Category: Clive Bates

  • Bad Science

    Bad Science

    Photo: olly

    What is bad science, and why is there so much of it?

    By Clive Bates

    Every Friday afternoon, I receive the worst email of the week. It is an automated search on the PubMed database, an index of the biomedical literature covering over 30 million published papers. The search tries to pick up new studies relevant to tobacco harm reduction and typically finds 30–70 new papers each week. Once the email comes in, I look through the abstracts and write down hot takes on the ones that seem relevant to policy or practice. Then I share with public health and consumer advocates. To be honest, it is often a dispiriting experience. Despite the scattering of excellent “must-read” papers, many are truly awful. I have been doing this since 2016, and the volume of papers has roughly doubled.

    So, what have I learned by going through this painful weekly ritual? There are distinct patterns repeated in the literature, including poor methodology, poor interpretation of results and, almost always, poor extrapolation from findings to policy. There are obvious biases and sometimes near-comical desperation to find fault in reduced-risk products. Let me provide a list of some of the most common flaws.

    • Poor toxicology. The 16th century Swiss physician Paracelsus coined a maxim now expressed as “the dose makes the poison.” The detectable presence of a hazardous chemical does not mean it is toxic. There must be sufficient exposure to the human body to cause harm. As an example, many studies find metal residues in vape liquids and aerosols, but usually at levels that create no basis for concern.
    • Lack of meaningful comparisons. Many studies will present data on the effects of smoke-free products without context, such as a comparison with cigarette smoke, or some objective risk benchmark, such as the standards used for occupational health exposures. Without such context, it is impossible to assess whether the findings are a basis for concern or for reassurance. So, the question is always, “how much exposure, and is that a little or a lot?”
    • Observations versus risks. Nicotine is a stimulant and has many effects on the body, but epidemiological studies do not generally show nicotine exposure to be harmful to health. For example, there are regular headlines reporting that nicotine can cause an acute stiffening of the aorta, the largest artery in the body. But is that bad news? It seems less disturbing when we find that coffee, exercise or even exposure to music can have the same effects.
    • Unrealistic operating conditions. A range of studies makes machine measurements of emissions from heated aerosol products in unrealistic conditions that no human user could tolerate because of the terrible taste. Using this unrealistic method, researchers often find high levels of toxic chemicals. But this is about as sophisticated as testing the residues from the surface of burnt and blackened toast—and concluding that eating toast for breakfast increases cancer risk.
    • Over-interpreting animal and cell studies. There are many studies of human cells tested in Petri dishes (“in vitro”), but these are tests on cells without all the defenses and regenerative capacity they have in the body. Test on animals (“in vivo”) must recognize that animals have very different physiology to humans and are sometimes bred to have vulnerabilities. In both cases, creating a realistic equivalent to the exposures a human would experience can be challenging. These studies can’t tell us much conclusively about human risk. At best, they can provide valuable clues. At worst, they can mislead.
    • The wrong counterfactual. Many studies beg the question, “what would have happened if vaping did not exist?”—without that, it is hard to determine what effect vaping is having. For example, if there were no vape option, would pregnant women who currently vape be abstinent, or would they smoke? That should affect the advice of health professionals. Many are concerned about youth vaping, but for the youth who would otherwise be smoking, maybe vaping provides a significant benefit. That should affect the approach of policymakers and regulators. These assumptions are known as “counterfactuals,” and they are hidden and hard to determine, which makes them open to bias.
    • Correlation ≠ causation. Many studies find a correlation (usually referred to as an association) between vaping and some harmful effect. But too many studies suggest that vaping causes the harmful effect. Take, for example, vaping and Covid-19. A 2020 study suggested Covid was abnormally high in young vapers, concluding that vaping is a “significant underlying risk factor” for coronavirus disease. But critics pointed out that people who vape may be more likely to work in occupations where they are more easily exposed. Are vapers the type of people who are more likely to ignore masking guidelines and stay-at-home mandates? These other risk factors that may be more common in vapers are known as “confounders” and are a pervasive challenge in nicotine and tobacco science.
    • Reverse causation. Some studies find that vaping is associated with, say, respiratory illness. But what if some people who smoke switch to vaping precisely because their respiratory health is deteriorating? There would be an observable association, but the respiratory illness would be causing the vaping, not the other way around.
    • Confounding by smoking history. There has been a recent spate of studies claiming that vaping causes heart disease or respiratory conditions like chronic obstructive pulmonary disease. Almost everyone old enough to both vape and to experience these conditions has a smoking history, usually decades long, contributing to the disease. In such studies, it is impossible to isolate the effect of vaping from smoking. In some cases, the vaping has even commenced after the event or diagnosis.
    • Misunderstanding gateway effects. Does vaping lead to smoking? If that were the case for significant numbers, vaping could be almost as harmful as smoking. There are studies that show that young people who vape are also more likely to smoke. But that does not mean the vaping causes the smoking. More likely, the characteristics of the individual (e.g., rebelliousness) or their circumstances (e.g., parents, peer group) incline them to both smoking and vaping. This is a rival explanation to the gateway effect and is sometimes known as the “common liability” theory.
    • Selection effects. Some studies will focus on people who are unusually dependent on nicotine and therefore find it harder to quit. For example, in some cases, it is more likely that vaping will be tried by people who have not succeeded with any other method. This doesn’t mean vaping is less effective, just that the people using the products find quitting harder. This is a common error in studies of concurrent vaping and smoking, often known as “dual use.” The dual users are more dependent and tend to be more intense smokers with higher toxic exposures.
    • Weird study populations. Not all studies conducted on social media are useless, but most are. The people discussing vaping or smoking on Twitter or Facebook are not representative of the vaping and smoking populations. Their views are not gathered systematically in the way surveys work. Trends over time might be helpful, but most snapshots tell us little.
    • Baseless policy conclusions. Policy conclusions like “ban e-cigarette flavors to protect kids” are disappointingly common in the literature. To justify a policy requires numerous considerations that will go beyond the findings of any single data paper and stretch into economics and ethical considerations. Such considerations would include, for example, the assessment of unintended consequences (will kids smoke instead?) and trade-offs (between the interests of teenagers and adults).

    Such a list does not explain why there is so much bad science, given these errors are simple to understand and mostly avoidable. I believe the answer lies in the incentives of those doing the science. Major U.S. federal research funders are aiming for a “world free of tobacco use,” which also means free of nicotine use. Tobacco regulatory science funded by regulators will be inclined to find justifications for regulation and intervention, not liberalization. There could also be deeper drivers: without the significant harms of smoking, there isn’t much justification for the whole field of tobacco control. Perhaps the emergence of much safer smoke-free nicotine products threatens livelihoods, careers and entire university departments, and bad science is the reaction. Maybe researchers gain prestige from alarming media coverage. These are all subtle conflicts of interest that are never acknowledged or recognized, yet they are pervasive drivers of bias.

    It will surprise some, but I have noticed that science from the tobacco industry rarely crosses these lines. That is also down to incentives. The tobacco and nicotine industry must satisfy skeptical regulators about the safety and effectiveness of its next-generation reduced-risk products. It conducts research for product stewardship reasons and, in part, to take precautions against product liability litigation. The industry is incentivized to do good science.

    It is time to address these problems by establishing a more constructively challenging environment for tobacco and nicotine science. This is not just an abstract academic curiosity. Public health credibility and the lives of millions are at stake.

    Clive Bates is the director of Counterfactual Consulting and the former director of Action on Smoking and Health (U.K.).
  • The Bullshit Asymmetry Principle

    The Bullshit Asymmetry Principle

    Photo: kurgu128

    The idea that e-cigarette flavors hook kids is simple, compelling—and false.

    By Clive Bates

    In a fact sheet titled “Flavored E-cigarettes Hook Kids,” the U.S.-based Campaign for Tobacco-Free Kids asserts that “Flavored e-cigarettes are undermining the nation’s overall efforts to reduce youth tobacco use and putting a new generation of kids at risk of nicotine addiction and the serious health harms that result from tobacco use.” Let us call this “the activist proposition.”

    The challenge with simple but false activist propositions is that refuting them can require a lengthy embrace of more complex arguments. Brandolini’s law, also known as the bullshit asymmetry principle, can be expressed: “The amount of energy needed to refute bullshit is an order of magnitude larger than to produce it.” In this article, we shall demonstrate Brandolini’s law by addressing the simple but false activist proposition about flavored e-cigarettes through a series of questions.

    First, do flavors cause youth tobacco or nicotine use? The activist proposition builds in an assumption that flavors cause e-cigarette use. Lots of young people use flavored e-cigarettes. Therefore, it is claimed, flavored e-cigarettes must cause young people to use e-cigarettes. But how likely is that? We know from the past that a high proportion of young people can use tobacco if they choose to, mostly without flavors. According to the Monitoring the Future survey, for most of the 1990s, U.S. 12th-grade past 30-day cigarette smoking prevalence was at or above 30 percent. By 2021, teenage cigarette smoking had fallen around 4 percent, but nicotine vaping had reached 20 percent. Perhaps there is a persistent demand for nicotine or tobacco, regardless of whether it is flavored. Also, let’s look over time. In the United States, high school past 30-day vaping was 11.3 percent in 2016, rose to 27.5 percent in 2019 but fell to 14.1 percent by 2022. Yet there was very little change in the availability of flavored e-cigarettes to explain these swings. There are also countries where flavors are widely available but youth vaping is relatively low. Take the U.K., for example, which takes a positive approach to tobacco harm reduction and vaping. Thousands of flavored products are available, but according to a recent official evidence assessment, youth vaping remains below 10 percent. And the U.K. offers us a further important insight: “[D]ata showed that most young people who had never smoked were also not currently vaping (98.3 percent).” This tells us that vaping is highly concentrated in adolescents already open to tobacco use.

