- Friday, 26 April 2019 19:54
Respuesta a “Nuevos productos de tabaco, una amenaza para el control de tabaco y la salud pública de México”
Riccardo Polosa MD PhD1,2, Salvatore Urso MSc2, Konstantinos E. Farsalinos MD MPH3,4,5
1 Department of Clinical and Experimental Medicine, University of Catania, Catania (Italy)
2 Center of Excellence for the acceleration of Harm Reduction (CoEHAR), University of Catania, Italy
3 Department of Cardiology, Onassis Cardiac Surgery Centre, Kallithea, Greece
4 Department of Pharmacy, University of Patras, Greece
5 National School of Public Health, Athens, Greece
Prof. Riccardo Polosa
AOU Policlinico Vittorio Emanuele
Edificio 4, piano 2
Via S. Sofia, 78
electronic cigarettes; Electronic Nicotine Delivery Systems; smoking; adverse effects; prevention and control; legislation and jurisprudence; Mexico
To the Editor.
We read with serious concern the position article by Reynales-Shigematsu et al. about combustion-free nicotine delivery products and public health . The authors not only fail to present a balanced overview of the risk-benefit ratio of these new technologies, but grossly misrepresent the existing evidence and ignore the broad consensus that Electronic Nicotine Delivery Systems (ENDS), Alternative Nicotine Delivery Systems (ANDS), and E-Cigs (electronic cigarettes or vaporizers) use is considerably less harmful than continuation of smoking [2-6]. By placing a greater emphasis on potential risks and disregarding possible benefits the authors fail to consider that ENDS, ANDS and E-Cigs use may represent an opportunity for public health.
While we acknowledge the controversy on various issues such as their utility in smoking cessation, and their impact on vulnerable populations [7-9], a healthy debate about combustion-free products is hardly compatible with a positioning article that describes them as a “threat” to public health and tobacco control in Mexico. In support of their alarmist position the authors selectively cherry pick the scientific literature and incorrectly appraise the evidence. They also fail to present important official positions from many leading organizations [3,4,6,10] about the less harmful potential of E-Cigs. For example, a long-standing position of Public Health England is that E-cigs are approximately 95% less harmful than smoking .
When discussing the potential risks from exposure to toxic compounds in E-cig aerosol emissions they misrepresent the scientific evidence or fail to consider alternative (more plausible) explanations for the study findings. For example, position paper’s references 8 and 9 showed no alarming levels of diacetyl or 2,3-pentanedione for human health. Likewise, metals were detected but their levels were either negligible (see references 10 and 11), or - if significant – clearly related to unrealistic experimental conditions (see reference 12), or to defective designs of e-cigarettes that have long been withdrawn from the market (see reference 13). Also, research findings based on in vitro models cited in references 14 and 15 cannot be considered predictive for biological responses in human under normal condition of use. In stark contrast with concerns raised in toxicological in vitro and animal models, there is now emerging evidence from real-life surveys and prospective evaluation of lung health that long term E-cig use is unlikely to raise significant lung health concerns in healthy smokers as well as in respiratory patients [11-13]. Last but not least, it is not unexpected to measure high levels to carbonyls and VOC’s when calibration of the puffing regime in vaping machines and power settings of the E-cigs are unrealistic (see references 16, 17 and 19-21). The notion that high aldehydes levels are formed only under unrealistic experimental conditions has been recently confirmed by elegant replication studies [14,15].
The position article conveys an unwarranted sense of alarm on health risks from nicotine consumption by mentioning the 2016 US Surgeon General Report (see reference 27). Unfortunately, the Report’s conclusions on E-cig use are unsubstantiated because it discusses exclusively the risk of nicotine in the tobacco smoke and not in E-cig aerosol emissions. To infer health risks, nicotine delivered by combustion-free products needs to be appropriately assessed. The 2016 US Surgeon General Report has been recently criticized .
To argue the risk that E-Cig trial and usage might induce young Mexican to start tobacco smoking (the so-called gateway effect), the authors mention a longitudinal cohort study of more than 10,000 junior high school students from Mexico City, Guadalajara and Monterrey (see reference 31). Once again, study findings are misrepresented; authors state that 10% of students tried E-Cigs at baseline and then claim that “…after only one year of follow-up, …, 19% had used them, and 12% were current users (vapers)”. These alarming percentage figures are not reported in the study (!) and in stark contrast with the statement “… we did not find a significant association between trial of e-cigarettes at baseline and e-cigarette use at follow up”, indicating that the study captured purely experimentation which is not expected to be associated with any dependence or health harm. The authors also fail to mention that the main association between E-Cig trial at baseline and “conventional cigarette use” at follow up was not even statistically significant thus not justifying any claim that E-Cig trial propitiates smoking initiation among Mexican youth. As for many other similar studies, it must be noted that conceptual understanding of controlling for shared liability - as the most plausible model for any potential gateway effect [17,18] - is missing in the position article by Reynales-Shigematsu et al.
