NOT PEER REVIEWED This ad watch shows an interesting example of illegal marketing activity of an e-cigarette company in Korea. However, the description of the trend of e-cigarette prevalence among Korean adolescents is not correct. According to the national annual surveys that the author quoted (reference 4), prevalence of current (30-day) e-cigarette use among Korean adolescents was 4.7% in 2011 and 5.0% in 2014. It decreased continuously after then, and it was 4.0% in 2015 and 2.5% in 2016. Even though there have been active marketing activities by e-cigarette companies, strict regulations on e- cigarettes enacted by the Korean government (i.e. tax levy, ban on sales to minors, restriction of use in public places, and restriction of advertisement, promotion and sponsorship) hindered increase of or even reduced e- cigarette prevalence among Korean adolescents.

Conflict of Interest:

None declared

Conflict of Interest:

None declared

NOT PEER REVIEWED Bauld et al [1] draw an analogy between indoor vaping and the use of bronchodilators for asthma ("if and when vapour products with a medicinal license become available, it will be important to allow their use indoors, just as asthma inhalers, which dispense a drug and propellants into the atmosphere, can be used indoors.")

Surely, they cannot be serious here?

Newman et al showed the amount of dosed drug exhaled by asthmatics ranged from just 0.2%-1.7% across different puffing behaviours [2]. A typical person who uses an asthma puffer would be unwise to use it more than 4-6 times a day [3] whereas vapers can take up to 610 puffs a day, with an average of around 200 [4].

Conversely, the objective of many ENDS users is the absolute opposite. As this article puts it "At the end of the day, Sub Ohm vaping comes down to three words: big ass clouds" [5] Etter [6] notes that "These newer devices deliver more power, more cloud density, [my emphasis] more intense flavors and a better 'throat hit' than older models."

With this generation of ENDS becoming more popular, we would expect to see clouding increase. As we know [7], many vapers in a room can send particle counts above those recorded in room where smoking is allowed.

There is simply no comparison between the asthma medication and propellant a few asthmatics might exhale into (for example) a crowded bar over a few hours and what potentially dozens of vapers could generate in the sort of exuberant clouding sessions that vaping in bars can entail. And unlike vapers, asthmatics do not participate in asthma puffer social events.

This vaper puts things plainly https://www.youtube.com/watch?v=6c5Ln69hWUc

References

1. Bauld L, McNeill A, Hajek P, Britton J, Dockrell M. E-cigarette use in public places: striking the right balance. Tob Control 2016; doi:10.1136/tobaccocontrol-2016-053357

2. Newman SP, Weisz AWB, Talaee N, Clarke SW. Improvement of drug delivery with a breath actuated pressurised aerosol for patients with poor inhaler technique. Thorax 1991; 46:712-16.

3. Partners Healthcare. Asthma Center. Chapter 33: How many times a day can I safely use my bronchodilator inhaler? http://www.asthma.partners.org/NewFiles/BoFAChapter33.html

4. Martin E, Clapp PW, Rebuli ME et al . E-cigarette use results in suppression of immune and inflammatory-response genes in nasal epithelial cells similar to cigarette smoke. merican Journal of Physiology - Lung Cellular and Molecular Physiology Published 10 June 2016 Vol. no. , DOI: 10.1152/ajplung.00170.2016

5. Kriegel D. What is sub ohm vaping? Our sub ohm vaping guide & tips http://vaping360.com/what-is-sub-ohm-vaping-and-the-dangers-of-sub- ohm-vapes/ 2015;May 26.

6. Etter J-F. A longitudinal study of cotinine in long-term users of e-cigarettes. Drug and Alcohol Dependence 2016;160:218-221.

7. Soule EK, Maloney SF, Spindle TR, et al. Electronic cigarette use and indoor air quality in a natural setting. Tob Control 2016;???. doi:10.1136/tobaccocontrol-2015-052772

Conflict of Interest:

None declared

NOT PEER REVIEWED In the last decade, electronic cigarettes (EC) have become increasingly popular in particular among smokers. Most EC users choose to use nicotine containing liquids (electronic nicotine delivery system, ENDS); these ENDS can be considered as similar to nicotine replacement therapies. Among the several questions EC use raises, one is of major importance: Are EC a smoking cessation aid and if yes to what extent compared to existing pharmacotherapies such as nicotine replacement therapies, varenicline or bupropion? Several systematic reviews tried to approach the role of EC as a smoking cessation aid. As of today, only two randomized trials assessed the efficacy of EC with controversial results (1,2). As an editorial (3) and the last systematic review (4) concluded, because of the absence of well- designed and sufficiently powered randomized, controlled, head-to-head therapeutic trials the current accumulation of data originating essentially from observational studies does not allow us to make any conclusion as to EC's therapeutic efficacy in smoking cessation. Manzoli et al. (5, 6) assessed abstinence from tobacco cigarettes or tobacco and electronic cigarettes ('any product') in a prospective cohort study. They included at baseline EC only users, individuals using tobacco cigarettes and EC (dual use) and those using only tobacco cigarettes. They reported the 12-month (5) and 24-month (6) results in two separate papers the latter published online in the June 2016 issue of Tobacco Control. For both papers, the analyses were restricted to individuals whose data were available at 12 or 24 months (completers). This study raises the question whether observational studies assessing efficacy should be analyzed similarly to randomized efficacy trials for which the gold standard approach is the intent-to treat-analysis (ITT) (7) which defines the population submitted to the main data analysis. Table 1. https://docs.google.com/document/d/1RM5mvK1s85N1iZZ_kKiHkKiMsS1SVl4YMPTj6ALHvS8/edit?usp=sharing compares Manzoli et al. results for the 12-month and 24-month abstinence outcomes (5,6). For all baseline categories, completers' abstinence rates are higher than abstinence rates of the baseline population that we can call here as the "ITT" population i.e. of all individuals included. Of particular interest is that EC only users had higher tobacco cigarettes but not 'any product' abstinence rates both at 12 and 24 months than the two other groups. The (unadjusted) "ITT" tobacco cigarettes abstinence rates are 42% and 40.8 % versus the completers abstinence rates of 61.9% and 61.1 % at 12 and 24 months, respectively; all higher than among dual users or tobacco cigarette only users suggesting that EC can be an aid to quit smoking. Unfortunately, both papers report only confounder adjusted odds ratios for completers and not for the "ITT" population. Observational studies looking for treatment efficacy could be analyzed like randomized efficacy trials (8,9) to narrow the gap between randomized clinical trials and observational data (8). Non-ITT, usually completer analyses, aim to estimate the effect of treatments received as opposed to treatments assigned under the ITT approach and by this exclude all factors contributing to non-completion of the trial (lost to follow up, adverse events, discontinuation for any reasons). The advantage of the ITT analysis is that it evaluates the true treatment effect which is the sum of the biological effects, positive or negative such as adverse events, and study adherence. The limitation of the ITT analysis of randomized efficacy trials is the underestimation of efficacy because of non- treatment related confounders (e.g. lost to follow-up for moving to another city). On the other hand, completer analysis overestimates efficacy by ignoring e.g. discontinuation because of adverse events and cannot, therefore, help to assess the benefit/risk ratio of a given intervention. Until results of high-quality, large-scale, comparative, randomized trials of EC' efficacy will be available, data of well conducted prospective observational studies as that of Manzoli at al. (5,6) could estimate EC's efficacy by analyzing "ITT" data and not completers' data while adjusting for all available and potential confounders. Thus, in the Manzoli et al. study (5,6) adjusted "ITT" population abstinence rates would have provided more convincing results about EC's efficacy as an aid for smoking cessation than completers' adjusted abstinence rates. REFERENCES 1. Caponnetto P, Campagna D, Cibella F, et al. EffiCiency and Safety of an eLectronic cigAreTte (ECLAT) as tobacco cigarettes substitute: a prospective 12-month randomized control design study. PLoS One. 2013 Jun 24;8(6):e66317. doi: 10.1371/journal.pone.0066317. Print 2013. 2. Bullen C, Howe C, Laugesen M, et al. Electronic cigarettes for smoking cessation: a randomised controlled trial. Lancet. 2013 Nov 16;382(9905):1629-37. doi: 10.1016/S0140-6736(13)61842-5. Epub 2013 Sep 9. 3. Bernstein SL. Electronic cigarettes: more light, less heat needed. Lancet Respir Med. 2016; Feb;4(2):85-7. doi: 10.1016/S2213-2600(16)00010- 2. Epub 2016 Jan 14 4. Malas M, van der Tempel J, Schwartz R, et al. Electronic Cigarettes for Smoking Cessation: A Systematic Review. Nicotine Tob Res. 2016 Apr 25. pii: ntw119. [Epub ahead of print] Review. 5. Manzoli L, Flacco ME, Fiore M, et al. , Electronic cigarettes efficacy and safety at 12 months: Cohort Study. PLoS One. 2015 Jun 10;10(6):e0129443. doi: 10.1371/journal.pone.0129443. eCollection 2015. 6. Manzoli L, Flacco ME, Ferrante M, et al. Cohort study of electronic cigarette use: effectiveness and safety at 24 months. Tob Control. 2016 Jun 6. pii: tobaccocontrol-2015-052822. doi: 10.1136/tobaccocontrol-2015- 052822. [Epub ahead of print] 7. Detry MA, Lewis RJ. The Intention-to Treat principle. How to assess the true effect of choosing a medical treatment. JAMA 2014; 312:85-86. 8.Wilcox A, Wacholder S. Observational data and clinical trials. Narrowing the gap? Editorial. Epidemiology 2008;19: 765. 9. Herna?n MA, Alonso A, Logan R, et al. Observational studies analyzed like randomized experiments: an application to postmenopausal hormone therapy and coronary heart disease. Epidemiology. 2008;19:766-779.

Conflict of Interest:

None declared

NOT PEER REVIEWED I am writing in response to sight of an article published by you about my work for the International Tax and Investment Center (ITIC). The ITIC guidebook published in 2011 "The Illicit Trade in Tobacco Products and How to Tackle it" makes it clear in the Executive Summary that it is "a compilation of facts and views from a wide range of sources including respected academics, private sector consultants, journalists, international enforcement organizations, government revenue authorities and industry". It also states in the very first footnote that the case studies were provided by industry, consultants and academics and other references include the Framework Convention Alliance, the World Bank Economic of Tobacco Toolkit, ASH Action on Smoking and Health and the WHO and Framework Convention Alliance are listed under "Interesting Links". I wrote this guidebook for ITIC as an independent consultant with academic freedom to ensure it presented a balanced picture of the issues and attributed input to the appropriate sources. I have never lobbied on behalf of an industry or individual company. As the former UK senior civil servant in a revenue authority who was privileged to lead the first UK Alcohol and Tobacco Fraud Review in 1997, my motivation in writing this guidebook has been to pass on my knowledge and experience of the illegal tobacco trade to assist officials in developing countries in improving their administration of excise taxation and anti-smuggling controls. I do not work for the tobacco industry and I have never smoked - in fact, I have suffered from asthma all my life and was delighted to see workplace smoking bans in the UK. I have never sought to undermine tobacco control policies. Rather, I have sought to help the tax and enforcement authorities to reduce opportunities for illegal trade, reduce demand and detect and prosecute the criminals and terrorists who profit from illegal trade drawing heavily on the UK experience in successfully reducing illegal trade in tobacco products from over 20% in 2000 to around 10% currently whilst maintaining one of the highest tax rates in the world. It is undeniable that products that are light, portable and subject to high levels of tax attract criminals. The guidebook (and the second edition published in 2013) makes it clear that there are, however, several drivers and facilitators of illegal trade in tobacco products including tobacco taxation policy, corruption, protectionist measures, inadequate legislation such as penalties, inadequate enforcement and public tolerance though it is my personal view that the economic drivers of supply and demand are the most important. Whilst advocating balanced tax policies in the guidebook, I went on to explain that sustaining high tax rates and maintaining manageable rates of illegal trade can only be achieved through a comprehensive strategic approach encompassing all legitimate stakeholders both public and private sector, national and international - as in the various refreshed versions of the UK Tobacco Strategy. As a former administrator I was trained and required to treat all taxpayers fairly without favouring one industry or one company over another. This has to be a key feature of effective tax and customs administration all over the world. The tobacco industry is a significant payer of excise revenue - second only to the hydrocarbon oil industry - and as long as it sells legal products and complies with legislative requirements it deserves the same treatment as any other industry. It is a feature of good tax administration to have dialogue with taxpayers and their representative associations and I have no hesitation in recommending this way of working to senior officials in Ministries of Finance and Revenue Authorities/Customs around the world. Indeed, the UK has long had and published Memoranda of Agreement with the tobacco industry as well as with other excise industries. I am puzzled by the article's criticism of a reference to Codentify in the 2011 edition of the guidebook as I do not see any such reference. The case study box on page 28 refers to International Track and Trace Standards and the information attributed to the four major international tobacco companies but Codentify is not mentioned as this is merely an illustration of the standards in place among key players in the industry. It is placed after a much more lengthy page on Article 15 of the WHO Framework Convention on Tobacco Control which the conclusions in para. 7.5 fully support but point out that rigorous enforcement, international cooperation and cooperation with the private sector are essential as legislation alone cannot eliminate illicit trade. With trillions of movements of tobacco products across the world daily there are never going to be sufficient enforcement resources to detect all illicit movements. Seizure rates, even in those countries that pride themselves on top class enforcement, do not exceed 20% to 23% and in the EU (see page 9 of the 2013 edition of the guidebook) were around 7% in 2011. Seizure rates can be expected to be considerably less in relation to illicit trade in most developing countries. So, enforcement authorities need all the help they can get from others in the public sector. This includes health and education authorities who are best placed to provide awareness campaigns and develop strategies to reduce demand and it includes help from legitimate industry who can provide additional intelligence on the markets, trends and those suspected of undermining their legal sales in the marketplace i.e. the international criminal organizations and terrorists. Moving on to the criticism of the WCO for allowing me to present a two day course on excise taxation policy, administration and enforcement, I would challenge anyone to present a meaningful course on excise taxation, administration and enforcement without referring to tobacco taxation or to illicit trade in excise products. The course included material on alcohol with input from the Spirits industry and the Beer industry and material on fuel taxation with input from the Oils industry as well as input on tobacco taxation from a representative of the tobacco industry. Customs officials have to deal with numerous products and legislation and their national training rarely provides them with material on excise taxes which they are tasked with protecting on imports, exports and transit shipments. Providing customs officials with basic broad awareness of the key excise taxes, how they work, good administrative and enforcement practices as well as stakeholder perspectives is really important in improving the performance of customs officials around the world. All the course material was thoroughly vetted by the WCO before the course so delegates were assured of receiving balanced and useful material.

Conflict of Interest:

None declared

NOT PEER REVIEWED Thanks for Mr. Middleton's information that there are local tobacco manufacturers in Hong Kong. I made a mistake when reading the materials. I have amended this in the updated version.