    Second, so what does cause youth tobacco or nicotine use? Most of the evidence points to characteristics of the individual and their circumstances not tobacco product features. Tobacco use is driven by a complex mix of psychosocial factors, including genetics, parental smoking, poverty, delinquency, rebelliousness, low self-esteem, peer group, etc. A 2016 literature review identified 98 conceptually different potential predictors of smoking onset. A 2019 study looked at stated reasons for e-cigarette use and concluded there were two main drivers: “alternative to cigarettes” and the “larger social environment.” For some young people, tobacco or nicotine use may have functional benefits. It may modulate stress or anxiety, improve concentration or help control conditions such as attention deficit hyperactivity disorder (ADHD). For others, it may be just frivolous and experimental. In 2019, the U.S. Centers for Disease Control and Prevention asked young people why they vaped; the top reason was, “I was curious about them.”

    Third, what would teenage vapers do if they were not vaping? Implicit in the activist proposition is the idea that removing flavors will remove the reason to vape and stop the user from vaping. At one level, there is some truth in this. If the products are bland, unpleasant or tasteless, perhaps no one will use them. But here is the problem: What if the demand for tobacco and nicotine has deeper psychosocial causes, such as those discussed above? Removing the flavored products does not make the demand go away. Would the teenage vapers just give up vaping and do more homework and piano practice instead? If the underlying demand remains, that is unlikely. Teenagers interested in nicotine might revert to cigarettes, cigars or other tobacco products. We have some evidence for this: When e-liquid flavors were banned in San Francisco in 2019, there was an increase in teenage smoking compared to other areas where flavors had not been banned. This is hardly a surprise—in one study, young adults were asked what they would do if e-cigarette flavors were banned. About one-third said they were likely to switch to cigarettes.

    In 2022, Boston-based public health scientists Mike Siegel and Amanda Katchmar reviewed the body of evidence on youth smoking and vaping, concluding that it “suggests that youth e-cigarette use has instead worked to replace a culture of youth smoking.” Economic analysis also backs this idea—when prices of e-cigarettes increase, youth vaping falls, but youth smoking rises. That tells us that e-cigarettes and cigarettes function as substitutes. If regulators ban e-cigarette flavors, then they should not be surprised if more smoking is the result. For that reason, Siegel and Katchmar concluded “[W]e propose a reevaluation of current policies surrounding e-cigarette sales so that declines in e-cigarette use will not come at the cost of increasing cigarette use among youth and adults.” That is very troubling for the activist proposition—it means policies to address youth vaping cannot be evaluated without concern for their effect on youth smoking. It also means that some youth vaping may be a diversion from smoking and is beneficial. It follows that regulation discouraging vaping could easily be harmful.

    Fourth, how would a ban on flavors work? The logic of the activist proposition is that a ban on flavored products would remove flavored products from the market, thus removing the reason for young people to vape. But that is not how prohibitions work in practice. A prohibition does not cause the prohibited product to disappear. But in practice, a prohibition causes the perturbation of a market. It causes changes to the behavior of consumers, legal and illegal suppliers, prices and availability. Foreseeable consequences include switching to cigarettes or other tobacco products; switching to other substances; switching e-cigarettes to the permitted flavors; illicit trade in flavored liquids; home mixing and informal selling; cross-border trade or internet sales; stockpiling and workarounds such as sales of flavors for aromatherapy. Prohibitions change the supply side, and rarely for the better. There should be no mystery about this: Despite longstanding prohibition, the Monitoring the Future survey shows that U.S. 12th-grade past 30-day cannabis use has been around 20 percent and daily use around 5 percent for about the past 25 years. Some of these responses to flavor prohibition will clearly increase harm compared to vaping. Because smoking is so much more harmful, it would only take a slight uptick in smoking to offset any benefit of significantly reduced teenage vaping. But there are also hazards arising from informal manufacturing and workarounds. Illicit supply will bring adolescents into contact with criminal networks as consumers and potentially as low-level participants.

    Fifth, what is really going on with youth vaping? I believe there are two broad patterns of youth vaping and two distinct behaviors at work, but these are often conflated. The first is frivolous and experimental use, where young people try new things. This has characteristics of a frothy fad: infrequent use, transient and unpredictable. The second is more determined nicotine use: frequent, intense and entrenched. But this group is more likely to be the adolescents who would otherwise be using cigarettes or other tobacco products. The first group contributes to the “youth vaping epidemic” narrative but is not really a cause for great public health concern. The second group represents the migration of nicotine use in society to far safer technologies and is likely beneficial for public health. The activist proposition, however, requires policymakers to believe there is no latent demand for nicotine use and that removing products will eliminate nicotine from society. But it is much more plausible to think of the demand for nicotine in similar terms to alcohol, caffeine, cannabis and other recreational substances. People use nicotine for a reason, and there will be a long-term demand for it. The task for policymakers and regulators is to make that acceptably safe and to resist simplistic activist propositions that are likely to do more harm than good.

    In November 2022, the Campaign For Tobacco Free Kids celebrated the success of a mass activist campaign to secure Proposition 31, a ban on flavored products in California. They may have won their political battle, and their aggressive promotion of the activist proposition has again prevailed. But nowhere in its advocacy literature does this powerful coalition level with California’s voters about the underlying drivers of youth nicotine use, the linkages between smoking and vaping, and the risks of unintended consequences. They can deny this real-world complexity, but policies built on bullshit have a nasty tendency to go wrong, to do more harm than good and to call into question the credibility of their advocates.

    Clive Bates is the director of Counterfactual Consulting and the former director of Action on Smoking and Health (U.K.).
  • Transformation and Its Enemies

    Transformation and Its Enemies

    Photo: Chan2545

    The twin strategies of migration away from combustible nicotine products and diversification into new businesses underpin the tobacco industry transformation. Why is there so much opposition?

    By Clive Bates

    How should a rational and dispassionate public health advocate think about tobacco companies? How should tobacco companies think about public health?

    The simple and lazy answer is that they are sworn enemies in a permanent and irreconcilable conflict. This idea has now been immortalized as a guiding principle by the World Health Organization. The “scream test” devised by Australian anti-tobacco campaigners was a crude forerunner of the WHO’s principle: “If a new policy gets no reaction from the tobacco industry, it rarely has an impact, but if the industry screams blue murder, the impact will be large.” If the industry hates it, it must be good for public health.

    But what if there are policies, practices and messages that are good for the tobacco industry and public health? Or bad for both? One of the accusations frequently thrown at public health advocates who favor tobacco harm reduction is that they are doing the bidding of Big Tobacco. No one likes to be accused of that. But implicit in that accusation is either the assumption that tobacco harm reduction cannot be good for both or worse, that it is more important to hurt the tobacco industry than to serve public health. We see this playing out in the industry’s twin-track efforts to transform by migration and diversification: migration into noncombustible nicotine products and diversification into non-nicotine businesses in which they have natural commercial advantages.

    These issues loom large in the transition strategies of tobacco companies, which range across a continuum from “not bothered; we like the business as it is” to “this is the competitive play of the 21st century, and we’re all in.” In my view, the transition strategies of the companies will be highly beneficial for both public health and the companies that successfully transform. Transition involves giant companies moving out of the merchant-of-death business and into something closer to selling mild and popular recreational stimulants. For public health reasons, I would be happy if tobacco companies made handsome profits from a diversified business far less reliant on cigarettes. Yet their efforts to attempt this attract strident opposition at every turn.

    Why? I think it is worth unpacking this opposition a little.

    First, is the continued sale of cigarettes just too much to bear? How can public health welcome transformation when the companies involved are still hooking kids, selling trillions of cigarettes and killing millions of people? Here, public health advocates must understand the nature of the market and a corporation. Every country has a lawful market for cigarettes. Commercial tobacco sales are permitted, regulated and taxed by governments. There is also a demand for cigarettes, with over a billion smokers consuming over 5 trillion cigarettes annually. This demand will inevitably be matched by supply, and the suppliers are, by definition, the tobacco industry. We should treat this as a given not an act of evil—a fact of life that we may not like that much but that constitutes the reality in which we try to secure public health gains. I am all for putting pressure on the cigarette trade through tobacco control measures, but these are the prerogative of governments. We should expect companies to compete vigorously for market share within the parameters set by policy and law. That should not be a shock; it is what companies do. Public health advocacy should be focused on influencing the regulatory, fiscal and communications environment in which tobacco companies operate and challenging abusive business practices. Other than gratifying righteousness, it serves little purpose to condemn tobacco companies for what they are and must be. What matters is how this can change.

    Second, should we only trust the tobacco industry when they pull out of cigarettes? There have been numerous calls for companies to stop selling cigarettes. The problem is that the advocates of this idea believe the companies should just do it unilaterally. Public health colleagues need a better grasp of shareholders and fiduciary duties. The companies cannot simply squeeze or shut down a lucrative earnings flow to their shareholders. The management would be fired, the company taken over or the cigarette assets sold as a going concern with no public health benefit. Ironically, the companies, to varying degrees, do have viable exit strategies for cigarettes—migration of the nicotine business to noncombustibles and diversification to “adjacent” industries such as plant biotechnology and vaccines, inhalation technologies and recreational stimulants. This strategy to exit the cigarette trade meets an essential requirement; if successful, it can work well for shareholders. The irony is that public health campaigners lament the slow progress in phasing out cigarettes. Yet, at the same time, they oppose every element of the only commercially viable strategy to bring it about: migration and diversification.

