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  1. A tobacco carve-out is the way for the future

    I would like to respond to this paper by Drope J and Chavez JJ whose analysis focuses on cigarettes, not tobacco leaf production and trade, and seeks to question the "conventional wisdom" that "trade liberalization naturally leads to lower prices for tobacco products, increased consumption and decreased levels of regulation." The authors use theoretically guided empirical research to demonstrate there is little cause for concern on the negative impact of trade liberalization on tobacco control policies. They have focused on Southeast Asia as an "ideal most likely case" because the region has experienced recent trade liberalization regionally and multilaterally, and because the "tobacco control proponents from the region continue to voice loud concern about the issue suggesting that it is perceived as a genuine threat," and conclude their proposal to carve out tobacco from trade agreements is "sub -optimal". The authors omitted and overlooked some crucial evidence, details, and developments on tobacco, trade and tobacco control on the ground which I will address in this response. There are also some errors which need to be corrected.

    Firstly, trade liberalization through new free trade agreements are not just about eliminating tariffs, but includes addressing "non-tariff barriers" such as national legislation, product standards, services, investment, intellectual property rights, government procurement and environment which may be just as important or even more important than tariffs for regional economic integration. In the Trans-Pacific Partnership (TPP) to which the authors refer, only 5 chapters of the total 29 chapters actually deal with traditional trade issues while the rest are about dismantling non-tariff barriers to trade. There is the real threat that corporations are using trade agreements to get special benefits that they would find much more difficult to get through the standard legislative process. Trade agreements' impacts on tobacco control, among others, include challenging clean indoor air rules, controls on sale and distribution of tobacco products, cigarette content regulation and bans on tobacco advertising and promotions. It is in this context that the impact of trade liberalization on tobacco control should be seen and not limited to the narrow scope of tariffs alone.

    Secondly, transnational tobacco companies (TTC) themselves have traditionally supported the lowering of tariff barriers to tobacco both historically and continue to support it even now for the added value it brings them to influence non-tariff barriers. Philip Morris International (PMI), for example, in its submission to the TPP said, "The negotiations should be comprehensive and lead to the complete elimination of all tariffs on all goods. There are tools - such as longer phase-out periods and temporary special safeguards - that can be used to mitigate the impact on products deemed "sensitive" by participating national governments."

    Trade liberalisation - The authors are rather dismissive of previous studies on trade liberalisation and tobacco control in East Asia such as papers by Honjo and Kawachi, and Chaloupka and Laixuthai as being limited to a narrow set of market conditions since they involved state-owned tobacco monopolies, where tobacco control policies were mostly non-existent and there was no obvious policy based counter-force to the sudden changes in the tobacco marketplace. The Honjo and Kawachi study actually provides clear evidence that the opening of Japanese markets to the TTC "stalled a decline in smoking prevalence" and the contributing factors to opening of the market included removal of non-trade barriers such as the actual elimination of restrictions on advertising and promotion on tobacco products, which saw an increase of marketing and promotion by these companies. This is also consistent with strategies revealed in the internal industry documents which suggest that besides tariffs elimination the American companies also wanted: "(b) access to all retail outlets. (c) Eliminate advertising limitations. (d) Allow us to do effective market research and product test marketing."

    Affordability - The data of the authors show the RIP (relative income price) of only Brunei, Cambodia and Philippines have reduced. However according to the data of the Southeast Asia Tobacco Control Alliance, the RIP of cigarettes also decreased for Lao, Indonesia and Vietnam, besides Philippines and Cambodia, meaning that overall, cigarettes became cheaper across many countries in the ASEAN region following the introduction of AFTA.

    The authors refer to Figure 3 to illustrate changes in consumption per capita, demonstrating mixed results, though not precisely in the same pattern they observe with affordability. They point out the most pronounced declines have occurred in Malaysia, Myanmar and Cambodia, and that the only clear upward trend is in Indonesia. However this description does not match data in Figure 3 accordingly. For example Figure 3 shows Myanmar's per capita consumption has remained unchanged (around 200 sticks), while the decline in Singapore has been reversed as of 2006. After identifying Indonesia as the only county with a "clear upward trend" the authors go on to say Vietnam is the only ASEAN country with a "strong upward trend".