It does not affect the analysis as the government taxes based on number of cigarettes sold rather than manufactured, but I sincerely appreciate your valuable advice.

For the analysis part, it is not easy to have an "official figure" of illicit cigarette consumption. During the peer review stage, I indeed have discussed with the reviewers which source is preferable. I adopt the figures provided by the tobacco sellers, but also list the Euromonitor a reviewer suggested for readers' reference. Noted that these figures lead to the same result, as the total tobacco consumption (tax + illicit) drops after the tax increasing, which rebuts the traditional economic view that tobacco duty is not an effective method because of smuggling.

It is also not an easy job to determine how much price is affordable for people esp youngsters. However when we find out that smuggling shall not be a concern when the government increases the tax rate, it is clear that tobacco duty is a powerful tool to control cigarette consumption.

Conflict of Interest:

None declared

NOT PEER REVIEWED The author appears to believe that the main problem with the FDA is that it is not doing enough to prevent new niche cigarette products reaching the market. This focus of concern is misplaced, given several thousand cigarette products are readily available and smokers are spoilt for choice with or without these new products. I have no great desire to see new cigarette products coming on the market, but is this really the most pressing agenda?

There are important issues for FDA and Congress to address, but on which the author did not comment. Allow me to suggest five:

1. FDA's governing framework for tobacco, the Tobacco Control Act, is unfit for the purpose of managing reduced risk products. It is designed to raise a high regulatory barrier to entry to a market dominated by worst products and to suppress innovation in better products. At the same time, it has protected the existing cigarette trade by 'grandfathering' the thousands of products that were on the market at 17 Feb 2007 and offering them an easy ride for subsequent modifications. A new legislative framework for recreational nicotine products is required.

2. FDA regulation is unlikely to offer a feasible route to market for most vapour products. ?Its approach will cause chaos in the marketplace, even though these products are helping many to quit smoking. The vapour category would be largely wiped out and confined to the tobacco industry's high volume commodity products if FDA proceeds on its present course. That would provide further protection for the cigarette trade and stimulate a black market. Workarounds, a change in the predicate date or simply doing nothing would be an improvement.

3. FDA's approach does little that supports and a lot that suppresses innovation, regardless of whether particular innovations are desirable for consumers. For example, under the proposed framework for vapour products to access the market, a third generation e-cigarette manufacturer would likely need to go through a new and hugely burdensome authorisation (PMTA) to introduce new safety features like temperature control or to improve nicotine delivery through better aerosol science. A notification regime with an FDA right to intervene if the evidence justifies it would be preferable to a cumbersome authorisation regime.

4. FDA applies a bizarre approach to communicating the far lower risk of products like snus to consumers. This starts with a default FDA-imposed warning that is technically correct but not truthful because it is highly misleading ("this product is not a safe alternative to smoking"). It then requires tobacco companies to calculate if they are rich enough, the data extensive enough and whether it is sufficiently in their commercial interest to go through an arduous process to convince the FDA to allow them to change the warning to something more truthful ("No tobacco product is safe, but this product presents substantially lower risks to health than cigarettes") - and face hostile resistance from tobacco control campaigner such as the author. FDA and CDC should be assessing the relative risks of these products, and communicating them clearly - so that public risk perceptions become, as far as possible, aligned with scientific reality.

5. FDA suffers from mission creep - a regulator should not be involved in campaigning. FDA should function, and be seen to function, as a neutral technocratic regulatory agency, leaving the hype to public health bodies like the CDC. In this case, there is a further problem - the scientific foundations of the new smokeless campaign are very poor and undermine FDA's credibility more generally. FDA should stick to its core mission and do it better.

Matthew L. Myers and his campaign would do better to consider the important issues in nicotine regulation, not expend time, money and credibility on marginal issues with negligible public health value.

Conflict of Interest:

I am a long-standing advocate for tobacco harm reduction and run the Counterfactual blog. I have no competing interests with respect to any relevant industry.

It is enormously helpful when researchers consider new, not-yet-tried tobacco control interventions (such as this study's consideration of warning messages on cigarette sticks), especially when researchers figure out effective ways to evaluate the not-yet-tried interventions.

Some additional possibilities related to new warnings or pack changes that might be considered:

(1) Put instructions for use in all cigarette packs that instruct smokers (with explanations) about how they can minimize the harms and risks to themselves and to others from their consumption of the cigarettes, such as:

-- Do not smoke the cigarettes

-- Do not smoke near anyone else

-- Do not smoke in enclosed spaces

-- Do not smoke by inhaling

-- If inhaled, inhale as shallowly as possible

-- Do not smoke more than a few puffs of each cigarette (or do not smoke more than halfway)

-- Do not smoke in bed or when tired

-- Make sure all smoked cigarettes are fully extinguished before discarding

-- Discard of all cigarettes carefully (do not litter, do not discard in waterways, do not leave where children or pets might consume).

(2) Make one cigarette in each pack a rolled-up scroll of information or instructions for use for smokers (which would also reduce the number of cigarettes that could be smoked in each pack, perhaps reducing consumption).

(3) Audio warnings that play each time a pack is opened or a cigarette is extracted (now possible with available technologies).

Conflict of Interest:

None declared

NOT PEER REVIEWED The recent endgame review by McDaniel et al1 demonstrates a major flaw in thinking within the tobacco control community. The industry is seen as dominated by the "big tobacco" cigarette companies. The real life industry is intensely competitive and highly fragmented. There are, within the industry, many who could effectively partner with the public health community, if given the opportunity to do so. Because of this flaw in thinking, the tobacco control community has been unwilling to consider any role for tobacco harm reduction or electronic cigarettes in any public health initiative. E-cigarettes have the potential to substantially reduce smoking-related illness and death and do so without recruiting significant numbers teens or other non-smokers to nicotine use. .2-5

The McDaniel paper1 lists sixteen end-game proposals, fourteen of which consist of partial or total bans on aspects of the manufacture or sale of non-pharmaceutical nicotine delivery products. Only two, one referencing e-cigarettes and another "advantage cleaner nicotine products over combustibles" make any reference to tobacco industry participation in pursuit of tobacco control objectives. Both are discouraged as unproven and impractical despite substantial scientific evidence to the contrary.

The time has come for the public health community to engage in dialogue with those stakeholders in tobacco-related industries who are ready, willing and able to partner with public health in pursuit of shared public health objectives. The purpose of this dialogue would be to help secure reductions in tobacco-related illness and death not likely achievable by other means.

Experience to date with e-cigarettes gives us grounds for optimism that this could easily be done without recruitment of teens and other non- users to nicotine use. .2-4

A world in which tobacco-related addiction, illness and death have been reduced to trivial public health problems could be achieved within our lifetimes. Achieving this goal will require re-orienting tobacco control from a crusade against all things "tobacco," to a public health initiative considering all options for the prevention of addiction, illness and death. This is a goal not likely achievable by any other means. A seemingly small change in the wording of our tobacco control goal from "a tobacco-free society" to "a smoke-free society" would get us most of the way there. References

1. McDaniel PA, Smith EA, Malone RE. The tobacco endgame: A qualitative review and synthesis. Tob Control 2015 28 August; Special Communication Published On Line:1-11. 2. Nitzkin JL. The case in favor of e-cigarettes for tobacco harm reduction. International Journal of Environmental Research and Public Health 2014;11:6459-71. 3. Nitzkin JL. E-cigarettes: A life-saving technology or a way for tobacco companies to re-normalize smoking in American society? FDLI's Food and Drug Policy Forum 2014 30 June;4(6):1-17. 4. McNeill A, Brose L, Calder R, Hitchman S. E-cigarettes: An evidence update. A report commissioned by Public Health England [https://www.gov.uk/government/publications/e-cigarettes-an-evidence- update]. A an Evidence Update Plus Policy Implications. London, England, August, 2015. 19 August 2015. 5. Farsalinos K, Polosa R. Safety evaluation and risk assessment of electronic cigarettes as tobacco cigarette substitutes: A systematic review. Therapeutic Advances in Drug Safety 2014;5(20):67-86

Conflict of Interest:

I currently serve as Senior Fellow for Tobacco Policy for the R Street Insitute

NOT PEER REVIEWED To the Editors, In the article entitled, "Weight control belief and its impact on the effectiveness of tobacco control policies on quit attempts: findings from the ITC 4 Country Project" I noticed a problem regarding the measurement of weight control beliefs. This variable (weight control beliefs associated with tobacco use) is measured using only one question. The researchers indicate, "In order to identify weight concerns related to smoking, we exploit a question that measures smokers' level of agreement with the following statement using a 5-point scale (strongly agree, agree, neither agree nor disagree, disagree and strongly disagree): Smoking helps weight control" (Shang et. al, p.2, 2015). This statement illustrates the limited manner in which the aforementioned variable was measured. While the limitation of weight control beliefs being analyzed using self- reporting was addressed, the limitation of using only one question to measure this variable was not. In the study entitled, "Smoking Expectancies, Weight Concerns, and Dietary Behaviors in Adolescence" the authors noted that they used the appetite control factor of the Smoking Consequences Questionnaire (SCQ) to determine weight control beliefs. The author of "Smoking Expectancies, Weight Concerns, and Dietary Behaviors in Adolescence indicates, "Participants who endorsed smoking were given 5 possible consequences of smoking and were asked to rate the likelihood of each consequence on a 10-point scale from 'completely unlikely' to 'completely likely.' The statements included, 'Smoking controls my appetite,' 'Smoking keeps my weight down,' 'Cigarettes keep me from overeating,' 'Cigarettes keep me from eating more than I should,' and, 'Smoking helps me control my weight.' Scores were an average across all items" (Cavallo et. al., p. 68, 2010). This multifaceted approach to measuring a variable is a more thorough and a more accurate measure of the weight control variable. This more detailed measure, as indicted by the author, has been measured by three different criteria: internal consistence, degree of factor loading, and coefficient significance (.72 to .97). This measure starkly compares to the measure used in the article, "Weight control belief and its impact on the effectiveness of tobacco control policies on quit attempts: findings from the ITC 4 Country Project", which was only measured in its degree of sensitivity.

References

Cavallo, D. A., Smith, A. E., Schepis, T. S., Desai, R., Potenza, M. N., & Krishnan-Sarin, S. (2010). Smoking expectancies, weight concerns, and dietary behaviors in adolescence. Pediatrics, 126(1), e66-e72.

Shang, C., Chaloupka, F. J., Fong, G. T., Thompson, M., Siahpush, M., & Ridgeway, W. (2015). Weight control belief and its impact on the effectiveness of tobacco control policies on quit attempts: findings from the ITC 4 Country Project. Tobacco control. doi:10.1136/tobaccocontrol- 2014-051886

Conflict of Interest:

None declared

NOT PEER REVIEWED Cavazos-Rehg et al. compared the results of Google Trends relative search volume (RSV) data for non-cigarette tobacco use with data from state- and national-level youth surveys.[1] Given the authors' findings of positive correlations with Google Trends and survey data, we agree with the conclusion that Google Trends may be a potential tool to provide real- time monitoring for non-cigarette tobacco use. The 2014 National Youth Tobacco Survey indicates that electronic nicotine delivery system (ENDS) use has tripled by middle and high school students from 2013-2014.[2] We have conducted a preliminary review of Google Trends RSV data for ENDS to detect if there were trends that may mirror acquisition patterns of ENDS within and outside of the US.

The methods we used were similar to Ayers et al., who conducted a data analysis from Google search engines from January 2008 through September 2010.[3] We compiled a list of search terms in singular and plural forms that reflected the most commonly used search terms for ENDS including "e cig," "e cigarette," "electronic cigarette," and popular name brands. To continue building the list, we added popular "related terms" as indicated by Google Trends searches. When search terms exceeded the 30- word limit, we compared RSV for individual terms and removed those with the lowest RSV. Irrelevant (non-ENDS) results were excluded.[1] Results were limited to October 2011 to May 2015 and included all countries. Search queries range from 0-100 in volume, with the highest RSV assigned a 100.[4]

Similar to prior work,[3] ENDS emerged in all markets and RSV trends have slowly increased since 2011, peaking in January each year. This suggests that interest in information on ENDS is growing, and that there has been a recent shift in interest by country compared to prior findings.[3] The greatest RSV of ENDS is in the United Kingdom (100), followed by the United States (84), Ireland (63), Cyprus (46), Malta (42), Canada (41), Trinidad and Tobago (35), Australia (33), Philippines (29), and New Zealand (29).

Web search data can help fill gaps by providing a timely understanding of real-world activity and good temporal and spatial resolution.[5] It is unclear how these search patterns reflect use patterns in youth. Future investigations with comparisons to youth surveillance datasets and population-level efforts using real-time monitoring of youth interest,[6] and tracking of use patterns may help to inform timely prevention programs and policies for ENDS, other non- tobacco, and tobacco products.

References

1. Cavazos-Rehg PA, Krauss MJ, Spitznagel EL, et al. Monitoring of non-cigarette tobacco use using Google trends. Tob Control. 2015;24(3):249 -255.

2. Centers for Disease Control and Prevention. E-cigarette use triples among middle and high school students in just one year. Centers for Disease Control and Prevention Newsroom. 2015. http://www.cdc.gov/media/releases/2015/p0416-e-cigarette-use.html (accessed 01 Jun 2015).

3. Ayers JW, Ribisl KM, Brownstein JS. Tracking the rise in popularity of electronic nicotine delivery systems (electronic cigarettes) using search query surveillance. Am J Prev Med. 2011;40(4):448-453.

4. Google Trends. About Google Trends. Google. 2015. https://support.google.com/trends/answer/4355164?hl=en&ref_topic=4365531 (accessed 05 Jun 2015).

5. Mohebbi M, Dan Vanderkam JK, Kodysh J, et al. Google correlate whitepaper. Google. 2011:1-6. https://www.google.com/trends/correlate/whitepaper.pdf (accessed 01 Jun 2015).

6. Goel S, Hofman JM, Lahaie S, et al. Predicting consumer behavior with web search. Proc Natl Acad Sci U S A. 2010;107(41):17486-17490.

Conflict of Interest:

None declared

NOT PEER REVIEWED We explicitly did not do a systematic review, which would have included things such as assessing articles for quality and assessing for presence of publication bias. Instead we opted for a narrative review. This decision was made given the limited time available for the authors to complete the supplement prior to the World Conference on Tobacco or Health and the small number of available articles after our literature search. Our exclusion and inclusion criteria were also stated (see Figure 1). Lastly, our search was up until September 9, 2014, therefore any articles published afterwards were not included in the publication. We believe that this paper represents a significant contribution concerning a newly emerging threat to the health of the public.

Conflict of Interest:

None declared

This letter responds to misrepresentations in a recent article by Daniel Stevens and Stanton Glantz (1). In the article, Stevens and Glantz question my integrity based on some questions during a 4-day deposition which I gave in 2014 in a legal proceeding against my employer. These writers cite snippets from the 1,000+-page transcript of that deposition, relating the text of a facetious note that I had sent to my boss almost 20 years ago in 1996. The writers use a small portion of that note, together with my answers to other deposition questions, taken out of context, to infer that I gave questions from the open-book examination for recertification to my co-workers to answer for me.