    Third, is tobacco harm reduction just the “nicotine maintenance strategy of Big Tobacco”? The concern is that diversification is merely a cunning ruse to escape the inevitable demise of the tobacco industry and the nicotine market. Here, public health advocates need to think more carefully about the product and where it is heading. I believe there is a far more robust long-term market for nicotine than for smoking. That’s because nicotine use is popular among many for its impacts on stress, anxiety, concentration and pleasurable sensations. And nicotine itself is not that harmful. The main reason people have stopped using nicotine over several decades is the health impacts of smoking and the pressures from policies and taxation to address the health impacts of smoking. The early stages of migration to noncombustibles have been welcomed by many as a harm reduction option for smokers. But in the longer term, the noncombustible products represent the basis for a nicotine market that operates within the normal boundaries of acceptable risk. This may open a frightening vista for some in public health. Nicotine products with minimal harm create weird new challenges that we have yet to fully grasp. The deterrence effects from the harms of smoking are lost, the case for taxes and regulation to control use is diminished, the designation of nicotine as an addictive agent no longer applies and the whole purpose of the vast complex of tobacco control interests is lost. There is only a case for tobacco control if there are serious harms. Otherwise, it becomes a moralistic war on drugs enterprise.

    Fourth, is diversification just an exercise in reputation laundering? Much tobacco control activism now relies on “denormalizing” the industry and, by inference, whatever the industry touches. Tobacco companies can deploy their human resources, facilities, assets and intellectual property to branch out into new businesses for which they have inbuilt advantages. Shocking venom and energy have gone into attacking companies and their staff for some of their efforts to develop or acquire pharmaceutical businesses, invest in vaccine production, exploit their plant biotechnology expertise, enter new markets for personal well-being recreational drugs or even provide ventilators to struggling hospitals. It is bizarre. What is achieved by preventing companies from moving into new businesses that reduce the dependence on cigarettes? This can only be explained by a fear that the industry will reform itself into a more normal business and that arguments grounded in denormalization will fail. The arguments from tobacco control are peculiarly aesthetic—it just looks wrong for a tobacco company to make drugs to treat chronic obstructive pulmonary disease (COPD) or provide Covid-19 vaccines. But why is this so wrong? What are the ethics of opposing the development and deployment of a vaccine or COPD treatment if these would otherwise be successful in the market?

    Finally, will migration and diversification be additional and not replace cigarettes? Maybe Big Tobacco is building even bigger, more voracious businesses? Here, public health advocates need to grasp what shapes a market. Ultimately, that is up to consumers and what they are inclined to buy. But in a market like this, policymakers and communicators have a role. For example, they can make taxation and regulation proportionate to risk. They can communicate candidly about risks. They can have better insights into unintended consequences or test and reject assumptions that fail to hold water in real life. Some companies may grow bigger through migration and diversification or even acquire a larger share of the cigarette business—that is how competition works. What matters for public health is not what individual companies are doing, though it matters greatly to the companies. What counts is the migration of the whole market to reduced-harm products instead of cigarettes, which is strongly affected by public health policies and communications. If the companies also diversify to keep their shareholders engaged and exploit their advantages during a transition, what exactly is wrong with that?

    In public health, we need to stop our warrior rhetoric and think harder about the world as it really works and what will change it for the better.

    Clive Bates is the director of Counterfactual Consulting and the former director of Action on Smoking and Health (U.K.).
  • How to Save 100 Million Lives

    How to Save 100 Million Lives

    Photo: Smoore

    Innovation and creative destruction in the evolving tobacco market will render cigarettes obsolete and end the burden of smoking-related disease—if we let it.

    By Clive Bates

    Let’s play strategy consultants. Imagine an international public health agency has hired us. We are tasked to advise on reducing the global burden of noncommunicable disease associated with tobacco and nicotine use and how to do it as deeply and rapidly as possible. Our assignment is to propose a clear-eyed, unemotional and results-driven approach to addressing this problem. What would we do?

    First, we define, limit and quantify the problem. According to the Global Burden of Disease study published in The Lancet, in 2019, around 1.1 billion people smoked 7.4 trillion cigarettes. Worldwide, 7.7 million died from smoking-related disease and 200 million disability-adjusted life-years were lost. On top of the burden of mortality, there are additional economic and welfare harms from smoking. Then there are further harms caused by the policy response, such as regressive taxes, stigmatizing campaigns and restrictions on smoking. These policies might be justified to reduce disease and protect nonsmokers, but they add to the welfare burden for people who continue to smoke. The problem is overwhelmingly caused by smoking tobacco—inhaling products of tobacco combustion—and not directly by the use of the drug nicotine.

    Second, we determine why this problem persists. If it causes so much harm, surely it is just a matter of informing people? This seemed like the obvious answer to the anti-smoking pioneers of the 1960s onward. Doctors would educate people on the risks, and people who smoke would reassess their interests and would stop smoking or never start. Some analysts suggest that this could be the only anti-smoking strategy that has ever worked, but it has been painfully slow. Our working theory is that the underlying demand for nicotine is robust and potentially dependence forming. We determine that for some people, nicotine use may be rational or appealing for its mood control, cognitive advantages and pleasurable sensations. We note the long delay between the positive reinforcing experience of smoking and the most severe health effects and how people tend to devalue or discount negative impacts far in the future compared to gratification today. But if we can separate the experience of using nicotine from the harms of using it by smoking, maybe there is a way around this.

    Third, we ask what is wrong with what we are already doing. Maybe it is a matter of letting evidence-based tobacco policy work through multiple countries and generations. Yet, despite 50 years of concerted action, we still have about one in seven adults smoking in the United Kingdom and the United States and about one in four in the European Union. Now that 80 percent of the world’s smokers are in low-income and middle-income countries, we ask if the intense and sustained regulatory, fiscal and campaign focus necessary to drive down smoking and nicotine use are viable and sustainable. Or would the process be slow and incremental as it has been in Europe and North America? We look for signs that the World Health Organization Framework Convention on Tobacco Control (FCTC) has been working but find surprisingly little credible evaluation. The available analysis, published in the BMJ, found no evidence “to indicate that global progress in reducing cigarette consumption has been accelerated by the FCTC treaty mechanism.”

    Fourth, can we go further with the established measures? The problem with pulling harder on the existing levers is that we may start to run up against barriers of public consent and political acceptability (politicians are only willing to be tough on voters up to a point), or we start to see escalating unintended secondary consequences. For example, high tobacco taxes are regressive and likely to trigger black markets or adverse behavioral responses. The public might see smoking bans in workplaces as acceptable to protect workers, but would they feel the same way about banning smoking outdoors? We might push harder with enforcement, but the danger is that the measures start to look illiberal, excessive or unfair. What about escalating and just banning cigarettes or forcing manufacturers to remove the nicotine? After all, if that is the problem, why not take the most direct way to address it? Again, we run into difficulties of public consent, political appetite and perverse consequences that are all too foreseeable given the experience with drug and alcohol prohibitions.

    Fifth, what innovative options are available to expedite progress? Here, there really is a potential game-changer. If the underlying demand is for the experience of using nicotine and the harm is caused by the use of nicotine by smoking and inhaling products of combustion, then there is an obvious path forward. Our key strategy advice is to do everything possible to refocus the nicotine market from the dangerous smoking products to the much safer smoke-free products, for which estimates suggest there are already more than 100 million users. There are two reasons to adopt this strategy. First, it provides a relatively simple way for existing smokers to switch to products that eliminate nearly all the additional risks of continued smoking. When someone who smokes switches, they do not have to give up the nicotine, a sensory experience, or much of the behavioral ritual. Second, these products provide low-risk alternatives available to people who wish to use nicotine in the future. This second function is essential because we do not believe it will be possible to stop future nicotine use any more than we could wind down the use of caffeine, alcohol or cannabis. To the extent we have managed to reduce demand for nicotine, it is mainly on the back of messaging and measures to address the harm caused by smoking. But it is precisely that harm we are trying to eliminate. We need to rethink our relationship with nicotine.

    Sixth, how could we expedite progress? Here, we may rely on what the economist Joseph Schumpeter termed a “gale of creative destruction” or the “process of industrial mutation that continuously revolutionizes the economic structure from within, incessantly destroying the old one, incessantly creating a new one.” So, should we just wait for this process to run its course? Of course not! Four critical contextual pressures will drive the inevitable creative destruction of the cigarette market. The right strategy for government, civil society and the tobacco industry is to shape them to expedite the obsolescence of smoking to create a viable nicotine market with acceptable risks:

    1. The information environment – what do people believe about smoking and the alternatives? What do trusted professionals and organizations say and advise? What do newspapers report, and how reliably do scientists communicate their findings in scientific papers and press releases? A significant tobacco control effort has been made to engineer misperceptions about relative risk and to dissuade smokers who would switch from making that move. The information environment is highly contaminated with harmful misinformation.
    2. The regulatory environment – regulations can encourage consumers to move from high-risk to low-risk products—an approach we know as “risk-proportionate regulation.” However, the regulatory landscape for cigarette alternatives is filling up with anti-proportionate regulation: prohibitions and stealth prohibitions, including outright bans, bans on flavors, limits on nicotine levels, advertising bans and so on. Again, the current trends protect the cigarette trade.
    3. The fiscal environment – the tax system can create incentives for consumers, retailers and manufacturers to favor low-risk smoke-free alternatives over high-risk cigarettes. But we now see persistent calls to raise taxes on vaping and heated-tobacco products to equivalent levels to cigarettes. Again, the direction is anti-proportionate when it comes to taxation.
    4. The innovation environment – how favorable are the market conditions to the emergence of improved products and new entrant firms? Is the market competitive, or does oligopoly form a barrier to innovation? Does it require massive regulatory costs and delays to bring a product to market (e.g., the U.S. Food and Drug Administration) or notification or compliance with standards (e.g., the European Union)? Can innovators communicate with consumers and explain their innovation, or are advertising and other commercial communications banned? Does innovation go into improving customer experience relative to cigarettes, or is it primarily directed to regulatory compliance that does little for product users?

