
Professor of Economics at the University of Illinois at Chicago,
criticized the reliability of the study's estimates in using an
inconsistent approach and the lack of details about the empty pack
surveys, the main source of data for the estimates.
In June 2014, the South East Asia Tobacco Control Alliance (SEATCA)
released a critique of the "Asia-11 Illicit Tobacco Indicator 2012"
showing how its estimates are being used to rescind tobacco tax policies.
As illustrated in Hong Kong's experience, the SEATCA critique revealed
that the ITIC-OE report overestimated the total illegal consumption in
other countries in South East Asia. In the case of Vietnam, it claimed
that in 2012 about 103.3 billion cigarettes consumed in Vietnam were
illegal, which amounted to 19.4% of total cigarette consumption. The
estimate was based primarily on the data of a tobacco industry group, the
Vietnam Tobacco Association (VTA), and the full details of the
methodology were not disclosed. The report admitted that data were
collected only in urban areas, but it failed to mention that 68.3% of the
Vietnamese population live in rural areas. This means that the findings
are not representative of the Vietnamese population and are very likely
biased since illicit cigarettes consumption is concentrated in big cities
and near borders.
Unfortunately, as in Hong Kong, the glossy ITIC-OE study took its
toll on tobacco tax policy in Vietnam. The Government of Vietnam
considered the results of the study and opted for a less than ambitious
tobacco tax rate increase. When the Ministry of Finance proposed a rather
moderate tobacco tax roadmap in March 2014 (an increase from 65% to 75% in
July 2015 and to 85% in January 2018), they noted that their decision was
influenced by the illicit cigarette issue. The scope of illicit cigarettes
consumption and the associated government revenue loss continued to be
highlighted both in the press and during the policy debates until November
2014, when the National Assembly adopted an even weaker excise tax law: an
increase to 70% in Jan 2016, and to 75% in 2019. Since these taxes are
based on ex-factory price, and the tobacco industry is in full control of
that price, the full impact on cigarette retail prices and tax revenue is
likely to be minuscule. The average real retail cigarettes prices are
expected to increase by less than 1% per year in the period from 2015 to
2020 (5.8% in 6 years), which, given the 5-6% annually per capita real
income grows, is insufficient to prevent cigarette consumption from
rising.
In summary, the Asia-Illicit Tobacco Indicator 2012 report was as non-
transparent in Hong Kong as it was in Vietnam and nine other countries
covered by the report. It was used to undermine a pro-health tobacco tax
policy supported both by public health advocates as well as the general
public. We thank Tobacco Control for publishing the findings of Hong Kong
colleagues, which successfully challenged the invalid evidence and
arguments supported by the tobacco industry. We hope that other countries
in Asia and elsewhere will follow Hong Kong's initiative and expose the
tobacco industry's tactic to undermine pro-health tobacco tax policies
that signatories to the WHO FCTC are committed to under Article 6 of the
Convention.
Thank you
Sincerely,
Son Dao , Hana Ross and Sophapan Ratanachena
NOT PEER REVIEWED I commend the authors on a significant effort involved in conducting
this rather insightful research.
Having conducted qualitative research on FCTC implementation in the
Pacific, I can provide comment in relation to the Cook Islands which may
explain why MPOWER measures mentioned here did not achieve decreases in
prevalence (at least in the figures obtained in this study).
NOT PEER REVIEWED I commend the authors on a significant effort involved in conducting
this rather insightful research.
Having conducted qualitative research on FCTC implementation in the
Pacific, I can provide comment in relation to the Cook Islands which may
explain why MPOWER measures mentioned here did not achieve decreases in
prevalence (at least in the figures obtained in this study).
Firstly, the Cook Islands Tobacco Control Act was introduced in 2007
and accompanying regulations in 2008, and stakeholders informed me that
compliance to these regulations was not strictly enforced until 2009 -
hence their implementation on the ground may not have been felt until the
latter period of or after this data was collected.
Secondly, accurate, timely, comparative data on prevalence is
extremely difficult to obtain in many small island nations such as those
in the Pacific. I am unsure of the exact calculations behind the MPOWER
reports and how these figures were extrapolated, but they are likely to be
an estimation that is rather different to what other (national) studies
suggest. The Cook Islands Census suggests a decrease in prevalence from
29% in 2006 to 20% in 2011. The Cook Islands GYTS (limited to those aged
13-15) suggests a decrease from 45% in 2003 to 35% in 2008, indicating the
trend in prevalence is contrary to the statistics obtained in MPOWER.
These potential limitations are duly noted in your study, but I
thought this additional information would (a) be of interest and provide
some context to these issues, and (b) serve to caution anyone who may
suggest that MPOWER measures have not been effective in the Cook Islands
(or elsewhere).
Of course it would also be great to see further points of data
collection beyond 2009, which would also give a better indication of
trends over time.
NOT PEER REVIEWED
We welcome the timely review published by Hill et al. [1], and agree
that more research is needed to assess the equity impacts of tobacco
control interventions. The results of the review indicated that "increases
in tobacco price have a pro-equity effect on socioeconomic disparities in
smoking", but that "evidence on the equity impact of other interventions
was inconclusive [...]". The inconclusiveness o...
NOT PEER REVIEWED
We welcome the timely review published by Hill et al. [1], and agree
that more research is needed to assess the equity impacts of tobacco
control interventions. The results of the review indicated that "increases
in tobacco price have a pro-equity effect on socioeconomic disparities in
smoking", but that "evidence on the equity impact of other interventions
was inconclusive [...]". The inconclusiveness of findings with regard to
smoking ban policies may be partly due to date limitations for the
database searches, which included evidence from January 2006 through
November 2010. It may also be partly due to the assessment of equity in
outcomes that related only to active smoking. Although a benefit of
smoking ban policy implementation may be a reduction in active smoking,
this outcome is dependent upon an individual's personal response to the
intervention. However, the primary purpose for implementing comprehensive
smoking ban policies is to reduce secondhand smoke exposure among the
population through environmental change. It is therefore important to
assess whether the successful implementation of smoking ban policies has
pro-equity health effects.
Our previous research indicated that the national smoking ban policy
in the Republic of Ireland was associated with immediate reductions in all
-cause and cause-specific cardiovascular, cerebrovascular, and respiratory
mortality, and that these mortality reductions were primarily due to
reductions in population exposure to secondhand smoke [2]. Our subsequent
assessment of the socioeconomic differentials of these mortality
reductions in the Republic of Ireland suggested that inequalities in
smoking-related mortality were immediately reduced following smoking ban
implementation [3]. Furthermore, given the higher rates of smoking-related
mortality in the most deprived group, even equitable reductions across
socioeconomic groups resulted in decreased inequalities in mortality [3].
Partial smoking ban policies do not fully protect health [4], and are
likely to yield negative equity effects as a result of policy exclusions
for workplaces and hospitality venues located in more deprived areas [5].
In contrast, comprehensive smoking ban policies provide equal protection
for all against secondhand smoke exposure. Indeed, previous studies have
indicated that comprehensive smoking ban policies are effective public
health interventions for reducing both exposure to secondhand smoke and
other indoor air pollutants [6-11], the benefits of which are experienced
by all employees and patrons of restaurants, bars, and other public
places, regardless of individual socioeconomic group. Therefore, we wish
to highlight that the evidence for pro-equity effects of comprehensive
smoking ban policies may be more conclusive when additional health-related
outcomes are considered.
References
1. Hill S, Amos A, Clifford D, Platt S (2014) Impact of tobacco
control interventions on socioeconomic inequalities in smoking: review of
the evidence. Tob Control 23: e89-e97.
2. Stallings-Smith S, Zeka A, Goodman P, Kabir Z, Clancy L (2013)
Reductions in cardiovascular, cerebrovascular, and respiratory mortality
following the national irish smoking ban: interrupted time-series
analysis. PLoS One 8: e62063.
3. Stallings-Smith S, Goodman P, Kabir Z, Clancy L, Zeka A (2014)
Socioeconomic differentials in the immediate mortality effects of the
national Irish smoking ban. PLoS One 9: e98617.
4. Tan CE, Glantz SA (2012) Association between smoke-free
legislation and hospitalizations for cardiac, cerebrovascular, and
respiratory diseases: a meta-analysis. Circulation 126: 2177-2183.
5. Lewis GH, Osborne DC, Crayford TJ, Brown AC (2006) Partial smoking
ban would worsen health inequalities. Bmj 332: 362.
6. Fong GT, Hyland A, Borland R, Hammond D, Hastings G, et al. (2006)
Reductions in tobacco smoke pollution and increases in support for smoke-
free public places following the implementation of comprehensive smoke-
free workplace legislation in the Republic of Ireland: findings from the
ITC Ireland/UK Survey. Tob Control 15 Suppl 3: iii51-58.
7. Connolly GN, Carpenter CM, Travers MJ, Cummings KM, Hyland A, et
al. (2009) How smoke-free laws improve air quality: a global study of
Irish pubs. Nicotine Tob Res 11: 600-605.
8. Goodman P, Agnew M, McCaffrey M, Paul G, Clancy L (2007) Effects
of the Irish smoking ban on respiratory health of bar workers and air
quality in Dublin pubs. Am J Respir Crit Care Med 175: 840-845.
9. Mulcahy M, Evans DS, Hammond SK, Repace JL, Byrne M (2005)
Secondhand smoke exposure and risk following the Irish smoking ban: an
assessment of salivary cotinine concentrations in hotel workers and air
nicotine levels in bars. Tob Control 14: 384-388.
10. Valente P, Forastiere F, Bacosi A, Cattani G, Di Carlo S, et al.
(2007) Exposure to fine and ultrafine particles from secondhand smoke in
public places before and after the smoking ban, Italy 2005. Tob Control
16: 312-317.
11. Eisner MD, Smith AK, Blanc PD (1998) Bartenders' respiratory
health after establishment of smoke-free bars and taverns. JAMA 280: 1909-
1914.
NOT PEER REVIEWED Tobacco is an interesting consumer product. It is legal, toxic and
dangerous. It kills people when used as intended. There is a global
initiative to reduce use of this product opposed heavily by those
profiting from it, tobacco industry stockowners. Industry has successfully
blurred consumers, health professionals and policy makers over the years
with false science, modulation of product and misleading m...
NOT PEER REVIEWED Tobacco is an interesting consumer product. It is legal, toxic and
dangerous. It kills people when used as intended. There is a global
initiative to reduce use of this product opposed heavily by those
profiting from it, tobacco industry stockowners. Industry has successfully
blurred consumers, health professionals and policy makers over the years
with false science, modulation of product and misleading marketing,
product manipulation and new nicotine devices. In the 1970's the first anti-
smoking movement was followed by the "light cigarette"- concept, in the 1990's
when carcinogens entered public health discussion with environmental tobacco
smoke, the industry came out with "less carcinogen" concept. Now the focus is
finally moving to the pure addictive compound of tobacco, nicotine as we
see the rise of "pure nicotine" -concept with electronic devices for
inhaling nicotine in aerosols. So basically this industry has modified its
very toxic product as we public health people have been responding to
these new products, but really seeing, that old products remain available.
In comparison with the petrol industry, which has faced similar
challenges, for example high amount of lead needed in motors being
environmental health threat. Reaction of the petrol industry was similar to the tobacco
industry: developing new products, both cars and fuels. However, there is
one distinct difference. These high-lead fuels are no longer on the market,
but cigarettes are. So, if we have no courage to ban nicotine, why not
follow the pattern of population protection strategies and ban the most
harmful products first and then gradually move into nicotine free time.
Taxing may help, but a gradual shift is worth thinking about, isn't it?
In this rejoinder, we will address the recent response by Mary
Assunta to our article, "Complexities at the intersection of tobacco
control and trade liberalisation: evidence from Southeast Asia." To be
sure, we believe that trade policy remains a very important issue for
public health both in Southeast Asia and globally. Before addressing the
specific concerns raised by the reader, it is worthwhile to restate the
ove...
In this rejoinder, we will address the recent response by Mary
Assunta to our article, "Complexities at the intersection of tobacco
control and trade liberalisation: evidence from Southeast Asia." To be
sure, we believe that trade policy remains a very important issue for
public health both in Southeast Asia and globally. Before addressing the
specific concerns raised by the reader, it is worthwhile to restate the
overarching argument, goals and approach in the original article. In
brief, we argue and demonstrate empirically that over the last 15-20
years, sometimes considerable changes in trade policy have not
systematically undermined tobacco control in Southeast Asia. Moreover, we
also posit that penetration of the region by large international tobacco
firms through investment is likely playing a much larger role in affecting
public health policy. We do not discount trade entirely and largely agree
with the reader that it has had some specific important effects, but these
incidents do not undermine our general thesis.
We completely concur with the reader's first concern that trade
liberalization should be conceptualized as more than tariffs. This indeed
was exactly our concern and largely motivated the research. In previous
research and in discourse at international meetings, we observe too much
emphasis on the more elementary aspects of liberalization and not enough
on some of the areas that the reader, too, points out as important. The
reader appears to have overlooked particularly both the abstract and the
conclusion, which raise concerns with critical issues such as intellectual
property rules and investor-state dispute settlement. We wish for the
focus to be the right one, too, and it seems that we are on the same page
for this goal.
On the second major point, it appears that the reader is suggesting
that transnational tobacco corporations use tariff reduction as a
springboard into seeking further non-tariff liberalization. We would not
dispute this contention, but we would also like to see much more
compelling and rigorous evidence of this dynamic. The Philip Morris
International (PMI) submission to the Transpacific Partnership (TPP) cited
by the reader does not really make this connection sufficiently, in
particular because the included passage is still really about tariffs or
closely-related ancillary policies.
The reader's third concern revolves around a purported dismissive
treatment of the findings of Chaloupka and Laixuthai (1996), and Honjo and
Kawachi (2000), particularly on the advertising dynamic. When we wrote,
"Tobacco control policies were mostly nonexistent in these contexts too,
so there was no obvious policy-based counter-force to the sudden changes
in the tobacco marketplace" (which the reader cites almost verbatim in
their critique), we were referring to the lack of these types of
restrictions. We do not and would not dispute the important role that
increased marketing played in re-shaping these contexts - it was
undoubtedly an important part of the increase in imports and subsequent
consumption. But our broader conceptual point is that the context in most
countries now is different than it was in East Asia in the 1980s. First,
most countries are already highly liberalized both in terms of trade and
of investment. In most if not all of Southeast Asia, multinational
tobacco firms are already firmly entrenched in terms of trade, investment
and marketing (Vietnam is a partial exception because of tariff walls and
the market constraints on multinational firms in their joint ventures with
the state-owned tobacco enterprise). Thus, in many markets, firms have
already been marketing for years and further liberalization in the
classical sense is likely to make little difference strictly speaking.
There is also good news in the contemporary era quite different than the
1980s in that some countries have strong marketing restrictions in place.
The fourth concern in the response focuses on affordability. The
reader's primary concern is that their data do not match ours. We re-
checked our data and calculations, and remain confident in them. We are
using the most up-to-date market data from proprietary sources such as
Euromonitor and ERC (these services frequently update old data rendering
older versions obsolete). While these sources are far from perfect, most
in the tobacco control sub-field believe that they remain the best
available for these types of data. It is critical to stress that we are
using the cheapest brand (typically, a local brand, though not necessarily
the most popular) for our calculations with the explicit logic that we
want to explore barriers to consumer market entry (i.e. what is the least
amount of money that it would take for someone to smoke regularly). Many
other articles on tobacco affordability use prices of the most popular
brand and/or an international brand such as Marlboro to calculate
affordability. As we explain in the article, these choices are simply not
theoretically suitable for our purposes. When we run cursory analyses with
these other prices, we do note some of the differences that the reader
points out; however, such differences are not relevant to our discussion.