It is well-understood that recertification candidates must complete the self-assessment examination themselves (2), which is precisely what I did in both 1992 and 1996. Period. I stand by my sworn testimony that I did not provide questions from either my 1992 or 1996 recertification examinations to anyone to answer for me, and that my examination responses were my own work. This is made clear in the deposition transcript and I refute this attempt by Stevens and Glantz to suggest otherwise.

I am taken aback by the willingness of Tobacco Control to accept the sort of "scholarship" pursued by Stevens and Glantz. These authors advise special scrutiny of my work, with specific mention of my lead authorship of the Industry Menthol Report that was written at the request of the FDA (3). I stand by the scientific integrity of and conclusions in that report, as well as by the comments provided to FDA on the recently-voided TPSAC menthol report (4), and on FDA's own Preliminary Scientific Evaluation of menthol (5).

Jonathan Daniel Heck, Ph.D., DABT, ATS

References

1. Stevens D, Glantz S. Tob Control Published Online First: May 12, 2015, doi:10.1136/ tobaccocontrol-2015-052271.

2.http://www.abtox.org/Candidates/ABOT_recertification/ABOT_recertification_policy.aspx (accessed May 19, 2015)

3 http://www.fda.gov/downloads/AdvisoryCommittees/CommitteesMeetingMaterials/TobaccoProductsScientificAdvisoryCommittee/UCM249320.pdf (accessed May 19, 2015).

4 http://www.lorillard.com/pdf/fda/Comments_to_FDA_on_TPSAC_Report.pdf (accessed May 19, 2015)

5. http://www.lorillard.com/wp-content/uploads/2013/11/PSE- Response_Lorillard_Final.pdf (accessed May 19, 2015)

Conflict of Interest:

I am a full-time employee of the Lorillard Tobacco Company. I have been asked on occasion to provide testimony in litigation involving my employer. I have done so from time to time, and receive no payment for this beyond the normal salary and benefits of my employment

NOT PEER REVIEWED Dear Editor,

Research on waterpipe smoking, also called hookah, is still emerging, and research on second-hand hookah exposure is still in its nascent stages. However, after reading the review on the various effects of second -hand waterpipe smoke exposure by Kumar et al recently published in Tobacco Control1, we noted several major issues in its execution and have serious reservations about the potential of this review as a tool in the development of public health policy. First, the authors failed to synthesize all available research on the topic into their review, by utilizing only two electronic search databases. When a search was conducted in CINAHL, we found one more relevant article that could have been included in this review2. However, we are unable to judge as the authors don't present the inclusion criteria for the review. Furthermore, we found another systematic review on this topic and found that the amount of nicotine absorption resulting from daily hookah use was similar to that of daily cigarette use3. This is concerning because the authors did not include the older systematic review in the narrative nor did they derive information from it; consequently, calling into question the relevance of the current review. In addition, the authors were unclear regarding their methodology. They only provided a list of search terms and failed to specify any inclusion criteria, making it impossible for anyone to replicate their review. Second, the authors did not seem to have assessed the scientific quality of the included studies, negatively affecting the transparency of the review process. Thus, readers cannot properly assess its quality as a comprehensive review of the current body of literature or assess the validity of the findings that were included in the review. They also failed to assess publication bias, which would have been a relevant issue as they only included published studies. Given that a number of reporting guidelines for reviews have been produced, these issues are almost unjustifiable. Although the authors examined an important, often overlooked public health issue, their review suffered from major methodological flaws that could not be ignored. Unfortunately, the review's weaknesses prevent it from being a proper synthesis of the current body of research on the effects of second-hand exposure to hookah smoke and a useful tool for assisting decision-making in public health policy.

REFERENCES 1 Kumar SR, Davies S, Weitzman M, Sherman S. A review of air quality, biological indicators and health effects of second-hand waterpipe smoke exposure. Tob Control. 2015; 24: i54-i59. doi: 10.1136/tobaccocontrol-2014 -052038 2 Aydin A, Kiter G, Durak H, Ucan ES, Kaya GC, Ceylan E. Water-pipe smoking effects on pulmonary permeability using technetium-99m DTPA inhalation scintigraphy. Ann Nucl Med. 2004; 18(4): 285-289. doi: 10.1007/BF02984465 3 Neergaard J, Singh P, Job J, Montgomery S. Waterpipe smoking and nicotine exposure: a review of the current evidence. Nicotine Tob Res. 2007; 9(10): 987-994. doi: 10.1080/14622200701591591

Conflict of Interest:

None declared

NOT PEER REVIEWED

We refer to the article, "Did the tobacco industry inflate estimates of illicit cigarette consumption in Asia? An empirical analysis" Chen J, et al. published in Tobacco Control on November 25, 2014 (Tob Control 2015;0:1-7) and concur with the important points raised in this article. While the article focuses on Hong Kong, other countries in South East Asia also faced a similar experience. The authors revealed that the tobacco industry-funded study on the illicit trade of cigarettes in Asia, "Asia-11 Illicit Tobacco Indicator 2012" by the International Tax and Investment Center (ITIC) and Oxford Economics (OE) inflated the extent of illicit consumption in Hong Kong by 133-337 percent. Similarly, other scholars have also questioned the methodology applied in this report. For example, Dr. Frank Chaloupka, Distinguished Professor of Economics at the University of Illinois at Chicago, criticized the reliability of the study's estimates in using an inconsistent approach and the lack of details about the empty pack surveys, the main source of data for the estimates. In June 2014, the South East Asia Tobacco Control Alliance (SEATCA) released a critique of the "Asia-11 Illicit Tobacco Indicator 2012" showing how its estimates are being used to rescind tobacco tax policies. As illustrated in Hong Kong's experience, the SEATCA critique revealed that the ITIC-OE report overestimated the total illegal consumption in other countries in South East Asia. In the case of Vietnam, it claimed that in 2012 about 103.3 billion cigarettes consumed in Vietnam were illegal, which amounted to 19.4% of total cigarette consumption. The estimate was based primarily on the data of a tobacco industry group, the Vietnam Tobacco Association (VTA), and the full details of the methodology were not disclosed. The report admitted that data were collected only in urban areas, but it failed to mention that 68.3% of the Vietnamese population live in rural areas. This means that the findings are not representative of the Vietnamese population and are very likely biased since illicit cigarettes consumption is concentrated in big cities and near borders.

Unfortunately, as in Hong Kong, the glossy ITIC-OE study took its toll on tobacco tax policy in Vietnam. The Government of Vietnam considered the results of the study and opted for a less than ambitious tobacco tax rate increase. When the Ministry of Finance proposed a rather moderate tobacco tax roadmap in March 2014 (an increase from 65% to 75% in July 2015 and to 85% in January 2018), they noted that their decision was influenced by the illicit cigarette issue. The scope of illicit cigarettes consumption and the associated government revenue loss continued to be highlighted both in the press and during the policy debates until November 2014, when the National Assembly adopted an even weaker excise tax law: an increase to 70% in Jan 2016, and to 75% in 2019. Since these taxes are based on ex-factory price, and the tobacco industry is in full control of that price, the full impact on cigarette retail prices and tax revenue is likely to be minuscule. The average real retail cigarettes prices are expected to increase by less than 1% per year in the period from 2015 to 2020 (5.8% in 6 years), which, given the 5-6% annually per capita real income grows, is insufficient to prevent cigarette consumption from rising. In summary, the Asia-Illicit Tobacco Indicator 2012 report was as non- transparent in Hong Kong as it was in Vietnam and nine other countries covered by the report. It was used to undermine a pro-health tobacco tax policy supported both by public health advocates as well as the general public. We thank Tobacco Control for publishing the findings of Hong Kong colleagues, which successfully challenged the invalid evidence and arguments supported by the tobacco industry. We hope that other countries in Asia and elsewhere will follow Hong Kong's initiative and expose the tobacco industry's tactic to undermine pro-health tobacco tax policies that signatories to the WHO FCTC are committed to under Article 6 of the Convention.

Thank you

Sincerely, Son Dao , Hana Ross and Sophapan Ratanachena

Conflict of Interest:

None declared

NOT PEER REVIEWED We welcome the timely review published by Hill et al. [1], and agree that more research is needed to assess the equity impacts of tobacco control interventions. The results of the review indicated that "increases in tobacco price have a pro-equity effect on socioeconomic disparities in smoking", but that "evidence on the equity impact of other interventions was inconclusive [...]". The inconclusiveness of findings with regard to smoking ban policies may be partly due to date limitations for the database searches, which included evidence from January 2006 through November 2010. It may also be partly due to the assessment of equity in outcomes that related only to active smoking. Although a benefit of smoking ban policy implementation may be a reduction in active smoking, this outcome is dependent upon an individual's personal response to the intervention. However, the primary purpose for implementing comprehensive smoking ban policies is to reduce secondhand smoke exposure among the population through environmental change. It is therefore important to assess whether the successful implementation of smoking ban policies has pro-equity health effects.

Our previous research indicated that the national smoking ban policy in the Republic of Ireland was associated with immediate reductions in all -cause and cause-specific cardiovascular, cerebrovascular, and respiratory mortality, and that these mortality reductions were primarily due to reductions in population exposure to secondhand smoke [2]. Our subsequent assessment of the socioeconomic differentials of these mortality reductions in the Republic of Ireland suggested that inequalities in smoking-related mortality were immediately reduced following smoking ban implementation [3]. Furthermore, given the higher rates of smoking-related mortality in the most deprived group, even equitable reductions across socioeconomic groups resulted in decreased inequalities in mortality [3].

Partial smoking ban policies do not fully protect health [4], and are likely to yield negative equity effects as a result of policy exclusions for workplaces and hospitality venues located in more deprived areas [5]. In contrast, comprehensive smoking ban policies provide equal protection for all against secondhand smoke exposure. Indeed, previous studies have indicated that comprehensive smoking ban policies are effective public health interventions for reducing both exposure to secondhand smoke and other indoor air pollutants [6-11], the benefits of which are experienced by all employees and patrons of restaurants, bars, and other public places, regardless of individual socioeconomic group. Therefore, we wish to highlight that the evidence for pro-equity effects of comprehensive smoking ban policies may be more conclusive when additional health-related outcomes are considered.

References

1. Hill S, Amos A, Clifford D, Platt S (2014) Impact of tobacco control interventions on socioeconomic inequalities in smoking: review of the evidence. Tob Control 23: e89-e97.

2. Stallings-Smith S, Zeka A, Goodman P, Kabir Z, Clancy L (2013) Reductions in cardiovascular, cerebrovascular, and respiratory mortality following the national irish smoking ban: interrupted time-series analysis. PLoS One 8: e62063.

3. Stallings-Smith S, Goodman P, Kabir Z, Clancy L, Zeka A (2014) Socioeconomic differentials in the immediate mortality effects of the national Irish smoking ban. PLoS One 9: e98617.

4. Tan CE, Glantz SA (2012) Association between smoke-free legislation and hospitalizations for cardiac, cerebrovascular, and respiratory diseases: a meta-analysis. Circulation 126: 2177-2183.

5. Lewis GH, Osborne DC, Crayford TJ, Brown AC (2006) Partial smoking ban would worsen health inequalities. Bmj 332: 362.

6. Fong GT, Hyland A, Borland R, Hammond D, Hastings G, et al. (2006) Reductions in tobacco smoke pollution and increases in support for smoke- free public places following the implementation of comprehensive smoke- free workplace legislation in the Republic of Ireland: findings from the ITC Ireland/UK Survey. Tob Control 15 Suppl 3: iii51-58.

7. Connolly GN, Carpenter CM, Travers MJ, Cummings KM, Hyland A, et al. (2009) How smoke-free laws improve air quality: a global study of Irish pubs. Nicotine Tob Res 11: 600-605.

8. Goodman P, Agnew M, McCaffrey M, Paul G, Clancy L (2007) Effects of the Irish smoking ban on respiratory health of bar workers and air quality in Dublin pubs. Am J Respir Crit Care Med 175: 840-845.

9. Mulcahy M, Evans DS, Hammond SK, Repace JL, Byrne M (2005) Secondhand smoke exposure and risk following the Irish smoking ban: an assessment of salivary cotinine concentrations in hotel workers and air nicotine levels in bars. Tob Control 14: 384-388.

10. Valente P, Forastiere F, Bacosi A, Cattani G, Di Carlo S, et al. (2007) Exposure to fine and ultrafine particles from secondhand smoke in public places before and after the smoking ban, Italy 2005. Tob Control 16: 312-317.

11. Eisner MD, Smith AK, Blanc PD (1998) Bartenders' respiratory health after establishment of smoke-free bars and taverns. JAMA 280: 1909- 1914.

Conflict of Interest:

None declared

In this rejoinder, we will address the recent response by Mary Assunta to our article, "Complexities at the intersection of tobacco control and trade liberalisation: evidence from Southeast Asia." To be sure, we believe that trade policy remains a very important issue for public health both in Southeast Asia and globally. Before addressing the specific concerns raised by the reader, it is worthwhile to restate the overarching argument, goals and approach in the original article. In brief, we argue and demonstrate empirically that over the last 15-20 years, sometimes considerable changes in trade policy have not systematically undermined tobacco control in Southeast Asia. Moreover, we also posit that penetration of the region by large international tobacco firms through investment is likely playing a much larger role in affecting public health policy. We do not discount trade entirely and largely agree with the reader that it has had some specific important effects, but these incidents do not undermine our general thesis.

We completely concur with the reader's first concern that trade liberalization should be conceptualized as more than tariffs. This indeed was exactly our concern and largely motivated the research. In previous research and in discourse at international meetings, we observe too much emphasis on the more elementary aspects of liberalization and not enough on some of the areas that the reader, too, points out as important. The reader appears to have overlooked particularly both the abstract and the conclusion, which raise concerns with critical issues such as intellectual property rules and investor-state dispute settlement. We wish for the focus to be the right one, too, and it seems that we are on the same page for this goal.

On the second major point, it appears that the reader is suggesting that transnational tobacco corporations use tariff reduction as a springboard into seeking further non-tariff liberalization. We would not dispute this contention, but we would also like to see much more compelling and rigorous evidence of this dynamic. The Philip Morris International (PMI) submission to the Transpacific Partnership (TPP) cited by the reader does not really make this connection sufficiently, in particular because the included passage is still really about tariffs or closely-related ancillary policies.