    These pressures will fundamentally change the tobacco market, perhaps ruining some companies but making revitalized giants out of others. A determined goal-driven strategist would shape these four environments to harness market dynamics for public health. That will mean challenging those purporting to represent public health interests while doing all they can to delay the market-based obsolescence of the cigarette. They may slow a necessary and inevitable transformation and cost thousands of lives. But ultimately, innovation and creative destruction will prevail. Every stakeholder involved should grasp the implications of that and act accordingly.

    “Accessing Innovation” is the theme for this year’s GTNF, to be held in Washington, D.C., Sept. 27–29, 2022.

    Clive Bates is the director of Counterfactual Consulting and the former director of Action on Smoking and Health (U.K.).
  • Nicotine And The Weirdness Of Harm

    Nicotine And The Weirdness Of Harm

    Photo: artefacti

    The availability of nicotine with minimal harm justifies a complete rethink of our approach to this legal recreational drug.

    By Clive Bates

    Whisper it quietly, but people use nicotine for a reason. Nicotine has psychoactive effects that provide functional benefits and pleasurable sensations to its users. Neal Benowitz, a global authority on nicotine, writing in the U.S. Annual Review of Pharmacology and Toxicology in 2009, summarized the effects: “In humans, nicotine from tobacco induces stimulation and pleasure and reduces stress and anxiety. Smokers come to use nicotine to modulate their level of arousal and for mood control in daily life. Smoking may improve concentration, reaction time and performance of certain tasks.”

    Writing in the journal Nicotine & Tobacco Research in 2018, the neuroscientist Paul Newhouse described the cognitive benefits of nicotine: “Cognitive improvement is one of the best-established therapeutic effects of nicotinic stimulation. Nicotine improves performance on attentionally and cognitively demanding vigilance tasks and response inhibition performance, suggesting that nicotine may act to optimize attention/response mechanisms as well as enhancing working memory in humans.”

    With such characteristics, one is tempted to ask why nicotine has so few users. It turns out this is a serious question with some interesting implications. The answer is that nicotine use is strongly associated with the harms of smoking and an addiction so powerful that former U.S. Surgeon General C. Everett Koop compared it to heroin or cocaine. The iron grip of nicotine addiction keeps people smoking even though they are well aware of the lethal consequences.

    Nicotine seems to provide valuable benefits for people whose lives are difficult and stressful, those prone to anxiety or distraction or those who just enjoy the strange mixture of its stimulating and calming effects. Perhaps that could mean most of us? At one point, it did. In the decades before the health implications of smoking were widely understood, smoking prevalence was very high. In the United Kingdom in 1948–1952, smoking prevalence was about 80 percent for men and 40 percent for women. That compares to a combined total of around 14 percent today. But the overwhelming driver of this decline has been intense concern about harm to health and the introduction of policies to reduce these harms by making smoking less appealing, more expensive and more difficult to do. But maybe our concerted public health efforts to reduce disease and death caused by smoking deterred people who would otherwise have benefited from or enjoyed the mood-regulating and cognitive benefits of nicotine had it been available in safer forms.

    So, here is the interesting question. What if nicotine use is no longer all that harmful? What if the real problem was always the inhalation of toxic smoke while trying to consume nicotine for its benefits? As early as 1991, the leading medical journal The Lancet reflected on how the nicotine landscape might look after the year 2000: “There is no compelling objection to the recreational and even addictive use of nicotine provided it is not shown to be physically, psychologically or socially harmful to the user or to others.”

    In my view, we have reached the position where smoke-free nicotine products, such as e-cigarettes, heated tobacco, smokeless tobacco or nicotine pouches, can provide nicotine at acceptably low risk. By acceptably low risk, I don’t mean perfect safety, but within society’s normal risk appetites for consumption and other recreational activities. If continuing innovation in the design of the products ultimately leads to smoking cigarettes becoming obsolete, then the vast burden of smoking-related disease will decline and fade away.

    So why is there so much opposition to low-risk nicotine products? Why do so much effort and money go into trying to demonstrate that these products are harmful? I call this the weirdness of harm, and it takes several forms.

    First, perhaps good science shows these products are very harmful and should be treated no differently than cigarettes? We can rule out this explanation quite easily. The toxicants found in users’ blood, saliva and urine are far fewer, and the levels are far lower than in smokers. Credible data show a range of benefits in switching from smoking to smoke-free products, and there is little convincing evidence to suggest material risks at present. We might be concerned about currently unknown long-term effects, but these are more likely to be trivial than severe and may be tackled if and when they emerge, which they haven’t so far. Yet the ferocity of the backlash against safer products goes far beyond doubts about safety or concern for the welfare of consumers. It looks more like a reaction to a threat.

    Second, much safer products pose an existential threat to a powerful interest group. As a profession, tobacco control exists only because of a need to control severe harm to health. A significant part of the professional tobacco control field could ultimately be rendered irrelevant and unemployed by safer forms of nicotine. The whole edifice of careers, grants, university departments, journals, conferences, advocacy campaigns and the personal prestige of anti-tobacco warriors has harm as its foundation. Otherwise, it becomes the equivalent of “coffee control,” which barely exists. That creates strong, perverse incentives to find (or fabricate) harms to sustain the profession. That conflict of interest is large and pervasive, yet it is paradoxically invisible and never acknowledged or discussed. But for many, it means good news is unwelcome, and bad news is good news. Take, for example, the muted reactions to the recent sharp decline in U.S. teen smoking compared to the apparent enthusiasm that has greeted the long list of (unfounded) scares about nicotine vaping, such as e-cigarette or vaping use-associated lung injury, popcorn lung and seizures.

    Third, without harm, the case for a nicotine-free society falls apart. Harm is the primary reason for abstinence from nicotine. Gallus and colleagues found that about 80 percent of smokers quit because they currently experience harm, expect harm in the future, have taken a doctor’s advice about harm or worry about harming others. Only 2.8 percent mentioned “loss of pleasure or desire to smoke.” But if the products are no longer harmful, where does that leave those who feel we should aspire to be a “nicotine-free society”? That goal likely arises from a mixture of motives: a loathing of the tobacco industry and a sense that “harm reduction” is an unfair escape from its inevitable destruction, an instinctive disgust about the drug choices of others or just the stoical sentiment that if people can be abstemious, they should be. Harm has always been the trump card of the proponents of a nicotine-free society, but their case is greatly diminished if it rests mainly on moral instincts.

    Fourth, it is possible that nicotine use will increase without the deterrent effect of harm. This arises from a basic but unsettling economic argument. The underlying demand for nicotine was once very high but has been suppressed by harm to the user and related policies. The harms of smoking are part of the overall nonmonetary costs (health, stigma, welfare) of using nicotine to the individual. Low-risk products and proportionate regulation will reduce or eliminate these costs. All other things being equal, lower costs mean that nicotine use should increase. Many will be uncomfortable with the prospect of nicotine use rising after years of sustained decline. But we should recall that the effort to reduce nicotine use was driven by the harms of smoking not by opposition to the effects of nicotine as a drug. If we successfully address the public health goal, these smoking-related deterrence effects will no longer apply.

    Fifth, harm is integral to the definition of addiction. The casual and sloppy use of the word addiction is pervasive in public health. It is always worth asking what is meant by “addiction.” In the formal Addiction Ontology, serious harm is integral to the definition of addiction: “A mental disposition toward repeated episodes of abnormally high levels of motivation to engage in a behavior, acquired as a result of engaging in the behavior, where the behavior results in risk or occurrence of serious net harm” (emphasis added).

    The inclusion of serious net harm in the definition of addiction is intended “to limit the class to things that merit a treatment and public health response.” A similar reference to harm is also included in other definitions, such as those of the U.S. National Institute on Drug Abuse and the American Psychiatric Association. So, it could be argued that without the associated harm from exposure to smoke, nicotine would no longer be classified as addictive and would simply join the short but growing list of psychoactive chemicals people enjoy and society accepts, like caffeine, alcohol and increasingly, cannabinoids. C. Everett Koop’s 1988 comparison of nicotine to heroin was a powerfully provocative statement, but in the context of safer nicotine products and the U.S. opioid epidemic, the comparison is not convincing.

    The emerging range of smoke-free consumer tobacco and nicotine products means much more than tobacco harm reduction or an elegant way to help smokers quit. The availability of nicotine with minimal harm justifies a complete rethink of our approach to this legal recreational drug.

    Clive Bates is the director of Counterfactual Consulting and the former director of Action on Smoking and Health (U.K.).
  • Policy Masterstroke or Political Quagmire?

    Policy Masterstroke or Political Quagmire?

