July 8th, 2020

The past is not the future - what lies ahead for tobacco and nicotine?

“Prediction is very difficult, especially about the future” – Niels Bohr, Physicist

Let’s have some debate on the future of tobacco, nicotine, tobacco control and the tobacco and vaping industry. Here are three provocative pieces to get things moving.

First, directly below, The past is not the future in tobacco control,  by pro-harm-reduction veterans of the tobacco wars with a historical perspective ending with four recommendations for a changed approach. I reproduce below the abstract and four main recommendations below and include my comments on the recommendations.

Second, a piece by me, The endgame revisited, highlighting the epic confusion of objectives at the heart of tobacco control and looking at where it is all heading – if everything goes well.

Third, in an email exchange, I was asked and answered the question: What is going wrong?.  That was also the subject of my 11-minute talk at GFN, so I add the video from that too.

Please give me your views in the comments… if we get a good debate I might make a new blog from it or add them to this blog.

1. The past is not the future in tobacco control

Cummings KM, Ballin S, Sweanor D. The past is not the future in tobacco control. Prev Med (Baltim). 2020 Jun 27;106183. [link][temporary access to PDF via Google Drive]

Abstract

In this paper we have attempted to identify missed opportunities to change the trajectory of smoking and smoking caused diseases in America over the past 100 years. Many of the missed opportunities identified are due to the actions of cigarette manufacturers who misled the public about the dangers of cigarette smoking, the addictiveness of nicotine, and the feasibility of providing lower risk alternative nicotine delivery products to addicted smokers. An important lesson learned from the past is that treating all tobacco/nicotine products as equivalently harmful is counterproductive to public health as it only serves to protect the most lethal nicotine product – cigarettes. Since 2000, the evolving marketplace of lower risk nicotine products combined with regulatory authority over tobacco products represents a new opportunity to dramatically transform the cigarette business in ways that were never imagined when the war on tobacco was raging decades ago. However, this requires embracing risk-proportionate regulation, taxation policies, and providing consumers with accurate public messaging on product relative risks. A regulatory framework based on sound science that encourages and rewards new or existing manufacturers to invest in consumer acceptable lower risk products to replace cigarettes needs to be encouraged. The past is indeed not the future in smoking control, but it may be difficult to escape the past unless a realignment of market forces and policies can be achieved.
The payload of the paper is 4 major recommendations and a summary, which I reproduce below…  my brief take on the four follows that:

1. Embrace the Concept of Regulating Tobacco Products Based on the Continuum of Risk 

Regulating based on the continuum of risk was a major component of the FDA/CTP July 2017 announcement and has conceptually been supported by many in the public health and scientific community, consumers, and even many in the manufacturing sector [44, 78 ]. As a start, public health organizations should be unified in supporting FDA‘s logical 2018 plan to establish a very low nicotine standard for combustible tobacco rendering cigarettes non -addictive [44,78, 82]. If this plan were implemented, one analysis suggests that approximately 5 million additional adult smokers could quit smoking within one year of implementation and, over time, more than 33 million people – mostly youth and young adults – would avoid becoming regular smokers, thus avoiding many millions of tobacco -related deaths [82]. Simultaneously public health groups should recognize and support a more flexible and adaptable regulatory framework that that will allow science -based lower risk products into the marketplace more expeditiously, while working to ensure that such products are not available, targeted or used by any children or adolescents.
Comment on 1. Yes, of course – risk-proportionate regulation is essential and in any other field it would be wholly uncontroversial and the normal practice of regulators (though not always successful).  But its supporters including me need to do more to specify what this would look like and how it would address real or perceived problems.  We need to understand, in detail, what is behind prohibitions of THR approaches – for example, the EU snus ban. It clearly isn’t public health and for supporters of the ban, risk-proportionate regulation is an irrelevance. The alternative approaches [prohibition][medicine][cigarette equivalence] and the justifications for them demand a deeper analysis – because therein lies the barrier to risk-proportionate regulation.

2. Update the Tobacco Control Act 

It has been over 10 years since the passage of the Tobacco Control Act. The statute needs to be critically reviewed and updated to reflect the changing marketplace of nicotine delivery products. Such review and updating of FDA statutes is routine in other areas of regulation such as foods, drugs, and medical devices. As a follow -up to the Institute of Medicine’s 2000 report Clearing the Smoke, public health groups and others could ask the FDA/CTP to request that the Health and Medicine Division of the National Academies of Science to do a thorough assessment on how the Tobacco Control Act might be updated to adapt to a rapidly evolving tobacco and nicotine market place [98]. Areas of review might focus on and include:
a) defining common terminologies and definitions that can allow for greater public understanding, and provide consistency in statutory, regulatory, and legal relevance;
b) creating product standards for the various categories of products that includes combustible products, non -combustible tobacco, nicotine products, and other possible alternatives;
c) developing comprehensive labeling, marketing and educational campaigns that would reflect the risks and relative risks of the products both in terms of product categories as well as individual products so that the public, users of products, the medical profession, and others would better understand the risks and relative risks of using one type of product over another; and
d) restructuring oversight of products so that all tobacco and nicotine products are under the same regulatory authorization within the CTP.
Comment on 2. Re-opening the US Tobacco Control Act should only be attempted once (1) has been successful – which probably requires (3) and (4) to work first.  The four recommendations would have been better cast as sequential and contingent. As things stand in the US Congress, a new TCA would be even worse than the one there is.  Much better in my view would be to persuade FDA to use its considerable latitude in interpreting the TCA to implement risk-proportionate regulation using the existing law.  For example, making category-wide decisions about non-combustibles, using more standards to bring transparency and efficiency to the authorisation process, relying more on individual risk for pre-market approval and addressing population risk with post-market surveillance.

