The E-Cigarette Debate: What Counts as Evidence?

Amy Lauren Fairchild, PhD, MPH; Ronald Bayer, PhD; Ju Sung Lee, MHA

Disclosures

Am J Public Health. 2019;109(7):1000-1006. 

In This Article

Abstract and Introduction

Abstract

Two major public health evaluations of e-cigarettes—one from the National Academies of Science, Engineering, and Medicine (NASEM), the other from Public Health England (PHE)—were issued back to back in the winter of 2018. While some have read these analyses as broadly consistent, providing support for the view that e-cigarettes could play a role in smoking harm reduction, in every major respect, they come to very different conclusions about what the evidence suggests in terms of public health policy. How is that possible?

The explanation rests in what the 2 reports see as the central challenge posed by e-cigarettes, which helped to determine what counted as evidence. For NASEM, the core question was how to protect nonsmokers from the potential risks of exposure to nicotine and other contaminants or from the risk of smoking combustible cigarettes through renormalization. A precautionary standard was imperative, making evidence that could speak most conclusively to the question of causality paramount. For PHE, the priority was how to reduce the burdens now borne by current smokers, burdens reflected in measurable patterns of morbidity and mortality. With a focus on immediate harms, PHE turned to evidence that was "relevant and meaningful."

Thus, competing priorities determined what counted as evidence when it came to the impact of e-cigarettes on current smokers, nonsmoking bystanders, and children and adolescents. A new clinical trial demonstrating the efficacy of e-cigarettes as a cessation tool makes understanding how values and framing shape core questions and conclusive evidence imperative.

Introduction

In September 2018, the Food and Drug Administration (FDA) launched a $60 million campaign targeted at adolescents who had used or might be tempted to use e-cigarettes. Employing graphic imagery, the campaign depicts hideous worm-like creatures crawling under the skin and into the lungs and brains of otherwise blemish-free adolescents. The ads sound an urgent warning: "There is an epidemic spreading" and "vaping can put dangerous chemicals into your lungs" (Figure 1).[1] Nicotine itself is identified as the ultimate threat. The agency's "Don't Get Hacked" campaign evokes Reefer Madness, suggesting that nicotine triggers a kind of wild-eyed mania or personality hacking, in which nicotine transforms adolescents into robots that lack the autonomy or charm of a chatbot (Figure A, available as a supplement to the online version of this article at http://www.ajph.org). The approach was a muscular counter to e-cigarette advertising that blurred the boundary between an addictive product and candy or cereal (Figure 2).[2]

Figure 1.

The Food and Drug Administration's "An Epidemic Is Spreading" Antivaping Campaign
Source. Food and Drug Administration.1

Figure 2.

Gummy Bear E-Cigarette Advertisement
Source. Stanford University.2

Making this forceful challenge to e-cigarettes remarkable is that, when he took office, FDA Commissioner Scott Gottlieb announced a new approach to tobacco control. A continuum of risk would define FDA policy: products involving lesser harms should edge out deadly combustible products. In making this sharp turn, the FDA was responding not only to a perceived epidemic of youth vaping but also to an evidence review from the National Academies of Science, Engineering, and Medicine (NASEM) that it had commissioned.[3]

The FDA approach could not stand in sharper contrast with the Public Health England (PHE) strategy. For PHE, which has published its own reviews, the evidence provided additional support for a national policy in which e-cigarettes had become an official part of a campaign to address morbidity and mortality from tobacco smoking. In October 2017, England's expert national public health agency advised smokers, "stop smoking with an e-cigarette" (Figure 3). PHE has also produced guides on how to switch from smoking to vaping. Although we focused in this analysis on the divide that separates the United States and England, England is in fact a global outlier on the question of e-cigarettes. Australia's national science research agency, for example, has taken a very different stance and maintains a ban on nicotine sales.[4] Indeed, some have argued that, at its very origins, funds from the tobacco industry tainted the English conviction that people "smoke for the nicotine but die from the tar."[5,6] (p1431)

Figure 3.

Public Health England's 2017 Stoptober Campaign

Underpinning the 2 approaches are very different takes on the evidence. The 2 agencies issued their evaluations of the evidence nearly back to back in the winter of 2018. Some have read these analyses as broadly consistent, providing support for the view that e-cigarettes could play a role in smoking harm reduction. Yet, in every major respect, they come to very different conclusions about what the evidence suggests in terms of public health policy. The differences between the 2 reports turn on the profoundly important question of what should count as evidence for policymakers.

Fundamentally, the 2 reports differed on whose risk was to be given priority. For PHE, the central public health concern was how to protect the health of current smokers. For the United States, the pivotal issue was the protection of children and nonsmokers—innocent bystanders. The formulation of the questions and inclusion and exclusion criteria is always a value-based process. Understanding these different values is critical to mapping the politics of smoking harm reduction as debate intensifies about disruptive high-impact nicotine products like Juul,[7] which has been at the center of a storm of concern over youths, and heated tobacco products like the Philip Morris IQOS, which some suggest could help to lower toxicity standards in a way that could affect combustible products. The debate is bound to become ever more acrimonious now that Altria, the manufacturer of Marlboro, has acquired a substantial financial interest in Juul.

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