    Image: Zerbor

    Rules to reduce nicotine in cigarettes are back on the agenda.

    By Clive Bates

    On June 21, the United States Federal government announced its intention to develop a rule requiring deeply reduced nicotine levels in cigarettes on sale in the United States. This idea has been in circulation since first proposed in 1994 and was given a new lease of life in the FDA comprehensive plan in 2017. In late 2021, New Zealand adopted this policy and has committed to introducing legislation this year. The zombie policy is back, and it walks among us. Despite the warped logic of taking out the relatively benign nicotine and leaving the very harmful tar, despite the obvious practical problems of mounting a de facto cigarette prohibition at this scale, and despite the weird ethics of encouraging people to switch from one smoking product to another smoking product, this idea just will not die. How should we consider this proposal from a tobacco market transformation perspective?

    First, let us consider how this would work in practice. Regulators would introduce a rule requiring that cigarettes must have a very low nicotine level in the tobacco, say 0.4 mg per gram of tobacco compared to typically 16mg per gram—a 40-fold reduction. The level would be so low that nicotine could not play a meaningful role in the smoking experience, and “compensation” to obtain a satisfactory nicotine dose by puffing harder would not be possible. For unexplained reasons, regulators and researchers think that people would continue to buy and use these products, but smoke less and not become addicted to them. That forms the basis of the public health rationale for such a rule. But this is absurd.

    Second, the science is weak. Given that the main reason people smoke is to experience the effects of the stimulant nicotine, using low-nicotine cigarettes is among the least likely of all the possible responses to such a rule. After trying such products once, few smokers be willing to hand over hard-earned cash at the corner store for cigarettes with no noticeable nicotine. Yet nearly all the science to support rulemaking assumes that smokers will use these products and then finds out what happens if they do. But trials are not markets. In a trial, the subjects are volunteers and agree to participate. They are paid or incentivised to stick with the trial protocol and are usually provided with free cigarettes. This is nothing like real life.

    Third, what matters in real life is how users and suppliers respond to the disruption. A low-nicotine rule would eliminate the lawful supply of nicotine cigarettes. But it does not make them disappear from the market. It changes who supplies them, how, and at what price, creating incentives to develop a black market. The established producers would not remain passive either. They will find other lawful ways to sell nicotine-bearing smokes, for example, by selling cigars or hand-rolling tobacco or promoting workarounds such as personal cigarette-making machines. Consumers who use nicotine cigarettes will not automatically become abstinent or lose their interest in nicotine just because the FDA introduces a rule. Maybe they switch to black market cigarettes, cigars, or vaping. Nothing remains constant. A new rule disrupts the market, but it does not mean smokers will automatically do what regulators hope they will. The question is, what would they do, and can this be influenced?

    Fourth, regulators must shape the behavioural and market response to the rule. Merely implementing a low nicotine rule does not determine its public health impact. The pattern of behavioural responses to the rule will determine the overall effect. “Good pathways” like switching from smoking to vaping will compete with “bad pathways” like switching to black market products. Confidence in good behavioural responses to a rule should be a precondition for its introduction. Suppose we hope a reduced nicotine rule would prompt a migration of smokers to smoke-free alternatives. Three conditions would need to be met to incentivise migration from smoking to vaping. (1) the smoke-free products must be affordable, attracting zero or minimal tax. (2) the products would need to appeal to smokers by offering a diverse selection of flavours, good nicotine delivery, and a range of devices to suit all needs. (3) consumers must be aware of the benefits of switching, notably the dramatically reduced health risk compared to smoking. Sadly, there is no sign that the U.S. tobacco control community is working towards these meeting these preconditions, though there is a little more policy coherence in New Zealand.

    Fifth, there is a paradox at the heart of this proposal. A reduced nicotine rule needs good pathways to the low-risk options discussed above to make it viable. But when those preconditions are met, a low nicotine rule loses most of its purpose. Meeting the preconditions for a rule is a more useful policy than the rule itself. When those conditions are met, everyone who wants to quit smoking by switching can make an informed choice and just do it. What is the case for coercing the smoking holdouts? Surely, the state’s role should be to get in their corner with help and encouragement, not a big regulatory stick. And what if some people are fully aware of the risks, fully understand their options to switch to high-quality, low-risk alternatives, but still don’t want to switch? Should they be made to? And anyway, would anyone in public health want smokers to switch to a low-nicotine cigarette when they could be encouraged to vape? Imagine if a manufacturer brought out a vaping or heated tobacco product with the same nicotine delivery and toxicity profile as a low-nicotine cigarette? No one would take such a product seriously, let alone propose it as a public health intervention.

    Sixth, but what about youth? One of the big ideas that underpin this proposal is that non-addictive cigarettes would stop teenagers from falling into the trap of addiction and lifelong smoking and harm. This is now a much weaker argument than in 1994 when the reduced nicotine cigarette idea was conceived. In 1994, 12th grade past-30-day smoking prevalence was 31 percent. In 2021, it was down to 4 percent, according to the University of Michigan Monitoring the Future survey. The current trend in youth smoking is sharply downwards from a low base. Teenage vaping is likely doing the job that reduced nicotine cigarettes were once supposed to do – eliminate teen smoking. The other argument is that no evidence exists that this de facto cigarette prohibition would work. Consider the case of youth marijuana use. The Monitoring the Future survey shows that 12th grade past-30-day prevalence has been steady at an average of around 21 percent since 1994. But throughout most of this period, marijuana has been completely prohibited. The point is that banning something does not make it disappear or mean that teenagers cannot access it. It is more likely to mean they participate in illicit supply.

    Seventh, the politics will be very fraught. Though the legal base for such a rule would be Section 907 of the Tobacco Control Act, it would be a mistake to believe this could be done as a narrow technocratic rule-making exercise. Such a measure would impact a wide range of stakeholders far beyond the FDA’s routine contacts. U.S. cigarette sales are about $80 billion annually, and every part of that supply chain, from farmers to convenience store retailers, would be affected. There would be a substantial hit on the cigarette tax and master settlement receipts to State budgets. Law enforcement would be drawn in, with the potential for some of the adverse impacts we have seen in the War on Drugs. Then there is the question of identity politics. Surely, tobacco control activists have noticed that even sensible public health responses to the Covid-19 pandemic became weaponised into polarising identity politics. How would the Federal government intervening in the personal behaviour of 34 million American smokers play out in the febrile and divisive political climate that has developed in the U.S. since 2016? Which political leader will take a hard look at this measure and conclude, “yes, that is just what I need to win the next election”?

    In my view, measures like a low-nicotine rule are fantasy “policy masterstrokes”, in which a massive problem is solved with the swish of the regulator’s pen. I doubt this measure will ever work in real life. It will be mired in a practical, legal and political quagmire until it is no longer relevant. In the meantime, it is a distraction from the more useful, feasible and respectful regulatory business of setting up risk-proportionate regulation, fair taxation, and honest risk communication about smoke-free nicotine products. Migration of the market for consumer nicotine from smoking to smoke-free is the practical and viable way to make cigarettes obsolete and end the epidemic of smoking-related disease. A policy that relies on the consent of users rather than prohibition and coercion is far more likely to succeed.

    Clive Bates is the director of Counterfactual Consulting and the former director of Action on Smoking and Health (U.K.).
  • The Takeaways

    The Takeaways

    Photo: Jhvephotos | Dreamstime.com

    What lessons should regulators learn from the United States?

    By Clive Bates

    The U.S. Food and Drug Administration has had jurisdiction over tobacco products since Congress passed the Tobacco Control Act and it entered into force in 2009. Through its Center for Tobacco Products (CTP), the FDA regulates tobacco products, which include nicotine products such as e-cigarettes and e-liquids in the United States. With the recent retirement of Mitchell Zeller, the CTP’s director since 2013, it is an excellent time to take stock. Here we look at six lessons from the experience that might help guide regulation in other jurisdictions.

    First lesson: Understand how well-intentioned but poorly designed regulation can harm public health. The regulation of newer, safer products should reflect the political reality that the most hazardous products, cigarettes, will remain pervasively available. In the United States, variants of just under 3,000 cigarette products have been on the market since 2009, largely untouched by onerous regulation. The Royal College of Physicians signaled the risks that flow from excessive regulation of safer alternatives in its 2016 report Nicotine without smoke: “… if [a risk-averse and precautionary] approach also makes e-cigarettes less easily accessible, less palatable or acceptable, more expensive, less consumer-friendly or pharmacologically less effective, or inhibits innovation and development of new and improved products, then it causes harm by perpetuating smoking.”

    Regulatory regimes that are tougher on the alternatives to cigarettes function as anti-competitive barriers to entry. Sound regulatory practice requires efficiency, transparency and predictability with burdens proportionate to risk. Unfortunately, the premarket tobacco product application process by which safer products must enter the market to compete with cigarettes is astonishingly expensive and opaque and fails any test of proportionate regulation. It functions to protect the cigarette trade and concentrate the vape market into a monoculture of uninspiring products. This is partly the law itself, but much is down to how the FDA has interpreted its responsibilities under the law.

