516 e-Letters

  • Study alleging Philip Morris International used the EVALI outbreak to market IQOS requires substantial methodological revision and further peer review, or retraction


    A brief review of this ‘Industry Watch’ article alleging heated tobacco product advertising through an earned media approach highlights significant methodological errors that are serious enough to invalidate the article’s conclusions, including its title. The authors allege that Philip Morris International (PMI) used the e-cigarette, or vaping, product use associated lung injury (EVALI) outbreak to promote IQOS in September 2019 and the weeks that followed. Using the authors’ own tool (TobaccoWatcher.org), we replicated their search strategy and revealed several fundamental and concerning errors in the authors’ analysis.

    They report a rise in news stories mentioning IQOS on and after 25th September 2019, and falsely attribute this rise to an article published on our website on 24th September 2019, which they also falsely describe as a “press release”, despite it never being published through a press release distribution service. Our analysis shows that the authors failed to consider several confounding and unrelated events that caused the rise in news coverage of both IQOS and EVALI during the time period in question and which can be found by replicating the authors’ search strategy in TobaccoWatcher.org.

    For example, on 25th September 2019, Philip Morris International (PMI) issued a single press release via Business Wire (1) entitled “Philip Morris International Inc. and Altria Group, Inc. End Merger Discussions” (PMI/Altria Annou...

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  • Trials Transparency in E-cigarette Research


    On behalf of my co-authors, we thank Dr. Mishra for taking the time to comment on our paper examining reporting of trials registered by Juul Labs Inc.

    We do not doubt that Juul has submitted the results from all of these studies to the FDA as part of their Premarket Tobacco Product Application (PMTA). Unfortunately, this step does not ensure the full results of these trials will be made available to the public, clinicians, and other key stakeholders.

    We also acknowledge and appreciate that since conducting our analysis in August 2020, two additional studies, of the five we examined, have appeared in the peer reviewed literature (published in December 2020 and January 2021)[1,2] and additional results may become available through other methods. We understand that these publications may contain additional outcome reporting compared to the posters we assessed. We welcome any and all additional results disclosures from Juul Labs. That said, we believe the risk of outcome reporting bias remains and is, unfortunately, not addressed in Juul’s comment despite being a major facet of our paper. The one publication that was available as of our analysis date excluded 4 of the 19 prespecified secondary outcomes without comment and another 5 outcomes had clear issues in their reporting compared to the registered outcomes. While we have not conducted a detailed assessment of the two new publications, it is apparent that journal publication does no...

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  • Response to “E-cigarette manufacturers’ compliance with clinical trial reporting expectations: a case series of registered trials by Juul Labs.”


    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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  • Review of this study suggests its findings are based on a major confounding error


    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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  • Our original findings and conclusions remain plausible


    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 to criticisms suggests White Hat Bias

    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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  • Authors’ Response Reveals Several New and Serious Issues

    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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  • Our primary assertion is not impacted by the limitations in our statistical analyses

    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...

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  • Some discrepancies and limitations


    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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  • Response to Wang, 'Some discrepancies and limitations'


    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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