In response to the reader's concern about our interpretation of
Figure 3, we appreciate the correction about Myanmar. The reader is
correct that we erroneously indicated Myanmar when we meant, instead, to
include Singapore in this list of countries with noticeable decline. As
the reader rightly points out, Myanmar stayed about the same. In the
process of writing the manuscript, we re-did this figure several times -
ironically largely because we thought that the Singapore and Myanmar
results were not accurate - with updated data (see the discussion above -
sometimes we observed reversals in country-level trends after receiving
market data updates) and unfortunately failed to update the text
completely.
We should also clarify the reader's misconception in Figure 3's
interpretation about our apparent confusion around Indonesia and Vietnam.
We actually split them apart in our narrative in order to draw attention
to each of them. As we suggest, the broader contexts and dynamics in the
two countries are quite different, but we wanted to highlight the
similarity in outcome (increased consumption per capita) in two quite
different scenarios. More broadly and importantly, the crux of the figure
is the inconsistency across countries. Even our tiny descriptive error
outlined in the paragraph above does not change this important
characteristic in any way.
In terms of the reader's very minor concern about our description of
Vietnam as being "closed," please refer to Table 1, which discusses tariff
rates. We do not purport to make a broader interpretation of openness (or
"closedness" as the case is here) than the straightforward one that we
clearly lay out. We also cite the joint venture activity that the reader
seems to suggest as new and excluded information (see Table 4).
We appreciate the reader's interesting discussion on affordability in
Malaysia. We are very interested in the possibility that tobacco firms
operating in Malaysia were able to keep prices down by importing cheaper
leaf. However, the reader's discussion focuses on the delay of the
prohibition of selling "kiddie" packs, conflating the actual causal
relationships. Specific to the dynamic of tobacco leaf prices, it is also
important to note that FAO price data suggest that these prices are
increasingly global with limited cross-country variation (FAO STAT 2014).
Moreover, leaf comprises only a surprisingly small part of the overall
"cost" of a cigarette, so changes in leaf prices are unlikely to have
enormous impact on affordability.
In many ways, the complexities that the reader points out with the
kiddie packs only strengthen our overall argument that the broader
political economy of tobacco control is much more complex than changes in
trade policies. That the tobacco industry is devious and employs many
tactics only reinforces the important notion that the public health
community has to keep the broader context in mind. Like the brief
discussion above about one aspect of the complexities of measuring
affordability (Which cigarette price should we use? Lowest? Most popular?
Most commonly collected? Recognized international brand?), the dynamic
that the reader describes raises another complexity - the definition of
pack size for the calculation. Alas, this discussion about the vagaries
of measurement in affordability - though very important - is beyond the
purview of our brief study about trade liberalization.
We thank the reader for pointing out our reversal of the dates for
the investments in Malaysia and Indonesia. We appreciate the reader's
keen sense of accuracy, but our main point remains unchanged:
transnational tobacco firms are highly active investors in the region.
Investment is almost certainly more important than trade liberalization in
terms of affecting the dynamics that we discuss, including affordability
and relevant policies.
In the Philippines-Thailand dispute at the World Trade Organization
(WTO), the reader appears to confuse the basic tenets of Article 5.3 of
the World Health Organization's (WHO) Framework Convention on Tobacco
Control (FCTC). One of the key goals of Article 5.3 is to ensure that the
tobacco industry is excluded from direct participation in making tobacco
control policy. The article also presses for transparency when
governments deal with the tobacco industry more generally, but the FCTC
does not ask governments to cease all relationships with the tobacco
industry. Elsewhere, the authors and colleagues have examined in
considerable depth (e.g. Chavez et al 2014; Drope et al 2014) the lack of
irrefutable evidence that the tobacco industry did anything that is not
permitted - in the FCTC or otherwise - to get the Philippines government
to pursue the dispute at the WTO. That the industry helped to pay some of
the legal costs (incidentally, we failed to obtain confirmation of this
scenario in our on-the-ground research) is neither illegal nor unusual.
Firms in many other industries in other countries have behaved similarly
at the WTO and it is not expressly prohibited. Perhaps the reader
believes that pursuing such a case is tantamount to an incentive, which
Article 5.3 does identify as not permissible, but the case for such a
dynamic remains to be made. While we personally feel that governments
should not pursue these cases on behalf of the tobacco industry, it is
clearly in trade ministries' mandates to act to protect their
constituents, of which the tobacco industry is one.
Rather than relying on anecdotal and often unverified media accounts,
we formally interviewed dozens of the key official and unofficial players
involved in this and related dynamics in the Philippines and we did not
find any "smoking gun" evidence of corrupt behavior. What the public
health community considers "bad" or undesirable behavior does not
necessarily qualify as corruption. Finally, we never suggested that civil
society had to produce the evidence - as researchers, we should not care
from where the evidence comes. We should, however, care deeply about the
quality of the evidence, and be able to gather it and evaluate its
validity and reliability with considerable objectivity.
Finally, in regard to the referenced Joint Memorandum Circular (JMC),
it is worth noting that there are internal struggles within the
Philippines as the domestic tobacco control legislation (RA 9211) and the
FCTC remain in some or even considerable tension. Many government
departments point out that the FCTC has never been properly domesticated
with enabling legislation as the political and legal structure in the
Philippines requires (see Magallona 2013 for a discussion of how this
works). So, in the eyes of many, the JMC does not have the force of law
(see Lencucha et al, forthcoming).
In regard to the concern about regulatory chill, we do not purport at
any point that regulatory chill does not exist; rather, the actual dynamic
that we examine in the article is that chill is a very difficult
phenomenon to identify unequivocally. To take the reader's example of New
Zealand, our colleagues (officials in governments) have explained to us
that there is limited political support for plain packaging beyond
Minister Turia and some in the Maori Party and the Green Party. In brief,
our sources suggest not only that the minister lacks support from many
other key actors (including particularly in the minority government's
coalition-leading National Party), but that blaming regulatory uncertainty
("chill") is a thinly-veiled and convenient excuse to avoid pushing the
legislation that a number of officials simply do not want. The scenario
in New Zealand seems likely to be precisely the dynamic that we are
discussing in this article. Incidentally, the dynamic that we examine may
be just as or even more problematic to the public health community than
basic "chill." We cannot speak to what is happening in this area in
Malaysia as it was not part of our research - perhaps it is regulatory
chill in the truest sense - but it has to be demonstrated rigorously.
From personal perspectives, we are quite concerned about regulatory chill,
and particularly for low- and middle-income countries that rightfully fear
costly litigation, but as we state clearly and for which we make a
compelling case, as a scholarly community we simply do not yet understand
well the actual dynamics of regulatory chill. Clearly, it is a much
needed avenue of future research.
After the discussion of regulatory chill, the reader reiterates one
of our key conclusions - which we do not seek to prove empirically - that
investment almost certainly plays a significant role in affecting the
tobacco control outcomes examined in this research. Our discussion is
fully congruent with the reader's observation that investment in countries
like the Philippines and Indonesia is surely having a significant effect
on tobacco control and related efforts. Again, we are advocating not only
more systematic research on trade policies' effects on tobacco control,
but more broadly, to expand research focus to the dynamics around
investment in the tobacco sector.
Finally, on the issue of a tobacco carve-out in the TPP, we would
suggest that typical dynamics of the international system - well developed
theoretically and substantiated empirically - suggest that the prospects
for a Malaysia-style proposal are likely to be rather dim (for a broad set
of relevant theoretical discussions, see, for example, Baldwin 1993).
First, international agreements are deeply affected by state power and in
the TPP scenario, Malaysia is a relatively weak actor, while several of
the other much stronger states have stated an explicit preference for an
alternative arrangement (the US) or have intimated that a carve-out is not
likely to be acceptable (Japan). Second, and intrinsically related to the
first dynamic, in an international trade negotiation like the TPP, all
parties must agree, so the prospect of total agreement on a complete
tobacco carve-out is currently not strong. It is possible that other
countries will use the Malaysia proposal as a foil in order to find some
middle ground, which might still work out well for public health. It is
also possible that because the proposal is so unpopular with some key
actors that negotiating parties might choose ultimately to exclude it
entirely from the negotiation (much the same way that trade has thus far
been excluded from the Framework Convention on Tobacco Control). Finally,
we highly doubt that Malaysia will withdraw from the TPP if it does not
get its way on tobacco, which suggests strongly that it is probably not
the most important issue on its trade ministry's negotiating agenda.
The dynamics above also apply to the re-negotiation of the thousands
of existing agreements that the reader suggests is attainable with some
hard work. Unfortunately, both theory and recent experience suggest a
genuine struggle to negotiate trade agreements more broadly. For example,
the WTO's Doha round was essentially stuck for more than a dozen years and
the supposed breakthrough in 2013 was eventually about the relatively non-
controversial area of trade facilitation and ignored the many other
pressing issues that have contributed to the long gridlock (WTO 2013). It
is also important to consider that many international economic agreements
do not come up for renegotiation naturally or will not expire for many
years. Any enthusiasm for re-negotiation may eventually be tempered by
the sheer size of the endeavor. We do agree, however, that a TPP that
enshrines health in a way that protects and promotes tobacco control and
public health is a crucial set of goals for the global community.
It is also important to consider that the idea of a tobacco carve-out
is mostly untested. We fear that it will not be the panacea that many
advocates suggest. Tobacco exclusion may even be detrimental in some
circumstances by perpetuating market structures that serve strong pro-
tobacco interests - for example, by preserving the market share of
politically-strong tobacco firms (this dynamic is somewhat similar to a
scenario where under certain conditions marketing restrictions can also
serve to preserve market share for powerful incumbent firms). In two
recent major international economic agreements, the Pacific Island
Countries Trade Agreement (PICTA) and the South Africa-European Union
Trade, Development and Cooperation Agreement (TDCA), it was a major
transnational tobacco firm operating in favorable domestic conditions
pushing governments for a tobacco exclusion policy (personal communication
with a South African treasury official).
A final and more crucial point is that the international trading
system has rules that seek to tackle the complexities of making policies
across sectors (e.g. public health and economic policies). As Drope and
Lencucha (2014) discuss, the seminal Thailand - Cigarettes case at the
General Agreement on Tariffs and Trade (GATT) actually laid a reasonable
foundation for how to make good public health policy that integrates
successfully with world trade rules and goals (see for example, paragraphs
77-78 from GATT 1990). In some ways, the slightly bizarre U.S.-Clove
Cigarettes case also generated some similar proactive discussion from the
WTO wherein the panel was explicit about permitting the banning of tobacco
additives as long as it was not discriminatory (see McGrady 2011 for a
discussion). The panel reports demonstrate these dynamics clearly (see
WTO 2011, 2012).
As a broader community - i.e. beyond tobacco control - we suggest
that we need to develop a world trading system that can accommodate many
other important health-related issues such as unhealthy foods, alcohol and
access to medicines (to name only a few) that sit squarely at the nexus of
public health and economic policymaking. Re-working or tweaking some of
the rules of the world trading system might be a good place to start. But
we are unwilling to throw out all of the existing rules and are suggesting
that they have even sometimes served to try to integrate health and trade
meaningfully in ways that do not necessarily undermine health (see the
examples in the paragraph above). Another recent case worthy of
consideration is the Philippines - Distilled Spirits dispute at the WTO,
which ultimately was the primary catalyst for the recent successful
tobacco excise tax reform in the Philippines (see Chavez et al 2014; Drope
et al 2014). We underscore in our article, and reinforce in this
rejoinder, that the international economic system is complex, but it is
not without opportunities to promote public health.
In regard to the quote from a Philippine trade official about a lack
of support for a tobacco carve- out in ASEAN, it is important to reiterate
context. First, the official was speaking about the AFTA, not the TPP,
which is to what the reader is referring. Second, returning to the
original interview transcript, the official also stated that no
influential trade official that s/he knew of was in favor of a carve-out.
Whether the Malaysian proponents prove to be sufficiently influential to
include a tobacco exclusion in AFTA still remains to be seen. Finally,
this was a key informant interview of an influential actor in one country
in this regional agreement - these are not our views necessarily and we do
not at all purport that these are the only views. Moreover, we do not
suggest anywhere in the research that the tobacco carve-out discussion is
only occurring in Southeast Asia. We set up our case study justification
for Southeast Asia by acknowledging the regional discussion, but this does
not suggest that there is no discussion of carve-outs elsewhere in the
global community.
In sum, the key argument in our article that trade policy has not
systematically undermined tobacco control in Southeast Asia remains
strongly supported. Moreover, the reader appears to concur with us that
investment is a key variable in the political economy of tobacco control
in the region. In many ways, it appears that we and the reader are simply
coming from entirely different epistemological and methodological
traditions. We are seeking to identify and explain broader patterns across
time and space (in this case, countries in Southeast Asia) and learn from
them, where in contrast the reader seeks to focus in large part on the
exceptions to the patterns that we are underscoring. We acknowledge the
complementarity of research that seeks an approach focused on important
exceptions and identify some effective recent articles in this research
vein (see endnotes 24 and 34-38), but it is important to recognize that
each approach offers distinct utility. In an important research topic and
moral cause - such as the health-trade nexus - we need to take great care
not to prematurely dismiss others' rigorous and transparent work, and
exploring a wealth of different approaches can only be good.
REFERENCES
Baldwin R. (ed.) Neorealism and Neoliberalism: The Contemporary
Debate, Columbia University Press, 1993.
Chaloupka F, Laixuthai A. U.S. Trade Policy and Cigarette Smoking in
Asia [Internet]. National Bureau of Economic Research; 1996 Apr. Report
No.: 5543. Available from: http://www.nber.org/papers/w5543.
Chavez JJ, Drope J, Lencucha R, McGrady B. The Political Economy of
Tobacco Control in the Philippines: Trade, Foreign Direct Investment and
Taxation 2014. Quezon City: Action for Economic Reforms and Atlanta:
American Cancer Society.
Drope J, Chavez JJ, Lencucha R, McGrady B. The Political Economy of
Foreign Direct Investment: Evidence from the Philippines. Policy and
Society 2014; 33: 39-52.
Drope J, Lencucha R. "Evolving Norms at the Intersection of Health
and Trade." Journal of Health Politics, Policy and Law 2014; 39, 3: 591-
631.
FAO STAT. Tobacco leaf - world price and export unit value. 2014.
General Agreement on Tariffs and Trade (GATT). Panel Report: Thailand
- Restrictions on Importation of and Internal Taxes on Cigarettes 1990.
BISD DS10/R-37S/200. Geneva: GATT (November 7).
Honjo K, Kawachi I. Effects of Market Liberalisation on Smoking in
Japan. Tob Control. 2000;9(2):193-200.
Lencucha R, Drope J, Chavez JJ. Whole-of-government approaches to
NCDs: The case of the Philippines Interagency Committee on Tobacco.
Forthcoming, Health Policy and Planning.
Magallona, MM. The Supreme Court and International Law Problems and
Approaches in Philippine Practice. 2013 Philippine Law Journal 85(1, 2).
Available at http://plj.upd.edu.ph/wp-content/uploads/2013/06/PLJ-volume-
85-issue-1-2-THE-SUPREME-COURT-AND-INTERNATIONAL-LAW-PROBLEMS-AND-
APPROACHES-IN-PHILIPPINE-PRACTICE-Merlin-M.-Magallona.pdf.
McGrady B. Tobacco Product Regulation and the WTO: US - Clove
Cigarettes. O'Neill Institute Briefing Paper - 12 September 2011.
Washington DC: Georgetown University.
Pacific Island Countries Trade Agreement (PICTA). Nauru, 2001.
World Trade Organization (WTO). Panel Report: United States -
Measures Affecting the Production and Sale of Clove Cigarettes 2011.
Geneva: WTO (WT/DS406/R).
World Trade Organization (WTO). Appellate Body Report: United States
- Measures Affecting the Production and Sale of Clove Cigarettes 2012.
