Ηλεκτρονικό τσιγάρο: µύθοι και πραγµατικότητα

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1 Πανελλήνια Σεµινάρια Οµάδων Εργασίας Ιωάννινα Φεβρουάριος 2015 Ηλεκτρονικό τσιγάρο: µύθοι και πραγµατικότητα Βασιλική Ν. Γιαννακοπούλου MD, Phds, FESC, FEAS Διευθ. ΕΣΥ Θριάσιο Νοσοκοµείο Συνεργάτης Λιπιδαιµικού Ιατρείου ΩΚΚ

2 Δεν υπάρχει σύγκρουση συµφερόντων

3 Tobacco Kills More Americans/year Than Alcohol, Cocaine, Crack, Heroin, Homicide,

4 Tobacco Kills More Americans/year Than Alcohol, Cocaine, Crack, Heroin, Homicide,

5 Το ηλεκτρονικό τσιγάρο αποτελείται: 1. Ένα πλαστικό σωλήνα, που περιέχει µια επαναφορτιζόµενη µπαταρία λιθίου 2. Ένα ηλεκτρονικό θερµαντήρα/ρυθµιστή 3. Ένα δοχείο ψεκασµού (atomizer) µε µεµβράνη συγκράτησης των συστατικών 4. Ένα φυσίγγιο (cartridge) µιας χρήσης µε διάλυµα νικοτίνης/µη νικοτινούχων ουσιών 5. Στο µπροστινό τµήµα έχει τοποθετηµένη µια δίοδος / λυχνία LED, που παράγει κόκκινο φως, που παροµοιάζει µε καύτρα αναµµένου τσιγάρου 6. Το πίσω τµήµα είναι διαµορφωµένο σε επιστόµιο

6 Τι περιέχει?! Το υγρό αναπλήρωσης του φυσιγγίου µιας χρήσης περιέχει νικοτίνη (σε ποικίλη συγκέντρωση από 0-16 mg), χηµικά πρόσθετα και καρυκεύµατα (π.χ. αρωµατικό σοκολάτας, µέντας, καφέ, φρούτων κλπ.). Τα χηµικά πρόσθετα είναι συνήθως προπυλενογλυκόλη (propylene Glycol- PG) ή φυτική γλυκερίνη (vegetable glycerin). Τα ηλεκτρονικά τσιγάρα είναι σχεδιασµένα να ξαναγεµίζουν είτε µε υγρό αναπλήρωσης είτε µε νέα φυσίγγια που περιέχουν το κατάλληλο υγρό αναπλήρωσης

7 ! Myosamine! Anabasine! β-nicotyrine Επικίνδυνα για τον άνθρωπο!amino-tadafanil Ανάλογο του cialis & του rimonabant! Nitrosamines Καρκινογόνες! Glycol Τοξική σε δόσεις

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10 History! It was first patented by Herbert A. Gilbert in 1963 described as "a smokeless non-tobacco cigarette" (replacing burning tobacco and paper with heated, moist, flavored air heated the nicotine solution and produced steam)! In 1967, was approached by several companies interested in manufacturing it, but it was never commercialized and disappeared from the public record after 1967! In 2003 Hon Lik, (Chinese pharmacist), is widely credited with the invention of the 1st generation e-cigarette! 2004 introduced to the Chinese domestic market by Golden Dragon Holdings renamed Ruyan! In started exporting its products before receiving its first international patent in 2007 (1 st in 2004 in

11 ! On 19 December 2012 the European Commission adopted its proposal to revise the European Union Tobacco Products Directive 2001/37/EC which included proposals to introduce restrictions on the use and sales of e-cigarettes! On 8 October 2013 the European Parliament in Strasbourg voted down the Commission's proposal to introduce medical regulation for e-cigarettes, but proposed that cross-border marketing of e-cigarettes be regulated similarly to tobacco products, meaning that sales of e-cigarettes to under 18s would be prohibited in the European Union, along with most cross-border advertising! Warning labels also would be required

12 ! In Austria nicotine-containing cartridges are classified as medicinal products & e-cigarettes for nicotine inhalation as medical devices! In Bulgaria, Czech Republic, Hungary, Germany, Ireland, Latvia, Lithuania, Poland, Romania, are legal! In Danemark, Netherlands, Finland, Italy, Switzerland, and in the United Kingdom there are controversies! The FDA classified electronic cigarettes as drug delivery devices and subject to regulation under the Food, Drug, and Cosmetic Act (FDCA) before importation and sale in the USA. The classification was challenged in court, and overruled in January 2010 by Federal District Court Judge Richard J. Leon, citing that "the devices should be regulated as tobacco products rather than drug or medical products