3. Support Civil Dialogue on Issues of Smoking Harm Reduction 

The current climate in smoking harm reduction has become toxic and emotional, non – scientific, and counterproductive to achieving the public health goal of reducing premature deaths caused by using smoked tobacco (i.e., mainly cigarettes). We are not suggesting that we dismiss the past bad actions of the cigarette manufacturers, nor accept the claims of manufacturers of alternative nicotine products. Rather, we need to heed the lessons of the past so as not to make the same mistakes going forward. The Tobacco Control Act created a framework that should incentivize manufacturers to move away from profiting from the sale of cigarettes that causes so much harm to consumers. Promoting dialogue summits would allow for participants to engage in a civil manner, educate one another about challenges and opportunities and agree to specific measurable goals and objectives. Bringing stakeholders together will not resolve all differences but it will allow serious and responsible stakeholders the opportunity to bring ideas forward and find areas of common ground that can more rapidly advance population health. As an example, issues and concerns related to adolescent use of tobacco and nicotine products should be a major topic of concern, not only by the public health and tobacco control communities but by federal, state, and local policy makers and regulators, parents and teachers, responsible retailers and distributers, and many of those associated with the manufacturing businesses. While many stakeholders share common ground in this area, the polarizing and media driven approach that has been taken over the last several years has, in our view, caused what has become a war of rhetoric, with a lot of finger pointing and a failure to bring interested parties together to discuss how to collectively deal with the issue and find workable solutions to protect youth while allowing smokers to have access to cleaner alternative nicotine products.
Comment on 3. I do not think the reluctance to engage in civilised discourse is symmetric or the fault of THR advocates. The authors need a better analysis of why this has not happened successfully and inclusively despite many well-intentioned and ongoing attempts.  Even attending GFN now is deemed a sign of being a tobacco industry front.  In my view, the abstinence-only advocates have worked tirelessly to marginalise and delegitimize pro-THR voices, especially the user community and its representatives.  I think the reason is that they know the debate would be unsettling and the introduction of empathy into the discourse (essentially the proposal made here) would be destabilising to ideological positions they hold for reasons other than public health.  I don’t like, but can’t help, this negative tone because it’s how I see it and feel it.

4. Encourage Collaborative Scientific Research and Product Innovation

It is often said that it should be good science that drives the implementation of sound policies. The FDA/CTP could be doing much more to encourage academic scientists to partner with new or existing manufacturers to advance science in ways that would accelerate the introduction of lower risk products into the market place. All parties and stakeholders should be held accountable to meeting and following the strictest standards for peer review. There should be greater collaboration and data sharing, and a shared commitment to open science. Science should not be cherry picked for public relations purposes. The FDA/CTP can play an important role in further facilitating such discussions, helping set research priorities which would have a positive impact on the regulatory decision -making. For example, the FDA/CTP could in theory invite manufacturers to voluntarily utilize their peer review system to vet proposals designed to assist manufacturers prepare their PMTA and MRTP applications thereby opening this process , making it more competitive, transparent, and less secretive. Product manufacturers also ought to be incentivized to share their internal research and market data more widely with public health scientists so that there is greater confidence in product claims. The FDA/CTP and other groups can and should do more to hold scientific workshops that allow scientists and researchers to meet in a safe -haven environment and where opportunities would be allowed for seemingly opposing interests to find common ground in areas of science, research and innovation. Innovators of products should not be shut out because some regard them as industry.
Comment on 4. FDA/CTP and NIH could do a great deal to change the culture that its research funding nourishes. But they have not done that. In fact, they have celebrated and lavishly funded institutions and PIs with hard advocacy and unscientific perspectives. It’s almost as if as regulator, they are spending money to make the case for regulation and therefore their own pivotal role.   Those signals may change with a change of leadership, though I doubt it because the problem-finding incentive structure will not change.  Until it does, the scientific community in this field needs to own the problem, to clean house and stop tolerating the tsunami of really poor science that pours out of universities with made-for-media conclusions and press releases.

Summary

In summary, embracing risk -proportionate tobacco product regulation and taxation policies along with providing consumers with accurate public messaging on product relative risks offers the prospect of aligning market forces with public health goals to reduce deaths caused by cigarettes in ways that were never imagined decades ago. A regulatory framework based on sound science that encourages and rewards new or existing manufacturers to invest in consumer acceptable lower risk products to replace cigarettes needs to be encouraged. The past is indeed not the future in smoking control, but it may be difficult to escape the past unless a realignment of market forces and policies can be achieved.
Comments on summary: I agree with much of the analysis and prescriptions, but I fear the authors are trying too hard to frame the problem as a misunderstanding between people with common aims but a different way to go about it. This is commendable, but in my view a departure from a quite nasty and cynical reality – I think a closer look at the incentives and priors of those involved will explain why these perfectly reasonable recommendations have so far and will continue to struggle to find traction. One subject of study that is conspicuously absent in tobacco control is sociological or anthropological research into tobacco control itself – what are its aims and methods? What characteristics predict leadership? What are the attitudes to smokers and vapers? What moral intuitions underpin the work of researchers and activists?

