Managing nicotine without smoke to save lives now: Evidence for harm minimization
Introduction
We often attribute smoking's incredible toll on public health to tobacco products in general. However, the overwhelming majority of tobacco-related deaths are caused by inhaling lethal smoke chiefly from cigarettes as well as from all types of cigars, hookah, roll your own, pipes and bidis. In 2017, smoking prematurely killed over 7 million people worldwide.(World Health Organization, 2017) At this rate, over 1 billion premature deaths will accrue globally during the 21st century.(World Health Organization, 2008) In the United States (US), 530,000 smokers per year die prematurely, and about 16 million more smokers suffer debilitating chronic disease burdens (Centers for Disease Control and Prevention, 2017). Despite 50 years of concerted and successful tobacco control efforts to eliminate all tobacco products, the death caused by smoking persists at unacceptable levels (Abrams et al., 2015). Several endgame strategies have been proposed to stay the course, eliminate all tobacco use, and destroy the tobacco industry (Warner, 2013). The stay-the-course framework strives to protect non-users, especially youth at any costs, and also expects all smokers to quit in this Utopian vision of a world without nicotine. But the implementation of this endgame is slow, difficult to attain and remains unrealized.
There have been enormous changes in the tobacco and nicotine product landscape over the last decade, culminating in a fundamental re-thinking of the role of nicotine and tobacco in society. In July 2017, the US Food and Drug Administration (FDA) announced a new national comprehensive nicotine management strategy: “The FDA agency's new tobacco strategy has two primary parts: reducing the addictiveness of combustible cigarettes while recognizing and clarifying the role that potentially less harmful tobacco products could play in improving public health…The availability of potentially less harmful tobacco products could reduce risk while delivering satisfying levels of nicotine for adults who still need or want it [emphasis added].” (Gottlieb and Zeller, 2017) (p.1). Strategies to reduce the addictiveness of combustible tobacco products are discussed in detail elsewhere (Benowitz and Fraiman, 2017; Benowitz et al., 2017), but it is important to note that the two parts are complementary. Reduced risk noncombustible nicotine products (NNPs) can provide smokers with an alternative source of enjoyable nicotine and preferably some time before introducing a product standard for reducing addictiveness in combustibles to accelerate a mass-migration away from smoked tobacco/cigarettes (Benowitz et al., 2017; Benowitz, 2017).
The last 10 years have witnessed other unprecedented changes in the nicotine and tobacco product marketplace (Abrams, 2014a). New innovations in electronic cigarettes, heat-not-burn tobacco products and other substantially less harmful products are emerging. The world has not seen such technology-driven disruption in nicotine delivery since the 1880’s, with the invention of the cigarette rolling machine (Abrams et al., 2015; Brandt, 2007).
Another recent development is the emergence of the new field of tobacco and nicotine regulatory science (Wipfli et al., 2017; Ashley et al., 2014), which focuses on research directly relevant to informing policy and regulation of tobacco and nicotine products. Regulation of tobacco-derived nicotine (both medicinal cessation therapy and consumer products for adult recreational use) by the US FDA (U.S. Food and Drug Administration, n.d.) is now a critical part of any reframing of nicotine and tobacco use in society. In 2018, Public Health England (PHE) (McNeill et al., 2018) and the US National Academies of Sciences, Engineering and Medicine (NASEM) (National Academies of Sciences Engineering, and Medicine, 2018) updated and synthesized the science base. There was increasing convergence in the science with some differences in emphasis derived from different predisposing ideological conviction (i.e., stay-the-course or harm reduction) in the interpretation of some of the scientific data. Warner summarized differences as being possibly driven more by emotion rather than rationality in his Doll-Winder Public Health Theme Address: How to Think - Not Feel - about Tobacco Harm Reduction (Warner, 2018).
Rapid technological innovation in the nicotine and tobacco product marketplace, the new regulatory climate, and the stronger science focus is on maximizing benefits and minimizing harms for public health at a population level.
