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E-Cigarettes, Harm Reduction, and Tobacco Control

A Path Forward?
Published:January 22, 2021DOI:https://doi.org/10.1016/j.mayocp.2020.11.022

      Abbreviations and Acronyms:

      EVALI (E-cigarette or vaping product use-associated lung injury), FDA (Food and Drug Administration), MRTP (modified-risk tobacco products), NIH (National Institutes of Health), NRT (nicotine-replacement therapy), PMTA (pre-market tobacco product application)
      The 34th Surgeon General’s Report on Smoking and Health, published early in 2020, prominently noted that prevalence of cigarette smoking among US adults has declined from nearly 43% in 1964, to a low of 14% in 2018. This represents the smallest percentage of adult smokers in the United States since just after World War I, a century ago, and has resulted in saving millions of lives and debilitating illnesses.
      US Department of Health and Human Services
      Smoking Cessation: A Report of the Surgeon General.
      These findings should be cause for celebration of what is, without doubt, one of the greatest public health achievements of the past century. Driven by the collaborative efforts of clinicians, scientists, public health experts, political and policy advocates, and advocacy organizations, the magnitude of progress and the long-term trends of declining smoking prevalence made the demise of cigarette smoking seem almost inevitable. In fact, the 2014 Surgeon General’s Report suggested that we might be entering the era of “the tobacco endgame,” a period of exceedingly low prevalence of adult smoking and little-to-no uptake of smoking by youth and young adults.
      US Department of Health and Human Services
      The Health Consequences of Smoking—50 Years of Progress: A Report of the Surgeon General.
      Progress, however, may be in danger of stalling. Instead of celebration and continued collaboration, the tobacco-control community finds itself bogged down in an extended conflict, often quite vitriolic, pitting former allies against each other, splitting public health into factions, seeing the same data interpreted differently, and putting future progress in ending the use of combusted tobacco at risk.
      • Fairchild A.L.
      • Bayer R.
      • Lee J.S.
      The e-cigarette debate: what counts as evidence?.
      • Pisinger C.
      • Dagli E.
      • Filippidis F.T.
      • et al.
      ERS and tobacco harm reduction.
      • Britton J.
      • George J.
      • Bauld L.
      • et al.
      A rational approach to e-cigarettes: challenging ERS policy on tobacco harm reduction.
      • Harvard T.H.
      Chan School of Public Health. The e-cigarette dilemma: a public health perspective. 2019.
      • Glynn T.J.
      E-cigarettes and the future of tobacco control.
      • Cummings K.M.
      • Hammond D.
      E-cigarettes: striking the right balance.
      • Fairchild A.
      • Healton C.
      • Curran J.
      • Abrams D.
      • Bayer R.
      Evidence, alarm, and the debate over e-cigarettes.
      • Baker T.B.
      • Fiore M.C.
      What we do not know about e-cigarettes is a lot.

