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jeudi 22 octobre 2020

Ma contribution critique au brouillon du rapport sur la vape du Comité Scientifique de l'UE (SCHEER)


Le Comité scientifique de la Commission européenne (SCHEER) a publié la version préliminaire de son rapport sur le vapotage dans le contexte de l’Union Européenne et de sa directive TPD. Il est possible à « toutes parties concernées » de soumettre une contribution à ce brouillon sur le site de la Commission. Les règles de soumission sont assez peu incitatrices à participer, pourtant il serait important et précieux pour les autorités européennes d’avoir un avis de bien meilleure qualité scientifique que cette première version. Pour participer, la date limite est lundi 26 octobre à minuit. Ne faites pas de copier/coller de mon avis (mais vous pouvez vous inspirer des idées qui vous semblent pertinentes). 

Je partage ici seulement ma contribution sur le résumé court (abstract). J’ai également commenté d’autres parties du brouillon de rapport, sans être exhaustif. Les éléments du rapport étant assez répétitifs, je doute qu’il soit intéressant de lire l’ensemble, mais si vous voulez, demandez-moi par mail. 

Quelques autres commentaires : Alistair a écrit une opinion pertinente à la sortie du brouillon du SCHEER sur Vaping Post ;  Clive Bates a publié sur son blog une critique de fond, et son message au SCHEER ; et Christopher Snowdon a aussi commenté le sujet hier sur son blog.

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We welcome SCHEER’s efforts to assess the topic of vaping in the context created by the TPD in the EU, prior to possible discussions on its revision. However this draft report fails to provide an adequate assessment in the European context on several points:

1) It does not make a relative risk assessment between vaping and cigarettes when almost all vaping users in the EU are or have been smokers (McNeill, 2018 ; Farsalinos 2016);

2) A large part of the studies cited concern products from outside the EU market; or, do not distinguish between uses with or without nicotine (or otherwise); and come from regulatory context radically different from that created by the TPD;

3) Some important European studies are not reviewed;

4) Another gap in relation to its mandate, the SCHEER draft never addresses the impact of regulations and/or actions of authorities on the issues addressed (Hua-Hie Yong, 2017 ; Ward, 2020).

It would have been desirable the Scientific Committee analysed risks produced by the different national implementations:

  • evolution of smoking prevalence and evolution of the risks linked, between country tolerant to vaping, e.g. France, and country stigmatising vaping, e.g. Spain;
  • the effects of ban flavours and high taxes, e.g. Estonia, and the risks associated with the creation of a vast black market out of control.

On the abstract text itself, we note:

[p. 2 l. 14] The data presented in the report do not seem to allow asserting strong evidence of systemic cardiovascular effects (Benowitz, 2016 ; Shahab, 2017).

[p.2 l.16] & [p.2 l.37] Data for products marketed under the TPD regime, which is the subject of this report, cannot support a carcinogenic risk by nitrosamine accumulation. Nicotine used in the EU is a highly purified grade (TPD art. 20 §3.d, 2014). This point indicates a more general confusion in the heterogeneous data used by the SCHEER, who does not seem to have discriminated the relevant data for specific European situation created by TPD.

 [p. 2 l. 42 ss] The gateway hypothesis is not supported by the evidence presented in this report. The studies presented suffer from critical problems, including a lack of consideration of the risk co-factor of parental smoking and friends smoking, high attrition bias, etc. (Chan et al. 2020). The main meta-analysis presented has authors’ self-report bias. The scientific criteria for validating a causal hypothesis as the gateway theory are not met (Etter, 2017). More robust European studies, notably the OFDT study in France, show effects incompatible with this hypothesis (Chyderiotis, 2019). All this chapter and conclusion need to be completely revised.

[p. 2 l. 49 ss.] Many data were not included in the report. Cochrane review found 50 clinical studies and conclude to moderate-certainty evidence vaping with nicotine increase quit rate compared to NRT (Hartmann-Boyce, 2020). Preliminary results from other clinical studies (Eisenberg, ACC.20) are in the same direction. Santé Publique France has demonstrated that at least 700,000 people have quit smoking in a consolidated way thanks to vaping before 2017 (Pasquereau, 2017). Based on the Eurobarometer 429, an estimated 6 million EU citizens had quit with the help of vaping in 2014 (Farsalinos, 2016). The Smoking Toolkit Study showed that smoking cessation increased by ~70,000 net additional successful quitters thanks to vaping in 2017 in England (ASH, 2020). etc.

We recommend a thorough and rigorous revision of the draft report before its transmission to the Commission.

