71 e-Letters

published between 2018 and 2021

  • 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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  • 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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  • 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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  • 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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  • 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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  • 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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  • 'Tobacco crisis is industrially made' is a western construct, prevents effective solutions

    The single-minded focus in this article that only multinational tobacco companies are to blame for the tobacco epidemic presents a narrow view of the problem and ultimately prevents formulation of effective interventions. It is also a uniquely western framing which does not apply to large swathes of the developing world where most tobacco users currently live.

    In India for instance, home to the second largest population of tobacco users totaling nearly 270 million, industrially produced cigarettes form a small component of overall use, with hand-rolled bidis being far more widely used, and even more prevalent, comprising twice the number of smokers, is the smokeless form, khaini. Both bidis and khaini are produced by a largely unorganised sector and are not industrially made. This situation is mirrored across many countries in Asia and other parts of the developing world — where over 80% of tobacco users live and where 90% of tobacco cultivation is done.

    Further, about half of the global tobacco trade is run by state-owned tobacco companies (SOTCs), and a majority of these nations are part of the FCTC protocol, yet continue to operate without focus or repercussions. The Indian state owns nearly a third of the cigarette monopoly. Despite this, it currently chairs WHO’s executive board.

    Hence, to cast the tobacco crisis as industrially made and caused by multinational tobacco companies can’t be farther from the truth. While they h...

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  • What did you expect?

    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.

  • We Must Seek Harmony

    Ruth Malone's pursuit of common ground in the tobacco control and broader public health communities is most welcome. As I emphasize in a new commentary that has received wide circulation (https://drive.google.com/file/d/1C1nk1XEZ8WhnOXtCGTqHdeqomc9HOuko/view), we must collectively climb out of our bunkers, come to the table and genuinely work together. Everyone, on all sides of the concurrent debates over tobacco harm reduction and protecting youth must stop skirting the truth when it feels inconvenient and open our minds and ears to all of the science that is before us, while discouraging and abandoning studies and pronouncements that are demonstrably biased or inadequate. We must move beyond the adversarial nature of the debate and transparently acknowledge areas of ambiguity or concern.
    Combating the smoking epidemic is a social justice issue, as too little attention is now being given in many places, including the U.S., to prioritizing the importance of promoting adult smoking cessation and, for those adults addicted to smoking who cannot or are unwilling to quit nicotine -- many of whom are socially marginalized, poor, less educated, experience serious mental health conditions, or are members of the military or veterans -- helping them switch to less-hazardous, noncombustible forms of nicotine.
    Regardless of ideology and policy preferences, we...

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  • Fighting tobacco harm in the new nicotine landscape

    Professor Malone’s call for a better understanding of the context of the tobacco epidemic is timely. For tobacco as for sugar and alcohol, the extent of population harm is linked to the historic growth of an oligopoly which has used economies of scale, aggressive sales tactics and ingredient modification to transform commodities into highly-processed, convenient and affordable artefacts1-3. At a time when the pandemic has brought the role of governments in protecting the public into greater focus, the implementation of market restrictions which we know to be effective in reducing demand (higher tax, minimum price, minimum pack size)4 should receive a new impetus.

    Professor Malone’s call to unite opponents and proponents of ‘newer and novel nicotine and tobacco products’ (NNNTPs) around opposition to the tobacco industry should be heeded. Imperial Brands’s recent decision to turn back to ‘neglected’ cigarettes after being ‘overly focused’ on alternative nicotine products shows that profits, not smokers’ lives, will always be the tobacco companies’ priority5. The enormous influence exercised by the tobacco industry over governments worldwide is perhaps the most pressing tobacco control issue today, with countries including the US continuing to score highly on the Global Index of Tobacco Industry Interference6.

    As to whether NNNTPs represent a ‘breakthrough’, it is not so much the products themselves that are disruptive, but rather the...

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