LIAF's Ricardo Polosa urges Malaysian Health Institute Director to keep e-cigarettes legal

[Bill Godshall]

To the Director of the Malaysian Institute of Respiratory Medicine - Datuk Dr Abdul Razak Muttalif


I am writing in relation to the e-cig ban that appears to be under consideration in Malaysia http://www.nst.com.my/nation/general/ban-sale-of-e-cigarettes-1.307078 Our understanding is that Malaysian Ministry of Health is seeking scientific evidence before it acts http://www.nst.com.my/life-times/su...ce-before-banning-shisha-e-cigarette-1.314695

As Director of the Centre for tobacco Prevention and Dependence Treatment, at the University of Catania (Italy), and as Scientific Director of LlAF (translated acronym for Italian No Smoking Association), I have dedicated many years of my clinical and research activity to fight against tobacco smoking. More effective approaches are needed to contrast tobacco smoking and reduce cigarette consumption worldwide. Recent scientific evidence now indicates that e-cigarettes are safe and effective substitute of tobacco smoking.

The body of information on the composition of the contents of e-cigarette cartridges, refill fluid and vapour generated by the devices is growing. This indicates wide variation in composition of contents and vapour, but overall there is no evidence that e-cigarettes may expose users to concentrations of toxins sufficient to cause harm (1-6).
Supporting evidence
1 Laugesen M: Safety Report on the Ruyan E-cigarette Cartridge and Inhaled Aerosol. Health New Zealand Ltd. Christchurch, New Zealand, 2008. Available at Health New Zealand
2. Cahn Z, Siegel M: Electronic cigarettes as a harm reduction strategy for tobacco control: a step forward or a repeat of past mistakes? J Public Health Policy 2011, 32:16-31.
3. Etter J-F, Zäther E, Svensson S: Analysis of refill liquids for electronic cigarettes. Addiction 2013: online first - doi: 10.1111/add.12235.
4. Goniewicz ML, Knysak J, Gawron M, Kosmider L, Sobczak A, Kurek J, Prokopowicz A, Jablonska-Czapla M, Rosik-Dulewska C, Havel C, Jacob III P, Benowitz N: Levels of selected carcinogens and toxicants in vapour from electronic cigarettes. Tobacco Control 2013, doi:10.1136/tobaccocontrol-2012-050859.
5. Williams M, Villarreal A, Bozhilov K, Lin S, Talbot P: Metal and silicate particles including nanoparticles are present in electronic cigarettes cartomizer fluid and aerosol. PLoS ONE 2013,8:e57087. Doi:10.1371/journal.pone.0057987.
6. Romagna G, Allifranchini E, Bocchietto E, Todeschi S, Esposito M, Farsalinos K. Cytotoxicity evaluation of electronic cigarette vapor extract on cultured mammalian fibroblasts (ClearStream-LIFE): comparison with tobacco cigarette smoke extract. Inhalation Toxicology 2013, 25:354-361.

There is evidence from case reports (7,8) and user surveys that e-cigarettes help people to quit smoking (9,10). Also a few clinical trials have been published (11-13). For example in smokers not intending to quit the use of e-cigarettes decreased cigarette's consumption and in some it elicited enduring tobacco abstinence. Moreover, no significant side effects were reported and substantial health gains could be achieved by e-cigarette users.
Supporting evidence
7. Caponnetto P, Polosa R, Auditore R, Russo C, Campagna D: Smoking Cessation with E-Cigarettes in Smokers with a Documented History of Depression and Recurring Relapses. International Journal of Clinical Medicine 2011, 2:281-284.
8. Caponnetto P, Polosa R, Russo C, Leotta C, Campagna D: Successful smoking cessation with electronic cigarettes in smokers with a documented history of recurring relapses: a case series. Journal of Medical Case Reports 2011, 5:1-6.
9. Etter J-F, Bullen C: Electronic cigarette: users profile, utilization, satisfaction and perceived efficacy. Addiction 2011, 106:2017-2028.
10. Siegel M, Tanwar K, Wood K: Electronic cigarettes as a smoking-cessation tool: results from an online survey. American Journal of Preventive Medicine 2011, 40:472-475.
11. Polosa R, Morjaria JB, Caponnetto P, Campagna D, Russo C, Alamo A, Amaradio M, Fisichella A. Effectiveness and tolerability of electronic cigarette in real-life: a 24-month prospective observational study. Intern Emerg Med. 2013 Jul 20. [Epub ahead of print]
12. Caponnetto P, Campagna D, Cibella F, Morjaria JB, Caruso M, Russo C, Polosa R. 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.
13. Polosa R, Caponnetto P, Morjaria JB, Papale G, Campagna D, Russo C. Effect of an electronic nicotine delivery device (e-Cigarette) on smoking reduction and cessation: a prospective 6-month pilot study. BMC Public Health. 2011 Oct 11;11:786.