    They describe Vietnam as the only country that continues to have a "closed tobacco sector." It is unclear what exactly this means as the state owned Vinataba has joint-venture agreements with both British American Tobacco (BAT) and PMI.

    Change in affordability - The authors make considerable reference to Malaysia, indicating it has experienced the greatest change with substantial imports, prices, policies and the tobacco trade. The authors point out when the government increased specific excise taxes from RM28 per kilogram to RM220 per 1000 sticks by 2010, cigarettes became less affordable. What has been omitted is the tobacco industry gained by importing cheaper leaves and mitigated the cigarette price increases by successfully lobbying to delay the implementation of regulations banning kiddie packs (less than 20 sticks) which was passed in 2004 but only implemented in 2010. The tobacco industry kept cigarettes affordable through the sale of kiddie packs. Contrary to the graph in Figure 2 showing cigarettes becoming "dramatically less affordable" in Malaysia, another study conducted by the International Tobacco Control Project, found affordability to have increased by 1.9% over the four years (2005 - 2009). These findings show that tobacco taxes and prices did not increase at a rate high enough to offset income growth, and cigarettes became more affordable to consumers.

    Using small packs to keep cigarettes affordable particularly to the young is further confirmed in the internal tobacco industry documents on Malaysia. PMI for example, in their internal documents say, "...As the total outlay for a pack of 20's became too prohibitive for our younger adult smokers we should consider smaller packings. Currently we plan to reduce the price of our 14's pack from M$2.40 to M$2.20. Should this move not yield the desired results, we will launch a 10's and 7's packing in this strong growth segment."

    An error that needs correction is about the PMI factory in Malaysia. According to the authors, "PMI opened a new US$40 million plant in Malaysia in 2005, while purchasing remaining shares in Sampoerna Indonesia, which they had partly purchased in 1995." In actual fact PMI opened its manufacturing facility in Malaysia in 1995, which was its first plant in Asia. Ten years later in 2005 PMI purchased PT HM Sampoerna in Indonesia.

    The authors refer to Thailand and Vietnam as being the "only countries with a WHO MFN rate of 60% or greater" - this is a typographical error for WTO as the WHO does not offer any MFN status to any countries.

    In February 2008, the Philippines government filed a complaint to the WTO, claiming a bias against imported cigarette brands in Thailand. The authors claim that while tobacco control civil society groups in the Philippines have expressed concern that the case is a violation of FCTC Article 5.3 because tobacco firms in the Philippines, particularly Philip Morris-Fortune Tobacco, might have exerted inappropriate pressure on the Philippine government to pursue the case, the groups have not produced unequivocal evidence of an Article 5.3 violation. Firstly, the authors have failed to recognise that there are many newspaper reports indicating that the case was filed by the Philippines government on behalf of Philip Morris which cannot be ignored and warrant an investigation to ascertain if there is indeed an Article 5.3 violation. Secondly, the authors have not clarified why it is civil society's responsibility to provide the evidence and not the government's to facilitate an investigation when in the Philippines there is a mechanism to implement Article 5.3 through the Joint Memorandum Circular (JMC) 2010- 01 of the Civil Service Commission and Department of Health.

    Regulatory chill - On regulatory chill the authors claim it is difficult to identify such incidents definitively because there can be "multiple explanations for governments' policy choices". It appears the authors may be ignorant of tobacco control activities on the ground. In the case of New Zealand which has started legislative process on plain packaging of tobacco and seen first reading in Parliament, the legislators won't pass it into law "until legal action in Australia has been settled". BAT and Imperial Tobacco, which sued the Australian government, have threatened to take similar action if plain packaging is introduced in New Zealand. The New Zealand Prime Minister said they decided not to take a chance in breaking any trade rule, that it would be too expensive for New Zealand to face a legal challenge from tobacco companies. Similarly the Malaysian Health Minister has said Malaysia will watch the legal outcome in Australia on plain packaging.

    The authors are dismissive about regulatory chill in the context of the developing nations being studied. If it is too expensive for New Zealand to fight such legal challenges, the reality is even more stark for low and middle income countries which simply cannot afford protracted legal battles. This is illustrated in Uruguay's experience of being unable to afford legal costs in meeting PMI's challenge and seeking assistance from US philanthropies. The challenge launched in 2010 is still ongoing. Uruguay's President has now made an appeal to the US President for assistance in stopping PMI from annulling their tobacco control legislation.