A troubling divisiveness has emerged about rethinking the tobacco control framework. When disruptive change occurs, diffusion of innovation (theory about how new technologies spread) involves multiple streams of influence (e.g., Kingdon's model where policy, politics, and problem focus converge in a “window of opportunity” (Kingdon, 2003)). During the early stages of responding to disruption, hypothetical fears about unknown consequences abound, coupled with an instinctive resistance to changing course (Kuhn, 2012; Abrams and Niaura, 2015). Over 400 years ago, Sir Francis Bacon warned about divisiveness based on prior ideological beliefs of the types being experienced by the tobacco/nicotine community today: (Bacon, 1960)
As scientific evidence accumulates, reason prevails over emotional attachment to prior preconceived ideology. Tobacco control's struggle with change is no different than in other fields.“The human understanding when it has once adopted an opinion draws all things else to support and agree with it. And though there be a greater number and weight of instances to be found on the other side, yet these it either neglects and despises, or else by some distinction sets aside and rejects, in order that by this great and pernicious predetermination the authority of its former conclusion may remain inviolate.”
Divisiveness and uncertainty aside, the opportunity lost by not changing course must also be considered. In light of the dramatic changes in the product landscape, by not taking some risks to speed the demise of deadly smoked tobacco, then worldwide over the next century the lives of a billion smokers are ultimately at stake. While all agree that saving lives from smoked tobacco is paramount, the tactics of how to move forward are unclear as long as the differences in the core underlying framework remain unresolved (McNeill et al., 2018; National Academies of Sciences Engineering, and Medicine, 2018). The deep question boils down to whether one can accept that NNPs are less harmful, can displace smoked tobacco and that the makers and marketers of NNPs can profit from a legal product provided they comply with reasonable rules of the road (e.g., are regulated, sell to adults only, do not sell or engage in marketing to underage youth). In the next sections we explore what specific frameworks and scientific evidence provide a roadmap for maximizing the benefits and minimizes the risks of NNPs.
Section snippets
Overview
In considering a new framework for harm minimization, some prior tobacco control strategies will be continued, others modified, and some abandoned as iatrogenic. For example, effective policies such as taxing cigarettes, smoke free indoor air laws and reimbursement of pharmacotherapies for cessation treatment would remain. But if smokers receive deceptive information about exaggerated NNP harms or that all products are harmful (absolute risk) without direct comparison to the much greater
Making a population impact: modeling state transitions to characterize benefits over harms
As stated previously, the core principle for the alignment of stakeholders is that regulatory, other strategies and tactics and communications are made proportional to the relative harms of each class of products and every NNP product is always compared with deadly smoking. The FDA's Center for Tobacco Products' public health standard implies an integrated consideration of product benefits and harms at the individual and population levels (including likelihoods of initiation and cessation).
Proactively communicating accurate, evidence-based information to the public
Public education must ensure consumers of nicotine containing products are accurately informed about differential harms compared to deadly smoking (relative risk) and not simply compared to no use (absolute risk) (Abrams et al., 2018). A related need is to sharpen the language describing similarities and differences between combustible and noncombustible tobacco and NNPs along the harm continuum. Because nicotine is primarily derived from the tobacco plant, legal definitions of tobacco products
Conclusions: reaffirming harm minimization and smoking control as the new tobacco control
Charting a new course in tobacco control via harm reduction must be seriously considered. Innovations in technology and accelerating adoption of NNPs have taken the “tobacco control” community, policymakers and cigarette companies by storm and surprise (Abrams, 2014a; Abrams et al., 2018). In many other areas, technological advances transform behaviors at the population level. New products consistently, although not always predictably, make old ones obsolete. In light of NNPs, which themselves
Disclosure statement
The authors are not aware of any affiliations, memberships, funding, or financial holdings that might be perceived as affecting the objectivity of this review.
Acknowledgments
ACV was supported by the Centers of Biomedical Research Excellence P20GM103644 award from the National Institute of General Medical Sciences. The content is solely the responsibility of the author and does not necessarily represent the official view of the National Institutes of Health.
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2022, SSM - Population HealthCitation Excerpt :It is widely acknowledged that minimizing tobacco-related harm at the population level depends not only on the degree of risk reduction of smoke-free tobacco and nicotine products (TNP), such as heated tobacco products and e-cigarettes, but also on their adoption by adults who would otherwise continue to smoke (Abrams et al., 2018; Beaglehole et al., 2019; Smith et al., 2016).