Moreover, a number of studies have shown that the risks of second hand vapor from e-cigarette use is very small in comparison to those associated with second hand tobacco smoke (14-16). While second hand smoke must be eliminated in workplaces and public places, the current data provide no justification for eliminating e cigarette use in these places.
Supporting evidence
14. Schripp T, Markewitz D, Uhde E, Salthammer T: Does e-cigarette consumption cause passive vaping ? Indoor Air 2013, 23:25-31.
15. McAuley T, Hopke P, Zhao J, Babaian S: Comparison of the effects of e-cigarette vapor and cigarette smoke on indoor air quality. Inhal Toxicol 2012, 24:850-857.
16. Flouris A, Chorti M, Poulianiti K, Jamurtas A, Kostikas K, Tzatzarakis M, Wallave Hayes A, Tsatsakis A, Koutedakis Y: Acute impact of active and passive electronic cigarette smoking on serum cotinine and lung function. Inhal Toxicol. 2013, 25:91-101.

The current evidence is thin and more research is clearly needed, but it is likely that these products will prove useful in the fight against tobacco also in Malaysia. Therefore, Malaysian Health Authorities should carefully consider the public health potential of the e-cigarettes.

As we recently stated in a scientific letter to The Lancet (that will be published in the September issue), <<Excessive and ill-conceived regulation will marginalize e-cigarettes by making them unattractive to smokers and less competitively priced compared with tobacco products.>>

My piece of advice with regard to future regulation of these products in your country is that it should primarily address quality standards of liquids used in e-cigarettes (e-liquids) and should require: 1) evidence that good manufacturing practices (GMP) have been followed; 2) official documentation reporting contents and concentrations in e-liquids to regulators; and 3) clear, accurate, and detailed labeling about the contents and the possible dangers of products handling (e.g. accidental poisoning) that may derive from improper e-cigarette use.

One such regulatory framework already exists; e-liquid may be marketed as dietary supplements providing no claims about preventing or treating disease are made. Under dietary supplements regulation, manufacturers must indicate a product is not dangerous prior to introduction. Being compliant to national GMP policies it is all is required in order to ensure that e-liquids are produced in a quality manner, do not contain contaminants or impurities, are accurately labelled, and held under conditions to prevent adulteration. Additional safety principles can be implemented including a rule requiring that e-liquid manufactures submit reports of serious adverse events linked to the use of their products. Obviously, the simple scheme of dietary supplements regulation must be integrated by the already existing directives about electronic products safety (for example, in the EU, these class of products must comply with CE marking and accompanying Declaration of Conformity before marketing).

As Director of one of the highest and most respectable Health Institutions of your Country, you have the duty to provide Malaysians smokers with truthful health information and legal access to a far less hazardous alternative to tobacco smoking. Please do not hesitate to contact me if you need more clarifications.

Prof. Riccardo Polosa
LIAF Chief Scientific Advisor

 

[Placebo Effect]

As does longtime friend of vaping Jeff A. Stier of the National Center for Public Policy Research

http://www.nst.com.my/opinion/lette...nsible-approach-to-help-smokers-quit-1.340052

 

[Bill Godshall]

And a letter from Dr. Farsalinos.

Letter to: Datuk Dr Abdul Razak Muttalif
Athens, 19 August 2013

Dear Dr Muttalif,

I am writing this letter as the principle investigator of all research studies on electronic cigarettes that have been performed at Onassis Cardiac Surgery Center in Athens, Greece. The purpose is to draw your attention on the electronic cigarette issue in the context of your authority and pending decisions about their availability and regulation in Malaysia.