Geneva: WTO.
World Trade Organization (WTO). Agreement on Trade Facilitation. 6
December 2013. See https://mc9.wto.org/system/files/documents/w8_0.pdf.
I would like to respond to this paper by Drope J and Chavez JJ whose
analysis focuses on cigarettes, not tobacco leaf production and trade, and
seeks to question the "conventional wisdom" that "trade liberalization
naturally leads to lower prices for tobacco products, increased
consumption and decreased levels of regulation." The authors use
theoretically guided empirical research to demonstrate there is little
cause for...
I would like to respond to this paper by Drope J and Chavez JJ whose
analysis focuses on cigarettes, not tobacco leaf production and trade, and
seeks to question the "conventional wisdom" that "trade liberalization
naturally leads to lower prices for tobacco products, increased
consumption and decreased levels of regulation." The authors use
theoretically guided empirical research to demonstrate there is little
cause for concern on the negative impact of trade liberalization on
tobacco control policies. They have focused on Southeast Asia as an "ideal
most likely case" because the region has experienced recent trade
liberalization regionally and multilaterally, and because the "tobacco
control proponents from the region continue to voice loud concern about
the issue suggesting that it is perceived as a genuine threat," and
conclude their proposal to carve out tobacco from trade agreements is "sub
-optimal". The authors omitted and overlooked some crucial evidence,
details, and developments on tobacco, trade and tobacco control on the
ground which I will address in this response. There are also some errors
which need to be corrected.
Firstly, trade liberalization through new free trade agreements are
not just about eliminating tariffs, but includes addressing "non-tariff
barriers" such as national legislation, product standards, services,
investment, intellectual property rights, government procurement and
environment which may be just as important or even more important than
tariffs for regional economic integration. In the Trans-Pacific
Partnership (TPP) to which the authors refer, only 5 chapters of the total
29 chapters actually deal with traditional trade issues while the rest are
about dismantling non-tariff barriers to trade. There is the real threat
that corporations are using trade agreements to get special benefits that
they would find much more difficult to get through the standard
legislative process. Trade agreements' impacts on tobacco control, among
others, include challenging clean indoor air rules, controls on sale and
distribution of tobacco products, cigarette content regulation and bans on
tobacco advertising and promotions. It is in this context that the impact of
trade liberalization on tobacco control should be seen and not limited to
the narrow scope of tariffs alone.
Secondly, transnational tobacco companies (TTC) themselves have
traditionally supported the lowering of tariff barriers to tobacco both
historically and continue to support it even now for the added value it
brings them to influence non-tariff barriers. Philip Morris International
(PMI), for example, in its submission to the TPP said, "The negotiations
should be comprehensive and lead to the complete elimination of all
tariffs on all goods. There are tools - such as longer phase-out periods
and temporary special safeguards - that can be used to mitigate the impact
on products deemed "sensitive" by participating national governments."
Trade liberalisation -
The authors are rather dismissive of previous studies on trade
liberalisation and tobacco control in East Asia such as papers by Honjo
and Kawachi, and Chaloupka and Laixuthai as being limited to a narrow set
of market conditions since they involved state-owned tobacco monopolies,
where tobacco control policies were mostly non-existent and there was no
obvious policy based counter-force to the sudden changes in the tobacco
marketplace. The Honjo and Kawachi study actually provides clear evidence
that the opening of Japanese markets to the TTC "stalled a decline in
smoking prevalence" and the contributing factors to opening of the market
included removal of non-trade barriers such as the actual elimination of
restrictions on advertising and promotion on tobacco products, which saw an
increase of marketing and promotion by these companies. This is also
consistent with strategies revealed in the internal industry documents
which suggest that besides tariffs elimination the American companies also
wanted: "(b) access to all retail outlets. (c) Eliminate advertising
limitations. (d) Allow us to do effective market research and product test
marketing."
Affordability -
The data of the authors show the RIP (relative income price) of only
Brunei, Cambodia and Philippines have reduced. However according to the
data of the Southeast Asia Tobacco Control Alliance, the RIP of
cigarettes also decreased for Lao, Indonesia and Vietnam, besides
Philippines and Cambodia, meaning that overall, cigarettes became cheaper
across many countries in the ASEAN region following the introduction of
AFTA.
The authors refer to Figure 3 to illustrate changes in consumption
per capita, demonstrating mixed results, though not precisely in the same
pattern they observe with affordability. They point out the most
pronounced declines have occurred in Malaysia, Myanmar and Cambodia, and
that the only clear upward trend is in Indonesia. However this description
does not match data in Figure 3 accordingly. For example Figure 3 shows
Myanmar's per capita consumption has remained unchanged (around 200
sticks), while the decline in Singapore has been reversed as of 2006.
After identifying Indonesia as the only county with a "clear upward trend"
the authors go on to say Vietnam is the only ASEAN country with a "strong
upward trend".
They describe Vietnam as the only country that continues to have a
"closed tobacco sector." It is unclear what exactly this means as the
state owned Vinataba has joint-venture agreements with both British
American Tobacco (BAT) and PMI.
Change in affordability - The authors make considerable reference to
Malaysia, indicating it has experienced the greatest change with
substantial imports, prices, policies and the tobacco trade. The authors
point out when the government increased specific excise taxes from RM28
per kilogram to RM220 per 1000 sticks by 2010, cigarettes became less
affordable. What has been omitted is the tobacco industry gained by
importing cheaper leaves and mitigated the cigarette price increases by
successfully lobbying to delay the implementation of regulations banning
kiddie packs (less than 20 sticks) which was passed in 2004 but only
implemented in 2010. The tobacco industry kept cigarettes affordable
through the sale of kiddie packs. Contrary to the graph in Figure 2
showing cigarettes becoming "dramatically less affordable" in Malaysia,
another study conducted by the International Tobacco Control Project,
found affordability to have increased by 1.9% over the four years (2005 -
2009). These findings show that tobacco taxes and prices did not increase
at a rate high enough to offset income growth, and cigarettes became more
affordable to consumers.
Using small packs to keep cigarettes affordable particularly to the
young is further confirmed in the internal tobacco industry documents on
Malaysia. PMI for example, in their internal documents say, "...As the
total outlay for a pack of 20's became too prohibitive for our younger
adult smokers we should consider smaller packings. Currently we plan to
reduce the price of our 14's pack from M$2.40 to M$2.20. Should this move
not yield the desired results, we will launch a 10's and 7's packing in
this strong growth segment."
An error that needs correction is about the PMI factory in Malaysia.
According to the authors, "PMI opened a new US$40 million plant in
Malaysia in 2005, while purchasing remaining shares in Sampoerna
Indonesia, which they had partly purchased in 1995." In actual fact PMI
opened its manufacturing facility in Malaysia in 1995, which was its
first plant in Asia. Ten years later in 2005 PMI purchased PT HM Sampoerna
in Indonesia.
The authors refer to Thailand and Vietnam as being the "only
countries with a WHO MFN rate of 60% or greater" - this is a typographical
error for WTO as the WHO does not offer any MFN status to any countries.
In February 2008, the Philippines government filed a complaint to the
WTO, claiming a bias against imported cigarette brands in Thailand. The
authors claim that while tobacco control civil society groups in the
Philippines have expressed concern that the case is a violation of FCTC
Article 5.3 because tobacco firms in the Philippines, particularly Philip
Morris-Fortune Tobacco, might have exerted inappropriate pressure on the
Philippine government to pursue the case, the groups have
not produced unequivocal evidence of an Article 5.3 violation. Firstly,
the authors have failed to recognise that there are many newspaper reports
indicating that the case was filed by the Philippines government on behalf
of Philip Morris which cannot be ignored and warrant an
investigation to ascertain if there is indeed an Article 5.3 violation.
Secondly, the authors have not clarified why it is civil society's
responsibility to provide the evidence and not the government's to
facilitate an investigation when in the Philippines there is a mechanism
to implement Article 5.3 through the Joint Memorandum Circular (JMC) 2010-
01 of the Civil Service Commission and Department of Health.
Regulatory chill -
On regulatory chill the authors claim it is difficult to identify such
incidents definitively because there can be "multiple explanations for
governments' policy choices". It appears the authors may be ignorant of
tobacco control activities on the ground. In the case of New Zealand which
has started legislative process on plain packaging of tobacco and seen
first reading in Parliament, the legislators won't pass it into law "until
legal action in Australia has been settled". BAT and Imperial Tobacco,
which sued the Australian government, have threatened to take similar
action if plain packaging is introduced in New Zealand. The New Zealand
Prime Minister said they decided not to take a chance in breaking any
trade rule, that it would be too expensive for New Zealand to face a legal
challenge from tobacco companies. Similarly the Malaysian Health Minister
has said Malaysia will watch the legal outcome in Australia on plain
packaging.
The authors are dismissive about regulatory chill in the context of
the developing nations being studied. If it is too expensive for New
Zealand to fight such legal challenges, the reality is even more stark for
low and middle income countries which simply cannot afford protracted legal
battles. This is illustrated in Uruguay's experience of being unable to
afford legal costs in meeting PMI's challenge and seeking assistance from US
philanthropies. The challenge launched in 2010 is still ongoing.
Uruguay's President has now made an appeal to the US President for
assistance in stopping PMI from annulling their tobacco control
legislation.
The authors' conclusion that the very mixed results across key
aspects of the trade and tobacco nexus suggest that there is no clear-cut
link between trade liberalisation and a decline in tobacco control and/or
an increase in tobacco consumption in Southeast Asia must be seen in the
context of the errors and omissions pointed out above. While the authors
need not address all aspects, such as ways in which the TTC benefited from
AFTA beyond tariff reductions and conducted efforts to thwart tobacco
control measures, they could have mentioned them in the limitations.
Indonesia and the Philippines are the two countries where the TTC have
consolidated their presence by acquiring or merging with local companies.
BAT which exited the Philippines has since returned in 2012 and has
benefited from the recent tax hikes through what it calls a more "level
playing field".
Tobacco carve-out -
The authors claim that simply arguing trade liberalisation is bad for
tobacco control and that excluding the tobacco sector from economic
agreements is the solution is a "suboptimal" strategy. The authors have
attributed this call for a tobacco carve-out to "tobacco control
proponents from the region" as in a proposal limited to a specialised
group. The authors' doubts about the political viability of excluding
tobacco from such economic agreements have already been contradicted by
the Malaysian government's formal tabling of just such a provision in the
TPPA in August 2013. Malaysia's proposal received wide media coverage.
The complete carve-out proposal is based on the recognition that tobacco
products are uniquely harmful and the global consensus that nations must
act to reduce tobacco use, according to the WHO Framework Convention on
Tobacco Control (FCTC).
In reality the call for a tobacco carve-out is not confined to just
"tobacco control proponents from the region" but is echoed by public
health advocates, medical groups, academics and lawyers from New Zealand,
Australia, the US and Peru. Additionally in January 2014 the
Attorneys General of 45 states in the US urged the US Trade Representative
to exclude tobacco from the TPP entirely, stressing that "there is no
policy justification for including tobacco products in agreements that are
intended to promote and expand trade and investment generally." Needless
to say these Attorneys General are not from Southeast Asia.
Malaysia's proposal to the TPP was submitted by officials from the
Ministry of International Trade and reiterated by the Minister
contradicting the authors' claim that there is a "gap between trade and
health practitioners". This also lays bare the authors' quote from a
Filipino high-ranking trade official that "no key trade or finance
officials in ASEAN countries are openly supportive of this proposal
(tobacco exclusion)".
The authors say tobacco exclusion may even be problematic and advise
tobacco control proponents to counteract aggressive marketing by the
tobacco industry by being more prudent and pursuing FCTC-compliant bans on
tobacco advertising, promotion and sponsorship. If the authors simply
recognized the fact that Australia plain packaging was challenged despite
"being prudent" then they would realize that their recommendation for
prudence has no basis and is not an alternative to the so-called
suboptimal solution. The Australian plain pack example also clearly
explains the regulatory chill effect in other countries that the authors
dismiss.
In questioning the political viability of tobacco exclusions, the
authors focus on the challenges of the broader task of affecting trade
negotiations successfully but not on the benefits. Of course, nothing in
tobacco control was achieved easily, more so in trade agreements. They
have all been hard fought battles and we continue to fight them in
developing countries.
The authors refer to the "additional burdens of returning to hundreds
of previously negotiated economic agreements" but they should know that
the practical solution is when these agreement expire and/or come up for
renewals, to address tobacco then. Hence it is vital to secure a tobacco
exclusion in the TPP, touted to be the 21st Century free trade agreement
to provide the standard for future agreements.
References
Public Citizen, Trans-Pacific Partnership (TPP): Job Loss, Lower
Wages and Higher Drug Prices http://www.citizen.org/TPP
Editorial Board, This Time, Get Global Trade Right, New York Times,
19 Apr 2014, http://www.nytimes.com/2014/04/20/opinion/sunday/this-time-
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Saclag, DED. WTO arbitration over cigarette taxes again likely,
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arbitration-over-cigarette-taxes-again-likely&id=84912
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The article of Cummins et al. (1) is based on a survey
which according to the authors considers electronic cigarette a risk
for populations with mental health conditions.
First of all, in our opinion it is not correct to agglomerate and treat
all mental health conditions in the same way. It would be like
considering all physical illness the same way. Fever is like a
cancer? A specific phobia is like schizophrenia?
It 'is...
The article of Cummins et al. (1) is based on a survey
which according to the authors considers electronic cigarette a risk
for populations with mental health conditions.
First of all, in our opinion it is not correct to agglomerate and treat
all mental health conditions in the same way. It would be like
considering all physical illness the same way. Fever is like a
cancer? A specific phobia is like schizophrenia?
It 'is true that there is a high level of smoking prevalence in
individuals with mental health conditions but it varies according to
mental health conditions e.g. schizophrenia, major depression,
bipolar disorder.
In two studies we have shown for the first time that regular use of E-
cigarettes substantially decreased consumption of conventional cigarettes
without causing significant side effects in chronic schizophrenic patients
and in depressed patients who smoke (2,3). Large prospective randomized controlled
are now required to confirm these initial observations (4,5).
If these studies further confirm the potential use of the ecig as a tool
in the fight against smoking, we could see the resources of this
instrument rather than just the limits. Millions of lives could be saved
and the smoking cessation centers, in real life settings, could boast a
range of proposed therapies able to increase their level of clinical
efficacy and improve their level of attractiveness for the smoker who
thinks to improve their health and quality of life.
Although not formally regulated, the e-cigarette may help smokers with
mental health conditions to reduce their cigarette consumption or remain
abstinent and reduce the burden of smoking-related morbidity and
mortality. The ultimate goal is to propose an effective intervention to
reduce the harm of tobacco smoking for this challenging population.
References
1. Cummins SE, Zhu S, Tedeschi GJ, Gamst AC, Myers MG. Use of e-
cigarettes by individuals with mental health conditions. Tob Control
doi:10.1136/tobaccocontrol-2013-051511
2. Caponnetto P, Auditore R, Russo C, Cappello G C, Polosa R: Impact of an
Electronic Cigarette on Smoking Reduction and Cessation in Schizophrenic
Smokers: A Prospective 12-Month Pilot Study. Int. J. Environ. Res. Public
Health 2013, 10: 446-461.
3. P Caponnetto, R Polosa, R Auditore, C Russo, D Campagna: Smoking
Cessation with E-Cigarettes in Smokers with a Documented History of
Depression and Recurring Relapses. International Journal of Clinical
Medicine 2(3), Vol.2 No.3, July 2011.