The reader's third concern revolves around a purported dismissive treatment of the findings of Chaloupka and Laixuthai (1996), and Honjo and Kawachi (2000), particularly on the advertising dynamic. When we wrote, "Tobacco control policies were mostly nonexistent in these contexts too, so there was no obvious policy-based counter-force to the sudden changes in the tobacco marketplace" (which the reader cites almost verbatim in their critique), we were referring to the lack of these types of restrictions. We do not and would not dispute the important role that increased marketing played in re-shaping these contexts - it was undoubtedly an important part of the increase in imports and subsequent consumption. But our broader conceptual point is that the context in most countries now is different than it was in East Asia in the 1980s. First, most countries are already highly liberalized both in terms of trade and of investment. In most if not all of Southeast Asia, multinational tobacco firms are already firmly entrenched in terms of trade, investment and marketing (Vietnam is a partial exception because of tariff walls and the market constraints on multinational firms in their joint ventures with the state-owned tobacco enterprise). Thus, in many markets, firms have already been marketing for years and further liberalization in the classical sense is likely to make little difference strictly speaking. There is also good news in the contemporary era quite different than the 1980s in that some countries have strong marketing restrictions in place.

The fourth concern in the response focuses on affordability. The reader's primary concern is that their data do not match ours. We re- checked our data and calculations, and remain confident in them. We are using the most up-to-date market data from proprietary sources such as Euromonitor and ERC (these services frequently update old data rendering older versions obsolete). While these sources are far from perfect, most in the tobacco control sub-field believe that they remain the best available for these types of data. It is critical to stress that we are using the cheapest brand (typically, a local brand, though not necessarily the most popular) for our calculations with the explicit logic that we want to explore barriers to consumer market entry (i.e. what is the least amount of money that it would take for someone to smoke regularly). Many other articles on tobacco affordability use prices of the most popular brand and/or an international brand such as Marlboro to calculate affordability. As we explain in the article, these choices are simply not theoretically suitable for our purposes. When we run cursory analyses with these other prices, we do note some of the differences that the reader points out; however, such differences are not relevant to our discussion.

In response to the reader's concern about our interpretation of Figure 3, we appreciate the correction about Myanmar. The reader is correct that we erroneously indicated Myanmar when we meant, instead, to include Singapore in this list of countries with noticeable decline. As the reader rightly points out, Myanmar stayed about the same. In the process of writing the manuscript, we re-did this figure several times - ironically largely because we thought that the Singapore and Myanmar results were not accurate - with updated data (see the discussion above - sometimes we observed reversals in country-level trends after receiving market data updates) and unfortunately failed to update the text completely.

We should also clarify the reader's misconception in Figure 3's interpretation about our apparent confusion around Indonesia and Vietnam. We actually split them apart in our narrative in order to draw attention to each of them. As we suggest, the broader contexts and dynamics in the two countries are quite different, but we wanted to highlight the similarity in outcome (increased consumption per capita) in two quite different scenarios. More broadly and importantly, the crux of the figure is the inconsistency across countries. Even our tiny descriptive error outlined in the paragraph above does not change this important characteristic in any way.

In terms of the reader's very minor concern about our description of Vietnam as being "closed," please refer to Table 1, which discusses tariff rates. We do not purport to make a broader interpretation of openness (or "closedness" as the case is here) than the straightforward one that we clearly lay out. We also cite the joint venture activity that the reader seems to suggest as new and excluded information (see Table 4).

We appreciate the reader's interesting discussion on affordability in Malaysia. We are very interested in the possibility that tobacco firms operating in Malaysia were able to keep prices down by importing cheaper leaf. However, the reader's discussion focuses on the delay of the prohibition of selling "kiddie" packs, conflating the actual causal relationships. Specific to the dynamic of tobacco leaf prices, it is also important to note that FAO price data suggest that these prices are increasingly global with limited cross-country variation (FAO STAT 2014). Moreover, leaf comprises only a surprisingly small part of the overall "cost" of a cigarette, so changes in leaf prices are unlikely to have enormous impact on affordability.

In many ways, the complexities that the reader points out with the kiddie packs only strengthen our overall argument that the broader political economy of tobacco control is much more complex than changes in trade policies. That the tobacco industry is devious and employs many tactics only reinforces the important notion that the public health community has to keep the broader context in mind. Like the brief discussion above about one aspect of the complexities of measuring affordability (Which cigarette price should we use? Lowest? Most popular? Most commonly collected? Recognized international brand?), the dynamic that the reader describes raises another complexity - the definition of pack size for the calculation. Alas, this discussion about the vagaries of measurement in affordability - though very important - is beyond the purview of our brief study about trade liberalization.

We thank the reader for pointing out our reversal of the dates for the investments in Malaysia and Indonesia. We appreciate the reader's keen sense of accuracy, but our main point remains unchanged: transnational tobacco firms are highly active investors in the region. Investment is almost certainly more important than trade liberalization in terms of affecting the dynamics that we discuss, including affordability and relevant policies.

In the Philippines-Thailand dispute at the World Trade Organization (WTO), the reader appears to confuse the basic tenets of Article 5.3 of the World Health Organization's (WHO) Framework Convention on Tobacco Control (FCTC). One of the key goals of Article 5.3 is to ensure that the tobacco industry is excluded from direct participation in making tobacco control policy. The article also presses for transparency when governments deal with the tobacco industry more generally, but the FCTC does not ask governments to cease all relationships with the tobacco industry. Elsewhere, the authors and colleagues have examined in considerable depth (e.g. Chavez et al 2014; Drope et al 2014) the lack of irrefutable evidence that the tobacco industry did anything that is not permitted - in the FCTC or otherwise - to get the Philippines government to pursue the dispute at the WTO. That the industry helped to pay some of the legal costs (incidentally, we failed to obtain confirmation of this scenario in our on-the-ground research) is neither illegal nor unusual. Firms in many other industries in other countries have behaved similarly at the WTO and it is not expressly prohibited. Perhaps the reader believes that pursuing such a case is tantamount to an incentive, which Article 5.3 does identify as not permissible, but the case for such a dynamic remains to be made. While we personally feel that governments should not pursue these cases on behalf of the tobacco industry, it is clearly in trade ministries' mandates to act to protect their constituents, of which the tobacco industry is one.

Rather than relying on anecdotal and often unverified media accounts, we formally interviewed dozens of the key official and unofficial players involved in this and related dynamics in the Philippines and we did not find any "smoking gun" evidence of corrupt behavior. What the public health community considers "bad" or undesirable behavior does not necessarily qualify as corruption. Finally, we never suggested that civil society had to produce the evidence - as researchers, we should not care from where the evidence comes. We should, however, care deeply about the quality of the evidence, and be able to gather it and evaluate its validity and reliability with considerable objectivity.

Finally, in regard to the referenced Joint Memorandum Circular (JMC), it is worth noting that there are internal struggles within the Philippines as the domestic tobacco control legislation (RA 9211) and the FCTC remain in some or even considerable tension. Many government departments point out that the FCTC has never been properly domesticated with enabling legislation as the political and legal structure in the Philippines requires (see Magallona 2013 for a discussion of how this works). So, in the eyes of many, the JMC does not have the force of law (see Lencucha et al, forthcoming).

In regard to the concern about regulatory chill, we do not purport at any point that regulatory chill does not exist; rather, the actual dynamic that we examine in the article is that chill is a very difficult phenomenon to identify unequivocally. To take the reader's example of New Zealand, our colleagues (officials in governments) have explained to us that there is limited political support for plain packaging beyond Minister Turia and some in the Maori Party and the Green Party. In brief, our sources suggest not only that the minister lacks support from many other key actors (including particularly in the minority government's coalition-leading National Party), but that blaming regulatory uncertainty ("chill") is a thinly-veiled and convenient excuse to avoid pushing the legislation that a number of officials simply do not want. The scenario in New Zealand seems likely to be precisely the dynamic that we are discussing in this article. Incidentally, the dynamic that we examine may be just as or even more problematic to the public health community than basic "chill." We cannot speak to what is happening in this area in Malaysia as it was not part of our research - perhaps it is regulatory chill in the truest sense - but it has to be demonstrated rigorously. From personal perspectives, we are quite concerned about regulatory chill, and particularly for low- and middle-income countries that rightfully fear costly litigation, but as we state clearly and for which we make a compelling case, as a scholarly community we simply do not yet understand well the actual dynamics of regulatory chill. Clearly, it is a much needed avenue of future research.

After the discussion of regulatory chill, the reader reiterates one of our key conclusions - which we do not seek to prove empirically - that investment almost certainly plays a significant role in affecting the tobacco control outcomes examined in this research. Our discussion is fully congruent with the reader's observation that investment in countries like the Philippines and Indonesia is surely having a significant effect on tobacco control and related efforts. Again, we are advocating not only more systematic research on trade policies' effects on tobacco control, but more broadly, to expand research focus to the dynamics around investment in the tobacco sector.

Finally, on the issue of a tobacco carve-out in the TPP, we would suggest that typical dynamics of the international system - well developed theoretically and substantiated empirically - suggest that the prospects for a Malaysia-style proposal are likely to be rather dim (for a broad set of relevant theoretical discussions, see, for example, Baldwin 1993). First, international agreements are deeply affected by state power and in the TPP scenario, Malaysia is a relatively weak actor, while several of the other much stronger states have stated an explicit preference for an alternative arrangement (the US) or have intimated that a carve-out is not likely to be acceptable (Japan). Second, and intrinsically related to the first dynamic, in an international trade negotiation like the TPP, all parties must agree, so the prospect of total agreement on a complete tobacco carve-out is currently not strong. It is possible that other countries will use the Malaysia proposal as a foil in order to find some middle ground, which might still work out well for public health. It is also possible that because the proposal is so unpopular with some key actors that negotiating parties might choose ultimately to exclude it entirely from the negotiation (much the same way that trade has thus far been excluded from the Framework Convention on Tobacco Control). Finally, we highly doubt that Malaysia will withdraw from the TPP if it does not get its way on tobacco, which suggests strongly that it is probably not the most important issue on its trade ministry's negotiating agenda.

The dynamics above also apply to the re-negotiation of the thousands of existing agreements that the reader suggests is attainable with some hard work. Unfortunately, both theory and recent experience suggest a genuine struggle to negotiate trade agreements more broadly. For example, the WTO's Doha round was essentially stuck for more than a dozen years and the supposed breakthrough in 2013 was eventually about the relatively non- controversial area of trade facilitation and ignored the many other pressing issues that have contributed to the long gridlock (WTO 2013). It is also important to consider that many international economic agreements do not come up for renegotiation naturally or will not expire for many years. Any enthusiasm for re-negotiation may eventually be tempered by the sheer size of the endeavor. We do agree, however, that a TPP that enshrines health in a way that protects and promotes tobacco control and public health is a crucial set of goals for the global community.

It is also important to consider that the idea of a tobacco carve-out is mostly untested. We fear that it will not be the panacea that many advocates suggest. Tobacco exclusion may even be detrimental in some circumstances by perpetuating market structures that serve strong pro- tobacco interests - for example, by preserving the market share of politically-strong tobacco firms (this dynamic is somewhat similar to a scenario where under certain conditions marketing restrictions can also serve to preserve market share for powerful incumbent firms). In two recent major international economic agreements, the Pacific Island Countries Trade Agreement (PICTA) and the South Africa-European Union Trade, Development and Cooperation Agreement (TDCA), it was a major transnational tobacco firm operating in favorable domestic conditions pushing governments for a tobacco exclusion policy (personal communication with a South African treasury official).

A final and more crucial point is that the international trading system has rules that seek to tackle the complexities of making policies across sectors (e.g. public health and economic policies). As Drope and Lencucha (2014) discuss, the seminal Thailand - Cigarettes case at the General Agreement on Tariffs and Trade (GATT) actually laid a reasonable foundation for how to make good public health policy that integrates successfully with world trade rules and goals (see for example, paragraphs 77-78 from GATT 1990). In some ways, the slightly bizarre U.S.-Clove Cigarettes case also generated some similar proactive discussion from the WTO wherein the panel was explicit about permitting the banning of tobacco additives as long as it was not discriminatory (see McGrady 2011 for a discussion). The panel reports demonstrate these dynamics clearly (see WTO 2011, 2012).

As a broader community - i.e. beyond tobacco control - we suggest that we need to develop a world trading system that can accommodate many other important health-related issues such as unhealthy foods, alcohol and access to medicines (to name only a few) that sit squarely at the nexus of public health and economic policymaking. Re-working or tweaking some of the rules of the world trading system might be a good place to start. But we are unwilling to throw out all of the existing rules and are suggesting that they have even sometimes served to try to integrate health and trade meaningfully in ways that do not necessarily undermine health (see the examples in the paragraph above). Another recent case worthy of consideration is the Philippines - Distilled Spirits dispute at the WTO, which ultimately was the primary catalyst for the recent successful tobacco excise tax reform in the Philippines (see Chavez et al 2014; Drope et al 2014). We underscore in our article, and reinforce in this rejoinder, that the international economic system is complex, but it is not without opportunities to promote public health.

In regard to the quote from a Philippine trade official about a lack of support for a tobacco carve- out in ASEAN, it is important to reiterate context. First, the official was speaking about the AFTA, not the TPP, which is to what the reader is referring. Second, returning to the original interview transcript, the official also stated that no influential trade official that s/he knew of was in favor of a carve-out. Whether the Malaysian proponents prove to be sufficiently influential to include a tobacco exclusion in AFTA still remains to be seen. Finally, this was a key informant interview of an influential actor in one country in this regional agreement - these are not our views necessarily and we do not at all purport that these are the only views. Moreover, we do not suggest anywhere in the research that the tobacco carve-out discussion is only occurring in Southeast Asia. We set up our case study justification for Southeast Asia by acknowledging the regional discussion, but this does not suggest that there is no discussion of carve-outs elsewhere in the global community.

In sum, the key argument in our article that trade policy has not systematically undermined tobacco control in Southeast Asia remains strongly supported. Moreover, the reader appears to concur with us that investment is a key variable in the political economy of tobacco control in the region. In many ways, it appears that we and the reader are simply coming from entirely different epistemological and methodological traditions. We are seeking to identify and explain broader patterns across time and space (in this case, countries in Southeast Asia) and learn from them, where in contrast the reader seeks to focus in large part on the exceptions to the patterns that we are underscoring. We acknowledge the complementarity of research that seeks an approach focused on important exceptions and identify some effective recent articles in this research vein (see endnotes 24 and 34-38), but it is important to recognize that each approach offers distinct utility. In an important research topic and moral cause - such as the health-trade nexus - we need to take great care not to prematurely dismiss others' rigorous and transparent work, and exploring a wealth of different approaches can only be good.

REFERENCES

Baldwin R. (ed.) Neorealism and Neoliberalism: The Contemporary Debate, Columbia University Press, 1993.

Chaloupka F, Laixuthai A. U.S. Trade Policy and Cigarette Smoking in Asia [Internet]. National Bureau of Economic Research; 1996 Apr. Report No.: 5543. Available from: http://www.nber.org/papers/w5543.

Chavez JJ, Drope J, Lencucha R, McGrady B. The Political Economy of Tobacco Control in the Philippines: Trade, Foreign Direct Investment and Taxation 2014. Quezon City: Action for Economic Reforms and Atlanta: American Cancer Society.