      Harm Reduction

      The immediate precipitating factor in this conflict has been the introduction of the e-cigarette in the United States in 2007.
      • Nguyen D.
      • Aamodt G.
      Electronic cigarettes the past, present and future: the history of e-cigarettes.
      (The term e-cigarette in this article refers generically to the multiple electronic nicotine-delivery devices that deliver inhaled aerosol by heating liquid, usually containing nicotine.) But e-cigarettes are really only representative of the larger concept fueling this debate, the public health approach known as “harm reduction,” generally considered to be an approach to risky behavior that prioritizes minimizing the damage from that behavior, rather than eliminating the behavior itself.
      • Marlatt G.A.
      Harm Reduction: Pragmatic Strategies for Managing High-Risk Behaviors.
      • Inciardi J.A.
      • Harrison L.D.
      Harm reduction: National and International Perspectives.
      • Ho A.F.
      Move over Hippocrates: Harm reduction as the new paradigm for health care. 2017.
      • Fairchild A.L.
      • Bayer R.
      • Colgrove J.
      The renormalization of smoking? E-cigarettes and the tobacco "endgame.".
      • Vinchurkar S.
      • Jain N.
      • Jhamtani R.
      • Gupta S.
      Tobacco harm reduction: underpinning issues, challenges, and scope for innovation.
      The concept of harm reduction has long been a pillar of public health practice; examples include use of methadone and needle exchanges, rather than the more daunting task of eliminating intravenous drug use; use of condoms during sexual activity, rather than relying only on sexual abstinence; or use of helmets and seatbelts, rather than forgoing use of bicycles or cars.
      In the tobacco-control community, however, harm reduction has been interpreted somewhat differently, often pitting committed practitioners against each other, with one side arguing that the only path to eliminating the scourge of combusted tobacco use is abstinence from all forms of tobacco and nicotine (with the possible exception of Food and Drug Administration [FDA]-approved nicotine-replacement therapy [NRT]), whereas the other side argues that it is combusted cigarettes that should be eliminated because they are responsible for the overwhelming portion of the damage from tobacco use and it is nonsensical to dismiss less harmful nicotine alternatives by demanding absolute safety.
      • Chapman S.
      E-cigarettes: the best and the worst case scenarios for public health.
      • Warner K.E.
      How to think-not feel-about tobacco harm reduction.
      • Abrams D.B.
      Promise and peril of e-cigarettes: can disruptive technology make cigarettes obsolete?.
      In part, this split occurred because early versions of “reduced harm” tobacco products (eg, the filtered cigarettes of the 1950s and low-tar and nicotine cigarettes of the 1960s and 1970s) proved to be no less harmful,
      US Department of Health and Human Services
      The Health Consequences of Using Smokeless Tobacco: A Report of the Advisory Committee to the Surgeon General: NIH Publication No. 86-2874.
      exacerbating the distrust of any ”harm reduction” products, whether promoted by the tobacco industry itself or independent companies. Whether the newest generation of e-cigarettes and smokeless tobacco, with documented reductions in harm, at least in the short term, will create the opportunity to bridge the current divide between these 2 positions will depend largely on the willingness of the individuals and organizations involved in this issue to accept some form of harm reduction as a means of reducing the toll of death and disease from combusted tobacco use.

      Nicotine

      Further complicating this conflict are differing views of nicotine and its possible role in the elimination of combusted cigarette use. Nicotine is the constituent of tobacco smoke that causes positive reinforcement and dependence on smoking; nicotine withdrawal during periods of abstinence often drives relapse to smoking during the first few weeks of an attempt to quit.
      • Gottlieb S.
      • Zeller M.
      A nicotine-focused framework for public health.
      ,
      • Prochaska J.J.
      • Benowitz N.L.
      Current advances in research in treatment and recovery: Nicotine addiction.
      Nicotine replacement therapies (NRTs) in the form of nicotine patch and nicotine gum were approved by the US FDA and introduced into the United States in the late 1980s. Three decades on, although there is no doubt about the efficacy and safety of NRT,
      • Hartmann-Boyce J.
      • Chepkin S.C.
      • Ye W.
      • Bullen C.
      • Lancaster T.
      Nicotine replacement therapy versus control for smoking cessation.
      it may be under-used for treatment by some smokers and health care providers because of concerns that it will perpetuate nicotine addiction
      • Foulds J.
      • Hughes J.
      • Hyland A.
      • et al.
      Barriers to use of FDA-approved smoking cessation medications: implications for policy action. 2009.
      or because of misplaced concerns about nicotine itself.
      • Steinberg M.B.
      • Bover Manderski M.T.
      • Wackowski O.A.
      • Singh B.
      • Strasser A.A.
      • Delnevo C.D.
      Nicotine risk misperception among US physicians. J Gen Intern Med. 2020. [Epub ahead of print].
      For most health care providers, however, the therapeutic target is complete cessation of all tobacco use. If this can be achieved, even in the face of long-term use of NRT (because of continued nicotine dependence), the harm of tobacco use is eliminated. Similar arguments for harm reduction are being made now for e-cigarettes.