2. The endgame revisited

The endgame revisited, Tobacco Reporter, 1 July 2020 [link]
By Clive Bates

It is time to confront the fundamental confusion about the public health aims for tobacco and nicotine policy

In 2013, the journal Tobacco Control published a supplement, “The Tobacco Endgame,” setting out various ways in which various experts thought a tobacco-free society could be attained. Ideas included annually increasing age limits, a cap and trade system, outright prohibition, taking control of the industry and making it put itself out of business, and removing most of the nicotine from cigarettes. In the intervening seven years, most of these ideas have not progressed at all. And rightly so, as I argued in a detailed critique, these policies are mostly impractical or excessively coercive and would fail if tried. The only one that attracted any real interest was the idea of lowering nicotine concentrations in cigarettes to make the product subaddictive (i.e., to eliminate the main reason people smoke). But even this de facto prohibition has not fared well. After backing the idea in 2017, the U.S. Food and Drug Administration (FDA) dropped the reduced nicotine rule from its regulatory plan in 2019. The most senior researchers engaged in the idea recently acknowledged that its viability would depend on the availability of credible safer alternatives to smoking.

So, all this begs the question, where is the endgame now? Or maybe the more interesting prior question is: endgame for what? What will end and what, if anything, will continue? Does the endgame mean the end of tobacco and nicotine use? Or is the endgame, as I believe, the final stages of a transition—a shift from an unsustainable to a sustainable nicotine market?

At the heart of this question is a fundamental confusion about the public health aims for tobacco and nicotine policy. This dispute is rarely surfaced and never resolved but confronting it has now become unavoidable. At least five objectives can be identified in tobacco control: (1) reducing disease and premature death; (2) eliminating smoking and smoke exposure; (3) eliminating tobacco; (4) destroying the tobacco industry; and (5) achieving the nicotine-free society or “ending nicotine addiction.” When the consumer nicotine market was supplied almost exclusively by cigarettes, it was possible for activists to say, “all of the above.” Activists could get away without having to declare or even recognize their underlying aims or to face the trade-offs and tensions between them.

No longer.

Even in the 1990s, splits in tobacco control were already emerging over snus, an obscure Scandinavian oral tobacco product. The faction interested in reducing disease was intrigued by Sweden’s abnormally low smoking rate. Toxicology and epidemiology suggested that substantially lower rates of disease in Swedish men were due to use of snus as an alternative to smoking. For that group, the harm reduction potential of snus had great potential. However, the faction interested in the end of tobacco saw the European Union’s ban on snus (other than in Sweden) as a win and incremental progress toward their goal of the tobacco-free society. Thirty years later, snus remains banned in the European Union despite undeniable evidence that snus reduces smoking and by doing so, reduces individual and population harm. This willingness to forego major public health benefits should tell us something fundamental: The dominant tobacco control faction is engaged in a war-on-drugs mission and not, as often assumed, a public health crusade. It is trying to forge a path toward a nicotine-free society with little concern for the collateral damage inflicted to health on the way to meeting its goal.

However, the rise of vapor and heated-tobacco products in the last 10 years means this is no longer a localized conflict. The harm reduction “proof of concept” of snus can now be generalized to an experience much closer to smoking in every respect other than harm to health. Add in the recent developments in oral nicotine pouches, which will make snus-like products more acceptable to a much larger population, and the diverse portfolio of smoke-free alternatives to smoking is starting to look quite formidable. The products available to nicotine users have changed beyond recognition in the last 10 years. If we project forward through another 10 years or 20 years of innovation in these new categories, imagine how the market could look in 2030 or 2040.

This is the opening phase of the technology disruption now roiling the industry. But it is also disrupting the tobacco control community by surfacing the tensions between its objectives. In particular, we are seeing the goal of the “nicotine-free society” coming to the fore, with an increasing stress on nicotine and the inclusion of goals to end nicotine use or “nicotine addiction” where there was previously an aim to pursue the end of smoking or to prevent disease.

Even many public health supporters of “tobacco harm reduction” see the smoke-free products as an expedient and effective way of helping to stop smoking—a sort of pimped-up nicotine-replacement therapy. And that is a good argument, as far as it goes. But it doesn’t really settle the question of our collective attitude to nicotine over the longer term.

To look ahead, let’s consider the situation in Norway where daily smoking among 16-year-old to 24-year-old women has fallen from 15 percent to only 1 percent in just 10 years, according to 2019 data from Statistics Norway. Have they stopped using nicotine? No, they have been using snus from the outset. By 2019, daily snus use was at 14 percent in this group. That group is now using nicotine without ever starting to smoke, and they probably never will. Harm reduction supporters argue that this is “a win” for public health because without the use of snus, many of these young women would otherwise be smoking. But how will that argument look in 10 years or 20 years when cigarette smoking may be well on the way to obsolescence?