The authors claim that “smokers who use E Cigs have significantly less chances to stop smoking”, but the work referenced (two Cochrane reviews – see position paper’s references 33 and 34 as well as two randomised controlled trials - see reference 35 from Bullen el. and reference 36 from Caponnetto et al.) does not support this claim. In fact, a recently published high quality randomised controlled trial  has shown E-Cigs to be two times more efficient in sustaining 12 month smoking abstinence than nicotine replacement therapies. The authors also quote from the study by Rigotti et al. (see reference 37) that “…only 10.1% of smokers who used the E Cig stopped smoking after six months versus 26.6% of smokers who did not use it”. However, the results of this cohort study (not a clinical trial) provide no information on the effectiveness of E-Cig usage in smoking cessation. This is because of selection bias; participants abstinent by that time were very likely abstinent at the trial end and had no need to try E-Cigs or any other cessation product, whereas treatment failures were more likely to try an alternative like an E-Cig during the study.
By identifying dual users as a pointblank failure the authors exhibit a deep misunderstanding of the real life conditions of the smoking cessation process. It is wholly unreasonable to expect smokers to suddenly, and abruptly, convert immediately to exclusive vaping. Dual use represents a natural and expected phenomenon towards smoking cessation, and the same phenomenon exists with smoking cessation medications such as nicotine replacement therapies. Moreover, demographic studies do show an effective contribution of E-Cigs to smoking cessation at population levels that coincide with the positive evaluation from the best-designed clinical trials .
The authors' dismissal of the potential role of E-Cigs, ENDS and ANDS as part of a harm reduction strategy for Mexico is based on demanding compliance with a complete replacement of smoking and a complete absence of recruitment of non-smokers (norm NOM 028-SSA2-2009). These are evidently lofty goals, but when stated in maximalist terms and without a time frame or a public policy plan they read like an effort to place unrealistic preconditions that no new harm reduction product can ever (and immediately) meet. Contrary to the authors’ contention, there is sufficient independent evidence that the recreational usage of E-Cigs, when endorsed by public health authorities, can successfully fulfill more pragmatic (yet realistic and beneficial) goals, such as: contributing to accelerate the decay of smoking prevalence with negligible exploration and consumption by adult and adolescent non-smokers. This is happening in the United Kingdom, as has been reported in comprehensive reviews by institutions that are not conflicted with the manufacturers of the products or the tobacco industry [3,4]. In fact, there is no country in the world where the availability of e-cigs has slowed or reversed the decline in smoking, and in some cases acceleration in smoking decline has been observed (UK) .
The authors recommend that a “Regulation of the new tobacco products should be implemented in alignment with the highest possible restriction level under provisions of every article in the WHO FCTC”. We disagree: regulation must be risk proportionate, which is the most reasonable and science-based option. Usage of E-Cigs, ENDS and ANDS significantly reduces exposure to toxins and relevant health risks compared to smoking. A regulation (as combustible tobacco products) based on the authors' extreme interpretation of the Precautionary Principle would cancel their potential contribution to public health improvement, as it would signal to smokers that there is no health benefit in switching and would keep them smoking. Such a position has been critized for abusing the precautionary principle [22-24]. In fact, the authors' proposed regulation unintentionally favors and protects the tobacco cigarette trade by placing onerous unnecessary restrictions to a competing (and much less harmful) array of products.
The 15 million cigarette smokers in Mexico require accurate scientific information on the advantages and risks of switching to E-Cigs, ENDS and ANDS. By focusing only on their risks and dismissing their potential for public health improvement on the basis of very weak and selective evidence, the authors of this positioning article are depriving Mexican smokers of key information on a harm reduction alternative that can vastly improve their health. Public health is not a science of emotions and of unrealistic measures. It is a science of mathematics and calculations of the benefit/risk ratio and, most importantly, it is the science of facing with realism the substantial smoking problem and coming up with realistic solutions. While immediate and complete elimination of smoking is certainly desirable by anyone, we express our concern that this cannot realistically be achieved by eliminating the biggest competitor of tobacco cigarettes which at the same time is a substantially less harmful product that perfectly fits into a tobacco harm reduction strategy.
 Reynales-Shigematsu LM, Barrientos-Gutiérez I, Zavala-Arciniega L, Arillo-Santillán E. Nuevos productos de tabaco, una amenaza para el control de tabaco y la salud pública en México. Salud Publica Mex. 2018;60:598-604.
 Farsalinos KE, Polosa R. Safety evaluation and risk assessment of electronic cigarettes as tobacco cigarette substitutes: a systematic review. Ther Adv Drug Saf. 2014 Apr;5(2):67-86.