    Second lesson: Use standards and a notification regime rather than a product-by-product regime. The problem with an authorization regime is that it requires a public health agency to say “yes” to allowing a nicotine product onto the market. For institutional cultural reasons, many will find this challenging to do. Asymmetries in risk aversion mean regulators tend to be far more reluctant to accept the risk of saying “yes” and something bad happening than saying “no” and something good not happening. Both outcomes are harmful, but the former is what energizes regulators while the latter is hidden. A further issue with authorization systems is that they are easily politicized, providing a focus for campaign organizations to press for the decisions they want from regulatory agencies. For example, the FDA has been pushed hard by well-funded campaigns to ban flavored e-cigarette products. In contrast, the European Union has used a notification system with standards codified into the EU’s Tobacco Products Directive and, as a result, has a diverse and competitive market without a huge problem of youth uptake and far less political tension.

    Third lesson: The regulator should accept the same disciplines it imposes on the regulated entities. The Tobacco Control Act, which is the FDA’s regulatory foundation, repeatedly refers to “appropriate for the protection of public health” as a guiding principle. For example, this test is applied to new nicotine products as part of the premarket review process. But does the FDA ensure that its own approach is appropriate for the protection of public health? By setting the burden of proof so high, the FDA has implemented a de facto ban on flavors other than tobacco and (possibly) menthol in vaping products. This is probably a response to intense and well-funded activism. But it will have the effect (if not the intent) of closing all the vape shops and radically collapsing the diversity of products on the U.S. market. Imagine if the FDA had to prove that its approach to flavors is “appropriate for the protection of public health.” That is precisely what it would have to do if it introduced a product standard to ban flavored products. The agency would not be able to do it, and it should not be doing it by default.

    Fourth lesson: Risk perceptions matter, and regulators can help. One of the important purposes of public health regulation is to promote consumer behaviors that improve health. That should include, for example, making it easier and more desirable to vape than to smoke. But that cannot work if consumers do not understand which options are safer. In the United States, despite federal communications budgets of hundreds of millions of dollars, the public risk perceptions about nicotine are in a terrible state and, in many cases, deteriorating. In 2020, less than 3 percent of adults held the correct belief that e-cigarettes are much less harmful than cigarettes, but 62 percent wrongly believed that e-cigarettes are as harmful or more harmful than cigarettes—a view for which there is no evidence. Seventy-two percent wrongly believe that smokeless tobacco is no less harmful than cigarettes. A majority (56 percent) wrongly believe that nicotine is the primary cause of smoking-related cancer. The statements and communications campaigns of regulators and public health agencies like the Centers for Disease Control and Prevention  in the United States can improve these perceptions or make them worse. Either through risk aversion or by design, the leading federal agencies have contributed to the landscape of poor risk perceptions and have hence undermined their own effectiveness. This has especially been the case through agency efforts to deter youth use. These have strayed into the exaggeration of the harms of nicotine vaping and inappropriately capitalized on the scare over the outbreak of lung injuries in 2019 that was widely but falsely attributed to nicotine vaping.

    Fifth lesson: Apply some skepticism and science to the claims of activists. A regulator should be objective and cautious about activists’ claims and draw on the best possible science to guide its actions. Between 2017 and 2019, the rate of vaping among U.S. high school students shot up from 11.7 percent to 27.5 percent, an alarming rise by any standard. This generated a climate of moral panic in the public, media and politics—with flavored vapes and the marketing practices of e-cigarette companies blamed for the rise. Cooler heads advised caution and to look more carefully at the underlying patterns. That was good advice. It turned out that most teen vaping was infrequent, most frequent use was concentrated in young people who might otherwise be smoking, and very few tobacco-naive users showed any sign of dependence. We know that the causes of youth vaping are similar to the causes of youth smoking: characteristics of the individual and their circumstances rather than the products being the primary driver. For many young people, their frequent vaping may have been a beneficial displacement from smoking or diversion from cigarette uptake. From 2019 to 2021, teenage vaping fell sharply, especially among the infrequent users, suggesting that the dramatic rise had been a frothy and transient fad. Yet, by basing a response on the headline numbers rather than the underlying usage patterns, the FDA may have done more harm than good to both adolescents and adult smokers by overreacting to a moral panic based on a false premise. The science and data were there to navigate this crisis with a steady hand, but the FDA chose the path of least resistance and accepted activists’ claims at face value and acted accordingly.

    Sixth lesson: Adopt a realistic economic and behavioral model. How can a regulator use its powers wisely and make proper determinations if it has a poor grasp of the products and behaviors it is regulating? One way of looking at vaping products is that they are a form of smoking cessation device, a kind of pimped-up nicotine-replacement therapy. In that case, a regulator might demand clinical trials to show efficacy in smoking cessation and intervene to reduce “abuse liability”—the risk that the product will attract users for reasons other than its therapeutic indication. The other way of looking at vaping products is that they are competitive alternatives to cigarettes for people who wish to use nicotine for whatever reason. They work by presenting a rival value proposition to smokers. To do this successfully, they must be appealing and pleasurable and meet the needs of people who do not even want to quit smoking (those most at risk from smoking-related harm). Few medical or public health regulators have the conceptual tools to deal with ideas like pleasure or appeal without seeing them as an abuse liability. In reality, vaping and heated-tobacco products are best understood as part of a major technology transition from combustible to noncombustible technologies in the consumer nicotine market. The regulatory regime for such products needs to encourage and not suppress innovation, allowing innovators to do the heavy lifting in securing the eventual obsolescence of cigarettes. That is a far more ambitious aim than placing smoking cessation products on the market. Alas, few regulators, including the FDA, appear equipped for the challenge.

    Clive Bates is the director of Counterfactual Consulting and the former director of Action on Smoking and Health (U.K.).
  • Fighting The Wrong War

    Fighting The Wrong War

    Image: nosyrevy

    The automatic criticism of everything associated with tobacco is not merely misguided; it has the potential to do real harm.

    By Clive Bates

    Yes, the tobacco companies worked hard to acquire a terrible reputation over many decades. With the publication of authoritative reports on smoking and health in the early 1960s, the tobacco companies entered a prolonged existential battle with reality. Emerging science threatened one of the most lucrative cash cows ever milked. What became known as the tobacco wars were fought over doubt, the marshy no-man’s land between ignorance and certainty, and it was ugly. That war essentially ended around the turn of the century with ignominious defeats in the courts and at the hands of the U.S. states’ attorneys general. It became clear that the costs of deceit and obfuscation were just too high. With advancing scientific knowledge, the companies would be left clinging to indefensible positions, and their executives would look increasingly absurd.

    But where are we today? Let us consider six recent developments.

    First, in March 2022, the World Health Organization blocked approval of a new SARS-CoV-2 vaccine even though Canada’s regulator had approved it and despite the Canadian government investing in its development. The WHO’s reason? The vaccine is made by a biotech company, Medicago, in which the tobacco company Philip Morris International holds a minority stake. The WHO argues that this would be to protect health policy from “tobacco industry interference.” The global health agency seemed to care little about suppressing the expanded supply of a new vaccine with possibly innovative benefits to a world that will need Covid-19 vaccines for the foreseeable future. And it didn’t explain how a company could conceivably exert any influence through this implausible route or why it might try.

    Second, in September 2021, tobacco control activists tried to stop a tobacco company, again PMI, from acquiring a pharmaceutical company, Vectura, that specializes in inhalation technologies. When they failed to stop the acquisition, they resorted to bullying directed against the scientists at Vectura, threatening to isolate and marginalize them from the scientific community. The activists argue that such investments “legitimize tobacco industry participation within health debates.” But they did not explain why PMI’s clearly stated strategy of diversification to facilitate its transition out of the cigarette trade would be a bad thing or something that they should try to prevent.

    Third, in July 2021, the board of the scholarly Society for Research on Nicotine and Tobacco (SRNT) voted to ban tobacco industry employees from attending the SRNT’s annual conference. Employees of the tobacco industry were already prohibited from SRNT membership. The SRNT defines the tobacco industry as any company owned (in part or whole) by a commercial tobacco manufacturer, implicitly tainting any effort at pro-health diversification or innovation. Yet, the society’s January 2020 guiding principles declared, “SRNT supports, without bias, the generation, dissemination and facilitates debate of rigorous science to address challenging public health questions regardless of the direction the evidence leads.” The tobacco companies now produce some of the highest-quality science in the field in connection with products that can significantly improve health. The SRNT’s words about open-mindedness and freedom from bias are undoubtedly noble, but they failed in their first collision with reality.

    Fourth, in May 2021, the specialist journal Nicotine & Tobacco Research produced a reasoned argument for accepting the occasional paper from an industry source. “Some feel that the tobacco industry’s history, motives and current activities should exclude them from publishing in the journal. Others feel equally strongly that science should be judged on its merits, irrespective of its origins. […] Our current position requires us to sit with this tension and trust that our editorial and review process, and our policies, will ensure that work can be judged on its merits whilst also allowing reviewers and readers to form a view based on its origins.” But in October 2021, the journal issued an “update,” which was little more than an abject reversal of the reasoned policy it had set out six months earlier. The journal felt compelled to follow the direction set by the board of the SRNT. The quality of the science or contemporary evidence of manipulation of scientific discourse was not offered as a justification. However, racial equity and the diversification of the industry were among the stated reasons.

    Fifth, in May 2021, the leading vape company, Juul, published a series of papers summarizing the behavioral science behind its premarket tobacco product application to the U.S. Food and Drug Administration. A special issue of the American Journal of Health Behavior brought together 13 papers covering everything from switching behaviors to retailer compliance. It was all collected in a single publication and free to read. But such brazen openness provoked fury in the tobacco control establishment. The British Medical Journal quoted Matthew L. Myers, president of the Campaign for Tobacco-Free Kids, saying, “… one thing should be abundantly clear: Research funded by tobacco companies cannot be treated as a credible source of science or evidence. No credible scientific journal should allow a tobacco company to use it for this purpose.” Even United States senators took time off from running the country to protest to the FDA at the impertinence of a company publishing its science in an accessible format. Some of the attacks focused on Juul paying fees to the journal for open publication, though that is a standard publishing model. Perhaps critics believed it would somehow serve the public interest if the 13 papers were paywalled, spread over multiple subscription-only journals and published on different dates? So far, no one has found any material fault with the actual science. So far, none of Juul’s critics has shown any curiosity about the findings and what they mean for public health policy.