Here we need to confront the deeper question about nicotine that goes beyond harm reduction in which the cigarette is the reference point for harm. The concept of harm reduction feels unsatisfactory in this context—what if no one uses a harmful product to start with? If there is going to be a long-term market for nicotine, the question becomes how to regulate a recreational nicotine market based on consumer-appealing products with risks that are within our normal appetites for risk? I believe the product portfolio is now evolving toward how it could look over the longer term—smokeless and electrically heated tobacco and nicotine products. I don’t expect the combustible products to disappear but to become a niche interest—like vinyl records in a world dominated by digital music streaming.

For some in tobacco control, this is a nightmare vision. This is not the nicotine-free society that has been their ultimate endgame. But if the harms are not particularly large and the drug is popular, why should governments stop people using it? Drug use is pervasive in human society and throughout history, perhaps started by our hominid ancestors millions of years ago. Nicotine, a relative newcomer, was domesticated between 6,000 years and 8,000 years ago. To say that a drug should be legal and available in relatively safe form is not to endorse its use or somehow to recommend it but to acknowledge that some people may wish to use it, and there isn’t a good reason to stop them by force of law. That idea has both philosophical and practical underpinnings. The philosophical foundation recognizes adult autonomy and the right to indulge in risky behaviors that do not harm others. The practical experience of prohibitions is that they do not work (a new supply chain is established by criminals) and cause serious harms to the individual and to wider society.

Prohibition does not even protect adolescents. Despite federal prohibition, past-30-day use of cannabis among U.S. 12th graders has been over 20 percent for at least a decade. The recent U.S. lung injury outbreak that hospitalized 2,800 and killed 689 was largely a consequence of reckless criminal behavior in the illicit supply of cannabis (THC) vapor products.

As a drug, nicotine is relatively innocuous—it doesn’t cause serious disease, intoxication, overdose, violence, road accidents, sexual vulnerability, incapacitation or family breakdown. Perversely, this relative safety becomes a serious tactical problem for the war-on-drugs tendency in tobacco control. If the prospects of cancer, lung disease and heart disease are greatly diminished, why should people fear nicotine? It is even possible that more people will take up nicotine if the consequences of using it are much less dreadful—that would be the economist’s assumption. Harm (from smoking) is the most persuasive reason not to use nicotine, and that reason is going up in a puff of vapor. In a weirdly inverted way, the greatest threat to the nicotine-free society is the availability of relatively safe nicotine products. I think that explains why so much strenuous, even desperate, effort is going into finding serious harms in smoke-free products though, beyond reasonable doubt, there are none.

3. What is going wrong?

I’m quite sure that most of the tobacco control community is currently acting in a way that supports the market for cigarettes and is prolonging the epidemic of smoking-related disease.  As David Sweanor puts it: they never miss an opportunity to miss an opportunity.  Where is the problem?

Candidates for responsibility for the faltering progress of tobacco harm reduction, especially in the United States, are as follows:
  • the multi-million dollar campaign against vaping/THR driven by arrogant billionaire prejudices and the ideological preferences of a few high profile activists
  • the flagrant bias and deceits of public health agencies like CDC (e.g. over EVALI, popcorn lung, brain disease, youth vaping and SG reports),
  • the modern media bias to producing clickbait driven by online engagement metrics and scientifically-illiterate (or scientifically-indifferent) journalists
  • the leadership in tobacco control and its approach – it was brought up fighting tobacco wars and that’s what it does
  • the work of ideologically motivated bad actors in science and their extensive networks of influence
  • the generation of a moral panic about vaping with anti-vaping campaigns like the Real Cost that are likely to generate curiosity and interest in vaping
  • the biases induced by FDA funding – it establishes a problem-finding rather than opportunity-seeking dynamic
  • the poor policy-making and implementation by FDA and states and worldwide (try to find impact assessments that consider unintended consequences),
  • the incredibly burdensome and uselessness of the PMTA route to market and MRTP route to claims combine to deny informed choice and this will get worse
  • the failure (or determination) of FDA not to make PMTA/MRTP more efficient, transparent and predictable
  • the prohibitionist outlook of WHO and its dogmatic stance against innovation in tobacco and nicotine products
  • the political grandstanding of European Union politicians and officials who do not understand the consequences of regulation and apparently do not care
  • the insularity of tobacco control – why so little interest in snus in Scandinavia, HTP in Japan, vaping in the UK – why so little interest in debate/discussion?
  • the misplaced unconditional opposition to anything the tobacco or vaping industry does, even if it is good, and the false premises of FCTC Article 5.3 and its guidance
Until public perceptions of relative risk are roughly aligned with reality and there is a supportive pro-innovation, policy, regulatory and communications environment, we do not know the potential of vaping, smokeless, oral nicotine and heated tobacco as consumer technologies. The weakness is not in the products or their likely evolution over the next two decades, but in the hostile environment into which they have been introduced.

GFN 2020: what has gone wrong?

4. Comments

Please comment on this and give you view.  Rule: please keep it polite and don’t get personal and start accusing individuals.

15 comments to The past is not the future – what lies ahead for tobacco and nicotine?

  • Mike Cummings

    First, I’d like to thank Clive for getting this dialogue going and thank those who have participated so far.
    Second, I’d like to address some of the comments from Jon Fell about my paper since he raises some interesting points.