 Nicotine without smoke: Tobacco harm reduction, A report by the Tobacco Advisory Group of the Royal College of Physicians RCP, 2016. http://www.rcplondon.ac.uk/projects/outputs/nicotine-without-smoke-tobacco-harm-reduction-0
 A McNeill, L S Brose, R Calder, L Bauld, D Robson. Evidence review of e-cigarettes and heated tobacco products 2018. A report commissioned by Public Health England. https://www.gov.uk/government/publications/e-cigarettes-and-heated-tobacco-products-evidence-review
 Glasser A.M. et al 2016. Overview of Electronic Nicotine Delivery Systems: A Systematic Review. Am J Prev Med. 2017 Feb;52(2):e33-e66.
 National Academies of Sciences, Engineering, and Medicine (NASEM). 2018. Public health consequences of e-cigarettes. Washington, DC: The National Academies Press. doi: https://doi.org/10.17226/24952.
 Polosa R. E-cigarettes unlikely to raise significant health concerns in airways disease. Respirology. 2018 Apr;23(4):435-436.
 Saitta D, Chowdhury A, Ferro GA, Nalis FG, Polosa R. A Risk Assessment Matrix for Public Health Principles: The Case for E-Cigarettes. Int J Environ Res Public Health. 2017 Mar 31;14(4).
 Polosa R, Caponnetto P. The Health Effects of Electronic Cigarettes. N Engl J Med. 2016 Dec 29;375(26):2608. PubMed PMID: 28032962.
 Douglas CE, Henson R, Drope J, Wender RC. The American Cancer Society public health statement on eliminating combustible tobacco use in the United States. CA Cancer J Clin. 2018 Jul;68(4):240-245.
 Farsalinos KE, Romagna G, Tsiapras D, Kyrzopoulos S, Voudris V. Characteristics, perceived side effects and benefits of electronic cigarette use: a worldwide survey of more than 19,000 consumers. Int J Environ Res Public Health. 2014;11(4):4356–4373.
 Morjaria JB, Mondati E, Polosa R. E-cigarettes in patients with COPD: current perspectives. Int J Chron Obstruct Pulmon Dis. 2017 Nov 1;12:3203-3210. doi:10.2147/COPD.S135323.
 Polosa R, Cibella F, Caponnetto P, Maglia M, Prosperini U, Russo C, Tashkin D. Health impact of E-cigarettes: a prospective 3.5-year study of regular daily users who have never smoked. Sci Rep. 2017 Nov 17;7(1):13825. doi:10.1038/s41598-017-14043-2.
 Farsalinos KE, Kistler KA, Pennington A, Spyrou A, Kouretas D, Gillman G. Aldehyde levels in e-cigarette aerosol: Findings from a replication study and from use of a new-generation device. Food Chem Toxicol. 2018 Jan;111:64-70. doi: 10.1016/j.fct.2017.11.002.
 Farsalinos KE, Voudris V, Spyrou A, Poulas K. E-cigarettes emit very high formaldehyde levels only in conditions that are aversive to users: A replication study under verified realistic use conditions. Food Chem Toxicol. 2017 Nov;109(Pt 1):90-94. doi: 10.1016/j.fct.2017.08.044.
 Polosa R, Russell C, Nitzkin J, Farsalinos KE. A critique of the US Surgeon General's conclusions regarding e-cigarette use among youth and young adults in the United States of America. Harm Reduct J. 2017 Sep 6;14(1):61. doi: 10.1186/s12954-017-0187-5.
 Vanyukov MM, Tarter RE, Kirisci L, Kirillova GP, Maher BS, Clark DB. Liability to substance use disorders: 1. Common mechanisms and manifestations. Neurosci Biobehav Rev. 2003 Oct;27(6):507-15.
 Etter JF. Gateway effects and electronic cigarettes. Addiction. 2018 Oct;113(10):1776-1783. doi: 10.1111/add.13924.
 Hajek P, Phillips-Waller A, Przulj D, Pesola F, Myers Smith K, Bisal N et al, A Randomized Trial of E-Cigarettes versus Nicotine Replacement Therapy. N Engl J Med 2019; 380:629-637 https://doi: 10.1056/NEJMoa1808779
 Villanti AC, Feirman SP, Niaura RS, Pearson JL, Glasser AM, Collins LK, Abrams DB. How do we determine the impact of e-cigarettes on cigarette smoking cessation or reduction? Review and recommendations for answering the research question with scientific rigor. Addiction. 2018 Mar;113(3):391-404.
 Farsalinos KE, Le Houezec J. Regulation in the face of uncertainty: the evidence on electronic nicotine delivery systems (e-cigarettes). Risk Manag Healthc Policy. 2015 Sep 29;8:157-67.
 Saitta D, Chowdhury A, Ferro GA, Nalis FG, Polosa R. A Risk Assessment Matrix for Public Health Principles: The Case for E-Cigarettes. Int J Environ Res Public Health. 2017 Mar 31;14(4). pii: E363. doi: 10.3390/ijerph14040363.
 Caponnetto P, Saitta D, Sweanor D, Polosa R. What to consider when regulating electronic cigarettes: Pros, cons and unintended consequences. Int J Drug Policy.2015 Jun;26(6):554-9. doi: 10.1016/j.drugpo.2015.03.001.