Pesko’s central argument is that it does not matter that Friedman’s assessment of the effect of San Francisco’s ban on the sale of flavored tobacco products is not based on any data collected after the ban actually went into force. In particular, Friedman’s “after” data were collected in fall 2018, before the ordinance was enforced on January 1, 2019.[1] Pesko incredibly argues that Friedman’s “before-after” difference-in-difference analysis is valid despite the fact that she does not have any “after” data.
Pesko justifies this position on the grounds that the effective date of the San Francisco ordinance was July, 2018. While this is true, it is a matter of public record that the ordinance was not enforced until January 1, 2019 because of the need for time for merchant education and issuing implementing regulations.[2]
Friedman is aware of the fact that the enforcement of the ordinance started on January 1, 2019 and used that date in her analysis. In her response[3] to critiques[4] of her paper, she stated “retailer compliance jumped from 17% in December 2018 to 77% in January 2019 when the ban went into effect.” Friedman thought the YRBSS data was collected in Spring 2019; she only learned that the “2019” San Francisco YRBSS data she used were in fact collected in fall 2018 from our paper.[1]
Rather than simply accepting this as an honest error and suggesting Friedman withdraw her paper, Pesko is offering an after-the-fact justification for the cl...
Pesko’s central argument is that it does not matter that Friedman’s assessment of the effect of San Francisco’s ban on the sale of flavored tobacco products is not based on any data collected after the ban actually went into force. In particular, Friedman’s “after” data were collected in fall 2018, before the ordinance was enforced on January 1, 2019.[1] Pesko incredibly argues that Friedman’s “before-after” difference-in-difference analysis is valid despite the fact that she does not have any “after” data.
Pesko justifies this position on the grounds that the effective date of the San Francisco ordinance was July, 2018. While this is true, it is a matter of public record that the ordinance was not enforced until January 1, 2019 because of the need for time for merchant education and issuing implementing regulations.[2]
Friedman is aware of the fact that the enforcement of the ordinance started on January 1, 2019 and used that date in her analysis. In her response[3] to critiques[4] of her paper, she stated “retailer compliance jumped from 17% in December 2018 to 77% in January 2019 when the ban went into effect.” Friedman thought the YRBSS data was collected in Spring 2019; she only learned that the “2019” San Francisco YRBSS data she used were in fact collected in fall 2018 from our paper.[1]
Rather than simply accepting this as an honest error and suggesting Friedman withdraw her paper, Pesko is offering an after-the-fact justification for the claim that Friedman’s conclusion is still valid despite not being based on any data after the ordinance actually took effect.
In addition to this central issue, Pesko raised some other minor points that we address below.
Pesko criticised the CDC for providing unequal access to data. This is false. We simply used the request form on the CDC public website (https://www.cdc.gov/healthyyouth/data/yrbs/contact.htm) and were directed to reach the San Francisco School District that conducted the YRBSS to confirm these dates.
Pesko argued that our discussion of the tobacco industry promoting Friedman’s study is irrelevant. We disagree. The tobacco industry and its allies and front groups have widely used Friedman’s conclusion “that reducing access to flavored electronic nicotine delivery systems may motivate youths who would otherwise vape to substitute smoking”[5] to oppose local and state flavored tobacco sales restrictions.
References:
1 Liu J, Hartman L, Tan ASL, et al. Youth tobacco use before and after flavoured tobacco sales restrictions in Oakland, California and San Francisco, California. Tob Control 2022;:tobaccocontrol-2021-057135. doi:10.1136/tobaccocontrol-2021-057135
2 Vyas P, Ling P, Gordon B, et al. Compliance with San Francisco’s flavoured tobacco sales prohibition. Tob Control 2021;30:227–30. doi:10.1136/tobaccocontrol-2019-055549
3 Friedman AS. Further Considerations on the Association Between Flavored Tobacco Legislation and High School Student Smoking Rates-Reply. JAMA Pediatr 2021;175:1291–2. doi:10.1001/jamapediatrics.2021.3293
4 Maa J, Gardiner P. Further Considerations on the Association Between Flavored Tobacco Legislation and High School Student Smoking Rates. JAMA Pediatr 2021;175:1289–90. doi:10.1001/jamapediatrics.2021.3284
5 Friedman AS. A Difference-in-Differences Analysis of Youth Smoking and a Ban on Sales of Flavored Tobacco Products in San Francisco, California. JAMA Pediatr 2021;175:863–5. doi:10.1001/jamapediatrics.2021.0922
¶ I enjoyed reading this paper. I appreciate the author's use of difference-in-difference (DD) methodology. There were some things I found unclear that I would like to ask the authors to comment on.
¶ First, could the authors provide greater clarity on the model for column 1 of Table 1? Is the dependent variable here a yes/no for current cigarette use? The authors write, "Adolescents reported lifetime and prior month use of cigarettes, which we combined into a count variable of days smoked in the past month (0–30)." How does lifetime cigarette use help the authors to code the current number of cigarette days? The authors later state that they show that "increasing implementation of flavoured tobacco product restrictions was associated not with a reduction in the likelihood of cigarette use, but with a decrease in the level of cigarette use among users." Do the authors mean lifetime cigarette use here, or current cigarette use? The authors estimate this equation with an "inflation model," which I am not aware of. Could the authors provide more information on this modelling technique? This is not discussed in the "Analysis" section.
¶ Second, I felt like this statement is too strong. "Our findings suggest that[...] municipalities should enact stricter tobacco-control policies when not pre-empted by state law." Municipalities need to weigh many factors in making these decisions, including the effects of popu...
¶ I enjoyed reading this paper. I appreciate the author's use of difference-in-difference (DD) methodology. There were some things I found unclear that I would like to ask the authors to comment on.
¶ First, could the authors provide greater clarity on the model for column 1 of Table 1? Is the dependent variable here a yes/no for current cigarette use? The authors write, "Adolescents reported lifetime and prior month use of cigarettes, which we combined into a count variable of days smoked in the past month (0–30)." How does lifetime cigarette use help the authors to code the current number of cigarette days? The authors later state that they show that "increasing implementation of flavoured tobacco product restrictions was associated not with a reduction in the likelihood of cigarette use, but with a decrease in the level of cigarette use among users." Do the authors mean lifetime cigarette use here, or current cigarette use? The authors estimate this equation with an "inflation model," which I am not aware of. Could the authors provide more information on this modelling technique? This is not discussed in the "Analysis" section.
¶ Second, I felt like this statement is too strong. "Our findings suggest that[...] municipalities should enact stricter tobacco-control policies when not pre-empted by state law." Municipalities need to weigh many factors in making these decisions, including the effects of population health (not just to youth tobacco use). This study provides evidence from a single state that may not be generalizable to other states without preemption policies. Other studies have found unintended negative effects of flavor policies, and these studies should be referenced to balance the discussion section.
¶ I applaud the authors for providing an early data point on the effect of these policies, but certainly more work in this space is needed before policy recommendations can be made. The authors may also wish to consider for future difference-in-difference papers whether there is evidence in support of the parallel trends assumption , which is a crucial assumption underpinning the reliability of the model.
¶ References:
¶ Friedman, Abigail S. "A difference-in-differences analysis of youth smoking and a ban on sales of flavored tobacco products in San Francisco, California." JAMA pediatrics 175, no. 8 (2021): 863-865.
¶ Xu, Yingying, Lanxin Jiang, Shivaani Prakash, and Tengjiao Chen. "The Impact of Banning Electronic Nicotine Delivery Systems on Combustible Cigarette Sales: Evidence From US State-Level Policies." Value in Health (2022).
¶ The authors make some points in their article that are reasonable: 1) the generalizability of San Francisco's flavor ban compared to other places is an open question, and 2) the original study uses the San Francisco ban effective date rather than enforcement date. The original author (Friedman), who does not accept tobacco industry funding and is a well-respected scientist in the field, had pointed to both facts in her original article. So that information isn’t new.
¶ The current authors appear to construct a straw man argument claiming that Friedman argued that she was studying the effect of San Francisco enforcing its flavor ban policy. Friedman specifically wrote in her original article that she was studying, “a binary exposure variable [that] captured whether a complete ban on flavored tobacco product sales was in effect in the respondent’s district on January 1 of the survey year.” She specifically uses effect in the above sentence, so there is no ambiguity that she is studying effective date. San Francisco’s flavor ban effective date was July 2018 (Gammon et al. 2021).
¶ The authors found new information that the San Francisco YRBSS survey was collected between November to December of 2018. Gammon et al. 2021 (Appendix Figure 1) shows that flavored e-cigarette sales declined in San Francisco between the effective date and the end of August 2018 (compensating for a 30-day look-back period for the YRBSS question wording), even though the flavor ban...
¶ The authors make some points in their article that are reasonable: 1) the generalizability of San Francisco's flavor ban compared to other places is an open question, and 2) the original study uses the San Francisco ban effective date rather than enforcement date. The original author (Friedman), who does not accept tobacco industry funding and is a well-respected scientist in the field, had pointed to both facts in her original article. So that information isn’t new.
¶ The current authors appear to construct a straw man argument claiming that Friedman argued that she was studying the effect of San Francisco enforcing its flavor ban policy. Friedman specifically wrote in her original article that she was studying, “a binary exposure variable [that] captured whether a complete ban on flavored tobacco product sales was in effect in the respondent’s district on January 1 of the survey year.” She specifically uses effect in the above sentence, so there is no ambiguity that she is studying effective date. San Francisco’s flavor ban effective date was July 2018 (Gammon et al. 2021).
¶ The authors found new information that the San Francisco YRBSS survey was collected between November to December of 2018. Gammon et al. 2021 (Appendix Figure 1) shows that flavored e-cigarette sales declined in San Francisco between the effective date and the end of August 2018 (compensating for a 30-day look-back period for the YRBSS question wording), even though the flavor ban was not yet fully enforced. This could be due to early supply-side responses to the flavor ban (e.g., some businesses discontinuing selling flavored e-cigarettes immediately upon the law’s effective date), or demand for e-cigarettes falling due to publicity related to the flavor ban effective date. The fact that e-cigarette sales continued falling in the latter half of 2018 until full enforcement kicked in on 1/1/2019 does not by itself invalidate Friedman’s model specifically looking at effective date. Therefore, there is nothing flawed about the concept of studying the effect that the flavor ban effective date (which led to a documented decline in flavored e-cigarette sales in San Francisco between July 2018 through the end of August 2018) had on youth cigarette use measured in the San Francisco YRBSS in November to December of 2018 (compared to other locations not adopting flavor bans).
¶ The current TC paper makes many inaccurate statements that appear to undermine most of the paper.
¶ • "Thus, the San Francisco survey preceded the enforcement of its flavoured tobacco sales restriction (January 2019), making the 2019 YRBSS an inappropriate data source for evaluating the effects of the city’s flavoured tobacco sales restriction."
¶ This is not true. The decline in flavored e-cigarette sales between the July 2018 effective date to the end of August 2018 could have clearly resulted in spillover effects in the youth cigarette use marketplace. The authors provide no acknowledgement of this in their paper.
¶ • "If youth smoking rates increased similarly in Oakland following that city’s sales restriction, this would lend credence to the call for caution against flavoured tobacco sales restrictions. However, if the patterns differ, we should identify alternate explanations for the rise in San Francisco’s youth smoking prevalence."
¶ This is faulty logic. It's entirely possible that policies adopted in two separate cities could exhibit different effects (including one having an effect and the other having no effect) depending on the population's underlying preferences for tobacco products and different evasion opportunities. I don’t know if there is a reason that this could be the case or not, but that’s irrelevant. What is relevant is that the loose language as currently written is inaccurate and could lead people to conclude the wrong thing in other contexts. The authors also fail to provide statistical testing of their Oakland model as required by STROBE guidelines, nor do they acknowledge that unlike the original study their own pre-post analysis is limited by not having a counterfactual group of non-treated areas, and so there is no ability to control for trends over time.
¶ • "Since there was no ban on non-menthol cigarettes sales, we would have expected to see an increase in sales of cigarettes if youth had been switching products."
¶ • “The study actually found an overall trend of a reduction in both total tobacco sales and cigarette sales in San Francisco following the flavoured tobacco product sales restriction, further suggesting that flavoured products were not being substituted by other unflavoured tobacco products or cigarettes.”
¶ Assuming for a moment that we can observe cigarette sales sold to youth, it would be entirely possible that these cigarette sales could decline in San Francisco but decline by more in the control areas due to secular trends; therefore, suggesting the flavor ban would need to increase cigarette sales to youth is inaccurate. And of course the authors do not observe who buys these cigarettes (youth or adults), so sales data for the population as a whole does not necessarily refute youth use patterns.
¶ • “However, in order to imply causality, there cannot be ambiguous temporal precedence.”
¶ • “do not include the policy enactment and enforcement dates that are required to avoid erroneous conclusions like those in the recent analysis of the San Francisco flavoured sales restriction.”
¶ The authors state that Friedman is ambiguous about the policy timing, but this is not the case as she clearly states she is studying effective date. That is not ambiguous. The authors also state that Friedman’s study has erroneous conclusions. I do not see anything erroneous about the limited scope of her research question studying effective date.
¶ The authors also refer in their references to conversation with the CDC-Office on Smoking and Health regarding the YRBSS data collection date. This reference is incomplete per STROBE guidelines, and should include a specific individual that the authors spoke with and a date of the conversation. Since this conversation was with a government employee it is especially important that there is not the perception of the government leaking information to certain groups of scientists but not others, so full disclosure is needed here. Other researchers have tried to get effective dates for the YRBSS survey from the CDC before but have been rebuffed, creating concerns regarding inequal access to data, as well as concerns regarding if this communication between the CDC and the researchers was authorized or not.
¶ Additionally, I found the author’s discussion of the tobacco industry promoting Friedman’s study as irrelevant. This discussion has the unfortunate effect of muddying the waters of what is supposed to be a focus on the science of Freidman’s article, and could easily lead people to conclude that Friedman herself has industry funding, which is not true. None of us are impervious to industry attempts to use our research for their own gain; in fact, if we start to attack researchers whose work is used by industry, this gives industry an easy way to discredit the researchers they are most threated by (by finding a way to cite their research in industry reports and publications, etc.). How research is used after the publication process is not relevant to this debate over the merits of the science of Friedman’s original article.
¶ Reference:
¶ Gammon, Doris G., Todd Rogers, Jennifer Gaber, James M. Nonnemaker, Ashley L. Feld, Lisa Henriksen, Trent O. Johnson, Terence Kelley, and Elizabeth Andersen-Rodgers . "Implementation of a comprehensive flavoured tobacco product sales restriction and retail tobacco sales." Tobacco Control (2021).
We would like to thank Mr. Wang for his feedback on our paper, Indicators of dependence and efforts to quit vaping and smoking among youth in Canada, England and the USA.
With regards to the ‘discrepancies’ in vaping and smoking prevalence between those reported in Table 1 and an earlier publication [1], we have previously published these same estimates [2], along with a description of the survey weighting procedures—which were modified since the first estimates were published (as outlined in a published erratum to the cited publication [3]). Briefly, since 2019, we have been able to incorporate the smoking trends from national ‘gold standard’ surveys in Canada and the US into the post-stratification sampling weights. A full description is provided in the study’s Technical Report [4], which is publicly available (see http://davidhammond.ca/projects/e-cigarettes/itc-youth-tobacco-ecig/).
Mr. Wang has also noted a change in the threshold used for a measure of frequent vaping/smoking: ≥20 days in past 30 days rather than ≥15 days, as previously reported [1]. We have adopted the convention of reporting using ≥20 days in past 30 days to align with the threshold commonly used by the US Centers for Disease Control for reporting data from the National Youth Tobacco Survey (NYTS), as well as the Population Assessment of Tobacco and Health (PATH) Study and the Mo...
We would like to thank Mr. Wang for his feedback on our paper, Indicators of dependence and efforts to quit vaping and smoking among youth in Canada, England and the USA.
With regards to the ‘discrepancies’ in vaping and smoking prevalence between those reported in Table 1 and an earlier publication [1], we have previously published these same estimates [2], along with a description of the survey weighting procedures—which were modified since the first estimates were published (as outlined in a published erratum to the cited publication [3]). Briefly, since 2019, we have been able to incorporate the smoking trends from national ‘gold standard’ surveys in Canada and the US into the post-stratification sampling weights. A full description is provided in the study’s Technical Report [4], which is publicly available (see http://davidhammond.ca/projects/e-cigarettes/itc-youth-tobacco-ecig/).
Mr. Wang has also noted a change in the threshold used for a measure of frequent vaping/smoking: ≥20 days in past 30 days rather than ≥15 days, as previously reported [1]. We have adopted the convention of reporting using ≥20 days in past 30 days to align with the threshold commonly used by the US Centers for Disease Control for reporting data from the National Youth Tobacco Survey (NYTS), as well as the Population Assessment of Tobacco and Health (PATH) Study and the Monitoring the Future (MTF) survey—three of the most widely cited sources of data for youth vaping.[5,6,7]
Mr. Wang questioned whether the process for ascertaining parental consent may bias the survey responses. Ascertaining parental consent among minors is a common and required practice in most jurisdictions. To the extent that young respondents may not have provided honest responses due to concerns about confidentiality, the likely impact would be to under-report smoking and vaping status. However, the recruitment process has not changed over the course of the study; thus, this is unlikely to account for the trends over time reported in our paper. In addition, the trends in the ITC Youth Tobacco and Vaping Surveys are very similar to the trends in vaping reported by national surveillance surveys in the US,[5] Canada, [8,9,10] and England.[11]
Regarding Mr. Wang’s assertion that “when asking participants quitting plans, it is better to clarify the quitting of traditional tobacco products or quitting nicotine products”, we can confirm that questions about intentions to quit and cessation were indeed asked separately for smoking and vaping. Thus, if a youth reported smoking cigarettes and vaping e-cigarettes, they would have been asked cessation-related questions in different sections of the survey for each of cigarettes and e-cigarettes/vaping.
Finally, Mr. Wang has noted seasonal variation in smoking and vaping rates. Despite some variations in the exact survey timing, the ITC Youth Tobacco and Vaping Surveys have been conducted over a similar time period in each year. For example, across the first three waves of the survey, 64%, 79% and 74% of surveys, respectively, were conducted in the month of August. As noted above, trends in vaping prevalence over time from the ITC surveys align very closely with other national surveys over the same period. With respect to specific findings reported in our Tobacco Control manuscript, we would not expect any material differences in levels of dependence, cessation-related outcomes or vaping brands due to the minor variation in data collection periods.
We hope this additional information will provide context for interpreting the study results and feedback on the manuscript.
References
1. Hammond D, Reid JL, Rynard VL, Fong GT, Cummings KM, McNeill A, Hitchman S, et al. Prevalence of vaping and smoking among adolescents in Canada, England, and the United States: repeat national cross sectional surveys. BMJ. 2019; 365: l2219. doi: 10.1136/bmj.l2219.
2. Hammond D, Rynard V, Reid JL. Changes in prevalence of vaping among youth in the United States, Canada, and England, 2017 to 2019. JAMA Pediatr. 2020;174(8):797-800. doi: 10.1001/jamapediatrics.2020.0901.
3. Published Erratum: Prevalence of vaping and smoking among adolescents in Canada, England, and the United States: repeat national cross sectional surveys. BMJ. 2020 Jul 10;370:m2579. doi: 10.1136/bmj.m2579.
4. Hammond D, Reid JL, Rynard VL, Burkhalter R. ITC Youth Tobacco and E-Cigarette Survey:
Technical Report – Wave 3 (2019). Waterloo, ON: University of Waterloo, 2020. http://davidhammond.ca/wp-content/uploads/2020/05/2019_P01P3_W3_Technica...
5. Park-Lee E, Ren C, Sawdey MD, et al. Notes from the Field: E-Cigarette Use Among Middle and High School Students — National Youth Tobacco Survey, United States, 2021. MMWR Morb Mortal Wkly Rep 2021;70:1387–1389. DOI: http://dx.doi.org/10.15585/mmwr.mm7039a4.
6. Hyland A, Kimmel HL, Borek N, on behalf of the PATH Study team. Youth and young adult acquisition and use of cigarettes and ENDS: The latest findings from the PATH Study (2013-2019). Society for Research on Nicotine & Tobacco Annual Conference, March 2020
7. Miech R, Johnston L, O’Malley PM, Bachman JG, Patrick ME. Trends in adolescent vaping, 2017-2019. N Engl J Med. 2019;381(15):1490-1491. doi:10.1056/NEJMc1910739.
8. Government of Canada. Detailed tables for the Canadian Student Tobacco, Alcohol and Drugs Survey 2016-17. Available from https://www.Canada.ca/en/health-Canada/services/canadian-student-tobacco...
9. Government of Canada. Canadian Tobacco, Alcohol and Drugs Survey (CTADS): Summary of Results for 2017. 2017. Available from https://www.Canada.ca/en/health-Canada/services/canadian-tobacco-alcohol....
10. Statistics Canada. Canadian Tobacco and Nicotine Survey, 2019. Available from https://www150.statcan.gc.ca/n1/daily-quotidien/200305/dq200305a-eng.htm.
11. Action on Smoking and Health UK. Use of e-cigarettes among young people in Great Britain, 2021. June 2021. Available from https://ash.org.uk/wp-content/uploads/2021/07/Use-of-e-cigarettes-among-...
There’s a published paper by Hammond and colleagues in 2019[1] using the same survey results, but there are some discrepancies.
1. The Table 2 of the 2019 paper, prevalence of vaping in 2018 for ever, past 30 days are 37.0% (1425), 14.6% (562) in Canada, 32.7% (1276), 8.9% (346) in England and 33.6% (1360), 16.2% (655) in the US, respectively. However, in this article’s Table 1, for vaping in the same year 2018 for ever, past 30 days are 33.2% (1275), 12.1% (463) in Canada, 33.1% (1283), 9.0% (351) in England and 33.1%(1336), 15.7% (635) in the US. More discrepancies can be found on cigarette smoking section as well. These numbers warrant further explanation particularly why numbers in Canada and the US decreased while numbers in England increased? Considering previous correction of numbers to the 2019 paper has raised serious concern among some readers[1], such timely clarification in this article will be very necessary.
2. The 2019 paper use the criteria of ≥15 days in past 30 days but the current paper adopts different criteria of ≥20 days in past 30 days, for both vaping and cigarette smoking. Further explanation is needed for such change.
Additionally, a few considerations on possible limitations of the paper’s findings:
1. Since the invitations were sent to nearly twice more parents than youth themselves according to the technical report[2], responds to survey questions might be biased because study has shown many...
There’s a published paper by Hammond and colleagues in 2019[1] using the same survey results, but there are some discrepancies.
1. The Table 2 of the 2019 paper, prevalence of vaping in 2018 for ever, past 30 days are 37.0% (1425), 14.6% (562) in Canada, 32.7% (1276), 8.9% (346) in England and 33.6% (1360), 16.2% (655) in the US, respectively. However, in this article’s Table 1, for vaping in the same year 2018 for ever, past 30 days are 33.2% (1275), 12.1% (463) in Canada, 33.1% (1283), 9.0% (351) in England and 33.1%(1336), 15.7% (635) in the US. More discrepancies can be found on cigarette smoking section as well. These numbers warrant further explanation particularly why numbers in Canada and the US decreased while numbers in England increased? Considering previous correction of numbers to the 2019 paper has raised serious concern among some readers[1], such timely clarification in this article will be very necessary.
2. The 2019 paper use the criteria of ≥15 days in past 30 days but the current paper adopts different criteria of ≥20 days in past 30 days, for both vaping and cigarette smoking. Further explanation is needed for such change.
Additionally, a few considerations on possible limitations of the paper’s findings:
1. Since the invitations were sent to nearly twice more parents than youth themselves according to the technical report[2], responds to survey questions might be biased because study has shown many parents are unaware of their children’s e-cigarette use[3]. Young participants who receive the questionnaire from their parents, in suspicion of their parents might know, may be unwilling to fill out honestly.
2. A clearer definition of stop smoking/quitting. In Table 3, when asking participants quitting plans, it is better to clarify the quitting of traditional tobacco products or quitting nicotine products. As some youth may treat vaping itself as quitting and some may not, the survey result might therefore, be ambiguous.
3. Seasonality. Previous studies have indicated seasonal variations in the initiation of smoking among adolescents[4], Unsupervised time out of school during the first months of summer vacation is a period of increased smoking behavior. However, significantly lower rates during September were observed which seem to be related to the beginning of school. Survey for this study were conducted July/August in 2017, August/September in 2018 and 2019. As cross-sectional study only offers a snapshot of the situation, to conduct surveys at different months with fluctuating trends would inevitably lower the liability of the result.
[1] Hammond, D., Reid, J. L., Rynard, V. L., Fong, G. T., Cummings, K. M., McNeill, A., Hitchman, S., et al. (2019). Prevalence of vaping and smoking among adolescents in Canada, England, and the United States: repeat national cross sectional surveys. BMJ (Clinical Research Ed.), 365, l2219.
[2] Hammond D, Reid JL, White CM. ITC Youth Tobacco and E-Cigarette Survey:
Technical Report – Wave 3 (2019. Waterloo, ON: University of Waterloo, 2020. http://
davidhammond.ca/wp-content/uploads/2020/05/2019_P01P3_W3_TechnicalReport_updated202005.pdf
[3] Wu T and Chaffee BW. Parental Awareness of Youth Tobacco Use and the Role of Household Tobacco Rules in Use Prevention. Pediatrics. 2020;146(5): e20194034
[4] Colwell, B., Ramirez, N., Koehly, L., Stevens, S., Smith, D. W., & Creekmur, S. (2006). Seasonal variations in the initiation of smoking among adolescents. Nicotine & Tobacco Research, 8(2), 239–243.
NOT PEER REVIEWED
We thank Mr. Clive Bates (1) and Dr. Moira Gilchrist (2) for their reconsideration of our work (3) and previous response where we corrected some errors (4). We also reiterate that all data informing our Industry Watch are publicly available at Tobacco Watcher (https://tobaccowatcher.globaltobaccocontrol.org/) for anyone to analyze. As with any analyses of observational data, there are limitations and we do not disagree with some of the limitations that Gilchrist and Bates point out in our analyses (as we addressed nearly all of these in our previous response (4)). However, we remain unchanged in our conclusion that, as the title of our initial article stated, “Philip Morris International used the e-cigarette, or vaping, product use associated lung injury (EVALI) outbreak to market IQOS heated tobacco” (3).
While statistical analysis indicated a correlation between (a) PMI’s public statements regarding EVALI and their IQOS brand of heated tobacco posted to their corporate “media center” (5) and (b) trends in news coverage of EVALI and IQOS, our primary assertion is that PMI used EVALI to market IQOS. The necessary and sufficient analysis to substantiate this assertion is reporting what PMI publicly claimed, which we did by analyzing the statement made by PMI which promoted IQOS through mentioning, contrasting or describing it along with EVALI and/or vaping.
NOT PEER REVIEWED
We thank Mr. Clive Bates (1) and Dr. Moira Gilchrist (2) for their reconsideration of our work (3) and previous response where we corrected some errors (4). We also reiterate that all data informing our Industry Watch are publicly available at Tobacco Watcher (https://tobaccowatcher.globaltobaccocontrol.org/) for anyone to analyze. As with any analyses of observational data, there are limitations and we do not disagree with some of the limitations that Gilchrist and Bates point out in our analyses (as we addressed nearly all of these in our previous response (4)). However, we remain unchanged in our conclusion that, as the title of our initial article stated, “Philip Morris International used the e-cigarette, or vaping, product use associated lung injury (EVALI) outbreak to market IQOS heated tobacco” (3).
While statistical analysis indicated a correlation between (a) PMI’s public statements regarding EVALI and their IQOS brand of heated tobacco posted to their corporate “media center” (5) and (b) trends in news coverage of EVALI and IQOS, our primary assertion is that PMI used EVALI to market IQOS. The necessary and sufficient analysis to substantiate this assertion is reporting what PMI publicly claimed, which we did by analyzing the statement made by PMI which promoted IQOS through mentioning, contrasting or describing it along with EVALI and/or vaping.
The full text of the PMI’s public statement is available in the appendix of our original piece (the version available presently on the PMI website has been changed) and we analyze excerpts to make our case below.
PMI’s statement recounted the EVALI outbreak beginning: “Skepticism and fear around vaping has emerged following the cases of respiratory illness and deaths in the US associated with the use of e-cigarettes.” PMI then contrasted this against their IQOS heated tobacco product, writing “on April 30 2019, the FDA authorized IQOS for sale in the US, finding that marketing of the product would be ‘appropriate for the protection of public health’ [quotes used in the original release].” As we previously argued, some readers (especially novice consumers) can interpret this as implying the FDA endorses IQOS and such statements are not allowed. The Food, Drug and Cosmetic Act prohibits ‘any expressed or implied statement...that either conveys, or misleads or would mislead consumers into believing that [a tobacco] product is approved by the Food and Drug Administration’ (ACT 21 U.S.C. § 331(tt)). The same “appropriate for the protection of public health” statement also implies that IQOS is safer than vaping, a claim disallowed by the FDA.
While Bates and Gilchrist may still object to our assertions that PMI’s intent in publishing their statement was to promote IQOS using EVALI, this objection contrasts with public statements PMI executives have made that are perhaps even clearer in their intent. For example, a Wall Street Journal article began “tobacco giant Philip Morris International Inc. says vaping fears in the U.S. should give a boost to the recent launch of its IQOS smoking alternative” and cited PMI executives discussing how EVALI could be a boon for IQOS promotion just days after PMI published the materials we studied (6).
