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
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}
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.
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/
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
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.
We thank Cummings and colleagues for their interest in and comments on our umbrella review published recently in Tobacco Control.[1] The authors criticize us for not including the latest studies. Yet, for an umbrella review, those studies need to be in a published review to be included, as we indicated in our methods and limitations. Generally, given the lengthy review and publication processes, any review will not be inclusive of all studies in a field that has as high a publication breadth and intensity as tobacco regulatory science. In addition, the authors mentioned that our meta-analysis was not available in PROSPERO pre-registration. This is because the review registration was completed in the very early stages of the review. We have updated this information in PROSPERO now to include the meta-analysis. The issue of overlap was addressed in our limitations, as we had to screen over 3,000 studies included in our selected reviews. However, given the importance of this issue for the meta-analysis, we performed a new meta-analysis that included the individual studies in each domain instead of using the odds ratio reported by the review to eliminate the effect of including the same study more than one time on our results. We confirm that the results of the new meta-analysis, which includes each study only once, are similar to the original meta-analysis (Supplement A: https://www.publichealth.me...
We thank Cummings and colleagues for their interest in and comments on our umbrella review published recently in Tobacco Control.[1] The authors criticize us for not including the latest studies. Yet, for an umbrella review, those studies need to be in a published review to be included, as we indicated in our methods and limitations. Generally, given the lengthy review and publication processes, any review will not be inclusive of all studies in a field that has as high a publication breadth and intensity as tobacco regulatory science. In addition, the authors mentioned that our meta-analysis was not available in PROSPERO pre-registration. This is because the review registration was completed in the very early stages of the review. We have updated this information in PROSPERO now to include the meta-analysis. The issue of overlap was addressed in our limitations, as we had to screen over 3,000 studies included in our selected reviews. However, given the importance of this issue for the meta-analysis, we performed a new meta-analysis that included the individual studies in each domain instead of using the odds ratio reported by the review to eliminate the effect of including the same study more than one time on our results. We confirm that the results of the new meta-analysis, which includes each study only once, are similar to the original meta-analysis (Supplement A: https://www.publichealth.med.miami.edu/_assets/pdf/meta-analysis.pdf).
The authors also accuse us of not being transparent about our adopted classification of evidence strategy, while a careful check of the reference we provided shows it (Morton et al. Page 131 (Box 4-2).[2] This classification is also adopted by the National Academies of Sciences.[3] Our assessment of the gateway effect as high evidence is consistent with this classification (National Academies of Sciences, Engineering, and Medicine 2018; Page 5, Box S-2: High evidence (including conclusive and substantial) (Supplement B: https://www.publichealth.med.miami.edu/_assets/pdf/level-of-evidence.pdf).[3] Generally, we object to the authors’ characterization that observational studies cannot imply causality. In fact, carefully designed observational studies led to most of what we know about major risks to health, such as smoking, hypertension, diabetes, and high cholesterol levels.[4-7]
We excluded research supported by the tobacco industry, given the ample evidence of the industry's fraudulent scientific behavior, which prompts objective scientists to question the extent to which industry-sponsored authors report methods and results accurately.[8, 9] We note that our stance regarding industry-supported publications is also consistent with the policy of Tobacco Control. Contrary to the commentary’s critique, the message about nicotine’s effect on the developing brain is supported by evidence from human and animal studies and endorsed by the CDC as well as major credible public health bodies.[10-13]
The authors state that comparing ENDS to cigarette smoking is needed, given their potential to help addicted smokers quit. Alas, an accurate comparison of these products is currently not feasible. Unlike cigarettes, which were suspected of causing lung cancer as far back as the late 19th century and for which we have more than a half-century of robust evidence of the health effects, we have much more modest literature on ENDS health effects, spanning less than two decades.[14] Also, unlike today’s combustible cigarette, a rather standardized tobacco use method with a standardized pattern of use and standardized assessment tools, ENDS are not standardized. The heterogeneity of ENDS products, their use patterns, and still nascent long-term ENDS exposure assessment tools make accurate comparisons impossible. In fact, even the same product, manufactured by the same maker, can have variability in its liquid content and ingredient proportions.[15] While the commentary criticized our review based on the acknowledged lack of long-term data about ENDS effects on health, they make an unsubstantiated claim that the group most likely to use ENDS on a persistent basis are smokers.