    The authors' conclusion that the very mixed results across key aspects of the trade and tobacco nexus suggest that there is no clear-cut link between trade liberalisation and a decline in tobacco control and/or an increase in tobacco consumption in Southeast Asia must be seen in the context of the errors and omissions pointed out above. While the authors need not address all aspects, such as ways in which the TTC benefited from AFTA beyond tariff reductions and conducted efforts to thwart tobacco control measures, they could have mentioned them in the limitations. Indonesia and the Philippines are the two countries where the TTC have consolidated their presence by acquiring or merging with local companies. BAT which exited the Philippines has since returned in 2012 and has benefited from the recent tax hikes through what it calls a more "level playing field".

    Tobacco carve-out - The authors claim that simply arguing trade liberalisation is bad for tobacco control and that excluding the tobacco sector from economic agreements is the solution is a "suboptimal" strategy. The authors have attributed this call for a tobacco carve-out to "tobacco control proponents from the region" as in a proposal limited to a specialised group. The authors' doubts about the political viability of excluding tobacco from such economic agreements have already been contradicted by the Malaysian government's formal tabling of just such a provision in the TPPA in August 2013. Malaysia's proposal received wide media coverage. The complete carve-out proposal is based on the recognition that tobacco products are uniquely harmful and the global consensus that nations must act to reduce tobacco use, according to the WHO Framework Convention on Tobacco Control (FCTC).

    In reality the call for a tobacco carve-out is not confined to just "tobacco control proponents from the region" but is echoed by public health advocates, medical groups, academics and lawyers from New Zealand, Australia, the US and Peru. Additionally in January 2014 the Attorneys General of 45 states in the US urged the US Trade Representative to exclude tobacco from the TPP entirely, stressing that "there is no policy justification for including tobacco products in agreements that are intended to promote and expand trade and investment generally." Needless to say these Attorneys General are not from Southeast Asia.

    Malaysia's proposal to the TPP was submitted by officials from the Ministry of International Trade and reiterated by the Minister contradicting the authors' claim that there is a "gap between trade and health practitioners". This also lays bare the authors' quote from a Filipino high-ranking trade official that "no key trade or finance officials in ASEAN countries are openly supportive of this proposal (tobacco exclusion)".

    The authors say tobacco exclusion may even be problematic and advise tobacco control proponents to counteract aggressive marketing by the tobacco industry by being more prudent and pursuing FCTC-compliant bans on tobacco advertising, promotion and sponsorship. If the authors simply recognized the fact that Australia plain packaging was challenged despite "being prudent" then they would realize that their recommendation for prudence has no basis and is not an alternative to the so-called suboptimal solution. The Australian plain pack example also clearly explains the regulatory chill effect in other countries that the authors dismiss.

    In questioning the political viability of tobacco exclusions, the authors focus on the challenges of the broader task of affecting trade negotiations successfully but not on the benefits. Of course, nothing in tobacco control was achieved easily, more so in trade agreements. They have all been hard fought battles and we continue to fight them in developing countries.

    The authors refer to the "additional burdens of returning to hundreds of previously negotiated economic agreements" but they should know that the practical solution is when these agreement expire and/or come up for renewals, to address tobacco then. Hence it is vital to secure a tobacco exclusion in the TPP, touted to be the 21st Century free trade agreement to provide the standard for future agreements.

    References

    Public Citizen, Trans-Pacific Partnership (TPP): Job Loss, Lower Wages and Higher Drug Prices http://www.citizen.org/TPP

    Editorial Board, This Time, Get Global Trade Right, New York Times, 19 Apr 2014, http://www.nytimes.com/2014/04/20/opinion/sunday/this-time- get-global-trade-right.html?hp&rref=opinion Accessed 4 Jun 2014

    Khor, M. TPPA affecting health policies? Global Trends, The Star, 1 Jul 2013, http://www.thestar.com.my/Opinion/Columnists/Global- Trends/Profile/Articles/2013/07/01/TPPA-affecting-health-policies/ Accessed 4 Jun 2014