Drope J, Chavez JJ, Lencucha R, McGrady B. The Political Economy of Foreign Direct Investment: Evidence from the Philippines. Policy and Society 2014; 33: 39-52.

Drope J, Lencucha R. "Evolving Norms at the Intersection of Health and Trade." Journal of Health Politics, Policy and Law 2014; 39, 3: 591- 631.

FAO STAT. Tobacco leaf - world price and export unit value. 2014.

General Agreement on Tariffs and Trade (GATT). Panel Report: Thailand - Restrictions on Importation of and Internal Taxes on Cigarettes 1990. BISD DS10/R-37S/200. Geneva: GATT (November 7).

Honjo K, Kawachi I. Effects of Market Liberalisation on Smoking in Japan. Tob Control. 2000;9(2):193-200.

Lencucha R, Drope J, Chavez JJ. Whole-of-government approaches to NCDs: The case of the Philippines Interagency Committee on Tobacco. Forthcoming, Health Policy and Planning.

Magallona, MM. The Supreme Court and International Law Problems and Approaches in Philippine Practice. 2013 Philippine Law Journal 85(1, 2). Available at http://plj.upd.edu.ph/wp-content/uploads/2013/06/PLJ-volume- 85-issue-1-2-THE-SUPREME-COURT-AND-INTERNATIONAL-LAW-PROBLEMS-AND- APPROACHES-IN-PHILIPPINE-PRACTICE-Merlin-M.-Magallona.pdf.

McGrady B. Tobacco Product Regulation and the WTO: US - Clove Cigarettes. O'Neill Institute Briefing Paper - 12 September 2011. Washington DC: Georgetown University.

Pacific Island Countries Trade Agreement (PICTA). Nauru, 2001.

World Trade Organization (WTO). Panel Report: United States - Measures Affecting the Production and Sale of Clove Cigarettes 2011. Geneva: WTO (WT/DS406/R).

World Trade Organization (WTO). Appellate Body Report: United States - Measures Affecting the Production and Sale of Clove Cigarettes 2012. Geneva: WTO.

World Trade Organization (WTO). Agreement on Trade Facilitation. 6 December 2013. See https://mc9.wto.org/system/files/documents/w8_0.pdf.

Conflict of Interest:

None declared

The article of Cummins et al. (1) is based on a survey which according to the authors considers electronic cigarette a risk for populations with mental health conditions. First of all, in our opinion it is not correct to agglomerate and treat all mental health conditions in the same way. It would be like considering all physical illness the same way. Fever is like a cancer? A specific phobia is like schizophrenia? It 'is true that there is a high level of smoking prevalence in individuals with mental health conditions but it varies according to mental health conditions e.g. schizophrenia, major depression, bipolar disorder. In two studies we have shown for the first time that regular use of E- cigarettes substantially decreased consumption of conventional cigarettes without causing significant side effects in chronic schizophrenic patients and in depressed patients who smoke (2,3). Large prospective randomized controlled are now required to confirm these initial observations (4,5). If these studies further confirm the potential use of the ecig as a tool in the fight against smoking, we could see the resources of this instrument rather than just the limits. Millions of lives could be saved and the smoking cessation centers, in real life settings, could boast a range of proposed therapies able to increase their level of clinical efficacy and improve their level of attractiveness for the smoker who thinks to improve their health and quality of life. Although not formally regulated, the e-cigarette may help smokers with mental health conditions to reduce their cigarette consumption or remain abstinent and reduce the burden of smoking-related morbidity and mortality. The ultimate goal is to propose an effective intervention to reduce the harm of tobacco smoking for this challenging population.

References

1. Cummins SE, Zhu S, Tedeschi GJ, Gamst AC, Myers MG. Use of e- cigarettes by individuals with mental health conditions. Tob Control doi:10.1136/tobaccocontrol-2013-051511 2. Caponnetto P, Auditore R, Russo C, Cappello G C, Polosa R: Impact of an Electronic Cigarette on Smoking Reduction and Cessation in Schizophrenic Smokers: A Prospective 12-Month Pilot Study. Int. J. Environ. Res. Public Health 2013, 10: 446-461. 3. P Caponnetto, R Polosa, R Auditore, C Russo, D Campagna: Smoking Cessation with E-Cigarettes in Smokers with a Documented History of Depression and Recurring Relapses. International Journal of Clinical Medicine 2(3), Vol.2 No.3, July 2011. 4. Caponnetto P, Polosa R, Auditore R, Minutolo G, Signorelli M, Maglia M, Alamo A, Palermo F, Aguglia E. Smoking cessation and reduction in schizophrenia (SCARIS) with e-cigarette: study protocol for a randomized control trial. Trials. 2014 Mar 22;15:88 5. http://clinicaltrials.gov/ct2/show/NCT02124187

Conflict of Interest:

None declared

Gottlieb rightly provides us evidence to question Food and Drug Administration (FDA) policy.(1) Indeed, the 2009 law giving the Agency the authority to regulate tobacco was useless as FDA's Advisory Committee issued a report which failed to recommend a ban on menthol cigarettes despite evidence of its devastating effects, a major setback for public health.(2) Is FDA only overcautious as Gottlieb suggested? Its professionalism, competence and integrity may be questioned too! First, FDA has even promoted the advantages of menthol in terms of harm reduction.(3) Recurrence occurs, but this time the author failed to disclose his link with FDA.(4) These reports are weak post hoc analyses and, most of all, rely on a grossly flawed controlled group: menthol smokers should be not be compared to smokers of non menthol cigarettes but to non smokers because the tobacco industry has a well-documented history of developing and marketing these brands to recruit racial minorities and youth who would not have smoked otherwise. Second, FDA's Center for Tobacco Products recently announced it will analyse cigarette constituents more accurately and reliably, helping to ensure that accurate scientific data are collected to help fill current gaps regarding the chemical and physical properties of tobacco products, and more generally, improve information regarding the harms associated with tobacco use. "Quality control and sample testing parameters ... will be conducted ... to allow for certification of product physical parameters and constituent levels ..." (http://www.fda.gov/AboutFDA/CentersOffices/OfficeofMedicalProductsandTobacco/AbouttheCenterforTobaccoProducts/ucm391336.htm)" Cigarettes kill more than 400,000 US people annually in the US, but quality control will replace tobacco control! What could be next? Considering the importance of the global warming issue, the addition to tobacco of the single "cool" molecule, the organic compound obtained from peppermint, could be rewarded with an Ecolabel through a partnership with the Environmental Protection Agency. The European Union moved forward, issuing a directive to ban all characterizing favors in 28 countries, though the menthol flavor will be given a four-year derogation to 2020. Could the FDA be under corporate influence? As a Frenchman, I note that FDA did not hesitate to ban Mimolette, a French cheese, in May 2013. Some said it was a retaliation to prevent Europe from banning US GMO food exports. I am not surprised that 37% of American people agreed with conspiracist beliefs such as "FDA is deliberately preventing the public from getting natural cures for cancer and other diseases because of pressure from drug companies."(5)

1 Gottlieb M. Overcautious FDA has lost its way. Tob Control 2014;23:187-8.

2 Siegel M. A Lost opportunity for public health - The FDA Advisory Committee Report on menthol. N Engl J Med 2011;364:2177-9.

3 Rostron B. Lung cancer mortality risk for U.S. menthol cigarette smokers. Nicotine Tob Res 2012;14:1140-4.

4 Rostron B. Menthol cigarette use and stroke risk among US smokers: A critical reappraisal. JAMA Intern Med 2014. Online Mar 10. doi: 10.1001/jamainternmed.2013.9600.

5 Oliver JE, Wood T. Medical Conspiracy Theories and Health Behaviors in the United States. JAMA Intern Med 2014. Online Mar 17. doi: 10.1001/jamainternmed.2014.190.

Conflict of Interest:

None declared

Dear Editor

Cartwright (1) has clearly mis-read our article on PMI's Project Star report(2). The central premise of our article is not that illicit is overestimated but that the Project Star report cannot be relied on as a source of data on illicit until there is significantly greater transparency over the underlying methodology and data inputs and the contractual arrangements under which it is conducted. KPMG itself would appear to acknowledge this stating clearly in a disclaimer in each of its Project Star reports that the data cannot be relied on: "KPMG wishes all parties to be aware that KPMG's work for Philip Morris International was performed to meet specific terms of reference agreed between PMI and KPMG and that there were particular features determined for the purposes of the engagement. The Report should not therefore be regarded as suitable to be used or relied on by any other person for any other purpose."

This lack of transparency is again underlined by Cartwright's failure to mention in his letter that KPMG receives ?10million from PMI to produce Project Star, his largest contract (http://www.kpmg.com/uk/en/about/aboutkpmg/kpmgfoundation/pages/robin- cartwright.aspx). He also claims this is a project for the European Commission and Philip Morris yet the Commission denies this. It is increasingly difficult to see where the truth lies here. KPMG's claim that the Project Star reports are recognised across Europe as the most "comprehensive" study of its kind is not disputed. No-one else has the financial backing or the political self-interest, in the case of PMI, to produce a report of this size. But comprehensive does not equal accurate, reliable and transparent. It doesn't matter how many cigarette packs are collected if the empty pack survey is designed to overestimate illicit as growing evidence suggests industry empty pack surveys are(2). Our paper clearly acknowledges that the model used in the Project Star report has merit but while PMI are so closely involved in the report and supply the majority of data to be used in the model, it cannot be relied on. Overwhelming evidence shows the extent to which the tobacco industry is prepared to manipulate science and data in its own interest(3). The illicit trade in tobacco is no exception(2,4). Anna B Gilmore1, Silvano Gallus2, Andy Rowell1, Luk Joossens3 1Department for Health and UK Centre for Tobacco and Alcohol Studies (UKCTAS), University of Bath, Claverton Down Road, Bath, UK 2Department of Epidemiology, IRCCS--Istituto di Ricerche Farmacologiche Mario Negri,Milan, Italy 3Association of the European Cancer Leagues and Foundation Against Cancer, Brussels, Belgium

Competing interests: The authors of this letter authored the paper being criticised by Cartwright and ABG, SG & LJ were part of the PPACTE study which Cartwright also criticises.

(1) Cartwright RM. KPMG response to 'Towards a greater understanding of illicit tobacco trade in Europe: a review of the PMI funded 'Project Star' report'. Tobacco Control Published Online First 5 March 2014 http://tobaccocontrol.bmj.com/content/early/2014/01/16/tobaccocontrol-2013 -051240.full?sid=ffae5533-cd43-46d0-ae48-3f2d6c0d9b00#responses. (2) Gilmore AB, Rowell A, Gallus S et al. Towards a greater understanding of the illicit tobacco trade in Europe: a review of the PMI funded 'Project Star'. Tobacco Control Published Online First 11 December 2013 doi:10.1136/tobaccocontrol-2013-051240. (3) Michaels D. Doubt is our Product. New York: Oxford University Press, 2008. (4) Rowell A, Evans-Reeves K, Gilmore AB. Tobacco Industry Manipulation of Data on and Press Coverage of the Illicit Tobacco Trade in the UK. Tobacco Control (in press).

Conflict of Interest:

The authors of this letter authored the paper being criticised by Cartwright and ABG, SG & LJ were part of the PPACTE study which Cartwright also criticises.

NOT PEER REVIEWED Dear Editor,

The recent article by Cai et al, reported that male gender, young age, low educational attainment, and tobacco cultivation are predictors of tobacco use and second-hand smoke (SHS) exposure in rural China [1]. Neighborhood-level income was the only contextual predictor of tobacco use and SHS exposure identified. Hence, the authors suggested that "future interventions to reduce smoking and exposure to SHS in China should focus more on tobacco farmers, less-educated individuals and on poor rural communities." (pg. ii19)

Nevertheless, Cai and colleagues also found that the Han majority had higher prevalence of smoking and SHS exposure when compared to ethnic minorities (p<0.05). Differences in health outcomes and risk factors have been reported among the Han population when compared to other Chinese ethnic minorities [2,3]. Stratified analysis might elucidate unique risk factors to smoking and SHS exposure between ethnic groups important for the design of tobacco control strategies.

In addition, Cai et al. showed that townships varied widely in the proportion of the population who were ethnic minorities (3.1% to 97.1%). In the study of contextual determinants of health, results and implications should not ignore such vast differences in ethnic composition between areas. Important information might be conveyed if results were stratified by the proportion of ethnic minorities in the area (e.g. high, medium, low). Ethnic minorities living in areas with a high proportion of the population of the same ethnic minority may experience better health [4]. Therefore, it might also be important to compare the risk of smoking and SHS exposure among individuals living in areas highly populated by their ethnic group versus those residing in areas where they are the minority group.

Cultural differences and ethnic composition of a geographic area should be considered in the design and implementation of tobacco control programs and in the allocation of resources. Resources may be better spent in areas with a high proportion of the Han population; while areas with a high minority population may be at decreased risk. Interventions should be culturally appropriate to minimize the expenditure of resources on ineffective strategies.

Diana M. Sheehan, MPH

References

1. Cai L, Wu X, Goyal A, et al. Multilevel analysis of the determinants of smoking and second-hand smoke exposure in a tobacco- cultivating rural area of southwest China. Tob Control 2013;22(suppl2):ii16-20.

2. Ruixing Y, Hui L, Jinzhen W, et al. Association of diet and lifestyle with blood pressure in the Guangxi Hei Yi Zhuang and Han populations. Public Health Nutr 2009;12(4):553-561.

3. Sun H, Zhang Q, Luo X, et al. Changes of adult population health status in China from 2003 to 2008. PLoS One 2011;6(12):e28411.

4. Inagami S, Borell LN, Wong MD, et al. Residential segregation and Latino, black and white mortality in New York City. J Urban Health 2006;83(3):406-20.

Conflict of Interest:

None declared

Conflict of Interest:

None declared

NOT PEER REVIEWED Because the authors cite just seven major tobacco-related news events in the seven year period they reviewed (Figure 2), I question whether their tabulation of the "volume of news media stories on tobacco" (page 6) provides a meaningful representation of the coverage of tobacco-related issues in the mass media. Is not a front-page article on a tobacco- related subject in The New York Times or The Washington Post--or a lead story on NBC NIghtly News or The Today Show--of far greater importance, in terms of both content and readership, than the publication of any number of brief items? In other words, missing from this analysis is a year-by- year list of nationally significant news stories on tobacco.

One measure that could be used to quantify the relative importance of tobacco stories in a given year is the daily Index to Businesses in The Wall Street Journal (WSJ). By this indicator (and by my daily reading of the print editions of the WSJ, The New York Times, The Financial Times, USA Today, and two local US dailies), my impression is that in recent years there has been a relative handful of significant tobacco news stories. This is at odds with the authors' finding of an average of 3 tobacco-related newspaper stories, 4 newswire stories, and 1 television news story each day for seven years. Although the authors attempted to correct for duplication, I suspect a large percentage of these stories were variations on a theme or the same news thread.

