International Journal of Drug Policy 25 (2014) 1147–1148
Contents lists available at ScienceDirect
International Journal of Drug Policy journal homepage: www.elsevier.com/locate/drugpo
Viewpoint
Asking the wrong questions about e-cigarettes: The case for cautious classification夽 Stan Shatenstein ∗ Editor & Publisher, STAN Bulletin, Smoking & Tobacco Abstracts & News, 5492-B Trans Island, Montreal, QC, Canada H3W 3A8
Farsalinos and Stimson (2014) make an elaborate case for classifying electronic cigarettes (e-cigarettes) as conventional consumer products, not medications, but there is inadequate scientific underpinning for each of the claims they make, and they leave a multitude of questions begging. Do e-cigarettes (e-cigs) “exert physiological effects above or more intense from what is expected from. . . the use of common products” – the criterion Farsalinos and Stimson set for classifying e-cigs legally as medications? They must, or Farsalinos and colleagues, in a new IJERPH paper (Farsalinos, Romagna, Tsiapras, Kyrzopoulos, & Voudris, 2014), would not have found, in a survey of more than 19,000 e-cigarette users, complete substitution of smoking by 81.0% of participants. Although a user survey does not carry the scientific weight of a prospective study or a randomised controlled trial, any product that can lead 81% of even a self-selecting group of users to stop smoking is, by definition, uncommon. Farsalinos and Stimson criticise attempts to define e-cigarettes as tobacco products, yet admit themselves that the nicotine in ecigs “comes from tobacco leaves and is not produced synthetically.” The fact that “lower levels [of nicotine are] absorbed to the blood stream” makes merely a quantitative, not a qualitative difference. What is the basis for this ‘intensity’ criterion when the authors argue the nicotine in electronic cigarettes should only be considered a medication “if nicotine uptake and subsequent effects were much more intense compared to tobacco cigarettes”? The authors’ logic is similarly difficult to follow when discussing short-term and long-term use of e- cigarettes for the purpose of smoking cessation. In either case, smokers are, by their own accounts, trying to quit with the aid of e-cigarettes, just as they would with NRT (nicotine replacement therapy), bupropion, varenicline or any other method. Why does the availability of “a huge variety of devices” and the “search for more efficient and pleasing products” make any difference? There would be no interest or urgency in having e-cigarettes
DOI of original article: http://dx.doi.org/10.1016/j.drugpo.2014.03.003. 夽 The author is editor and publisher of an electronic bulletin devoted to smoking and health issues and a 2012 recipient of the American Cancer Society’s Luther L. Terry award for Outstanding Community Service in the field of tobacco control. ∗ Tel.: +1 514 486 1243. E-mail addresses: [email protected], [email protected] http://dx.doi.org/10.1016/j.drugpo.2014.07.017 0955-3959/© 2014 Elsevier B.V. All rights reserved.
available to the public unless they were plausibly posited as cessation tools. The authors repeat the assumption that e-cigarettes provide nicotine “from a less harmful product”. That seems logical, and may well prove to be true, but as they summarise the literature themselves, they must acknowledge that a product delivering a drug that is not innocuous (Eisenbud, 2013; Harte, 2014; Horne et al., 2014) in a delivery device that is not proven safe (Arkell, 2013) should have to hurdle the highest regulatory bars, not the lowest. The grave historical error in allowing cigarette marketing to flourish and the tobacco industry to thrive is no excuse for inadequate e-cigarette regulation. On the contrary, it is an incentive to ensure the best and safest possible regulatory environment. Farsalinos and Stimson note that the tobacco industry is heavily invested in e-cigarettes now, yet the authors still claim e-cigs “are mainly marketed by the industry as alternative-to-smoking products, and not as products having therapeutic properties or for treating smoking and nicotine addiction.” The best response to this argument is found in the Stanford School of Medicine library of ecigarette ads juxtaposed against those for conventional cigarettes. The marketing ploys and implicit health claims are near-identical and can only get worse without a rigorous regulatory framework, as already evidenced by a US congressional report on e-cigarette manufacturers targeting of youths (Durbin et al., 2014). If, as the authors admit, “there are no long-term studies evaluating whether electronic cigarette use has any beneficial health effects to humans”, then why the urgency to have them freely available on the open market and why their eagerness to classify them as “recreational consumer products”? What are the “requirements of everyday life” with which e-cigarettes are allegedly compatible? And what exactly is a “long-term consumer product. . . adjusted individually by each consumer according to his or her perceived pleasure and satisfaction” unless that’s a code phrase for self-titered drug use? Beyond all those limitations to the logic of their presentation, Farsalinos and Stimson fail to even discuss the biggest potential downsides of e-cigarettes, from the threat to secondhand smoke bans, to dual use, to tobacco product brand extension and marketing, as well as the renormalisation of smoking behaviour. Finally, the authors include a Conflict of Interest statement noting two types of support from e-cigarette manufacturers. This does
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S. Shatenstein / International Journal of Drug Policy 25 (2014) 1147–1148
not disqualify them from the right to issue a Commentary, but it is both remarkable and unusual to ever see researchers in the field of smoking and health mention “the positive experience of nicotine” and the “joy and pleasure” of cigarettes. One is always reminded at such times of Upton Sinclair’s dictum: “It is difficult to get a man to understand something, when his salary depends on his not understanding it.” Conflict of interest statement No conflict of interest. References Arkell, H. (2013, September). E-cigarette wrecked car when it EXPLODED ‘like a firework’ while being charged overnight leaving seats destroyed and windows blackened. Daily Mail,. London, UK. Accessed 23.04.14.
