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.
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}
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
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...
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 not necessarily guarantee the full reporting of all specified outcomes. This unfortunately holds true throughout the reporting of clinical research. [3, 4]
Additionally, we showed that for the conference posters identified by our searches there was a clear risk of unreported outcomes for these short-format publications. Potentially making some studies only available as posters or abstracts risks further outcome reporting issues or delays.
In Footnote 9 of the comment, Dr. Mishra states that “Section 801 of the Food and Drug Administration Amendments Act of 2007 (FDAAA) and implementing regulations issued by the National Institutes of Health (NIH) do not require registration of clinical trials involving tobacco products”
The Final Rule is entirely silent on the specific coverage status of tobacco products. Searching the Final Rule document for the word “Tobacco” reveals 0 results.[5] Another Final Rule issued well after the Sottera decision, 21 CFR 201, 801, and 1100, and an FDA guidance document both make clear that under certain circumstances tobacco products can be considered covered under the FDAAA.[6, 7]
To quote the FDA Guidance:
“If an ENDS product is marketed for tobacco cessation or for any other therapeutic purpose, the product is a drug or device, rather than a tobacco product, under the authorities of FDA’s Center for Drug Evaluation and Research or Center for Devices and Radiological Health, and appropriate approval must be sought to market a product as a drug or device.” (Page 9)
And 21 CFR 201, 801, and 1100:
“Whether the product, as used in the study, is subject to regulation as a drug depends on whether the product is being investigated for any of the purposes described in § 1100.5(a) or (b) of this rule. To determine if a product made or derived from tobacco is being investigated for one of these purposes, FDA generally would review the protocol for the study, including the proposed methods and measures. In the Agency’s experience, the proposed methods and measures for a study can provide insight into the purposes for which a product is being investigated.” (Page 2213)
We also note that the FDAAA Final Rule requires trials of drugs and devices to report regardless of whether or not they plan to seek any approvals with the FDA [5]:
“The final rule maintains the proposal to require the submission of results information for applicable clinical trials of unapproved, unlicensed, or uncleared products, regardless of whether FDA approval, licensure, or clearance is or will be sought or obtained.” (Page 64995)
We discuss the relevant legal frameworks, and their unfortunate ambiguity, in more depth in the manuscript.
Our determination of potential FDAAA coverage was based on public registration information directly provided by Juul and matched to official published criteria for determining FDAAA coverage. As stated in their comment, Juul Labs have now updated many of their registrations to no longer match these criteria. However the registered trials we assessed contained outcomes related to the uptake and pharmacokinetics of nicotine in the body, a key feature of addiction, and measures directly relevant to smoking cessation like product use, dependency, urge to smoke, and aspects of withdrawal. It is, however, ultimately up to the FDA to make official determinations about which trials are covered under the FDAAA based on their assessment of the purpose and outcomes of a given study.
Regardless of the exact regulatory status of these trials, a matter we hope the FDA will offer further clarity on, we strongly encourage Juul Labs to consider amending their existing registrations with the results of these trials. ClinicalTrials.gov offers a rapid, public, open source repository for trial results that enhances their availability, transparency, and discoverability and should not preclude subsequent peer reviewed publications.[8] It is clear from their response that Juul Labs understands the importance of trial registration and reporting to the public and scientific community, and we welcome this recognition. ClinicalTrials.gov allows for full results to be reported, without space limitations or delays associated with journal publication, and with a clear public link to all prespecified outcomes and other registered details. While the FDAAA compels this type of reporting, there is no limitation on voluntary submission of results if trials are not covered under the law. We strongly believe it is in the public interest that all outcomes for all trials that form PMTA applications should be fully and publicly reported in a timely manner. Currently this does not appear to be the case even if it may have improved since our evaluation.
Whether compelled to report by legal requirements or not, we hope Juul will consider setting a strong precedent for transparency in tobacco-industry e-cigarette research by adhering to global ethical standards [9] and reporting their full trial results for these, and future, trials to ClinicalTrials.gov and assuage any doubts about selective reporting of results or outcomes.
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...