    Sixth, since 2017, there have been intense and ongoing attacks on the nonprofit Foundation for a Smoke-Free World. The foundation’s stated mission is “to end smoking in this generation.” But because it was set up with a billion-dollar, 12-year commitment from a tobacco company, it has been the subject of intense hostility. Did anyone stop to ask whether research on ending smoking in this generation might be a good idea? Instead, the WHO and tobacco control mainstream would rather the research was never done and that the money was kept by the company. Why?

    What is Going on Here?

    First, this hostility has nothing to do with bad science or inappropriate influence. The tobacco companies, the larger vaping companies and industry consultants produce very high-quality science. Much of it captures the harms caused by cigarettes and shows how such harms could be reduced. Their regulatory science must convince skeptical regulators and withstand public, professional and legal scrutiny for signs of manipulation. Today, tobacco industry science must be and generally is credible.

    Second, several companies are indeed trying to influence the debate about the evolution of the tobacco and nicotine market. But this is in a direction that would be good for public health. With varying assertiveness, the companies want to diversify from combustible products to much safer noncombustible nicotine products and from nicotine businesses to non-nicotine businesses. They would like to discuss the policy frameworks that would cause this to happen more quickly. Tobacco control activists do not like this argument. It implies a future for their nemesis, Big Tobacco, and a diversion from their path to the “nicotine-free society,” a Utopian ideal typical of the War on Drugs. Rather than confront the science head-on, they would prefer the arguments not to be made or not to be heard.

    Third, their cause is served by framing the tobacco and nicotine issue in the simplifying Manichean certainties of good and evil. This makes for more straightforward stories. It supports a well-worn narrative that describes a predatory industry hooking teenagers into lifelong possession by an addictive drug. That sells well, even though it is a grotesque simplification and misunderstanding of how nicotine use works in reality. It also means tobacco control benefits from “white hat bias,” in which embarrassingly poor science escapes scrutiny and challenge. The result has been a steady debasement of the currency of tobacco control sciences.

    Fourth, the most profound reason is that tobacco control activists really need an enemy. They frame their work in war-like language, and the leaders had their formative experiences in the tobacco wars of the last century. The Campaign for Tobacco-Free Kids now uses the slogan “Taking on the Toughest Fights for 25 Years.” Fighting wars is what they do, even if this is increasingly at the expense of public health. It is why the WHO and others cling to the principle that there is an irreconcilable conflict between the interests of tobacco companies and public health. That way, there will always be a battle, they always have the prestige of war heroes, and there will always be money, conferences and entire institutions devoted to the struggle. But permanent belligerence will leave us in a slow-moving stalemate. If there is to be a war, can we please make it a common front against disease and death and not a rerun of the battles of the last century?

    Clive Bates is the director of Counterfactual Consulting and the former director of Action on Smoking and Health (U.K.).
  • The Evil Twins

    The Evil Twins

    Photo: Taco Tuinstra

    Prohibition and illicit trade

    By Clive Bates

    The remote Himalayan Kingdom of Bhutan was the poster child of tobacco control for many years. It appeared that Bhutan had drawn the obvious conclusion from decades of scientific research and had finally done the right thing. In 2004, the kingdom banned the sale of all tobacco products. Tobacco control activists were delighted.

    Jump forward to 2020, and the picture is not so rosy. In a joint report by the government and the World Health Organization office in Bhutan, “The Big Ban: Bhutan’s Journey Toward a Tobacco-Free Society,” Health Minister Dechen Wangmo, sets out the situation: “The black market, one that emerged after the ban, is the number one challenge that Bhutan is faced with when it comes to tobacco control. The Global Youth Survey 2013 reports an increase in the number of school children between ages 13 and 15 using tobacco products. It increased from 24 percent in 2006 to 30 percent in 2013.”

    According to the WHO, Bhutan has high levels of ongoing tobacco use despite prohibition. The WHO representative to Bhutan, Rui Paulo de Jesus, provides a candid explanation: “So long as the demand within the country persists, it will continue to fuel the illicit market that has expanded since the ban of its sale in early 2000. Unfortunately, as studies indicate, Bhutanese youth are at the center of this growing illegal trade in tobacco and its products.”

    Prohibition as a Perturbation

    Unusually for the WHO, the words above contain some essential truths about tobacco policy and prohibitions. The first and most important insight is that while demand for a product persists, a prohibition will just change how the product is supplied. A prohibition does not make a product disappear, even if that’s what politicians and policymakers would like. Instead, a prohibition is a perturbation of a dynamic market: a disruption that reconfigures the behavior of suppliers and consumers, changing who supplies the product, what products are available and under what terms. Prices can go up to reflect the costs and risk of illicit supply. Alternatively, prices can fall as no tax is paid on illicit goods. Illicit commerce is unregulated and ultimately controlled by violence rather than by consumer protection or contract law. An unregulated illegal market creates real dangers to consumers. The 2019 outbreak of severe and often fatal lung disease was caused by adding a harmful additive, vitamin E acetate, to illicit cannabis (THC) vapes as a cutting agent. Arguably, this disaster would never have happened had cannabis vaping products been widely available legally and without excessive taxation.

    Participation in Criminal Supply Chains

    The second insight is that young people may see the opportunity to make fast money as foot soldiers in an illicit irregular supply chain. It should be a significant consideration in assessing the case for prohibitions supposedly aimed at “protecting kids.” If adolescents want access to the banned products, then a prohibition policy will likely draw young people into the illicit supply chain and an early experience of criminality. Alternatively, the illegal supply of, say, cannabis could diversify to provide prohibited nicotine products as well. For example, in the United States, the Monitoring the Future survey shows that past 30-day cannabis use among 12th grade students has been around 20 percent for the last 25 years. That means there is a ready-made illicit supply chain for providing tobacco or vaping products to young people, should that prove attractive to cannabis suppliers.

    Types of Prohibition

    Not all prohibitions are as pervasive and straightforward as Bhutan’s. Let’s consider two further categories. First, many tobacco and nicotine policies have a partial prohibition element. By this, I mean the policies are intended to deter the use of the product rather than to protect the user. For example, a ban on flavored e-liquids has a prohibitionist purpose, but a ban on a toxic ingredient in e-liquids has a consumer protection purpose—an important distinction. Caps on nicotine strength or requiring a prescription to access vaping products are partial prohibitions. In On Liberty, John Stuart Mill famously equated taxes on stimulants to prohibition: “To tax stimulants for the sole purpose of making them more difficult to be obtained is a measure differing only in degree from their entire prohibition and would be justifiable only if that were justifiable.”

    The United States and New Zealand have proposals to reduce nicotine in cigarettes to a minimal “subaddictive” level. This is essentially a prohibition of cigarettes dressed up as a sophisticated regulatory intervention. Without adequate nicotine, cigarettes are worthless for most users, and they might as well be prohibited. The practical question is what would happen next: Would users quit altogether, move to illicit cigarettes or, for example, switch to vaping? The least likely outcome is any significant or sustained use of low-nicotine cigarettes.

    Second, a particular category needs to be defined for the prohibition of products that are beneficial to the user. The snus ban in the European Union has persisted since 1992 despite a mountain of evidence that snus has had a radically positive impact on public health in Sweden and Norway, where it is widely available. There may be arguments for prohibiting harmful products like cigarettes, even if there are doubts about the practicalities, perverse consequences and ethical implications for adult autonomy. But how can anyone defend the prohibition of much safer products that function as alternatives to cigarettes? Yet, there is now a lavishly funded international campaign to do exactly that. The international respiratory health organization The Union is calling for vaping and heated-tobacco products to be banned in all low-income and middle-income countries. That would cover 80 percent of the world’s smokers. This crazy logic is equivalent to campaigners against sexually transmitted diseases pressing for the prohibition of condoms in the hope that it would deter sex by making it more dangerous.

    More Enforcement?

    Although the WHO’s representative in Bhutan concisely described the problem, he still followed the eternal prohibitionist playbook and called for more enforcement effort. “WHO shares the country’s concerns, and it appears timely that Bhutan embraces the Protocol to Eliminate Illicit Trade in Tobacco Products the country is yet to ratify.”

    But this idea, embracing hi-tech track-and-trace technology, seems implausible in the environment of a developing country and an informal economy in tobacco products. Further, more enforcement muscle brings problems of its own. It is expensive, violent and prone to bribery, corruption and abuse of office. Drug prohibition in the United States is notoriously associated with racism. As the Drug Policy Alliance puts it, “People of color experience discrimination at every stage of the criminal legal system.”

    Prohibition by Trial and Error

    Perhaps the big policy questions cannot be answered until a prohibition has been tried and experience gained? Beware! The danger is that temporary prohibitions may have irreversible effects. Prohibitionists should turn to the 2020 experience in South Africa in which the government banned tobacco sales with a justification based on a Covid-19 response. Research by independent economists at the University of Cape Town concluded that the legal supply had been replaced by illicit supply with a substantial loss of tax revenue. But now that tobacco users have found illegal suppliers to evade prohibition, what is to stop them from continuing to avoid tobacco taxation?