Bates and Gilchrist may similarly still object that other events (such as the failed merger talks between Altria and PMI (7)) may be responsible for news coverage of IQOS and EVALI. However, generating earned media about an issue is not a one-shot game. Any public relations expert could attest that a multi-modal strategy is required to get an issue in the news media agenda including a media statement, follow-up interviews, case studies, activations, integrations, etc.
Our assertion is that the EVALI outbreak was used by PMI as part of an overall strategy to promote IQOS - a fact we discovered in our Industry Watch piece. For example, the Irish Times reported that PM had called off merger talks with Altria, “…after it became apparent the US government crackdown on vaping could have a negative impact given Altria’s stake in Juul.” André Calantzopoulos, PMI’s chief executive, said that they had decided to focus on its launch of IQOS, which was not a vaping product (8) --thereby again leveraging EVALI to promote its new product.
We echo our previous call for the FDA to investigate the statement PMI published and subsequent news coverage for compliance and if a violation has occurred appropriate regulatory actions be taken. We call on the tobacco control community to invest in surveillance of industry speech and research on the potential impacts of industry speech that can inform additional regulations governing marketing channels such as websites, online news sources and other digital media.
Thank you for the corrections and for acknowledging the omission. The additional analysis performed by ITC is greatly appreciated and provides further insight into the impact of both interventions. Although unstated, Canada’s regional characterizing flavour bans contributed significantly to the development of a national menthol additive ban as chronicled by the U.S. Tobacco Control Legal Consortium[1] . I look forward to reading the full analysis when published.
NOT PEER REVIEWED
Reducing smoking rates in older smokers will achieve a far greater reduction in deaths & disease and do this much earlier than reducing already much lower smoking rates in teens & young populations. Tobacco harm reduction (THR) options, such as vaping, Heated Tobacco Products (HTP), snus & nicotine pouches, all avoid inhalation of smoke from tobacco combustion and are less risky than smoking cigarettes which are responsible for the death of more than 50% of long term smokers. Cigarette sales in Japan declined by over 40% in five years after HTPs entered the Japanese market in 2016. There are now many other examples of other THR options substituting for deadly cigarettes in other countries.
New drug harm reduction interventions usually face fierce opposition for many years after their introduction. Needle syringe programs to reduce HIV spread among and from people who inject drugs were still strongly resisted long after the evidence for their effectiveness, safety and cost effectiveness was incontrovertible. It is not surprising to me therefore, as a veteran of many battles over new drug harm reduction interventions, to observe the acrimonious debate over THR.
If it is made easy for older smokers to switch to THR options, the benefits will not only be an acceleration in the decline of smoking related deaths and disease, but also a more rapid decline in cigarette sales.
NOT PEER REVIEWED
In his comment, Les Hagen brings up an important distinction between two types of restrictions on menthol: a menthol additive ban, and a menthol characterizing flavour ban. Canada's menthol ban across the provinces did indeed involve both types. Between May 2015 and July 2017, Nova Scotia, Alberta, Quebec, Ontario, Prince Edward Island, and Newfoundland & Labrador implemented characterizing flavour bans, whereas New Brunswick implemented a menthol additive ban [1]. When the Federal Government implemented a menthol additive ban in October 2017 [2] , it applied only to the remaining provinces—British Columbia, Saskatchewan, Manitoba—as well as Nunavut, Yukon, and the Northwest Territories. Thus, the "menthol cigarette ban" in Canada is a mixture of the two types.
Our article [3] evaluated the impact of menthol bans implemented between the 2016 and 2018 waves of the Canadian arm of the ITC Four Country Smoking and Vaping Surveys. Hagen incorrectly stated that "the analysis was performed exclusively on provincial characterizing flavour bans." In fact, the provinces evaluated in our study included both those that implemented characterizing flavour bans (Quebec, Ontario, Prince Edward Island, Newfoundland & Labrador) and those that implemented the Federal menthol additive ban (British Columbia, Saskatchewan, Manitoba).
In our original study, we did not test for differences between the two kinds of bans, beca...
NOT PEER REVIEWED
In his comment, Les Hagen brings up an important distinction between two types of restrictions on menthol: a menthol additive ban, and a menthol characterizing flavour ban. Canada's menthol ban across the provinces did indeed involve both types. Between May 2015 and July 2017, Nova Scotia, Alberta, Quebec, Ontario, Prince Edward Island, and Newfoundland & Labrador implemented characterizing flavour bans, whereas New Brunswick implemented a menthol additive ban [1]. When the Federal Government implemented a menthol additive ban in October 2017 [2] , it applied only to the remaining provinces—British Columbia, Saskatchewan, Manitoba—as well as Nunavut, Yukon, and the Northwest Territories. Thus, the "menthol cigarette ban" in Canada is a mixture of the two types.
Our article [3] evaluated the impact of menthol bans implemented between the 2016 and 2018 waves of the Canadian arm of the ITC Four Country Smoking and Vaping Surveys. Hagen incorrectly stated that "the analysis was performed exclusively on provincial characterizing flavour bans." In fact, the provinces evaluated in our study included both those that implemented characterizing flavour bans (Quebec, Ontario, Prince Edward Island, Newfoundland & Labrador) and those that implemented the Federal menthol additive ban (British Columbia, Saskatchewan, Manitoba).
In our original study, we did not test for differences between the two kinds of bans, because the number of menthol smokers across the seven provinces in our evaluation study was low (N=138). However, we did report that there were no statistically significant differences in smoking cessation outcomes between menthol and non-menthol smokers across the seven provinces, consistent with the possibility that there were no differences between a characterizing flavour ban and an additive ban. Hagen's comment did prompt us to do the explicit analysis, comparing the four provinces with characterizing flavour bans to the three provinces with menthol additive bans.
Consistent with our previously reported findings of no differences across the seven provinces, the explicit comparison found no significant differences in smoking cessation outcomes among daily and among all smokers between menthol smokers and non-menthol smokers in provinces with menthol additive bans vs provinces with menthol characterizing flavour bans. Thus, the findings do indeed, as Hagen aimed to highlight, point to the positive impact of the characterizing flavour ban, being not different from that of the national menthol additive ban ─ with the caution that the small sample sizes afforded low statistical power to test for differences.
Our follow-up analysis also showed that a significantly higher percentage of pre-ban menthol smokers reported that they still smoked menthols at follow-up in provinces with menthol characterizing flavour bans, compared with provinces with menthol additive bans (25.3% vs 8.4%, p=0.02). We will describe these results more fully in a forthcoming paper.
There are complexities in the distinctions between a characterizing flavour ban and an additive ban. Each would call upon different kinds of regulatory oversight. For example, the European Union's characterizing flavour ban under the 2016 Tobacco Products Directive [4] required the establishment of an Independent Advisory Panel to determine whether a particular tobacco product has a characterizing flavour, with input from a technical group of sensory and chemical assessors, whose methodology is "based on a comparison of the smelling properties of the test product with those of reference products." [5] In contrast, regulating an additive ban requires product testing to determine the presence of a banned additive.
As jurisdictions consider measures to eliminate the well-documented impact of menthol in increasing attractiveness and reducing harshness of combustible tobacco products [6], these differences in regulatory capacity need to be considered.
3. Chung-Hall J, Fong GT, Meng G, et al. Evaluating the impact of menthol cigarette bans on cessation and smoking behaviours in Canada: longitudinal findings from the Canadian arm of the 2016–2018 ITC Four Country Smoking and Vaping Surveys. Tobacco Control Published Online First: 05 April 2021. doi: 10.1136/tobaccocontrol-2020-056259
6. Tobacco Products Scientific Advisory Committee. Menthol cigarettes and public health: review of the scientific evidence and recommendations. Rockville, MD: Food and Drug Administration, 2011.
NOT PEER REVIEWED
We thank Pesko for his comments and the opportunity for us to respond and clarify.
First, we appreciate Pesko’s clarification that Cotti et al. (2020) clustered standard errors to account for clustering. In the present study, we used multilevel analysis not only to account for clustering of respondents (i.e., design effects) but also to incorporate different error terms for different levels of the data hierarchy which yields more accurate Type I error rates than nonhierarchical methods where all unmodeled contextual information ends up pooled into a single error term of the model.
Second, we understand that Cotti et al. (2020) evaluated the magnitude of e-cigarette tax values, which does not contradict to our statement because our study focused on the effects of e-cigarette excise tax policies on individual e-cigarette use and prevalence rather than aggregated sales at state or county levels. We also clearly described the reason why we examined the e-cigarette excise tax policy implementation indicator rather than its magnitude in our paper’s discussion section.
Third, our study used a nationally representative sample of young adults (rather than a nationally representative sample of general adult population). While we understand Pesko’s concern that a sample’s representativeness might be lost when subgroups are explored, we believe our use of sampling weights in analysis has reduced such a concern.
NOT PEER REVIEWED
We thank Pesko for his comments and the opportunity for us to respond and clarify.
First, we appreciate Pesko’s clarification that Cotti et al. (2020) clustered standard errors to account for clustering. In the present study, we used multilevel analysis not only to account for clustering of respondents (i.e., design effects) but also to incorporate different error terms for different levels of the data hierarchy which yields more accurate Type I error rates than nonhierarchical methods where all unmodeled contextual information ends up pooled into a single error term of the model.
Second, we understand that Cotti et al. (2020) evaluated the magnitude of e-cigarette tax values, which does not contradict to our statement because our study focused on the effects of e-cigarette excise tax policies on individual e-cigarette use and prevalence rather than aggregated sales at state or county levels. We also clearly described the reason why we examined the e-cigarette excise tax policy implementation indicator rather than its magnitude in our paper’s discussion section.
Third, our study used a nationally representative sample of young adults (rather than a nationally representative sample of general adult population). While we understand Pesko’s concern that a sample’s representativeness might be lost when subgroups are explored, we believe our use of sampling weights in analysis has reduced such a concern.
Fourth, in Table 3, please note that vaping product excise tax policy indicator is a time-variant variable in Model 1. However, to present results of a standard difference-in-differences model with a binary indicator, the policy implementation status was operationalized as a time-invariant variable in Model 2, which is not unusual.
Disclosure: We did not receive any funding from the tobacco industry.
References
1. Cotti, C. D., Courtemanche, C. J., Maclean, J. C., Nesson, E. T., Pesko, M. F., & Tefft, N. (2020). The effects of e-cigarette taxes on e-cigarette prices and tobacco product sales: evidence from retail panel data. National Bureau of Economic Research. NBER Working Paper No. w26724.
We appreciate the comments from Bates and the opportunity for us to respond and clarify.
First, Bates' argument heavily relies on the assumption that e-cigarettes and combustible cigarettes are substitutes, which is theoretically possible as some consider vaping as a harm reduction alternative to combustible cigarettes. Empirically, however, there have been mixed findings about whether e-cigarettes and combustible cigarettes are substitutes (or complements). Bates cited Pesko et al. (2020) that concludes e-cigarettes and combustible cigarettes are substitutes, whereas other studies have shown that they are complements. For example, Cotti et al. (2018) found that higher cigarette excise taxes, in fact, decrease sales of both e-cigarettes and combustible cigarettes, suggesting that they are complements. Such mixed results abate Bates' argument that taxing ENDS could lead to more use of combustible cigarettes.
Second, Bates might have ignored that our study focused on young adults aged 18-24 years rather than general adults when examining the effect of vaping product tax on e-cigarette use. Although Pesko et al. (2020) suggests that e-cigarettes and combustible cigarettes are substitutes, the findings are based on the general adult population (average age: 55 years) which may not be generalizable to the young adult population. In fact, one study conducted by Abouk and Adams (2017) indicates that e-cigarettes and combustible ci...
We appreciate the comments from Bates and the opportunity for us to respond and clarify.
First, Bates' argument heavily relies on the assumption that e-cigarettes and combustible cigarettes are substitutes, which is theoretically possible as some consider vaping as a harm reduction alternative to combustible cigarettes. Empirically, however, there have been mixed findings about whether e-cigarettes and combustible cigarettes are substitutes (or complements). Bates cited Pesko et al. (2020) that concludes e-cigarettes and combustible cigarettes are substitutes, whereas other studies have shown that they are complements. For example, Cotti et al. (2018) found that higher cigarette excise taxes, in fact, decrease sales of both e-cigarettes and combustible cigarettes, suggesting that they are complements. Such mixed results abate Bates' argument that taxing ENDS could lead to more use of combustible cigarettes.
Second, Bates might have ignored that our study focused on young adults aged 18-24 years rather than general adults when examining the effect of vaping product tax on e-cigarette use. Although Pesko et al. (2020) suggests that e-cigarettes and combustible cigarettes are substitutes, the findings are based on the general adult population (average age: 55 years) which may not be generalizable to the young adult population. In fact, one study conducted by Abouk and Adams (2017) indicates that e-cigarettes and combustible cigarettes are not substitutes for young people. Established cigarette smokers may use e-cigarettes as a cessation tool but it is less common in young adults. In addition, even if e-cigarettes and combustible cigarettes are substitutes to some degree, the direction of substitution as well as co-use versus subsequent use should not be overlooked. Studies have shown that e-cigarettes may serve as a gateway to future combustible cigarette smoking among young people. For example, a study conducted by Hair et al. (2021) shows that youth and young adults who reported ever e-cigarette use had significantly higher odds of ever cigarette use one year later. Therefore, e-cigarette use versus combustible cigarette smoking is not simply an issue of substitution in particular among young people.
Disclosure: We did not receive any funding from the tobacco industry.
References:
1. Abouk, R., & Adams, S. (2017). Bans on electronic cigarette sales to minors and smoking among high school students. Journal of Health Economics, 54, 17-24.
2. Cotti, C., Nesson, E., & Tefft, N. (2018). The relationship between cigarettes and electronic cigarettes: Evidence from household panel data. Journal of Health Economics, 61, 205-219.
3. Hair, E. C., Barton, A. A., Perks, S. N., Kreslake, J., Xiao, H., Pitzer, L., ... & Vallone, D. M. (2021). Association between e-cigarette use and future combustible cigarette use: Evidence from a prospective cohort of youth and young adults, 2017–2019. Addictive Behaviors, 112, 106593.
4. Pesko, M. F., Courtemanche, C. J., & Maclean, J. C. (2020). The effects of traditional cigarette and e-cigarette tax rates on adult tobacco product use. Journal of Risk and Uncertainty, 60(3), 229-258.
NOT PEER REVIEWED
I have a number of concerns with the paper as currently written.
1) The authors write: “Besides, none of the previous studies except Pesko et al (15) that examined the associations between vaping product excise tax adoption and ENDS use has accounted for the clustering of respondents within the same localities…” This is not accurate, as citation 19 also clusters standard errors at the locality level in all specifications.
2) The authors write: "A working paper reported reduced ENDS sales, but not ENDS use prevalence or behaviours, after implementation of a vaping product excise tax policy. (19)” This is not accurate, as the cited study uses the magnitude of e-cigarette tax values, rather than an indicator variable for tax implementation. States have adopted e-cigarette taxes of different magnitudes and a number of them (such as California) have changed the magnitudes of these taxes after adoption. All of this variation is used in citation 19, contrary to the current study’s description. It's also unclear from the sentence whether citation 19 studied use and found imprecise estimates, or did not study use. It's the latter and this should be clarified. It's also unclear why the authors did not use magnitude of e-cigarette taxes themselves in the current paper, as has been commonly done in the referenced literature.
3) Authors write they use a “nationally representative sample of US young adults.” I do not beli...
NOT PEER REVIEWED
I have a number of concerns with the paper as currently written.
1) The authors write: “Besides, none of the previous studies except Pesko et al (15) that examined the associations between vaping product excise tax adoption and ENDS use has accounted for the clustering of respondents within the same localities…” This is not accurate, as citation 19 also clusters standard errors at the locality level in all specifications.
2) The authors write: "A working paper reported reduced ENDS sales, but not ENDS use prevalence or behaviours, after implementation of a vaping product excise tax policy. (19)” This is not accurate, as the cited study uses the magnitude of e-cigarette tax values, rather than an indicator variable for tax implementation. States have adopted e-cigarette taxes of different magnitudes and a number of them (such as California) have changed the magnitudes of these taxes after adoption. All of this variation is used in citation 19, contrary to the current study’s description. It's also unclear from the sentence whether citation 19 studied use and found imprecise estimates, or did not study use. It's the latter and this should be clarified. It's also unclear why the authors did not use magnitude of e-cigarette taxes themselves in the current paper, as has been commonly done in the referenced literature.
3) Authors write they use a “nationally representative sample of US young adults.” I do not believe this is not accurate. The TUS-CPS sample itself may be nationally representative, but this representativeness may be lost when subgroups are explored.
4) The “vaping product excise tax policy” variable in Table 3 appears to be re-defined mid-table. Based on the discussion of the results, in column 1 it appears that this variable is an indicator equal to 1 only at the time when a state has an e-cigarette tax in place. In column 2 though, this indicator equals 1 when a state ever has an e-cigarette tax in place (even prior to it being in place). The use of the same row for a variable that changes across columns is unusual and can easily lead to the wrong interpretation.
NOT PEER REVIEWED
This article does not distinguish between characterizing flavour (menthol) bans that were implemented in Canadian provinces between 2015 and 2017 and the implementation of a national ban on menthol additives in Canada in October 2017. Although unreported, the analysis was performed exclusively on provincial characterizing flavour bans. This significant distinction should be reported to ensure that researchers and policy makers are aware of the potential impact of a characterizing flavour ban and to ensure that this policy measure is not dismissed or discounted.
NOT PEER REVIEWED
I would like to make three comments by way of a brief post-publication review.
1. The impacts of vaping tax on smoking have been completely overlooked
For a study of e-cigarette taxation to have any public health relevance, it must consider the impact of e-cigarette prices on *cigarette* demand. Cigarettes and e-cigarettes are economic substitutes. The demand for one responds to changes in the price of the other, an idea well understood in economics and quantified through the concept of cross-elasticity. The paper appears to pay no regard to the impact of vaping taxes on cigarette demand, Yet such effects might easily overwhelm any benefits from reduced e-cigarette use - in fact, impact on demand for other tobacco products and the development of informal markets are by far the most important impacts of a vaping tax. By way of example, a 2020 paper by Pesko et al. [1] concluded:
"Our results suggest that a proposed national e-cigarette tax of $1.65 per milliliter of vaping liquid would raise the proportion of adults who smoke cigarettes daily by approximately 1 percentage point, translating to 2.5 million extra adult daily smokers compared to the counterfactual of not having the tax."
2. The case for reducing adult vaping by taxation has not been made
The authors have based their paper on an unexamined assumption that it is a justifiable goal of policy to lower rates of adult e-cigarette use. Why should...
NOT PEER REVIEWED
I would like to make three comments by way of a brief post-publication review.
1. The impacts of vaping tax on smoking have been completely overlooked
For a study of e-cigarette taxation to have any public health relevance, it must consider the impact of e-cigarette prices on *cigarette* demand. Cigarettes and e-cigarettes are economic substitutes. The demand for one responds to changes in the price of the other, an idea well understood in economics and quantified through the concept of cross-elasticity. The paper appears to pay no regard to the impact of vaping taxes on cigarette demand, Yet such effects might easily overwhelm any benefits from reduced e-cigarette use - in fact, impact on demand for other tobacco products and the development of informal markets are by far the most important impacts of a vaping tax. By way of example, a 2020 paper by Pesko et al. [1] concluded:
"Our results suggest that a proposed national e-cigarette tax of $1.65 per milliliter of vaping liquid would raise the proportion of adults who smoke cigarettes daily by approximately 1 percentage point, translating to 2.5 million extra adult daily smokers compared to the counterfactual of not having the tax."
2. The case for reducing adult vaping by taxation has not been made
The authors have based their paper on an unexamined assumption that it is a justifiable goal of policy to lower rates of adult e-cigarette use. Why should this be a policy goal any more than reducing caffeine use or moderate alcohol use? The goal of public health policy is to address significant harms or self-destructive patterns of use, not to modify behaviours that the authors find distasteful. What are the harms that justify state intervention to reduce adult vaping with a tax? Further, they appear indifferent to welfare costs and the distributional impact of imposing a regressive tax burden on people who use vaping products. Tobacco control advocates should become more familiar with the idea that punitive policies impose harm on users, even though these users are supposed to be the intended beneficiaries. For example, a vaping tax harms families by drawing on the household budget of those who continue to vape.
3. The analysis to support the policy recommendations is wholly inadequate
The authors make over-confident policy recommendations without considering the full range of impacts of the measures they are proposing.
"Our findings suggest that adopting a vaping product excise tax policy may help reduce ENDS use and suppress the increase of ENDS use prevalence among young adults. Considering that there are still a number of US states that have not implemented vaping product excise tax policy, wider adoption of such policy across the nation would likely help mitigate ENDS use prevalence."
Without considering all the possible responses to the tax they support, they may easily be proposing tobacco control policies that do more harm than good. In fact, the most important public health impact of this policy is entirely excluded from the analysis. That is the effect of a vaping tax on smoking or other tobacco use. Given the two orders of magnitude difference in risk between smoking and vaping, only a tiny uptick in smoking would be needed to completely offset the benefits, if any, arising from reduced vaping
NOT PEER REVIEWED
Replication attempts are one of the self-correcting mechanisms of science, and we thank the Authors for their response to our concerns and their attempt to replicate aspects of their study [1]. Regrettably, they have failed to adequately address the central point raised in our letter of 23rd April 2021, namely that the title and conclusions of their original Article are patently invalid and have no basis in fact or evidence [2]. Instead of strengthening their argument in support of the Article’s findings and conclusions, the Authors’ response considerably weakens them. Strikingly, the Authors reveal several new and serious issues and yet maintain that their “principle finding is unchanged”.
Methodological Problems:
The Authors acknowledge that they were unable to replicate an important aspect of their original analysis, namely that a Philip Morris International (PMI) News Article [3] published on its website (falsely described as a “press release”) was “republished […] in 14 additional news outlets”. In their response, they note that “Our original assertion that there were 14 duplicate articles is not supported by our replication analysis”. This failure to replicate a key finding—in their own proprietary database, which several of them co-developed—is concerning. The Authors provide no explanation for the irregularity. Notably, on 20th April 2021, we were able to source these 14 articles in Tobacco Watcher since they were clearly mar...
NOT PEER REVIEWED
Replication attempts are one of the self-correcting mechanisms of science, and we thank the Authors for their response to our concerns and their attempt to replicate aspects of their study [1]. Regrettably, they have failed to adequately address the central point raised in our letter of 23rd April 2021, namely that the title and conclusions of their original Article are patently invalid and have no basis in fact or evidence [2]. Instead of strengthening their argument in support of the Article’s findings and conclusions, the Authors’ response considerably weakens them. Strikingly, the Authors reveal several new and serious issues and yet maintain that their “principle finding is unchanged”.
Methodological Problems:
The Authors acknowledge that they were unable to replicate an important aspect of their original analysis, namely that a Philip Morris International (PMI) News Article [3] published on its website (falsely described as a “press release”) was “republished […] in 14 additional news outlets”. In their response, they note that “Our original assertion that there were 14 duplicate articles is not supported by our replication analysis”. This failure to replicate a key finding—in their own proprietary database, which several of them co-developed—is concerning. The Authors provide no explanation for the irregularity. Notably, on 20th April 2021, we were able to source these 14 articles in Tobacco Watcher since they were clearly marked as “additional coverage” of the PMI News Article. Of the total, 5 of the “duplicate articles” were no longer accessible online and none of the remaining 9 mentioned IQOS at all. All of them were reporting on the EVALI outbreak and flavor ban proposals, a fact that we raised in our April letter to the Authors.
The Authors note that Tobacco Watcher is “a dynamic resource with continuous data collection and processing”. We could not find any information about the computational environment of the database, nor does there appear to be any public information about factors that can impact reproducibility and replicability. Specifically, we could not find any published information about how it collects, processes, and analyzes data, how it is version controlled and what data management plans are in place. However, a poster presentation by some of the Authors indicates that media articles are “automatically coded” using “natural language processing, trained on human-coded data” [4]. It is therefore difficult to understand why results relating to media articles from 2019—generated from an automatic coding process—could abruptly change over the course of two months in 2021. Of course, it is entirely plausible that the 14 articles had been falsely coded, and that this error was manually addressed at some point between April 20th and June 10th, 2021. The Authors should explain if this was the case, or whether changes to the underlying Tobacco Watcher algorithms caused the change—and if so, how. They should also provide an explanation of why they remain confident in the rest of their trend analyses, given the apparent instability of Tobacco Watcher over time.
Because of the Authors’ failure to replicate this important aspect of their study, there is no valid evidence to show any direct link between the PMI News Article and the increase in media coverage of IQOS and EVALI. The Authors’ invalid assumption that the PMI News Article was “republished” was presumably relied upon to support their title and conclusions and yet the evidence for this has now been shown to be nonexistent—not just by our analysis, but also by the Authors’ subsequent failure to replicate their initial finding.
Confounding Factors Ignored:
Given that the Authors have now shown that they do not have any evidence to support a direct, causal relationship between the PMI News Article and subsequent news coverage including both the terms IQOS and EVALI, potential confounders become central to the question of whether their title and conclusions are supported or not. Whilst they now concede that their evidence merely demonstrates that a causal relationship is “plausible”, they continue to ignore or dismiss other more likely explanations. Many confounding factors were laid out in our April letter—with sources beyond those emanating solely from PMI—and they provide important information about the news media environment that could credibly have caused a rise in articles mentioning IQOS and EVALI (including in particular the official press releases [5] by PMI and Altria on 25th September 2019—announcing that their proposed merger talks were over and that the companies would focus on launching IQOS in the U.S.— as well as a press release from the U.S. Centers for Disease Control related to EVALI). Generally, in epidemiology, sociology and other fields, there are at least three main criteria that should be met in order to establish a causal relationship: the cause occurs before the effect; the cause and the effect covary; and a lack of plausible alternative explanations [6]. By dismissing the most plausible explanations for the increase in media coverage, and failing to provide any credible alternative evidence to explain their hypothesis, the overall analysis and conclusion presented by the Authors fails to meet these criteria for causality.
Attempt to Shift the Burden of Proof:
The Authors make logical errors in defense of their Article. They state that “PMI has not provided any verifiable disclosure about how they circulated these materials [the PMI News Article] beyond their publication and availability on internet search engines and social media”. Any perceived lack of disclosure on the part of PMI does not render the Authors’ claims any more valid. To the contrary, the burden of proof is on them to provide evidence for their assertions. In the three months since we first wrote to the Authors to express our concerns, it would have been perfectly possible for them to: (a) list which news articles actually refer to the PMI News Article and/or use the phrases ‘IQOS’ AND ‘EVALI’ (rather than ‘vaping’ and ‘illness’, which are not identical search terms); and (b) rapidly and independently verify whether any of the journalists writing about both IQOS and EVALI had seen the PMI News Article by simply asking them.
Unsubstantiated, Yet Definitive Language:
The title “Philip Morris International used the e-cigarette, or vaping, product use associated lung injury (EVALI) outbreak to market IQOS heated tobacco” is a statement purporting to be factual. However, the Authors now state that their original findings and conclusions are merely “plausible” and admit “we cannot know PMI’s intent”. Plausibility is not a statement of fact or truth. Instead, it implies that an argument is not fully formed, appears specious, superficially fair or reasonable, but in fact could be either right or wrong. As such, the title and other conclusory allegations in the Article are—by the Author’s own admission—not supported. Having ignored or discounted evidence that makes the Author’s conclusions implausible, the final paragraph of their response makes clear that in the absence of evidence, their conclusion rests solely on the Author’s distrust of the industry.
Summary:
In summary, the conclusion that “Philip Morris International used the e-cigarette, or vaping, product use associated lung injury (EVALI) outbreak to market IQOS heated tobacco” can be disproven using the authors’ own tool, an analysis method that actually takes into account concomitant news events, the Authors’ acknowledgment that they failed to replicate an important aspect of their findings, and their concession that their title is merely “plausible”. The entire premise of the EVALI/IQOS Article is patently invalid and substantial revision or retraction of this paper remains urgently warranted.
NOT PEER REVIEWED
The authors’ response published on 14 July 2021 is far from satisfactory and implausibly asserts that “Our original findings and conclusions remain plausible” [1]
The original study [2] uses a media analysis to make a claim that a statement made by the tobacco company Philip Morris International (PMI) about an outbreak of lung disease in the US [3] was a marketing ploy for its heated tobacco product, iQOS. At the time, the lung injury outbreak was falsely attributed by many to nicotine vaping. Heated tobacco products are an alternative to nicotine vaping for smokers looking for a low-risk alternative to smoking.
I will now list some of the problems with this claim.
1. The research findings do not support the headline claim
The study title contains a strong and unqualified assertion of cynical opportunism on the part of the company. The new formulation that findings "remain plausible" does not justify the confidence in the assertion made in the title. "Plausible" is a reasonable basis for choosing a hypothesis to investigate, but a far from sufficient basis for drawing an aggressive conclusion. The authors do not seem to dispute the technical or factual accuracy of the statement about iQOS and EVALI made by PMI. Their allegation is about malign motives and, as such, it should be a cause for caution and a high standard of evidence.