    To what extent is addiction a conspiracy versus something inherent to traditional mass-market tobacco products?
    Product design, intentional or otherwise, is undoubtedly one of several factors that helped fuel the smoking epidemic of the 20th century. Other factors included automation which allowed companies to make cigarettes cheaply, and competition (the break up American Tobacco company in 1911 under the Sherman Anti-Trust Act). However, without creating a product that was easy to inhale, that delivered nicotine rapidly to the lungs, leading ultimately to the need to smoke every day, cigarettes would have been as popular as they became. RJR is often given credit for the invention of the modern cigarette – Camel. The success of the Camel blend was obvious because if was adopted by their competitors – Camel 1913; Lucky Strike 1916, Chesterfield – reformulated 1918 – these three brands dominate for the next 40 years. Having a product that people want is step one. Packaging and marketing of the product follows. Certainly, the growth of cigarettes in the first half of the century was driven by mass marketing and the absence of health concerns. The conspiracy to conceal the health risks of smoking is hatched in the early 1950s. However, the companies certainly understood why people were buying their cigarettes and nicotine was a key essential ingredient.
    How much of a difference to the addictive nature of cigarettes did design changes from the fifties onwards really make?
    Great question. Cigarettes were addictive before the 1950s and continued to be addictive afterward. However, understanding of why people smoked and how different design features would influence nicotine delivery certain advanced a lot from the 1950s onward. There were many design modifications to cigarettes from the 1950’s forward – filters, blends, reconstituted tobacco, expanded tobacco, use of different types of additives, etc. In the 1950s companies are extracting nicotine from tobacco and reapplying it in ways that allowed them to control dosing and consumer response. There was research going on to evaluate consumer response to extracted tobaccos.
    We now know that the design changes that companies implemented turned out not to lower the risks of smoking and there is evidence that suggests risks increased over time. Thun MJ, Carter BD, Feskanich D, et al. 50-year trends in smoking-related mortality in the United States. N Engl J Med. 2013;368(4):351-364. doi:10.1056/NEJMsa1211127
    Did companies really mislead consumers about the “feasibility of providing lower-risk alternative nicotine products”? Does that count as one of the ‘missed opportunities’?
    Yes, they did. By the 1950’s the companies had been put on notice that cigarettes caused lung cancer and probably other diseases as well. How did companies misled consumers – they lied about the health risk, they added filterers which they knew would not protect smokers (it was a marketing gimmick according to an executive form American Tobacco company in 1953). A 1967 BAT memo discusses the solution to the problem – make the smoke non-inhalable; remove the nicotine. They told the public they were going to fund scientific research on the allegations of smoking ad disease and share he information with the public. On and on….
    The key questions is whether they could create a safer product. They could take the nicotine out of the cigarettes. And it would’ve made a huge difference. (see paper by Levy et al. The Public Health Gains Had Cigarette Companies Chosen to Sell Very Low Nicotine Cigarettes. Nicotine & Tobacco Research, 2020, 1–9. doi:10.1093/ntr/ntaa128). They could’ve made the smoke hard to inhale. Traditional cigar smoke has a pH above 8.0 making it unpleasant to inhale. Smokers of traditional cigars have a much lower risk of disease compared to cigarette smokers because of smoke inhalation. Of course, you don’t have to burn tobacco to get nicotine – smokeless tobacco has been around for a long time and is much safer to use compared to cigarettes. Finally, the companies could have done more to reduce the toxins, and as the paper points out there are early patents for e-cigarettes. Project Ariel is an e-cigarette developed by BAT in the mid-1960s. I don’t dispute that it might have taken lower to move these products into the marketplace, but likely much sooner than happened. Of course, the most obvious.
    Can cigarette companies change?
    Cigarette companies have evolved and will continue to do so. Thus, change is a given. What kind of change is what counts? Right now, the incentives for change aren’t pushing companies to move away from making cigarettes. The cost of manufacturing a pack of cigarettes in the US is, according to Wall Street analyses, roughly 30 cents. The companies’ gross revenue (net of taxes, MSA payments etc.) is $2.30. A profit margin of 87%. No other legal product has on a sustainable basis come close. However, with appropriate regulatory incentives that could change. However, this requires embracing risk-proportionate regulation and taxation policies along with providing consumers with accurate public messaging on product relative risks. A regulatory framework based on sound science that encourages and rewards new or existing manufacturers to invest in consumer acceptable lower risk products to replace cigarettes needs to be encouraged. The past is indeed not the future in smoking control, but it may be difficult to escape the past unless a realignment of market forces and policies can be achieved.
    If you can’t stop mentioning the (tobacco) war, does that create its own barriers to dialogue and progress?
    You can’t erase the past, but you can learn from it. The point of the paper was not merely to blame cigarette companies, but to try to critically assess the mistakes made and being made by public health folks. Dialogue is important.
    Does an insistent focus on industry behaviour hinder consideration of other reasons why smokers still smoke or use other tobacco / nicotine products? Are all smokers victims or patients who need to be treated? Is there no room for discussion of pleasure as distinct from the mere satisfying of a craving? What other motivations are important for tobacco and nicotine consumers?
    There are really two parts to this response. First, it is clear that much of the disease and death caused by cigarettes is the result of how cigarettes are made to be hard to stop using, because of nicotine delivery. Accepting the FDA’s proposal to lower the nicotine so as to dramatically lower the abuse liability of cigarettes would mean that smokers would have choice to smoke, to get the pleasure of watching he smoke, getting taste from the tobacco, etc. What Clive acknowledges, and I agree with, most smokers would choice not to smoke, or not smoke in the same way as they do today – day in and day out, 10, 15, 20+ cigs per day. I favor a choice cigarette which is one where smokers can easily stop using if they chose.
    Second, are all smoker’s victims? Many are, but it would be hard to say all. Of course, it depends on what you mean by the term victim, which is a loaded term. I think we might agree that those who get sick from smoking are victims? Those who have been deceived or mislead probably are victims. Of course, that is no to say that may people claim to enjoy smoking and give lots of reasons for doing it. Some might even do it without nicotine – free choice.
    If smokers are patients, does that make e-cigarette users patients too? Where is the room to ‘rethink nicotine’
    I think the point of this question is who is the target group for alternative nicotine products like e-cigarettes? I would say from a public health smoking harm reduction perspective – daily cigarette smokers would be the target. I believe that is the group where the benefit will be most easily demonstrated. The question you are asking which is legitimate should we be concerned about nonsmokers (both never and former smokers) adopting e-cigarettes. It is a good question. From a smoking harm reduction perspective, it is hard to justify expanding the market to include nonsmokers.
    I would say the risks and benefits of e-cigarettes are well known for nonsmokers, there could be benefits that would justify what are likely to be some modest risks.
    The 4 proposals
    • Comment : The concept of mandating the removal of essentially all nicotine from cigarettes is accepted uncritically throughout the paper, without consideration of the practical or ethical challenges involved. If the alternatives to cigarettes are attractive enough to consumers, then smokers will switch to them anyway.
    • Response: There is probably more science to support very low nicotine in cigarettes than there is for the assumption that smokes will gladly switch to e-cigarettes with the right messaging as Clive suggests. We’ve had e-cigarettes widely accessible in the US and elsewhere for a decade in the US and England, and the impact on smoking behavior is not zero, but it is not huge either The promise and hype of yet better products is more bluster than fact so far…however, like Clive I have hope that things will evolve. But if you want to move people rapidly away from cigarettes, lower the appeal of cigarettes and improve the appeal of the alternatives—it seems like these ideas are synergistic and I can’t get my head around Clive’s claim that setting a standard for nicotine in cigarettes is prohibition. It is not. Companies can still make them, they can still try to sell them, people can buy and use them….that is not prohibition. The point is most smokers will not stick with them and companies will transform to smoking that is more economic viable. Their free choice.

