eLetters

519 e-Letters

  • In reply: Youth tobacco use before and after flavoured tobacco sales restrictions in Oakland, California and San Francisco, California

    NOT PEER REVIEWED
    These arguments by Pesko and Friedman cannot undo the central flaw in the Friedman paper. We are surprised that Pesko and Friedman continue to argue that Friedman’s analysis of the YRBSS fall data as “after” data is valid despite the Friedman paper defining the exposure variable as follows: “A binary exposure variable captured whether a complete ban on flavoured tobacco product sales was in effect in the respondent’s district on January 1 of the survey year.”[1] If Friedman had intended to treat the period immediately after July 21 2018 as the “after” period, why had she not selected July 21 of each year as the cut-off date for indicating exposure to the policy effects? It seems apparent that Friedman chose the January 1, 2019 as the cut-off for “after” data because she knew this was the enforcement date and she assumed wrongly that the YRBSS data were collected after January 1, 2019. This is evident in her own response[2] to a critique[3] of her paper as we already noted in our previous response.[4]
    Friedman states that “the official/legislated effective date are used to ensure that resulting estimates capture unconfounded responses to the policy change.” Again, if this approach made sense in the specific San Francisco case, why did Friedman use January 1, 2019 in her paper? Perhaps because it simply doesn’t make sense to attribute a policy’s effects before the policy is actually implemented. Similarly, the use of enforcement date rather than...

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  • Revisiting the Research on Flavor Bans and Youth Smoking: A Response to Liu et al (2022)

    NOT PEER REVIEWED
    On March 17th, 2021, Tobacco Control published a paper online revealing that the 2019 wave of the Youth Risk Behavior Surveillance System (YRBSS) in San Francisco was fielded in the fall of 2018, as opposed to spring of 2019 as is typical for that survey. [1] On March 21st 2022, I received confirmation from San Francisco’s YRBSS site coordinator that the 2019 wave was fielded from November 5th, 2018 to December 14th, 2018. I appreciate Liu and colleagues bringing this to light. However, their claim that this information invalidates the findings from my 2021 JAMA Pediatrics paper [2] —linking San Francisco’s ban on sales of flavored tobacco and nicotine products to increases in youth cigarette smoking—is both methodologically and historically inaccurate: it overlooks both the assumptions required for difference-in-differences research designs and the full timeline of San Francisco’s flavor ban implementation.

    In its simplest form, a difference-in-difference (DD) analysis of a particular policy compares outcomes in jurisdictions that did vs. did not adopt the policy, before vs. after that policy officially went into effect (See Figure at https://figshare.com/articles/figure/Figure_1_BasicDDExplanation_pdf/203...). If time-trends in the adopting and non-adopting jurisdictions’ outcomes were parallel in the pre-policy period, the non-adopters’ trends are c...

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  • What did you expect?

    NOT PEER REVIEWED
    If PMI attempted to profit from the “EVALI” scaremongering they could only do so because of the blatantly dishonest reporting of that issue by federal authorities, activist academics, tobacco control organisations and the media who quote them with question. It was obvious as early as August 2019 that the lung injuries were caused by black market THC cartridges cut with vitamin E acetate and not nicotine containing e-cigarettes and the CDC eventually came to the same conclusion. Yet activists in positions of authority continue to link the injuries with nicotine vaping, thus providing a fertile ground of misinformation in which such marketing campaigns can flourish.

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

    NOT PEER REVIEWED

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

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

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

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  • Trials Transparency in E-cigarette Research

    NOT PEER REVIEWED

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

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

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

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

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

    NOT PEER REVIEWED

    A review of this study has been published by the target of its criticism, the tobacco company Philip Morris International (PMI), via the post-publication review server Qeios [1]

    The main finding of this study, and the allegation raised in its title, is that PMI cynically used an outbreak of lung injuries in the United States (initially but incorrectly attributed to nicotine vaping) to promote its heated tobacco product, iQOS. Heated tobacco products are one alternative to vaping for those looking for a safer alternative to smoking. On 24th September 2019, PMI published an information notice about its products in response to the lung injury outbreak. The authors assert that PMI was trying to gain commercial publicity from a health crisis: a serious allegation. But the allegation appears to be based on a major error by the authors.

    The study used a "fully automated media analysis engine" to count stories that mention iQOS around that time, showing that there were considerably more than usual. On this basis, the authors concluded that PMI's unethical promotional gambit had worked. However, the day after PMI allegedly disreputably sought publicity for iQOS, the company also issued a press release disclosing that merger negotiations with the American tobacco company, Altria, had ceased. PMI and Altria have a joint marketing agreement for iQOS in the United States. The end of merger talks would be big news in the business pre...

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  • Our original findings and conclusions remain plausible

    NOT PEER REVIEWED

    We thank Dr. Moira Gilchrist (1) for her careful attention to our work (2). Gilchrist argues our principal findings were erroneous and any change in news coverage of IQOS and the e-cigarette, or vaping, product use associated lung injury (EVALI) outbreak were confounded by other Philip Morris International (PMI) media materials and not those specifically discussing EVALI and IQOS (3) which we attributed our findings to. However, a deeper inspection of this argument suggests our original findings and conclusions remain plausible.

    Tobacco Watcher is a dynamic resource with continuous data collection and processing. Thus, the results of analyses on the platform can vary over time. On June 10, 2021 we replicated our analysis. After correcting an error that the PMI’s materials on EVALI and IQOS (3) was initially published on 24 September 2021 (not 25 September) the principal finding is unchanged. News coverage mentioning both “IQOS” and EVALI (i.e., including the terms ‘vaping’ and ‘illness’) reached an all-time high immediately after PMI published materials about EVALI and IQOS on their website. Thirty days prior to PMI posting this material (August 25th through September 23rd) 2.0 news stories per day matched our search compared to 12.8 for the 30 days after their publication (September 24th through October 23rd), with 384 news reports matching our keyword search for the latter period. Our original assertion that there were 14 duplicate articl...

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  • The authors' response to criticisms suggests White Hat Bias

    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...

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  • Authors’ Response Reveals Several New and Serious Issues

    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...

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