    Shaffer ER, Brenner, JE. Houston, TP. International trade agreements: a threat to tobacco control policy Tob Control 2005;14:ii19-ii25 doi:10.1136/tc.2004.007930

    Philip Morris. The perspective of Philip Morris International on smoking and health issues. Text of discussion document used at top management meeting. March 29, 1985. Bates Number 2023268329-49. http://www.pmdocs.com/getallimg.asp?DOCID=2023268329/8337 Cited in: Hammond R, Howell A, Trust us - we're the tobacco industry. Action on Smoking and Health (UK), Campaign for Tobacco-Free Kids. April 2001. http://tobaccofreekids.org.

    Submission of Philip Morris International in response to the request for comments concerning the proposed Trans-Pacific Partnership trade agreement, 25th January 2010, www.regulations.gov/#!documentDetail;D=USTR- 2009-0041-0016 .

    Honjo K, Kawachi I. "Effects of Market Liberalisation on Smoking in Japan." Tobacco control 9.2 (2000): 193-200.

    RJ Reynolds. RJRTI point paper. 17 Aug 1982. Bates No. 503772107/2109. RJ Reynolds. http://legacy.library.ucsf.edu/tid/nkf85d00

    RJ Reynolds. RJR report. Oct 1983. Bates No. 503779375/9422. RJ Reynolds. http://legacy.library.ucsf.edu/tid/rie85d00

    Southeast Asia Tobacco Control Alliance. ASEAN Tobacco Tax Report Card Executive Summary, May 2014, http://seatca.org/dmdocuments/ASEAN%20tax%20Report%20Summary.pdf

    Ministry of Health Malaysia. Control of Tobacco Product Regulations 2004, Labelling and Packaging Part VI. 16. (1), 7 Sep 2004, http://seatca.org/dmdocuments/Malaysia%20-%20TC%20Regs%202004.pdf

    ITC Project (March 2012). ITC Malaysia National Report. Findings from Wave 1 to 4 Surveys (2005-2009). University of Waterloo, Waterloo, Ontario, Canada; Universiti Sains Malaysia, Pulau Pinang, Malaysia; and Ministry of Health, Putrajaya, Malaysia http://www.mysihat.gov.my/v2/promosi/images/stories/pusatmaklumat/itcreport.pdf

    Assunta M, Chapman S. Industry sponsored youth smoking prevention programme in Malaysia: a case study in duplicity, Tob Control 2004;13:ii37 -ii42 doi:10.1136/tc.2004.007732

    Philip Morris. Malaysia: 3 year plan 1994 to 1996. 1994. Philip Morris. Bates No. 2504033230/3262. http://legacy.library.ucsf.edu/tid/epq19e00.

    Philip Morris International. history, http://www.pmi.com/eng/about_us/pages/our_history.aspx

    McConey G. Corporate weekly highlights by region. 20 Oct 1995. Philip Morris. Bates No. 2046386290/6296. http://legacy.library.ucsf.edu/tid/bhi67d00

    TJI. Tobacco Journal, Clove Encounter: Philip Morris acquires Sampoerna, Accessed 2 June 2014, http://www.tobaccojournal.com/show_artikel.php3?id=4344

    Saclag, DED. WTO arbitration over cigarette taxes again likely, Business World Online, 18 Mar 2014, http://www.bworldonline.com/content.php?section=Economy&title=WTO- arbitration-over-cigarette-taxes-again-likely&id=84912

    Desiderio LD. WTO dispute settlement body meets on Phl-Thai cigarette tax issue, 20 Apr 2014,http://www.philstar.com/business/2014/04/20/1313883/wto-dispute-body- meets-phl-thai-cigarette-tax-issue

    Remo A. Thai response to cigarette case with WTO 'insufficient', Philippine Daily Inquirer, 12 May 2014, http://business.inquirer.net/170208/thai-response-to-cigarette-case-with- wto-insufficient

    Flores MFE. New WTO troubles seen with Thailand, Business World Online, 27 May 2014 http://www.bworldonline.com/content.php?section=Economy&title=New-WTO- troubles-seen-with-Thailand&id=88111