    • Comment: I agree with Clive that opening up the TCA for redesign might currently run the risk of an even worse outcome than we have already.
    • Response: Sure, that could happen, but the FDA evolves all the time as the marketplace evolves. Fixing the regulation in a time warp that never considered the evolution of the tobacco product market landscape is the problem.

    • Comment: Dialogue is a good idea, but I worry that the views expressed in this paper actually help to cement attitudes which make constructive dialogue harder. Rather than arguing that adolescent use of nicotine products should be “a major topic of concern” I would frame it differently: concern over youth use of nicotine products shouldn’t let us lose sight of the major gains to be made for overall population heath from a much wider uptake of these products by people who would otherwise smoke.
    • Response: I accept the criticism and suggestion for reframing. I agree with you.

    • Comment: My impression is that product manufacturers can and do seek to share their research and market data widely, but are often met with an attitude that anything coming from them is tainted. Very large sums of money seem currently to be allocated in US research budgets to projects trying to prove that this is the case. Changing that dynamic probably needs a fundamental reset.
    • Response: I think finding a way for improved sharing of data would help. I agree there is a taint that makes it hard for academics to ask for data and likely a similar response from industry to share it. But, not all companies need to be the same…competition for transparency might actually be an advantage. I’m skeptical that important data is being withheld not only from scientists but also from investors. A

    • Jon Fell

      Thank you very much Dr Cummings for such a detailed and thoughtful response. I hope you don’t mind if I follow up on a few of the further points you raise.

      Nicotine removal
      You describe a 1967 BAT memo that discusses making the smoke from cigarettes non-inhalable and removing the nicotine as a ‘solution to the problem’. But can any company unilaterally decide to make its products so unpalatable to consumers that hardly anyone actually wants to buy it? Is that practically any different to just deciding to stop producing and selling cigarettes?
      You might say that mandating nicotine removal gets round the problem of companies not wanting to take this step unilaterally. But I do agree with Clive that this is tantamount to prohibition. Your remarks that “Some might even do it [smoke] without nicotine” and “most smokers will not stick with them” acknowledge that most people who smoke won’t want to consume cigarettes without nicotine – that is the whole point of the policy. Imagine doing something similar with alcoholic beverages: somebody might try to argue that mandating the removal of almost all alcohol didn’t amount to prohibition because people would still have the pleasure of pouring and tasting the drink, but who would be convinced by that?