To navigate the complexity of ENDS, we adopted a consumer rights stand that recognizes that every consumer needs to be aware of the potential risks and benefits of the products they are using. So, although the evidence is inconclusive about the real-world effects of ENDS in helping smokers quit, and the fact that the FDA has not yet approved any of them as a cessation device, we have created some messages to support this based on evidence from randomized clinical trials.[16] We agree that it will take more time before robust scientific evidence about the long-term effects of ENDS accumulates, but this lack of knowledge should not be an excuse for failing to alert users of potential adverse health consequences of ENDS use. The public has a right to know whether any novel product that was being used by a significant proportion of the population contains known toxicants, despite lacking robust evidence of long-term effects on health. Why should ENDS be any different?
References
1. Asfar, T., et al., Risk and safety profile of electronic nicotine delivery systems (ENDS): an umbrella review to inform ENDS health communication strategies. Tobacco Control, 2022: p. tobaccocontrol-2022-057495.
2. Morton, S., et al., Finding what works in health care: standards for systematic reviews. 2011.
3. National Academies of Sciences, E., Medicine., Public health consequences of e-cigarettes. 2018.
4. Mahmood, S.S., et al., The Framingham Heart Study and the epidemiology of cardiovascular disease: a historical perspective. The lancet, 2014. 383(9921): p. 999-1008.
5. Doll, R., et al., Mortality in relation to smoking: 50 years' observations on male British doctors. Bmj, 2004. 328(7455): p. 1519.
6. Kannel, W.B. and D.L. McGee, Diabetes and cardiovascular disease: the Framingham study. Jama, 1979. 241(19): p. 2035-2038.
7. Castelli, W.P., et al., Incidence of coronary heart disease and lipoprotein cholesterol levels: the Framingham Study. Jama, 1986. 256(20): p. 2835-2838.
8. Kessler, G., Amended Final Opinion. USA v. Philip Morris, 2006.
9. Pisinger, C., N. Godtfredsen, and A.M. Bender, A conflict of interest is strongly associated with tobacco industry-favourable results, indicating no harm of e-cigarettes. Prev Med, 2019. 119: p. 124-131.
10. Centers for Disease Control and Prevention. It’s not like you can buy a new brain. 2019 [cited 2022 November 29th]; Available from: https://www.cdc.gov/tobacco/basic_information/e-cigarettes/Quick-Facts-o...
11. Goriounova, N.A. and H.D. Mansvelder, Short-and long-term consequences of nicotine exposure during adolescence for prefrontal cortex neuronal network function. Cold Spring Harbor perspectives in medicine, 2012. 2(12): p. a012120.
12. England, L.J., et al., Nicotine and the developing human: a neglected element in the electronic cigarette debate. American journal of preventive medicine, 2015. 49(2): p. 286-293.
13. Surgeon General, U., E-Cigarette Use Among Youth and Young Adults. A Report of the Surgeon General. 2016, Retrieved from Atlanta, GA: https://ecigarettes. surgeongeneral. gov ….
14. Proctor, R.N., The history of the discovery of the cigarette–lung cancer link: evidentiary traditions, corporate denial, global toll. Tobacco control, 2012. 21(2): p. 87-91.
15. Yassine, A., et al., Did JUUL alter the content of menthol pods in response to US FDA flavour enforcement policy? Tobacco control, 2022. 31(Suppl 3): p. s234-s237.
16. Hajek, P., et al., A Randomized Trial of E-Cigarettes versus Nicotine-Replacement Therapy. N Engl J Med, 2019. 380(7): p. 629-637.
The paper by Asfar et al (1) had a noble objective, which was to inform ENDS health risk communications by updating the 2018 evidence review by the US. National Academies of Sciences, Engineering and Medicine (NASEM) (2). The need for improved risk communications about ENDS is reinforced by a recent study which found that only 17.4% of US smokers believe that nicotine vaping is safer than smoking (3). While ENDS use is not safe, the evidence from toxicant exposure studies does show that ENDS use is far safer than smoking cigarettes and may benefit public health by assisting those who smoke to quit smoking (4, 5).