Another measure is newspaper editorial cartoons. Even taking into consideration the decimation in the ranks of political cartoonists at US dailies due to the steep decline in newspaper readership, editorial cartoons on tobacco issues are now rare. In the heady days of anti- tobacco activism in the US in the 1980s and 1990s, I catalogued more than 700 editorial cartoons on tobacco.

I wonder if the best way to gauge the weight given to the coverage of tobacco-related issues in a given year would be to compare it to the attention given to other issues, both health-related (eg, AIDS, obesity, gun control, alcohol problems) and less directly health-related (eg, the economy, unemployment, terrorism).

Ultimately, I am unconvinced that quantity beats quality when it comes to reports on tobacco in the mass media. What matters is the prominence of news coverage of significant issues, not the number of articles all counted as equal.

Conflict of Interest:

None declared

NOT PEER REVIEWED The warning of this article is important, but not limited to the Trans-Pacific Partnership. Switzerland and USA, as countries which have not ratified, are not obliged to follow Article 5.3 of the WHO Framework Convention on Tobacco Control. One of the reasons for the largest tobacco companies to move their headquarters to Switzerland was the location of the World Trade Organisation in this country. Some time ago I attempted to draw attention to this danger: https://secure.avaaz.org/en/petition/exclude_tobacco_nicotine_from_free_trade_agreements/. I hope that Fooks and Gilmore will succeed in starting a broader movement.

Conflict of Interest:

None declared

The prospect of a tobacco endgame in which death and disease from tobacco would be virtually eliminated is very exciting. We read the May 2013 issue of Tobacco Control on the Tobacco Endgame with great interest. The issue features 20 articles by esteemed co-authors who are known internationally for their work on tobacco control. Each individual article is excellent; however, we were surprised and disappointed that this special issue ignored the very substantial problem of psychiatric comorbidity among smokers. Studies increasingly demonstrate that this group buys and uses more tobacco than any other disparity group (MMWR 2013). They are also very likely to die early from tobacco use, suffer economic burden, and suffer unique consequences such as psychiatric medication complications. The focus of much of the issue is on regulatory approaches or potential changes to tobacco products that may reduce cigarette smoking. While these empirically supported approaches are important, data from New York (http://www.health.ny.gov/prevention/tobacco_control/reports/statshots/volume5) indicates that many important public health policies do not adequately influence smokers with psychiatric comorbidity. A true "end game" strategy must acknowledge the tremendous proportion of smokers with psychiatric comorbidity and offer strategies for addressing this vulnerable population. We agree with Dr Malone when she says that a tobacco endgame "addresses tobacco as a systems issue...{that} reframes strategic debates...{and} advances social justice (Malone 2013, p i42)." Dr. Malone's words validate our concern that psychiatric comorbidity was rarely mentioned in this issue. The word "mental" appears twice (Thomas p56; Chapman p 35) and "comorbid" appears twice (Hatsukami, p 36; Benowitz p 16). A special issue on a tobacco endgame that ignores a group that is hugely overrepresented among current smokers makes it even more likely that this disparate population will continue to be ignored. In past decades the US was successful in driving down smoking rates through public health efforts. Recently these efforts have stalled and we need to consider a new approach. While detailing a comprehensive strategy is beyond the scope of this letter, we are calling for focused efforts, targeting disparate population groups like the poor and the mentally ill. A population approach is reasonable as long as it is also mindful of the "who" that are left smoking. These groups should be given a priority designation for future funding, policy and research efforts because any "endgame" that leaves them behind is no endgame at all.

Conflict of Interest:

None declared

NOT PEER REVIEWED Sincere thanks, Dr. Borland, for your insightful comments recognizing the inherent conflicts between harm elimination and reduction, between policy and profits. As a nicotine cessation educator monitoring the latest wave of irresponsible harm reduction marketing, I have grave concerns that we are only one youth fad away from seeing adolescent nicotine dependency rates skyrocket.

Nicotine addiction is every bit as permanent a disease as alcoholism. It is a wanting disorder in which brain dopamine pathways assign the same use priority to nicotine as they do to eating food. But instead of desiring food 2 to 3 times daily, imagine feeling wanting, urges or craves 15, 20 or even 30 times daily. Imagine that next fix quickly being life's new #1 priority, no longer being able to recall the beauty of going weeks, months and years without once wanting for nicotine.

Marketing suggesting that replenishment anxiety relief is "pleasure" is akin to suggesting that it feels good to stop pounding your fingers with a hammer. We are also seeing laughable harm reduction marketing centered on the concept of "freedom," or that nicotine is as safe as caffeine.

U.S. First Amendment commercial free speech concerns will likely trump marketing control initiatives. In nations where non-profit control is possible, history suggests that keen awareness as to financial conflicts among those permitted to define policy is critical if dependency onset avoidance and effective cessation are goals.

Your government agenda concerns are warranted, Dr. Borland. Nearly four years since passage of the U.S. Family Smoking Prevention and Tobacco Control Act and we have yet to see any meaningful change. Imagine 400,000 annual smoking related deaths and no sense of political urgency.

Imagine knowing that NRT shows efficacy against placebo in studies we know were not blind, while totally ignoring NRT's population level ineffectiveness evidence-base, and the prospect that three decades of feeding replacement nicotine to nicotine addicts may have cost millions their lives.

I am convinced that replacement nicotine has effectively destroyed cessation. Having watched decline in adult smoking grind to near standstill, we now watch as the frustrated harm reductionist throws cessation under the bus.

I live in a nation where this year cold turkey is again expected to generate more successful ex-smokers than all other methods combined. Yet, locating any researcher curious as to the keys to successful abrupt cessation is mission impossible. If neo-nicotine industry influence is allowed to define government's harm reduction agenda expect more of the same.

I submit that advancing delivery technology and declining prices are already heralding the cigarette's demise. As the cigarette industry moves toward enhanced smokeless, NRT and electronic nicotine delivery, the pharmaceutical industry is moving from cessation into maintenance. Market forces are causing it to occur without intervention.

But if heroin were legal would we allow it to be marketed in front of children? An immediate priority should be to compel stores to choose between marketing one of the planet's most captivating chemicals and having adolescents as customers. How hard would it be to pass local laws requiring that "all" nicotine products be sold inside clearly marked nicotine sales locations, where underage youth may not enter? Anyway, well done, Dr. Borland, in encouraging this much needed discussion.

Conflict of Interest:

Director of an abrupt nicotine cessation website and author of "Freedom from Nicotine - The Journey Home"

NOT PEER REVIEWED Simon and Melanie,

Thanks for the article. With respect, i'm not convinced by your arguments here however.

Firstly, it is incorrect to broadly assume that millions upon millions of people in the 'real world' quit smoking unassisted. Some of them may have, but most would have been given some kind of assistance, albeit even if very brief. It may be advice from their GP, watched television health marketing messages, received cessation strategy suggestions from friends and relatives, biofeedback on their blood pressure or lung x-ray, advice in a book...and so on. Are you saying that this is not cessation assistance? It's just that it's not the more intense assistance such as NRT that you may be referring to.

Of the millions and millions of those who have quit that you refer to without the more intensive interventions, you do not mention just how many of these are now either a. dead from smoking or b. living a life of misery due to not quitting soon enough. It is a simple but compelling public health argument that we must try to reduce the risk of smoking related disease as best we can, and as soon as we can. This means embracing evidence based interventions such as group behaviour therapy and medications like varenicline. We can not escape the fact that these more intensive approaches increase the odds of quitting (see cochrane reviews)

We will never know just how many people quit 'unassiste'd yet contracted a smoking related disease. Yet they may however have otherwise lived a long and 'relatively' healthy life if only they had professional, intensive support earlier.

Sure, it remains to be seen if devices like the e-cig will enhance cessation, but if it turns out that it actually does, then there is a solid argument to support it's use. If I can increase my odds of quitting now by using say the e-cig, i'd rather at least try that than finally quitting 'unassisted'years down the track only to wind up with lung cancer.

Conflict of Interest:

Consultant conducting smoking cessation interventions and cessation skills training

NOT PEER REVIEWED The decision to ban tobacco industry-funded research in the Journal could be the opportunity for pointless byzantine discussions from the pros and cons.(1) However, the issue is more concrete. First, Ruth Malone acknowledged the editorial board for vigorous discussions and I would like to know how many members opposed the ban. Second, what is the definition of a tobacco industry for the Journal? Cancer Research UK has issued a Code of Practice on tobacco industry funding to universities after the Nottingham University scandal. (http://www.cancerresearchuk.org/science/funding/terms-conditions/funding- policies/policy-tobacco/ssLINK/CR_016307) It provides precise definitions. The scope is large with five possibilities, including "owning a tobacco company". Accordingly, will the Journal ban research from Chinese universities? Indeed, they are owned by China as China National Tobacco Co. the largest tobacco company in the world, no less. Last, what amount of resources will be provided and what procedures will be implemented to check that papers submitted to the Journal are not funded by the tobacco industry?

1 Malone RE. Changing Tobacco Control's policy on tobacco industry- funded research Tob Control 2013;22:1-2

Conflict of Interest:

None declared

Dear Editor,

We are grateful that the eLetter from Ms Cunnison provides an opportunity for us to clarify some aspects of our work [1].

In the past there has been no authoritative guidance on the protection of public health from risks from particulate matter (PM) in indoor air. It is therefore a welcome development that the recent WHO Air Quality Guidelines for Indoor Air [2] concluded that there is no convincing evidence for a difference in the hazardous nature of PM from indoor sources as compared with those from outdoors, and the document thus goes on to recommend that the 2005 WHO outdoor air quality guidance for PM should be applied to indoor environments [3]. Therefore, regardless of the location of the sources, PM2.5 concentrations should be kept at levels below 25 ?g/m3 averaged over a 24-h period and less than 10 ?g/m3 averaged over a year.

We acknowledge that car journeys are always much less than 24 hours and in our paper we clearly stated that comparison of measurements with the WHO PM2.5 guidance level should be done with some caution as this health-based value is based on a 24-hour average. However, we also say it is "important to consider that children who are exposed to SHS in cars may also be exposed to SHS within their home setting and so, while we do not have data here on 24 h average levels, it is reasonable to assume that the time spent in the car will only be one of several micro-environments where children may be exposed to SHS and hence elevated PM2.5 levels over the course of the day."

To add to this point our group have also recently reported 24-hour PM2.5 levels measured in over 100 homes in Scotland and Ireland [4]. It is interesting to note that the concentrations in the 20 smoking homes in that study averaged over 140 ?g/m3 compared to average of 10 ?g/m3 in the 80 non-smoking homes, both values averaged over 24-hours.

We consider that our data highlight that smoking in cars exposes children to high levels of second-hand cigarette smoke. Steps to discourage smoking in these semi-public spaces will, in our opinion, increase public awareness of the dangers of exposing children to SHS within indoor settings and encourage smokers to stop exposing children to cigarette smoke in all situations.

Dr Sean Semple, Mr Andrew Apsley, Dr Karen Galea, Dr Laura MacCalman, Mrs Brenda Friel, Ms Vicki Snelgrove.

References

1. Semple S, Apsley A, Galea KS, Maccalman L, Friel B, Snelgrove V. Secondhand smoke in cars: assessing children's potential exposure during typical journey conditions. Tob Control. 2012;21:578-83.

2. World Health Organisation. (2010). WHO Guidelines for Indoor Air Quality. Selected Pollutants. ISBN 978 92 890 0213 4. Copenhagen, Denmark,WHO. Available at http://www.euro.who.int/__data/assets/pdf_file/0009/128169/e94535.pdf [accessed 19th October 2012]

3. World Health Organisation. (2005) WHO Air Quality Guidelines. Global update. Available at http://www.who.int/phe/health_topics/outdoorair_aqg/en/ [accessed 19th October 2012].

4. Semple S, Garden C, Coggins M, Galea KS, Whelan P, Cowie H, S?nchez-Jim?nez A, Thorne PS, Hurley JF, Ayres JG. Contribution of solid fuel, gas combustion, or tobacco smoke to indoor air pollutant concentrations in Irish and Scottish homes. Indoor Air. 2012;22:212-23.

Conflict of Interest:

None declared

Conflict of Interest:

Author of http://f2cscotland.blogspot.co.uk/

Smith et al provides us with a remarkable review of tobacco industry efforts to influence tobacco tax which deserves several comments.(1)

First, such efforts can be quite successful as in France: From February 2004 to September 2012 there was no increase in tobacco taxes, accordingly cigarette sales remained unchanged and smoking prevalence of the youngest increased during Sarkozy's presidency, an exception among developed countries.(2) The WHO must scrutinize the implementation of Article 5.3 of the Framework Convention on Tobacco Control which requires protecting public health policies from the influence of the tobacco industry. Indeed, the French example of the influence of the tobacco industry on a government is not unique.(3)

Second, the 16th point of industry tactics (Table 2 in 1) which is "trying to undermine tobacco control experts" can be harder and damaging, eg. slapping and sacking.(4) In November 2009, one of us (GD) was sued for libel by the French tobacconists' Union, because he stated on television that cigarettes kill two smokers each year for every tobacconist. In December 2009 as a tenured senior consultant in GD's unit, I (AB) was sacked by the Ministry of Health, even against the advice of the National Statutory Committee. Both of us won in court, the tobacconists' claim was rejected in 2011 by the Appeal Court and the sacking was cancelled in 2012 by the Administrative Court of Paris on the grounds that it was illegal.(5) However, none of us received compensation for the damages.

Third, even low and middle income countries can successfully resist tobacco industry efforts to influence tobacco control. Uruguay's tobacco- control campaign is associated with a substantial, unprecedented decrease in tobacco use of 4*3% per year during 2005-11.(6) We must keep in mind that the little Uruguay (GDP $31 billion) has been even sued in 2009 by the giant Philip Morris ($25 billion in total revenues for a market capitalization of $95 billion) before the World Bank's International Center for Settlement of Investment Disputes.(7)

Integrity, courage and mainly enduring efforts are needed against the tobacco industry.

References

1 Smith KE, Savell E, Gilmore AB. What is known about tobacco industry efforts to influence tobacco tax? A systematic review of empirical studies. Tob Control 2012, Online First August 12. DOI: 10.1136/tobaccocontrol-2011-050098

2 Braillon A, Mereau AS, Dubois G. [Tobacco control in France: effects of public policy on mortality].Presse Med. 2012;41:679-81.

3 Arnott D, Berteletti F, Britton J et al. Can the Dutch Government really be abandoning smokers to their fate? Lancet 2012;379:121-2.