2. No specific articles were provided to substantiate the...
NOT PEER REVIEWED
The authors’ response published on 14 July 2021 is far from satisfactory and implausibly asserts that “Our original findings and conclusions remain plausible” [1]
The original study [2] uses a media analysis to make a claim that a statement made by the tobacco company Philip Morris International (PMI) about an outbreak of lung disease in the US [3] was a marketing ploy for its heated tobacco product, iQOS. At the time, the lung injury outbreak was falsely attributed by many to nicotine vaping. Heated tobacco products are an alternative to nicotine vaping for smokers looking for a low-risk alternative to smoking.
I will now list some of the problems with this claim.
1. The research findings do not support the headline claim
The study title contains a strong and unqualified assertion of cynical opportunism on the part of the company. The new formulation that findings "remain plausible" does not justify the confidence in the assertion made in the title. "Plausible" is a reasonable basis for choosing a hypothesis to investigate, but a far from sufficient basis for drawing an aggressive conclusion. The authors do not seem to dispute the technical or factual accuracy of the statement about iQOS and EVALI made by PMI. Their allegation is about malign motives and, as such, it should be a cause for caution and a high standard of evidence.
2. No specific articles were provided to substantiate the claim
The headline finding is not, however, even remotely plausible. The company has made it clear that it made its iQOS-EVALI statement available passively for information purposes. If it had generated even one story among 384 the authors say that matched their keyword search in the 30 days after publication, the authors could have produced it. If they had a good case and wanted to avoid a retraction, they could have looked through these results (or to save time, articles published in the two weeks after PMI's statement) and shown at least some articles clearly derive from the statement. Though searching only with Google, I have been unable to identify a single article. That doesn't mean there aren't any, but it's not me making the allegations. The authors are making the allegations and the burden of evidence is with them. They should now respond with examples of articles that support their critique and publish the list of 384 articles captured in their search as a supplementary file that is open to anyone to examine
3. Confounding by other news is a fatal problem for this study
The problem of confounding by other news related to the company, product and sector at around the same time is overwhelming. PMI published its iQOS-EVALI statement on 24 September 2019 [3]. This period coincided with; the end of merger talks between Altria and PMI on 25 September [4]; also on the same day, Juul announced the departure of its CEO and new corporate practices (Juul is part-owned by Altria) [5]; a new iQOs product was launched by PMI on 26 September [6]; there was an ongoing controversy with high news value developments on a lung injury outbreak in the United States, which was at the time often falsely attributed to nicotine vaping. For example, a significant CDC press release on 27 September [7].
4. Many news media will have covered several issues at once
The timing in question was a crisis period for products and companies making low-risk alternatives to cigarettes. It will have generated many news pieces that would have covered specific stories but also rounded up the other news. For example, Reuters reported both the PMI-Altria merger news and Juul restructuring in the same piece on 25 September 2019 with references to both lung injures and to iQOS, but without any reference to PMI's 24 September 2019 statement. [8]
5. The study method has no credible approach to confounding
Much of the response seems to be devoted to discussing sloppy though trivial errors in the original paper. This is a distraction from addressing the fundamental flaw, on which the response has relatively little to say. Without some sort of strategy to address confounding by other news and thereby to isolate from the signal (of PMI cynical opportunism) from the cacophonous noise of the news flow at the time, the authors have no basis for their claim. On top of this, the failure to produce a single article that appears to be derived in whole or even in part from the allegedly cynical communication suggests the authors have nothing.
6. Failure to put findings to the company
There is no sign here that the authors contacted the company or made any efforts to verify their story or check for alternative explanations. Why not? Why is it acceptable to avoid this most basic of journalistic practices simply because the authors are writing in an academic journal and about an organisation they do not like?
Just because the object of this research is the tobacco industry, it doesn't mean scientific standards or research and investigative ethics should be jettisoned. Precisely because the target of this research is a tobacco company, it makes a good test of scientific integrity and ‘white hat bias’. [9]
“White Hat Bias is bias leading to distortion of research-based information in the service of what may be perceived as righteous ends.”
[9]. The concept originates with: Cope MB, Allison DB. White Hat Bias: Examples of its Presence in Obesity Research and a Call for Renewed Commitment to Faithfulness in Research Reporting. Int J Obes (Lond) 2010;34(1):84. https://www.ncbi.nlm.nih.gov/pmc/articles/PMC2815336/
We thank Dr. Moira Gilchrist (1) for her careful attention to our work (2). Gilchrist argues our principal findings were erroneous and any change in news coverage of IQOS and the e-cigarette, or vaping, product use associated lung injury (EVALI) outbreak were confounded by other Philip Morris International (PMI) media materials and not those specifically discussing EVALI and IQOS (3) which we attributed our findings to. However, a deeper inspection of this argument suggests our original findings and conclusions remain plausible.
Tobacco Watcher is a dynamic resource with continuous data collection and processing. Thus, the results of analyses on the platform can vary over time. On June 10, 2021 we replicated our analysis. After correcting an error that the PMI’s materials on EVALI and IQOS (3) was initially published on 24 September 2021 (not 25 September) the principal finding is unchanged. News coverage mentioning both “IQOS” and EVALI (i.e., including the terms ‘vaping’ and ‘illness’) reached an all-time high immediately after PMI published materials about EVALI and IQOS on their website. Thirty days prior to PMI posting this material (August 25th through September 23rd) 2.0 news stories per day matched our search compared to 12.8 for the 30 days after their publication (September 24th through October 23rd), with 384 news reports matching our keyword search for the latter period. Our original assertion that there were 14 duplicate articl...
We thank Dr. Moira Gilchrist (1) for her careful attention to our work (2). Gilchrist argues our principal findings were erroneous and any change in news coverage of IQOS and the e-cigarette, or vaping, product use associated lung injury (EVALI) outbreak were confounded by other Philip Morris International (PMI) media materials and not those specifically discussing EVALI and IQOS (3) which we attributed our findings to. However, a deeper inspection of this argument suggests our original findings and conclusions remain plausible.
Tobacco Watcher is a dynamic resource with continuous data collection and processing. Thus, the results of analyses on the platform can vary over time. On June 10, 2021 we replicated our analysis. After correcting an error that the PMI’s materials on EVALI and IQOS (3) was initially published on 24 September 2021 (not 25 September) the principal finding is unchanged. News coverage mentioning both “IQOS” and EVALI (i.e., including the terms ‘vaping’ and ‘illness’) reached an all-time high immediately after PMI published materials about EVALI and IQOS on their website. Thirty days prior to PMI posting this material (August 25th through September 23rd) 2.0 news stories per day matched our search compared to 12.8 for the 30 days after their publication (September 24th through October 23rd), with 384 news reports matching our keyword search for the latter period. Our original assertion that there were 14 duplicate articles is not supported by our replication analysis.
We recognize that for any observational data analysis there are alternative explanations. However, Gilchrist’s alternative explanations are debatable. First, she argues the materials published by PMI on EVALI and IQOS (3) were not a “press release” and therefore could not have engendered a change in media coverage. We now refer to the materials published by PMI on EVALI and IQOS as a “public statement” published on PMI’s website. Yet, PMI has not provided any verifiable disclosure about how they circulated these materials beyond their publication and availability on internet search engines and social media, a concern we raised in our study (2). Regardless, PMI’s public statement was potentially consumed and amplified by other media makers. Second, she assumes the increase in news coverage was due to a PMI publication entitled “Philip Morris International Inc. and Altria Group, Inc. End Merger Discussions” (4) which does not mention EVALI. While a sizable percentage of the news articles we studied mention the merger, their inclusion of IQOS and EVALI suggests the possibility of additional source material for these stories. It is plausible that information from the published materials we studied tying IQOS and EVALI and the larger merger story were discussed in tandem.
There were factual errors in our report that we missed during the copy edit of our piece: the date of PMI’s materials being published was misstated (25 versus 24 September), the date of another reference was misstated, and references were misordered. Additionally, the date we submitted our piece was misstated due to a production system issue created by a delay in submitting the revised version. Last, in light of PMI stating that the 25 September publication was not a press release, the article has been amended accordingly. We have provided Tobacco Control with an errata to correct these errors. However, the principal conclusion of our work was unaffected by any error.
While we can measure the potential spillover effect of published claims, we cannot know PMI’s intent. It is paramount that the earned media strategies of the tobacco industry come under closer inspection. The tobacco industry has used varied tactics to sow misimpressions that favor them and their products, a fact well documented in both the scientific literature and courts of law (5); earned media campaigns may be yet another.
References
1. Gilchrist M. Study alleging Philip Morris International used the EVALI outbreak to market IQOS requires substantial methodological revision and further peer review, or retraction. Tob Control Rapid Response.
2. Ayers JW, Leas EC, Dredze M, et al. Tob Control. Epub ahead of print: doi:10.1136/ tobaccocontrol-2021-056661.
3. Philip Morris International. Lung illnesses associated with use of vaping products in the US. Available: https://www.pmi.com/media-center/news/lung-illnesses-associated-with-use... [Accessed 10 Mar 2021].
4. Philip Morris International. Philip Morris International Inc. and Altria Group, Inc. End Merger Discussions. https://philipmorrisinternational.gcs-web.com/static-files/78a6afb3-107d... Accessed 11 June 2021.
5. Ong EK, Glantz SA. Constructing "sound science" and "good epidemiology": tobacco, lawyers, and public relations firms. Am J Public Health. 2001;91.
A review of this study has been published by the target of its criticism, the tobacco company Philip Morris International (PMI), via the post-publication review server Qeios [1]
The main finding of this study, and the allegation raised in its title, is that PMI cynically used an outbreak of lung injuries in the United States (initially but incorrectly attributed to nicotine vaping) to promote its heated tobacco product, iQOS. Heated tobacco products are one alternative to vaping for those looking for a safer alternative to smoking. On 24th September 2019, PMI published an information notice about its products in response to the lung injury outbreak. The authors assert that PMI was trying to gain commercial publicity from a health crisis: a serious allegation. But the allegation appears to be based on a major error by the authors.
The study used a "fully automated media analysis engine" to count stories that mention iQOS around that time, showing that there were considerably more than usual. On this basis, the authors concluded that PMI's unethical promotional gambit had worked. However, the day after PMI allegedly disreputably sought publicity for iQOS, the company also issued a press release disclosing that merger negotiations with the American tobacco company, Altria, had ceased. PMI and Altria have a joint marketing agreement for iQOS in the United States. The end of merger talks would be big news in the business pre...
A review of this study has been published by the target of its criticism, the tobacco company Philip Morris International (PMI), via the post-publication review server Qeios [1]
The main finding of this study, and the allegation raised in its title, is that PMI cynically used an outbreak of lung injuries in the United States (initially but incorrectly attributed to nicotine vaping) to promote its heated tobacco product, iQOS. Heated tobacco products are one alternative to vaping for those looking for a safer alternative to smoking. On 24th September 2019, PMI published an information notice about its products in response to the lung injury outbreak. The authors assert that PMI was trying to gain commercial publicity from a health crisis: a serious allegation. But the allegation appears to be based on a major error by the authors.
The study used a "fully automated media analysis engine" to count stories that mention iQOS around that time, showing that there were considerably more than usual. On this basis, the authors concluded that PMI's unethical promotional gambit had worked. However, the day after PMI allegedly disreputably sought publicity for iQOS, the company also issued a press release disclosing that merger negotiations with the American tobacco company, Altria, had ceased. PMI and Altria have a joint marketing agreement for iQOS in the United States. The end of merger talks would be big news in the business press and would likely include a discussion of consequences for iQOS.
So, an analysis that tries to measure media interest in PMI and iQOS for cynical publicity purposes at that time would be heavily confounded by other unrelated but newsworthy developments concerning the same company and product. A check of the press releases by the company should have raised the alarm. PMI also states that it did not seek any publicity for its safety notice about iQOS, which PMI says the authors:
"falsely describe as a “press release”, despite it never being published through a press release distribution service"
Now that it has been pointed out, it is quite clear that a serious error has been made here that undermines the foundations of the study and renders the allegation made in the title baseless. The simple way to deal with this is to acknowledge the error, retract the article, apologise, and resolve to be more careful in future. That should take a couple of hours, not several months and there would be no shame in it. That this has not happened is troubling.
[1] Moira Gilchrist (PMI) Review of: Philip Morris International used the e-cigarette, or vaping, product use associated lung injury (EVALI) outbreak to market IQOS heated tobacco. Qeios. [https://www.qeios.com/read/NLZDBR}
I write on behalf of Juul Labs in response to “E-cigarette manufacturers’ compliance with clinical trial reporting expectations: a case series of registered trials by Juul Labs.” We appreciate the public health community’s interest in understanding the Company’s research. However, we want to clarify the article’s reporting on Juul Labs’ research program and publications to date, as well as our legal obligations to report the results of clinical investigations.
First, our studies were conducted in anticipation of our submission of a Premarket Tobacco Product Application (PMTA) to the U.S. Food and Drug Administration (FDA). As such, raw data, results, and statistical code underlying our analyses of all ten registered Juul Labs studies referenced in the Tobacco Control paper have been submitted to FDA (1)
In addition, we have been working on sharing our data in publications and posters. In fact, by the end of this month, we will have published or presented data on nine of the ten studies, in addition to having provided the clinical results to FDA. Of our ten registered studies, we have published the results of four (2, 3, 4, 5) submitted the results of an additional two studies for peer review, presented the results of two as posters (6,7) and have the results of one accepted for presentation this summer. We appreciate that the authors of the Tobacco Control paper may have drafted their article months ago, but note that there...
I write on behalf of Juul Labs in response to “E-cigarette manufacturers’ compliance with clinical trial reporting expectations: a case series of registered trials by Juul Labs.” We appreciate the public health community’s interest in understanding the Company’s research. However, we want to clarify the article’s reporting on Juul Labs’ research program and publications to date, as well as our legal obligations to report the results of clinical investigations.
First, our studies were conducted in anticipation of our submission of a Premarket Tobacco Product Application (PMTA) to the U.S. Food and Drug Administration (FDA). As such, raw data, results, and statistical code underlying our analyses of all ten registered Juul Labs studies referenced in the Tobacco Control paper have been submitted to FDA (1)
In addition, we have been working on sharing our data in publications and posters. In fact, by the end of this month, we will have published or presented data on nine of the ten studies, in addition to having provided the clinical results to FDA. Of our ten registered studies, we have published the results of four (2, 3, 4, 5) submitted the results of an additional two studies for peer review, presented the results of two as posters (6,7) and have the results of one accepted for presentation this summer. We appreciate that the authors of the Tobacco Control paper may have drafted their article months ago, but note that there are outdated references to publication or presentation of the five studies included by the authors in their analysis. While the article asserts that just one of the five studies that was incorrectly registered as an “applicable device clinical trial” has been published, as of this writing, results from three of the five studies have been published. (8) Across our research program, we have published a total of 17 articles (all publicly available on our science website www.juullabsscience.com) and are working on additional publications.
Finally, although not obligated to do so (9), Juul Labs voluntarily submitted registration information for ten studies to the ClinicalTrials.gov registry. As voluntary submissions, all of the studies should have been registered as a “voluntary other trial.” Due to an administrative error at Juul Labs, six of those studies were instead registered as an “applicable device clinical trial.” These errors are in the process of being corrected and, in fact, four of the studies have been formally updated on ClinicalTrials.gov to reflect this change. (10, 11, 12, 13)
We look forward to continuing to share results from our science and research program with the scientific and public health community as we work to advance harm reduction for adults who smoke, and to support the scientific basis for the category.
Sincerely, Snigdha Mishra, SVP Regulatory Science
On behalf of my co-authors, we thank Dr. Mishra for taking the time to comment on our paper examining reporting of trials registered by Juul Labs Inc.
We do not doubt that Juul has submitted the results from all of these studies to the FDA as part of their Premarket Tobacco Product Application (PMTA). Unfortunately, this step does not ensure the full results of these trials will be made available to the public, clinicians, and other key stakeholders.
We also acknowledge and appreciate that since conducting our analysis in August 2020, two additional studies, of the five we examined, have appeared in the peer reviewed literature (published in December 2020 and January 2021)[1,2] and additional results may become available through other methods. We understand that these publications may contain additional outcome reporting compared to the posters we assessed. We welcome any and all additional results disclosures from Juul Labs. That said, we believe the risk of outcome reporting bias remains and is, unfortunately, not addressed in Juul’s comment despite being a major facet of our paper. The one publication that was available as of our analysis date excluded 4 of the 19 prespecified secondary outcomes without comment and another 5 outcomes had clear issues in their reporting compared to the registered outcomes. While we have not conducted a detailed assessment of the two new publications, it is apparent that journal publication does no...
On behalf of my co-authors, we thank Dr. Mishra for taking the time to comment on our paper examining reporting of trials registered by Juul Labs Inc.
We do not doubt that Juul has submitted the results from all of these studies to the FDA as part of their Premarket Tobacco Product Application (PMTA). Unfortunately, this step does not ensure the full results of these trials will be made available to the public, clinicians, and other key stakeholders.
We also acknowledge and appreciate that since conducting our analysis in August 2020, two additional studies, of the five we examined, have appeared in the peer reviewed literature (published in December 2020 and January 2021)[1,2] and additional results may become available through other methods. We understand that these publications may contain additional outcome reporting compared to the posters we assessed. We welcome any and all additional results disclosures from Juul Labs. That said, we believe the risk of outcome reporting bias remains and is, unfortunately, not addressed in Juul’s comment despite being a major facet of our paper. The one publication that was available as of our analysis date excluded 4 of the 19 prespecified secondary outcomes without comment and another 5 outcomes had clear issues in their reporting compared to the registered outcomes. While we have not conducted a detailed assessment of the two new publications, it is apparent that journal publication does not necessarily guarantee the full reporting of all specified outcomes. This unfortunately holds true throughout the reporting of clinical research. [3, 4]
Additionally, we showed that for the conference posters identified by our searches there was a clear risk of unreported outcomes for these short-format publications. Potentially making some studies only available as posters or abstracts risks further outcome reporting issues or delays.
In Footnote 9 of the comment, Dr. Mishra states that “Section 801 of the Food and Drug Administration Amendments Act of 2007 (FDAAA) and implementing regulations issued by the National Institutes of Health (NIH) do not require registration of clinical trials involving tobacco products”
The Final Rule is entirely silent on the specific coverage status of tobacco products. Searching the Final Rule document for the word “Tobacco” reveals 0 results.[5] Another Final Rule issued well after the Sottera decision, 21 CFR 201, 801, and 1100, and an FDA guidance document both make clear that under certain circumstances tobacco products can be considered covered under the FDAAA.[6, 7]
To quote the FDA Guidance:
“If an ENDS product is marketed for tobacco cessation or for any other therapeutic purpose, the product is a drug or device, rather than a tobacco product, under the authorities of FDA’s Center for Drug Evaluation and Research or Center for Devices and Radiological Health, and appropriate approval must be sought to market a product as a drug or device.” (Page 9)
And 21 CFR 201, 801, and 1100:
“Whether the product, as used in the study, is subject to regulation as a drug depends on whether the product is being investigated for any of the purposes described in § 1100.5(a) or (b) of this rule. To determine if a product made or derived from tobacco is being investigated for one of these purposes, FDA generally would review the protocol for the study, including the proposed methods and measures. In the Agency’s experience, the proposed methods and measures for a study can provide insight into the purposes for which a product is being investigated.” (Page 2213)
We also note that the FDAAA Final Rule requires trials of drugs and devices to report regardless of whether or not they plan to seek any approvals with the FDA [5]:
“The final rule maintains the proposal to require the submission of results information for applicable clinical trials of unapproved, unlicensed, or uncleared products, regardless of whether FDA approval, licensure, or clearance is or will be sought or obtained.” (Page 64995)
We discuss the relevant legal frameworks, and their unfortunate ambiguity, in more depth in the manuscript.
Our determination of potential FDAAA coverage was based on public registration information directly provided by Juul and matched to official published criteria for determining FDAAA coverage. As stated in their comment, Juul Labs have now updated many of their registrations to no longer match these criteria. However the registered trials we assessed contained outcomes related to the uptake and pharmacokinetics of nicotine in the body, a key feature of addiction, and measures directly relevant to smoking cessation like product use, dependency, urge to smoke, and aspects of withdrawal. It is, however, ultimately up to the FDA to make official determinations about which trials are covered under the FDAAA based on their assessment of the purpose and outcomes of a given study.
Regardless of the exact regulatory status of these trials, a matter we hope the FDA will offer further clarity on, we strongly encourage Juul Labs to consider amending their existing registrations with the results of these trials. ClinicalTrials.gov offers a rapid, public, open source repository for trial results that enhances their availability, transparency, and discoverability and should not preclude subsequent peer reviewed publications.[8] It is clear from their response that Juul Labs understands the importance of trial registration and reporting to the public and scientific community, and we welcome this recognition. ClinicalTrials.gov allows for full results to be reported, without space limitations or delays associated with journal publication, and with a clear public link to all prespecified outcomes and other registered details. While the FDAAA compels this type of reporting, there is no limitation on voluntary submission of results if trials are not covered under the law. We strongly believe it is in the public interest that all outcomes for all trials that form PMTA applications should be fully and publicly reported in a timely manner. Currently this does not appear to be the case even if it may have improved since our evaluation.
Whether compelled to report by legal requirements or not, we hope Juul will consider setting a strong precedent for transparency in tobacco-industry e-cigarette research by adhering to global ethical standards [9] and reporting their full trial results for these, and future, trials to ClinicalTrials.gov and assuage any doubts about selective reporting of results or outcomes.
A brief review of this ‘Industry Watch’ article alleging heated tobacco product advertising through an earned media approach highlights significant methodological errors that are serious enough to invalidate the article’s conclusions, including its title. The authors allege that Philip Morris International (PMI) used the e-cigarette, or vaping, product use associated lung injury (EVALI) outbreak to promote IQOS in September 2019 and the weeks that followed. Using the authors’ own tool (TobaccoWatcher.org), we replicated their search strategy and revealed several fundamental and concerning errors in the authors’ analysis.
They report a rise in news stories mentioning IQOS on and after 25th September 2019, and falsely attribute this rise to an article published on our website on 24th September 2019, which they also falsely describe as a “press release”, despite it never being published through a press release distribution service. Our analysis shows that the authors failed to consider several confounding and unrelated events that caused the rise in news coverage of both IQOS and EVALI during the time period in question and which can be found by replicating the authors’ search strategy in TobaccoWatcher.org.
For example, on 25th September 2019, Philip Morris International (PMI) issued a single press release via Business Wire (1) entitled “Philip Morris International Inc. and Altria Group, Inc. End Merger Discussions” (PMI/Altria Annou...
A brief review of this ‘Industry Watch’ article alleging heated tobacco product advertising through an earned media approach highlights significant methodological errors that are serious enough to invalidate the article’s conclusions, including its title. The authors allege that Philip Morris International (PMI) used the e-cigarette, or vaping, product use associated lung injury (EVALI) outbreak to promote IQOS in September 2019 and the weeks that followed. Using the authors’ own tool (TobaccoWatcher.org), we replicated their search strategy and revealed several fundamental and concerning errors in the authors’ analysis.
They report a rise in news stories mentioning IQOS on and after 25th September 2019, and falsely attribute this rise to an article published on our website on 24th September 2019, which they also falsely describe as a “press release”, despite it never being published through a press release distribution service. Our analysis shows that the authors failed to consider several confounding and unrelated events that caused the rise in news coverage of both IQOS and EVALI during the time period in question and which can be found by replicating the authors’ search strategy in TobaccoWatcher.org.
For example, on 25th September 2019, Philip Morris International (PMI) issued a single press release via Business Wire (1) entitled “Philip Morris International Inc. and Altria Group, Inc. End Merger Discussions” (PMI/Altria Announcement). The release noted that “the companies have agreed to focus on launching IQOS in the U.S.” PMI is listed on the New York Stock Exchange and is therefore subject to the rules of the NYSE and the Securities and Exchange Commission, including requirements for the disclosure of material events such as the PMI/Altria Announcement. We estimate that during a date range similar to that used by the authors, of the total number of stories retrieved using the authors’ search terms, >85% were reporting on the above noted PMI/Altria Announcement. The authors failed to mention this and other confounders in their discussion.
The authors state that “the original PMI press release (sic) was republished (including editing or revisions to make the republication consistent with the publisher’s format) in 14 additional news outlets.” We performed a full text review of the 14 articles mentioned and of those that were still accessible, none mentioned IQOS. The authors’ conclusion that “PMI capitalised on EVALI by using an earned news media strategy to market their IQOS brand of heated tobacco for free across scores of news outlets that reached millions of readers. This marks the first known case where a tobacco company used the EVALI outbreak to promote tobacco products” is therefore completely unsupported by their own data.
These facts, and other errors detected in this article, were communicated to the authors on 23rd April 2021. In summary, we believe that the article is unreliable, and that urgent substantial revision or retraction is warranted to prevent other studies citing the currently published inaccuracies.
NOT PEER REVIEWED
The single-minded focus in this article that only multinational tobacco companies are to blame for the tobacco epidemic presents a narrow view of the problem and ultimately prevents formulation of effective interventions. It is also a uniquely western framing which does not apply to large swathes of the developing world where most tobacco users currently live.
In India for instance, home to the second largest population of tobacco users totaling nearly 270 million, industrially produced cigarettes form a small component of overall use, with hand-rolled bidis being far more widely used, and even more prevalent, comprising twice the number of smokers, is the smokeless form, khaini. Both bidis and khaini are produced by a largely unorganised sector and are not industrially made. This situation is mirrored across many countries in Asia and other parts of the developing world — where over 80% of tobacco users live and where 90% of tobacco cultivation is done.
Further, about half of the global tobacco trade is run by state-owned tobacco companies (SOTCs), and a majority of these nations are part of the FCTC protocol, yet continue to operate without focus or repercussions. The Indian state owns nearly a third of the cigarette monopoly. Despite this, it currently chairs WHO’s executive board.
Hence, to cast the tobacco crisis as industrially made and caused by multinational tobacco companies can’t be farther from the truth. While they h...
NOT PEER REVIEWED
The single-minded focus in this article that only multinational tobacco companies are to blame for the tobacco epidemic presents a narrow view of the problem and ultimately prevents formulation of effective interventions. It is also a uniquely western framing which does not apply to large swathes of the developing world where most tobacco users currently live.
In India for instance, home to the second largest population of tobacco users totaling nearly 270 million, industrially produced cigarettes form a small component of overall use, with hand-rolled bidis being far more widely used, and even more prevalent, comprising twice the number of smokers, is the smokeless form, khaini. Both bidis and khaini are produced by a largely unorganised sector and are not industrially made. This situation is mirrored across many countries in Asia and other parts of the developing world — where over 80% of tobacco users live and where 90% of tobacco cultivation is done.
Further, about half of the global tobacco trade is run by state-owned tobacco companies (SOTCs), and a majority of these nations are part of the FCTC protocol, yet continue to operate without focus or repercussions. The Indian state owns nearly a third of the cigarette monopoly. Despite this, it currently chairs WHO’s executive board.
Hence, to cast the tobacco crisis as industrially made and caused by multinational tobacco companies can’t be farther from the truth. While they have a share of the blame, such a construct fails to recognise the ground reality experienced by most of the world’s tobacco users, diverts attention from drawing up effective policies and shields some of the biggest contributors to the problem.
NOT PEER REVIEWED
If PMI attempted to profit from the “EVALI” scaremongering they could only do so because of the blatantly dishonest reporting of that issue by federal authorities, activist academics, tobacco control organisations and the media who quote them with question. It was obvious as early as August 2019 that the lung injuries were caused by black market THC cartridges cut with vitamin E acetate and not nicotine containing e-cigarettes and the CDC eventually came to the same conclusion. Yet activists in positions of authority continue to link the injuries with nicotine vaping, thus providing a fertile ground of misinformation in which such marketing campaigns can flourish.
NOT PEER REVIEWED
Ruth Malone's pursuit of common ground in the tobacco control and broader public health communities is most welcome. As I emphasize in a new commentary that has received wide circulation (https://drive.google.com/file/d/1C1nk1XEZ8WhnOXtCGTqHdeqomc9HOuko/view), we must collectively climb out of our bunkers, come to the table and genuinely work together. Everyone, on all sides of the concurrent debates over tobacco harm reduction and protecting youth must stop skirting the truth when it feels inconvenient and open our minds and ears to all of the science that is before us, while discouraging and abandoning studies and pronouncements that are demonstrably biased or inadequate. We must move beyond the adversarial nature of the debate and transparently acknowledge areas of ambiguity or concern.
Combating the smoking epidemic is a social justice issue, as too little attention is now being given in many places, including the U.S., to prioritizing the importance of promoting adult smoking cessation and, for those adults addicted to smoking who cannot or are unwilling to quit nicotine -- many of whom are socially marginalized, poor, less educated, experience serious mental health conditions, or are members of the military or veterans -- helping them switch to less-hazardous, noncombustible forms of nicotine.
Regardless of ideology and policy preferences, we...
NOT PEER REVIEWED
Ruth Malone's pursuit of common ground in the tobacco control and broader public health communities is most welcome. As I emphasize in a new commentary that has received wide circulation (https://drive.google.com/file/d/1C1nk1XEZ8WhnOXtCGTqHdeqomc9HOuko/view), we must collectively climb out of our bunkers, come to the table and genuinely work together. Everyone, on all sides of the concurrent debates over tobacco harm reduction and protecting youth must stop skirting the truth when it feels inconvenient and open our minds and ears to all of the science that is before us, while discouraging and abandoning studies and pronouncements that are demonstrably biased or inadequate. We must move beyond the adversarial nature of the debate and transparently acknowledge areas of ambiguity or concern.
