Review of: "Successful countering of tobacco industry efforts to overturn Thailand's ENDS ban"

Potential competing interests: Gerry Stimson is a director of Knowledge-Action-Change and has received grants from the Foundation for a Smoke-Free World (FSFW). FSFW is a US nonprofit 501(c)(3) private foundation. Charles Gardner is CEO of the International Network of Nicotine Consumer Organizations which has received grants from FSFW. FSFW had no role in the planning or execution of this review. Asa Saligupta coordinates ENDS Cigarette Smoke Thailand which is an unfunded volunteer group. All authors advocate for safer nicotine products as alternatives to smoking.

Board or Ethics committee should be required [vii] -a requirement shared also by Mahidol University, the lead author's institution. [viii] Retrospective ethical approval. Subsequent to our complaint to the Editor, the first author retrospectively applied for research ethics exemption from Mahidol University, which was mysteriously backdated to 25 th November, three days after the paper was first published and before we made our complaint.
In our view the BMJ, and the relevant ethics review boards, lack adequate guidance on ethical issues for studies using public domain information from living individuals. The paper amounts to the harassment of a volunteer body -ECST -by well-resourced academics and a well-resourced academic journal. Attacks on consumer and patient groups are unacceptable in any health field, but are especially repugnant in a setting where they may cause risk of reprisals by authoritarian-leaning governments. The paper does not reach the BMJ standard that research is "undertaken with care and respect". [ix] Biased framing of the research topic Readers are entitled to expect a balanced framing of the issues in a paper published as Original Research.
The authors are unapologetically antipathetic to tobacco harm reduction and the use of safer nicotine products, and applaud the efforts of Thai tobacco control organisations to resist demands to rescind the ban on the sale of e-cigarettes. The bias is apparent in the two research questions which set the scene: "This paper uses Thailand to address the two questions: (1) What are tactics (sic) that the TI [tobacco industry] and pro--ENDS advocacy groups have employed to pressure the government to overturn the ENDS ban? (2) How has public health successfully countered these tactics?" Most of the Introduction and the Discussion are framed around the authors' position that bans are best. It is evident in the distorted discussion about Public Health England's assessment of the data on the relative harmfulness of e-cigarettes and tobacco cigarettes, and the presentation of the USA FDA decision to allow IQOS to be placed on the market. This bias results in the strange selection, use and interpretation of data. For example, many of the statements made by ECST and PMI that are reported in the paper are based on the available scientific literature. Yet the way these statements are presented seeks disingenuously to suggest that these statements might be false. The authors suggest that Thai tobacco control organisations 'corrected' information from those who were in favour of e-cigarettes, and warned the public about the dangers of ecigarettes. Qeios, CC-BY 4.0 · Review, August 5, 2021 Qeios ID: X6586U · https://doi.org/10.32388/X6586U 3/15

Methodological considerations Association and inference
A common flaw in epidemiological work is to confuse correlation with causation, a mistake made by the second author which led to a retraction in a peer-reviewed journal. [x] The authors have fallen into the same trap with this paper.
Their fundamental error is in presuming that similar statements and actions made by different organisations indicate that the organisations are related and are working to a shared plan.
Analogies with other areas will indicate the flaw. For example: car manufacturers such as Ford and environmental groups such as Greenpeace have a mutual interest in the uptake of electric cars -Ford because petrol and diesel cars will be phased out, and Greenpeace for the health of the planet. To hint that Greenpeace is funded by, or works in conjunction with, Ford would be ridiculous and probably actionable because of the resultant damage to Greenpeace's reputation.
A similarity of view and action does not mean similarity of motive or joint working. ECST is a pro-vaping organisation, and PMI produces IQOS, a heated tobacco product (HTP). E-cigarettes and HTPs are different products, though both are non-combustible and are included under the same legislation in Thailand. The authors assume that because both ECST and PMI want to reverse the ENDS ban, they are working together and to the same agenda. They are not. ECST is a vaping advocacy group, concerned with reversing the ban on the sale of e-cigarettes in Thailand. PMI wants to reverse the ban on ENDS so that it might market IQOS -its current priority is the sale of HTPs and it has no current ambitions to market e-cigarettes. The authors are wrong in assuming that ECST and PMI have the same agenda. Both ECST and PMI have an interest in tobacco harm reduction and safer nicotine products -one for personal health reasons, the other for commercial reasons.
Similarity of views and actions does not prove relationships between organisations and individuals. Such assertions would not stand up as evidence in a court of law and should not stand as evidence in the court of social or policy science. This is a fatal methodological flaw and is sufficient for the paper to have been rejected by Tobacco Control.