    Radio New Zealand News. Tobacco packaging bill introduced, 17 Dec 2013, http://www.radionz.co.nz/news/political/231106/tobacco-packaging- bill-introduced Accessed 4 June 2014

    Su R. New Zealand's Plain Packaging Bill Up For First Reading, Tobacco Companies Warn Of Legal Battle, International Business Times, Australia, 11 Feb 2014, http://au.ibtimes.com/articles/538174/20140211/new -zealand-australia-tobacco-plain-packaging.htm#.U46W8yiZo-0 Accessed 4 Jun 2014

    The Edge. Getting tough on tobacco, 5 Jun 2013, https://my.news.yahoo.com/getting-tough-tobacco-023311948.html

    OECD. Investor-State, Supra note 92, at 17

    Salazar R. Why U.S. Companies Are Increasingly Unwelcomed in South America, 22 May 2014, http://www.huffingtonpost.com/rafael-salazar/why-us- companies-are-incr_b_5372677.html?utm_hp_ref=politics&ir=Politics Accessed 4 Jun 2014

    Hurt RD, et al. Roadmap to a tobacco epidemic: transnational tobacco companies invade Indonesia, Tob Control 2012;21:3 306-312

    Alechnowicz K, Chapman S. The Philippine tobacco industry: "the strongest tobacco lobby in Asia" Tob Control 2004;13:ii71-ii78 doi:10.1136/tc.2004.009324

    Inside U.S. Trade. Daily News: Malaysia Poised To Table Complete Carveout From TPP For Tobacco Measures, 25 Aug 2013

    Inside U.S. Trade. Daily News: U.S. Official Says TPP Countries Will Consult Internally On Tobacco Proposals, 28 Aug 2013

    The Star Online. Malaysia's move to snuff out tobacco products in TPPA lauded, Sep 2, 2013. Accessed 3 Jun 2014 http://www.thestar.com.my/News/Nation/2013/09/02/Msias-move-to-snuff-out- tobacco-products-in-TPPA-lauded.aspx/

    The Editorial Board. The Hazard of Free-Trade Tobacco, 31 Aug 2013, http://www.nytimes.com/2013/09/01/opinion/sunday/the-hazard-of-free-trade- tobacco.html?_r=0 Accessed 3 Jun 2014

    Lester S. Trade, Tobacco, and the TPP, The Huffington Post, 3 Sep 203, http://www.huffingtonpost.com/simon-lester/trade-tobacco-and-the- tpp_b_3805584.html , Accessed June 2014

    PR Newswire. Malaysia Applauded for Strong Proposal to Protect Tobacco Control Measures Under Trans-Pacific Partnership Trade Agreement, 26 Aug 2013, http://www.reuters.com/article/2013/08/26/cftfk-malaysia- idUSnPNDC69353+1e0+PRN20130826 Accessed 4 Jun 2014

    Kelsey J. Preliminary Analysis: Why a tobacco 'exception 'from ISDS won't sufficiently protect tobacco control measures, Faculty of Law, The University of Auckland, New Zealand, http://ash.org/wp- content/uploads/2014/02/ISDS-tobacco-exception.pdf

    AFTINET Media Release. US push at Ministerial Meeting fails and tobacco burns Trans - Pacific Trade Deal, 24 Aug 2014 http://aftinet.org.au/cms/sites/default/files/Brunei%20media%20release%20amended%20240813.pdf

    Center for Policy Analysis on Trade and Health, U.S. TPP Tobacco Proposal Doomed by Loopholes; Malaysia Exclusion/Carve Out Necessary, http://www.cpath.org/id59.html

    Cohen B. Attorneys general don't want trade agreement to include tobacco. Legal Newsline Legal Journal, March 1, 2014. Available at: http://legalnewsline.com/issues/tobacco/246834-attorneys-general-dont-want -trade-agreement-to-include-tobacco

    Conflict of Interest:

    None declared

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  2. Silver linings and improvement of our resources for smoking cessation interventions.

    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:

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  3. An impartial, independent and transparent process

    Euromonitor International is a world leader in strategy research for consumer markets, with over 40 years of experience in developed and emerging economies. Through a combination of specialist industry knowledge and in-country research expertise, Euromonitor aims to build a market consensus view of the size, shape and trends in each industry we cover. Tobacco is no different, and both duty paid and illicit sales are researched in the same way as all other consumer products.

