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Electronic nicotine delivery systems: a research agenda
  1. Jean-François Etter1,
  2. Chris Bullen2,
  3. Andreas D Flouris3,
  4. Murray Laugesen4,
  5. Thomas Eissenberg5
  1. 1Institute of Social and Preventive Medicine, Faculty of Medicine, University of Geneva, Geneva, Switzerland
  2. 2Clinical Trials Research Unit, Faculty of Medical and Health Science, University of Auckland, Auckland, New Zealand
  3. 3FAME Laboratory, Institute of Human Performance and Rehabilitation, Centre for Research and Technology Thessaly, Trikala, Greece
  4. 4Health New Zealand Ltd., Christchurch, New Zealand
  5. 5Department of Psychology and Institute for Drug and Alcohol Studies, Virginia Commonwealth University, Richmond, Virginia, USA
  1. Correspondence to Jean-François Etter, Institute of social and preventive medicine, University of Geneva, CMU, case postale, CH-1211 Geneva 4, Switzerland; jean-francois.etter{at}unige.ch
  • Competing interests CB's salary is paid by The University of Auckland and his research is supported by grants from the New Zealand Health Research Council (HRC), the University of Auckland and the NZ Heart Foundation. He has previously undertaken tobacco control research supported by the New Zealand Ministry of Health, and by Niconovum, Sweden, prior to the purchase of this company by RJ Reynolds. He is currently an investigator on a study involving reduced nicotine cigarettes in which the products were purchased by the University of Auckland from Vector Group Ltd, US. He has previously undertaken research on ENDS funded by HealthNZ, in which the study products were supplied by Ruyan, Hong Kong; and he is the principal investigator on an HRC-funded efficacy trial of ENDS that will use products provided by a NZ-based ENDS retailer. Other than these relationships, he has no conflicts of interest to declare. TE's salary is paid by Virginia Commonwealth University and his research is supported by grants from the US National Institutes of Health (R01CA103827 and R01CA120142). In the past he has served as a paid consultant to the National Association of Attorneys General regarding litigation against a tobacco company. He has served as an expert consultant for the World Health Organization regarding ENDS. Also, he has been retained by the US FDA as a consultant but, as of this writing, has not served in this capacity in any way and has received no payment from the FDA. Other than these relationships, he has no conflicts of interest to declare. J-FE's salary is paid by the University of Geneva. He has served as an unpaid expert consultant for the World Health Organization regarding ENDS, and as a paid consultant for Pfizer, a manufacturer of smoking cessation medications, in 2006–2007 (on the Swiss varenicline advisory board). The University of Geneva received trial medications from Pfizer in 2006 for a study conducted by J-FE. No competing interest since then. AF has no competing interests to declare. ML has researched various nicotine products including ENDS for several firms and universities, and advised several distributors, but has no financial interest in any of these.

Abstract

Electronic nicotine delivery systems (ENDS, also called electronic cigarettes or e-cigarettes) are marketed to deliver nicotine and sometimes other substances by inhalation. Some tobacco smokers report that they used ENDS as a smoking cessation aid. Whether sold as tobacco products or drug delivery devices, these products need to be regulated, and thus far, across countries and states, there has been a wide range of regulatory responses ranging from no regulation to complete bans. The empirical basis for these regulatory decisions is uncertain, and more research on ENDS must be conducted in order to ensure that the decisions of regulators, health care providers and consumers are based on science. However, there is a dearth of scientific research on these products, including safety, abuse liability and efficacy for smoking cessation. The authors, who cover a broad range of scientific expertise, from basic science to public health, suggest research priorities for non-clinical, clinical and public health studies. They conclude that the first priority is to characterize the safety profile of these products, including in long-term users. If these products are demonstrated to be safe, their efficacy as smoking cessation aids should then be tested in appropriately designed trials. Until these studies are conducted, continued marketing constitutes an uncontrolled experiment and the primary outcome measure, poorly assessed, is user health. Potentially, this research effort, contributing to the safety and efficacy of new smoking cessation devices and to the withdrawal of dangerous products, could save many lives.

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Footnotes

  • Provenance and peer review Not commissioned; externally peer reviewed.

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