      E-Cigarettes

      When e-cigarettes first became widely available in the United States approximately a decade ago, they were welcomed by some as a useful addition to the existing range of tools available to smokers who wanted to quit. Others argued that e-cigarettes were an unknown entity, both in terms of safety and effectiveness, and should be put aside until more scientific evidence became available.
      The science, to date, including thousands of e-cigarette–focused papers and 2 major government-sponsored reviews in the United States and the United Kingdom,
      • Eaton D.
      • Kwan L.
      • Stratton K.
      National Academies of Sciences Engineering and Medicine, Health and Medicine Division, Board on Population Health and Public Health Practice, Public Health Consequences of E-Cigarettes.
      ,
      • McNeill A.
      • Brose L.S.
      • Calder R.
      • Bauld L.
      • Robson D.
      Evidence review of ecigarettes and heated tobacco products 2018.
      suggests that e-cigarettes are, in general, less harmful than combusted cigarettes and may be more useful in helping smokers quit than existing nicotine-replacement products.
      • Hartmann-Boyce J.
      • McRobbie H.
      • Lindson N.
      • et al.
      Electronic cigarettes for smoking cessation.
      Importantly, and in contrast to the evidence for NRT, the long-term effects of e-cigarette use remain unknown, owing to their relatively recent introduction.
      • Baker T.B.
      • Fiore M.C.
      What we do not know about e-cigarettes is a lot.

      The Food and Drug Administration

      Meanwhile, the FDA has suggested a conceptual approach that may address some of the concerns on both sides of this issue. The FDA has proposed that the wide array of tobacco and nicotine products available in the United States be viewed along a “continuum of risk,” acknowledging that all products are not equally harmful, ranging from NRT products at the lowest end of the harm continuum, through combusted cigarettes at the highest end.
      • Gottlieb S.
      • Zeller M.
      A nicotine-focused framework for public health.
      This concept, first proposed in the 2014 Surgeon General’s Report, is generally accepted, in principle, by virtually all involved in the harm-reduction debate, with the exception of those few who reject the use of all nicotine products.

      The Clinician’s Dilemma

      Caught in the middle of this ongoing debate is the clinician who wants to help patients stop smoking but is barraged from all sides with both conflicting interpretations of the same scientific evidence and selective use of evidence to bolster one side or the other’s argument. Many clinicians employ the precautionary principle and advise tobacco-smoking patients to use only FDA-approved medications, including NRT, in their attempts to quit. Others, looking at the same evidence, advise patients who have failed to quit using FDA-approved medications to consider e-cigarettes as quitting tools.
      Responsible clinical practice cannot continue in this vein, unable to engage in informed decision making about whether or not to advise the use of e-cigarettes for cessation of smoking with a patient who is continuing to be exposed to the known, serious harms of combusted tobacco smoking. Clinicians need clear guidance from trusted sources and confidence in the products they recommend.

      A Path Forward?

      For most of the 50+-year history of efforts to eliminate cigarette smoking in the United States, the participants in this effort have been remarkably united. There was a common enemy—the tobacco industry—and steadily accumulating scientific evidence to help guide these efforts.
      Although there have been previous disagreements, such as concerns over the 1998 Master Settlement Agreement between state attorneys general and the tobacco industry, it is only in the past decade that this unity has become significantly frayed, and all involved are aware of the sources of that disunity: e-cigarettes, proximally, and harm reduction, distally.
      So, as Vladimir Lenin asked in his influential pamphlet at the turn of the nineteenth century, “What is to Be Done? Burning Questions for Our Movement,”

      Lenin VI. What Is To Be Done? Burning Questions of Our Movement Lenin’s Selected Works. Vol 1; 1902.