4. Caponnetto P, Polosa R, Auditore R, Minutolo G, Signorelli M, Maglia M,
Alamo A, Palermo F, Aguglia E. Smoking cessation and reduction in
schizophrenia (SCARIS) with e-cigarette: study protocol for a randomized
control trial. Trials. 2014 Mar 22;15:88
5. http://clinicaltrials.gov/ct2/show/NCT02124187
Euromonitor International is a world leader in strategy research for
consumer markets, with over 40 years of experience in developed and
emerging economies. Through a combination of specialist industry knowledge
and in-country research expertise, Euromonitor aims to build a market
consensus view of the size, shape and trends in each industry we cover.
Tobacco is no different, and both duty paid and illicit sales are
rese...
Euromonitor International is a world leader in strategy research for
consumer markets, with over 40 years of experience in developed and
emerging economies. Through a combination of specialist industry knowledge
and in-country research expertise, Euromonitor aims to build a market
consensus view of the size, shape and trends in each industry we cover.
Tobacco is no different, and both duty paid and illicit sales are
researched in the same way as all other consumer products.
As impartial market analysts, our research methodology has been
developed over decades and continues to deliver well-respected and widely
used data and insights. For a full description please visit
http://www.euromonitor.com/research-methodology.
In short our aim is to build an industry consensus view of each
market by accessing all relevant public domain material and enhancing this
through an in-country trade survey. The volume and strength of published
source material behind our global systems will vary depending on the
market or category in question and as a result some data sets are more
"hard sourced" than others. This is a widely accepted challenge of
researching international markets.
For Tobacco, trade surveys are conducted with a representative range
of industry stakeholders in each national market, from government bodies
to tobacco brand owners, retailers and health groups, reflecting our wide
client base as well as varied opinions and agendas. By its very nature,
illicit trade in tobacco is a contentious area that is difficult to
quantify - there is often dissonance between sources. A key element of the
value-add of Euromonitor's work lies in our ability to scrutinise and
reconcile differing views by considering illicit trade against local
knowledge of the market and its wider context of national economic
performance, trends in cigarette taxation, movements in unit prices, duty
paid sales (including trends in illicit and duty paid combined) and
smoking populations, as well as porosity of national borders, law
enforcement efforts, and product availability. The context and drivers
behind our figures are explored in accompanying market analysis reports on
each country we research.
As such we are confident Euromonitor International presents the most
widely accepted and realistic estimate of the illicit market, based on an
integrated view of the wider industry context and the factors that
contribute towards it - no single source or figure is taken as definitive.
That said, our clients accept and acknowledge that researching
challenging markets is part of an iterative process. We are constantly
improving our coverage and understanding of consumer products as we access
a wider range of sources in each annual revisit of our industries. As a
result our data may change from one annual update to the next based on new
sources becoming available, key sources resizing markets or an improved
understanding of how to interpret local source material. We are
transparent in our methods and our sourcing and all clients have access to
our analysts and the assumptions that go in to building our data.
Crucially Euromonitor International is an independent company with no
agenda other than to reflect markets and trends as accurately as possible.
As such we are completely impartial, with no bias or reliance on any
single source. Indeed as analysts we welcome all constructive debate and
regularly engage with industry stakeholders from across the board to
review sources and challenge assumptions with the aim of developing
greater understanding of difficult-to-research areas.
Gottlieb rightly provides us evidence to question Food and Drug
Administration (FDA) policy.(1) Indeed, the 2009 law giving the Agency the
authority to regulate tobacco was useless as FDA's Advisory Committee
issued a report which failed to recommend a ban on menthol cigarettes
despite evidence of its devastating effects, a major setback for public
health.(2) Is FDA only overcautious as Gottlieb suggested? Its
professio...
Gottlieb rightly provides us evidence to question Food and Drug
Administration (FDA) policy.(1) Indeed, the 2009 law giving the Agency the
authority to regulate tobacco was useless as FDA's Advisory Committee
issued a report which failed to recommend a ban on menthol cigarettes
despite evidence of its devastating effects, a major setback for public
health.(2) Is FDA only overcautious as Gottlieb suggested? Its
professionalism, competence and integrity may be questioned too!
First, FDA has even promoted the advantages of menthol in terms of harm
reduction.(3) Recurrence occurs, but this time the author failed to
disclose his link with FDA.(4) These reports are weak post hoc analyses
and, most of all, rely on a grossly flawed controlled group: menthol
smokers should be not be compared to smokers of non menthol cigarettes but
to non smokers because the tobacco industry has a well-documented history
of developing and marketing these brands to recruit racial minorities and
youth who would not have smoked otherwise.
Second, FDA's Center for Tobacco Products recently announced it will
analyse cigarette constituents more accurately and reliably, helping to
ensure that accurate scientific data are collected to help fill current
gaps regarding the chemical and physical properties of tobacco products,
and more generally, improve information regarding the harms associated
with tobacco use. "Quality control and sample testing parameters ... will
be conducted ... to allow for certification of product physical parameters
and constituent levels ..."
(http://www.fda.gov/AboutFDA/CentersOffices/OfficeofMedicalProductsandTobacco/AbouttheCenterforTobaccoProducts/ucm391336.htm)"
Cigarettes kill more than 400,000 US people annually in the US, but quality control
will replace tobacco control!
What could be next? Considering the importance of the global warming
issue, the addition to tobacco of the single "cool" molecule, the organic
compound obtained from peppermint, could be rewarded with an Ecolabel
through a partnership with the Environmental Protection Agency.
The European Union moved forward, issuing a directive to ban all
characterizing favors in 28 countries, though the menthol flavor will be
given a four-year derogation to 2020.
Could the FDA be under corporate influence? As a Frenchman, I note that
FDA did not hesitate to ban Mimolette, a French cheese, in May 2013. Some
said it was a retaliation to prevent Europe from banning US GMO food
exports. I am not surprised that 37% of American people agreed with
conspiracist beliefs such as "FDA is deliberately preventing the public
from getting natural cures for cancer and other diseases because of
pressure from drug companies."(5)
1 Gottlieb M. Overcautious FDA has lost its way. Tob Control
2014;23:187-8.
2 Siegel M. A Lost opportunity for public health - The FDA Advisory
Committee Report on menthol. N Engl J Med 2011;364:2177-9.
3 Rostron B. Lung cancer mortality risk for U.S. menthol cigarette
smokers. Nicotine Tob Res 2012;14:1140-4.
4 Rostron B. Menthol cigarette use and stroke risk among US smokers:
A critical reappraisal. JAMA Intern Med 2014. Online Mar 10. doi:
10.1001/jamainternmed.2013.9600.
5 Oliver JE, Wood T. Medical Conspiracy Theories and Health Behaviors
in the United States. JAMA Intern Med 2014. Online Mar 17. doi:
10.1001/jamainternmed.2014.190.
It is important for tobacco control policymakers to know the
advantages and disadvantages of different tax policies. It is quite
another thing to move a tax system to optimize tax policy for tobacco
control since there are multiple obstacles to systems change. In addition,
health advocates often do not invest enough time and effort to
understanding the economics of tax systems and the structural impediments
in existing l...
It is important for tobacco control policymakers to know the
advantages and disadvantages of different tax policies. It is quite
another thing to move a tax system to optimize tax policy for tobacco
control since there are multiple obstacles to systems change. In addition,
health advocates often do not invest enough time and effort to
understanding the economics of tax systems and the structural impediments
in existing laws and policies to improve the tax structure.
Consider for a moment the huge amount the tobacco industry invests in the
economics of tobacco, and how it gives big money to lobby and influence
tax policy. I applaud economists who are willing to study and fight for
strong tobacco control tax policies, but in LMIC they are usually far too
few. It is time for local/national health professionals to realize they
better invest in working with economic leaders if they really wish to
influence tax and health investment policies over the long term. Only then
will there be health in all policies, including tax policies on tobacco
and many other products that are necessary to sustain and promote health.
Cartwright (1) has clearly mis-read our article on PMI's Project Star
report(2). The central premise of our article is not that illicit is
overestimated but that the Project Star report cannot be relied on as a
source of data on illicit until there is significantly greater
transparency over the underlying methodology and data inputs and the
contractual arrangements under which it is conducted. KPMG i...
Cartwright (1) has clearly mis-read our article on PMI's Project Star
report(2). The central premise of our article is not that illicit is
overestimated but that the Project Star report cannot be relied on as a
source of data on illicit until there is significantly greater
transparency over the underlying methodology and data inputs and the
contractual arrangements under which it is conducted. KPMG itself would
appear to acknowledge this stating clearly in a disclaimer in each of its
Project Star reports that the data cannot be relied on:
"KPMG wishes all parties to be aware that KPMG's work for Philip Morris
International was performed to meet specific terms of reference agreed
between PMI and KPMG and that there were particular features determined
for the purposes of the engagement. The Report should not therefore be
regarded as suitable to be used or relied on by any other person for any
other purpose."
This lack of transparency is again underlined by Cartwright's failure
to mention in his letter that KPMG receives ?10million from PMI to produce
Project Star, his largest contract
(http://www.kpmg.com/uk/en/about/aboutkpmg/kpmgfoundation/pages/robin-
cartwright.aspx). He also claims this is a project for the European
Commission and Philip Morris yet the Commission denies this. It is
increasingly difficult to see where the truth lies here.
KPMG's claim that the Project Star reports are recognised across Europe as
the most "comprehensive" study of its kind is not disputed. No-one else
has the financial backing or the political self-interest, in the case of
PMI, to produce a report of this size. But comprehensive does not equal
accurate, reliable and transparent. It doesn't matter how many cigarette
packs are collected if the empty pack survey is designed to overestimate
illicit as growing evidence suggests industry empty pack surveys are(2).
Our paper clearly acknowledges that the model used in the Project Star
report has merit but while PMI are so closely involved in the report and
supply the majority of data to be used in the model, it cannot be relied
on. Overwhelming evidence shows the extent to which the tobacco industry
is prepared to manipulate science and data in its own interest(3). The
illicit trade in tobacco is no exception(2,4).
Anna B Gilmore1, Silvano Gallus2, Andy Rowell1, Luk Joossens3
1Department for Health and UK Centre for Tobacco and Alcohol Studies
(UKCTAS), University of Bath, Claverton Down Road, Bath, UK
2Department of Epidemiology, IRCCS--Istituto di Ricerche Farmacologiche
Mario Negri,Milan, Italy
3Association of the European Cancer Leagues and Foundation Against Cancer,
Brussels, Belgium
Competing interests: The authors of this letter authored the paper
being criticised by Cartwright and ABG, SG & LJ were part of the
PPACTE study which Cartwright also criticises.
(1) Cartwright RM. KPMG response to 'Towards a greater understanding
of illicit tobacco trade in Europe: a review of the PMI funded 'Project
Star' report'. Tobacco Control Published Online First 5 March 2014
http://tobaccocontrol.bmj.com/content/early/2014/01/16/tobaccocontrol-2013
-051240.full?sid=ffae5533-cd43-46d0-ae48-3f2d6c0d9b00#responses.
(2) Gilmore AB, Rowell A, Gallus S et al. Towards a greater understanding
of the illicit tobacco trade in Europe: a review of the PMI funded
'Project Star'. Tobacco Control Published Online First 11 December 2013
doi:10.1136/tobaccocontrol-2013-051240.
(3) Michaels D. Doubt is our Product. New York: Oxford University Press,
2008.
(4) Rowell A, Evans-Reeves K, Gilmore AB. Tobacco Industry Manipulation of
Data on and Press Coverage of the Illicit Tobacco Trade in the UK. Tobacco
Control (in press).
Conflict of Interest:
The authors of this letter authored the paper being criticised by Cartwright and ABG, SG & LJ were part of the PPACTE study which Cartwright also criticises.
Significant factual inaccuracies relating to KPMG's annual report
into the European trade in illicit tobacco were made in a recent article
published in Tobacco Control by the BMJ. The report, which KPMG's
Strategy Group has been producing since 2005, is recognised by the UK
National Audit Office, OLAF and the OECD (and by other numerous national
customs authorities and government departments) as the most comprehensive...
Significant factual inaccuracies relating to KPMG's annual report
into the European trade in illicit tobacco were made in a recent article
published in Tobacco Control by the BMJ. The report, which KPMG's
Strategy Group has been producing since 2005, is recognised by the UK
National Audit Office, OLAF and the OECD (and by other numerous national
customs authorities and government departments) as the most comprehensive
study of its kind. The report has earned its solid, international
reputation because it is produced by an independent, professional advisory
firm, using a robust and consistently applied methodology.
The central premise of the article was that the KPMG report
overstates the illicit tobacco trade. However, KPMG estimates since 2005
have correlated within a range given by other organisations, including the
UK National Audit Office, Euromonitor, Joossens and the IARC, amongst many
others. For example, in 2007, Joossens estimated total consumption of
illicit tobacco within the EU to be 8.5%, while the KPMG report estimated
consumption at 8.4%.
Critically, the article misrepresented the methodology KPMG applies
in estimating the consumption of illicit tobacco. The research considers
a number of factors, including empty pack surveys. It is certainly true
that empty pack surveys do not provide the full picture but they do form
an important factor in the equation as they rely purely on physical
evidence, avoiding the variability of consumer bias in interview based
methods. An additional advantage of empty pack surveys is that they
provide a statistically robust and comparable volume of data as they are
conducted consistently across all European markets. In 2010 approximately
430,000 packs were collected throughout Europe in 1,400 population
centres. Additional analysis identifies if the empty pack survey may have
over or under-reported the level of non-domestic packs with the samples
being re-weighted to correct this.
The KPMG report also factors in consumer surveys (conducted by Ipsos
and Nielsen) which drill into the detail of consumers' travel habits,
overall consumption, gender and age to assess the level of legal non-
domestic purchases. Approximately 10% of the 160,000 survey respondents
both travel and purchase cigarettes abroad. These respondents are asked
about the country of purchase and brands purchased. This data can also be
adjusted where it appears to be under-reporting legal tobacco consumption.
For example, correction of under-reporting increased the allocation of
legally purchased packs from Spain to France and from Poland and the Czech
Republic to Germany.
The article goes on to offer an alternative estimation methodology:
the PPACTE study. However, it is prudent to consider the limitations of
this study; notably, the reliance on consumer studies which both under-
report tobacco consumption overall and, in particular, illicit tobacco
consumption. The PPACTE study also uses a substantially smaller sample
size e.g. the methodology used to calculate the illicit volumes equates to
an average of less than 200 per country.
The consumption of tobacco - illicit or otherwise - is understandably
a concerning issue for many people and organisations. While it may be
superficially appealing to discount a report funded by a tobacco company,
the methodology of the 'Project Star' report is robust and unbiased. This
data set is an important source of knowledge for the tobacco industry and
health campaigners alike. An issue can only be tackled, whether for
commercial or health reasons, if its nature and scale is understood. The
Project Star report is widely regarded, by companies and health and
government organisations, as the leading source of data on illicit tobacco
consumption in the EU.
Conflict of Interest:
Author of the report under examination in the paper published in December 2013, entitled 'Towards a greater understanding of the illicit tobacco trade in Europe: a review of the PMI funded 'Project Star''
The recent article by Cai et al, reported that male gender, young
age, low educational attainment, and tobacco cultivation are predictors of
tobacco use and second-hand smoke (SHS) exposure in rural China [1].
Neighborhood-level income was the only contextual predictor of tobacco use
and SHS exposure identified. Hence, the authors suggested that "future
interventions to reduce smo...
The recent article by Cai et al, reported that male gender, young
age, low educational attainment, and tobacco cultivation are predictors of
tobacco use and second-hand smoke (SHS) exposure in rural China [1].
Neighborhood-level income was the only contextual predictor of tobacco use
and SHS exposure identified. Hence, the authors suggested that "future
interventions to reduce smoking and exposure to SHS in China should focus
more on tobacco farmers, less-educated individuals and on poor rural
communities." (pg. ii19)
Nevertheless, Cai and colleagues also found that the Han majority had
higher prevalence of smoking and SHS exposure when compared to ethnic
minorities (p<0.05). Differences in health outcomes and risk factors
have been reported among the Han population when compared to other Chinese
ethnic minorities [2,3]. Stratified analysis might elucidate unique risk
factors to smoking and SHS exposure between ethnic groups important for
the design of tobacco control strategies.