Combating the smoking epidemic is a social justice issue, as too little attention is now being given in many places, including the U.S., to prioritizing the importance of promoting adult smoking cessation and, for those adults addicted to smoking who cannot or are unwilling to quit nicotine -- many of whom are socially marginalized, poor, less educated, experience serious mental health conditions, or are members of the military or veterans -- helping them switch to less-hazardous, noncombustible forms of nicotine.
Regardless of ideology and policy preferences, we must at the very least tell the public as well as health care practitioners the truth about nicotine. That means that all of the major national and international messengers in this area -- NGOs and government, alike -- should do everything possible to educate the world about the continuum of risk of nicotine products, as clearly described by the U.S. Food and Drug Administration in its comprehensive plan released in July 2017, and not sweepingly demonize nicotine, which devastatingly causes widespread dependence on cigarettes but itself does not cause the illnesses suffered by the users of tobacco and is, in fact, a drug approved by the FDA as being safe and effective when used for smoking cessation.
We won’t come together if we don’t come together with openness, honesty and integrity. The time for that is now.
NOT PEER REVIEWED
Professor Malone’s call for a better understanding of the context of the tobacco epidemic is timely. For tobacco as for sugar and alcohol, the extent of population harm is linked to the historic growth of an oligopoly which has used economies of scale, aggressive sales tactics and ingredient modification to transform commodities into highly-processed, convenient and affordable artefacts1-3. At a time when the pandemic has brought the role of governments in protecting the public into greater focus, the implementation of market restrictions which we know to be effective in reducing demand (higher tax, minimum price, minimum pack size)4 should receive a new impetus.
Professor Malone’s call to unite opponents and proponents of ‘newer and novel nicotine and tobacco products’ (NNNTPs) around opposition to the tobacco industry should be heeded. Imperial Brands’s recent decision to turn back to ‘neglected’ cigarettes after being ‘overly focused’ on alternative nicotine products shows that profits, not smokers’ lives, will always be the tobacco companies’ priority5. The enormous influence exercised by the tobacco industry over governments worldwide is perhaps the most pressing tobacco control issue today, with countries including the US continuing to score highly on the Global Index of Tobacco Industry Interference6.
As to whether NNNTPs represent a ‘breakthrough’, it is not so much the products themselves that are disruptive, but rather the...
NOT PEER REVIEWED
Professor Malone’s call for a better understanding of the context of the tobacco epidemic is timely. For tobacco as for sugar and alcohol, the extent of population harm is linked to the historic growth of an oligopoly which has used economies of scale, aggressive sales tactics and ingredient modification to transform commodities into highly-processed, convenient and affordable artefacts1-3. At a time when the pandemic has brought the role of governments in protecting the public into greater focus, the implementation of market restrictions which we know to be effective in reducing demand (higher tax, minimum price, minimum pack size)4 should receive a new impetus.
Professor Malone’s call to unite opponents and proponents of ‘newer and novel nicotine and tobacco products’ (NNNTPs) around opposition to the tobacco industry should be heeded. Imperial Brands’s recent decision to turn back to ‘neglected’ cigarettes after being ‘overly focused’ on alternative nicotine products shows that profits, not smokers’ lives, will always be the tobacco companies’ priority5. The enormous influence exercised by the tobacco industry over governments worldwide is perhaps the most pressing tobacco control issue today, with countries including the US continuing to score highly on the Global Index of Tobacco Industry Interference6.
As to whether NNNTPs represent a ‘breakthrough’, it is not so much the products themselves that are disruptive, but rather the fact that the most popular product i.e. the electronic cigarette did not originate with the tobacco industry, and that independent, non-tobacco companies have carved out a significant, perhaps even the largest slice of the market 7. The independent sector is routinely underreported because it is made up of a multitude of small to medium-sized companies rather than a few big players8, and because of market analysts’ outdated reliance on sales data from tobacco retail outlets rather than specialist shops. As Professor Malone says, the world is changing; the need to implement the provisions of the Framework Convention on Tobacco Control is as pressing as ever, but to fight tobacco harm in the new nicotine landscape, we need to move on from a simplistic conflation of tobacco and NNNTP industries. More sophisticated research is required to discern and illuminate the various strategies being employed by both tobacco and non-tobacco industry players in promoting combusted, smokeless or new nicotine products in different national markets, and to tease out the implications for population health and regulatory regimes.
1. Mintz SW. Sweetness and power. New York: Viking; 1985.
2. Schudson M. The Emergence of New Consumer Patterns: the case of the cigarette. In: Miller D, ed. Consumption: critical concepts in the social sciences: Routledge; 2001: 475-501.
3. Benson P. Commentary: Biopolitical injustice and contemporary capitalism. American Ethnologist 2012; 39(3): 488-90.
4. World Health Organization. WHO Framework Convention on Tobacco Control. Geneva: WHO 2004.
5. Nilsson P. Imperial Brands turns focus back to tobacco. Financial Times. 2021 27 January 2021.
6. Assunta M. Global Tobacco Industry Interference Index 2020. Bangkok, Thailand: Global Center for Good Governance in Tobacco Control (GGTC), 2020.
7. Brown R. Scaring the Giants: Vaping Category Report 2020. The Grocer. 2020 14 February 2020.
8. Levy DT, Lindblom EN, Sweanor DT, et al. An Economic Analysis of the Pre-Deeming US Market for Nicotine Vaping Products. Tobacco Regulatory Science 2019; 5(2): 169-81.
NOT PEER REVIEWED
I appreciated the editorial by Ruth Malone on finding "common ground" on the topic of product regulation and more broadly the role of tobacco control. I would certainly agree that the current climate in smoking harm reduction has become toxic and emotional, non-scientific, and counterproductive to achieving the public health goal of reducing premature deaths caused by using smoked tobacco (i.e., mainly cigarettes). I also agree that the cigarette companies are likely using this as a wedge to advance their own financial interests - what else would you expect? I don't think anyone interested in public health is suggesting that we dismiss the past bad actions of the cigarette manufacturers, nor accept the claims of manufacturers of alternative nicotine products. Rather, we need to heed the lessons of the past so as not to make the same mistakes going forward. The United States, the Tobacco Control Act created a framework that should incentivize manufacturers to move away from profiting from the sale of cigarettes that causes so much harm to consumers. Promoting dialogue summits would allow for participants to engage in a civil manner, educate one another about challenges and opportunities and agree to specific measurable goals and objectives. Bringing stakeholders together will not resolve all differences but it will allow serious and responsible stakeholders the opportunity to bring ideas forward and find areas of common ground...
NOT PEER REVIEWED
I appreciated the editorial by Ruth Malone on finding "common ground" on the topic of product regulation and more broadly the role of tobacco control. I would certainly agree that the current climate in smoking harm reduction has become toxic and emotional, non-scientific, and counterproductive to achieving the public health goal of reducing premature deaths caused by using smoked tobacco (i.e., mainly cigarettes). I also agree that the cigarette companies are likely using this as a wedge to advance their own financial interests - what else would you expect? I don't think anyone interested in public health is suggesting that we dismiss the past bad actions of the cigarette manufacturers, nor accept the claims of manufacturers of alternative nicotine products. Rather, we need to heed the lessons of the past so as not to make the same mistakes going forward. The United States, the Tobacco Control Act created a framework that should incentivize manufacturers to move away from profiting from the sale of cigarettes that causes so much harm to consumers. Promoting dialogue summits would allow for participants to engage in a civil manner, educate one another about challenges and opportunities and agree to specific measurable goals and objectives. Bringing stakeholders together will not resolve all differences but it will allow serious and responsible stakeholders the opportunity to bring ideas forward and find areas of common ground that can more rapidly advance population health. As an example, issues and concerns related to adolescent use of tobacco and nicotine products should be a major topic of concern, not only by the public health and tobacco control communities but by federal, state, and local policy makers and regulators, parents and teachers, responsible retailers and distributers, and many of those associated with the manufacturing businesses. While many stakeholders share common ground in this area, the polarizing and media driven approach that has been taken over the last several years has caused what has become a war of rhetoric, with a lot of finger pointing and a failure to bring interested parties together to discuss how to collectively deal with the issue and find workable solutions to protect youth while allowing smokers to have access to cleaner alternative nicotine products. It is often said that it should be good science that drives the implementation of sound policies. However, I fear that is not happening today. Finding "common ground" will be impossible so long as there remains an unwillingness to support civil dialogue on issues of smoking harm reduction. I hope that public health/ medial organizations like WHO, ACS, FDA, CDC and others will do more to facilitating real and open dialogue on how to accelerate a reduction of smoking caused disease and death than has been the case over the past decade.
NOT PEER REVIEWED
We thank Tobacco Control for the opportunity to respond to the comment above. Our study was obviously not looking into the harms of secondhand aerosol from e-cigarettes (SHA). Our paper departs from previous compelling research on the harms of SHA and assesses the prevalence and duration of such exposure among e-cigarette non-users, i.e., bystanders who are potentially exposed to the aerosols emitted by e-cigarette users.
Firstly, it is clear that we conducted the study on the basis of knowledge that bystanders were involuntarily exposed to potentially hazardous SHA in many places. We have clearly mentioned the growing evidence that supports our assertion about the potential harms of SHA in the Introduction and Discussion sections of the paper. SHA contains many toxicants, including nicotine, particulate matter and carcinogens (e.g., volatile organic compounds, polycyclic aromatic hydrocarbons, formaldehyde, acetaldehyde and tobacco specific nitrosamines-TSNAs). As mentioned, this evidence comes from previous scientific research (please, foresee the references 11 to 14 of our paper). Of special interest, fine particulate matter (PM2.5) concentration increased during e-cigarette use sessions with human volunteers in settings such as a room[1–3], during vapers’ conventions[4,5], and in vape shops and their neighbouring businesses[6]. Some TSNAs, such as N-nitrosonornicotine and nicotine-derived nitrosamine ketone, which are carcinogenic[7], hav...
NOT PEER REVIEWED
We thank Tobacco Control for the opportunity to respond to the comment above. Our study was obviously not looking into the harms of secondhand aerosol from e-cigarettes (SHA). Our paper departs from previous compelling research on the harms of SHA and assesses the prevalence and duration of such exposure among e-cigarette non-users, i.e., bystanders who are potentially exposed to the aerosols emitted by e-cigarette users.
Firstly, it is clear that we conducted the study on the basis of knowledge that bystanders were involuntarily exposed to potentially hazardous SHA in many places. We have clearly mentioned the growing evidence that supports our assertion about the potential harms of SHA in the Introduction and Discussion sections of the paper. SHA contains many toxicants, including nicotine, particulate matter and carcinogens (e.g., volatile organic compounds, polycyclic aromatic hydrocarbons, formaldehyde, acetaldehyde and tobacco specific nitrosamines-TSNAs). As mentioned, this evidence comes from previous scientific research (please, foresee the references 11 to 14 of our paper). Of special interest, fine particulate matter (PM2.5) concentration increased during e-cigarette use sessions with human volunteers in settings such as a room[1–3], during vapers’ conventions[4,5], and in vape shops and their neighbouring businesses[6]. Some TSNAs, such as N-nitrosonornicotine and nicotine-derived nitrosamine ketone, which are carcinogenic[7], have been identified in e-cigarette aerosol (reference 12 of our paper). Airborne nicotine concentration was found to increase after e-cigarette use in an experimental study in a room[1], in an observational study conducted in users’ and non-users’ homes (reference 13 of our paper), and in a study of vapers’ conventions[8]. Also, nicotine in SHA was found to be systematically absorbed by bystanders at levels comparable to secondhand tobacco smoke (references 10 and 42 of our paper), which is worrisome. Additionally, SHA may cause reduced lung function and asthma exacerbations among non-users exposed to it (references 15 and 16). Unfortunately, we are unable to review the study conducted by the California Department of Public Health that was mentioned in the comment, as the source is a blogsite without any specific reference to the scientific publication. Personal blogsites tend to be subjective and are dominantly used to express the bloggers’ personal views, even when these blogsites are maintained by academics. It is worth mentioning, our work was published in a peer-reviewed journal, developed by a team of researchers devoted to public health, and, importantly, who have no conflict of interests.
Secondly, the evidence available at the time of the writing of our paper shows that e-cigarette use and seeing e-cigarette use may renormalise tobacco smoking, induce relapse to smoking among former smokers and trigger initiation of e-cigarette use among non-smokers, particularly young people, by decreasing the harm perception of e-cigarettes (references 17 to 21, and 57). This means the concern around SHA is not only about the air quality but also the social norm it might shape.
In conclusion, based on the evidence mentioned, we wanted to know to what extent e-cigarette exposure was perceived among the general population in European countries; consequently, our study estimates the prevalence of passive exposure to SHA from e-cigarettes. Perhaps the “fear” (we prefer to say “concern”) should exist for selling or using products that may harm the health of people who use them and bystanders who are involuntarily exposed to their aerosols. Based on our results, current evidence, and arguments previously discussed[9], we continue to believe that governments should include e-cigarettes use in smoke-free laws.
References mentioned in this response:
1 Schober W, Szendrei K, Matzen W, et al. Use of electronic cigarettes (e-cigarettes) impairs indoor air quality and increases FeNO levels of e-cigarette consumers. Int J Hyg Environ Health 2014;217:628–37. doi:10.1016/j.ijheh.2013.11.003
2 van Drooge BL, Marco E, Perez N, et al. Influence of electronic cigarette vaping on the composition of indoor organic pollutants, particles, and exhaled breath of bystanders. Environ Sci Pollut Res 2019;26:4654–66. doi:10.1007/s11356-018-3975-x
3 Volesky KD, Maki A, Scherf C, et al. The influence of three e-cigarette models on indoor fine and ultrafine particulate matter concentrations under real-world conditions. Environ Pollut 2018;243:882–9. doi:10.1016/j.envpol.2018.08.069
4 Chen R, Aherrera A, Isichei C, et al. Assessment of indoor air quality at an electronic cigarette (Vaping) convention. J Expo Sci Environ Epidemiol 2018;28:522–9. doi:10.1038/s41370-017-0005-x
5 Soule EK, Maloney SF, Spindle TR, et al. Electronic cigarette use and indoor air quality in a natural setting. Tob Control 2017;26:109–12. doi:10.1136/tobaccocontrol-2015-052772
6 Li L, Nguyen C, Lin Y, et al. Impacts of electronic cigarettes usage on air quality of vape shops and their nearby areas. Sci Total Environ 2021;760:143423. doi:10.1016/j.scitotenv.2020.143423
7 Hecht SS. Biochemistry, Biology, and Carcinogenicity of Tobacco-Specific N -Nitrosamines. Chem Res Toxicol 1998;11:559–603. doi:10.1021/tx980005y
8 Johnson JM, Naeher LP, Yu X, et al. A biomonitoring assessment of secondhand exposures to electronic cigarette emissions. Int J Hyg Environ Health 2019;222:816–23. doi:10.1016/j.ijheh.2019.04.013
9 Wilson N, Hoek J, Thomson G, et al. Should e-cigarette use be included in indoor smoking bans? Bull World Health Organ 2017;95:540–1. doi:10.2471/BLT.16.186536
NOT PEER REVIEWED
I wish to express my dismay with the clear and obvious intention to promote an agenda of fear. One might ask why you are not looking to see whether there actually are any harms from second hand aerosol as the study clearly acts upon a preface that this is the case. I would point you to the CDC's own testing of the air quality found here. Something smells a lot less like science and a lot more like virtue signalling funded by an agenda eager to skip the important part of knowing what you're dealing with before searching for potential victims. https://tobaccoanalysis.blogspot.com/2017/05/vape-shop-air-sampling-by-c...
NOT PEER REVIEWED
Thank you for the opportunity to clarify and correct some of the recent statements about our research article, ‘Exploring the Twitter activity around the eighth meeting of the Conference of the Parties to the WHO Framework Convention on Tobacco Control’.
Mr Sarangapani, Director of the Association of Vapers India (AVI), is incorrect in claiming that our article makes “false allegations” and “unsubstantiated claims”, and that it frames AVI as a tobacco industry (TI) front group. We categorise his organisation as a ‘next generation product (NGP) advocate’ and we state that AVI is a member of the International Network of Nicotine Consumer Organisations (INNCO). We also report that INNCO has received funding from the Foundation for a Smoke-Free World (FSFW),[1] which is an organisation that continues to be funded solely by Philip Morris International.[2] Thus, AVI is a member of an organisation that receives indirect funds from Philip Morris International, via the FSFW. Those statements are factual and substantiated; readers can locate further details and references to the FSFW’s grantees and tax returns via our Tobacco Tactics pages, as referenced in our article. In his letter, Mr Sarangapani points out that the Founder-Director of AVI is the current President of INNCO’s Governing Board; however, our research article makes no mention of that fact. We clearly state that: “We found no evidence that the individuals affiliated with INNCO or its mem...
NOT PEER REVIEWED
Thank you for the opportunity to clarify and correct some of the recent statements about our research article, ‘Exploring the Twitter activity around the eighth meeting of the Conference of the Parties to the WHO Framework Convention on Tobacco Control’.
Mr Sarangapani, Director of the Association of Vapers India (AVI), is incorrect in claiming that our article makes “false allegations” and “unsubstantiated claims”, and that it frames AVI as a tobacco industry (TI) front group. We categorise his organisation as a ‘next generation product (NGP) advocate’ and we state that AVI is a member of the International Network of Nicotine Consumer Organisations (INNCO). We also report that INNCO has received funding from the Foundation for a Smoke-Free World (FSFW),[1] which is an organisation that continues to be funded solely by Philip Morris International.[2] Thus, AVI is a member of an organisation that receives indirect funds from Philip Morris International, via the FSFW. Those statements are factual and substantiated; readers can locate further details and references to the FSFW’s grantees and tax returns via our Tobacco Tactics pages, as referenced in our article. In his letter, Mr Sarangapani points out that the Founder-Director of AVI is the current President of INNCO’s Governing Board; however, our research article makes no mention of that fact. We clearly state that: “We found no evidence that the individuals affiliated with INNCO or its member organisations were themselves funded by FSFW or by the TI directly” (p4). I acknowledge that on page 5 of the article, we have referred to AVI by their Twitter handle (vapeindia), as opposed to the organisation’s full name.
Mr Cullip’s interpretation of our article as a “smear” against vaping consumer advocates is an inaccurate representation of our research. As set out in our research objectives (p2), we examined the main themes and sentiment of tweets about WHO FCTC COP8, identified and classified the most active tweeters, explored how people who tweeted about COP8 engaged with one another and, lastly, explored the presence of TI links among the most active tweeters. Our article makes no statements that denigrate vapers’ opinions. Rather, we conclude there was an extensive online presence by Philip Morris International (PMI) executives, and by organisations and individuals funded directly and indirectly by PMI (e.g. Consumer Choice Center, Foundation for a Smoke-Free World, INNCO, Knowledge-Action-Change). We conclude that our findings are consistent with PMI’s 2014 corporate affairs strategy, which was leaked as part of an exposé by Reuters.[3] Far from being a “mythical tobacco industry plot” as Mr Cullip claims, PMI’s corporate affairs strategy described engaging tobacco harm reduction advocates to “amplify and leverage the debate on harm reduction” around events such as the WHO FCTC COP.[3]
Dr Gilchrist’s letter contains several inaccurate assertions. Our research does not “malign” either the individuals or the organisations that participated in the Twitter debate during COP8. We do not use the term “front group” in relation to any of the organisations supporting tobacco harm reduction referred to in our article. Nor do we imply that “any person or organisation who publicly supports tobacco harm reduction are paid to do so by the industry”. Our research article presents a factual account of the most common topics and sentiment of tweets that used #COP8FCTC, the categories of individuals and organisations tweeting, and their networks and patterns of engagement with one another. Around one-fifth of the most active tweeters were either tobacco companies, third-party organisations that have received direct tobacco industry funding, or employees of those organisations. We refer (accurately) to those tweeters as ‘tobacco industry actors’; we provide a detailed definition of our inclusion criteria and provide references to evidence tobacco industry funding. The only specific criticism Dr Gilchrist makes about our study is that we did not explore links between the most active tweeters and non-tobacco industry sources of funding. Given the irreconcilable conflict between the tobacco industry’s interests and tobacco control policy interests, and given tobacco companies’ repeated attempts to influence policy via third parties and intermediaries,[4] our focus on documenting tobacco industry involvement in FCTC debates is justified. Unlike tobacco companies, public health advocacy groups do not stand to generate or lose billions of dollars in profit as a result of decisions made at WHO FCTC COP. Neither do they have a history of obfuscating their funding sources.
Professor Stimson’s letter incorrectly states that we claim tobacco industry money is behind all the activity on Twitter by harm reduction advocates; in fact, on page 4 we state: “…for 23 of the 50 NGP [next generation product] advocates, we found no publicly available evidence of any link with the TI”. Professor Stimson is correct that we state: “…vaping consumer advocacy groups that receive TI funding are emerging and attempting to influence the WHO.” He insinuates this claim is unsubstantiated, yet we provide clear evidence that factasia.org and INNCO, each of whom describe themselves as a vaping consumer advocacy organisation, receive funding from PMI (directly and indirectly, respectively).[1,5] We do not claim TI links with national vaping advocacy groups and, as already noted, we state: “We found no evidence that the individuals affiliated with INNCO or its members organisations were themselves funded by FSFW or by the TI directly” (p4). As Professor Stimson points out, our article includes a paragraph where we report that a member of INNCO, ProVapeo Mexico, encouraged vapers to tweet during COP8. Professor Stimson interprets our research as “picking on” that organisation, yet we make no criticism of ProVapeo Mexico’s activities. Our article documents only the facts about the number of tweets using #COP8FCTC that appear to have been posted as a result of ProVapeo Mexico’s appeal.
In response to Julie Woessner’s letter, at no point does our article state that INNCO is a tobacco front group. As I note above, our article documents substantial activity on Twitter during COP8 both by PMI, and by organisations (and people affiliated with those organisations) that have received money from PMI either directly, or indirectly via the FSFW. We believe this activity is consistent with proposed actions laid out in PMI’s leaked 2014 corporate affairs strategy, which included plans to: “Establish the concept of harm reduction as legitimate public policy in tobacco regulation”, “Identify and engage non-traditional 3rd party stakeholders/allies (e-cigarette manufacturers and retailers, adult consumers of RRP products, tobacco harm reduction advocates…” and “Amplify and leverage the debate on harm reduction around global events (eg, COP6)”.[3] We believe our findings raise important questions about PMI’s claims of transformation, as the activity we have documented appears part of a long-standing corporate affairs plan. Our article presents the facts that some harm reduction-related organisations receive PMI (or FSFW) funds. We do not cast those funded organisations as “nefarious”.
Our research aims to increase transparency in tobacco control policy-making. Making known any links between tobacco companies and individuals and organisations that participate in tobacco control policy debates, even if those links are indirect and occur through intermediaries, is in the public interest and consistent with the principles of WHO FCTC Article 5.3.[6] Vapers who belong to INNCO-affiliated organisations are also entitled to know the network (or “umbrella organization”) to which their organisation belongs receives tobacco industry funding via the FSFW. It is encouraging therefore to observe that following our publication, INNCO appears to have added a statement declaring its FSFW funding onto its homepage (that development appears to have occurred between 1 and 16 November 2020).[7,8]
We are transparent about our research funders. The researchers working on this paper were funded by Bloomberg Philanthropies through the STOP initiative, and by Cancer Research UK; neither funder, nor any of the STOP partners, had any role in the research conceptualisation, study design, data collection, analysis, decision to publish, or preparation of the manuscript.
Lindsay Robertson, MPH, PhD
Conflict of Interest: None declared
NOT PEER REVIEWED
I am writing as co-founder of Pro-Vapeo Mexico, a non-profit consumer association affiliated with the International Network of Nicotine Consumer Organisations (INNCO), explicitly mentioned in the article “Exploring the Twitter activity around the eighth meeting of the Conference of the Parties to the WHO Framework Convention on Tobacco Control”. The authors of this article explicitly recognize that “We found no evidence that the individuals affiliated with INNCO or its member organizations were themselves funded by FSFW [Foundation for a Smoke Free World] or by the TI [Tobacco Industry] directly”. While this statement is correct, it still leaves missing information that we believe it is necessary and useful, for the benefit of your readers, to fully clarify: not only has Pro Vapeo Mexico never received any funding (direct or indirect) from any industry sector (tobacco, e-cigarettes or pharmaceutical) or from INNCO or the FSFW, we are a fully independent NGO whose activities are not (and have never been) directed by the TI or the FSFW or INNCO. Our affiliation with INNCO stems from its role as an umbrella organization grouping consumer associations worldwide united in advocating for Tobacco Harm Reduction, a strategy to improve global health by providing adult smokers the option to consume nicotine without having to inhale toxic cigarette smoke.
Regrettably, the authors of the above-mentioned article claim that our twitter activity in the...
NOT PEER REVIEWED
I am writing as co-founder of Pro-Vapeo Mexico, a non-profit consumer association affiliated with the International Network of Nicotine Consumer Organisations (INNCO), explicitly mentioned in the article “Exploring the Twitter activity around the eighth meeting of the Conference of the Parties to the WHO Framework Convention on Tobacco Control”. The authors of this article explicitly recognize that “We found no evidence that the individuals affiliated with INNCO or its member organizations were themselves funded by FSFW [Foundation for a Smoke Free World] or by the TI [Tobacco Industry] directly”. While this statement is correct, it still leaves missing information that we believe it is necessary and useful, for the benefit of your readers, to fully clarify: not only has Pro Vapeo Mexico never received any funding (direct or indirect) from any industry sector (tobacco, e-cigarettes or pharmaceutical) or from INNCO or the FSFW, we are a fully independent NGO whose activities are not (and have never been) directed by the TI or the FSFW or INNCO. Our affiliation with INNCO stems from its role as an umbrella organization grouping consumer associations worldwide united in advocating for Tobacco Harm Reduction, a strategy to improve global health by providing adult smokers the option to consume nicotine without having to inhale toxic cigarette smoke.
Regrettably, the authors of the above-mentioned article claim that our twitter activity in the period 9-18 October 2018 -somehow- proves our alleged participation in a lobbying effort coordinated by the TI to disrupt the COP-8 WHO-FCTC meeting taking place at the time. This is ludicrous. Our tweets do not prove this claim, but instead reveal our effort to mobilize our community of consumers to claim our right to attend and participate in that COP WHO-FCTC meeting as a legitimate part of the civil society. We were only protesting against the unjustified exclusion from this event of INNCO and its affiliated consumer associations under the false contention that we formed a TI front. In fact, we intend to keep protesting until our right to attend and participate in COP WHO-FCTC meetings as part of the civil society is fulfilled.
When doing scientific research, following the scientific method, you have a hypothesis (question) that you are going to investigate - in this case: Does xxx consumer organisation have any direct ties to tobacco companies that influence their advocacy?
After you have chosen your method, you then gather your evidence, make an objective analysis and state your findings and make a conclusion.
Your method SHOULD be thorough and your research should be objective in order to maintain the integrity of your research (and yourself). The evidence will either prove/disprove your original hypothesis.
Instead, the authors have chosen to not only demonise the participation of consumers in the narrative of their own health, one has lobbied false claims about tobacco industry connections that do not exist.
It is very concerning that the authors find it necessary to disenfranchise the very people who are fighting for their right to make informed choices about their health. It defies logic, and the principles of fairness and decency.
It perhaps would have been more helpful to all concerned if the authors had done due diligence beyond looking at a website that does not have verified information, to cast aspersions on consumer advocacy organisations.
It definitely would be more productive to welcome the voices of the people for whom felt impassioned enough to get involved in consumer advocacy to help smokers not only hav...
When doing scientific research, following the scientific method, you have a hypothesis (question) that you are going to investigate - in this case: Does xxx consumer organisation have any direct ties to tobacco companies that influence their advocacy?
After you have chosen your method, you then gather your evidence, make an objective analysis and state your findings and make a conclusion.
Your method SHOULD be thorough and your research should be objective in order to maintain the integrity of your research (and yourself). The evidence will either prove/disprove your original hypothesis.
Instead, the authors have chosen to not only demonise the participation of consumers in the narrative of their own health, one has lobbied false claims about tobacco industry connections that do not exist.
It is very concerning that the authors find it necessary to disenfranchise the very people who are fighting for their right to make informed choices about their health. It defies logic, and the principles of fairness and decency.
It perhaps would have been more helpful to all concerned if the authors had done due diligence beyond looking at a website that does not have verified information, to cast aspersions on consumer advocacy organisations.
It definitely would be more productive to welcome the voices of the people for whom felt impassioned enough to get involved in consumer advocacy to help smokers not only have the choices they need switch to less harmful alternative, but to be informed consumers of safer nicotine products.
NOT PEER REVIEWED
It is disappointing to see the BMJ publishing a research paper which smears consumer advocates for tobacco harm reduction by attempting to link consumer activity on social media with the tobacco industry. One can only conclude that the goal was to devalue the opinions of former smokers who have found safer nicotine products to have been beneficial to their lives.
I write as chair of the UK New Nicotine Alliance and as it is highly likely that tweets from our supporters have been included in this research, so we welcome the right to reply to the article.