      the tobacco control movement must ask itself “What is to be done?” to get past the current impasse and continue on toward the tobacco endgame. Moving forward will require compromise and flexibility on the part of all involved, while maintaining strict adherence to producing and following good science and sound medical principles.
      More specifically, the following suggestions may help break the current impasse:
      • Refocus tobacco control efforts on the combusted cigarette. As noted, the 2014 Surgeon General’s Report was very clear in identifying the combusted cigarette as the cause of the vast majority of deaths and disease from tobacco and the recommended focus of all tobacco- control efforts. All those involved in this field should, before undertaking any tobacco-control effort, ask whether the primary goal of that effort is to reduce the prevalence of combusted cigarette use. If that question cannot be answered affirmatively, the proposed action should be reconsidered. This would require a renewed focus on the public health implications of the tobacco control field’s priorities: that is, prioritizing actions that are most likely to result in the greatest health gains at the population level, even if that means compromise on some issues such as the complete elimination of smokeless tobacco or non-NRT nicotine use.
      • Continue tobacco control policies that have proved effective. Despite the current controversies, the tobacco control field should continue to support and implement the evidence-based interventions that have helped achieve the current 14% adult rate of prevalence: smoke-free environments, high taxation of the most dangerous tobacco products, widespread availability of cessation services, focused media campaigns, and production of unbiased, high-quality science.
        World Health Organization
        WHO Report on the Global Tobacco Epidemic.
        Centers for Disease Control and Prevention
        Best Practices for Comprehensive Tobacco Control Programs.
        • Ghebreyesus T.A.
        Progress in beating the tobacco epidemic.
      • Build upon the FDA’s “continuum of risk” concept. Recognize that, although there is no such thing as a wholly safe tobacco or nicotine product, all other nicotine-delivery products cause less harm than combusted cigarettes, and progress can be made—in tandem with good science—on determining which products pose lower health risks and may be helpful in reducing use of combusted tobacco.
      In addition, by adopting the FDA’s continuum-of-risk model,
      US Department of Health and Human Services
      The Health Consequences of Using Smokeless Tobacco: A Report of the Advisory Committee to the Surgeon General: NIH Publication No. 86-2874.
      divisive communication across the tobacco-control field may be calmed—although by no means eliminated—as it may be more productive to be able to discuss a range of potentially useful nicotine products to help smokers quit, including e-cigarettes, if NRT proves unhelpful for a given smoker.
      • Promote the science surrounding nicotine. It is well known in the tobacco-control community that nicotine, although addictive and certainly not harmless, is not the primary cause of death and disease from combusted tobacco use (recall Michael Russell’s dictum that “smokers smoke for the nicotine and die from the tar”).
        • Russell M.A.
        Low-tar medium-nicotine cigarettes: a new approach to safer smoking.
      Yet, a substantial portion of the public, and even some in public health, continue to believe that nicotine, no matter how delivered or in what amount, is a cause of cancer and other diseases.
      National Cancer Institute
      Beliefs about nicotine and low nicotine cigarettes among US adults, 2018.
      This belief stunts the use of nicotine replacement as a means of reducing use of combusted tobacco and needs to be rectified by promoting the large body of science behind use of NRT.
      • Support efforts to reduce uptake of nicotine by youth. Perhaps the single most volatile issue in the harm reduction and e-cigarette conflict has been uptake of e-cigarettes by youth. Although smoking rates for youths are now in the 5% range of prevalence, down from nearly 30% only a generation ago, there is concern among many that the rapid uptake of use of e-cigarettes by youths may lead to erosion of that success.
        • Cullen K.A.
        • Gentzke A.S.
        • Sawdey M.D.
        • et al.
        e-cigarette use among youth in the United States, 2019.
        • Zeller M.
        Youth e-cigarette use and the Food and Drug Administration's multifaceted approach.
        • Glantz S.A.
        • Bareham D.W.
        E-cigarettes: use, effects on smoking, risks, and policy implications.
        • Kozlowski L.T.
        Minors, moral psychology, and the harm reduction debate: the case of tobacco and nicotine.
        • Miller T.J.
        The harm-reduction quandary of reducing adult smoking while dissuading youth initiation.
        • Warner K.E.
        Will 5.6 million current American youth eventually die from smoking? The anatomy of a commonly accepted tobacco control measure. Tob Control. 2020.
      Alternatively, others believe that youth may have been diverted from combusted use through uptake of e-cigarettes.
      • Levy D.T.
      • Warner K.E.
      • Cummings K.M.
      • et al.
      Examining the relationship of vaping to smoking initiation among US youth and young adults: a reality check.
      Yet others point to the recent outbreak of e-cigarette or vaping product use-associated lung injury (EVALI)
      • Marlatt G.A.
      Harm Reduction: Pragmatic Strategies for Managing High-Risk Behaviors.
      as reason to eliminate use of e-cigarettes (although the Centers for Disease Control and Prevention has since made it clear that it was not traditional e-cigarettes that caused the EVALI outbreak but, instead, contaminated off-market cannabis products).
      • Gordon T.
      • Fine J.
      Cornering the suspects in vaping-associated EVALI.