In addition, Cai et al. showed that townships varied widely in the
proportion of the population who were ethnic minorities (3.1% to 97.1%).
In the study of contextual determinants of health, results and
implications should not ignore such vast differences in ethnic composition
between areas. Important information might be conveyed if results were
stratified by the proportion of ethnic minorities in the area (e.g. high,
medium, low). Ethnic minorities living in areas with a high proportion of
the population of the same ethnic minority may experience better health
[4]. Therefore, it might also be important to compare the risk of smoking
and SHS exposure among individuals living in areas highly populated by
their ethnic group versus those residing in areas where they are the
minority group.
Cultural differences and ethnic composition of a geographic area
should be considered in the design and implementation of tobacco control
programs and in the allocation of resources. Resources may be better spent
in areas with a high proportion of the Han population; while areas with a
high minority population may be at decreased risk. Interventions should be
culturally appropriate to minimize the expenditure of resources on
ineffective strategies.
Diana M. Sheehan, MPH
References
1. Cai L, Wu X, Goyal A, et al. Multilevel analysis of the
determinants of smoking and second-hand smoke exposure in a tobacco-
cultivating rural area of southwest China. Tob Control
2013;22(suppl2):ii16-20.
2. Ruixing Y, Hui L, Jinzhen W, et al. Association of diet and
lifestyle with blood pressure in the Guangxi Hei Yi Zhuang and Han
populations. Public Health Nutr 2009;12(4):553-561.
3. Sun H, Zhang Q, Luo X, et al. Changes of adult population health
status in China from 2003 to 2008. PLoS One 2011;6(12):e28411.
4. Inagami S, Borell LN, Wong MD, et al. Residential segregation and
Latino, black and white mortality in New York City. J Urban Health
2006;83(3):406-20.
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To the Editor:
The habit of water pipe smoking is rapidly extending in all occidental
countries. This rise in popularity appears to be correlated with the
advent on store shelves of an array of fruit-flavored tobacco mixtures,
which list ''molasses'' as a primary ingredient. Also there is a
widespread misperception among smokers that the water through which the smoke
bubbles acts as a filter, rendering...
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To the Editor:
The habit of water pipe smoking is rapidly extending in all occidental
countries. This rise in popularity appears to be correlated with the
advent on store shelves of an array of fruit-flavored tobacco mixtures,
which list ''molasses'' as a primary ingredient. Also there is a
widespread misperception among smokers that the water through which the smoke
bubbles acts as a filter, rendering it considerably less harmful than that
of cigarettes [1]. A recent systematic review showed that the main motives
for water pipe tobacco smoking were socializing, relaxation, pleasure and
entertainment. Peer pressure, fashion, and curiosity were additional
motives for university and school students [2]. However, the habit of
smoking tobacco in water pipes is an old practice in the Eastern
Mediterranean countries like Egypt, Jordan, Syria, Lebanon and Iraq [3].
Recently, Jaboc and collaborators (2013) published a crossover study about
biomarkers of toxicant exposure with water pipe compared with cigarettes.
The study included 13 volunteers from San Francisco (USA) who smoked both
cigarettes and water pipes. The results showed that water pipe was
associated with greater exposure to carbon monoxide, polycyclic aromatic
hydrocarbons and benzene compared with cigarette smoking. Finally, the
authors concluded that water pipe smoking is associated with a high risk of
leukemia related to high levels of benzene exposure [4].
If Jaboc and collaborators' (2013) conclusions were right, we would expect
higher prevalence of leukemia in the Eastern Mediterranean region compared
with the Occidental Countries.
Reviewing cancer registries in GLOBOCAN 2008, we can notice that adjusted
standardized mortality rates of leukemia in males are comparable in the
European Region (5.0 per 100.000) to the Eastern Mediterranean Region (4.7
per 100.000). A similar rate is noticed in the Americas Region (5.0 per
100.000) [5].
Deficient registration systems could not be the explanation. Neoplasms
principally attributed to smoking like lung, laryngeal and oro-pharyngeal
cancers have similar prevalence in Egypt like many of the occidental
countries [5].
Water pipe tobacco brands used in the study of Jacob and collaborators
(2013) were Nakhla and Al-Waha. These are the same brands usually consumed
in the Eastern Mediterranean countries, like Egypt. On examining the box
of Nakhla Double Apple brand, widely consumed in Spain, we can find a
clear notice that it contains 0% tar.
During the smoking process cigarette tobacco burns directly, whereas water
pipe tobacco does not burn in a self-sustaining manner and requires an
external heat source such as charcoal. I think that the high level of
polycyclic aromatic hydrocarbon and benzene in the urine samples of water
pipe smokers in the study of Jaboc and collaborators (2013) could be
attributed to the charcoal disks used in many occidental countries. These
quick lighting charcoal disks are impregnated in gasoil rich in polycyclic
aromatic hydrocarbons and benzene. Smoke from these impregnated charcoal
disks is inhaled by water pipe smokers [1]. In Eastern Mediterranean
countries like Egypt, natural charcoal is used and is burned slowly in
special clay or metallic receptacles [1,3]. This could explain the
comparable prevalence of leukemia in Egypt and Occidental Countries.
Examining quick lighting charcoal disk tubes available in Spain, we can
notice that they lack labeling about the hazards of their use for water
pipe smoking. Regulations and control for the use of these impregnated
charcoal disks in the European Countries are urgently needed.
REFERENCES
1. Shihadeh A. Investigation of mainstream smoke aerosol of the argileh
water pipe. Food Chem Toxicol 2003;41(1):143-52.
2. Akl EA, Jawad M, Lam WY, Co CN, Obeid R, Jihad Irani J. Motives,
beliefs and attitudes towards waterpipe tobacco smoking: a systematic
review. Harm Reduct J 2013;10:12.
3. Chaouachi K. The medical consequences of narghile (hookah, shisha) use
in the world. Rev Epidemiol Sante Publique 2007;55(3):165-170.
4. Jacob P 3rd, Abu Raddaha AH, Dempsey D, Havel C, Peng M, Yu L, Benowitz
NL. Comparison of nicotine and carcinogen exposure with water pipe and
cigarette smoking. Cancer Epidemiol Biomarkers Prev 2013;22(5):765-72.
5. International Agency for Research on Cancer. GLOBOCAN 2008. Available
at: http://globocan.iarc.fr/ (Accessed 31 August 2013).
NOT PEER REVIEWED The article by Berman et al "Estimating the cost of a smoking employee" has attempted to quantify the costs associated with employing smokers. As the article indicates several companies are now actively discriminating against smokers so it is important that any costs are fully justified. One area that concerns me about this is a tendency towards oversimplification of a complex situation. In particular the assu...
NOT PEER REVIEWED The article by Berman et al "Estimating the cost of a smoking employee" has attempted to quantify the costs associated with employing smokers. As the article indicates several companies are now actively discriminating against smokers so it is important that any costs are fully justified. One area that concerns me about this is a tendency towards oversimplification of a complex situation. In particular the assumption that the breaks a smoker takes from work are a cost to the employer. Clearly a smoking break is time away from workplace tasks, but the assumption that this is just about time at the desk ignores a growing body of evidence that taking regular breaks from work is beneficial to individual health (1), which might counter some of the negative health risks associated with smoking, and that breaks are also beneficial to workplace productivity. Research has suggested that people taking regular breaks are more creative, more focussed and ultimately more productive (2,3). Prolonged attention to an individual task has, somewhat counter-intuitively, been shown to hinder performance. Taking a break from the task improves overall focus (2). Similarly breaks that have a positive association for the person taking the break are linked to positive performance effects and lower levels of negative emotions (3). All of this suggests that smokers taking breaks might actually increase their performance and benefit employers. Not taking such effects into account is potentially unfair to smokers and also risks breaks being associated by employers with negative effects for all of us.
References:
1) Levene: http://dx.doi.org/10.2337%2Fdb10-1042
2) Ariga: http://dx.doi.org/10.1016/j.cognition.2010.12.007
3) Trougakos: http://dx.doi.org/10.1108/S1479-3555(2009)0000007005
We appreciate Dr. Blum's interest in our study and his comments.
Data used for our study were collected and coded based on the public
health surveillance model, which is more fully described elsewhere (1).
Only a carefully selected set of items from tobacco news stories were
coded over an extended period of time, with editorial cartoons and letters
to the editor not included in the system. The newspapers were
specific...
We appreciate Dr. Blum's interest in our study and his comments.
Data used for our study were collected and coded based on the public
health surveillance model, which is more fully described elsewhere (1).
Only a carefully selected set of items from tobacco news stories were
coded over an extended period of time, with editorial cartoons and letters
to the editor not included in the system. The newspapers were
specifically chosen based on their larger circulation numbers and
geographic representation. As often occurs with surveillance system data,
they can be more useful for generating than testing specific research
hypotheses (2).
We agree it would be valuable to assess the level of news coverage
for tobacco issues in the broader context of media coverage for other
topics; unfortunately, doing so was far beyond the scope this project.
There were, of course, many more tobacco activities or events over
the 7-year period contributing to higher levels of news coverage than we
could possibly highlight in the figures. We agree that prominence
accorded to tobacco news stories by news media gatekeepers, as assessed by
whether they appear on the front page of a newspaper or are mentioned
early in television broadcasts, or if they appear in elite media outlets
such as the New York Times, is important (3).
Additional items were added to the system beginning in 2007 that
allowed for some analyses of prominence from 2007-2010, and these findings
were mentioned in our paper. More research about prominence along the
lines suggested by Dr. Blum is warranted, and such research would,
ideally, confirm or deny his impression that there were only been a
handful of significant tobacco stories in recent years.
We believe the prominence versus quantity argument as it pertains to
news media coverage of tobacco represents a false choice: both are
important and they are interrelated. Tobacco control and prevention
activities or events that result in news stories in elite media are likely
to generate a large quantity of news coverage over time in other media
outlets. Conversely, if a large number of news stories about a specific
tobacco-related topic appear in other media outlets, they will likely gain
the attention of elite media gatekeepers and result in increased coverage
in their news venues.
1. Nelson DE, Evans WD, Pederson LL, et al. A national surveillance
system for tracking tobacco news stories. Am J Prev Med. 2007;32:79-85.
2. Lee LM, Teutsch SM, Thacker SB, St. Louis, ME (eds). Principles
& Practice of Public Health Surveillance (3rd ed). New York: Oxford
University Press; 2010.
3. Gorman L, McLean D. Media and Society into the 21st Century: A
Historical Introduction (2nd ed). Hoboken, NJ: Wiley-Blackwell; 2009.
NOT PEER REVIEWED Because the authors cite just seven major tobacco-related news events
in the seven year period they reviewed (Figure 2), I question whether
their tabulation of the "volume of news media stories on tobacco" (page 6)
provides a meaningful representation of the coverage of tobacco-related
issues in the mass media. Is not a front-page article on a tobacco-
related subject in The New York Times or The Washingt...
NOT PEER REVIEWED Because the authors cite just seven major tobacco-related news events
in the seven year period they reviewed (Figure 2), I question whether
their tabulation of the "volume of news media stories on tobacco" (page 6)
provides a meaningful representation of the coverage of tobacco-related
issues in the mass media. Is not a front-page article on a tobacco-
related subject in The New York Times or The Washington Post--or a lead
story on NBC NIghtly News or The Today Show--of far greater importance, in
terms of both content and readership, than the publication of any number
of brief items? In other words, missing from this analysis is a year-by-
year list of nationally significant news stories on tobacco.
One measure that could be used to quantify the relative importance of
tobacco stories in a given year is the daily Index to Businesses in The
Wall Street Journal (WSJ). By this indicator (and by my daily reading of
the print editions of the WSJ, The New York Times, The Financial Times,
USA Today, and two local US dailies), my impression is that in recent
years there has been a relative handful of significant tobacco news
stories. This is at odds with the authors' finding of an average of 3
tobacco-related newspaper stories, 4 newswire stories, and 1 television
news story each day for seven years. Although the authors attempted to
correct for duplication, I suspect a large percentage of these stories
were variations on a theme or the same news thread.
Another measure is newspaper editorial cartoons. Even taking into
consideration the decimation in the ranks of political cartoonists at US
dailies due to the steep decline in newspaper readership, editorial
cartoons on tobacco issues are now rare. In the heady days of anti-
tobacco activism in the US in the 1980s and 1990s, I catalogued more than
700 editorial cartoons on tobacco.
I wonder if the best way to gauge the weight given to the coverage of
tobacco-related issues in a given year would be to compare it to the
attention given to other issues, both health-related (eg, AIDS, obesity,
gun control, alcohol problems) and less directly health-related (eg, the
economy, unemployment, terrorism).
Ultimately, I am unconvinced that quantity beats quality when it
comes to reports on tobacco in the mass media. What matters is the
prominence of news coverage of significant issues, not the number of
articles all counted as equal.
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Mr. Clive Bates’ response to our article, the Foundation for a Smoke-Free World and healthy Indigenous futures: an oxymoron?, indicates the need to clarify several issues. In this response, we emphasise two key issues:
1. Organisations claiming to serve the good of the public, but who receive direct or third-party funding from the tobacco industry, are faced with serious conflicts of interest (COI); and
2. harm reduction is only part of a comprehensive approach to reducing commercial tobacco use.
As Indigenous peoples, we have an inherent responsibility to protect the health and wellbeing of Indigenous peoples now and for our future generations. The tobacco industry poses, and has posed in the past, a significant threat to our health and wellbeing. Therefore, we are deeply concerned about the Philip Morris-funded Foundation focusing on Indigenous peoples.
Philip Morris International, the Philip Morris Funded-Foundation and the Centre for Research Excellence: Indigenous Sovereignty and Smoking
Mr. Bates states that “There is no credible analysis (anywhere) of the actual, rather than the imagined, relationship between PMI and the Foundation for a Smokefree World”. This is incorrect 1-5. Researchers in journals such as The Lancet and Tobacco Control have analyzed key documents from the Foundation, including tax returns and bylaws that highlighted numerous relationship issues and conflicts of interest 1-5.
Addressi...
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I hope that Tobacco Control will offer a right of reply to the target of this one-sided criticism. In the meantime, let me put a few points to the authors:
1. There is no credible analysis (anywhere) of the actual, rather than the imagined, relationship between PMI and the Foundation for a Smokefree World (FSFW - ‘the Foundation’) that suggests PMI exerts material control over the Foundation. Its basic legal documents suggest otherwise. Nor have the authors explained why the Foundation's goal of ending smoking within a generation is somehow a bad thing or insincere.
2. Nor is there a credible assessment of the relationship between the Foundation and the new Centre for Research Excellence: Indigenous Sovereignty and Smoking (the Centre) that is the subject of criticism in this paper. There are two degrees of separation between the Centre and PMI, and the philosophy of the Foundation is to support centres of excellence and to leave them to get on with their work. The Centre has an excellent (Māori) leader and is quite capable of asserting its independence. How it would somehow do the bidding of PMI is not explained by the authors.
3. The authors dismiss the Centre’s focus on ‘harm reduction’ and instead emphasise: “the need to shift attention away from individuals to the true source of the problem: commercial tobacco and the companies that sell and promote it.”. While I share the sentiment about individual smoking cessat...
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We read with interest a recent publication by Li, et. al, entitled Association of smoking and electronic cigarette use with wheezing and related respiratory problems in adults: cross-sectional results from the Population Assessment of Tobacco and Health (PATH) study, wave 2. The primary finding, reported in the abstract, was that risk of wheezing and related respiratory symptoms was significantly increased in current exclusive e-cigarette users compared to never users, with an adjusted odds ratio of 1.67 (1.23, 2.15). We think the report is misleading for several reasons.