Rhetoric replaces research method
The paper does not set out clear methods for data collection and analysis, and the authors' approach bears no semblance to basic social science research methods. Instead, several rhetorical devices are used to give the impression that ECST and PMI worked in association. This tactic employs a slippery language of hints and insinuation. Such methods employed include: "The linkages between the pro-ENDS movement in Thailand"

"Exposing the links between PMI and the nominally independent pro-ENDS organisation, ECST…"
The phrase "nominally independent" was removed from V2 following our complaint.
The title of Table 1 -"TI lobbying activities to lift the ban on E cigarettes" indicates that ECST is considered part of the tobacco industry. Following our complaint the wording in this table was changed from "TI lobbying" to "Pro-ENDS lobbying".
"Tobacco industry tactics": The idea of "tobacco industry tactics" is used to organise the data. This is defined as creating front groups, using public relations to promote ENDS, lobbying decision-makers, seeking to discredit tobacco control advocates, and funding research to promote ENDS.
[xi] [xii] Qeios, CC-BY 4.0 · Review, August 5, 2021 Qeios ID: X6586U · https://doi.org/10.32388/X6586U 5/15 The concept of "tobacco industry tactics" leads the reader to believe there is something unusual and underhand about the advocacy methods used by the tobacco industry, and it follows that a consumer group that uses these "tactics" is ergo a tobacco organisation.
Most advocacy organisations -whether consumers, NGOs, philanthropic organisations, multilateral organisations or industry -use a similar package of lobbying, networking, media and social media, and research to pursue their aims and objectives. These are the basic advocacy toolkits used by any organisation seeking social or political change, and are recommended by the WHO. [xiii] Ironically the authors see no similarity between the actions taken by consumer advocates and those undertaken by tobacco control advocates. The term tobacco "tactic" is used only with respect to ECST, and the authors use a more neutral term "actions" to describe activities undertaken by tobacco control organisations.
"Tobacco industry tactics" is a rhetorical, rather than an analytical, tool: by definition, any organisation using such tactics is considered by the authors to be part of or under the control of the tobacco industry.

Evidential considerations
The claim that "front groups" were created to challenge the Thai legislation is false The paper refers to "pro-ENDS advocacy groups" in the plural and suggests the creation of front groups (plural) to reverse the ban on ENDS. Only one "pro-ENDS advocacy group" is actually discussed in the paper -ECST. It is reasonable to ask whether this is casual writing, or a deliberate attempt to confuse the reader that there were several groups created in response to the ban.
There is no evidence in the paper that any "front groups" were created to challenge the ban: the authors are aware that the ECST Facebook page was created in 2014, before the Thai ban on ENDS.
That the authors imply that ECST is a tobacco industry "front group": ECST is actually a loose-knit consumer group. It is a Facebook page with 92,500 followers. A small number of individuals administer the Facebook page. These individuals, on occasion, represent the views of Thai vapers to a wider audience.
ECST is not a legal organisation and cannot enter into any agreement with a third party. TOAT is the only entity allowed to manufacture tobacco products within the country. Formerly a monopoly, it is now an arm's length state enterprise, operating as an authority under the Ministry of Finance. As a result of ASEAN trade agreements, other companies are now able to import tobacco products. TOAT controls 70% of the tobacco market and fears inroads from external tobacco companies. [xiv] Company profits are being reduced by a new excise tax structure which came into effect in 2017. TOAT turned over THB70 billion in 2017 -bringing in substantial revenue to the Thai government. [xv] Market dominance and fear of competition would be a strong contender as an alternate hypothesis as to why the Thai government did not revoke the ban on ENDS, but this is not investigated in the paper.