The attempt to paint consumers as part of some mythical tobacco industry plot is offensive to individuals and organisations promoting tobacco harm reduction. We and our supporters, along with many other vapers, are systematically excluded from the FCTC conferences and yet have a strong stake in the outcomes of the meeting. Social media is one of the few opportunities we have to get our views across. Consumers of safer nicotine products have been acutely aware of an increasing warfare against the products which have helped them to stop smoking.
In 2018, there were clear threats being expressed by the WHO FCTC in advance of COP8 towards products that vaping consumers value highly for helping them to quit smoking. Many vapers travelled to Geneva in 2018 at their own expense, but as ‘members of the public’ were excluded from the meeting.
The article by Robertson et al was funded b...
NOT PEER REVIEWED
It is disappointing to see the BMJ publishing a research paper which smears consumer advocates for tobacco harm reduction by attempting to link consumer activity on social media with the tobacco industry. One can only conclude that the goal was to devalue the opinions of former smokers who have found safer nicotine products to have been beneficial to their lives.
I write as chair of the UK New Nicotine Alliance and as it is highly likely that tweets from our supporters have been included in this research, so we welcome the right to reply to the article.
The attempt to paint consumers as part of some mythical tobacco industry plot is offensive to individuals and organisations promoting tobacco harm reduction. We and our supporters, along with many other vapers, are systematically excluded from the FCTC conferences and yet have a strong stake in the outcomes of the meeting. Social media is one of the few opportunities we have to get our views across. Consumers of safer nicotine products have been acutely aware of an increasing warfare against the products which have helped them to stop smoking.
In 2018, there were clear threats being expressed by the WHO FCTC in advance of COP8 towards products that vaping consumers value highly for helping them to quit smoking. Many vapers travelled to Geneva in 2018 at their own expense, but as ‘members of the public’ were excluded from the meeting.
The article by Robertson et al was funded by Bloomberg Philanthropies: an organisation set up to distribute funds from an American multi-billionaire with antipathy to tobacco harm reduction.
In reality the article shows how successful THR consumer advocates are in dominating the Twittersphere around COP, and rightly so, because it is they are who are most affected by the outcome of COP meetings. Instead of attempting to denigrate these opinions, an altruistic approach would be to welcome the fact that consumers are engaging with the process and studying how consumer experience can help enhance public health outcomes. Sadly, this has not been considered by the authors of this report.
NOT PEER REVIEWED
Freedom of speech is a fundamental right in a free society. There is no justification to either interfere with the right of stakeholders to participate in the public debate regarding tobacco harm reduction policy, or to malign those that exercise that right. Given that the outcome of these policy discussions will affect the lives of more than one billion people on the planet who smoke, everyone must be free to advance arguments for and against any policy, and each argument must be scrutinized and evaluated on its evidence base and merits. Unfortunately, the recent paper in Tobacco Control—Exploring the Twitter activity around the eighth meeting of the Conference of the Parties to the WHO Framework Convention on Tobacco Control—missed the opportunity to do this.
Instead of engaging in a discussion on the key issues and arguments put forth in the public discussion around the eighth meeting of the Conference of the Parties (COP8), the authors employ diversionary ad hominem tactics. They mischaracterize Philip Morris International’s (PMI’s) legitimate participation in the public debate on the role that products with the potential to reduce the risk of harm compared to smoking can play in global public health policy. Using phrases like ‘tobacco industry actors’ and ‘front groups’ the authors falsely imply that any person or organization who publicly supports tobacco harm reduction are paid to do so by the tobacco industry, and specifically PMI....
NOT PEER REVIEWED
Freedom of speech is a fundamental right in a free society. There is no justification to either interfere with the right of stakeholders to participate in the public debate regarding tobacco harm reduction policy, or to malign those that exercise that right. Given that the outcome of these policy discussions will affect the lives of more than one billion people on the planet who smoke, everyone must be free to advance arguments for and against any policy, and each argument must be scrutinized and evaluated on its evidence base and merits. Unfortunately, the recent paper in Tobacco Control—Exploring the Twitter activity around the eighth meeting of the Conference of the Parties to the WHO Framework Convention on Tobacco Control—missed the opportunity to do this.
Instead of engaging in a discussion on the key issues and arguments put forth in the public discussion around the eighth meeting of the Conference of the Parties (COP8), the authors employ diversionary ad hominem tactics. They mischaracterize Philip Morris International’s (PMI’s) legitimate participation in the public debate on the role that products with the potential to reduce the risk of harm compared to smoking can play in global public health policy. Using phrases like ‘tobacco industry actors’ and ‘front groups’ the authors falsely imply that any person or organization who publicly supports tobacco harm reduction are paid to do so by the tobacco industry, and specifically PMI.
We fundamentally disagree with the authors’ approach. However, if they wish to pursue it in a robust way, we invite them to address an obvious inconsistency, and lack of rigor, in their present publication: the failure to explore the funding or linkages of individuals or organizations they deemed not to have tobacco industry links. By excluding this analysis, the authors have ignored the potential bias of almost one third of the Twitter accounts that they say engaged in the debate around COP8, including many who have links to their own funders (Bloomberg Philanthropies’ STOP: Stopping Tobacco Organizations and Products), and who have their own agendas (1-4) . Completing this analysis would be a useful way to shift from ad hominem attacks and move forward to a robust, science-based debate about tobacco harm reduction in the context of the next Conference of the Parties (COP9).
The importance of tobacco harm reduction policy to hundreds of millions of the world’s population means that it deserves a reasoned, fact-based dialogue between all parties, with science and consumers at the centre of discussion. It is legitimate to disagree, but ad hominem attacks have nothing to do with the argument at hand and simply serve to undermine progress. Dismissing views that differ from one’s own, or—worse still—attempting to intimidate dissenters into silence, will not move the debate forward. Emotions should not be allowed to dictate what and who does and does not get heard—truth and accuracy should be the only considerations.
For more than a decade, PMI has been at the forefront of researching, developing and scientifically assessing products that have the potential to reduce the risk of harm compared to smoking for adults who would otherwise continue to smoke. We are convinced that such products can contribute to improving public health. We are confident in the robustness of our scientific findings and the arguments in favor of tobacco harm reduction. We are proud of our scientists who have developed products that have the potential to reduce the risks of harm compared to smoking for those adults who do not quit. These products are precisely the ones which can make the policy of tobacco harm reduction work. We are open to discuss our strategies, actions and achievements with everyone who has a role to play in shaping public policy to reach better outcomes for men and women who smoke. If the authors of the recent paper—or anyone else—would like to engage in a factual discussion on the issues that really matter, we are ready and willing to debate with them.
(1) https://www.who.int/tobacco/about/partners/bloomberg/en/ (accessed 20 Nov 2020)
(2) https://www.fctc.org/about-us/ (accessed 23 Nov 2020)
(3) https://untobaccocontrol.org/kh/article-53/bloomberg-philanthropies-sele... (accessed 23 Nov 2020)
(4) https://www.tobaccofreekids.org/what-we-do/global/bloomberg (accessed 20 Nov 2020)
NOT PEER REVIEWED
It’s surprising finding oneself involuntarily part of a research study. Given no chance to contribute, perhaps I can offer privileged insight into the processes the authors seek to describe.
Analysis of tweets around the COP8 meeting show that nicotine consumer advocates were the most active, followed by public health advocates and the tobacco industry. My company – Knowledge Action Change – also tweeted, at the Geneva launch of our tobacco harm reduction report. [1] Tweeting by tobacco harm reduction advocates out-shadowed “official” FCTC messaging (and if the authors had searched #FCTCCOP8 and #COP8 as well as #COP8FCTC, they would have uncovered more).
The article asserts that tobacco industry money is behind this activity. But it is beyond this study’s narrow methodological reach to illuminate why nicotine consumer advocates tweet. My discussions with nicotine consumer advocates – the majority of whom are volunteers - demonstrate passionate interest in the policymaking that influences their lives. Having found safer alternatives to smoking, they fear that inappropriate regulation including bans will see their options disappear. They are frustrated that they are ignored by tobacco control policymakers, regulators and researchers. Barred from COP8 along with the public and press, consumer organisations are also barred from the NGO coalition Framework Convention Alliance. No other field of health policy excludes the affected. Consu...
NOT PEER REVIEWED
It’s surprising finding oneself involuntarily part of a research study. Given no chance to contribute, perhaps I can offer privileged insight into the processes the authors seek to describe.
Analysis of tweets around the COP8 meeting show that nicotine consumer advocates were the most active, followed by public health advocates and the tobacco industry. My company – Knowledge Action Change – also tweeted, at the Geneva launch of our tobacco harm reduction report. [1] Tweeting by tobacco harm reduction advocates out-shadowed “official” FCTC messaging (and if the authors had searched #FCTCCOP8 and #COP8 as well as #COP8FCTC, they would have uncovered more).
The article asserts that tobacco industry money is behind this activity. But it is beyond this study’s narrow methodological reach to illuminate why nicotine consumer advocates tweet. My discussions with nicotine consumer advocates – the majority of whom are volunteers - demonstrate passionate interest in the policymaking that influences their lives. Having found safer alternatives to smoking, they fear that inappropriate regulation including bans will see their options disappear. They are frustrated that they are ignored by tobacco control policymakers, regulators and researchers. Barred from COP8 along with the public and press, consumer organisations are also barred from the NGO coalition Framework Convention Alliance. No other field of health policy excludes the affected. Consumers use social media to speak out, asking others to do likewise. Picking on a tiny unfunded Mexican organisation for encouraging peers to tweet misunderstands how social media works: the FCA itself recently exhorted members to tweet in the week of the postponed COP9.
Prior assumptions about tobacco industry interference dominate this article (as with much of the Bath group’s work). The authors assert that ‘vaping consumer advocacy groups’ receive industry funding, but provide no evidence for this for any national or local group cited. Net result – the article both smears and further disempowers a disenfranchised population.
Do the authors apply their ‘theory of external influence’ to their own work? The Bath group shares over $20m from the anti-nicotine and anti-tobacco harm reduction Bloomberg Philanthropies. [2] Philanthro-capitalism comes with its own strings attached. [3]
Perhaps more productive would be social science insights into the views of consumer advocates and the narratives that both drive and divide a field in which all parties ostensibly share a common outcome - an end to smoking.
NOT PEER REVIEWED
We appreciate the authors’ concern about industry “astroturfing.” We believe astroturf activities undermine the genuine consumer movement that INNCO and its members represent. But the conclusions that the authors draw from their research are attenuated and inaccurate. In particular, we object strenuously to the authors’ conclusion that because INNCO has received funding from the Foundation for a Smoke-Free World (the Foundation), we are a tobacco front group.
INNCO was formed in 2016, a year before the Foundation was established. All of INNCO’s members are autonomous, independent consumer organisations, and with rare exception are run by volunteers on a shoe-string budget. These organisations joined forces to create INNCO, and they nominate and elect INNCO’s Governing Board members, who serve without compensation.
INNCO only accepts funding from sources where our independence as an organisation run by and for consumers is assured. INNCO operated for more than two years with only volunteer efforts and no funding. (Funding from the Foundation was received in December of 2018, which is after the period this paper covers.)
As the authors note, INNCO was formed in large part to ensure the consumer voice is heard on international platforms. However, we question the authors’ intent in casting our desire to engage as legitimate stakeholders as nefarious.
While the authors have cited numerous references on the motivations of t...
NOT PEER REVIEWED
We appreciate the authors’ concern about industry “astroturfing.” We believe astroturf activities undermine the genuine consumer movement that INNCO and its members represent. But the conclusions that the authors draw from their research are attenuated and inaccurate. In particular, we object strenuously to the authors’ conclusion that because INNCO has received funding from the Foundation for a Smoke-Free World (the Foundation), we are a tobacco front group.
INNCO was formed in 2016, a year before the Foundation was established. All of INNCO’s members are autonomous, independent consumer organisations, and with rare exception are run by volunteers on a shoe-string budget. These organisations joined forces to create INNCO, and they nominate and elect INNCO’s Governing Board members, who serve without compensation.
INNCO only accepts funding from sources where our independence as an organisation run by and for consumers is assured. INNCO operated for more than two years with only volunteer efforts and no funding. (Funding from the Foundation was received in December of 2018, which is after the period this paper covers.)
As the authors note, INNCO was formed in large part to ensure the consumer voice is heard on international platforms. However, we question the authors’ intent in casting our desire to engage as legitimate stakeholders as nefarious.
While the authors have cited numerous references on the motivations of the tobacco industry, they appear to not understand the tobacco harm reduction consumer space, relying solely on the previous work of their own organisation to draw inferences. Consumer advocates are passionate about alternatives that have helped them wean off smoking, and are committed to ensuring continued access for these potentially life-saving products.
Consumers are aligned with FCTC’s goals of mitigating tobacco-related death and disease, although our approach differs in that we reject prohibitionism and stigmatisation in favour of pragmatic, humane and ultimately more effective policies that recognise human rights and the agency of users to become proactive participants in improving their health. INNCO thus brings a unique, ear-to-the-ground perspective to tobacco control efforts, and should be welcomed as FCTC observers.
By encouraging governments, policymakers and others to view consumers and consumer groups as fronts for the tobacco industry, the authors deplatform and disenfranchise an already unfairly marginalised group. We urge the authors to consider the ethical implications of nudging decisionmakers to dismiss the consumer voice. This disregard of the most profoundly affected stakeholders occurs in no other health or policy arena.
NOT PEER REVIEWED
We object to the framing of Association of Vapers India (AVI), erroneously referred to as ‘Vape India’ in the paper, as a tobacco industry front group, without providing any basis for the claim except our membership of International Network of Nicotine Consumer Organisations (INNCO).
AVI was organised in August 2016, when consumers of low-risk alternatives came together to arrest the tide of state bans in India, which were being lobbied for by the Bloomberg Philanthropies network the authors belong to.[1] Though one of our directors is the current president of INNCO’s governing board, elected through a member vote in the 2020 General Assembly, he is serving in unpaid, honorary capacity.
AVI has not received funding from INNCO, nor from the Foundation for Smoke-free World (FSFW), and neither from the tobacco industry. Our work is financed through voluntary contributions, and like INNCO, the affairs are conducted by a governing board comprising unpaid consumer volunteers.
It is scurrilous to cast AVI as a tobacco industry group or anything other than a consumer-led movement that is seeking access to harm reduction avenues for India’s nearly 270 million tobacco users, among whom cancers are rising[2] even as most have meagre means to deal with the health consequences, which makes harm prevention a vital mitigation strategy. We are product agnostic and advocate access to lower-risk alternatives for both smokers and smokeless tobacco...
NOT PEER REVIEWED
We object to the framing of Association of Vapers India (AVI), erroneously referred to as ‘Vape India’ in the paper, as a tobacco industry front group, without providing any basis for the claim except our membership of International Network of Nicotine Consumer Organisations (INNCO).
AVI was organised in August 2016, when consumers of low-risk alternatives came together to arrest the tide of state bans in India, which were being lobbied for by the Bloomberg Philanthropies network the authors belong to.[1] Though one of our directors is the current president of INNCO’s governing board, elected through a member vote in the 2020 General Assembly, he is serving in unpaid, honorary capacity.
AVI has not received funding from INNCO, nor from the Foundation for Smoke-free World (FSFW), and neither from the tobacco industry. Our work is financed through voluntary contributions, and like INNCO, the affairs are conducted by a governing board comprising unpaid consumer volunteers.
It is scurrilous to cast AVI as a tobacco industry group or anything other than a consumer-led movement that is seeking access to harm reduction avenues for India’s nearly 270 million tobacco users, among whom cancers are rising[2] even as most have meagre means to deal with the health consequences, which makes harm prevention a vital mitigation strategy. We are product agnostic and advocate access to lower-risk alternatives for both smokers and smokeless tobacco users, adhering to harm reduction and human rights principles laid out in UN drug policies and in Article 1(d) of the FCTC charter.
We find these accusations especially mischievous in light of our Indian government owning a major 28% stake in the country’s cigarette monopoly and gaining directly from the e-cigarette ban,[3] despite which it was invited to chair COP8 proceedings, whereas consumer advocates, including from AVI, who were there to seek deliberations on their right to access lower-risk alternatives, and whom the FCTC policies affect most severely, were ousted after the plenary session on the pretext of preventing industry influence, left to protest outside the venue and use social media to make ourselves heard.
We strongly oppose this unfair application of Article 5.3 of FCTC which covets tobacco-trading governments but forcefully excludes consumers and attempts to delegitimize them under the garb of the same provision.
NOT PEER REVIEWED
Recent work from Ilies et al. (1) is very informative toward understanding the degree to which heated tobacco products might confer less health risk than combusted cigarettes. This publication extends well beyond the existing HTP emissions evidence base, much of which was not conducted by independent groups. The authors should be commended for leveraging strong methodology, and for their comprehensive evaluation of toxicants generated by these products.
While the methodology and results of this publication appear sound, there are a number of inaccurate claims that warrant criticism in the second paragraph of the Introduction section:
• The second paragraph discusses nicotine vaping products (e-cigarettes), however citation #2 (Centers for Disease Control and Prevention (CDC). Use of cigarettes and other tobacco products among students aged 13-15 years--worldwide, 1999-2005. MMWR Morb Mortal Wkly Rep 2006;55:553) utilize data from 1999 through 2005, which mostly spans a time frame prior to the invention of the first e-cigarette in 2004 (2), and certainly spans a timeframe prior to their widespread marketing in the United States. The citation follows the sentence “However, the death toll provoked by their [e-cigarettes] consumption has increased significantly, reaching 650,000 annually, and it is likely to rise over the coming year…” This citation is clearly inapplicable to the unfounded claim being made about deaths attributable to e-ci...
NOT PEER REVIEWED
Recent work from Ilies et al. (1) is very informative toward understanding the degree to which heated tobacco products might confer less health risk than combusted cigarettes. This publication extends well beyond the existing HTP emissions evidence base, much of which was not conducted by independent groups. The authors should be commended for leveraging strong methodology, and for their comprehensive evaluation of toxicants generated by these products.
While the methodology and results of this publication appear sound, there are a number of inaccurate claims that warrant criticism in the second paragraph of the Introduction section:
• The second paragraph discusses nicotine vaping products (e-cigarettes), however citation #2 (Centers for Disease Control and Prevention (CDC). Use of cigarettes and other tobacco products among students aged 13-15 years--worldwide, 1999-2005. MMWR Morb Mortal Wkly Rep 2006;55:553) utilize data from 1999 through 2005, which mostly spans a time frame prior to the invention of the first e-cigarette in 2004 (2), and certainly spans a timeframe prior to their widespread marketing in the United States. The citation follows the sentence “However, the death toll provoked by their [e-cigarettes] consumption has increased significantly, reaching 650,000 annually, and it is likely to rise over the coming year…” This citation is clearly inapplicable to the unfounded claim being made about deaths attributable to e-cigarette use.
• Citation #3 also supports claims about e-cigarette use, however the cited paper (Sinha DN, Kumar A, Bhartiya D, et al. Smokeless tobacco use among adolescents in global perspective. Nicotine Tob Res 2017;19:1395–6) references non-combusted tobacco products in general, as opposed to the many publications which have looked explicitly at e-cigarette use in a more comprehensive fashion. After reading the Sinha et al. research letter, I am not sure that e-cigarettes were considered at all.
• Citation #4 (US Department of Commerce CB. National cancer Institute and centers for disease control and prevention Co-Sponsored tobacco use supplement to the current population survey 2007) does not provide a direct link to any supporting data/publication. It appears the authors are generally referring to the 2006-2007 Tobacco Use Supplement to the Current Population Survey (CPS-TUS), which was conducted in April 2006, August 2006, and January 2007 (3). The first report of an e-cigarette being imported to the United States is from August 2006 (https://rulings.cbp.gov/ruling/M85579), and the 2006-2007 CPS-TUS did not include any survey items related to e-cigarettes. As such, there is no data from the 2006-2007 CPS-TUS that supports the claim “[e-cigarettes] are highly addictive and can cause serious health problems”.
• The claim “More than 30 carcinogenic compounds in high concentrations were identified, leading to severe health hazards such as oral, pharyngeal, oesophageal and pancreatic cancers” is unfounded, as there is no longitudinal data linking e-cigarettes and cancer to date, nor am I aware of evidence that over 30 carcinogenic compounds in “high concentrations” have been identified in any studies of e-cigarette emissions. Additionally, the provided citation (citation #5: Hatsukami D, Zeller M, Gupta P, et al. Smokeless tobacco and public health: a global perspective 2014) does not talk about e-cigarettes even once.
• Citation #6 (Gupta R, Gupta S, Sharma S, et al. Risk of coronary heart disease among smokeless tobacco users: results of systematic review and meta-analysis of global data. Nicotine and Tobacco Research 2019;21:25–31) also does not pertain to e-cigarettes at all, and the accompanying claim “Cardiovascular death risks and stillbirths were also shown to increase up to four times, signalling real concerns regarding human health safety” is baseless with respect to the epidemiological literature on e-cigarettes.
While these concerns do not directly impact the study results or conclusions, e-cigarettes have become a polarizing topic in the tobacco control community and beyond. As such, claims about e-cigarettes must be made with the utmost care, based on rigorous scientific evidence and sound, balanced interpretations of relevant findings. This publication will be read and cited many times over as heated tobacco products continue to proliferate in tobacco markets across the globe, making it that much more important to address these misleading, and at times, blatantly false claims.
References:
1. Ilies BD, Moosakutty SP, Kharbatia NM, et al. Identification of volatile constituents released from IQOS heat-not-burn tobacco HeatSticks
using a direct sampling method. Tobacco Control. Published Online First: 26 May 2020. doi: 10.1136/tobaccocontrol-2019-055521
2. Henningfield JE & Zaatari GS. Electronic nicotine delivery systems: emerging science foundation for policy. Tobacco Control
2010;19:89e90. doi:10.1136/tc.2009.035279
3. US Department of Commerce, Census Bureau (2006-2007). National Cancer Institute and Food and Drug Administration co-sponsored
Tobacco Use Supplement to the Current Population Survey. 2006-2007. https://cancercontrol.cancer.gov/brp/tcrb/tus-cps/
NOT PEER REVIEWED
The meta-analysis by Khouja et al. confirms the strong association in young people between e-cigarette use and subsequent smoking.[1] The critical issue is whether the relationship is causal. If there is a causal relationship, there are several factors which diminish its impact.
Firstly, most of the studies used ‘ever smoking’ as the outcome. Ever smoking is a poor marker for smoking-related harm as most smoking by vapers who later smoke is experimental and infrequent and few progress to established smoking (100+ lifetime cigarettes). Shahab et al. found that only 2.7% of youth who tried e-cigarettes first progressed to established smoking. Only established smoking is linked to significant smoking-related death and disease.[2]
Secondly, the absolute number of non-smokers who progress from vaping to smoking is small as smoking precedes vaping in the vast majority of cases (70-85%).[3] If there is a gateway from vaping to smoking, this only affects a minority of young vapers.
Thirdly, the authors use Bradford Hill’s dose-response and specificity criteria to assess whether the association between vaping and subsequent smoking is likely to be causal.
They acknowledge that the dose-response criterion is mostly based on nicotine dependence, indicating that that nicotine dependent vapers are more likely to progress to smoking. However, nicotine dependence in non-smoking vapers is rare, less than 4% in the 2018 National Youth T...
NOT PEER REVIEWED
The meta-analysis by Khouja et al. confirms the strong association in young people between e-cigarette use and subsequent smoking.[1] The critical issue is whether the relationship is causal. If there is a causal relationship, there are several factors which diminish its impact.
Firstly, most of the studies used ‘ever smoking’ as the outcome. Ever smoking is a poor marker for smoking-related harm as most smoking by vapers who later smoke is experimental and infrequent and few progress to established smoking (100+ lifetime cigarettes). Shahab et al. found that only 2.7% of youth who tried e-cigarettes first progressed to established smoking. Only established smoking is linked to significant smoking-related death and disease.[2]
Secondly, the absolute number of non-smokers who progress from vaping to smoking is small as smoking precedes vaping in the vast majority of cases (70-85%).[3] If there is a gateway from vaping to smoking, this only affects a minority of young vapers.
Thirdly, the authors use Bradford Hill’s dose-response and specificity criteria to assess whether the association between vaping and subsequent smoking is likely to be causal.
They acknowledge that the dose-response criterion is mostly based on nicotine dependence, indicating that that nicotine dependent vapers are more likely to progress to smoking. However, nicotine dependence in non-smoking vapers is rare, less than 4% in the 2018 National Youth Tobacco Survey (NYTS).[4]
They point out that studies with ‘negative control outcomes’ would reduce specificity but do not cite any studies to demonstrate this. A number of studies have found that vaping also predicts other risky behaviors such as alcohol, marijuana and other substance use.[5,6] There is no biologically plausible mechanism for e-cigarette use being a causal factor for these other behaviours. We think that, like smoking, these associations are best explained by a common liability.[7]
Finally, the recent study by Shahab et al. using NYTS data found that nicotine vaping appears to be protective against future smoking.[2] Teens who vaped first were significantly less likely to subsequently become established smokers than 1) those who smoked first and 2) a matched group of non-vapers.
Their findings suggest that, if there is a gateway from vaping to smoking it is very small and is outweighed by a much larger effect of diverting youth away from cigarette smoking.
References
1. Khouja JN, Suddell SF, Peters SE, et al. Is e-cigarette use in non-smoking young adults associated with later smoking? A systematic review and meta-analysis. Tobacco control 2020 doi: 10.1136/tobaccocontrol-2019-055433 [published Online First: 2020/03/12]
2. Shahab L, Beard E, Brown J. Association of initial e-cigarette and other tobacco product use with subsequent cigarette smoking in adolescents: a cross-sectional, matched control study. Tobacco control 2020 doi: 10.1136/tobaccocontrol-2019-055283
3. Berry KM, Reynolds LM, Collins JM, et al. E-cigarette initiation and associated changes in smoking cessation and reduction: the Population Assessment of Tobacco and Health Study, 2013-2015. Tobacco control 2018;28(1):42-49. doi: 10.1136/tobaccocontrol-2017-054108
4. West R, Brown J, Jarvis M. Epidemic of youth nicotine addiction? What does the National Youth Tobacco Survey reveal about high school ecigarette use in the USA? 2019 [Available from: https://www.qeios.com/read/article/391 accessed 24 February 2020.
5. Park E, Livingston JA, Wang W, et al. Adolescent E-cigarette use trajectories and subsequent alcohol and marijuana use. Addictive behaviors 2020;103:106213. doi: 10.1016/j.addbeh.2019.106213 [published Online First: 2019/12/22]
6. Rigsby DC, Keim SA, Adesman A. Electronic Vapor Product Usage and Substance Use Risk Behaviors Among U.S. High School Students. J Child Adolesc Psychopharmacol 2019;29(7):545-53. doi: 10.1089/cap.2019.0047 [published Online First: 2019/07/26]
7. Vanyukov MM, Tarter RE, Kirillova GP, et al. Common liability to addiction and "gateway hypothesis": theoretical, empirical and evolutionary perspective. Drug and alcohol dependence 2012;123 Suppl 1:S3-17. doi: 10.1016/j.drugalcdep.2011.12.018 [published Online First: 2012/01/21]
NOT PEER REVIEWED
Miech and colleagues demonstrate declines in prevalence of non-medical use of prescription drugs among US high school students and show that these declines can be explained by trends in cigarette smoking.1 These observations are taken as support of the gateway hypothesis in which cigarette smoking increases the likelihood of subsequent other drug use. The authors further argue that these results are inconsistent with a ‘common liability’ model, and that the common liability model predicts that adolescent drug use would have “stayed steady or even increased as adolescents continued to use these drugs regardless of whether they smoked.” In this scenario, adolescents with a predilection toward substance might substitute cigarettes with other drugs as smoking rates decline.
However, this conceptualization of the common liability model is inconsistent with how such models are typically understood. Models that posit a common liability do not assert that the degree of liability is fixed in the population, such that changes in risk for use of one drug increases risk for other drug use. Instead, common liability can be influenced by environmental factors and environmental changes can coherently impact multiple outcomes, resulting in trends similar to those observed by Miech and colleagues.
For over 40 years, Problem Behavior Theory has provided a comprehensive theory and empirical approach to common liability. “Problem behaviors” (later termed...
NOT PEER REVIEWED
Miech and colleagues demonstrate declines in prevalence of non-medical use of prescription drugs among US high school students and show that these declines can be explained by trends in cigarette smoking.1 These observations are taken as support of the gateway hypothesis in which cigarette smoking increases the likelihood of subsequent other drug use. The authors further argue that these results are inconsistent with a ‘common liability’ model, and that the common liability model predicts that adolescent drug use would have “stayed steady or even increased as adolescents continued to use these drugs regardless of whether they smoked.” In this scenario, adolescents with a predilection toward substance might substitute cigarettes with other drugs as smoking rates decline.
However, this conceptualization of the common liability model is inconsistent with how such models are typically understood. Models that posit a common liability do not assert that the degree of liability is fixed in the population, such that changes in risk for use of one drug increases risk for other drug use. Instead, common liability can be influenced by environmental factors and environmental changes can coherently impact multiple outcomes, resulting in trends similar to those observed by Miech and colleagues.