First, the main multivariable analysis (Table 2) did not adequately adjust for important confounders that impact wheeze, most importantly, cigarette smoking history. In most analyses of medical outcomes in adults, pack-years of smoking has a strong relation to smoking-related diseases, over-and-above current smoking status. Since three quarters of vapers in the main model were ex-smokers, cigarette smoking history is almost certainly contributing to the size and significance of the main reported finding. Other combustible tobacco use and current marijuana smoking would also be expected to exacerbate cough and wheeze. Our bet is that large numbers of e-cigarette users also use marijuana.
The authors partially addressed smoking history with a secondary analysis (Table 3), in which they stratified by former smoking status. In that analysis, vaping was not significantl...
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A key finding of this paper does not find its way into the abstract namely, "no significant differences in wheezing and related respiratory symptoms was found when comparing current vapers who never smoked with never smokers. " This tends to suggest, unsurprisingly, that it is the prior smoking history that is the critical factor in current wheeze. The paper supports the harm reduction hypothesis for switching to vaping completely from smoking as per the conclusion. But the conclusion also states in the first line, "Vaping was associated with increased risk of wheezing and related respiratory symptoms, " which is incorrect without adding "in current smokers." Vapers who previously smoked have lower risk than those who continue to smoke, including dual users, and those who never smoked have no increased risk.
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We would like to clear up some misconceptions in Dr. Glantz’s reply to our recent article (1). First, our analytic approach did not assume linearity as the title of Dr. Glantz’s response implies. On the contrary, we applied a log linear form, which not only better fit the data, but also incorporates non-linearities. Additionally, we also conducted and provided results using a linear form in the supplementary material, which yielded similar results.
In his reply to our paper, Dr. Glantz claims that we should have started the vaping period in 2009 rather than in 2014 or 2013. However, we feel this criticism is wrong since we provided extensive data in the paper showing that vaping among youth was minimal until at least 2013.
Show MoreConsequently, we focused on when vaping became more widespread and, by most accounts, became a concern. Further, we conducted analyses that considered changes in trend for other years and obtained qualitatively similar results when the transition was specified as dating back to 2013 or 2012. We also conducted analyses which allowed for changes in trend in both 2009 and 2014 and found no change in trend from 2009 onward, whereas the change in trend from 2014 onward continued to hold. We understand that Dr. Glantz and colleagues in another paper (2) used 2009 as a base year for vaping. However, we feel this choice was a poor one since virtually no students were using e-cigarettes in 2009, and hence vaping would not be...
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PMI finally responded to my paper in Tobacco Control1 showing that the data submitted in their MRTP application to the FDA to market IQOS with reduced risk claims did not actually support claims of reduced risks.
Specifically, PMI’s MRTP application included their 3-month study of 24 non-cancer biomarkers of potential harm (which PMI calls “clinical risk endpoints,” CRE) in humans using IQOS compared to conventional cigarettes. These biomarkers include measures of inflammation, oxidative stress, lipids, blood pressure, and lung function. (PMI did separate studies of biomarkers of exposure, several of which are carcinogens.) While PMI’s application emphasizes that these biomarkers generally changed in positive directions, my examination of the data revealed no statistically detectable difference between IQOS and conventional cigarettes for 23 of the 24 BOPH in Americans and 10 of 13 in Japanese. Moreover, it is likely that the few significant differences were false positives. Thus, despite delivering lower levels of some toxicants, PMI’s own data failed to show consistently lower risks of harm in humans using IQOS compared to conventional cigarettes.
Their undated response, “The Difference between IQOS and Continued Smoking,”2 presents two arguments:
• The original study submitted to FDA was “NOT DESIGNED to serve as the sole pivotal evidence with regards to CRE’s and to show statistically significant changes in the CREs.”...
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David Levy and colleagues’ paper “Examining the relationship of vaping to smoking initiation among US youth and young adults: a reality check” used data from all the surveys over time that measured youth and young adult e-cigarette use and smoking and concluded there was a substantial increase in youth vaping prevalence beginning in about 2014. Time trend analyses showed that the decline in past 30-day smoking prevalence accelerated by two to four times after 2014. Indicators of more established smoking rates, including the proportion of daily smokers among past 30-day smokers, also decreased more rapidly as vaping became more prevalent.
The inverse relationship between vaping and smoking was robust across different data sets for both youth and young adults and for current and more established smoking. While trying electronic cigarettes may causally increase smoking among some youth, the aggregate effect at the population level appears to be negligible given the reduction in smoking initiation during the period of vaping's ascendance.
The good news is that Levy and colleagues are finally accepting the overwhelming evidence that kids who start with e-cigarettes are more likely to end up smoking cigarettes, the so-called “gateway effect.”
Now they have fallen back to arguing that the gateway effect is not big enough to overcome the benefits of e-cigs as substitutes for cigarettes.
The approach they used, interrupted ti...
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In view of the rising prevalence of adolescent smoking worldwide, it makes a lot of sense to strictly limit cigarette sales only to alcohol licensed premises, particularly, in countries where there are minimum age requirements for buying alcohol. In a previous letter (1) to Lancet Global Health we had argued in favor of the same as we believe that restricting sale of cigarettes or other tobacco products will bring about a decrease in consumption by adolescents.
Smoking addictions are usually acquired during adolescence and this usually happens due to an apparently unregulated sale of tobacco products. Regulation is difficult when the number of tobacco selling establishments far exceeds the managing capacity of local administration. In India, adolescents have unrestricted access to tobacco products as small vendors, whose only source of income is by selling tobacco products, tend not to compromise on any business opportunity.
Although there is a positive association between alcohol and smoking, as the authors have pointed out “tobacco sales are not financially important for the majority of alcohol-licensed tobacco retailers”, so it is a win-win situation for preventing initiation of cigarette smoking by adolescents as alcohol vendors will have no incentive to bypass regulations by selling tobacco products to those who do not qualify as per legal age restrictions. In India, smoking and consumption of alcohol are also social taboos and th...
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Show MoreMore than 1,000 participants were exposed to IQOS in our clinical studies. The authors of the letter “Possible hepatotoxicity of IQOS" based their analysis on approximatively 10% of the data instead of examining the data as a whole. For example, for the five-day exposure studies in confinement, they stated that the percentage of participants with elevated bilirubin in IQOS arm was more than three times higher than that observed in the smoking abstinence (SA) arm in the European study (8.8% [7 participants] in IQOS arm, 2.6% [1 participant] in SA arm). However, they missed reporting that this percentage was lower in the IQOS arm than in the cigarette smoking (CC) arm in the Japanese study (10% [8 participants] in IQOS arm, 15% [6 participants] in CC arm). They also stated that the mean increase in alanine aminotransferase (ALT) was higher with IQOS than with CC or SA in the Japanese study but did not report that in the European study, the mean increase in ALT was lower in the IQOS arm than in the CC or SA arm.
Similarly, for the 90-day exposure studies in an ambulatory setting, they mentioned that the percentage of participants with increased ALT levels after 60 days of exposure was higher within the IQOS arm (6.3% [5 participants] in IQOS arm, 0% in CC arm, 2.6% [1 participant] in SA arm) in the U.S. study. However they omitted to mention that in the Japanese study, this percentage was lower in IQOS arm compared with CC or SA arms after 3...
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This study has some important findings that could, if replicated, guide FDA decision making on applications from manufacturers to make modified risk tobacco product claims. However, while it does not detract from the study’s findings, the article does not accurately describe the standards FDA must apply when evaluating those applications. The abstract inaccurately suggests that tobacco products in the U.S. may make reduced-risk or reduced-exposure claims so long as they are not misleading, and does not mention that any explicit or implicit reduced-exposure or reduced-risk claims may not be legally made without first submitting an application to FDA and receiving a permissive order, which considers various other factors, as well.
The introduction of the paper does a bit better, accurately stating that the Tobacco Control Act requires prior review by FDA before making lower-exposure or lower-risk claims. But it then suggests that manufacturers can receive that permission if they either demonstrate that the product lowers harm or risk compared with other tobacco products or if they demonstrate that the product is free of or contains reduced levels of harmful chemicals and the related claims don’t mislead consumers to believe that the reduced-exposure means lower risk. While that description is accurate as far as it goes, it leaves off the enormously important requirement, in both cases, that a manufacturer’s application for permission to...
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The "serious criticism" that Mr. Bates refers to is from him (on another website).
In order for the FDA to issue an order allowing Philip Morris International to market IQOS in the United States as a reduced risk tobacco product, the law required that, among other things, FDA "determines that the applicant [PMI] has demonstrated that such product [IQOS], as it is actually used by consumers will significantly reduce harm and the risk of tobacco- related disease to individual tobacco users."
That is why PMI provided the information of biomarkers of potential harm to the FDA. and how they compare to values observed in smokers. My paper shows that, using PMI's own data, IQOS will not significantly reduce risk to consumers compared with cigarettes.
Bates ignores this reality and instead talks about biomarkers of exposure, which is a different question.
NOT PEER REVIEWED The main problem with the claim of equivalence between smoking and switching to iQOS is that some biomarkers of potential harm change over a much longer timeframe than the 90-day duration of the trials. Biomarkers of potential harm can reflect years of accumulated physical changes arising from smoking and only improve slowly after smoking cessation. The trial did, of course, pick up very substantial reductions in biomarkers of exposure, which would, over time, emerge as reductions in biomarkers of potential harm.
Show MoreThis would have been apparent and obvious to readers if the paper had also shown the results for the third arm of the trial, smoking abstinence. The biomarkers of potential harm for smoking abstinence and for switching to iQOS are quite similar in this trial. This is a curious omission. Furthermore, biomarkers of exposure turned quite similar for both switching to iQOS and smoking abstinence - both are greatly reduced, which is an encouraging finding about the iQOS product.
It is unlikely that anyone would argue against smoking abstinence on the basis of the biomarkers of potential harm in the original PMI study. However, the author has selectively used the iQOS data from these trials without the context of the smoking abstinence data to oppose the Modified Tobacco Product Application that PMI made to the U.S. FDA - the author's attempt to block this reduced-risk product from entering the US market.
...
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The potential presence of formaldehyde cyanohydrin in the polylactic acid (PLA) filter of Marlboro Heatstick when heated was reported by Davis and al. PLA is a biodegradable thermoplastic derived from renewable resources such as corn starch. This tentative identification is based on the GC-MS analysis of the headspace of a heated piece of PLA, and the subsequent compound identification by mass spectra matching (acceptance criteria >85%) with the spectra library of the National Institute of Standard and Technology (NIST). However, this was not confirmed by injecting a purchased analytical grade reference standard, in order to unambiguously prove the presence of formaldehyde cyanohydrin. Therefore, we decided to repeat the experiment using headspace injection gas chromatography coupled to high resolution mass spectrometry under similar conditions as described in the publication. Our headspace GC-HR-MS analyses showed four peaks, at retention times of 16.38, 16.47, 17.14, and 18.58 min, in good agreement with the reported data reported (figure 4).
From the analysis of reference standards, we have confirmed the presence of both e-caprolactone (CAS# 502-44-3) and (S,S)-lactide (CAS# 4511-42-6) eluting at 16.47 and 17.14 min, respectively. We identified triacetin (CAS# 102-76-1) at 18.58 min, based on the reference standard, instead of 1,2-diacetin (their EI mass spectra are very similar).
Show MoreHowever, we have demonstrated unambiguously the a...
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Euromonitor International is a privately held, independent provider of strategic market research with no agenda other than to present the most realistic illicit trade data impartially and within its wider industry context. Subscribers to Euromonitor’s Passport Tobacco database are varied and include tobacco control/ public health groups, academia, retailers, manufacturers of raw materials as well as tobacco brand owners and banks/ consultancies, amongst others.
These same stakeholders are approached by Euromonitor for comment on industry trends, including those of illicit sales. Euromonitor’s stated sources for illicit cigarettes sales thus include trade press, customs offices, interviews with manufacturers and retailers, government and academic organisations. This is reconciled against local knowledge of the market and illicit trade’s wider context – eg national economic performance, trends in taxation, unit prices and duty paid sales, porosity of borders, law enforcement efforts, and so on. There is no reliance on any one source.
By its very nature, illicit trade in tobacco products is a contentious area and one that is difficult to quantify – there are often wide discrepancies between various sources on illicit trade, reflecting vested interests in either deflating or inflating figures. In these circumstances, Euromonitor strives to present the most widely accepted and realistic estimate of the illicit market, based on a holistic...
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Coleman et al’s important report [1] on transitions in the vaping and smoking status of a nationally representative cohort of American 18+ adults who use electronic cigarettes (EC) from the PATH study provides rich data that can greatly advance our understanding of the natural history of EC use and their potential in harm reduction.
However, we were struck by the absence of emphasis in the report of what is perhaps its most important finding. If we examine the report’s data and consider the net impact of vaping on the critical goals of having vapers stopping smoking and vaping non-smokers not starting to smoke, the findings are very disturbing and should strong reason for pause among those advocating e-cigarettes as a game-changing way of stopping smoking.
At Wave 2, 12 months on from Wave 1, of the cohort of 2036 dual users (EC + smoking) only 104 (5.1%) had transitioned to using only EC and another 143 (7%) had quit both EC and smoking for a combined total of 247 or 12.1%. Of the 896 exclusive EC users at Wave 1, 277 (30.9%) had stopped vaping at Wave 2. Together, 524 out of the 2932 EC users (17.9%) followed from Wave 1 might be considered to have had positive outcomes at Wave 2.
The other side of the coin however, shows that of the 2036 dual users at Wave 1, 886 (43.5%) relapsed to using cigarettes exclusively. In addition, among the 896 exclusive EC users from Wave 1, 109 (12.2%) had stopped vaping and were now smoking, wit...
Show MoreNOT PEER REVIEWED
The potential presence of formaldehyde cyanohydrin in the polylactic acid (PLA) filter of Marlboro Heatstick when heated was reported by Davis and al. PLA is a biodegradable thermoplastic derived from renewable resources such as corn starch. This tentative identification is based on the GC-MS analysis of the headspace of a heated piece of PLA, and the subsequent compound identification by mass spectra matching (acceptance criteria >85%) with the spectra library of the National Institute of Standard and Technology (NIST). However, this was not confirmed by injecting a purchased analytical grade reference standard, in order to unambiguously prove the presence of formaldehyde cyanohydrin. Therefore, we decided to repeat the experiment using headspace injection gas chromatography coupled to high resolution mass spectrometry under similar conditions as described in the publication. Our headspace GC-HR-MS analyses showed four peaks, at retention times of 16.38, 16.47, 17.14, and 18.58 min, in good agreement with the reported data reported (figure 4).
From the analysis of reference standards, we have confirmed the presence of both e-caprolactone (CAS# 502-44-3) and (S,S)-lactide (CAS# 4511-42-6) eluting at 16.47 and 17.14 min, respectively. We identified triacetin (CAS# 102-76-1) at 18.58 min, based on the reference standard, instead of 1,2-diacetin (their EI mass spectra are very similar).
Show MoreHowever, we have demonstrated unambiguously the a...
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The reporting of the results of this study is far from complete, which is concerning given the highly politicised controversy that surrounds this product. I hope the authors should respond to this comment by publishing supplementary material with all the data they collected in a an accessible form such a CSV file and summarised in tables in a supplementary memo.
In particular, the authors should provide all data on the following:
+ Vaping and JUUL current use (used in past 30-days) prevalence stratified by age, clearly differentiating between 18 and over and under-18s
+ Frequency of use of vaping products and JUUL within the 30 days among current (past-30 days) users, ideally using the same frequency breakdown used in the National Youth Tobacco Survey
+ Breakdown of vaping status by smoking status and frequency of vaping and JUUL use - to help determine the extent to which regular JUUL use is concentrated among smokers
+ Smoking prevalence and frequency
There is a rare opportunity to gain insights into a live controversy, yet the reporting of the survey is so incomplete it is difficult to draw any serious conclusions from it about the overall effect. For example, JUUL maybe displacing other vaping products used by youth as it is in the market overall. JUUL may be functioning as an alternative to smoking in both adolescents and adults and contributing to achieving smoke-free public health objectives.