    As impartial market analysts, our research methodology has been developed over decades and continues to deliver well-respected and widely used data and insights. For a full description please visit http://www.euromonitor.com/research-methodology.

    In short our aim is to build an industry consensus view of each market by accessing all relevant public domain material and enhancing this through an in-country trade survey. The volume and strength of published source material behind our global systems will vary depending on the market or category in question and as a result some data sets are more "hard sourced" than others. This is a widely accepted challenge of researching international markets.

    For Tobacco, trade surveys are conducted with a representative range of industry stakeholders in each national market, from government bodies to tobacco brand owners, retailers and health groups, reflecting our wide client base as well as varied opinions and agendas. By its very nature, illicit trade in tobacco is a contentious area that is difficult to quantify - there is often dissonance between sources. A key element of the value-add of Euromonitor's work lies in our ability to scrutinise and reconcile differing views by considering illicit trade against local knowledge of the market and its wider context of national economic performance, trends in cigarette taxation, movements in unit prices, duty paid sales (including trends in illicit and duty paid combined) and smoking populations, as well as porosity of national borders, law enforcement efforts, and product availability. The context and drivers behind our figures are explored in accompanying market analysis reports on each country we research.

    As such we are confident Euromonitor International presents the most widely accepted and realistic estimate of the illicit market, based on an integrated view of the wider industry context and the factors that contribute towards it - no single source or figure is taken as definitive.

    That said, our clients accept and acknowledge that researching challenging markets is part of an iterative process. We are constantly improving our coverage and understanding of consumer products as we access a wider range of sources in each annual revisit of our industries. As a result our data may change from one annual update to the next based on new sources becoming available, key sources resizing markets or an improved understanding of how to interpret local source material. We are transparent in our methods and our sourcing and all clients have access to our analysts and the assumptions that go in to building our data.

    Crucially Euromonitor International is an independent company with no agenda other than to reflect markets and trends as accurately as possible. As such we are completely impartial, with no bias or reliance on any single source. Indeed as analysts we welcome all constructive debate and regularly engage with industry stakeholders from across the board to review sources and challenge assumptions with the aim of developing greater understanding of difficult-to-research areas.

    Conflict of Interest:

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  4. FDA has definitively lost its way.

    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.

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  5. An analysis of limitations of tax policy is not a policy fix

    It is important for tobacco control policymakers to know the advantages and disadvantages of different tax policies. It is quite another thing to move a tax system to optimize tax policy for tobacco control since there are multiple obstacles to systems change. In addition, health advocates often do not invest enough time and effort to understanding the economics of tax systems and the structural impediments in existing laws and policies to improve the tax structure. Consider for a moment the huge amount the tobacco industry invests in the economics of tobacco, and how it gives big money to lobby and influence tax policy. I applaud economists who are willing to study and fight for strong tobacco control tax policies, but in LMIC they are usually far too few. It is time for local/national health professionals to realize they better invest in working with economic leaders if they really wish to influence tax and health investment policies over the long term. Only then will there be health in all policies, including tax policies on tobacco and many other products that are necessary to sustain and promote health.

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  6. Re:KPMG response to 'Towards a greater understanding of illicit tobacco trade in Europe: a review of the PMI funded 'Project Star' report', published in Tobacco Control (BMJ) on 11th December 2013

    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.

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  7. KPMG response to 'Towards a greater understanding of illicit tobacco trade in Europe: a review of the PMI funded 'Project Star' report', published in Tobacco Control (BMJ) on 11th December 2013

    Significant factual inaccuracies relating to KPMG's annual report into the European trade in illicit tobacco were made in a recent article published in Tobacco Control by the BMJ. The report, which KPMG's Strategy Group has been producing since 2005, is recognised by the UK National Audit Office, OLAF and the OECD (and by other numerous national customs authorities and government departments) as the most comprehensive study of its kind. The report has earned its solid, international reputation because it is produced by an independent, professional advisory firm, using a robust and consistently applied methodology.