An important limitation of the umbrella review method utilized by the authors is that it does not directly attempt to systematically characterize new research. This is a concern because the marketplace of ENDS products used by consumers has evolved since the 2018 NASEM report (4, 5). Furthermore, the authors have included some meta-analyses of selected reviews for some domains, but these meta-analyses were not in the Prospero pre-registration (6), nor explained in the paper. It’s thus unclear how or why certain reviews were selected for meta-analysis, and also whether the comparators are the same for these reviews. More importantly, these meta-analyses risk single studies contributing multiple times to the same pooled estimate. The authors noted this as a limitation commenting inaccurately that ‘it was impossible to identify articles that were included in...
The paper by Asfar et al (1) had a noble objective, which was to inform ENDS health risk communications by updating the 2018 evidence review by the US. National Academies of Sciences, Engineering and Medicine (NASEM) (2). The need for improved risk communications about ENDS is reinforced by a recent study which found that only 17.4% of US smokers believe that nicotine vaping is safer than smoking (3). While ENDS use is not safe, the evidence from toxicant exposure studies does show that ENDS use is far safer than smoking cigarettes and may benefit public health by assisting those who smoke to quit smoking (4, 5).
An important limitation of the umbrella review method utilized by the authors is that it does not directly attempt to systematically characterize new research. This is a concern because the marketplace of ENDS products used by consumers has evolved since the 2018 NASEM report (4, 5). Furthermore, the authors have included some meta-analyses of selected reviews for some domains, but these meta-analyses were not in the Prospero pre-registration (6), nor explained in the paper. It’s thus unclear how or why certain reviews were selected for meta-analysis, and also whether the comparators are the same for these reviews. More importantly, these meta-analyses risk single studies contributing multiple times to the same pooled estimate. The authors noted this as a limitation commenting inaccurately that ‘it was impossible to identify articles that were included in multiple reviews’. In our view this serious methodological flaw merits removal of all pooled estimates from their analyses. Additionally in several places, association is conflated with causality (e.g. “ENDS use impedes smoking cessation”) when based on observational data. The classification of evidence is also not transparent, cannot be found in the source the authors cited, and in places does not follow from the evidence presented (e.g. gateway evidence classified as high when based on observational studies).
The review also excludes research reviews supported by ENDS manufacturers. While we recognize and agree with the authors’ concerns about possible bias in industry publishing, we also believe that the exclusion of such research without any analysis of the scientific merits of the research itself precludes a comprehensive assessment of the scientific literature regarding the health risks of ENDS. Also, excluding industry publications necessarily eliminates from consideration evidence that the Center for Tobacco Products may be asked to consider when it is reviewing product applications for product marketing authorizations and modified risk claims.
The paper falls short, as well, in addressing the risk communication implications of the findings since the authors’ recommendations often do not match the evidence of what is known and not known about the risks of using ENDS. A careful analysis of suggested risk messages contained in supplementary material to the paper finds messages that do not appear to be supported by the evidence reviewed in the paper. For example, the suggested risk messages that "nicotine in vapes can harm memory, concentration, and learning in young people," "vaping nicotine can harm learning ability in young people," and "exposure to nicotine during adolescence can interfere with brain development" do not appear to be derived from a comprehensive review of scientific evidence. The evidence of nicotine having adverse effects on brain development or learning in adolescents comes primarily from rodent studies where dosing of nicotine is not necessarily analogous to exposure from ENDS.
For most of the topics reviewed, the umbrella review reveals that the health risks of ENDS remain unsettled at this time. Whilst biomarker exposure data clearly indicate reduced risk compared to tobacco cigarettes (4), we would suggest restraint is needed in communicating absolute risk information to the public (7). Also we would go one step further in noting that whatever the health risks of ENDS may be, they are going to be most observable in those persons using ENDS on a persistent basis for months or years at a minimum. For example, the health risks of cigarette smoking do not reliably emerge until after smokers exceed 10 pack-years or more of exposure (87). Few studies of ENDS health risks have actually focused on the likely higher risk group of persistent ENDS users (4).