T...
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The authors state "These stores have largely stopped carrying e-cigarettes at the same time as starting to stock IQOS HEETS (HEATSTICKS), the cigarette-like component that is smoked in the IQOS device,..." but provide no insight into why that is. Are these retailers being incentivised to stop selling e-cigs by PMI?
While the risk profile of IQOS is uncertain, the product is highly likely to be much more harmful than vaping e-cigs. Commercial tactics that promote IQOS over vaping devices, excluding the latter from retail chains, would be of major concern for tobacco control.
Can the authors enlighten us?
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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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Berry et al (1) report an analysis of two waves of the Population Assessment of Tobacco and Health (PATH) study focused on the association between the initiation of e-cigarette use by Wave 2 and cigarette abstinence/reduction assessed at Wave 2. They conclude that daily e-cigarette use is associated with both cigarette abstinence and reduced consumption among continuing smokers. While this addresses an important question, we argue that such analyses should be adjusted for the reason e-cigarettes are being used.
From Wave 1 of PATH (2), we know that ~75% of smokers agreed that e-cigarettes were useful to help people quit. However, ~80% agreed that e-cigarettes allowed someone to replace a cigarette where smoking was prohibited. From the first reason, we can hypothesize that e-cigarette use might be associated with cigarette abstinence/reduction. However, from the second reason, we can also hypothesize that e-cigarettes would be associated with neither cigarette abstinence nor reduction. The recent National Academies report (3) recommended that any assessment of the role of e-cigarettes in cigarette cessation/reduction should focus on smokers who used e-cigarettes to help them quit.
Show MorePATH Wave 2 data does include information on whether smokers tried to quit in the previous year, as well as whether they used e-cigarettes to aid the last quit attempt. Previous research (4) has shown that over half of the smoking population will not ha...
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Feliu et al’s conclusion “in the European Union countries with the higher scores in the Tobacco Control Scale, which indicates higher tobacco control efforts, have lower prevalence of smokers, higher quit ratios and higher relative decreases in their prevalence rates of smokers.” deserved comment.
First, it seems a tautology. Tobacco control policies are robustly evidence based. Accordingly, more efforts, less smokers.
Second, a PubMed search with “"tobacco control scale" only retrieved 27 articles since 2006 and no validation published yet. Obviously, the Scale poorly correlated with smoking rate: r2 being .58 in 2002/3, .15 in 2006/7 and .06 in 2010/11.(From table 3 in 2; n= 11 European countries).
Third, why make simple stuff complex? This surrogate is complex to calculate and its items are subjective because issuing a decree is useless if no implementation were enforced. In contrast, the smoking rate and its evolution are simple and reliable! How France can be ranked 4th among 28 countries with a 57/100 score (1) while smoking prevalence has been plateauing for so long at more than 30%? In France, from 2004 to 2017 no relevant increase in tobacco taxes, no implementation of the legal smoking ban in cafés or of the ban of sale to minors despite sting operations by NGO showing evidence of serious breaches.(3)
Fourth, claiming “the European Union should continue implementing comprehensive tobacco control pol...
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This paper’s core findings are quite helpful: (1) Tax/price increases for non-cigarette tobacco products can effectively reduce their use; and (2) Tax/price increases for non-cigarette tobacco products could prompt some users to increase their cigarette smoking if comparable tax/price increases for cigarettes are not done at the same time. But the paper’s related analysis is incomplete, producing misleading conclusions, largely because the paper focuses on cigarettes versus non-cigarette tobacco products without also considering the more important distinction for health-directed tobacco tax strategies between smoked tobacco products and non-combustible tobacco products.
In its abstract, the paper concludes that the “positive substitutability between cigarettes and non-cigarette tobacco products suggest that tax and price increases need to be simultaneous and comparable across all tobacco products.” But the paper does not appear to consider that the only substitutions that could significantly increase public health harms would be if the tax increases prompted some non-combusted tobacco product users to move to more-harmful smoking or prompted some smokers who would otherwise do so not to move to less-harmful non-combusted tobacco products. As a result, the paper fails to acknowledge that significant tax/price increases for only combusted tobacco products would not prompt any harm-increasing substitution and would directly secure desirable...
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The paper by Filippidis et al [1] provides data re-confirming the well-known fact that most ex-smokers attempt to quit without using any form of assistance, whether pharmaceutical, professional or via e-cigarettes. Moreover, the proportion of ex-smokers trying to quit unaided increased substantially in Europe between 2012-17 (ex-smokers using no assistance increased from 73.9% to 80.7%), a period where e-cigarette use accelerated in some nations.
Regrettably however, this study does not permit any comparison of success rates by method, as no data are reported on which method of cessation (assisted v unassisted) was used by ex-smokers on their last, final (and so successful) quit attempt.
The authors report that those “who successfully quit reported much lower use of cessation assistance compared with smokers who had tried to quit without success” and suggest that this might reflect indication bias, whereby those who find it harder to quit self-select to use assistance, leaving the low hanging fruit of non- or less addicted smokers to fall off the smoking tree using their own determination.
While this will be true for some, there are many former heavy smokers who quit without assistance. This argument also borrows assumptions from the discredited hardening hypothesis [2], which holds, in the face of evidence to the contrary, that as smoking prevalence falls the concentration of hardened, more deeply addicted smokers increase...
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...
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...
NOT PEER REVIEWED In his critique, Stan Glantz, PhD interprets and presents our study as doing something we explicitly warned readers it was not intended to do. He argues that “the model is based on a series of assumptions that are inconsistent with empirical evidence.” However, we explicitly state and he reiterates, that the model is not meant to be predictive. In our previous work (Addiction 2017: NTR 2017), we presented a framework to help better understand the effects of e-cigarettes and argued that we need better information before we rush to judgement about the actual impact of e-cigarette use.
Our goal in writing this paper was simply to show that e-cigarettes could help us reach a real smoking and tobacco control endgame. In the US, we have made great progress applying traditional policies, such as tax increases, smoke-free air laws and media campaigns. However, SimSmoke models for the US and other countries indicate that traditional tobacco control policies can only get us partially to the endgame. We think that we can achieve more. Many countries have complied fully or near fully with the FCTC and still have unacceptably high rates of smoking prevalence. The point of our paper is to show that strategies shifting smokers to e-cigarettes can play a role in achieving the endgame.
While Glantz recognizes that we provide a “pessimistic” as well as an “optimistic” scenario, he dwells on the optimistic scenario. Many in the public health community see...
Show MoreNOT PEER REVIEWED The data, interpretations and implications of the data modelling exercise conducted by Levy et al(1) should not go unchallenged. Regardless of the number and confidence of the opinions voiced, and the observation of lower levels of selected toxicants in e-cigarette users that are alluded to, there is great uncertainty about the extent to which harm might be reduced by the exclusive use of electronic cigarette rather than combustible tobacco. On this background, to describe one of two models, a 95% harm reduction as optimistic and the second, still a substantial, hopeful estimate of 60% reduction as pessimistic betrays a bias at the outset. The use of this “pessimistic” descriptor would to a casual reader imply that the truth lay, inevitably, somewhere between the two estimates.
Then there is the detail of the model. Firstly, the use of Holford projections(2) overestimated 2015 smoking rates in the US by at least 10% compared to CDC data(3) - underestimating the recent rate of decline in smoking prevalence in men and women between 2005 and 2015 by one-third. A higher base rate and slower rate of decline exaggerate tobacco-related harms in the status quo – naturally favouring each of the modelled scenarios. Starting with lower, more accurate estimates of current smoking and rates of decline would also increase the counterbalancing harms from initiation in non-smokers.
There are other obvious problems. In the status quo, 20% of boys and 14...
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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...
Show MoreNOT PEER REVIEWED It is disappointing that Robert Proctor’s advocacy for tobacco abolition, so clearly expressed in his magisterial ‘Golden Holocaust’ (2011) and, indeed, in Tobacco Control (1), appears to have been diluted to the same degree that he now seems in favour of diluting the concentration of nicotine in cigarettes. And this in spite of the various potential difficulties he points out in implementing the proposal to reduce nicotine in cigarettes to sub-addictive levels, not least that it could well result in decades-long delays before such cigarettes might eventually replace conventional ones.
I also have argued that the only realistic way to deal with the tobacco problem is through abolition (2). This is easier than it might seem, because, as Robert Proctor himself has said (1):
‘[S]moking is not a recreational drug; most smokers do not like the fact they smoke and wish they could quit.’
Is it not time for tobacco abolition, rather than ‘control’, to become part of the debate?
symonds@tokyobritishclinic.com
1. Proctor RN. Why ban the sale of cigarettes? The case for abolition. Tobacco Control 2013;22:i27-i30.
2. http://nicotinemonkey.com/?p=1702
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...
Show MoreNOT 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 In the second column of this article, the author describes findings from a survey in Japan (Tabuchi et al, 2016, reference 15). However, there is a misinterpretation of Tabuchi et al’s table 2 which leads to wrong percentages for having tried heat not burn products in Caputi’s article. The figures 8.4% and 7.8% are not the percentages who had ever tried these products in the population but instead percentages out of those respondents who had ever tried an e-cigarette or a heat not burn product.
The actual figures for the population are therefore about 0.6% for iQOS (8.4% of 6.6%) and 0.5% for Ploom (7.8% of 6.6%).
Further information on the ever use of different products by age, gender and smoking status (about 1% of 15-19 year olds had tried each of the two heat not burn products), is found in supplementary table 3 of Tabuchi et al.
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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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Show MoreBackground
E-cigarette is a delusive name for what the product actually is; an electronic vaporization device. Basic parts of an e-cigarette include: a tank containing the liquid to be vaporized, some sort of heating element, a battery to power the device, and a mouth piece. The liquid, often referred to as e-liquid, usually contains a base (for production of thick vapor) and flavor. E-liquid may or may not contain nicotine. The heating element converts the e-liquid into aerosol, which is then inhaled by the user. While many models resemble a conventional cigarette, others look nothing alike. Colloquially referred to vaporizers, such models have become more common in the recent years.
In the western world e cigarettes proposed as a tobacco control strategy for possible nicotine reduction and stressed on policy appraisals of harm and safety on regulation of other ingredients of the products. The related conflicts and controversies of e cigarettes as a contemporary tobacco control are discussed (1).
E-cigarettes began to appear in the Indian market around 2010. Today, E-cigarettes pose a complex challenge for the tobacco stricken country. According to Global Adult Tobacco Survey (GATS) 2010, 34.6% of the Indian adults were current tobacco users with 14% of adults indulging in current tobacco smoking (5.7% current cigarette smokers, 9.2% current bidi smokers) (2). Global Youth Tobacco Survey (GYTS) 2009 estimated current toba...
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The editors of this journal, Tobacco Control, and specifically the authors of the editorial “Blog fog? Using rapid response to advance science and promote debate” [1] highlight the need - or requirement, depending on the viewpoint - of utilising a specified platform to debate the finer points of an article.
From an academic standpoint, individuals that have an interest in a specific field of study - such as Tobacco Control - will see, and respond to, such articles in the appropriate manner. However, one of the pitfalls prevalent in any rapid response platform, and this isn’t limited to the journal Tobacco Control, is the necessity of the journal’s guidelines to adhere to a specific writing format. This does have some advantages in keeping the debate over an article related exclusively to the article. However, there are some respondents that prefer to write an unabridged version of a critique lest the comment not pass the rapid response system for publication.
There are several advantages to publishing a critique of an article outside the rapid response system [2] that allows for a broader audience to read and respond to both the article content and the critique.
Personal blogs often reflect the style of the author, and also allow for greater freedom of expression including the use of imagery to illustrate vital points that many readers find both enjoyable and informative.
Providing a platform within the journal must allo...
Show MoreNOT PEER REVIEWED This seems a good case for encouraging rechargeable cigalikes and 3rd generation refillable systems in the locations that charge a low cigarette tax.
Time for subsidies?
This is a test message to ascertain if BMJ and Tobacco Control have gotten the rapid response feature up and running. If so this message should appear and those scientists globally wanting to file responses will be immediately alerted that this is now possible. The essence of any critique I personally may have with the BlogFog article is summarized in my declarations of intellectual COI. Submitted March 2nd, 2017.
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The editors of this journal, Tobacco Control, argue in their blog that debate about published articles should be concentrated on their rapid reaction facility. It is possible that they are making a constructive invitation to their critics to join a debating platform they might otherwise be wary of. However, the blog has been widely read as disparagement of other forms of engagement, notably social media and blogs. It is possible that the editors do not fully appreciate why people use blogs and social media to respond to papers they find problematic, and not Tobacco Control's rapid response feature. Here are several reasons:
1. Trust
Critics may consider, rightly or wrongly, that Tobacco Control has a track record of publishing papers that have dubious scientific merit, overconfident conclusions and policy recommendations that cannot be supported by the paper - almost always reinforcing a particular (abstinence-only) perspective. Critics may be concerned that their work will be treated unfairly or sidelined, or that they will be judged or ridiculed. They may distrust the editors, believe the journal is not impartial, or hold it in low esteem.
2. Conflict of interest and incentives
Not everyone is content to have their reactions edited or approved by the same people whose work they are criticising. Once a journal has published an article that is open to criticism, it develops a conflict of interest between its own r...
Show MoreNOT PEER REVIEWED The authors of this editorial assert that a journal article’s authors are “entitled to be aware of and respond to critiques”, and imply that this is only possible if critiques appear in a forum attached to the journal. Setting aside the fact that authors can easily become aware of and respond to critiques on other forums, I am curious if the authors could offer some basis for claiming such an entitlement? It seems quite contrary to all existing laws, principles of ethics, cultural norms, and standard practices that relate to commentary about published work. Moreover the behavior of many of these very authors suggests they are willing to go to great lengths to avoid being made aware of critiques.
It seems safe interpret the statement as saying that at least these particular authors would like responses to their work to appear on this page. And so, I am fulfilling their request. (Assuming this is allowed to appear, that is. I say that not because I believe there is anything in this comment that would warrant censorship, but to emphasize the blindness of this process. That is, the commentator really has no idea what will be allowed to appear.) I call the authors’ attention to two blog posts I have written critiquing this editorial to ensure they have the requested opportunity to be aware: https://antithrlies.com/2017/02/20/editors-of-t...
Show MoreNOT PEER REVIEWED
While I would agree that comments that are directly applied to the article in question are better than blogs scattered across the internet, this policy is entirely dependent on the willingness of editors to publish critical comments that may not be formatted or composed in a style that they are entirely comfortable with. Will editors provide feedback to, for example, citizen activists on why their comments were not published, and how they could change them to make them more acceptable? This seems unlikely, and will only reinforce the perceived inequality of position.
I would also be moved to wonder how editors will deal with rapid responses that link to lengthier works elsewhere? For example, the format of the rapid response does not lend itself well to appending images, which can often be useful to highlight problems.much more effectively than text.
A more likely outcome of this policy is, I fear, an increasing separation into two echo chambers with no overlap, and with far too little exchange of thoughts between the proponents and opponents of vaping, to the detriment of the vast majority who are neither,
NOT PEER REVIEWED This ad watch shows an interesting example of illegal marketing activity of an e-cigarette company in Korea. However, the description of the trend of e-cigarette prevalence among Korean adolescents is not correct. According to the national annual surveys that the author quoted (reference 4), prevalence of current (30-day) e-cigarette use among Korean adolescents was 4.7% in 2011 and 5.0% in 2014. It decre...