Electronic cigarettes have been developed as alternatives to smoking. They are part of tobacco harm reduction, a strategy of providing low-risk nicotine products so that consumers avoid the deleterious effects of smoking on their health [1]. The main reason for the existence of such a strategy is the inefficacy of currently approved medical methods for smoking cessation. Nicotine replacement therapies (NRTs) have a success rate of less than 6%, which could be mainly attributed to psychological support and not to NRTs themselves [2]. Oral medications generally have a success rate of less than 20%, even in highly motivated subjects [3]. At the same time, there is concern about their potential serious side-effects [4-6], with the US FDA issuing a black-box warning [7]. Therefore, it is an ethical duty of the scientific community and the regulatory authorities to provide alternatives to the vast majority of smokers who are unable to quit with current methods, considering that 1 billion deaths are expected worldwide due to smoking during the 21st century.

From a scientific perspective, it is important to mention that electronic cigarettes should be addressed to smokers only. I am not aware of any member of the electronic cigarette industry targeting youngsters or non-smokers as potential customers. As a result of this, current evidence supports that they are not appealing to youngsters or non-smokers. There are no reports in the literature of non-smoking youngsters developing addiction to electronic cigarettes. Surveys and analyses by respected organizations such as the Action on Smoking and Health (ASH) and Medicines and Healthcare products Regulatory Agency (MHRA) concluded that less than 1% of users are non-smokers and do not currently present any threat to youngsters [8,9]. Our group has made the largest ever worldwide survey on electronic cigarette users, with more than 20,000 participants; we found that 99.5% of users were smokers (unpublished data). Therefore, the electronic cigarette is a gateway from smoking rather than a gateway to smoking. The regulatory authorities can ensure that youngsters are kept away from electronic cigarettes by establishing strict punishments to vendors selling them to this age group.

The safety of electronic cigarettes when used long-term cannot be currently assessed. The reason is that it may need more than 10-15 years and thousands of people to be monitored in order to see any difference in disease. However, it should be reminded that the same applies for every consumer product or even pharmaceutical product approved for human use. For example, no long-term studies are needed before medications get marketing approval, even for those that are expected to be used for several years or life-long (such as anti-hypertensives and cholesterol-lowering medications). Safety is evaluated by monitoring long-term use after they are approved. The same should apply to electronic cigarettes. Banning the sales of electronic cigarettes will make it impossible for long studies to be performed. Moreover, such a decision is not supported by the currently-available evidence; on the contrary, all studies clearly show that they are by orders of magnitude less harmful compared to tobacco cigarettes. Toxic chemicals are present in minute quantities, making it questionable whether they can cause any long-term harm. Nitrosamines found in electronic cigarettes were 500-1400 times lower in quantity compared to one tobacco cigarette [10]; similarly, other toxins like formaldehyde and acetaldehyde were present in 9-450 times lower amounts [11]. Metals were expected to be found in some devices (several parts are made from metals), however, levels were still significantly lower compared to currently-established safety limits imposed by organizations such as the Occupation Safety and Health Administration or the Environmental Protection Agency. More importantly, toxicology studies have found that the vapor from electronic cigarettes has no or very mild toxicity on cultured cells, with cigarette smoke being once again more toxic by orders of magnitude [12]. On a clinical level, our group has shown that they do not cause any immediate adverse effect on cardiac function [13] and do not interfere with coronary circulation [14], unlike smoking which has negative effects on both processes. Therefore, all current evidence supports that they are safer not only for bystanders but also for the user.

Considering all the above-mentioned evidence, it would be an extreme paradox to either ban or impose strict regulations to electronic cigarettes while tobacco cigarettes are available and can be bought everywhere. Any effort to restrict electronic cigarette availability to smokers would have negative implications on their health. Any statement that discourages smokers from using electronic cigarettes would carry the risk of having several users relapse to smoking and would be completely unsupported by all current evidence. Electronic cigarettes are competing with tobacco cigarettes as a method to deliver nicotine; additionally they deal with the bio-behavioral aspect of smoking addiction. Every effort should concentrate on enhancing rather than restricting their availability. Tobacco cigarettes are already easier to use and easier to buy, therefore any strict regulation on electronic cigarettes will give tobacco an additional advantage [15]. I am confident that your intentions are to support the health and quality of life of people, and I hope this letter has improved your understanding and perspective on the issue of electronic cigarettes as a method to significantly reduce smoking-related harm.