4 Dubois G. Abuse of libel laws and a sacking: The gagging of public health experts in France. Tobacco Control Blog November 8th, 2010. Available at http://blogs.bmj.com/tc/2010/11/08/

5 Witton J and O'Reilly J. Tobacco scientist win against illegal sacking. Addiction 2012;107:1714-5

6 Abascal W, Esteves E, Goja B et al. Tobacco control campaign in Uruguay: a population-based trend analysis. Lancet 2012, Early Online Publication, 14 September. doi:10.1016/S0140-6736(12)60826-5

7 Lencucha R. Philip Morris versus Uruguay: health governance challenged. Lancet. 2010;376:852-3.

Conflict of Interest:

None declared

NOT PEER REVIEWED This study violates basic ethical principles of research conduct because it exposes children to unreasonable and unnecessary risks, intentionally encourages parents to put their children at risk, and fails to incorporate alternative methods that would reduce these risks.

The Helsinki declaration states that:

"The benefits, risks, burdens and effectiveness of a new intervention must be tested against those of the best current proven intervention, except in the following circumstances:

1. The use of placebo, or no treatment, is acceptable in studies where no current proven intervention exists; or

2. Where for compelling and scientifically sound methodological reasons the use of placebo is necessary to determine the efficacy or safety of an intervention and the patients who receive placebo or no treatment will not be subject to any risk of serious or irreversible harm. Extreme care must be taken to avoid abuse of this option."

In the present study, children in group 1 were provided with an intervention to reduce their exposure to secondhand smoke: parents were asked not to smoke in the presence of their children. Children in group 2 were not provided with any treatment. According to the Helsinki declaration, this would have been acceptable only if: (1) there was no treatment available; or (2) children receiving no treatment would not be subject to any risk of serious harm. Neither of these conditions are met.

Furthermore, this study goes beyond simply providing no treatment to the children in group 2. Instead of simply observing these children over time, the study protocol called for "asking" the parents not to change their smoking habits.

In other words, the investigators knowingly and intentionally placed the children in group 2 at significant risk of health damage.

In the United States, the federal regulations on the protection of human subjects (section 46.406a) would have allowed this research to be conducted on minors only if: "The risk represents a minor increase over minimal risk." This condition is clearly not met, as the risks of pneumonia, bronchitis, respiratory illness, and cardiovascular damage are a major increase over minimal risk.

Moreover, there was an alternative procedure available that would have provided the same scientific knowledge without putting children at substantially more than minimal risk. The investigators could have encouraged all parents not to smoke around their children and then followed all the children over time as a single group. Then, they could have assessed changes in secondhand smoke exposure and related those changes (or lack of changes) to the persistence or disappearance of sleep bruxism.

There is no justification for the investigators asking parents to continue to smoke in the presence of their children.

Rather than acknowledge that they made a mistake, the instead defend the study. But in defending the study, they deliver a definitive knock-out blow to their argument that the study was ethical. They point out that after being randomized to group 2, a number of the families dropped out of the study, refusing to participate because: "aware of the risks of SHS, [they] decided to reduce it and therefore did not participate."

If the subjects themselves realized that they were being put at undue risk by agreeing to participate in the study, then it is quite clear that this research was unethical. In fact, after a number of families refused to participate because of the risks to which they were being asked to be exposed, the IRB should have been informed and the study should have been halted.

The authors go on to justify their research by noting that "all of the parents of group 2 remaining in the trial were those who reported not being able to reduce children's exposure to SHS." This is an unacceptable argument. A feeling that one is not able to take a particular action is no justification for investigators putting the children of those subjects at risk and failing to deliver any intervention to encourage those parents to quit, reduce their smoking, or not smoke in the presence of their children.

Conflict of Interest:

None declared

NOT PEER REVIEWED Fotuhi et al concluded in their interesting study of patterns in smokers' cognitive dissonance-reducing beliefs that rationalisations about smoking change systematically with changes in smoking behaviour(1). Moreover, they argue that: i) changes in attitude on quitting are higher for 'functional' beliefs rather than 'risk-minimising' beliefs and ii) if smokers relapse these functional beliefs return to pre-quit levels, iii) that changes in beliefs follow the changes in behaviour (quitting), suggesting that iv) these changes are rationalisations invoked in the service of motivation to reduce cognitive dissonance and that v) smokers are able to reduce dissonance by modifying their beliefs in ways that help to rationalise their continued smoking.

We wish to suggest an alternative understanding. The functional belief items include questions such as "smoking calms you down when you are stressed or upset" and "smoking helps you concentrate better". We propose that these items are not examples of dissonance-reducing attitudes but are representations of smokers' genuine experiences of nicotine withdrawal 'in between' cigarettes or on quitting, i.e. 'stress' and 'poor concentration'(2). In this way they are more a proxy for the physiological states induced by nicotine deprivation rather than attitudes and beliefs per se. Therefore 'risk-minimising beliefs' such as 'the medical evidence that smoking is harmful is exaggerated' and 'you've got to die of something, so why not enjoy yourself and smoke' may more truly represent cognitive dissonance, as they do not overlap with experiences indicating withdrawal symptoms.

A misinterpretation of these withdrawal symptoms by smokers and a commonly held belief that smoking reduces stress will undoubtedly result in the kind of results that the authors report - but should these results really be interpretated as supporting their hypothesis? Once smokers stop smoking, withdrawal symptoms subside over ensuing weeks (3), with 'functional' justifications for smoking naturally receding. They would return when the smoker then recommences to a physiological state of dependency and nicotine deprivation.

The theory of reasoned action holds that attitude changes precede behavioural change (4). The authors conclude that their study shows conversely, for smokers that their changes in attitudes are likely to be a result of their changes in smoking behaviour. This interpretation does not prove causation if these 'cognitive-dissonance' measures are more an indication of the presence of physiological symptoms rather than attitudes and beliefs per se.

We do agree, however, with Fotuhi et al's proposal that public health measures should target smokers' beliefs that smoking reduces stress. This would promote greater understanding about the withdrawal process and link it to why pharmacotherapy can be a useful adjunct to quitting and thereby increase their sense of response and self-efficacy (5).

We have been working in Australia with Indigenous smokers who have a high prevalence of smoking. One of the teaching tools we have developed is a simple visual model to explain to the lay public in the context of a group or personal intervention why smoking increases stress levels, how withdrawal symptoms make smokers more stressed and how nicotine replacement therapy can be efficacious (6).

Resistance to anti-tobacco messages, and cognitive dissonance will most likely continue to plague smokers who do not feel able to quit. Although for Indigenous smokers, knowledge acquisition alone may not be enough to support successful cessation (7), we believe smokers' justifications for smoking may also represent the truth for them of their experiences of withdrawal, and a lack of understanding about nicotine deprivation.

References

1. Fotuhi O, Fong GT, Zanna MP, Borland R, Yong H-H, Cummings KM. Patterns of cognitive dissonance-reducing beliefs among smokers: a longitudinal analysis from the International Tobacco Control (ITC) Four Country Survey. Tobacco Control. January 3, 2012. doi: 10.1136/tobaccocontrol-2011-050139 2. Parrott AC, Garnham NJ, Wesnes K, Pincock C. Cigarette Smoking and Abstinence: Comparative Effects Upon Cognitive Task Performance and Mood State over 24 Hours. Human Psychopharmacology: Clinical and Experimental. 1996;11(5):391-400. 3. Hughes JR. Tobacco withdrawal in self-quitters. J Consult Clin Psychol. 1992;60(5):689-97. 4. Fishbein M, Ajzen, I. Belief, attitude, attention and behaviour: An introduction to theory and research. Reading, MA: Addison-Wesley; 1975. 5. Witte K, Meyer G., Martell, D. Effective health risk messages: a step- by-step guide. Thousand Oaks, CA: Sage Publications; 2001. 6. Baker F, Gould, GS. Blow Away The Smokes DVD: Quit Cafe Scene starts 13.00min. 2011 [4 July 2012]; Available from: http://www.blowawaythesmokes.com.au 7. Gould G, Munn, J, Watters, T, McEwen, A, Clough, A. Knowledge and views about maternal tobacco smoking and barriers for cessation in Aboriginal and Torres Strait Islanders: a systematic review and meta-ethnography. Nic Tob Res. 2012;under review

Conflict of Interest:

None declared

I would like to make one correction and some comments on this article's interpretations of our prior review article on hardening (Drug Alcohol Dependence 117:111-17, 2011).

The Cohen et al article cites the prior review as treating "tobacco control policies solely as a driver of quit attempts, with no impact on the ability to maintain abstinence after a quit attempt (p 266)." The article actually stated "tobacco control activities appear to more strongly influence a quit attempt whereas treatment. . . appears to more strongly influence the ability to abstain.(p 112) "

The article also proposes that rather than conduct more research on hardening as the prior review proposed, that we should more fully fund tobacco control interventions(p 265). Since when do research and tobacco control funds compete? Should we stop all lung cancer research as well?

The article also states knowing if hardening occurs "will not have bona fide implications" for tobacco control. The prior review outlined that if hardening was occuring due to the inability to stop due to increased nicotine dependence, this would suggest that a larger and larger group of smokers would be unlikely to quit without treatment. This assertion is based on the evidence that dependent drug users often need more than simple motivation to quit.

The article also states that "insistence that individual smokers are becoming more resistant to quitting and that populations are hardening (note my review never "insisted" this) is reminiscent of victim blaming. (p 266). If anything hardening recognizes that some smokers are unable to quit, not due to lack of motivation, but because they have a significant disorder (nicotine dependence) that can improve with treatment. This is more emphathic than it is victimizing. In fact, "denormalization" (i.e. stigmatization)is much more victim blaming than noting some smokers have a disorder. Would we say promoting antidepressants for those who cannot overcome depression by themselves is "victim blaming" whereas seeing depression as abnormal (i.e. denormalizing) is not?

Finally, many articles on hardening begin by pointing out that we have not really increased quit attempts or cessation success recently in the US (see article by Zhu). In response, many tobacco control advocates say essentially "it's not that the tobacco control actions don't work, it's because they have not been fully implemented." That is a reasonable hypothesis, but it is just a hypothesis. Although some correlational data support it (e.g. see success in CA), the more valid direct experimental tests via the many community trials do not consistently support the hypothesis (e.g. see Cochrane review of community trials).

Conflict of Interest:

I have received grants and consulting fees from several for-profit and non-profit companies that market medication and psychosocial treatments for smoking cessation or engage in tobacco control activities

Zawertailo, Selby and colleagues conclusion that free replacement nicotine (NRT) by mail is effective is deeply disturbing.[1] While the study's free abstract portrays free NRT by mail as a resounding success (21.4% smoking cessation at 6 months versus 11.6% for no-intervention), it neglects mention that under intent-to-treat analysis that there was zero benefit over no-intervention (an average of 8.7 percent 30-day point prevalence at 6 months for both mailed NRT and control).

All evidence presented in the 2008 Guideline Update relied exclusively upon intent-to-treat data. Here, the rates shared in the abstract ignore 2,746 six-month follow-ups where participants were successfully reached by phone. Why? Because they either hung-up or refused interview. It's a number greater than the 2,601 actually interviewed. Do happy, thankful and successful quitters normally hang-up after previously agreeing to follow-up?

A number of recent population studies have found NRT totally ineffective (Ferguson 2005, Doran 2006, Hartman NCI 2006, Pierce 2012, Alpert 2012 and Coleman 2012). The prospect of a billion smoking related deaths before century's end, now is not the time for creative quitting definitions which ignore disappointed or disgruntled participants.

John R. Polito, JD

[1] Zawertailo L, Dragonetti R, Bondy SJ, Victor JC and Selby P, Reach and effectiveness of mailed nicotine replacement therapy for smokers: 6-month outcomes in a naturalistic exploratory study. Tob Control. doi:10.1136/tobaccocontrol-2011-050303

Conflict of Interest:

Pro bono director of a cold turkey quitting forum.

NOT PEER REVIEWED Zhu and colleagues' population level findings contribute to a growing body of external real-world evidence supporting the conclusion that the quitting product marketing industry's "double your chances" mantra is false and deceptive, and that smoker reliance upon it is likely responsible for a host of negative consequences, including failure to quit and premature demise.[1]

Their review of twenty years of National Health Interview Survey data documents how, despite arrival of a host of new quitting products since 1991, the average annual cessation rate has seen little change. The rate has hovered around 4.4%, with the past decade showing a slight decline over the prior decade, dropping to 4.2% from 4.7%.[2]

The authors give more than 200 randomized quitting product trials a pass in labeling them "rigorous," while noting that clinical and real-world populations and environments differ. While true and less controversial, I submit that we cannot blind quitters with lengthy quitting histories as to the presence or absence of full-blown withdrawal. Placebo assignment awareness among expert quitters occurs within 72 hours of full nicotine cessation. I contend that placebo-controlled efficacy findings reflect expectations not worth, at levels roughly corresponding to study participant quitting experience.[3]

It is no secret that approved quitting products have failed to prevail over non-medication, non-NRT, unassisted and cold turkey quitters in nearly all population level assessments since 2000.[4] The burning question is why public health officials have not suspended current cessation policy, which in the U.S. continues to make approved quitting product use recommendations mandatory.

In June 2000, U.S. health officials intentionally turned their backs on the smoker's natural quitting instincts, in officially ending all support of cold turkey quitting. Since then, the U.S. Guideline has stated that, unless medically contraindicated, all quitters should be told to purchase and use approved quitting products.[5]

Interestingly, a number of the twenty-year time-line ticks inversely correspond to the intensity of quitting product marketing. For example, 1999 to 2001 saw a full percentage point drop. The June 2000 Guideline with its mandatory use recommendation received wide dissemination, with 44,000 copies of the 179 page document distributed by 2002.

Today, official U.S. Cessation policy is to undermine confidence in natural cessation at every opportunity. According to current policy, smokers should never attempt to abruptly end nicotine stimulation of brain dopamine pathways, but to continue stimulation via replacement nicotine, bupropion or varenicline.

Imagine being a cold turkey quitter, visiting the government's www.SmokeFree.gov quit smoking site, and being bombarded 173 times with the message to use "medication" or "medicine." Imagine downloading a copy of "Clearing the Air," the government's leading quitting booklet, and on page 10 under the "Cold Turkey" section being falsely told that "fewer than five percent of smokers can quit this way," that "most smokers have more success with one of the assisted quitting methods discussed below."[6]

Cold turkey remains the most popular and productive quitting method of all, generating more long-term successful ex-smokers than all other methods combined. I commend the authors for raising the unintended consequence of over-emphasis upon approved products. Imagine the confidence injury to natural cessation inflicted by three decades of cold turkey bashing. Imagine the hopelessness of repeatedly attempting cessation by use of the best science has to offer, and each time falling flat on your face.[7]

The authors suggest that the obvious solution isn't so much in working to improve interventions but finding ways to induce more attempts. While important, if placebo-controlled trials were fatally flawed, what do we really know about quitting? What would be the outcome of trials pitting those wanting to quit cold turkey against those wanting to use approved products?

