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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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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.
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
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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 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
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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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 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
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 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.
NOT PEER REVIEWED
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...
NOT PEER REVIEWED
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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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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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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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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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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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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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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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...
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...
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).
Show MoreHowever, we have demonstrated unambiguously the a...
NOT PEER REVIEWED
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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