Durbin, R. J., Waxman, H. A., Harkin, T., Rockefeller, J. D., IV, Blumenthal, R., Markey, E. J., et al. (2014, April). Gateway to addiction? A survey of popular electronic cigarette manufacturers and targeted marketing to youth. In US Congress. http://www.durbin.senate.gov/public/index.cfm/files/serve/?File id=81d14ff7f2f6-4856-af9d-c20c0b138f8f Eisenbud, D. K. (2013, May). Toddler who ingested liquid nicotine passes away. Jerusalem Post,. Accessed 23.04.14. Farsalinos, K. E., & Stimson, G. V. (2014, March). Is there any legal and scientific basis for classifying electronic cigarettes as medications? International Journal of Drug Policy (Epub ahead of print). Farsalinos, K. E., Romagna, G., Tsiapras, D., Kyrzopoulos, D., & Voudris, V. (2014). Characteristics, perceived side effects and benefits of electronic cigarette use: A worldwide survey of more than 19,000 consumers. International Journal of Environmental Research and Public Health, 11(4), 4356–4373 (Published 22.04.14). Harte, C. B. (2014, March). Nicotine acutely inhibits erectile tumescence by altering heart rate variability. Urology (Epub ahead of print). Horne, A. W., Brown, J. K., Nio-Kobayashi, J., Abidin, H. B., Adin, Z. E., Boswell, L., et al. (2014). The association between smoking and ectopic pregnancy: Why nicotine is bad for your fallopian tube. PLOS ONE, 9(February (2)), e89400. Sinclair, U. I. (1935). Candidate for governor: And how I got licked. University of California Press.
Contents lists available at ScienceDirect
International Journal of Drug Policy journal homepage: www.elsevier.com/locate/drugpo
Viewpoint
Asking the wrong questions about e-cigarettes: The case for cautious classification夽 Stan Shatenstein ∗ Editor & Publisher, STAN Bulletin, Smoking & Tobacco Abstracts & News, 5492-B Trans Island, Montreal, QC, Canada H3W 3A8
Farsalinos and Stimson (2014) make an elaborate case for classifying electronic cigarettes (e-cigarettes) as conventional consumer products, not medications, but there is inadequate scientific underpinning for each of the claims they make, and they leave a multitude of questions begging. Do e-cigarettes (e-cigs) “exert physiological effects above or more intense from what is expected from. . . the use of common products” – the criterion Farsalinos and Stimson set for classifying e-cigs legally as medications? They must, or Farsalinos and colleagues, in a new IJERPH paper (Farsalinos, Romagna, Tsiapras, Kyrzopoulos, & Voudris, 2014), would not have found, in a survey of more than 19,000 e-cigarette users, complete substitution of smoking by 81.0% of participants. Although a user survey does not carry the scientific weight of a prospective study or a randomised controlled trial, any product that can lead 81% of even a self-selecting group of users to stop smoking is, by definition, uncommon. Farsalinos and Stimson criticise attempts to define e-cigarettes as tobacco products, yet admit themselves that the nicotine in ecigs “comes from tobacco leaves and is not produced synthetically.” The fact that “lower levels [of nicotine are] absorbed to the blood stream” makes merely a quantitative, not a qualitative difference. What is the basis for this ‘intensity’ criterion when the authors argue the nicotine in electronic cigarettes should only be considered a medication “if nicotine uptake and subsequent effects were much more intense compared to tobacco cigarettes”? The authors’ logic is similarly difficult to follow when discussing short-term and long-term use of e- cigarettes for the purpose of smoking cessation. In either case, smokers are, by their own accounts, trying to quit with the aid of e-cigarettes, just as they would with NRT (nicotine replacement therapy), bupropion, varenicline or any other method. Why does the availability of “a huge variety of devices” and the “search for more efficient and pleasing products” make any difference? There would be no interest or urgency in having e-cigarettes
DOI of original article: http://dx.doi.org/10.1016/j.drugpo.2014.03.003. 夽 The author is editor and publisher of an electronic bulletin devoted to smoking and health issues and a 2012 recipient of the American Cancer Society’s Luther L. Terry award for Outstanding Community Service in the field of tobacco control. ∗ Tel.: +1 514 486 1243. E-mail addresses: [email protected], [email protected] http://dx.doi.org/10.1016/j.drugpo.2014.07.017 0955-3959/© 2014 Elsevier B.V. All rights reserved.