      Tobacco company incentives
      Mandating the removal of essentially all nicotine from US cigarettes would create very substantial negative externalities, covered in detail by the responses of Altria and Reynolds American to the FDA’s ANPRM in 2018. And it seems like one of the reasons for supporting that policy is a belief that current incentives for the tobacco industry to evolve aren’t strong enough.
      You’re right that the US cigarette industry is very profitable (although there are a few others whose gross profit margins come close to that). But the value financial markets apply to a business is based on the size and longevity of profit streams: it’s not much use generating high margins in a tiny or fast-shrinking market. If people who smoke are going to want to move to new products, then cigarette manufacturers are highly-incentivised to participate in that shift and grab a share of the new market: they won’t have a business left otherwise.
      So companies are already being pushed to move away from making cigarettes, and they are putting very large amounts of resource into vaping, tobacco heating, smokeless tobacco, nicotine pouches etc. Tobacco heating products account for around a quarter of the market in Japan, and are at or approaching double-digit market shares in South Korea, a number of central European countries, Italy, Greece and Portugal. Nicotine pouches are making rapid progress in the US, Switzerland and Denmark. And even after stalling under a barrage of hostile campaigning from activist groups and flat-footed regulatory measures, vaping in the US probably still accounts for around 14% of the combined combustible / vaping market. Of course it would be good to see stronger progress still, but I don’t think it’s fair to dismiss these efforts as ‘hype and bluster’. You don’t need ‘science’ to show that consumers will gladly switch from combustibles to new nicotine and tobacco products: there are lots of practical examples of it in the real world.
      Financial markets recognise these dynamics very clearly too, giving much higher valuation multiples to those companies that generate a greater proportion of their revenues from less harmful tobacco and nicotine products rather than cigarettes. For instance, the profit streams of Swedish Match and PMI are valued much more highly than those of BAT or Imperial Brands. Another illustration of the incentive to innovate is the valuations attracted by those companies operating in the vaping business without any prior connection to tobacco: the peak $38bn valuation for Juul, or the ~US$28bn market capitalisation of leading Chinese vaping hardware manufacturer Smoore, which recently listed in Hong Kong (for a very clear discussion of investor attitudes to tobacco harm reduction see this recent blog post from Pieter Vorster at Idwala Research: https://www.idwala.co.uk/blog/smoores-valuation-shows-strong-thr-appetite). There are already tens of billions of dollars at stake – incentive enough?

      Regulatory framework
      I completely agree that regulatory frameworks need to embrace sound science and risk-proportionate rules, but there seems to be a massive amount of work to do here. For instance, you mention that smokeless tobacco has been around for a long time and is much safer to use compared to cigarettes. But US smokeless products have to carry this message: WARNING: This product is not a safe alternative to cigarettes.” In the EU smokeless tobacco products are, ludicrously, banned altogether unless they are intended to be chewed rather than placed between lip and gum.
      Many members of the public believe that vaping is as harmful, or more harmful, than cigarettes. There is a huge job to do to correct mistaken beliefs, but at the same time there are very well-funded bodies, ostensibly part of the ‘public health’ establishment, apparently committed to continuing to wage their campaigns of disinformation. Thus organisations such as the WHO, the American Lung Association, and Bloomberg-funded Expose Tobacco attack vaping and unite in criticising the FDA’s decision to authorise the marketing of PMI’s IQOS in the US as a modified risk product ( https://www.who.int/news-room/detail/27-07-2020-who-statement-on-heated-tobacco-products-and-the-us-fda-decision-regarding-iqos; https://www.lung.org/media/press-releases/fda-puts-kids-public-health-at-risk; https://exposetobacco.org/wp-content/uploads/STP054_FDA_IQOS_Brief_v3.pdf).
      What’s really slowed down the shift in consumption from combustible to reduced-harm tobacco and nicotine products, inadequate tobacco company incentives or the lack of a sensible regulatory framework? For me there’s no contest today. The scarcity of sensible regulatory approaches, exacerbated by the vested interests of campaigning tobacco control groups and academics, has had a vastly more deleterious impact.

      Future nicotine use and rethinking nicotine
      Actually my question was more about long-term recreational as opposed to medicinal use of nicotine and tobacco. I doubt that these products can truly be effective or attractive to the supposed target market if your definition of harm reduction only involves them being marketed to people who currently smoke, because I’m not sure that most consumers want to think of themselves as victims (or patients) who need to be treated. And if you say it’s only harm reduction if these products are marketed to people who smoke, does that imply that the products are in fact dangerous, and make it harder to persuade people to switch?
      I think you acknowledge that non-smokers could get some benefits from e-cigarettes, and that risks are likely to be modest. I believe this too, but this argument doesn’t seem to be made loud enough in public health, or by nearly enough people. Clive describes a world of long-term recreational use of harmless nicotine as a ‘nightmare vision’ for some in tobacco control. Unless this issue is tackled head-on I worry, as he seems to, that the motivation for this probably-dominant faction to dig for non-existent harmful effects will just get stronger.

  • Jon Fell

    This paper from Renée O’Leary and Riccardo Polosa, Tobacco harm reduction in the 21st century, seems very relevant too: https://www.emerald.com/insight/content/doi/10.1108/DAT-02-2020-0007/full/html

  • Bill Godshall

    I also agree with virtually all of the comments by Jon Fell.

    As one who campaigned from 2004-2009 to stop the 2009 TCA from being enacted by US Congress (because it protects cigarettes from future market competition from less harmful noncombustible tobacco products, and protects large tobacco manufacturers from small competitors), and who campaigned from 2011-2014 against the FDA’s Deeming Rule (because it protects cigarettes from future market competition by hundreds of thousands of nicotine vapor products, and protects the largest vapor manufacturers from tens of thousands of small competitors), I think it important to note the two US authors of “The past is not the future in tobacco control” repeatedly urged Congress to enact the 2009 TCA by claiming it would benefit THR and public health by encouraging tobacco companies to manufacture more new THR products.