      Although there is no single answer to this central issue, the tobacco-control and public health communities should support all efforts by the FDA, scientific organizations, the National Institutes of Health, voluntary health organizations, and legislative bodies to protect—and extend—the successes in reducing tobacco use among youth. This effort will be a delicate balance, as former FDA Commissioner Scott Gottlieb has vividly described,
      US Food & Drug Administration
      Statement from FDA Commissioner Scott Gottlieb, M.D., on new steps to address epidemic of youth e-cigarette use. 2018.
      as we need to better control access to e-cigarettes as a potential “on-ramp” to combusted use for youth, while keeping the “off-ramp” open for adults who wish to quit use of combusted tobacco.
      • Support reasonable regulation of e-cigarettes by the FDA. The FDA has, perhaps, the central role in determining the future of e-cigarettes and harm reduction as potential tools for further reducing combusted tobacco use. They must find the correct balance between making potentially lower-risk products available for combusted tobacco users, while, at the same time, discouraging use of these products by nonsmokers, including youth. Examples of regulatory environments in which this can be achieved do exist: for example, the United Kingdom, where e-cigarettes are promoted for cessation of smoking, and use of e-cigarettes among youth remains low.
        Medicines and Healthcare Products Regulatory Agency
        E-cigarettes: regulations for consumer products 2020.
      Despite the complexities constraining the FDA approvals process (especially regarding the modified-risk tobacco product [MRTP] and pre-market product application [PMTA] processes), a wide array of channels are available for the public and the scientific community to convey their perspectives—and data—to the FDA as they consider how best to regulate tobacco. These communities should take full advantage of these opportunities and support the FDA in the application of solid science in making their decisions regarding regulation of e-cigarettes.
      • Promote more rigorous research into new, safer e-cigarette product development and responsible promotion. This will likely require public–private partnerships and a regulatory environment that supports acceptably safe and effective production of electronic nicotine-delivery devices, using standardized and well-monitored manufacturing processes, FDA licensing of all products that are legally allowed to be marketed, and oversight of marketing messages to restrict targeting youth.
      • Remember the clinician. Clinicians see patients every day who are smoking cigarettes, and they must navigate these issues, determining whether they should discourage e-cigarettes to aid in cessation of smoking because they may have long-term adverse health consequences, or encourage use of e-cigarettes for those patients who have tried approved smoking-cessation products without success. In the current situation, clinicians simply do not have answers based on evidence, and expert opinion is widely divergent.
      Clinicians must deal first-hand with the e-cigarette harm-reduction conflict, and they need good science and medical practice principles to guide them in advising their patients about the most effective and practical ways to quit smoking. It is up to the scientific and medical communities to do just that.
      • Be flexible, but not naïve, in assessing potential roles the tobacco and vaping industries may play in accelerating the decline of combusted cigarette smoking. If products such as e-cigarettes continue to show promise as a means of helping some combusted smokers stop, and consumers continue to show interest, the tobacco industry will likely move further into this product category, and the vaping industry (including independent companies, vape shops, etc.) would also likely expand. This would be a good business strategy, as—with more than 1 billion combusted cigarette smokers globally, a large proportion of whom want to stop—there may be a significant and profitable market for these products.
      If that proves to be the case, the tobacco-control, public health, and tobacco-regulatory communities may need to reconsider their wholly justified 50+-year history of opposing every action of the tobacco industry and enter an uneasy peace with them—and the newer vaping industry—for as many smokers as possible to have ready access to products with potential for accelerating the end of combusted cigarette smoking. Tobacco industry leaders have a stated goal to achieve a “smoke-free” future while more resources are used to promote noncombusted (and presumably less harmful) tobacco products. Although this declaration may be viewed as empty rhetoric, perhaps it also provides the opening to negotiate the eventual elimination of the manufacture, distribution, and sale of the combusted cigarette.

      Conclusion

      This discussion raises many questions, the most crucial of which is “Can the current divide in the tobacco control field be broached, even partially?” It would be naïve to think that by simply following the path suggested in this Commentary, this could be accomplished. Yet, to do nothing, to simply accept the status quo, is irresponsible and, without doubt, damaging to public health. Consider that in the few minutes it took to review the points in this Commentary, approximately 25 Americans and 300 people worldwide died of complications arising from their use of combusted tobacco. This is a toll that should be unacceptable to all of us, no matter where one stands on the issues presented here. We should not—and cannot—continue to engage in the divisive and shameful conflict that the e-cigarette era has visited upon the tobacco-control community; the lives of too many people are at stake. We can—and must—do better and move on to the combusted tobacco endgame.

      Supplemental Online Material

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