Les références de ce commentaire:

McNeill, A., Brose, L.S., Calder, R., Bauld, L. and Robson, D. (2018). Evidence review of e-cigarettes and heated tobacco products. Public Health England, London, UK https://www.gov.uk/government/news/phe-publishes-independent-expert-e-cigarettes-evidence-review

Farsalinos, K. E., et al. (2016). "Electronic cigarette use in the European Union: analysis of a representative sample of 27 460 Europeans from 28 countries." Addiction 111(11). https://onlinelibrary.wiley.com/doi/abs/10.1111/add.13506

Yong HH, Hitchman SC, Cummings KM, et al. Does the Regulatory Environment for E-Cigarettes Influence the Effectiveness of E-Cigarettes for Smoking Cessation?: Longitudinal Findings From the ITC Four Country Survey. Nicotine Tob Res. 2017;19(11):1268-1276. doi:10.1093/ntr/ntx056 https://www.ncbi.nlm.nih.gov/pmc/articles/PMC5896424/

Ward E, Anholt C, Gentry S, Dawkins L, Holland R, Notley C. A Qualitative Exploration of Consumers’ Perceived Impacts, Behavioural Reactions, and Future Reflections of the EU Tobacco Products Directive (2017) as Applied to Electronic Cigarettes. Tobacco Use Insights. January 2020. doi:10.1177/1179173X20925458 https://journals.sagepub.com/doi/full/10.1177/1179173X20925458

Benowitz, N. L., & Burbank, A. D. (2016). Cardiovascular toxicity of nicotine: Implications for electronic cigarette use. Trends in cardiovascular medicine, 26(6), 515–523. https://doi.org/10.1016/j.tcm.2016.03.001

Shahab, L, Goniewicz, ML, Blount, BC, et alNicotine, carcinogen, and toxin exposure in long-term e-cigarette and nicotine replacement therapy users. Ann Intern Med. 2017;166:390-400https://doi.org/10.7326/M16-1107 

Gateway or common liability? A systematic review and meta‐analysis of studies of adolescent e‐cigarette use and future smoking initiation. Gary C. K. Chan  Daniel Stjepanović  Carmen Lim  Tianze Sun  Aathavan Shanmuga Anandan  Jason P. Connor  Coral Gartner  Wayne D. Hall  Janni Leung - First published: 04 September 2020 https://doi.org/10.1111/add.15246

Gateway effects and electronic cigarettes, JeanFrançois Etter, Addiction, vol. 113 issue 10, 2018 https://doi.org/10.1111/add.13924

Sandra Chyderiotis, Tarik Benmarhnia, François Beck, Stanislas Spilka, Stéphane Legleye, Does e-cigarette experimentation increase the transition to daily smoking among young ever-smokers in France?, Drug and Alcohol Dependence, Volume 208, 2020, https://doi.org/10.1016/j.drugalcdep.2020.107853.

Hartmann-Boyce J, McRobbie H, Lindson N, Bullen C, Begh R, Theodoulou A, Notley C, Rigotti NA, Turner T, Butler AR, Hajek P. Electronic cigarettes for smoking cessation. Cochrane Database of Systematic Reviews 2020, Issue 10. Art. No.: CD010216. DOI: 10.1002/14651858.CD010216.pub4. https://www.cochrane.org/CD010216/TOBACCO_can-electronic-cigarettes-help-people-stop-smoking-and-do-they-have-any-unwanted-effects-when-used

E-cigarettes more effective than counseling alone for smoking cessation, AMERICAN COLLEGE OF CARDIOLOGY, march 2020, https://www.eurekalert.org/pub_releases/2020-03/acoc-eme033020.php

Pasquereau A, Quatremère G, Guignard R, Andler R, Verrier F, Pourchez J, Richard JB, NguyenThanh V. Baromètre de Santé publique France 2017. Usage de la cigarette électronique, tabagisme et opinions des 1875 ans. SaintMaurice : Santé publique France, 2019. https://www.researchgate.net/publication/337542002_USAGE_DE_LA_CIGARETTE_ELECTRONIQUE_TABAGISME_ET_OPINIONS_DES_18-75_ANS_Barometre_de_Sante_publique_France_2017

Action on Smoking and Health (ASH) Use of e-cigarettes (vapes) amoong adults in Great Britain, 2020 https://ash.org.uk/wp-content/uploads/2020/10/Use-of-e-cigarettes-vapes-among-adults-in-Great-Britain-2020.pdf 

Romain Dusautoir, Gianni Zarcone, Marie Verriele, Guillaume Garçon, Isabelle Fronval, Nicolas Beauval, Delphine Allorge, Véronique Riffault, Nadine Locoge, Jean-Marc Lo-Guidice, Sébastien Anthérieu : Comparison of the chemical composition of aerosols from heated tobacco products, electronic cigarettes and tobacco cigarettes and their toxic impacts on the human bronchial epithelial BEAS-2B cells, Journal of Hazardous Materials, Volume 401, 2021, https://doi.org/10.1016/j.jhazmat.2020.123417


1 commentaire :

  1. C'est bien qu'il y ait eu des contributions critiques mais évidemment c'est loin de suffire car le processus lui même est fortement biaisé et sous contrôle bureaucratique qui se fiche pas mal des gens qui ne sont pas de l'avis de leur commission. Les décisions sont prises par les politiques: c'est eux/elles qu'il faut convaincre et 'influencer', probablement une par une, de préférence par une approche personnalisée. Qui connaît une députée européenne, des assistants parlementaires, etc? A quand une enquête contre-rapport disponible dans différentes langues (pas seulement anglais) et largement diffusé? Combien de porte-paroles efficaces? etc. Bien entendu toujours merci pour ton énorme travail mais il en faut davantage avec une communication élargie et mieux organisée.

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