For over 40 years, Problem Behavior Theory has provided a comprehensive theory and empirical approach to common liability. “Problem behaviors” (later termed “risk behaviors”) can be modeled as a latent factor that predisposes an adolescent to use of multiple substances, delinquency, and other health risk behaviors.2,3 The latent factor is influenced by the environment at multiple levels. We rely on this framework in two recent papers that demonstrate that that US declines in tobacco use, other substance use, substance use disorders, delinquency, and sexual promiscuity among adolescents are consistent with a population-level reduction in a latent factor that predisposes to risk for all of these outcomes.4,5 Similarly, the externalizing spectrum of personality and psychopathology is postulated to arise from a common liability to multiple substance use and other disinhibitory disorders.6 Externalizing liability has been shown to change in response to specific environmental stressors such as minority stress and child maltreatment.7–10
Although common liability models do not invoke causal gateway effects, they are consistent with commonly observed gateway patterns, in which easily available drugs such as alcohol, cigarettes and marijuana are usually used prior to use of other drugs.5 Thus, trends observed by Miech and colleagues do not contradict the common liability model.
1. Miech R, Keyes KM, O’Malley PM, Johnston LD. The great decline in adolescent cigarette smoking since 2000: consequences for drug use among US adolescents. Tob Control. January 2020:tobaccocontrol-2019-055052.
2. Jessor R, Jessor SL. Problem Behavior and Psychosocial Development: A Longitudinal Study of Youth. Academic Press; 1977.
3. Jessor R. Risk behavior in adolescence: A psychosocial framework for understanding and action. Journal of adolescent Health. 1991;12(8):597-605.
4. Grucza RA, Krueger RF, Agrawal A, et al. Declines in prevalence of adolescent substance use disorders and delinquent behaviors in the USA: a unitary trend? Psychological Medicine. 2018;48(9):1494-1503.
5. Borodovsky JT, Krueger RF, Agrawal A, Grucza RA. A Decline in Propensity Toward Risk Behaviors Among U.S. Adolescents. Journal of Adolescent Health. 2019;65(6):745-751.
6. Krueger RF, Markon KE, Patrick CJ, Benning SD, Kramer MD. Linking antisocial behavior, substance use, and personality: an integrative quantitative model of the adult externalizing spectrum. J Abnorm Psychol. 2007;116(4):645-666.
7. Lehavot K, Simoni JM. The impact of minority stress on mental health and substance use among sexual minority women. Journal of Consulting and Clinical Psychology. 2011;79(2):159-170.
8. Eaton NR. Transdiagnostic psychopathology factors and sexual minority mental health: Evidence of disparities and associations with minority stressors. Psychology of Sexual Orientation and Gender Diversity. 2014;1(3):244-254.
9. Rodriguez-Seijas C, Stohl M, Hasin DS, Eaton NR. Transdiagnostic Factors and Mediation of the Relationship Between Perceived Racial Discrimination and Mental Disorders. JAMA Psychiatry. 2015;72(7):706.
10. Vachon DD, Krueger RF, Rogosch FA, Cicchetti D. Assessment of the Harmful Psychiatric and Behavioral Effects of Different Forms of Child Maltreatment. JAMA Psychiatry. 2015;72(11):1135.
NOT PEER REVIEWED
This is a well written original research about the burning issue of tobacco manufacturer lobbying. These manufacturing industries have developed strategies to undercut minimum price laws. By increasing tobacco taxes an effective policy has been designed to decrease tobacco use. In Pakistan currently, 209 million people smoke and about 83 billion cigarettes are smoked per year. As Pakistan has not ratified any anti-smoking policies, there should be great effort made to raise excise duties and taxes on tobacco companies to reduce the demand for cigarettes. In 2017 the local price of cigarettes was about 75 rupees of which half was excise duties [1].
With this expansion of taxes, there will be responses of reducing tobacco consumption, but the cigarette manufacturing industries developed specific promotions and lobbies to encourage their consumers to purchase lower taxed or lower priced tobacco products. It is the responsibility of health authorities to regulate the prices and promotion of such hazardous products [2]. According to WHO, “MPOWER” was the slogan in 2015, according to which M= monitor tobacco usage, P= Protect people from tobacco smoke, O= offering help to quit tobacco use, W= warning about its hazards, E= enforce to ban its advertisement, R = Raise tobacco taxes [3].
For smoke free Pakistan and all over the world four key factors should be instruments: Education, legislation, quitting support and financial policies.
NOT PEER REVIEWED
This is a well written original research about the burning issue of tobacco manufacturer lobbying. These manufacturing industries have developed strategies to undercut minimum price laws. By increasing tobacco taxes an effective policy has been designed to decrease tobacco use. In Pakistan currently, 209 million people smoke and about 83 billion cigarettes are smoked per year. As Pakistan has not ratified any anti-smoking policies, there should be great effort made to raise excise duties and taxes on tobacco companies to reduce the demand for cigarettes. In 2017 the local price of cigarettes was about 75 rupees of which half was excise duties [1].
With this expansion of taxes, there will be responses of reducing tobacco consumption, but the cigarette manufacturing industries developed specific promotions and lobbies to encourage their consumers to purchase lower taxed or lower priced tobacco products. It is the responsibility of health authorities to regulate the prices and promotion of such hazardous products [2]. According to WHO, “MPOWER” was the slogan in 2015, according to which M= monitor tobacco usage, P= Protect people from tobacco smoke, O= offering help to quit tobacco use, W= warning about its hazards, E= enforce to ban its advertisement, R = Raise tobacco taxes [3].
For smoke free Pakistan and all over the world four key factors should be instruments: Education, legislation, quitting support and financial policies.
1. Bate R. Large cigarette tax hikes, illicit producers, and organized crime: Lessons from Pakistan. AEI Paper & Studies. 2018 Jun 1:1.
2. Apollonio DE, Glantz SA. Tobacco industry promotions and pricing after tax increases: An analysis of internal industry documents.
3. World Health Organization. WHO report on the global tobacco epidemic 2015: raising taxes on tobacco. World Health Organization; 2015 Jul 31.
It should be noted that the Aspire Cleito coils used in this study have a manufacturer stated operating power range of between 55 and 75 watts. This is noted both on the box and laser etched into the side of the coil housing proper. it should be noted that the first data points in the graph ( to demonstrate the presence of CO in both liquid samples are in excess of the stated power range of the element.
"Strawnana" at 80 watts
"Black Ice" at 100 watts
This leads me to question the normalizing curve for the black ice sample as there are no data points in the graph (Figure 2) within the manufacturer noted operating range for that coil.
Furthermore, while this statement " ...though the bulk liquid temperature is controlled by boiling limits of the e-liquid component" would be accurate were the coil to be completely submerged in liquid, the mechanics of coil design will confound that principle. The resistance coils in electronic cigarettes are not, by design, submerged in liquid, they are in contact with a liquid saturated wick. Any heat energy applied to the coil whether in magnitude or duration, that exceeds the supply of liquid saturating the wick will result in a temperature spike which could cause the temperature to spike causing thermal degradation of what liquid does remain, and the singeing of the cotton wick.
It can be expected that where combustion occurs, carbon compounds will...
It should be noted that the Aspire Cleito coils used in this study have a manufacturer stated operating power range of between 55 and 75 watts. This is noted both on the box and laser etched into the side of the coil housing proper. it should be noted that the first data points in the graph ( to demonstrate the presence of CO in both liquid samples are in excess of the stated power range of the element.
"Strawnana" at 80 watts
"Black Ice" at 100 watts
This leads me to question the normalizing curve for the black ice sample as there are no data points in the graph (Figure 2) within the manufacturer noted operating range for that coil.
Furthermore, while this statement " ...though the bulk liquid temperature is controlled by boiling limits of the e-liquid component" would be accurate were the coil to be completely submerged in liquid, the mechanics of coil design will confound that principle. The resistance coils in electronic cigarettes are not, by design, submerged in liquid, they are in contact with a liquid saturated wick. Any heat energy applied to the coil whether in magnitude or duration, that exceeds the supply of liquid saturating the wick will result in a temperature spike which could cause the temperature to spike causing thermal degradation of what liquid does remain, and the singeing of the cotton wick.
It can be expected that where combustion occurs, carbon compounds will be present.
I would be interested in seeing the data sets to better understand exactly how far out of operating range CO began to manifest in the study.
The atomizer used for testing has a maximum rating of 80 watts.
200 watts was applied. Needless to say, horrible results occurred.
This is not reputable science, it is a failed experiment, it should never have been published.
Greetings –
We thank you for your response to our paper. We honor and acknowledge that there are more than 564 Tribal Nations and that each has their own name and language. In this article, we used the term “American Indian,” which was a decision guided by our long-standing work with cultural advisors in Minnesota. While we chose to use the term “American Indian,” we recognize that each Tribe and individual may prefer to use a different term. For additional context, please see another article titled “Why the World Will Never Be Tobacco-Free: Reframing “Tobacco Control” Into a Traditional Tobacco Movement,” available at https://www.ncbi.nlm.nih.gov/pmc/articles/PMC4984762/
Whilst it is true that Juul is not exactly popular with those on either side of the fence this article fails to address the major issue.
The impending regulation which Juul is said to have brought down on the vapor industry helps Juul by eliminating the competition. Only they, and other brands owned by tobacco companies have any hope of being able to afford the process to keep their products on the market. Independent manufacturers and the retailers who sell their products will simply be obliterated.
Considering that these are people who who have dedicated their lives and often their life savings to helping people switch to safer alternatives, and who are by far and away the most efficient at enforcing strict age verification for purchases, this is a tragedy, not something to be celebrated.
Lastly, as if it still needs to be said, the outbreak of acute lung injury in the US has not been linked with Juul, or any other commercially available nicotine vaping product.
I 100% understand the general good intent of this paper. I also must say that I am Cherokee but not "fullblooded" Cherokee. I did grow up in the heart of the Nation, though. However, could people please stop using the term "American Indian"? Indians are from India. Columbus got lost (even though he was a navigator), ran the one ship he captained aground where he was found by the Native population of the island he smashed into (which for the record was not anywhere near North America). He looked around and thought, "I'm on a beach, I was trying to find India, India has a beach. These people are not white, they are tan, Indians are tan! I'm in India!" He then spread his stupid to the world. Now every tan person originating from any American continent (which are when put together the same land mass as the entire "known" world at that time) are all Indians... Please stop. It's just offensive.
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.
NOT PEER REVIEWED
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.
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...
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.
NOT PEER REVIEWED
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.”...
NOT PEER REVIEWED
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.
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.
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
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
NOT PEER REVIEWED
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...
NOT PEER REVIEWED
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.
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...
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
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
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...
NOT PEER REVIEWED
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.
NOT PEER REVIEWED
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...
NOT PEER REVIEWED
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
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, 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 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.
NOT PEER REVIEWED
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.
NOT PEER REVIEWED
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.
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 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.
NOT PEER REVIEWED
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...
NOT PEER REVIEWED
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.
NOT PEER REVIEWED
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...
NOT PEER REVIEWED
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.
NOT PEER REVIEWED
We thank Dr. Jarvis for his appreciation of our historical scholarship but disagree that our conclusion, “the promotion of tobacco harm reduction may serve the interests of tobacco companies more effectively than the public,” is an attack.
Our paper is about how policy affects ideas and vice versa. The ideas guiding the product modification program led to bad outcomes. That these ideas have been reanimated merits critical assessment. Voluntary agreements led to industry influence over the ISCSH’s recommendations, which in turn undermined public health. We point out that some of the same premises that led the ISCSH astray are popular again. Jarvis claims that current UK harm reduction policy has nothing to do with the product modification program, and everything to do with the influence of the late Michael Russell. Russell’s impressive scholarship – and oft-quoted statement, “people smoke for the nicotine, but die from the tar” – is indeed hugely influential among proponents of tobacco harm reduction. Jarvis posits that Russell’s work serves as a “paradigm shift” on which the UK’s current embrace of long-term nicotine maintenance and tobacco harm reduction actually rests, and which severs any link between the failures of product modification and widespread fears of a redux today.
Yet Russell’s work represents more a variation in theme than it does revolution in content. Russell’s policy recommendations operate from the same premises a...
NOT PEER REVIEWED
We thank Dr. Jarvis for his appreciation of our historical scholarship but disagree that our conclusion, “the promotion of tobacco harm reduction may serve the interests of tobacco companies more effectively than the public,” is an attack.
Our paper is about how policy affects ideas and vice versa. The ideas guiding the product modification program led to bad outcomes. That these ideas have been reanimated merits critical assessment. Voluntary agreements led to industry influence over the ISCSH’s recommendations, which in turn undermined public health. We point out that some of the same premises that led the ISCSH astray are popular again. Jarvis claims that current UK harm reduction policy has nothing to do with the product modification program, and everything to do with the influence of the late Michael Russell. Russell’s impressive scholarship – and oft-quoted statement, “people smoke for the nicotine, but die from the tar” – is indeed hugely influential among proponents of tobacco harm reduction. Jarvis posits that Russell’s work serves as a “paradigm shift” on which the UK’s current embrace of long-term nicotine maintenance and tobacco harm reduction actually rests, and which severs any link between the failures of product modification and widespread fears of a redux today.
Yet Russell’s work represents more a variation in theme than it does revolution in content. Russell’s policy recommendations operate from the same premises as the ISCSH. While Russell criticized the ISCSH for its discount of compensation, (which he believed medium- high- nicotine cigarettes could help remedy) the same foundations appear in his recommendations: reduced toxicity is reduced risk, (1) collaboration with the tobacco industry doesn’t influence outcomes, (2) nicotine addiction is inevitable, (3) and products must be popular to curtail use. (4)
We caution that enthusiasm for the tantalizing fantasy of reduced risk products and tobacco industry resources may lead us to readopt the premises promoted by the tobacco industry for decades.
In their response, Drs. Britton and O’Connor implore public health to promote evidence-based tobacco harm reduction. We could not agree more.
1. The Lancet. Nicotine Use After the Year 2000. Lancet. 1991; 337: 1191-2.
2. Russell M. Conversation with Michael AH Russell. Addiction (Abingdon, England). 2004; 99: 9-19.
3. Jarvis M and Russell M. Comment on the Hunter Committee's second report. British medical journal. 1980; 280: 994.
4. Russell M. The future of nicotine replacement. British Journal of Addiction. 1991; 86: 653-8.
NOT PEER REVIEWED Martin Jarvis is right to describe the Hunter Committee era as “a sorry tale” that by and large is well told by Elias and Ling, but his assertion that “taken as a whole their paper reads more as an attack on current UK policy than as a scholarly contribution to the history of tobacco control” is way over the top, as is his criticism of “the editorial processes and decision-making of Tobacco Control”.
In a paper that runs to a little over five pages of text, there are very brief references to current policies on the first page, then further brief references towards the end, suggesting that there are lessons to be drawn from the earlier episodes.
The paper might indeed have expanded further on the industry-friendly record of the Hunter Committee, noting that after his term as Chairman of the Committee ended, Lord Hunter became a consultant for Imperial Tobacco, while a civil servant who worked on smoking and serviced the Hunter Committee went on to work for Gallahers. It might also have included more emphasis on the way tobacco substitutes dominated public discourse on tobacco policy issues during the 1970s (1), although in fairness to the authors they appear to have been misled by the re-writing of history evident in some of the material they cite, particularly from industry actors.
But this would simply have added more weight to the conclusion that during the 1970s discussion, debate and massive promotion of tobacco substitutes by t...
NOT PEER REVIEWED Martin Jarvis is right to describe the Hunter Committee era as “a sorry tale” that by and large is well told by Elias and Ling, but his assertion that “taken as a whole their paper reads more as an attack on current UK policy than as a scholarly contribution to the history of tobacco control” is way over the top, as is his criticism of “the editorial processes and decision-making of Tobacco Control”.
In a paper that runs to a little over five pages of text, there are very brief references to current policies on the first page, then further brief references towards the end, suggesting that there are lessons to be drawn from the earlier episodes.
The paper might indeed have expanded further on the industry-friendly record of the Hunter Committee, noting that after his term as Chairman of the Committee ended, Lord Hunter became a consultant for Imperial Tobacco, while a civil servant who worked on smoking and serviced the Hunter Committee went on to work for Gallahers. It might also have included more emphasis on the way tobacco substitutes dominated public discourse on tobacco policy issues during the 1970s (1), although in fairness to the authors they appear to have been misled by the re-writing of history evident in some of the material they cite, particularly from industry actors.
But this would simply have added more weight to the conclusion that during the 1970s discussion, debate and massive promotion of tobacco substitutes by tobacco companies succeeded in hijacking the tobacco public policy and media agenda, and diverted the government of the day from evidence-based approaches recommended by health authorities to reduce smoking. Elias and Ling have good reason to suggest that there are similarities between then and now.
In passing, Jarvis’s summary that the novel products of the day failed “because consumers rejected them” omits much. One important reason for the failure of tobacco substitutes was that industry rhetoric and hype to the contrary, there was ultimately justifiable concern, with concomitant media coverage, that “all the generally available brands contained 75 per cent tobacco, and were no more than additions to the low and low-to-middle tar range” (1). Indeed, it would have been quite possible for smokers switching to part-substitute brands to find themselves moving to higher tar products.
But before this message hit, there had been a mountain of industry-generated publicity promoting the notion that “safer” and (as inevitably reported) “safe” new brands were on the way. This approach was supported with public relations ploys such as an Imperial Tobacco press conference about part-substitute cigarettes the day after the launch of the 1977 Royal College of Physicians’ “Smoking Or Health” report. Not surprisingly, the tobacco trade press was quick to congratulate the company concerned on its success in diluting the impact of the College report.
1. Daube M. The politics of smoking: thoughts on the Labour record. Community Medicine. 1979; 1, 306-314
NOT PEER REVIEWED
Elias & Ling throw useful light on the slow-motion disaster that was the series of voluntary agreements begun in the 1970s between government and the tobacco industry in the UK, overseen by the Independent Scientific Committee on Smoking and Health (ISCSH). These had as their aim to address the issue of tobacco product modification to reduce the health risks of smoking. Industry produced new smoking materials with the aim of reducing the biological activity of the tar fraction of smoke from cigarettes, and agreed to a programme of gradual tar yield reduction across the years. The novel products failed because consumers rejected them (there were too few users even to recruit for trials to examine their potential benefits), and the reductions in machine-smoked tar yields were achieved largely through increasing filter ventilation. The material cited shows that the low tar programme fiasco was characterized by undue influence from tobacco industry and a complete lack of understanding of the dynamics of smoking behaviour on the part of the scientific experts charged by government with supervision of the programme.
This is a sorry tale from the early days of tobacco control, and Elias & Ling tell it well. So far so good. But in framing and interpreting their material they go well beyond the data they cite, and draw quite unwarranted conclusions about what they see as the deficiencies of the current UK harm reduction policy. Indeed, tak...
NOT PEER REVIEWED
Elias & Ling throw useful light on the slow-motion disaster that was the series of voluntary agreements begun in the 1970s between government and the tobacco industry in the UK, overseen by the Independent Scientific Committee on Smoking and Health (ISCSH). These had as their aim to address the issue of tobacco product modification to reduce the health risks of smoking. Industry produced new smoking materials with the aim of reducing the biological activity of the tar fraction of smoke from cigarettes, and agreed to a programme of gradual tar yield reduction across the years. The novel products failed because consumers rejected them (there were too few users even to recruit for trials to examine their potential benefits), and the reductions in machine-smoked tar yields were achieved largely through increasing filter ventilation. The material cited shows that the low tar programme fiasco was characterized by undue influence from tobacco industry and a complete lack of understanding of the dynamics of smoking behaviour on the part of the scientific experts charged by government with supervision of the programme.
This is a sorry tale from the early days of tobacco control, and Elias & Ling tell it well. So far so good. But in framing and interpreting their material they go well beyond the data they cite, and draw quite unwarranted conclusions about what they see as the deficiencies of the current UK harm reduction policy. Indeed, taken as a whole, their paper reads more as an attack on current UK policy than as a scholarly contribution to the history of tobacco control. Current policy, which had its beginnings some 20 years or more later, is painted as being an outgrowth of the low tar programme and as being similarly tainted with industry influence. It reflects no credit on the editorial processes and decision making of Tobacco Control that authors were permitted to get away with such unsupported conclusions in their published paper.
The idea that reduction in tar yield of cigarettes could be an effective way of reducing the health risks of smoking goes back to the 1960s at least. It was supported by many distinguished epidemiologists, including Doll, Peto, and Wynder. See for example this 1979 statement by Ernst Wynder: ““One of the things that has always appealed to me about science is that if I find something that makes biological sense, then I feel reassured. Thirty years ago, when we had a 40mg tar cigarette, if you smoked 30 cigarettes a day you were exposed to about 1200 mg tar a day. Today’s cigarettes have 20 mg tar, so you are exposed to 600 mg daily. If there’s one thing everybody can agree on, it is that all tobacco-related cancers are dose related.” (1)
What was lacking in this formulation was an understanding that the risk from products is not simply determined by their composition, but resides in the interaction between the user and the product – as Michael Russell pointed out, if tar yield was everything, the most dangerous product would be the large Cuban cigar (1).
Russell was an outspoken critic of the ISCSH’s record. In a 1980 comment on the committee’s second report (2) he noted “Most of all it [the report] is remarkable for the stunning naivety of its implicit model of smoking behaviour”. He pointed out that: “Lower risk cigarettes are equated with cigarettes with lower tar and nicotine yields. If people smoked cigarettes in the same way that smoking machines do, this would indeed be the case. But there is much evidence that they do not….The tendency for smokers to regulate their smoke intake has been ignored by the Hunter Committee”.
Russell was not a member of the ISCSH (indeed, the membership of the committee was heavily tilted towards epidemiology and toxicology, and included no behavioural science expertise). It is in Russell’s insights and policy prescriptions that we can see the real intellectual underpinnings of UK policy on harm reduction in recent years.
Russell had a number of key insights, the most fundamental of which is that people smoke for nicotine (3). This coupled with the observation that the harms of smoking come not from the drug people are seeking, but from contaminants of the delivery system used to obtain it, led to his dictum “People smoke for the nicotine, but die from the tar”. As early as the mid-1970s he began to advocate an approach to tobacco harm reduction that was based on an appreciation of nicotine’s role (4, 5). He was the first to expose the fallacy of low tar cigarettes (6) and the first to explore the potential of non-combustible nicotine products for harm reduction (7-9). His 1991 paper in the British Journal of Addiction (10) and editorial in The Lancet (11) set out a vision for a transformed nicotine market: “If a strategy were adopted to sanction and encourage the use of purified nicotine products as substitutes for smoking, and at the same time impose stringent regulations on permissible constituents of cigarette smoke …….. the virtual elimination of smoking could become a more realistic health promotion target” (11). This represents a paradigm shift from the failed approach adopted in the 1970s. How it, or something springing from it, became a part of UK tobacco control policy in recent years, is a story for others to tell. But it did not happen through tobacco industry influence.
References
1. Gori GB, Bock FG. Banbury Report 3: A Safe Cigarette? Cold Spring Harbor Laboratory; 1980.
2. Jarvis MJ, Russell MAH. Comment on the Hunter Committee's second report. British Medical Journal. 1980;5; 280(6219):994-5.
3. Russell MA. Cigarette smoking: natural history of a dependence disorder. Br-J-Med-Psychol. 1971;44(1):1-16.
4. Russell MA. Realistic goals for smoking and health. A case for safer smoking. Lancet. 1974;16; 1(851):254-8.
5. Russell MA. Low-tar medium-nicotine cigarettes: a new approach to safer smoking. Br-Med-J. 1976;12; 1(6023):1430-3.
6. Russell MAH, Jarvis M, Iyer R, Feyerabend C. Relation of nicotine yield of cigarettes to blood nicotine concentrations in smokers. British Medical Journal. 1980;280(6219):972-6.
7. Russell MAH, Jarvis MJ, Feyerabend C. A new age for snuff? Lancet. 1980;1; 1(8166):474-5.
8. Russell MAH, Jarvis MJ, Devitt G, Feyerabend C. Nicotine intake by snuff users. Br Med J. 1981;26; 283(6295):814-7.
9. Russell MAH, Jarvis MJ, West RJ, Feyerabend C. Buccal absorption of nicotine from smokeless tobacco sachets. Lancet. 1985;2(8468):1370.
10. Russell MAH. The future of nicotine replacement. Br-J-Addict. 1991;86(5):653-8.
11. Russell MAH. Nicotine use after the year 2000. The Lancet. 1991;337:1191-2.
NOT PEER REVIEWED Elias and Ling conclude that ‘Regulatory bodies should consider toxin exposure, and new products’ actual use, abuse potential and population health effects before endorsing them as safer’. We agree, and that is exactly what Public Health England and the Royal College of Physicians have done [1-4].
NOT PEER REVIEWED Elias and Ling conclude that ‘Regulatory bodies should consider toxin exposure, and new products’ actual use, abuse potential and population health effects before endorsing them as safer’. We agree, and that is exactly what Public Health England and the Royal College of Physicians have done [1-4].
NOT PEER REVIEWED The results provided by Stephens [1] may suggest to readers that since the concentrations of carcinogens are lower in vapourised nicotine products (VNPs), the risks of cancer are smaller compared to conventional cigarettes. The article uses the linear non-threshold model for risk assessment (a uniform cancer risk per unit dose from higher to lower doses), which is also used by most regulatory agencies. This model is considered to have a high degree of uncertainty; nevertheless, it implies that any dose of carcinogens increases the risk of cancer. Accordingly, the primary conclusion of Stephens and other’s[2] findings of the presence of carcinogens, particularly in heat-not-burn cigarettes (HNB) is that HNB poses a significant risk of cancer. In addition:
1) The article highlights a summation approach of overall cancer risk for each product, yet the individual concentrations of human carcinogens (for example, formaldehyde [3]) are still at risk level.
2) The assessment of carcinogenesis of low-level exposure to a mixture of chemicals is challenging [4]. Stephens’s summation model assumes that the effect of chemicals is independent. Even if we assume that for an individual chemical a lower concentration lowers carcinogenicity, we cannot rule out the potential effects of interactions among chemicals.
3) The analysis relies on holding consumption constant. However, manufacturer studies have suggested that consumption increases after a swi...
NOT PEER REVIEWED The results provided by Stephens [1] may suggest to readers that since the concentrations of carcinogens are lower in vapourised nicotine products (VNPs), the risks of cancer are smaller compared to conventional cigarettes. The article uses the linear non-threshold model for risk assessment (a uniform cancer risk per unit dose from higher to lower doses), which is also used by most regulatory agencies. This model is considered to have a high degree of uncertainty; nevertheless, it implies that any dose of carcinogens increases the risk of cancer. Accordingly, the primary conclusion of Stephens and other’s[2] findings of the presence of carcinogens, particularly in heat-not-burn cigarettes (HNB) is that HNB poses a significant risk of cancer. In addition:
1) The article highlights a summation approach of overall cancer risk for each product, yet the individual concentrations of human carcinogens (for example, formaldehyde [3]) are still at risk level.
2) The assessment of carcinogenesis of low-level exposure to a mixture of chemicals is challenging [4]. Stephens’s summation model assumes that the effect of chemicals is independent. Even if we assume that for an individual chemical a lower concentration lowers carcinogenicity, we cannot rule out the potential effects of interactions among chemicals.
3) The analysis relies on holding consumption constant. However, manufacturer studies have suggested that consumption increases after a switch to HNB devices [5]. For non-smokers or occasional smokers to whom HNBs are introduced as a safe product, any additional burden of toxicants increases the risk of cancer.
4) The conclusion concentrates on reduced risk of VNPs compared to the most harmful product (i.e tobacco smoke) and should also calculate elevated risk of using VNPs compared to background concentration.
In summary, smoking imposes exposure to a variety of toxicants with known and/or unknown health effect regardless of name, shape and means of use. These findings suggest that HNB cigarettes should be subject to the same regulations as tobacco cigarettes. The tobacco control community should communicate the absolute risks associated with these products. In particular, there is an urgent need for tobacco control policy actors to understand the potential absolute harms of heat-not-burn (HNB) cigarettes that PMI is pushing as ‘less harmful alternatives to smoking’ in their declared movement toward a smoke-free world (https://www.pmi.com/sustainability).
References:
[1] Stephens WE. Comparing the cancer potencies of emissions from vapourised nicotine products including e-cigarettes with those of tobacco smoke. Tobacco Control 2017.
[2] Auer R, Concha-Lozano N, Jacot-Sadowski I, et al. Heat-not-burn tobacco cigarettes: Smoke by any other name. JAMA Internal Medicine 2017.
[3] Cogliano VJ, Grosse Y, Baan RA, et al. Meeting report: summary of IARC monographs on formaldehyde, 2-butoxyethanol, and 1-tert-butoxy-2-propanol. Environmental health perspectives 2005:1205-1208.
[4] Goodson III WH, Lowe L, Carpenter DO, et al. Assessing the carcinogenic potential of low-dose exposures to chemical mixtures in the environment: the challenge ahead. Carcinogenesis 2015;36(Suppl_1):S254-S296.
[5] Lüdicke F, Baker G, Magnette J, et al. Reduced Exposure to Harmful and Potentially Harmful Smoke Constituents With the Tobacco Heating System 2.1. Nicotine & Tobacco Research 2017;19(2):168-175.
NOT PEER REVIEWED An often overlooked limitation in smoking-related studies based on surveys conducted by health institutions is the pressure on respondents to provide "the right answer." Especially in this area, where this population has been subjected to high intensity tobacco control policies and messages, sample representativeness cannot be established with certainty when those asking the questions are the originators and/or pursuers of these policies and messages and, undeniably, describing the effort as "denormalization" and seeking to form a stigma around smoking and smokers.