13 ! In Australia, the Federal Department of Health & Ageing classifies every form of nicotine, except for replacement therapies, as a form of poison in April 2014 Western Australia made it illegal! In Brazil, Mexico, Panama, Singapore, Turkey & United Arab Emirates is forbidden! In Hong Kong the sale and possession of nicotine-based e- cigarettes, classified as a Type I Poison! In South Korea, Nepal, Pakistan, Malaysia, Lebanon, Israel, India, Japan, Egypt have no clarified guidelines! In China is legal

14 Regulation! In February 2014 the EU Tobacco Products Directive was passed by the European Parliament. E-cigarettes containing up to 20 mg/ml come under the TPD. Above that level, or where medicinal claims are made they come under medicines regulation! Once the TPD comes into force, which is expected to be in the mid 2016 Member States will have two years to transpose the new rules into national law! Until then e-cigarettes not licenced as medicines will continue to be subject to general consumer protection Iaw and it is the responsibility of trading standards officers to rule on their safety

15 Deficiencies in declaration of liquid ingredients Evidence in 2012: For some liquids the nicotine content declared on the bottle differed markedly from the effective nicotine in the liquid. Some bottles contained more and some less nicotine than declared. New findings in 2013/2014: There is still debate on the nicotine content and the nicotine declaration on the bottles. In two studies, for most of the liquids analysed, the nicotine content and declaration corresponded quite well. Other groups found marked differences between measured and declared nicotine concentrations; in several cases the cartridges contained more nicotine than declared.

16 Findings 1: Many surveyed e-cig companies are promoting their products through sponsorship of youth-oriented events, and some companies are offering free samples of e-cig 2: Surveyed e-cig companies market them in flavors that appear to be designed to appeal to youth 3: E-cig are available for purchase in stores and online by children and teenagers 4: Surveyed e-cig manufacturers have significantly increased marketing expenditures (>59 millions $) 5: Many surveyed e-cig companies air television & radio advertisements, often with celebrity spokespeople, including during events & programs 6: Surveyed e-cig companies extensively utilize social media & product websites to promote their products 7: E-cig product warning labels lack uniformity and may confuse or mislead consumers

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23 CDC (Center for Disease Control & Prevention)! The nr of high school students who use e-cig was doubled in 2012 (2011: 4,7% to 10%)! The nr of middle school students >20%! About 1.78 million U.S. students had tried e-cig in 2012! 2 billion $ from the sales of e-cig which are sold under 200 brand names in 2013

24 Ash.briefing action on smoking & health March 2014

25 Reasons for trying e-cigarettes among Montana adults (>5000 participants) Montana Adult Tobacco Survey, Nov 2013

26 Characteristics, Perceived Side Effects & Benefits of E-cig Use: A Worldwide Survey of More than Results: 19,414 participants were included (0.5% reported not being smokers at the time of E-cig use initiation) Complete substitution of smoking was reported by 81.0% of participants (former smokers) Current smokers had reduced smoking consumption from 20 to 4 cig./day (using ECs for a median of 10 months), initiated EC use with a median of 18 mg/ml nicotine-concentration liquids; 21.5% >20 mg/ml. Only 3.5% were using 0-nicotine liquids The most important reasons for initiating EC use for both subgroups was to reduce the harmassociated with smoking and to reduce exposure of family members to second-hand smoking. Most considered ECs as less harmful than tobacco cigarettes, while 11.0% considered them absolutely harmless Side effects were reported by more than half of the participants (59.8%), with the most common being sore/dry mouth and throat; side effects were mild and in most cases were subsequently resolved (partially or completely). Participants experienced significant benefits in physical status and improvements in pre-existing disease conditions (including respiratory disease such as asthma and chronic obstructive lung disease). Being former smoker was independently associated with positive effects in health and improvements in disease conditions Int. J. Environ. Res. Public Health 22 April 2014

27 Conclusions: The results of this worldwide survey of dedicated users indicate that ECs are mostly used to avoid the harm associated with smoking. They can be effective even in highly-dependent smokers and are used as long-term substitutes for smoking. High levels of nicotine are used at initiation; subsequently, users try to reduce nicotine consumption, with only a small minority using non-nicotine liquids. Side effects are minor and health benefits are substantial, especially for those who completely substitute smoking with EC use. Further population and interventional studies are warranted. Int. J. Environ. Res. Public Health 22 April 2014 Onassis Cardiac Surgery Center Greece, Biol & Chem. Tox.Research Inst. Italy