With respect
Dr Konstantinos Farsalinos
Researcher, Department of Cardiology, Onassis Cardiac Surgery Center, Athens-Greece

References
[1] Phillips C.V. Debunking the claim that abstinence is usually healthier for smokers than switching to a low-risk alternative, and other observations about anti-tobacco-harm-reduction arguments. Harm Reduct J. 2009;6:29.
[2] Moore D, Aveyard P, Connock M, Wang D, Fry-Smith A, Barton P. Effectiveness and safety of nicotine replacement therapy assisted reduction to stop smoking: systematic review and meta-analysis. BMJ. 2009;338:b1024.
[3] Rigotti NA, Pipe AL, Benowitz NL, Arteaga C, Garza D, Tonstad S. Efficacy and safety of varenicline for smoking cessation in patients with cardiovascular disease: a randomized trial. Circulation. 2010;121:221-229.
[4] Ahmed AI, Ali AN, Kramers C, Härmark LV, Burger DM, Verhoeven WM. Neuropsychiatric adverse events of varenicline: a systematic review of published reports. J Clin Psychopharmacol. 2013;33:55-62
[5] Harrison-Woolrych M, Ashton J. Psychiatric adverse events associated with varenicline: an intensive postmarketing prospective cohort study in New Zealand. Drug Saf. 2011;34:763-772
[6] Harrison-Woolrych M, Maggo S, Tan M, Savage R, Ashton J. Cardiovascular events in patients taking varenicline: a case series from intensive postmarketing surveillance in New Zealand. Drug Saf. 2012;35:33-43
[7] Public Health Advisory: FDA Requires New Boxed Warnings for the Smoking Cessation Drugs Chantix and Zyban. FDA issued 07/01/2009.
Available at: Public Health Advisory: FDA Requires New Boxed Warnings for the Smoking Cessation Drugs Chantix and Zyban
[8] MHRA Commission on Human Medicines, Working Group on Nicotine Containing Products. 2013.
Available at: http://www.mhra.gov.uk/home/groups/comms-ic/documents/websiteresources/con286845.pdf
[9] Dockrell M, Morison R, Bauld L, McNeill A. E-Cigarettes: Prevalence and Attitudes in Great Britain. Nicotine Tob Res. 2013 May 23. [Epub ahead of print]
[10] Cahn Z, Siegel M. Electronic cigarettes as a harm reduction strategy for tobacco control: a step forward of a repeat of past mistakes? J Public Health Policy. 2011;32:16-31.
[11] Goniewicz ML, Knysak J, Gawron M, Kosmider L, Sobczak A, Kurek J, Prokopowicz A, Jablonska-Czapla M, Rosik-Dulewska C, Havel C, Jacob P 3rd, Benowitz N. Levels of selected carcinogens and toxicants in vapour from electronic cigarettes. Tob Control. 2013 Mar 6. [Epub ahead of print]
[12] Romagna G, Allifranchini E, Bocchietto E, Todeschi S, Esposito M, Farsalinos KE. Cytotoxicity evaluation of electronic cigarette vapor extract on cultured mammalian fibroblasts (ClearStream-LIFE): comparison with tobacco cigarette smoke extract. Inhal Toxicol. 2013;25:354-361.
[13] Farsalinos K, Tsiapras D, Kyrzopoulos S, Savvopoulou M, Avramidou E, Vassilopoulou D, Voudris V. Acute effects of using an electronic nicotine-delivery device (e-cigarette) on myocardial function: comparison with the effects of regular cigarettes. 2012, European Society of Cardiology. Available at: ESC | About the ESC | ESC Press Office | ESC Press Releases | Electronic cigarettes do not damage the heart
[14] Farsalinos K, Tsiapras D, Kyrzopoulos S, Stefopoulos C, Spyrou A, Tsakalou M, Avramidou E, Vasilopoulou D, Romagna G, Voudris V. Immediate effects of electronic cigarette use on coronary circulation and blood carboxyhemoglobin levels: comparison with cigarette smoking. 2013, European Society of Cardiology (accepted for presentation).
[15] Farsalinos K, Romagna G, Tsiapras S, Kyrzopoulos S, Voudris V. Evaluating Nicotine Levels Selection and Patterns of Electronic Cigarette Use in a Group of “Vapers” Who Had Achieved Complete Substitution of Smoking. Subst Abuse 2013 (in press).
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Thank you

Konstantinos Farsalinos, M.D.
Researcher, Onassis Cardiac Surgery Center, Athens Greece
Researcher, University Hospital Gathuisberg, Leuven, Belgium