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 Announcement). The release noted that “the companies have agreed to focus on launching IQOS in the U.S.” PMI is listed on the New York Stock Exchange and is therefore subject to the rules of the NYSE and the Securities and Exchange Commission, including requirements for the disclosure of material events such as the PMI/Altria Announcement. We estimate that during a date range similar to that used by the authors, of the total number of stories retrieved using the authors’ search terms, >85% were reporting on the above noted PMI/Altria Announcement. The authors failed to mention this and other confounders in their discussion.
The authors state that “the original PMI press release (sic) was republished (including editing or revisions to make the republication consistent with the publisher’s format) in 14 additional news outlets.” We performed a full text review of the 14 articles mentioned and of those that were still accessible, none mentioned IQOS. The authors’ conclusion that “PMI capitalised on EVALI by using an earned news media strategy to market their IQOS brand of heated tobacco for free across scores of news outlets that reached millions of readers. This marks the first known case where a tobacco company used the EVALI outbreak to promote tobacco products” is therefore completely unsupported by their own data.
These facts, and other errors detected in this article, were communicated to the authors on 23rd April 2021. In summary, we believe that the article is unreliable, and that urgent substantial revision or retraction is warranted to prevent other studies citing the currently published inaccuracies.
NOT PEER REVIEWED
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...
NOT PEER REVIEWED
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 have a share of the blame, such a construct fails to recognise the ground reality experienced by most of the world’s tobacco users, diverts attention from drawing up effective policies and shields some of the biggest contributors to the problem.
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.
NOT PEER REVIEWED
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...
NOT PEER REVIEWED
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 must at the very least tell the public as well as health care practitioners the truth about nicotine. That means that all of the major national and international messengers in this area -- NGOs and government, alike -- should do everything possible to educate the world about the continuum of risk of nicotine products, as clearly described by the U.S. Food and Drug Administration in its comprehensive plan released in July 2017, and not sweepingly demonize nicotine, which devastatingly causes widespread dependence on cigarettes but itself does not cause the illnesses suffered by the users of tobacco and is, in fact, a drug approved by the FDA as being safe and effective when used for smoking cessation.
We won’t come together if we don’t come together with openness, honesty and integrity. The time for that is now.
NOT PEER REVIEWED
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...
NOT PEER REVIEWED
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 fact that the most popular product i.e. the electronic cigarette did not originate with the tobacco industry, and that independent, non-tobacco companies have carved out a significant, perhaps even the largest slice of the market 7. The independent sector is routinely underreported because it is made up of a multitude of small to medium-sized companies rather than a few big players8, and because of market analysts’ outdated reliance on sales data from tobacco retail outlets rather than specialist shops. As Professor Malone says, the world is changing; the need to implement the provisions of the Framework Convention on Tobacco Control is as pressing as ever, but to fight tobacco harm in the new nicotine landscape, we need to move on from a simplistic conflation of tobacco and NNNTP industries. More sophisticated research is required to discern and illuminate the various strategies being employed by both tobacco and non-tobacco industry players in promoting combusted, smokeless or new nicotine products in different national markets, and to tease out the implications for population health and regulatory regimes.
1. Mintz SW. Sweetness and power. New York: Viking; 1985.
2. Schudson M. The Emergence of New Consumer Patterns: the case of the cigarette. In: Miller D, ed. Consumption: critical concepts in the social sciences: Routledge; 2001: 475-501.
3. Benson P. Commentary: Biopolitical injustice and contemporary capitalism. American Ethnologist 2012; 39(3): 488-90.
4. World Health Organization. WHO Framework Convention on Tobacco Control. Geneva: WHO 2004.
5. Nilsson P. Imperial Brands turns focus back to tobacco. Financial Times. 2021 27 January 2021.
6. Assunta M. Global Tobacco Industry Interference Index 2020. Bangkok, Thailand: Global Center for Good Governance in Tobacco Control (GGTC), 2020.
7. Brown R. Scaring the Giants: Vaping Category Report 2020. The Grocer. 2020 14 February 2020.
8. Levy DT, Lindblom EN, Sweanor DT, et al. An Economic Analysis of the Pre-Deeming US Market for Nicotine Vaping Products. Tobacco Regulatory Science 2019; 5(2): 169-81.