28 Pasquale Caponnetto et al PLoS ONE June 2013

29 Pasquale Caponnetto et al PLoS ONE June 2013

30 Pasquale Caponnetto et al PLoS ONE June 2013

31 10% 8% Pasquale Caponnetto et al PLoS ONE June 2013

32 Electronic cigarettes for smoking cessation: a randomised controlled trial Christopher Bullen, et al Auckland, New Zealand Lancet 6 September 2013 " 657 participants 18years " 289 used e-cig (A)--295 patches (B)--73 placebo e-cig (C) " Follow up for 6 months (September 2011-July 2013) " Verified abstinence:7,3% in (A)--5,8% in (B)--4,1% in (C) " Adverse events: 137 in (A) in (B)---36 in (C)

33 Christopher Bullen et al Lancet Sept. 2013

34 The statement of AACR and ASCO (American Association for Cancer Research--American Society of Clinical Oncology)! "We are concerned that e-cigarettes may encourage nonsmokers, particularly children, to start smoking and develop nicotine addiction. While e-cigarettes may reduce smoking rates and attendant adverse health risks, we will not know for sure until these products are researched and regulated"! "The FDA has signaled its willingness to regulate e-cigarettes and other electronic nicotine delivery systems, and we urge the agency to follow through on this intention" Clinical Cancer Research Journal of Clinical Oncology. January 08, 2015

35 ! The FDA should regulate all ENDS that meet the statutory definition of tobacco products! Manufacturers should be required to register with the FDA and report all product and ingredient listings, as well as the nicotine concentration in the ENDS solution! Packaging and advertising should be required to carry safety labels that include a warning about nicotine addiction! All ENDS advertising and marketing targeted at youth should be prohibited! Internet and other mail-order sellers of ENDS should

36 ! ENDS and ENDS liquid containing candy, along with other products aimed at youth, should be banned, unless evidence is produced that they do not encourage use by this population! Use should be prohibited in places where federal, state, or local law prohibit combustible tobacco products until the safety of secondhand aerosol exposure is established! Funding generated through tobacco product taxes, including any potential taxes levied on ENDS, should be used to help support research on ENDS and other tobacco products

37 ΠΡΟΤΑΣΕΙΣ ΕΚΕ <Προς τον ΕΟΦ ( ) υπ αριθµ / >! Απαιτούνται περαιτέρω ανεξάρτητες πολυκεντρικές τυχαιοποιηµένες µελέτες! Δεδοµένης της αβεβαιότητας στις κανονιστικές διατάξεις αν τα e-cig πρέπει να θεωρούνται προϊόντα καπνού εάν περιέχουν νικοτίνη ή ως συµπλήρωµα υγείας χρήσιµα για το µετριασµό ή τη διακοπή του καπνίσµατος εφ όσον δεν περιέχουν προϊόντα καπνού και της ασφάλειας της χρήσης των, συνιστάται η διακοπή εισαγωγής, διανοµής και πώλησης των προϊόντων αυτών! Έως ότου υπάρξει σαφής απόδειξη της ασφάλειας και της δραστικότητας των ηλεκτρονικών τσιγάρων, συνιστάται να σταµατήσει κάθε δραστηριότητα διαφήµισης

38 ! Συνιστάται να σταµατήσει η χρήση ηλεκτρονικών τσιγάρων σε περιοχές µη καπνιζόντων! Θα πρέπει να ξεκινήσουν καµπάνιες από το Υπουργείο Υγείας και Κοινωνικής Αλληλεγγύης, την ιατρική κοινότητα, µη κυβερνητικούς οργανισµούς προκειµένου να ενηµερωθεί σωστά ο πληθυσµός σχετικά για τα e-cig! Ιατροί, νοσηλευτές, προσωπικό ιατρείων ή κλινικών διακοπής του καπνίσµατος, δάσκαλοι και άλλα άτοµα, τα οποία έχουν την ευκαιρία επαφής µε καπνιστές, που επιθυµούν να διακόψουν το κάπνισµα, να αποθαρρύνουν τη χρήση e-cig ως µεθόδου µετριασµού, διακοπής /πρόληψης της υποτροπής του καπνίσµατος, έως ότου υπάρξουν σαφείς ερευνητικές και κλινικές αποδείξεις του ισχυρισµού αυτού! Ιδιαίτερα θα πρέπει να αποθαρρύνεται η χρήση των ηλεκτρονικών τσιγάρων από τα νέα άτοµα

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