We also take issue with the paper’s main conclusion that direct comparison between the harms of cigarettes and ENDS should be avoided (1). In fact, such comparisons are likely unavoidable and necessary since the group most likely to use ENDS on a persistent basis are those who have a history of cigarette use. Moreover, ENDS were originally developed as a cessation aid and evaluations of cessation aids almost always incorporate evidence on the relative harms compared to continuing to smoke. We do recognize that accounting for a person’s smoking history complicates evaluations of the health risks of ENDS, but dismissing such comparisons simply ignores the fact that ENDS are existing or potential cigarette substitutes for many smokers (4, 5). A recent review of biomarker studies found that compared to smoking, using ENDS leads to a substantial reduction in biomarkers of toxicant exposure associated with cigarette smoking, while also acknowledging that the degree of any residual risk from smoking remains unclear because of the lack of comparisons between long-term former smokers, and with those who have never smoked or used ENDS (4).
Communicating health risk information about ENDS has to have some context to be meaningful to consumers. A common misconception about tobacco use is that the most dangerous component of the product is nicotine (9-14). However, while nicotine can be addictive, it is the other toxicants in tobacco, especially burned tobacco, that are the true culprits of tobacco-related diseases (2, 4). Thus, when communicating information about the health risks of tobacco products, it makes sense to provide consumers with information about the relative health dangers from burned compared to unburned tobacco products. The example risk messages included in the supplementary materials to the paper appear to be developed with a goal of discouraging anyone from using a vaping product rather than to inform potential users about risks.
Public health authorities can reduce the risk of misinforming or confusing the public by acknowledging when evidence is incomplete or based on statistical association rather than clear evidence of causality, and by updating any statements or recommendations quickly when plausibly causal evidence becomes available (7).
References
1. Asfar T, Jebai R, Li W, et al. Risk and safety profile of electronic nicotine delivery systems (ENDS): an umbrella review to inform ENDS health communication strategies. Tob Control Epub ahead of print: [please include Day Month Year]. doi:10.1136/ tobaccocontrol-2022-057495
2. National Academies of Sciences, Engineering, and Medicine; Health and Medicine Division; Board on Population Health and Public Health Practice; Committee on the Review of the Health Effects of Electronic Nicotine Delivery Systems. Public Health Consequences of E-Cigarettes. Eaton DL, Kwan LY, Stratton K, editors. Washington (DC): National Academies Press (US); 2018 Jan 23.
3. Kim S, Shiffman S, Sembower MA. US adult smokers' perceived relative risk on ENDS and its effects on their transitions between cigarettes and ENDS. BMC Public Health. 2022 Sep 19;22(1):1771. doi: 10.1186/s12889-022-14168-8.
4. McNeill, A, Simonavičius, E, Brose, LS, Taylor, E, East, K, Zuikova, E, Calder, R and Robson, D (2022). Nicotine vaping in England: an evidence update including health risks and perceptions, September 2022. A report commissioned by the Office for Health Improvement and Disparities. London: Office for Health Improvement and Disparities.
5. Balfour DJK, Benowitz NL, Colby SM, Hatsukami DK, Lando HA, Leischow SJ, Lerman C, Mermelstein RJ, Niaura R, Perkins KA, Pomerleau OF, Rigotti NA, Swan GE, Warner KE, West R. Balancing Consideration of the Risks and Benefits of E-Cigarettes. Am J Public Health. 2021 Sep;111(9):1661-1672.
6. Rime Jebai, Wei Li, Oluwole Olusanya Joshua, Beck Graefe, Celia Rubio. Systematic Review of Reviews on the Harmful Effects of Electronic Nicotine Delivery Systems: Building Evidence for Health Communication Messaging. PROSPERO 2021 CRD42021241630 Available from: https://www.crd.york.ac.uk/prospero/display_record.php?ID=CRD42021241630
7. United States Surgeon General. Confronting Health Misinformation: The U.S. Surgeon General’ s Advisory on Building a Healthy Information Environment [Internet]. 2021 [cited 2022 Aug 9]. Available from: https://www.hhs.gov/sites/default/files/surgeon-general-misinformation-a...