Furthering this theory is the strongly implied factor contained in this study's "Limitations" section that the respondents have been plucked from prior tobacco research, thereby affording them even more knowledge about the opinions of the researchers. Those who volunteer for smoking-related studies -- perhaps even receiving incentive payments? -- cannot be dismissed as the type who will lean toward providing expected answers in order to please, are indicative of the type who already agree with the perceived direction of the study, or, as already stated, fear telling the truth to those they know hold a general disapproving attitude toward the subject at hand.
Right now the sample representativeness is skewed because of this. By how much remains the question. But one should not discount wondering what the responses would be and how different...
NOT PEER REVIEWED An often overlooked limitation in smoking-related studies based on surveys conducted by health institutions is the pressure on respondents to provide "the right answer." Especially in this area, where this population has been subjected to high intensity tobacco control policies and messages, sample representativeness cannot be established with certainty when those asking the questions are the originators and/or pursuers of these policies and messages and, undeniably, describing the effort as "denormalization" and seeking to form a stigma around smoking and smokers.
Furthering this theory is the strongly implied factor contained in this study's "Limitations" section that the respondents have been plucked from prior tobacco research, thereby affording them even more knowledge about the opinions of the researchers. Those who volunteer for smoking-related studies -- perhaps even receiving incentive payments? -- cannot be dismissed as the type who will lean toward providing expected answers in order to please, are indicative of the type who already agree with the perceived direction of the study, or, as already stated, fear telling the truth to those they know hold a general disapproving attitude toward the subject at hand.
Right now the sample representativeness is skewed because of this. By how much remains the question. But one should not discount wondering what the responses would be and how different the outcome if administered by an organization such as my own where the respondents would likely be more at ease. And while if started from scratch with recruitment it might also attract other-thinking smokers that could skew it the other way (but also then questioning this study's sample at the same time), it need not be necessary in regard to the study limitation present here today.
NOT PEER REVIEWED This paper is part of the ongoing discussion about saving lives from tobacco use. As a practicing oncologist and part-time Hospice physician, I have seen real benefit from "vaping". First, many Hospice patients, who have smoked for decades and are actively dying put themselves at real risk if they smoke real cigarettes while dying. Taking away cigarettes during the terminal illness just causes antagonism and much distress for the patient, their family, and the Hospice staff. Vaping at the end of life does prevent burns, suffering, and psychological distress.
For my oncology patients, I recommend vaping as an alternative to cigarettes for the many cigarette smokers who cannot "quit", despite real effort attempts with nicotine patches, gum, Wellbutrin, or Chantix. I do see lives improving, pulmonary function improving, and less stress in the exam setting, trying to convince the patient to quit yet another time.
We do need more research about cigarette alternatives for the existing nicotine addicts. There is, most definitely a role for these products, but also a need for researching the safety, efficacy, and best application of these products as an alternative for active adult smokers with health issues.
NOT PEER REVIEWED The 2014 Surgeon Generals Report (p. 875) stated ““The burden of death and disease from tobacco use in the U.S. is overwhelmingly caused by cigarettes and more must be done to end the deaths from combustible tobacco.” The aim of our study was to show the potential of policies to encourage cigarette smokers to switch to e-cigarettes as a way to reach or at least get closer to that goal. Indeed, FDA Commissioner Gottlieb and Director, Center for Tobacco Products Zeller in a July commentary in NEJM set out a two-pronged approach to the endgame of 1) policies making cigarettes less desirable and 2) policies making e-cigarettes a better substitute for cigarettes. We feel that Dr. Peters misses the point of the article, that the article is an exploratory exercise, and compounds his misunderstanding with unsubstantiated claims.
First, while Dr. Peters criticizes the 5% excess total mortality risk estimate for e-cigarettes relative to cigarettes and the pessimistic estimate, he does not make a coherent argument as to why we might expect worse outcomes, even though he is a respiratory physician and might be expected to point out specific scientific evidence vaping might approach smoking in harmfulness for respiratory illness at least. Indeed, we have seen no coherent argument for an alternative to the 5% estimate. We note that the UK Royal College of Physicians argued that it was likely to be less, while accepting the 5% as a likely upper bound (not the mos...
NOT PEER REVIEWED The 2014 Surgeon Generals Report (p. 875) stated ““The burden of death and disease from tobacco use in the U.S. is overwhelmingly caused by cigarettes and more must be done to end the deaths from combustible tobacco.” The aim of our study was to show the potential of policies to encourage cigarette smokers to switch to e-cigarettes as a way to reach or at least get closer to that goal. Indeed, FDA Commissioner Gottlieb and Director, Center for Tobacco Products Zeller in a July commentary in NEJM set out a two-pronged approach to the endgame of 1) policies making cigarettes less desirable and 2) policies making e-cigarettes a better substitute for cigarettes. We feel that Dr. Peters misses the point of the article, that the article is an exploratory exercise, and compounds his misunderstanding with unsubstantiated claims.
First, while Dr. Peters criticizes the 5% excess total mortality risk estimate for e-cigarettes relative to cigarettes and the pessimistic estimate, he does not make a coherent argument as to why we might expect worse outcomes, even though he is a respiratory physician and might be expected to point out specific scientific evidence vaping might approach smoking in harmfulness for respiratory illness at least. Indeed, we have seen no coherent argument for an alternative to the 5% estimate. We note that the UK Royal College of Physicians argued that it was likely to be less, while accepting the 5% as a likely upper bound (not the most pessimistic possible). Studies support the Royal College that non-combustible nicotine use is substantially less harmful than the smoke from combustion in clinical studies that smokers who switched to e-cigarettes reduced symptoms of pulmonary disease and cancer biomarkers (Shahib et al., Ann. Internal Med 2017; Glasser et al., AJPM, 2017; Benowitz and Fraiman, Nat Rev Cardiol. 2017).
Second, Dr. Peters clearly misunderstands the limitations of the longitudinal youth research. The studies to date cannot rule out confounders based on a shared liability model and, consequently, others suggest that fears of a gateway are overblown (Kozlowski & Warner, Drug & Alc Dep, 2017). These studies were conducted in a period when smoking and vaping rates were going in opposite directions or when smoking rates were continuing to decline more rapidly in the presence of reduced vaping (2013-16), and are based on very low levels of use (ever use or any monthly use, not regular use). The gateway theory is about population level relationships, and it cannot account for the two behaviours, cigarette use and e-cigarette use, going in opposite directions.
Third, Dr. Peters mischaracterizes the use of vaping. Where it is regularly available, vaping is the most used form of smoking cessation help, and, while the current evidence indicates it is at least as effective as nicotine replacement therapy (NRT’s) and possibly more so, as e-cigarettes are used by more smokers in quit attempts than NRT’s (Hartman-Boyce, Cochrane Reviews, 2016), and therefore will be having a larger net population effect. The recent population level analysis of Zhu et al (BMJ, 2017) shows an acceleration of the reduction in smoking prevalence in a period where the rapid uptake of vaping was the most notable change in the tobacco control environment and Levy et al (NTR, 2017) show a strong relationship between vaping, especially when done regularly, and both previous year quit attempts and quit success. A recent review confirms that e-cigarettes help smokers to quit and that studies of negative correlations between e-cigarette use and smoking cessation fail to meet reasonable but rigorous standards of scientific evidence (Villanti et al., Addiction, 2017).
Fourth, Dr. Peters claims that we underestimate the declining prevalence from 2009 to 2015, but does not point out the plausibility of a significant proportion of this change being due to the introduction of vaping. Indeed, this is precisely why we made the starting point for our projections (2012) when we did, at the point when the level of vaping was so small as to not have any appreciable possible impact on smoking rates.
As we indicated in our reply to Dr. Glantz, our goal in this study is not to predict the future, but to suggest a course for reaching an endgame of eliminating cigarettes tobacco use. Our hope is for tobacco control advocates to keep an open mind about the possibilities. Having smokers switch to e-cigarettes may not be the ideal outcome, but do we want to let the perfect continue to be the enemy of the possible?
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.
Pesko’s central argument is that it does not matter that Friedman’s assessment of the effect of San Francisco’s ban on the sale of flavored tobacco products is not based on any data collected after the ban actually went into force. In particular, Friedman’s “after” data were collected in fall 2018, before the ordinance was enforced on January 1, 2019.[1] Pesko incredibly argues that Friedman’s “before-after” difference-in-difference analysis is valid despite the fact that she does not have any “after” data.
Pesko justifies this position on the grounds that the effective date of the San Francisco ordinance was July, 2018. While this is true, it is a matter of public record that the ordinance was not enforced until January 1, 2019 because of the need for time for merchant education and issuing implementing regulations.[2]
Friedman is aware of the fact that the enforcement of the ordinance started on January 1, 2019 and used that date in her analysis. In her response[3] to critiques[4] of her paper, she stated “retailer compliance jumped from 17% in December 2018 to 77% in January 2019 when the ban went into effect.” Friedman thought the YRBSS data was collected in Spring 2019; she only learned that the “2019” San Francisco YRBSS data she used were in fact collected in fall 2018 from our paper.[1]
Rather than simply accepting this as an honest error and suggesting Friedman withdraw her paper, Pesko is offering an after-the-fact justification for the cl...
Show More¶ I enjoyed reading this paper. I appreciate the author's use of difference-in-difference (DD) methodology. There were some things I found unclear that I would like to ask the authors to comment on.
¶ First, could the authors provide greater clarity on the model for column 1 of Table 1? Is the dependent variable here a yes/no for current cigarette use? The authors write, "Adolescents reported lifetime and prior month use of cigarettes, which we combined into a count variable of days smoked in the past month (0–30)." How does lifetime cigarette use help the authors to code the current number of cigarette days? The authors later state that they show that "increasing implementation of flavoured tobacco product restrictions was associated not with a reduction in the likelihood of cigarette use, but with a decrease in the level of cigarette use among users." Do the authors mean lifetime cigarette use here, or current cigarette use? The authors estimate this equation with an "inflation model," which I am not aware of. Could the authors provide more information on this modelling technique? This is not discussed in the "Analysis" section.
¶ Second, I felt like this statement is too strong. "Our findings suggest that[...] municipalities should enact stricter tobacco-control policies when not pre-empted by state law." Municipalities need to weigh many factors in making these decisions, including the effects of popu...
Show More¶ The authors make some points in their article that are reasonable: 1) the generalizability of San Francisco's flavor ban compared to other places is an open question, and 2) the original study uses the San Francisco ban effective date rather than enforcement date. The original author (Friedman), who does not accept tobacco industry funding and is a well-respected scientist in the field, had pointed to both facts in her original article. So that information isn’t new.
Show More¶ The current authors appear to construct a straw man argument claiming that Friedman argued that she was studying the effect of San Francisco enforcing its flavor ban policy. Friedman specifically wrote in her original article that she was studying, “a binary exposure variable [that] captured whether a complete ban on flavored tobacco product sales was in effect in the respondent’s district on January 1 of the survey year.” She specifically uses effect in the above sentence, so there is no ambiguity that she is studying effective date. San Francisco’s flavor ban effective date was July 2018 (Gammon et al. 2021).
¶ The authors found new information that the San Francisco YRBSS survey was collected between November to December of 2018. Gammon et al. 2021 (Appendix Figure 1) shows that flavored e-cigarette sales declined in San Francisco between the effective date and the end of August 2018 (compensating for a 30-day look-back period for the YRBSS question wording), even though the flavor ban...
NOT PEER REVIEWED
We would like to thank Mr. Wang for his feedback on our paper, Indicators of dependence and efforts to quit vaping and smoking among youth in Canada, England and the USA.
With regards to the ‘discrepancies’ in vaping and smoking prevalence between those reported in Table 1 and an earlier publication [1], we have previously published these same estimates [2], along with a description of the survey weighting procedures—which were modified since the first estimates were published (as outlined in a published erratum to the cited publication [3]). Briefly, since 2019, we have been able to incorporate the smoking trends from national ‘gold standard’ surveys in Canada and the US into the post-stratification sampling weights. A full description is provided in the study’s Technical Report [4], which is publicly available (see http://davidhammond.ca/projects/e-cigarettes/itc-youth-tobacco-ecig/).
Mr. Wang has also noted a change in the threshold used for a measure of frequent vaping/smoking: ≥20 days in past 30 days rather than ≥15 days, as previously reported [1]. We have adopted the convention of reporting using ≥20 days in past 30 days to align with the threshold commonly used by the US Centers for Disease Control for reporting data from the National Youth Tobacco Survey (NYTS), as well as the Population Assessment of Tobacco and Health (PATH) Study and the Mo...
Show MoreNOT PEER REVIEWED
There’s a published paper by Hammond and colleagues in 2019[1] using the same survey results, but there are some discrepancies.
1. The Table 2 of the 2019 paper, prevalence of vaping in 2018 for ever, past 30 days are 37.0% (1425), 14.6% (562) in Canada, 32.7% (1276), 8.9% (346) in England and 33.6% (1360), 16.2% (655) in the US, respectively. However, in this article’s Table 1, for vaping in the same year 2018 for ever, past 30 days are 33.2% (1275), 12.1% (463) in Canada, 33.1% (1283), 9.0% (351) in England and 33.1%(1336), 15.7% (635) in the US. More discrepancies can be found on cigarette smoking section as well. These numbers warrant further explanation particularly why numbers in Canada and the US decreased while numbers in England increased? Considering previous correction of numbers to the 2019 paper has raised serious concern among some readers[1], such timely clarification in this article will be very necessary.
2. The 2019 paper use the criteria of ≥15 days in past 30 days but the current paper adopts different criteria of ≥20 days in past 30 days, for both vaping and cigarette smoking. Further explanation is needed for such change.
Additionally, a few considerations on possible limitations of the paper’s findings:
1. Since the invitations were sent to nearly twice more parents than youth themselves according to the technical report[2], responds to survey questions might be biased because study has shown many...
Show MoreNOT PEER REVIEWED
We thank Mr. Clive Bates (1) and Dr. Moira Gilchrist (2) for their reconsideration of our work (3) and previous response where we corrected some errors (4). We also reiterate that all data informing our Industry Watch are publicly available at Tobacco Watcher (https://tobaccowatcher.globaltobaccocontrol.org/) for anyone to analyze. As with any analyses of observational data, there are limitations and we do not disagree with some of the limitations that Gilchrist and Bates point out in our analyses (as we addressed nearly all of these in our previous response (4)). However, we remain unchanged in our conclusion that, as the title of our initial article stated, “Philip Morris International used the e-cigarette, or vaping, product use associated lung injury (EVALI) outbreak to market IQOS heated tobacco” (3).
While statistical analysis indicated a correlation between (a) PMI’s public statements regarding EVALI and their IQOS brand of heated tobacco posted to their corporate “media center” (5) and (b) trends in news coverage of EVALI and IQOS, our primary assertion is that PMI used EVALI to market IQOS. The necessary and sufficient analysis to substantiate this assertion is reporting what PMI publicly claimed, which we did by analyzing the statement made by PMI which promoted IQOS through mentioning, contrasting or describing it along with EVALI and/or vaping.
The full text...
Show MoreNOT PEER REVIEWED
Thank you for the corrections and for acknowledging the omission. The additional analysis performed by ITC is greatly appreciated and provides further insight into the impact of both interventions. Although unstated, Canada’s regional characterizing flavour bans contributed significantly to the development of a national menthol additive ban as chronicled by the U.S. Tobacco Control Legal Consortium[1] . I look forward to reading the full analysis when published.
1. Kerry Cork, Tobacco Control Legal Consortium, Leading from Up North: How Canada Is Solving the Menthol Tobacco Problem (2017). https://www.publichealthlawcenter.org/sites/default/files/resources/tclc...
NOT PEER REVIEWED
Reducing smoking rates in older smokers will achieve a far greater reduction in deaths & disease and do this much earlier than reducing already much lower smoking rates in teens & young populations. Tobacco harm reduction (THR) options, such as vaping, Heated Tobacco Products (HTP), snus & nicotine pouches, all avoid inhalation of smoke from tobacco combustion and are less risky than smoking cigarettes which are responsible for the death of more than 50% of long term smokers. Cigarette sales in Japan declined by over 40% in five years after HTPs entered the Japanese market in 2016. There are now many other examples of other THR options substituting for deadly cigarettes in other countries.
New drug harm reduction interventions usually face fierce opposition for many years after their introduction. Needle syringe programs to reduce HIV spread among and from people who inject drugs were still strongly resisted long after the evidence for their effectiveness, safety and cost effectiveness was incontrovertible. It is not surprising to me therefore, as a veteran of many battles over new drug harm reduction interventions, to observe the acrimonious debate over THR.
If it is made easy for older smokers to switch to THR options, the benefits will not only be an acceleration in the decline of smoking related deaths and disease, but also a more rapid decline in cigarette sales.
NOT PEER REVIEWED
In his comment, Les Hagen brings up an important distinction between two types of restrictions on menthol: a menthol additive ban, and a menthol characterizing flavour ban. Canada's menthol ban across the provinces did indeed involve both types. Between May 2015 and July 2017, Nova Scotia, Alberta, Quebec, Ontario, Prince Edward Island, and Newfoundland & Labrador implemented characterizing flavour bans, whereas New Brunswick implemented a menthol additive ban [1]. When the Federal Government implemented a menthol additive ban in October 2017 [2] , it applied only to the remaining provinces—British Columbia, Saskatchewan, Manitoba—as well as Nunavut, Yukon, and the Northwest Territories. Thus, the "menthol cigarette ban" in Canada is a mixture of the two types.
Our article [3] evaluated the impact of menthol bans implemented between the 2016 and 2018 waves of the Canadian arm of the ITC Four Country Smoking and Vaping Surveys. Hagen incorrectly stated that "the analysis was performed exclusively on provincial characterizing flavour bans." In fact, the provinces evaluated in our study included both those that implemented characterizing flavour bans (Quebec, Ontario, Prince Edward Island, Newfoundland & Labrador) and those that implemented the Federal menthol additive ban (British Columbia, Saskatchewan, Manitoba).
In our original study, we did not test for differences between the two kinds of bans, beca...
Show MoreNOT PEER REVIEWED
We thank Pesko for his comments and the opportunity for us to respond and clarify.
First, we appreciate Pesko’s clarification that Cotti et al. (2020) clustered standard errors to account for clustering. In the present study, we used multilevel analysis not only to account for clustering of respondents (i.e., design effects) but also to incorporate different error terms for different levels of the data hierarchy which yields more accurate Type I error rates than nonhierarchical methods where all unmodeled contextual information ends up pooled into a single error term of the model.
Second, we understand that Cotti et al. (2020) evaluated the magnitude of e-cigarette tax values, which does not contradict to our statement because our study focused on the effects of e-cigarette excise tax policies on individual e-cigarette use and prevalence rather than aggregated sales at state or county levels. We also clearly described the reason why we examined the e-cigarette excise tax policy implementation indicator rather than its magnitude in our paper’s discussion section.
Third, our study used a nationally representative sample of young adults (rather than a nationally representative sample of general adult population). While we understand Pesko’s concern that a sample’s representativeness might be lost when subgroups are explored, we believe our use of sampling weights in analysis has reduced such a concern.
Fourth, in Table 3,...
Show MoreNOT PEER REVIEWED
We appreciate the comments from Bates and the opportunity for us to respond and clarify.
First, Bates' argument heavily relies on the assumption that e-cigarettes and combustible cigarettes are substitutes, which is theoretically possible as some consider vaping as a harm reduction alternative to combustible cigarettes. Empirically, however, there have been mixed findings about whether e-cigarettes and combustible cigarettes are substitutes (or complements). Bates cited Pesko et al. (2020) that concludes e-cigarettes and combustible cigarettes are substitutes, whereas other studies have shown that they are complements. For example, Cotti et al. (2018) found that higher cigarette excise taxes, in fact, decrease sales of both e-cigarettes and combustible cigarettes, suggesting that they are complements. Such mixed results abate Bates' argument that taxing ENDS could lead to more use of combustible cigarettes.
Second, Bates might have ignored that our study focused on young adults aged 18-24 years rather than general adults when examining the effect of vaping product tax on e-cigarette use. Although Pesko et al. (2020) suggests that e-cigarettes and combustible cigarettes are substitutes, the findings are based on the general adult population (average age: 55 years) which may not be generalizable to the young adult population. In fact, one study conducted by Abouk and Adams (2017) indicates that e-cigarettes and combustible ci...
Show MoreNOT PEER REVIEWED
I have a number of concerns with the paper as currently written.
1) The authors write: “Besides, none of the previous studies except Pesko et al (15) that examined the associations between vaping product excise tax adoption and ENDS use has accounted for the clustering of respondents within the same localities…” This is not accurate, as citation 19 also clusters standard errors at the locality level in all specifications.
2) The authors write: "A working paper reported reduced ENDS sales, but not ENDS use prevalence or behaviours, after implementation of a vaping product excise tax policy. (19)” This is not accurate, as the cited study uses the magnitude of e-cigarette tax values, rather than an indicator variable for tax implementation. States have adopted e-cigarette taxes of different magnitudes and a number of them (such as California) have changed the magnitudes of these taxes after adoption. All of this variation is used in citation 19, contrary to the current study’s description. It's also unclear from the sentence whether citation 19 studied use and found imprecise estimates, or did not study use. It's the latter and this should be clarified. It's also unclear why the authors did not use magnitude of e-cigarette taxes themselves in the current paper, as has been commonly done in the referenced literature.
3) Authors write they use a “nationally representative sample of US young adults.” I do not beli...
Show MoreNOT PEER REVIEWED
This article does not distinguish between characterizing flavour (menthol) bans that were implemented in Canadian provinces between 2015 and 2017 and the implementation of a national ban on menthol additives in Canada in October 2017. Although unreported, the analysis was performed exclusively on provincial characterizing flavour bans. This significant distinction should be reported to ensure that researchers and policy makers are aware of the potential impact of a characterizing flavour ban and to ensure that this policy measure is not dismissed or discounted.
NOT PEER REVIEWED
I would like to make three comments by way of a brief post-publication review.
1. The impacts of vaping tax on smoking have been completely overlooked
For a study of e-cigarette taxation to have any public health relevance, it must consider the impact of e-cigarette prices on *cigarette* demand. Cigarettes and e-cigarettes are economic substitutes. The demand for one responds to changes in the price of the other, an idea well understood in economics and quantified through the concept of cross-elasticity. The paper appears to pay no regard to the impact of vaping taxes on cigarette demand, Yet such effects might easily overwhelm any benefits from reduced e-cigarette use - in fact, impact on demand for other tobacco products and the development of informal markets are by far the most important impacts of a vaping tax. By way of example, a 2020 paper by Pesko et al. [1] concluded:
"Our results suggest that a proposed national e-cigarette tax of $1.65 per milliliter of vaping liquid would raise the proportion of adults who smoke cigarettes daily by approximately 1 percentage point, translating to 2.5 million extra adult daily smokers compared to the counterfactual of not having the tax."
2. The case for reducing adult vaping by taxation has not been made
The authors have based their paper on an unexamined assumption that it is a justifiable goal of policy to lower rates of adult e-cigarette use. Why should...
Show MoreNOT PEER REVIEWED
Replication attempts are one of the self-correcting mechanisms of science, and we thank the Authors for their response to our concerns and their attempt to replicate aspects of their study [1]. Regrettably, they have failed to adequately address the central point raised in our letter of 23rd April 2021, namely that the title and conclusions of their original Article are patently invalid and have no basis in fact or evidence [2]. Instead of strengthening their argument in support of the Article’s findings and conclusions, the Authors’ response considerably weakens them. Strikingly, the Authors reveal several new and serious issues and yet maintain that their “principle finding is unchanged”.
Methodological Problems:
The Authors acknowledge that they were unable to replicate an important aspect of their original analysis, namely that a Philip Morris International (PMI) News Article [3] published on its website (falsely described as a “press release”) was “republished […] in 14 additional news outlets”. In their response, they note that “Our original assertion that there were 14 duplicate articles is not supported by our replication analysis”. This failure to replicate a key finding—in their own proprietary database, which several of them co-developed—is concerning. The Authors provide no explanation for the irregularity. Notably, on 20th April 2021, we were able to source these 14 articles in Tobacco Watcher since they were clearly mar...
Show MoreNOT PEER REVIEWED
The authors’ response published on 14 July 2021 is far from satisfactory and implausibly asserts that “Our original findings and conclusions remain plausible” [1]
The original study [2] uses a media analysis to make a claim that a statement made by the tobacco company Philip Morris International (PMI) about an outbreak of lung disease in the US [3] was a marketing ploy for its heated tobacco product, iQOS. At the time, the lung injury outbreak was falsely attributed by many to nicotine vaping. Heated tobacco products are an alternative to nicotine vaping for smokers looking for a low-risk alternative to smoking.
I will now list some of the problems with this claim.
1. The research findings do not support the headline claim
The study title contains a strong and unqualified assertion of cynical opportunism on the part of the company. The new formulation that findings "remain plausible" does not justify the confidence in the assertion made in the title. "Plausible" is a reasonable basis for choosing a hypothesis to investigate, but a far from sufficient basis for drawing an aggressive conclusion. The authors do not seem to dispute the technical or factual accuracy of the statement about iQOS and EVALI made by PMI. Their allegation is about malign motives and, as such, it should be a cause for caution and a high standard of evidence.
2. No specific articles were provided to substantiate the...
Show MoreNOT PEER REVIEWED
We thank Dr. Moira Gilchrist (1) for her careful attention to our work (2). Gilchrist argues our principal findings were erroneous and any change in news coverage of IQOS and the e-cigarette, or vaping, product use associated lung injury (EVALI) outbreak were confounded by other Philip Morris International (PMI) media materials and not those specifically discussing EVALI and IQOS (3) which we attributed our findings to. However, a deeper inspection of this argument suggests our original findings and conclusions remain plausible.
Tobacco Watcher is a dynamic resource with continuous data collection and processing. Thus, the results of analyses on the platform can vary over time. On June 10, 2021 we replicated our analysis. After correcting an error that the PMI’s materials on EVALI and IQOS (3) was initially published on 24 September 2021 (not 25 September) the principal finding is unchanged. News coverage mentioning both “IQOS” and EVALI (i.e., including the terms ‘vaping’ and ‘illness’) reached an all-time high immediately after PMI published materials about EVALI and IQOS on their website. Thirty days prior to PMI posting this material (August 25th through September 23rd) 2.0 news stories per day matched our search compared to 12.8 for the 30 days after their publication (September 24th through October 23rd), with 384 news reports matching our keyword search for the latter period. Our original assertion that there were 14 duplicate articl...
Show MoreNOT PEER REVIEWED
A review of this study has been published by the target of its criticism, the tobacco company Philip Morris International (PMI), via the post-publication review server Qeios [1]
The main finding of this study, and the allegation raised in its title, is that PMI cynically used an outbreak of lung injuries in the United States (initially but incorrectly attributed to nicotine vaping) to promote its heated tobacco product, iQOS. Heated tobacco products are one alternative to vaping for those looking for a safer alternative to smoking. On 24th September 2019, PMI published an information notice about its products in response to the lung injury outbreak. The authors assert that PMI was trying to gain commercial publicity from a health crisis: a serious allegation. But the allegation appears to be based on a major error by the authors.
The study used a "fully automated media analysis engine" to count stories that mention iQOS around that time, showing that there were considerably more than usual. On this basis, the authors concluded that PMI's unethical promotional gambit had worked. However, the day after PMI allegedly disreputably sought publicity for iQOS, the company also issued a press release disclosing that merger negotiations with the American tobacco company, Altria, had ceased. PMI and Altria have a joint marketing agreement for iQOS in the United States. The end of merger talks would be big news in the business pre...
Show MoreNOT PEER REVIEWED
I write on behalf of Juul Labs in response to “E-cigarette manufacturers’ compliance with clinical trial reporting expectations: a case series of registered trials by Juul Labs.” We appreciate the public health community’s interest in understanding the Company’s research. However, we want to clarify the article’s reporting on Juul Labs’ research program and publications to date, as well as our legal obligations to report the results of clinical investigations.
First, our studies were conducted in anticipation of our submission of a Premarket Tobacco Product Application (PMTA) to the U.S. Food and Drug Administration (FDA). As such, raw data, results, and statistical code underlying our analyses of all ten registered Juul Labs studies referenced in the Tobacco Control paper have been submitted to FDA (1)
In addition, we have been working on sharing our data in publications and posters. In fact, by the end of this month, we will have published or presented data on nine of the ten studies, in addition to having provided the clinical results to FDA. Of our ten registered studies, we have published the results of four (2, 3, 4, 5) submitted the results of an additional two studies for peer review, presented the results of two as posters (6,7) and have the results of one accepted for presentation this summer. We appreciate that the authors of the Tobacco Control paper may have drafted their article months ago, but note that there...
Show MoreNOT PEER REVIEWED
On behalf of my co-authors, we thank Dr. Mishra for taking the time to comment on our paper examining reporting of trials registered by Juul Labs Inc.
We do not doubt that Juul has submitted the results from all of these studies to the FDA as part of their Premarket Tobacco Product Application (PMTA). Unfortunately, this step does not ensure the full results of these trials will be made available to the public, clinicians, and other key stakeholders.