    Responsibility and Accountability

    One characteristic of prohibition advocates is a reluctance to assess the consequences of their work. The prohibition policy is their real goal, but the real-world consequences are of lesser concern. For example, the UN Office on Drugs and Crime has dogmatically resisted calls to conduct a thorough assessment of the benefits and detriments of the drug prohibition treaties it oversees. This mindset is already evident in the tobacco and nicotine field. In 2019, India’s federal government imposed a comprehensive ban on vaping products. In 2021, the WHO awarded India’s former health minister, Harsh Vardhan, its highest tobacco control medal “for spearheading the government of India’s legislation to ban e-cigarettes and heated-tobacco products”. However, this award was made without any evaluation of the impact of the prohibition on illicit trade, no consideration of the likely perverse consequences leading to more smoking or any reflection on the ethics of denying India’s 100 million smokers lawful access to much safer alternatives.

    Proposals for prohibitions, in all their forms, need a much stricter assessment of the likelihood of illicit trade, perverse but easily foreseeable consequences and the ethics of using the force of law to control individual risk behaviors. That has been a conspicuous failure with illicit drugs and alcohol. Let’s hope that policymakers learn those lessons and don’t repeat the mistakes with nicotine.

    Finally, a postscript. Following a temporary lifting of Bhutan’s tobacco ban in 2020 for Covid-19-related reasons, Bhutan’s National Assembly passed the Tobacco Control (Amendment) Bill 2021 and Tax Bill of Bhutan 2021. This lifts the ban and legalizes the selling, buying, possession, distribution and transportation of tobacco and tobacco products. The signature prohibition of tobacco control has officially failed.

    Clive Bates is the director of Counterfactual Consulting and the former director of Action on Smoking and Health (U.K.).
  • Transformers Versus Abolitionists

    Transformers Versus Abolitionists

    Photo: Grispb

    The two camps in tobacco control

    By Clive Bates

    In November, two major treaties had their Conference of the Parties (COP) meetings. COP26 of the U.N. Framework Convention on Climate Change (UNFCCC) was held in Glasgow, and COP9 of the WHO Framework Convention on Tobacco Control (FCTC) was held online. Both aim to address a globally significant problem, and both aim to achieve radical transformations in the markets for energy and tobacco, respectively.

    Yet, the approach differs significantly. There is tremendous pressure in the climate change treaty to eliminate the combustion of fossil fuels to mitigate environmental risk as rapidly as possible. Climate change activists demand a rapid transition to “net zero,” with energy production moving from coal, oil and gas to renewables such as solar, wind and hydro as soon as possible. Arguments rage about the nature of this transformation and the practicality and fairness of the transition needed to reach it. Should it include nuclear power? Should gas substitute coal? Should tree planting count as negative emissions? The climate treaty is all about harm reduction through market transformation. The debate is about the form of eventual transformation and the pathway to reach it.

    In tobacco and nicotine, we see a different debate. As with climate change, almost everyone agrees there is a problem. Using WHO figures, smoking causes about 8 million premature deaths annually, and many millions more fall severely ill with various forms of cancer, heart disease and respiratory conditions. But in public health, we are sharply divided into two camps—the transformers versus the abolitionists.

    The Transformers

    The transformers see the challenge as bringing down the intolerable burden of disease and death as far and as rapidly as possible by changing the nature of the market for nicotine. They point to the Sustainable Development Goal target (SDG 3.4) to reduce noncommunicable disease mortality by one-third by 2030 compared to 2015, and the inevitable future commitments will follow that. The transformers want the market for tobacco and nicotine to move away from combustible smoked products because the smoke causes most of the harm by far. The transformers are found among pragmatists in public health, the investment community and the companies in the nicotine and tobacco market. The challenge for companies is to transform without hurting their shareholders—they need an account of how the business will evolve. Tobacco control activists often say, “just stop selling cigarettes.” But a listed company can only do this through a credible transformation. Without the support of shareholders, executives would be fired, or the company would face a takeover.

    Two broad strategies are evident for tobacco companies’ transformation. The first strategy is pursuing noncombustible nicotine product market share and growth in a battle of innovation and consumer appeal. The companies are moving into vaping, pouches, smokeless and heated-tobacco products, with competition as a powerful driver of progress. The question that nags at transformers is whether this move is just a niche line extension or the formative stages of a strategic shift. The companies seem to vary, but they are now being tracked by a Tobacco Transformation Index. The second strategy is more subtle and involves diversification of the companies’ activities. This doesn’t mean buying up unrelated firms, such as food or automotive companies, and creating a conglomerate to dilute the tobacco business. Conglomerates are falling out of fashion, with even the once-mighty General Electric announcing the spin out of its healthcare, energy and aviation businesses. For tobacco companies, diversification must involve synergies—meaning the whole must be greater than the sum of the parts. So, for example, we see tobacco companies exploiting their expertise in plant biotechnology, inhalation science and their consumer insights into non-nicotine psychotropics.

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    The Abolitionists

    The abolitionists have a very different endgame in mind. Their implicit and increasingly explicit goal is to eradicate nicotine use and achieve a “nicotine-free society.” Once it is clear that this is the goal, the dogged opposition to transformation becomes straightforward to explain. Reduced-risk products like snus, vapes, pouches or heated-tobacco products are seen as little more than a lifeline for tobacco companies that would otherwise face imminent obliteration. They are not life-saving alternatives to cigarettes but a cynical nicotine maintenance strategy of Big Tobacco.

    There are two problems with the abolitionists.

    The first is that there is no evidence that the demand for nicotine is in decline. With at least a 6,000-year history and currently over a billion users, nicotine use remains a very large-scale and deep-rooted phenomenon. There is even less reason to expect declines in demand for nicotine in the future, and we may see the opposite. The main reason smokers give for quitting smoking is that they are experiencing or anticipating harmful health effects. Remove nearly all the harms associated with smoking, and the main reason for quitting nicotine since 1960 has been mostly eliminated. But this is problematic for the abolitionists: To justify the end of nicotine, nicotine use must be harmful. For abolitionists, the problem with much safer nicotine products is that they destroy the rationale for intervention. That is why there is not much interest in coffee and caffeine control. Unsurprisingly, therefore, we see abolitionists pushing contrived science to show these products really are harmful. They have had some success: The European and American public increasingly believes, incorrectly, that smoke-free products are equally or more dangerous than cigarettes, even though they obviously are not.

    The second problem with the abolitionist position is that the priority given to eliminating nicotine will mean more harm—more cancer and heart disease. This is because a different guiding priority leads, by design, to different trade-offs. If the goal is ending nicotine use, the abolitionist is more likely to be indifferent to whether someone is vaping or smoking. But those behaviors have very different impacts on health. A thought experiment illustrates the trade-off problem: Hypothetically, would you prefer 20 percent smoking or 10 percent smoking and 30 percent vaping? The second case means twice the nicotine use but half the smoking and much less harm. So while they may see the abolition of nicotine as a pure and uncluttered outcome, it will involve a lot more death and disease in the interim and probably indefinitely. Consider the EU ban on snus, which came into effect in 1991. For the abolitionists, this looks like an incremental step toward their nicotine-free society. To the transformers, it seems like a lost opportunity that puts dogma before health. In the intervening 30 years, how many smokers have been denied the option to almost eliminate their risk while the European Union continues to suffer about 700,000 smoking-related deaths annually? The ban on snus is not a step forward in the march toward a nicotine-free society but a step backward in the imperative to transform the European nicotine market.

    Governments are the Real Transformers

    In its February 2021 investor day press release, Philip Morris International made a short but remarkable statement about transformation: “The company believes that with the right regulatory frameworks, dialogue and support from civil society, cigarette sales can end within 10 to 15 years in many countries.” The company is saying to investors that its cash-cow—cigarettes—could be obsolete within the typical corporate planning horizon. This is a striking recognition of just how fast things could change if the transformation strategy were pursued purposefully by all parties. The other important idea here is that transformation needs to be a joint undertaking: Governments set the regulatory and fiscal framework. Governments, civil society, health professionals and academia create the “information environment,” shaping what people see, hear and think about their options. Imagine if everyone with a serious stake in public health got fully behind a transformation strategy?

    The Abolitionists Fighting Transformation

    The abolitionists are threatened by transformation as it will deny them the justification for a nicotine-free society. So they are fighting transformation, with agencies right up to the WHO pressing for the outright prohibition of noncombustible products or regulations that would treat low-risk products no differently than high-risk cigarettes. This approach has nothing to do with health and everything to do with the threat that low-risk products present to the goal of the nicotine-free society. We also see anti-tobacco activists trying to block the diversification strategy of tobacco companies—for example, making the absurd argument they should not even use their biotech capabilities to try to make Covid-19 vaccines. In the most disturbing case so far, activists tried to block tobacco industry diversification through the acquisition of a pharmaceutical company specializing in inhalation technologies. Once the transaction was completed, they threatened the employees with ostracization. One day, these scientists were good guys; the next day, they were bad guys, even though they were doing the same thing with the same purpose—just with different owners.

    It’s almost as if these activists need tobacco companies to be permanent cigarette companies and nothing else. Perhaps they need an unambiguously evil enemy that fits their activist business model rather than a transformation that threatens to deny them the reason to exist.

    Clive Bates is the director of Counterfactual Consulting and the former director of Action on Smoking and Health (U.K.).