    The central premise of the article was that the KPMG report overstates the illicit tobacco trade. However, KPMG estimates since 2005 have correlated within a range given by other organisations, including the UK National Audit Office, Euromonitor, Joossens and the IARC, amongst many others. For example, in 2007, Joossens estimated total consumption of illicit tobacco within the EU to be 8.5%, while the KPMG report estimated consumption at 8.4%.

    Critically, the article misrepresented the methodology KPMG applies in estimating the consumption of illicit tobacco. The research considers a number of factors, including empty pack surveys. It is certainly true that empty pack surveys do not provide the full picture but they do form an important factor in the equation as they rely purely on physical evidence, avoiding the variability of consumer bias in interview based methods. An additional advantage of empty pack surveys is that they provide a statistically robust and comparable volume of data as they are conducted consistently across all European markets. In 2010 approximately 430,000 packs were collected throughout Europe in 1,400 population centres. Additional analysis identifies if the empty pack survey may have over or under-reported the level of non-domestic packs with the samples being re-weighted to correct this.

    The KPMG report also factors in consumer surveys (conducted by Ipsos and Nielsen) which drill into the detail of consumers' travel habits, overall consumption, gender and age to assess the level of legal non- domestic purchases. Approximately 10% of the 160,000 survey respondents both travel and purchase cigarettes abroad. These respondents are asked about the country of purchase and brands purchased. This data can also be adjusted where it appears to be under-reporting legal tobacco consumption. For example, correction of under-reporting increased the allocation of legally purchased packs from Spain to France and from Poland and the Czech Republic to Germany.

    The article goes on to offer an alternative estimation methodology: the PPACTE study. However, it is prudent to consider the limitations of this study; notably, the reliance on consumer studies which both under- report tobacco consumption overall and, in particular, illicit tobacco consumption. The PPACTE study also uses a substantially smaller sample size e.g. the methodology used to calculate the illicit volumes equates to an average of less than 200 per country.

    The consumption of tobacco - illicit or otherwise - is understandably a concerning issue for many people and organisations. While it may be superficially appealing to discount a report funded by a tobacco company, the methodology of the 'Project Star' report is robust and unbiased. This data set is an important source of knowledge for the tobacco industry and health campaigners alike. An issue can only be tackled, whether for commercial or health reasons, if its nature and scale is understood. The Project Star report is widely regarded, by companies and health and government organisations, as the leading source of data on illicit tobacco consumption in the EU.

    Conflict of Interest:

    Author of the report under examination in the paper published in December 2013, entitled 'Towards a greater understanding of the illicit tobacco trade in Europe: a review of the PMI funded 'Project Star''

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  8. Cultural considerations for tobacco control strategies in rural China