We also acknowledge and appreciate that since conducting our analysis in August 2020, two additional studies, of the five we examined, have appeared in the peer reviewed literature (published in December 2020 and January 2021)[1,2] and additional results may become available through other methods. We understand that these publications may contain additional outcome reporting compared to the posters we assessed. We welcome any and all additional results disclosures from Juul Labs. That said, we believe the risk of outcome reporting bias remains and is, unfortunately, not addressed in Juul’s comment despite being a major facet of our paper. The one publication that was available as of our analysis date excluded 4 of the 19 prespecified secondary outcomes without comment and another 5 outcomes had clear issues in their reporting compared to the registered outcomes. While we have not conducted a detailed assessment of the two new publications, it is apparent that journal publication does no...
Show MoreNOT PEER REVIEWED
A brief review of this ‘Industry Watch’ article alleging heated tobacco product advertising through an earned media approach highlights significant methodological errors that are serious enough to invalidate the article’s conclusions, including its title. The authors allege that Philip Morris International (PMI) used the e-cigarette, or vaping, product use associated lung injury (EVALI) outbreak to promote IQOS in September 2019 and the weeks that followed. Using the authors’ own tool (TobaccoWatcher.org), we replicated their search strategy and revealed several fundamental and concerning errors in the authors’ analysis.
They report a rise in news stories mentioning IQOS on and after 25th September 2019, and falsely attribute this rise to an article published on our website on 24th September 2019, which they also falsely describe as a “press release”, despite it never being published through a press release distribution service. Our analysis shows that the authors failed to consider several confounding and unrelated events that caused the rise in news coverage of both IQOS and EVALI during the time period in question and which can be found by replicating the authors’ search strategy in TobaccoWatcher.org.
For example, on 25th September 2019, Philip Morris International (PMI) issued a single press release via Business Wire (1) entitled “Philip Morris International Inc. and Altria Group, Inc. End Merger Discussions” (PMI/Altria Annou...
Show MoreNOT PEER REVIEWED
The single-minded focus in this article that only multinational tobacco companies are to blame for the tobacco epidemic presents a narrow view of the problem and ultimately prevents formulation of effective interventions. It is also a uniquely western framing which does not apply to large swathes of the developing world where most tobacco users currently live.
In India for instance, home to the second largest population of tobacco users totaling nearly 270 million, industrially produced cigarettes form a small component of overall use, with hand-rolled bidis being far more widely used, and even more prevalent, comprising twice the number of smokers, is the smokeless form, khaini. Both bidis and khaini are produced by a largely unorganised sector and are not industrially made. This situation is mirrored across many countries in Asia and other parts of the developing world — where over 80% of tobacco users live and where 90% of tobacco cultivation is done.
Further, about half of the global tobacco trade is run by state-owned tobacco companies (SOTCs), and a majority of these nations are part of the FCTC protocol, yet continue to operate without focus or repercussions. The Indian state owns nearly a third of the cigarette monopoly. Despite this, it currently chairs WHO’s executive board.
Hence, to cast the tobacco crisis as industrially made and caused by multinational tobacco companies can’t be farther from the truth. While they h...
Show MoreNOT PEER REVIEWED
If PMI attempted to profit from the “EVALI” scaremongering they could only do so because of the blatantly dishonest reporting of that issue by federal authorities, activist academics, tobacco control organisations and the media who quote them with question. It was obvious as early as August 2019 that the lung injuries were caused by black market THC cartridges cut with vitamin E acetate and not nicotine containing e-cigarettes and the CDC eventually came to the same conclusion. Yet activists in positions of authority continue to link the injuries with nicotine vaping, thus providing a fertile ground of misinformation in which such marketing campaigns can flourish.
NOT PEER REVIEWED
Show MoreRuth Malone's pursuit of common ground in the tobacco control and broader public health communities is most welcome. As I emphasize in a new commentary that has received wide circulation (https://drive.google.com/file/d/1C1nk1XEZ8WhnOXtCGTqHdeqomc9HOuko/view), we must collectively climb out of our bunkers, come to the table and genuinely work together. Everyone, on all sides of the concurrent debates over tobacco harm reduction and protecting youth must stop skirting the truth when it feels inconvenient and open our minds and ears to all of the science that is before us, while discouraging and abandoning studies and pronouncements that are demonstrably biased or inadequate. We must move beyond the adversarial nature of the debate and transparently acknowledge areas of ambiguity or concern.
Combating the smoking epidemic is a social justice issue, as too little attention is now being given in many places, including the U.S., to prioritizing the importance of promoting adult smoking cessation and, for those adults addicted to smoking who cannot or are unwilling to quit nicotine -- many of whom are socially marginalized, poor, less educated, experience serious mental health conditions, or are members of the military or veterans -- helping them switch to less-hazardous, noncombustible forms of nicotine.
Regardless of ideology and policy preferences, we...
NOT PEER REVIEWED
Professor Malone’s call for a better understanding of the context of the tobacco epidemic is timely. For tobacco as for sugar and alcohol, the extent of population harm is linked to the historic growth of an oligopoly which has used economies of scale, aggressive sales tactics and ingredient modification to transform commodities into highly-processed, convenient and affordable artefacts1-3. At a time when the pandemic has brought the role of governments in protecting the public into greater focus, the implementation of market restrictions which we know to be effective in reducing demand (higher tax, minimum price, minimum pack size)4 should receive a new impetus.
Professor Malone’s call to unite opponents and proponents of ‘newer and novel nicotine and tobacco products’ (NNNTPs) around opposition to the tobacco industry should be heeded. Imperial Brands’s recent decision to turn back to ‘neglected’ cigarettes after being ‘overly focused’ on alternative nicotine products shows that profits, not smokers’ lives, will always be the tobacco companies’ priority5. The enormous influence exercised by the tobacco industry over governments worldwide is perhaps the most pressing tobacco control issue today, with countries including the US continuing to score highly on the Global Index of Tobacco Industry Interference6.
As to whether NNNTPs represent a ‘breakthrough’, it is not so much the products themselves that are disruptive, but rather the...
Show MoreNOT PEER REVIEWED
Show MoreI appreciated the editorial by Ruth Malone on finding "common ground" on the topic of product regulation and more broadly the role of tobacco control. I would certainly agree that the current climate in smoking harm reduction has become toxic and emotional, non-scientific, and counterproductive to achieving the public health goal of reducing premature deaths caused by using smoked tobacco (i.e., mainly cigarettes). I also agree that the cigarette companies are likely using this as a wedge to advance their own financial interests - what else would you expect? I don't think anyone interested in public health is suggesting that we dismiss the past bad actions of the cigarette manufacturers, nor accept the claims of manufacturers of alternative nicotine products. Rather, we need to heed the lessons of the past so as not to make the same mistakes going forward. The United States, the Tobacco Control Act created a framework that should incentivize manufacturers to move away from profiting from the sale of cigarettes that causes so much harm to consumers. Promoting dialogue summits would allow for participants to engage in a civil manner, educate one another about challenges and opportunities and agree to specific measurable goals and objectives. Bringing stakeholders together will not resolve all differences but it will allow serious and responsible stakeholders the opportunity to bring ideas forward and find areas of common ground...
NOT PEER REVIEWED
We thank Tobacco Control for the opportunity to respond to the comment above. Our study was obviously not looking into the harms of secondhand aerosol from e-cigarettes (SHA). Our paper departs from previous compelling research on the harms of SHA and assesses the prevalence and duration of such exposure among e-cigarette non-users, i.e., bystanders who are potentially exposed to the aerosols emitted by e-cigarette users.
Firstly, it is clear that we conducted the study on the basis of knowledge that bystanders were involuntarily exposed to potentially hazardous SHA in many places. We have clearly mentioned the growing evidence that supports our assertion about the potential harms of SHA in the Introduction and Discussion sections of the paper. SHA contains many toxicants, including nicotine, particulate matter and carcinogens (e.g., volatile organic compounds, polycyclic aromatic hydrocarbons, formaldehyde, acetaldehyde and tobacco specific nitrosamines-TSNAs). As mentioned, this evidence comes from previous scientific research (please, foresee the references 11 to 14 of our paper). Of special interest, fine particulate matter (PM2.5) concentration increased during e-cigarette use sessions with human volunteers in settings such as a room[1–3], during vapers’ conventions[4,5], and in vape shops and their neighbouring businesses[6]. Some TSNAs, such as N-nitrosonornicotine and nicotine-derived nitrosamine ketone, which are carcinogenic[7], hav...
Show MoreNOT PEER REVIEWED
I wish to express my dismay with the clear and obvious intention to promote an agenda of fear. One might ask why you are not looking to see whether there actually are any harms from second hand aerosol as the study clearly acts upon a preface that this is the case. I would point you to the CDC's own testing of the air quality found here. Something smells a lot less like science and a lot more like virtue signalling funded by an agenda eager to skip the important part of knowing what you're dealing with before searching for potential victims.
https://tobaccoanalysis.blogspot.com/2017/05/vape-shop-air-sampling-by-c...
NOT PEER REVIEWED
Thank you for the opportunity to clarify and correct some of the recent statements about our research article, ‘Exploring the Twitter activity around the eighth meeting of the Conference of the Parties to the WHO Framework Convention on Tobacco Control’.
Mr Sarangapani, Director of the Association of Vapers India (AVI), is incorrect in claiming that our article makes “false allegations” and “unsubstantiated claims”, and that it frames AVI as a tobacco industry (TI) front group. We categorise his organisation as a ‘next generation product (NGP) advocate’ and we state that AVI is a member of the International Network of Nicotine Consumer Organisations (INNCO). We also report that INNCO has received funding from the Foundation for a Smoke-Free World (FSFW),[1] which is an organisation that continues to be funded solely by Philip Morris International.[2] Thus, AVI is a member of an organisation that receives indirect funds from Philip Morris International, via the FSFW. Those statements are factual and substantiated; readers can locate further details and references to the FSFW’s grantees and tax returns via our Tobacco Tactics pages, as referenced in our article. In his letter, Mr Sarangapani points out that the Founder-Director of AVI is the current President of INNCO’s Governing Board; however, our research article makes no mention of that fact. We clearly state that: “We found no evidence that the individuals affiliated with INNCO or its mem...
Show MoreNOT PEER REVIEWED
I am writing as co-founder of Pro-Vapeo Mexico, a non-profit consumer association affiliated with the International Network of Nicotine Consumer Organisations (INNCO), explicitly mentioned in the article “Exploring the Twitter activity around the eighth meeting of the Conference of the Parties to the WHO Framework Convention on Tobacco Control”. The authors of this article explicitly recognize that “We found no evidence that the individuals affiliated with INNCO or its member organizations were themselves funded by FSFW [Foundation for a Smoke Free World] or by the TI [Tobacco Industry] directly”. While this statement is correct, it still leaves missing information that we believe it is necessary and useful, for the benefit of your readers, to fully clarify: not only has Pro Vapeo Mexico never received any funding (direct or indirect) from any industry sector (tobacco, e-cigarettes or pharmaceutical) or from INNCO or the FSFW, we are a fully independent NGO whose activities are not (and have never been) directed by the TI or the FSFW or INNCO. Our affiliation with INNCO stems from its role as an umbrella organization grouping consumer associations worldwide united in advocating for Tobacco Harm Reduction, a strategy to improve global health by providing adult smokers the option to consume nicotine without having to inhale toxic cigarette smoke.
Regrettably, the authors of the above-mentioned article claim that our twitter activity in the...
Show MoreNOT PEER REVIEWED
When doing scientific research, following the scientific method, you have a hypothesis (question) that you are going to investigate - in this case: Does xxx consumer organisation have any direct ties to tobacco companies that influence their advocacy?
After you have chosen your method, you then gather your evidence, make an objective analysis and state your findings and make a conclusion.
Your method SHOULD be thorough and your research should be objective in order to maintain the integrity of your research (and yourself). The evidence will either prove/disprove your original hypothesis.
Instead, the authors have chosen to not only demonise the participation of consumers in the narrative of their own health, one has lobbied false claims about tobacco industry connections that do not exist.
It is very concerning that the authors find it necessary to disenfranchise the very people who are fighting for their right to make informed choices about their health. It defies logic, and the principles of fairness and decency.
It perhaps would have been more helpful to all concerned if the authors had done due diligence beyond looking at a website that does not have verified information, to cast aspersions on consumer advocacy organisations.
It definitely would be more productive to welcome the voices of the people for whom felt impassioned enough to get involved in consumer advocacy to help smokers not only hav...
Show MoreNOT PEER REVIEWED
Show MoreIt is disappointing to see the BMJ publishing a research paper which smears consumer advocates for tobacco harm reduction by attempting to link consumer activity on social media with the tobacco industry. One can only conclude that the goal was to devalue the opinions of former smokers who have found safer nicotine products to have been beneficial to their lives.
I write as chair of the UK New Nicotine Alliance and as it is highly likely that tweets from our supporters have been included in this research, so we welcome the right to reply to the article.
The attempt to paint consumers as part of some mythical tobacco industry plot is offensive to individuals and organisations promoting tobacco harm reduction. We and our supporters, along with many other vapers, are systematically excluded from the FCTC conferences and yet have a strong stake in the outcomes of the meeting. Social media is one of the few opportunities we have to get our views across. Consumers of safer nicotine products have been acutely aware of an increasing warfare against the products which have helped them to stop smoking.
In 2018, there were clear threats being expressed by the WHO FCTC in advance of COP8 towards products that vaping consumers value highly for helping them to quit smoking. Many vapers travelled to Geneva in 2018 at their own expense, but as ‘members of the public’ were excluded from the meeting.
The article by Robertson et al was funded b...
NOT PEER REVIEWED
Show MoreFreedom of speech is a fundamental right in a free society. There is no justification to either interfere with the right of stakeholders to participate in the public debate regarding tobacco harm reduction policy, or to malign those that exercise that right. Given that the outcome of these policy discussions will affect the lives of more than one billion people on the planet who smoke, everyone must be free to advance arguments for and against any policy, and each argument must be scrutinized and evaluated on its evidence base and merits. Unfortunately, the recent paper in Tobacco Control—Exploring the Twitter activity around the eighth meeting of the Conference of the Parties to the WHO Framework Convention on Tobacco Control—missed the opportunity to do this.
Instead of engaging in a discussion on the key issues and arguments put forth in the public discussion around the eighth meeting of the Conference of the Parties (COP8), the authors employ diversionary ad hominem tactics. They mischaracterize Philip Morris International’s (PMI’s) legitimate participation in the public debate on the role that products with the potential to reduce the risk of harm compared to smoking can play in global public health policy. Using phrases like ‘tobacco industry actors’ and ‘front groups’ the authors falsely imply that any person or organization who publicly supports tobacco harm reduction are paid to do so by the tobacco industry, and specifically PMI....
NOT PEER REVIEWED
It’s surprising finding oneself involuntarily part of a research study. Given no chance to contribute, perhaps I can offer privileged insight into the processes the authors seek to describe.
Analysis of tweets around the COP8 meeting show that nicotine consumer advocates were the most active, followed by public health advocates and the tobacco industry. My company – Knowledge Action Change – also tweeted, at the Geneva launch of our tobacco harm reduction report. [1] Tweeting by tobacco harm reduction advocates out-shadowed “official” FCTC messaging (and if the authors had searched #FCTCCOP8 and #COP8 as well as #COP8FCTC, they would have uncovered more).
The article asserts that tobacco industry money is behind this activity. But it is beyond this study’s narrow methodological reach to illuminate why nicotine consumer advocates tweet. My discussions with nicotine consumer advocates – the majority of whom are volunteers - demonstrate passionate interest in the policymaking that influences their lives. Having found safer alternatives to smoking, they fear that inappropriate regulation including bans will see their options disappear. They are frustrated that they are ignored by tobacco control policymakers, regulators and researchers. Barred from COP8 along with the public and press, consumer organisations are also barred from the NGO coalition Framework Convention Alliance. No other field of health policy excludes the affected. Consu...
Show MoreNOT PEER REVIEWED
We appreciate the authors’ concern about industry “astroturfing.” We believe astroturf activities undermine the genuine consumer movement that INNCO and its members represent. But the conclusions that the authors draw from their research are attenuated and inaccurate. In particular, we object strenuously to the authors’ conclusion that because INNCO has received funding from the Foundation for a Smoke-Free World (the Foundation), we are a tobacco front group.
INNCO was formed in 2016, a year before the Foundation was established. All of INNCO’s members are autonomous, independent consumer organisations, and with rare exception are run by volunteers on a shoe-string budget. These organisations joined forces to create INNCO, and they nominate and elect INNCO’s Governing Board members, who serve without compensation.
INNCO only accepts funding from sources where our independence as an organisation run by and for consumers is assured. INNCO operated for more than two years with only volunteer efforts and no funding. (Funding from the Foundation was received in December of 2018, which is after the period this paper covers.)
As the authors note, INNCO was formed in large part to ensure the consumer voice is heard on international platforms. However, we question the authors’ intent in casting our desire to engage as legitimate stakeholders as nefarious.
While the authors have cited numerous references on the motivations of t...
Show MoreNOT PEER REVIEWED
We object to the framing of Association of Vapers India (AVI), erroneously referred to as ‘Vape India’ in the paper, as a tobacco industry front group, without providing any basis for the claim except our membership of International Network of Nicotine Consumer Organisations (INNCO).
AVI was organised in August 2016, when consumers of low-risk alternatives came together to arrest the tide of state bans in India, which were being lobbied for by the Bloomberg Philanthropies network the authors belong to.[1] Though one of our directors is the current president of INNCO’s governing board, elected through a member vote in the 2020 General Assembly, he is serving in unpaid, honorary capacity.
AVI has not received funding from INNCO, nor from the Foundation for Smoke-free World (FSFW), and neither from the tobacco industry. Our work is financed through voluntary contributions, and like INNCO, the affairs are conducted by a governing board comprising unpaid consumer volunteers.
It is scurrilous to cast AVI as a tobacco industry group or anything other than a consumer-led movement that is seeking access to harm reduction avenues for India’s nearly 270 million tobacco users, among whom cancers are rising[2] even as most have meagre means to deal with the health consequences, which makes harm prevention a vital mitigation strategy. We are product agnostic and advocate access to lower-risk alternatives for both smokers and smokeless tobacco...
Show MoreNOT PEER REVIEWED
Recent work from Ilies et al. (1) is very informative toward understanding the degree to which heated tobacco products might confer less health risk than combusted cigarettes. This publication extends well beyond the existing HTP emissions evidence base, much of which was not conducted by independent groups. The authors should be commended for leveraging strong methodology, and for their comprehensive evaluation of toxicants generated by these products.
While the methodology and results of this publication appear sound, there are a number of inaccurate claims that warrant criticism in the second paragraph of the Introduction section:
• The second paragraph discusses nicotine vaping products (e-cigarettes), however citation #2 (Centers for Disease Control and Prevention (CDC). Use of cigarettes and other tobacco products among students aged 13-15 years--worldwide, 1999-2005. MMWR Morb Mortal Wkly Rep 2006;55:553) utilize data from 1999 through 2005, which mostly spans a time frame prior to the invention of the first e-cigarette in 2004 (2), and certainly spans a timeframe prior to their widespread marketing in the United States. The citation follows the sentence “However, the death toll provoked by their [e-cigarettes] consumption has increased significantly, reaching 650,000 annually, and it is likely to rise over the coming year…” This citation is clearly inapplicable to the unfounded claim being made about deaths attributable to e-ci...
Show MoreNOT PEER REVIEWED
The meta-analysis by Khouja et al. confirms the strong association in young people between e-cigarette use and subsequent smoking.[1] The critical issue is whether the relationship is causal. If there is a causal relationship, there are several factors which diminish its impact.
Firstly, most of the studies used ‘ever smoking’ as the outcome. Ever smoking is a poor marker for smoking-related harm as most smoking by vapers who later smoke is experimental and infrequent and few progress to established smoking (100+ lifetime cigarettes). Shahab et al. found that only 2.7% of youth who tried e-cigarettes first progressed to established smoking. Only established smoking is linked to significant smoking-related death and disease.[2]
Secondly, the absolute number of non-smokers who progress from vaping to smoking is small as smoking precedes vaping in the vast majority of cases (70-85%).[3] If there is a gateway from vaping to smoking, this only affects a minority of young vapers.
Thirdly, the authors use Bradford Hill’s dose-response and specificity criteria to assess whether the association between vaping and subsequent smoking is likely to be causal.
They acknowledge that the dose-response criterion is mostly based on nicotine dependence, indicating that that nicotine dependent vapers are more likely to progress to smoking. However, nicotine dependence in non-smoking vapers is rare, less than 4% in the 2018 National Youth T...
Show MoreNOT PEER REVIEWED
Miech and colleagues demonstrate declines in prevalence of non-medical use of prescription drugs among US high school students and show that these declines can be explained by trends in cigarette smoking.1 These observations are taken as support of the gateway hypothesis in which cigarette smoking increases the likelihood of subsequent other drug use. The authors further argue that these results are inconsistent with a ‘common liability’ model, and that the common liability model predicts that adolescent drug use would have “stayed steady or even increased as adolescents continued to use these drugs regardless of whether they smoked.” In this scenario, adolescents with a predilection toward substance might substitute cigarettes with other drugs as smoking rates decline.
However, this conceptualization of the common liability model is inconsistent with how such models are typically understood. Models that posit a common liability do not assert that the degree of liability is fixed in the population, such that changes in risk for use of one drug increases risk for other drug use. Instead, common liability can be influenced by environmental factors and environmental changes can coherently impact multiple outcomes, resulting in trends similar to those observed by Miech and colleagues.
For over 40 years, Problem Behavior Theory has provided a comprehensive theory and empirical approach to common liability. “Problem behaviors” (later termed...
Show MoreNOT PEER REVIEWED
This is a well written original research about the burning issue of tobacco manufacturer lobbying. These manufacturing industries have developed strategies to undercut minimum price laws. By increasing tobacco taxes an effective policy has been designed to decrease tobacco use. In Pakistan currently, 209 million people smoke and about 83 billion cigarettes are smoked per year. As Pakistan has not ratified any anti-smoking policies, there should be great effort made to raise excise duties and taxes on tobacco companies to reduce the demand for cigarettes. In 2017 the local price of cigarettes was about 75 rupees of which half was excise duties [1].
With this expansion of taxes, there will be responses of reducing tobacco consumption, but the cigarette manufacturing industries developed specific promotions and lobbies to encourage their consumers to purchase lower taxed or lower priced tobacco products. It is the responsibility of health authorities to regulate the prices and promotion of such hazardous products [2]. According to WHO, “MPOWER” was the slogan in 2015, according to which M= monitor tobacco usage, P= Protect people from tobacco smoke, O= offering help to quit tobacco use, W= warning about its hazards, E= enforce to ban its advertisement, R = Raise tobacco taxes [3].
For smoke free Pakistan and all over the world four key factors should be instruments: Education, legislation, quitting support and financial policies.
1....
Show MoreNOT PEER REVIEWED
It should be noted that the Aspire Cleito coils used in this study have a manufacturer stated operating power range of between 55 and 75 watts. This is noted both on the box and laser etched into the side of the coil housing proper. it should be noted that the first data points in the graph ( to demonstrate the presence of CO in both liquid samples are in excess of the stated power range of the element.
"Strawnana" at 80 watts
"Black Ice" at 100 watts
This leads me to question the normalizing curve for the black ice sample as there are no data points in the graph (Figure 2) within the manufacturer noted operating range for that coil.
Furthermore, while this statement " ...though the bulk liquid temperature is controlled by boiling limits of the e-liquid component" would be accurate were the coil to be completely submerged in liquid, the mechanics of coil design will confound that principle. The resistance coils in electronic cigarettes are not, by design, submerged in liquid, they are in contact with a liquid saturated wick. Any heat energy applied to the coil whether in magnitude or duration, that exceeds the supply of liquid saturating the wick will result in a temperature spike which could cause the temperature to spike causing thermal degradation of what liquid does remain, and the singeing of the cotton wick.
It can be expected that where combustion occurs, carbon compounds will...
Show MoreNOT PEER REVIEWED
The atomizer used for testing has a maximum rating of 80 watts.
200 watts was applied. Needless to say, horrible results occurred.
This is not reputable science, it is a failed experiment, it should never have been published.
NOT PEER REVIEWED
Greetings –
We thank you for your response to our paper. We honor and acknowledge that there are more than 564 Tribal Nations and that each has their own name and language. In this article, we used the term “American Indian,” which was a decision guided by our long-standing work with cultural advisors in Minnesota. While we chose to use the term “American Indian,” we recognize that each Tribe and individual may prefer to use a different term. For additional context, please see another article titled “Why the World Will Never Be Tobacco-Free: Reframing “Tobacco Control” Into a Traditional Tobacco Movement,” available at https://www.ncbi.nlm.nih.gov/pmc/articles/PMC4984762/
NOT PEER REVIEWED
Whilst it is true that Juul is not exactly popular with those on either side of the fence this article fails to address the major issue.
The impending regulation which Juul is said to have brought down on the vapor industry helps Juul by eliminating the competition. Only they, and other brands owned by tobacco companies have any hope of being able to afford the process to keep their products on the market. Independent manufacturers and the retailers who sell their products will simply be obliterated.
Considering that these are people who who have dedicated their lives and often their life savings to helping people switch to safer alternatives, and who are by far and away the most efficient at enforcing strict age verification for purchases, this is a tragedy, not something to be celebrated.
Lastly, as if it still needs to be said, the outbreak of acute lung injury in the US has not been linked with Juul, or any other commercially available nicotine vaping product.
I 100% understand the general good intent of this paper. I also must say that I am Cherokee but not "fullblooded" Cherokee. I did grow up in the heart of the Nation, though. However, could people please stop using the term "American Indian"? Indians are from India. Columbus got lost (even though he was a navigator), ran the one ship he captained aground where he was found by the Native population of the island he smashed into (which for the record was not anywhere near North America). He looked around and thought, "I'm on a beach, I was trying to find India, India has a beach. These people are not white, they are tan, Indians are tan! I'm in India!" He then spread his stupid to the world. Now every tan person originating from any American continent (which are when put together the same land mass as the entire "known" world at that time) are all Indians... Please stop. It's just offensive.
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.
Addressi...
Show MoreNOT 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...
Show MoreNOT PEER REVIEWED
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...
Show MoreNOT PEER REVIEWED
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.
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.
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...
NOT PEER REVIEWED
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.”...
Show MoreNOT 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 ti...
Show MoreNOT 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...
Show MoreNOT PEER REVIEWED
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...
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...
Show MoreNOT PEER REVIEWED
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.
...
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
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...
Show MoreNOT PEER REVIEWED
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...
NOT PEER REVIEWED
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 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?
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 mo...
Show MoreNOT PEER REVIEWED
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...
NOT PEER REVIEWED
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...
Show MoreNOT PEER REVIEWED
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...
Show MoreNOT PEER REVIEWED
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....
Show MoreNOT PEER REVIEWED
We thank Dr. Jarvis for his appreciation of our historical scholarship but disagree that our conclusion, “the promotion of tobacco harm reduction may serve the interests of tobacco companies more effectively than the public,” is an attack.
Our paper is about how policy affects ideas and vice versa. The ideas guiding the product modification program led to bad outcomes. That these ideas have been reanimated merits critical assessment. Voluntary agreements led to industry influence over the ISCSH’s recommendations, which in turn undermined public health. We point out that some of the same premises that led the ISCSH astray are popular again. Jarvis claims that current UK harm reduction policy has nothing to do with the product modification program, and everything to do with the influence of the late Michael Russell. Russell’s impressive scholarship – and oft-quoted statement, “people smoke for the nicotine, but die from the tar” – is indeed hugely influential among proponents of tobacco harm reduction. Jarvis posits that Russell’s work serves as a “paradigm shift” on which the UK’s current embrace of long-term nicotine maintenance and tobacco harm reduction actually rests, and which severs any link between the failures of product modification and widespread fears of a redux today.
Yet Russell’s work represents more a variation in theme than it does revolution in content. Russell’s policy recommendations operate from the same premises a...
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...
Show MoreNOT PEER REVIEWED
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...
Show MoreNOT PEER REVIEWED
The paper, “Potential deaths averted in USA by replacing cigarettes with e-cigarettes” by David Levy et al. published in Tobacco Control on October 2, 2017, attracted a moderate amount of attention with its conclusion that “Compared with the Status Quo, replacement of cigarette by e-cigarette use over a 10-year period yields 6.6 million fewer premature deaths with 86.7 million fewer life years lost in the Optimistic Scenario. … Our projections show that a strategy of replacing cigarette smoking with vaping would yield substantial life year gains, …”
This is a pretty impressive result until you consider that the Optimistic Scenario is based on a series of assumptions that are of which are inconsistent with empirical evidence to date:
Cigarette smoking prevalence drops from 17% to 5% in 10 years (from 19.3% to 4.6% in men and from $14.1% to 4.6% in women between 2016 and 2026).
The existence of e-cigarettes does not, on average, depress quitting cigarettes.
There is no relapse from e-cigarette use to cigarette smoking.
No youth who initiate with e-cigarettes progress to cigarette use.
No dual use of cigarettes and e-cigarettes.
The evidence free claim that e-cigarettes are 5% as dangerous as cigarettes.
(These assumptions were not clearly stated in the main paper; we figured them out based on the appendix and by examining the Excel spreadsheet of the model that the authors s...
Show MoreNOT PEER REVIEWED 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.
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...
Show MoreNOT PEER REVIEWED
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...
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...
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.
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...
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...
Pages