NOT PEER REVIEWED Back when I used to own property with several hundred feet highway frontage, I was distressed to find and pick up an average of 50 or more butts along my property every time I walked the perimeter.
I thought about the bottle deposit idea as a solution, but many simply won't care and the unrefunded deposits end up as an added profit for the manufacturer.
Why not mandate a special plas...
NOT PEER REVIEWED Why is the LGBT at greater health risk?? and why was it necessary to even add that?? This makes me very upset that we are "targeted" as such! How is this.. or was this part of the study?
Conflict of Interest:
None declared
NOT PEER REVIEWED David Bareham cites 'Rip Tripper' as evidence that e-cigarette users report experiences of allergies being exacerbated in non users by vapour and describes Mr Tripper's subsequent rather mangled argument that the devices should not be used in enclosed public spaces as "eloquent".
Perhaps Mr Bareham is unaware that Mr Tripper has also claimed that vaping causes limb cramps and dry knuckles which...
NOT PEER REVIEWED When it comes to vaping my knowledge is somewhat advanced, in the hardware aspect I am in the forefront of technology, I test prototypes and beta models for manufacturers all around the globe, I also have acquired quite a bit of knowledge when it comes to the creation of flavors.
There's a big difference between something you like and what is referred to an "All Day Vape" or ADV and the impact t...
NOT PEER REVIEWED
This is not a particularly well constructed argument. In particular, the paragraph that states:
"If ENDS emissions were really benign, indoor vaping advocates should take courage and call for it to be allowed in classrooms, crèches, hospitals and neonatal wards. That they do not rather suggests that they know well that such a position would be irresponsible."
is possibly the worst excuse for a genuine point of debate it has ever been my misfortune to encounter. it is not even a particularly well constructed straw man.
Many things are considered normal and appropriate for the general population that would not be considered appropriate for a crèche, classroom or neonatal ward.
To use merely the first two examples that sprang to mind (and the list is almost endless):
Show MoreIncense sticks are widely used, and despite the clear emission of smoke, they are are not banned, or the subject of proposed bans, in most jurisdictions. Many people use them, but I doubt that any would do so in a crèche or neonatal ward. Yet, if we follow the same logic proposed here, this means that they are dangerous, and should be banned almost universally.
Similarly, fog machines are widely used in stage shows, nightclubs and even teenage discos. Despite the extremely strong similarity with vaping, both in chemical composition and particle size, there are not widespread calls for fog machines to be banned (I'm certainly not aware of...
NOT PEER REVIEWED The American Indoor Hygiene Association (AIHA) i.e. Experts in in this particular field on passive exposure, have, previously, concluded conversely to Bauld et al (1). As they state:
"If the only individual affected by using e-cigarettes were the vaper, the discussion could end here. That is not, however, the case. Similar to secondhand smoke, the ingredients exhaled by the vaper include nicot...
NOT PEER REVIEWED Bauld et al [1] draw an analogy between indoor vaping and the use of bronchodilators for asthma ("if and when vapour products with a medicinal license become available, it will be important to allow their use indoors, just as asthma inhalers, which dispense a drug and propellants into the atmosphere, can be used indoors.")
Surely, they cannot be serious here?
Newman et al showed the a...
NOT PEER REVIEWED The Internet is widely used source for purchasing and selling products. However,purchasing tobacco products online is a new trend. The internet vendors are often exempted from taxes leading to lowering the cost of cigarettes in certain countries.This is a really alarming situation as it would lead to increase in sales of tobacco products due to lower prices. Countries need to check this trend otherwise al...
NOT PEER REVIEWED In the last decade, electronic cigarettes (EC) have become increasingly popular in particular among smokers. Most EC users choose to use nicotine containing liquids (electronic nicotine delivery system, ENDS); these ENDS can be considered as similar to nicotine replacement therapies. Among the several questions EC use raises, one is of major importance: Are EC a smoking cessation aid and if yes to...
NOT PEER REVIEWED The study conducted in England by Petrescu and colleagues [1] concludes that there is a "potential for e-cigarette adverts to undermine tobacco control efforts by reducing a potential barrier (i.e. beliefs about harm) to occasional smoking". Clearly it is important to keep monitoring the impact of advertising, particularly on children, and this research paper is a welcome contribution. However, i...
The authors rightly point out that loopholes exist in some smoke-free air laws, exempting smoking of ???tobacco-free or herbal hookah products??? in public places.
In New York City, where this study took place, the governing laws are: (1) New York State Clean Indoor Air Act, and (2) New York City Smoke Free Air Act.[1] Between 2002-2003, both laws were amended to "prohibit smoking in virtually all in...
NOT PEER REVIEWED In June 2015 we published our paper "The smoking population in the USA and EU is softening not hardening" in the journal Tobacco Control. We showed that as smoking prevalence has declined over time, quit attempts increased in the USA and remained stable in Europe, US quit ratios increased (no data for EU), and consumption dropped in the USA and Europe. These results contradict the hardening hypothesis whi...
NOT PEER REVIEWED I am writing in response to sight of an article published by you about my work for the International Tax and Investment Center (ITIC). The ITIC guidebook published in 2011 "The Illicit Trade in Tobacco Products and How to Tackle it" makes it clear in the Executive Summary that it is "a compilation of facts and views from a wide range of sources including respected academics, private sector consultants,...
NOT PEER REVIEWED Thanks for Mr. Middleton's information that there are local tobacco manufacturers in Hong Kong. I made a mistake when reading the materials. I have amended this in the updated version.
It does not affect the analysis as the government taxes based on number of cigarettes sold rather than manufactured, but I sincerely appreciate your valuable advice.
For the analysis part, it is not easy...
NOT PEER REVIEWED Pressure the CDC and FDA to pressure state legislatures to outlaw the sale of filtered cigarettes. As I see it, this is the only viable solution for ending this litter problem. Cigarette smoking should be made as unappealing as possible to all concerned.
Conflict of Interest:
None declared
NOT PEER REVIEWED The author appears to believe that the main problem with the FDA is that it is not doing enough to prevent new niche cigarette products reaching the market. This focus of concern is misplaced, given several thousand cigarette products are readily available and smokers are spoilt for choice with or without these new products. I have no great desire to see new cigarette products coming on the market, but is this...
In a smaller sample of older teenagers, I recently extended and replicated some of Vasiljevic and colleagues' findings [1]. In line with their results, I found that e-cigarette advertisements did not increase interest in tobacco smoking, interest in using e-cigarettes or susceptibility to either behaviour.
In this experimental study, 65 UK non-smokers aged 16-19 years were randomised to viewing either six e-ci...
It is enormously helpful when researchers consider new, not-yet-tried tobacco control interventions (such as this study's consideration of warning messages on cigarette sticks), especially when researchers figure out effective ways to evaluate the not-yet-tried interventions.
Some additional possibilities related to new warnings or pack changes that might be considered:
(1) Put instructions for use in...
NOT PEER REVIEWED The recent endgame review by McDaniel et al1 demonstrates a major flaw in thinking within the tobacco control community. The industry is seen as dominated by the "big tobacco" cigarette companies. The real life industry is intensely competitive and highly fragmented. There are, within the industry, many who could effectively partner with the public health community, if given the opportunity to do so. Bec...
To the Editor,
Despite the seemingly decline in tobacco use, the habit is picked up by youths on a daily basis. According to the CDC fact sheet, tobacco use is established primarily during adolescence where 9 out of 10 cigarette smokers first initiate smoking by age 18. In the United States, more than 3,800 youths aged 18 years or younger try their first cigarette every day [1]. If the trend continues, about 5....
NOT PEER REVIEWED To the Editors, In the article entitled, "Weight control belief and its impact on the effectiveness of tobacco control policies on quit attempts: findings from the ITC 4 Country Project" I noticed a problem regarding the measurement of weight control beliefs. This variable (weight control beliefs associated with tobacco use) is measured using only one question. The researchers indicate, "In order to iden...
NOT PEER REVIEWED To the Editor:
Beyond the plea to divest from funding tobacco companies, shareholders need to consider the adverse impact of investing in industries and resource extraction that worsen eco-degradation.
At a group level, the impetus for environmentally accountable investing by colleges and universities can be better maintained by teaching every student the practical ways to minimize th...
NOT PEER REVIEWED Cavazos-Rehg et al. compared the results of Google Trends relative search volume (RSV) data for non-cigarette tobacco use with data from state- and national-level youth surveys.[1] Given the authors' findings of positive correlations with Google Trends and survey data, we agree with the conclusion that Google Trends may be a potential tool to provide real- time monitoring for non-cigarette tobacco use. T...
NOT PEER REVIEWED I read the research paper (other authors Ashvin, Emmanuel, Frank and Prabhat) with interest.
Quite a few new points have been brought out. One of the important political reasons for resistance is that hand made ones are done in rural areas where alternate means of employment are hard to come by. This results in the local political representative arguing against tax.
Alternatives such...
NOT PEER REVIEWED We explicitly did not do a systematic review, which would have included things such as assessing articles for quality and assessing for presence of publication bias. Instead we opted for a narrative review. This decision was made given the limited time available for the authors to complete the supplement prior to the World Conference on Tobacco or Health and the small number of available articles after ou...
This letter responds to misrepresentations in a recent article by Daniel Stevens and Stanton Glantz (1). In the article, Stevens and Glantz question my integrity based on some questions during a 4-day deposition which I gave in 2014 in a legal proceeding against my employer. These writers cite snippets from the 1,000+-page transcript of that deposition, relating the text of a facetious note that I h...
NOT PEER REVIEWED This comment summarizes, but mischaracterizes the findings and conclusions of our study. Our analyses and interpretation are based strictly on the letter of the Family Smoking Prevention and Tobacco Control Act (FSPTCA) and its requirements, including Section 911(b)(2)(ii), which bans "the use of explicit or implicit descriptors that convey messages of reduced risk including 'light', 'mild' and 'low', o...
NOT PEER REVIEWED Dear Editor,
Research on waterpipe smoking, also called hookah, is still emerging, and research on second-hand hookah exposure is still in its nascent stages. However, after reading the review on the various effects of second -hand waterpipe smoke exposure by Kumar et al recently published in Tobacco Control1, we noted several major issues in its execution and have serious reservations about th...
Frederieke S. van der Deen and Nick Wilson (on behalf of the other authors; both from the University of Otago, Wellington, New Zealand)
This electronic letter aims to give readers an update on the smoking prevalence projections to 2025 and beyond in New Zealand (NZ) that were provided in the paper by Ikeda et al. NZ is now one of four nations with an official smokefree goal (others are: Fin...
NOT PEER REVIEWED
We refer to the article, "Did the tobacco industry inflate estimates of illicit cigarette consumption in Asia? An empirical analysis" Chen J, et al. published in Tobacco Control on November 25, 2014 (Tob Control 2015;0:1-7) and concur with the important points raised in this article. While the article focuses on Hong Kong, other countries in South East Asia also faced a similar experience. The...
NOT PEER REVIEWED I commend the authors on a significant effort involved in conducting this rather insightful research.
Having conducted qualitative research on FCTC implementation in the Pacific, I can provide comment in relation to the Cook Islands which may explain why MPOWER measures mentioned here did not achieve decreases in prevalence (at least in the figures obtained in this study).
Firstly, th...
NOT PEER REVIEWED We welcome the timely review published by Hill et al. [1], and agree that more research is needed to assess the equity impacts of tobacco control interventions. The results of the review indicated that "increases in tobacco price have a pro-equity effect on socioeconomic disparities in smoking", but that "evidence on the equity impact of other interventions was inconclusive [...]". The inconclusiveness o...
NOT PEER REVIEWED Tobacco is an interesting consumer product. It is legal, toxic and dangerous. It kills people when used as intended. There is a global initiative to reduce use of this product opposed heavily by those profiting from it, tobacco industry stockowners. Industry has successfully blurred consumers, health professionals and policy makers over the years with false science, modulation of product and misleading m...
In this rejoinder, we will address the recent response by Mary Assunta to our article, "Complexities at the intersection of tobacco control and trade liberalisation: evidence from Southeast Asia." To be sure, we believe that trade policy remains a very important issue for public health both in Southeast Asia and globally. Before addressing the specific concerns raised by the reader, it is worthwhile to restate the ove...
I would like to respond to this paper by Drope J and Chavez JJ whose analysis focuses on cigarettes, not tobacco leaf production and trade, and seeks to question the "conventional wisdom" that "trade liberalization naturally leads to lower prices for tobacco products, increased consumption and decreased levels of regulation." The authors use theoretically guided empirical research to demonstrate there is little cause for...
The article of Cummins et al. (1) is based on a survey which according to the authors considers electronic cigarette a risk for populations with mental health conditions. First of all, in our opinion it is not correct to agglomerate and treat all mental health conditions in the same way. It would be like considering all physical illness the same way. Fever is like a cancer? A specific phobia is like schizophrenia? It 'is...
Euromonitor International is a world leader in strategy research for consumer markets, with over 40 years of experience in developed and emerging economies. Through a combination of specialist industry knowledge and in-country research expertise, Euromonitor aims to build a market consensus view of the size, shape and trends in each industry we cover. Tobacco is no different, and both duty paid and illicit sales are rese...
Gottlieb rightly provides us evidence to question Food and Drug Administration (FDA) policy.(1) Indeed, the 2009 law giving the Agency the authority to regulate tobacco was useless as FDA's Advisory Committee issued a report which failed to recommend a ban on menthol cigarettes despite evidence of its devastating effects, a major setback for public health.(2) Is FDA only overcautious as Gottlieb suggested? Its professio...
It is important for tobacco control policymakers to know the advantages and disadvantages of different tax policies. It is quite another thing to move a tax system to optimize tax policy for tobacco control since there are multiple obstacles to systems change. In addition, health advocates often do not invest enough time and effort to understanding the economics of tax systems and the structural impediments in existing l...
Dear Editor
Cartwright (1) has clearly mis-read our article on PMI's Project Star report(2). The central premise of our article is not that illicit is overestimated but that the Project Star report cannot be relied on as a source of data on illicit until there is significantly greater transparency over the underlying methodology and data inputs and the contractual arrangements under which it is conducted. KPMG i...
Significant factual inaccuracies relating to KPMG's annual report into the European trade in illicit tobacco were made in a recent article published in Tobacco Control by the BMJ. The report, which KPMG's Strategy Group has been producing since 2005, is recognised by the UK National Audit Office, OLAF and the OECD (and by other numerous national customs authorities and government departments) as the most comprehensive...
NOT PEER REVIEWED Dear Editor,
The recent article by Cai et al, reported that male gender, young age, low educational attainment, and tobacco cultivation are predictors of tobacco use and second-hand smoke (SHS) exposure in rural China [1]. Neighborhood-level income was the only contextual predictor of tobacco use and SHS exposure identified. Hence, the authors suggested that "future interventions to reduce smo...
NOT PEER REVIEWED To the Editor: The habit of water pipe smoking is rapidly extending in all occidental countries. This rise in popularity appears to be correlated with the advent on store shelves of an array of fruit-flavored tobacco mixtures, which list ''molasses'' as a primary ingredient. Also there is a widespread misperception among smokers that the water through which the smoke bubbles acts as a filter, rendering...
We appreciate Dr. Blum's interest in our study and his comments. Data used for our study were collected and coded based on the public health surveillance model, which is more fully described elsewhere (1). Only a carefully selected set of items from tobacco news stories were coded over an extended period of time, with editorial cartoons and letters to the editor not included in the system. The newspapers were specific...
NOT PEER REVIEWED Because the authors cite just seven major tobacco-related news events in the seven year period they reviewed (Figure 2), I question whether their tabulation of the "volume of news media stories on tobacco" (page 6) provides a meaningful representation of the coverage of tobacco-related issues in the mass media. Is not a front-page article on a tobacco- related subject in The New York Times or The Washingt...
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