available to the public unless they were plausibly posited as cessation tools. The authors repeat the assumption that e-cigarettes provide nicotine “from a less harmful product”. That seems logical, and may well prove to be true, but as they summarise the literature themselves, they must acknowledge that a product delivering a drug that is not innocuous (Eisenbud, 2013; Harte, 2014; Horne et al., 2014) in a delivery device that is not proven safe (Arkell, 2013) should have to hurdle the highest regulatory bars, not the lowest. The grave historical error in allowing cigarette marketing to flourish and the tobacco industry to thrive is no excuse for inadequate e-cigarette regulation. On the contrary, it is an incentive to ensure the best and safest possible regulatory environment. Farsalinos and Stimson note that the tobacco industry is heavily invested in e-cigarettes now, yet the authors still claim e-cigs “are mainly marketed by the industry as alternative-to-smoking products, and not as products having therapeutic properties or for treating smoking and nicotine addiction.” The best response to this argument is found in the Stanford School of Medicine library of ecigarette ads juxtaposed against those for conventional cigarettes. The marketing ploys and implicit health claims are near-identical and can only get worse without a rigorous regulatory framework, as already evidenced by a US congressional report on e-cigarette manufacturers targeting of youths (Durbin et al., 2014). If, as the authors admit, “there are no long-term studies evaluating whether electronic cigarette use has any beneficial health effects to humans”, then why the urgency to have them freely available on the open market and why their eagerness to classify them as “recreational consumer products”? What are the “requirements of everyday life” with which e-cigarettes are allegedly compatible? And what exactly is a “long-term consumer product. . . adjusted individually by each consumer according to his or her perceived pleasure and satisfaction” unless that’s a code phrase for self-titered drug use? Beyond all those limitations to the logic of their presentation, Farsalinos and Stimson fail to even discuss the biggest potential downsides of e-cigarettes, from the threat to secondhand smoke bans, to dual use, to tobacco product brand extension and marketing, as well as the renormalisation of smoking behaviour. Finally, the authors include a Conflict of Interest statement noting two types of support from e-cigarette manufacturers. This does
1148
S. Shatenstein / International Journal of Drug Policy 25 (2014) 1147–1148
not disqualify them from the right to issue a Commentary, but it is both remarkable and unusual to ever see researchers in the field of smoking and health mention “the positive experience of nicotine” and the “joy and pleasure” of cigarettes. One is always reminded at such times of Upton Sinclair’s dictum: “It is difficult to get a man to understand something, when his salary depends on his not understanding it.” Conflict of interest statement No conflict of interest. References Arkell, H. (2013, September). E-cigarette wrecked car when it EXPLODED ‘like a firework’ while being charged overnight leaving seats destroyed and windows blackened. Daily Mail,. London, UK. Accessed 23.04.14.
Durbin, R. J., Waxman, H. A., Harkin, T., Rockefeller, J. D., IV, Blumenthal, R., Markey, E. J., et al. (2014, April). Gateway to addiction? A survey of popular electronic cigarette manufacturers and targeted marketing to youth. In US Congress. http://www.durbin.senate.gov/public/index.cfm/files/serve/?File id=81d14ff7f2f6-4856-af9d-c20c0b138f8f Eisenbud, D. K. (2013, May). Toddler who ingested liquid nicotine passes away. Jerusalem Post,. Accessed 23.04.14. Farsalinos, K. E., & Stimson, G. V. (2014, March). Is there any legal and scientific basis for classifying electronic cigarettes as medications? International Journal of Drug Policy (Epub ahead of print). Farsalinos, K. E., Romagna, G., Tsiapras, D., Kyrzopoulos, D., & Voudris, V. (2014). Characteristics, perceived side effects and benefits of electronic cigarette use: A worldwide survey of more than 19,000 consumers. International Journal of Environmental Research and Public Health, 11(4), 4356–4373 (Published 22.04.14). Harte, C. B. (2014, March). Nicotine acutely inhibits erectile tumescence by altering heart rate variability. Urology (Epub ahead of print). Horne, A. W., Brown, J. K., Nio-Kobayashi, J., Abidin, H. B., Adin, Z. E., Boswell, L., et al. (2014). The association between smoking and ectopic pregnancy: Why nicotine is bad for your fallopian tube. PLOS ONE, 9(February (2)), e89400. Sinclair, U. I. (1935). Candidate for governor: And how I got licked. University of California Press.