8. Doll R, Peto R, Boreham J, Sutherland I. Mortality from cancer in relation to smoking: 50 years observations on British doctors. Br J Cancer. 2005 Feb 14;92(3):426-9. doi: 10.1038/sj.bjc.6602359.
9. O’Brien EK, Nguyen AB, Persoskie A, Hoffman AC. U.S. adults’ addiction and harm beliefs about nicotine and low nicotine cigarettes. Prev Med. 2017;96:94-100.
10. Steinberg MB, Bover-Manderski MT, Wackowski OA, Singh B, Strasser AA, Delnevo CD. Nicotine Risk Misperception Among US Physicians. J Gen Intern Med. 2021, 36(12):3888-3890.
11. Elton-Marshall T, Driezen P, Fong GT, et al. Adult perceptions of the relative harm of tobacco products and subsequent tobacco product use: Longitudinal findings from waves 1 and 2 of the population assessment of tobacco and health (PATH) study. Addict Behav. doi:10.1016/j.addbeh.2020.106337.
12. Parker MA, Villanti AC, Quisenberry AJ, Stanton CA, et al. Tobacco Product Harm Perceptions and New Use. Pediatrics. 2018 Dec;142(6):e20181505. doi: 10.1542/peds.2018-1505.
13. Yong HH, Gravely S, Borland R, Gartner C, et al. Perceptions of the Harmfulness of Nicotine Replacement Therapy and Nicotine Vaping Products as Compared to Cigarettes Influence Their Use as an Aid for Smoking Cessation? Findings from the ITC Four Country Smoking and Vaping Surveys. Nicotine Tob Res. 2022 Aug 6;24(9):1413-1421. doi: 10.1093/ntr/ntac087.
14. National Cancer Institute. Health Information National Trends Survey. HINTS 5 cycle 3, 2019. Available at: https://hints.cancer.gov/view-questions-topics/question-details.aspx?PK_...
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.
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-...
NOT 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...
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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...
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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...
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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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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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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 MoreWe thank Cummings and colleagues for their interest in and comments on our umbrella review published recently in Tobacco Control.[1] The authors criticize us for not including the latest studies. Yet, for an umbrella review, those studies need to be in a published review to be included, as we indicated in our methods and limitations. Generally, given the lengthy review and publication processes, any review will not be inclusive of all studies in a field that has as high a publication breadth and intensity as tobacco regulatory science. In addition, the authors mentioned that our meta-analysis was not available in PROSPERO pre-registration. This is because the review registration was completed in the very early stages of the review. We have updated this information in PROSPERO now to include the meta-analysis. The issue of overlap was addressed in our limitations, as we had to screen over 3,000 studies included in our selected reviews. However, given the importance of this issue for the meta-analysis, we performed a new meta-analysis that included the individual studies in each domain instead of using the odds ratio reported by the review to eliminate the effect of including the same study more than one time on our results. We confirm that the results of the new meta-analysis, which includes each study only once, are similar to the original meta-analysis (Supplement A: https://www.publichealth.me...
Show MoreThe paper by Asfar et al (1) had a noble objective, which was to inform ENDS health risk communications by updating the 2018 evidence review by the US. National Academies of Sciences, Engineering and Medicine (NASEM) (2). The need for improved risk communications about ENDS is reinforced by a recent study which found that only 17.4% of US smokers believe that nicotine vaping is safer than smoking (3). While ENDS use is not safe, the evidence from toxicant exposure studies does show that ENDS use is far safer than smoking cigarettes and may benefit public health by assisting those who smoke to quit smoking (4, 5).
Show MoreAn important limitation of the umbrella review method utilized by the authors is that it does not directly attempt to systematically characterize new research. This is a concern because the marketplace of ENDS products used by consumers has evolved since the 2018 NASEM report (4, 5). Furthermore, the authors have included some meta-analyses of selected reviews for some domains, but these meta-analyses were not in the Prospero pre-registration (6), nor explained in the paper. It’s thus unclear how or why certain reviews were selected for meta-analysis, and also whether the comparators are the same for these reviews. More importantly, these meta-analyses risk single studies contributing multiple times to the same pooled estimate. The authors noted this as a limitation commenting inaccurately that ‘it was impossible to identify articles that were included in...
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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...
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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...
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