    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

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  9. CARCINOGEN EXPOSURE WITH WATER PIPE SMOKING

    NOT PEER REVIEWED To the Editor: The habit of water pipe smoking is rapidly extending in all occidental countries. This rise in popularity appears to be correlated with the advent on store shelves of an array of fruit-flavored tobacco mixtures, which list ''molasses'' as a primary ingredient. Also there is a widespread misperception among smokers that the water through which the smoke bubbles acts as a filter, rendering it considerably less harmful than that of cigarettes [1]. A recent systematic review showed that the main motives for water pipe tobacco smoking were socializing, relaxation, pleasure and entertainment. Peer pressure, fashion, and curiosity were additional motives for university and school students [2]. However, the habit of smoking tobacco in water pipes is an old practice in the Eastern Mediterranean countries like Egypt, Jordan, Syria, Lebanon and Iraq [3]. Recently, Jaboc and collaborators (2013) published a crossover study about biomarkers of toxicant exposure with water pipe compared with cigarettes. The study included 13 volunteers from San Francisco (USA) who smoked both cigarettes and water pipes. The results showed that water pipe was associated with greater exposure to carbon monoxide, polycyclic aromatic hydrocarbons and benzene compared with cigarette smoking. Finally, the authors concluded that water pipe smoking is associated with a high risk of leukemia related to high levels of benzene exposure [4]. If Jaboc and collaborators' (2013) conclusions were right, we would expect higher prevalence of leukemia in the Eastern Mediterranean region compared with the Occidental Countries. Reviewing cancer registries in GLOBOCAN 2008, we can notice that adjusted standardized mortality rates of leukemia in males are comparable in the European Region (5.0 per 100.000) to the Eastern Mediterranean Region (4.7 per 100.000). A similar rate is noticed in the Americas Region (5.0 per 100.000) [5]. Deficient registration systems could not be the explanation. Neoplasms principally attributed to smoking like lung, laryngeal and oro-pharyngeal cancers have similar prevalence in Egypt like many of the occidental countries [5]. Water pipe tobacco brands used in the study of Jacob and collaborators (2013) were Nakhla and Al-Waha. These are the same brands usually consumed in the Eastern Mediterranean countries, like Egypt. On examining the box of Nakhla Double Apple brand, widely consumed in Spain, we can find a clear notice that it contains 0% tar. During the smoking process cigarette tobacco burns directly, whereas water pipe tobacco does not burn in a self-sustaining manner and requires an external heat source such as charcoal. I think that the high level of polycyclic aromatic hydrocarbon and benzene in the urine samples of water pipe smokers in the study of Jaboc and collaborators (2013) could be attributed to the charcoal disks used in many occidental countries. These quick lighting charcoal disks are impregnated in gasoil rich in polycyclic aromatic hydrocarbons and benzene. Smoke from these impregnated charcoal disks is inhaled by water pipe smokers [1]. In Eastern Mediterranean countries like Egypt, natural charcoal is used and is burned slowly in special clay or metallic receptacles [1,3]. This could explain the comparable prevalence of leukemia in Egypt and Occidental Countries. Examining quick lighting charcoal disk tubes available in Spain, we can notice that they lack labeling about the hazards of their use for water pipe smoking. Regulations and control for the use of these impregnated charcoal disks in the European Countries are urgently needed.

    REFERENCES 1. Shihadeh A. Investigation of mainstream smoke aerosol of the argileh water pipe. Food Chem Toxicol 2003;41(1):143-52. 2. Akl EA, Jawad M, Lam WY, Co CN, Obeid R, Jihad Irani J. Motives, beliefs and attitudes towards waterpipe tobacco smoking: a systematic review. Harm Reduct J 2013;10:12. 3. Chaouachi K. The medical consequences of narghile (hookah, shisha) use in the world. Rev Epidemiol Sante Publique 2007;55(3):165-170. 4. Jacob P 3rd, Abu Raddaha AH, Dempsey D, Havel C, Peng M, Yu L, Benowitz NL. Comparison of nicotine and carcinogen exposure with water pipe and cigarette smoking. Cancer Epidemiol Biomarkers Prev 2013;22(5):765-72. 5. International Agency for Research on Cancer. GLOBOCAN 2008. Available at: http://globocan.iarc.fr/ (Accessed 31 August 2013).

    Conflict of Interest:

    None declared

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  10. Taking Breaks: are smokers examples of model employees?

    NOT PEER REVIEWED The article by Berman et al "Estimating the cost of a smoking employee" has attempted to quantify the costs associated with employing smokers. As the article indicates several companies are now actively discriminating against smokers so it is important that any costs are fully justified. One area that concerns me about this is a tendency towards oversimplification of a complex situation. In particular the assumption that the breaks a smoker takes from work are a cost to the employer. Clearly a smoking break is time away from workplace tasks, but the assumption that this is just about time at the desk ignores a growing body of evidence that taking regular breaks from work is beneficial to individual health (1), which might counter some of the negative health risks associated with smoking, and that breaks are also beneficial to workplace productivity. Research has suggested that people taking regular breaks are more creative, more focussed and ultimately more productive (2,3). Prolonged attention to an individual task has, somewhat counter-intuitively, been shown to hinder performance. Taking a break from the task improves overall focus (2). Similarly breaks that have a positive association for the person taking the break are linked to positive performance effects and lower levels of negative emotions (3). All of this suggests that smokers taking breaks might actually increase their performance and benefit employers. Not taking such effects into account is potentially unfair to smokers and also risks breaks being associated by employers with negative effects for all of us. References: 1) Levene: http://dx.doi.org/10.2337%2Fdb10-1042 2) Ariga: http://dx.doi.org/10.1016/j.cognition.2010.12.007 3) Trougakos: http://dx.doi.org/10.1108/S1479-3555(2009)0000007005

    Conflict of Interest:

    None declared

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