And how difficult or expensive would it be to conduct prospective studies which follow and monitor cessation attempts, methods and outcomes among smoking patients of family practice physicians? How hard would it be to test five to ten minute patient counseling scripts within the treatment setting?

There has been almost no study of the common threads among successful cold turkey quitters. Could something as simple as a public health campaign which teaches that lapse almost always equals relapse, arm quitters with the most critical survival lesson of all, that one equals all, that one puff would be too many, while thousands never enough? I submit that it could.[8]

John R. Polito
Nicotine Cessation Educator

References:

[1] Polito JR, Are those who quit smoking paying with their lives because of NRT's failure? BMJ 2012; 344:e886.

[2] Zhu SH, Lee M, Zhuang YL, Gamst A, Wolfson T, Interventions to increase smoking cessation at the population level: how much progress has been made in the last two decades? Tob Control. 2012 Mar;21(2):110-8.

[3] Polito JR, Smoking cessation trials, CMAJ. 2008 Nov 4;179(10):1037-8; author reply 138. Free Full Text

[4] Polito JR, Are those who quit smoking paying with their lives because of NRT's failure? BMJ. 2012 Feb 7;344:e886. doi: 10.1136/bmj.e886.

[5] Fiore MC, Jaen CR, Baker TB, et al. Treating Tobacco Use and Dependence: 2008 Update. Clinical Practice Guideline. Rockville (MD): U.S. Department of Health and Human Services, Public Health Service, 2008. Full Text PDF

[6] NIH-Publication No. 11-1647, Clearing the Air, Printed Oct. 2008, Reprinted August 2011. Full Text PDF

[7] Polito JR, Dying truths about quitting methods, WhyQuit.com, Nov. 14, 2011. Full Text

[8] Polito JR, How to quit smoking, WhyQuit.com, December 18, 2010. Full Text

Conflict of Interest:

Pro bono director of an online cold turkey nicotine cessation forum.

Throwing the baby out with the bath water

Alain Braillon(a) MD, PhD, Gerard Dubois(b) MD, MPH.

(a) 27 rue Voiture. 80000 Amiens. France (b) Public Health. Amiens University Hospital. France

In an observational study Alpert and colleagues concluded that persons who have quit smoking relapsed at equivalent rates, whether or not they used nicotine replacement therapy (NRT) to help them in their quit attempts and challenged the funding of cessation medication policy.(1)

They failed to discuss the severe methodological limitations of their study which conflicts the evidences from so many randomized controlled trials. These include, to cite a few : a) the recall biases which challenge covariates quality; b) a major bias of selection considering the high percentages of non screened and of lost of follow-up during the three successive rows (see methods); c) the use of cut-points to derive subgroups for covariates which is not appropriate as there is a continuous distribution of the values with no obvious modal values; d) the absence of the measure of the initial quit rates with nicotine replacement therapy (NRT) and others methods; e) the effect of the comprehensive tobacco control policy implemented since 2002, a major confounding variable. Massachusetts now ranks 9th among the 50 states: 16.1% of the adult population (aged 18+ years) are current cigarette smokers.(2)

Finally, as a population study, the Massachusetts program is more convincing. Since 2006, Massachusetts has offered free treatments to help poor residents (Medicaid) stop smoking. When the program started, about 38 percent of poor Massachusetts residents smoked. By 2008, the smoking rate for poor residents had dropped to about 28 percent. This is 30,000 people in two and a half years, or one in six smokers. No changes were observed in those not covered by the plan (3) Tobacco cessation benefit that includes coverage for medications and behavioral treatments can significantly reduce smoking prevalence.(4)

1 Alpert HR, Connolly GN, Biener L. A prospective cohort study challenging the effectiveness of population-based medical intervention for smoking cessation. Tob Control. 2012. Oneline 10 Jan 2012. doi:10.1136/tobaccocontrol-2011-050129.

2 Centers for disease control and prevention. Smoking & tobacco use. State highlights 2010. Available at http://www.cdc.gov/tobacco/data_statistics/state_data/state_highlights/2010/states/massachusetts/index.htm Accessed 19 Jan 2012

3 Goodnough A. Massachusetts Antismoking Plan Gets Attention. 2009 Dec 16. The New York Times Available at http://www.nytimes.com/2009/12/17/us/17smoke.html Accessed 19 Jan 2012

4 Land T, Warner D, Paskowsky M et al. Medicaid coverage for tobacco dependence treatments in Massachusetts and associated decreases in smoking prevalence. PLoS One 2010 18;5(3):e9770.

Conflict of Interest:

Dr Braillon, a senior tenured consultant, was sacked in 2010 from Prof Dubois' unit by the French Department of Health against the advice of the National Statutory Committee. Prof Dubois was sued for libel by the French Tobacconists Union (Abuse of libel laws and a sacking: The gagging of public health experts in France. Tobacco control blog 8 November 2010). Prof Dubois is honorary president of Alliance Contre le Tabac and chairs the Addiction Committee of the National Academy of Medicine. He has received consulting fees from Pfizer.

Professor Chitta Choudhury Director, International Centre for Tropical Oral Health, UK

Nitte University Dept of Oral Biology Genomic Studies | Cen Oral Dis Prev Control, Mangalore, India.

NOT PEER REVIEWED I refer to the report "How online sales and promotion of snus contravenes current European Union legislation, published recently in Tob Control 21 January 2012. Like Snus, the online trade of Gutkha (Indian variety of Smokeless tobacco- ST) is gaining popularity as well as in several outlets in the UK. If you visit some of the shops in East and north-west London or in Birmingham, Manchester, Leeds, and Leister (where SE Asian immigrants are living) you can easily find many shops displaying various brands of Gutkha sachets. As a member of the National Institute of Clinical Excellence, (NICE, UK) stakeholders on Smokeless Tobacco control for SE Asian Migrants , I joined in a meeting and raised the question of why we can't stop such trade,likewise Snus. But the fact is that there is no strong legislative support to ban this trade. There is no doubt that online trade of ST products (not only Snus, also Guthka) is on rise. Anyway, the results of a database search regarding online sales and promotion of Snus revealed that online vendors are targeting non- Swedish EU citizens. Such online trade may also cross more distant borders, reaching Asia, Africa and Gulf countries. Of course, such business is against the EU regulation. The Snus is banned in the UK and EU countries, but not the Gutkha. We don't know why Gutkha is not banned in EU. In this context, I refer one of our discussions published in Tob Control 9 Nov 2010, suggesting that Snus and quid (eg. Gutkha) consumption is a risk factor not only for the occurrence of Oral Cancer, but also for development of Metabolic Syndrome http://tobaccocontrol.bmj.com/content/19/4/297/reply#tobaccocontrol_el_3489 In my opinion, we require a clear-cut and focused directive of the WHO Framework Convention on Tobacco Control that specifically addresses Snus and Gutkha. If we can not control online trade of Snus, it will be a bad situation, because the web-based trade crosses the border very quickly, not only in EU but also other parts of the world. The disturbing fact is that Sweden is a signatory of the FCTC yet the Swedish Government is getting revenue from this online Snus trade.

Professor Chitta CHOUDHURY | Nitte University & Int'l Centre of Tropical Oral Health, UK Director, Centre for Oral Disease Prevention & Control, NICE Stakeholder on ST control for SE Asian Migrants in the UK.

cr_choudhury@yahoo.co.uk

Conflict of Interest:

None declared

Many of Alpert, Connolly and Biener's population level NRT post- cessation findings are disturbing and worthy of further and deeper review. What's most baffling is that any government would invest so much confidence and so many lives in a product without demanding a shred of population level evidence as to its worth.

According to this paper, the odds of relapse for a heavily dependent NRT quitter who had quit less than six months were 3.53 times that of a heavily dependent quitter who quit without NRT or professional help. If true, that puts a rather hefty dent in NRT's most favored failure explanation, its selection bias theory.

This finding makes troubling the fact that varenicline (Chantix/Champix) failed to prevail in long-term point prevalence quitting over nicotine patch in the only head-to-head clinical trials to date (Aubin 2008 and Tsukahara 2010).

Alpert and colleagues do not attempt to explain the conflict between clinical trial and population level NRT findings. But I submit that this outcome was suggested by the first NRT clinical trial ever, the 1971 nicotine gum study by Ohlin and Westling.

Ohlin and Westling found that counseling and support ("ten visits and more persuasion") was superior to nicotine gum alone, but that nicotine gum could defeat placebo gum users. Even then, Ohlin and Westling documented obvious nicotine gum blinding concerns.

Try to name any other placebo-controlled study area where the condition sought to be treated (withdrawal) does not exist until researchers command its onset. Name any other study area where the placebo group is actually punished within 24 hours by a rising tide of anxieties.

Have three decades of referring to nicotine as "medicine" and its use "therapy" undermined natural learning and the quitter's ability to self- discover the most critical recovery lesson of all, that lapse almost always equals relapse, that one puff is too many and thousands never enough?

Nearly all population level quitting method surveys to date have found NRT less effective long-term than quitting without it. If true, are taxpayers today paying to reduce the quitter's odds of success? Are we responsible for undercutting their chances and costing many their lives?

John R. Polito Nicotine Cessation Educator

Conflict of Interest:

Pro bono director of a cold turkey stop smoking website.

One would imagine that public concern about butt litter would largely rise with the amount of butt litter that occurs. One would also reasonably imagine that news articles dealing with the "problem" of butt litter would similarly rise. If we take those two assumptions as being a given for the moment, and then look at the statistics uncovered by this research, we see something very interesting.

Using Google's time search feature we are able to search for news stories/articles in discrete time units. During the period of 10 inclusive years 1982 to 1991, there were 7 stories: i.e. less than one story per year. But during the inclusive 8 year period of 2002 to 2009, there were 242 stories, roughly 30 per year. That's over a 3,000% increase in public perception of and attention to the problem, which would indicate that there may have been as much as a 3,000% actual increase in the amount of butt litter between these two comparative periods.

Some of that may have been generated by increased paranoia about smoke and dislike/hatred of smoking and smokers, but it's likely that a great deal of it represents an actual and very serious increase in the problem.

So what changed in our society between those two periods that caused this problem to undergo such an incredible escalation? It could be that there are now far more smokers per given area than there were in the 1980s... but tobacco control statistics don't seem to bear that out: generally they claim a decrease in smokers while habitable/used land areas in cities/towns/beaches/parks etc have generally increased along with general population growth during those years. It could be that smokers are now less conscious of butt littering as a problem, but given the increase in media attention to the issue this is also unlikely to be a cause.

The one outstandingly obvious and overwhelming cause of this problem would seem to be the antismoking movement's insistence upon throwing smokers out into the streets to smoke rather than allow for provision of comfortably separated and ventilated indoor options and venues for smokers and their friends.

If cigarette butt pollution is indeed the true concern here, then such indoor options should clearly be explored. If however, as indicated in the abstract, the focus on cigarette butt litter is simply because such a focus is seen as a way to "justify environmental regulation and policies that raise the price of tobacco and further denormalise its use." -- a pure social engineering mechanism -- then such solutions will of course be ignored.

Which path do you think tobacco control will take?

Michael J. McFadden,

Author of "Dissecting Antismokers' Brains"

Conflict of Interest:

Author of "Dissecting Antismokers' Brains" Active member of (and sometimes officer in) a number of citizens' Free Choice groups. No compensation involved.

But the evidence is that no media campaign based on health warnings is likely to be effective.

So comparing different varieties of campaigns unlikely to be effective doesn't seem very productive.

Comparing varieties of campaigns using themes known to be effective, might be worthwhile.

Ref:

Evaluation of Antismoking Advertising Campaigns Lisa K. Goldman, MPP; Stanton A. Glantz, PhD. JAMA. 1998;279(10):772-777. doi: 10.1001/jama.279.10.772

Conflict of Interest:

None declared

Glantz and Polansky's paper is titled "Movies with smoking make less money" but it should have continued "... at the box office" because it failed to consider the major sources of revenue to film studios other than from box office receipts (DVD and blu-ray sales, rentals and video-on- demand or iVOD). They write that data from DVD sales and rentals are not available. However, Nash Information Services (which they reference) provide estimates from February 12, 2006 for DVD sales and for box office receipts from 1992. http://www.the-numbers.com/dvd/charts/annual/2010.php Nash explain "Precise information on DVD sales is not generally available. Our DVD sales figures are estimates based on studio figures, publicly available data, and private research on retail sales carried out by Nash Information Services. The figures include estimated sales at Wal-Mart and other retailers that do not publicly release sales information."

As can be seen, box office sales remain the dominant source of revenue to movie studios in the short term, but over time DVD purchases, rentals and iVODs combined can erode and sometimes overhaul that lead. It would be wise to re-calculate Glantz and Polansky's data (at least from 2006 from when DVD sales data is available) to see whether their conclusions hold. But this would still underestimate total revenue. While Nash provides rankings of DVD rentals, they do not provide their dollar value. In 2010, the US iVOD market was worth $385m http://www.internetretailer.com/2011/02/15/apple-has-65-streaming-demand- videos-market, a still small but rapidly growing fraction of the total income for movie studios as testified by the on-going demise of suburban video rental outlets.

I also remain perplexed as to how the proposed R-rating for smoking scenes would actually reduce exposures to these scenes in youth. As I have argued previously, studies in this field include R-rating movies in their exposure assessments. For example, in Sargent et al's 2007 paper, 40% of the films on the list provided to children to determine exposure were R- rated(1). Sargent et al have also shown that between 68-81% of US adolescents are allowed to watch R-rated movies(2-3). Many more watch without parental approval via downloads and file-sharing. Furthermore, 88.2% of youth-rated movies in the US now have no tobacco scenes (http://www.cdc.gov/mmwr/p...).

Putting these together, estimates of the effect of movie smoking exposure already include the impact of the R-rated solution being proposed to reduce that exposure. If youth who allegedly start smoking because of exposure to smoking in movies are already watching lots of R-rated movies, how would an R-rating significantly reduce such exposure? They would not see them in cinemas, but with consummate ease at home. Moving nearly all movies with smoking to R-rating would put the onus on parents to regulate their children's viewing. Few would disagree with that. But why would parents regulate their children more because of concern about smoking than they do now with because of concerns about exposure to strong violence and explicit sex in R-rated movies?

References

1. Sargent JD, Tanski SE, Gibson J. Exposure to movie smoking among US adolescents aged 10 to 14 years: a population estimate. Pediatrics. 2007 May;119(5):e1167-76.

2. Sargent JD, Beach ML, Dalton MA, Ernstoff LT, Gibson JJ, Tickle JJ, et al. Effect of parental R-rated movie restriction on adolescent smoking initiation: a prospective study. Pediatrics. 2004 Jul;114(1):149- 56. 3. de Leeuw RN, Sargent JD, Stoolmiller M, Scholte RH, Engels RC, Tanski SE. Association of smoking onset with R-rated movie restrictions and adolescent sensation seeking. Pediatrics. 2011 Jan;127(1):e96-e105.

Conflict of Interest:

None declared