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I appreciated the editorial by Ruth Malone on finding "common ground" on the topic of product regulation and more broadly the role of tobacco control. I would certainly agree that the current climate in smoking harm reduction has become toxic and emotional, non-scientific, and counterproductive to achieving the public health goal of reducing premature deaths caused by using smoked tobacco (i.e., mainly cigarettes). I also agree that the cigarette companies are likely using this as a wedge to advance their own financial interests - what else would you expect? I don't think anyone interested in public health is suggesting that we dismiss the past bad actions of the cigarette manufacturers, nor accept the claims of manufacturers of alternative nicotine products. Rather, we need to heed the lessons of the past so as not to make the same mistakes going forward. The United States, the Tobacco Control Act created a framework that should incentivize manufacturers to move away from profiting from the sale of cigarettes that causes so much harm to consumers. Promoting dialogue summits would allow for participants to engage in a civil manner, educate one another about challenges and opportunities and agree to specific measurable goals and objectives. Bringing stakeholders together will not resolve all differences but it will allow serious and responsible stakeholders the opportunity to bring ideas forward and find areas of common ground...
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I appreciated the editorial by Ruth Malone on finding "common ground" on the topic of product regulation and more broadly the role of tobacco control. I would certainly agree that the current climate in smoking harm reduction has become toxic and emotional, non-scientific, and counterproductive to achieving the public health goal of reducing premature deaths caused by using smoked tobacco (i.e., mainly cigarettes). I also agree that the cigarette companies are likely using this as a wedge to advance their own financial interests - what else would you expect? I don't think anyone interested in public health is suggesting that we dismiss the past bad actions of the cigarette manufacturers, nor accept the claims of manufacturers of alternative nicotine products. Rather, we need to heed the lessons of the past so as not to make the same mistakes going forward. The United States, the Tobacco Control Act created a framework that should incentivize manufacturers to move away from profiting from the sale of cigarettes that causes so much harm to consumers. Promoting dialogue summits would allow for participants to engage in a civil manner, educate one another about challenges and opportunities and agree to specific measurable goals and objectives. Bringing stakeholders together will not resolve all differences but it will allow serious and responsible stakeholders the opportunity to bring ideas forward and find areas of common ground that can more rapidly advance population health. As an example, issues and concerns related to adolescent use of tobacco and nicotine products should be a major topic of concern, not only by the public health and tobacco control communities but by federal, state, and local policy makers and regulators, parents and teachers, responsible retailers and distributers, and many of those associated with the manufacturing businesses. While many stakeholders share common ground in this area, the polarizing and media driven approach that has been taken over the last several years has caused what has become a war of rhetoric, with a lot of finger pointing and a failure to bring interested parties together to discuss how to collectively deal with the issue and find workable solutions to protect youth while allowing smokers to have access to cleaner alternative nicotine products. It is often said that it should be good science that drives the implementation of sound policies. However, I fear that is not happening today. Finding "common ground" will be impossible so long as there remains an unwillingness to support civil dialogue on issues of smoking harm reduction. I hope that public health/ medial organizations like WHO, ACS, FDA, CDC and others will do more to facilitating real and open dialogue on how to accelerate a reduction of smoking caused disease and death than has been the case over the past decade.
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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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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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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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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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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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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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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.
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Show MoreRuth 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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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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Show MoreI appreciated the editorial by Ruth Malone on finding "common ground" on the topic of product regulation and more broadly the role of tobacco control. I would certainly agree that the current climate in smoking harm reduction has become toxic and emotional, non-scientific, and counterproductive to achieving the public health goal of reducing premature deaths caused by using smoked tobacco (i.e., mainly cigarettes). I also agree that the cigarette companies are likely using this as a wedge to advance their own financial interests - what else would you expect? I don't think anyone interested in public health is suggesting that we dismiss the past bad actions of the cigarette manufacturers, nor accept the claims of manufacturers of alternative nicotine products. Rather, we need to heed the lessons of the past so as not to make the same mistakes going forward. The United States, the Tobacco Control Act created a framework that should incentivize manufacturers to move away from profiting from the sale of cigarettes that causes so much harm to consumers. Promoting dialogue summits would allow for participants to engage in a civil manner, educate one another about challenges and opportunities and agree to specific measurable goals and objectives. Bringing stakeholders together will not resolve all differences but it will allow serious and responsible stakeholders the opportunity to bring ideas forward and find areas of common ground...
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