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.
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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.
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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...
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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.
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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.
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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.
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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...
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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.
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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.
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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...
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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
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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...
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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.
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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...
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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/
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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...
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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.
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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...
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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,...
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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...
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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...
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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.
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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...
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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...
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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...
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