Failure to investigate equally the roles of tobacco control groups and harm
Qeios, CC-BY 4.0 · Review, August 5, 2021 Qeios ID: X6586U · https://doi.org/10.32388/X6586U 7/15 Stanton Glantz believes that there is evidence of an international network linking PMI, FSFW and tobacco harm reduction advocates. He asserts that:"While pro-tobacco forces represent the battle as one of local harm reduction advocates, we found that the pro-ENDS Thai efforts were tied into in (sic) international network that PMI has built with its Foundation for a Smoke-free World as a key facilitating agent (see infographic above)." [xvii] This is fantasy. Stanton Glantz thinks that PMI has developed an operational structure, using FSFW as the vehicle. It implies a chain of command between PMI and FSFW, and between FSFW and grant-funded INNCO does not provide operational or support funding to its member organisations, all of whom are distinct, independent, and autonomous bodies. INNCO's role is to enable coordination and cooperation across similar organizations around the world, as well as engaging in targeted national-and regional-level projects.
The statement that "ECST was linked to PMI through INNCO and FSFW" is thus meaningless.

Complaint to BMJ Tobacco Control
On close analysis the paper falls apart. Publication has, it must be concluded, resulted from inadequate peer review and editorial scrutiny at Tobacco Control.
This review has shown that the paper has irremediable ethical, methodological, analytical, conceptual, and evidential flaws. The findings and conclusions are unreliable. There are numerous other inaccuracies in the paper. A selection is given in the Supplementary Material (attached).

Immediately following the initial publication, ECST and INNCO (and others) submitted Responses to
Tobacco Control: these were not published, and a letter of complaint to the Editor, Ruth Malone, was ignored.
Subsequently the authors of this Review submitted a formal complaint and request for retraction on 11 th January 2021.
We suggested to the Editor that the article: is false and misleading; has the potential to damage scientific and public understanding of the field and cause damage to tobacco policy; has flawed assertions about links between vaping consumer groups and the tobacco industry; will be cited by those who seek to undermine the legitimacy of such groups; is damaging to, and places at potential risk, the individuals named in the paper; does not meet the BMJ criteria for research integrity. [xviii] We argued that the fundamental flaws in the paper could not be addressed by minor corrections and that it fulfills the COPE guidelines for retraction, namely that: it reports unethical research.
The complaint (substantially this Review article) stated the grounds for retraction were: The false claim that several "front" groups were created to challenge the Thai ban on the sale of ENDS; The false claim that ECST is a "front" group and/or working hand-in-hand with PMI; The misunderstanding of the nature of ECST and the accusation that it is a "front" group; The absence of ethical approval, that all allegations are against named people, are defamatory, and place individuals at risk; The false conclusions about the role of tobacco control organisations; The failure to investigate objectively and equally the two main groupings in the paper (tobacco control and tobacco harm reduction); The flawed methodological assumption that supposed network links reflect lines of influence from PMI to vaping advocacy organisations; The false imputation of a relationship between ECST and PMI mediated by INNCO.

Research integrity
We did not find that the paper had "fatal flaws" that would require retraction. The paper is based on review of publicly-available evidence related to a policy decision and focuses on the strategies used to make a case. The paper underwent peer review and subsequently, re-review by the editors, publication ethics and BMJ legal teams.

Ethical approval
We note that the analysis in the paper is based entirely on evidence from the public record about a policy decision, not on data from human subjects. There was no intervention or interaction with human subjects. However, after this concern was raised to the authors, out of an abundance of

Final comment
It would appear that the Editor of Tobacco Control is content to publish flawed papers. This review raises questions about internal scrutiny of submissions, and about the willingness of the journal to act promptly and comprehensively on complaints.
There is a place for dispassionate and objective social and policy research on both tobacco control and tobacco harm reduction advocacy, but this paper does not evidence such scholarship. It does not reflect well on the academic standing of Tobacco Control. We still find it difficult to understand how such a fatally flawed paper can be published in an academic journal.