    But had it not been for Altria’s aggressive lobbying of (and huge contributions to) US Congress, and Altria’s 2007 purchase of UST (which had been lobbying against the TCA), the TCA wouldn’t have been enacted.

    Also note that Altria (not the Big Pharma funded tobacco controllers) first urged FDA to impose the 2014 Deeming Rule in 2010 (to protect its recently acquired John Middleton Cigars from future market competition by hundreds of small cigar manufacturers), something that is also set to take effect Sept 9 when SE approvals (to a 2007 predicate cigar) are required to remain on the US market.

    All large tobacco companies endorsed all of FDA’s proposed tobacco regulations (including the Deeming Rule that bans >99.9% of nicotine vapor products Sept 9) up until the end of 2016 (until FDA proposed the extremely low nitrosamine regulation for smokeless tobacco products on the last week of Obama’s presidency).

    In 2014, Reynolds began lobbying many state legislatures to tax e-liquid by the ml (instead of ad valorem based on price) because doing so reduced Reynolds’ tax burden by 95% while greatly increasing tax burdens on open system vapers, vape shops and e-liquid manufacturers.

    And after Tom Cole (R-OK) introduced a bill to move the TCA’s 2007 predicate date to 2016, Altria and other large tobacco companies took over the bill (by convincing Reps Cole and Bishop to amend the bill in subsequent years to impose massive regulations on vapor products, and ultimately to eliminate the predicate date change for vapor products.

    Although tobacco controllers, FDA regulators, CDC propaganda, left wing Democrats, and the news media are all deserving of massive blame (for protecting cigarettes by demonizing and lobbying to ban low risk vapor and smokeless tobacco products), Altria and other large cigarette companies have also lobbied for the same anti-THR and anti-competitive cigarette protecting FDA tobacco regulations.

  • Jon Fell

    I very largely agree with your ‘Endgame revisited’ article but – while supporting the aims of its authors to shift the debate forward, encourage innovation and regulate tobacco products based on the risk continuum – found ‘The past is not the future in tobacco control’ somewhat curious. For a paper making that argument, to me it spends a surprisingly large amount of time looking backwards rather than forwards.

    I recall Clive once saying at the GTNF something along the lines of: “if you’re in public health and in favour of harm reduction, it helps to give yourself permission by making a big show of being anti-industry”. I can understand that, and appreciate and am grateful for the personal and career risks those advocating tobacco harm reduction might be taking. But I think it’s also worth asking whether the performative act itself can short-circuit fresh thinking, actually perpetuating the “toxic and emotional, non-scientific and counterproductive”. Does it run the risk of further “missed opportunities”?

    Here are some ideas / questions that the article raised for me:

    To what extent is addiction a conspiracy versus something inherent to traditional mass-market tobacco products?
    We are told early on that the rapid growth of cigarettes after their invention in the early twentieth century was because they used “fine cut tobaccos and blends which were milder to inhale, delivering nicotine into the large surface area of the lungs making cigarettes highly addictive”. But later on the authors argue that smokers find it hard to quit “because of the way cigarettes are designed. In other words, the crux of the smoking cessation problem has to do with the way cigarettes are engineered to cause and sustain nicotine addiction”.
    How much of a difference to the addictive nature of cigarettes did design changes from the fifties onwards really make? Were there materially different public health or smoking prevalence outcomes in countries where the cigarette industry evolved differently to the US, or where consumers used predominantly Virginian blend cigarettes, without the additives used in American blends? Was the experience in the Eastern ~Bloc or China, without the same kind of profit motive for manufacturers, any different?

    Did companies really mislead consumers about the “feasibility of providing lower-risk alternative nicotine products”? Does that count as one of the ‘missed opportunities’?
    I’m sceptical that patents from the 1920s and ‘30s, for removing nicotine from tobacco or for a proto e-cig, are evidence that reduced-risk products could have been produced a lot earlier than they were. Da Vinci is said to have designed a helicopter, but it still didn’t get built for another 400 years. Even allowing for the possibility of a US-wide conspiracy to stymie such products, how come nothing significant (ignoring snus and pharmaceutical therapies) emerged from the rest of the world for fifty years once the dangers of smoking became widely known? Where do efforts like the UK’s ‘new smoking material’, or the hundreds of millions of dollars spent on products like Reynolds’ Premier and PM USA’s Next de-nicotinised cigarette, fit into the picture? Haven’t, as the authors seem at the same time to recognise, “the internet and global product innovations” – I’d include leaps forward in battery and electronic component technology and miniaturisation – been the decisive factor in driving e-cigs from design concept to consumer reality?

    Can cigarette companies change?
    A large proportion of the paper is dedicated to a discussion of past industry misbehaviour, and its blame for past missed (US – what about international?) opportunities. I think it’s absolutely fair to “advise skepticism” with regard to the companies, but is there a point at which the healthily sceptical tips over into the unhelpfully cynical? If you treat the industry as essentially unchanging (which is the case from a legal perspective) and its participants as interchangeable, is it more difficult to understand the competitive dynamics which drive the market, and the factors which today determine shareholder value? Philip Morris Companies Inc and its successor, Altria, is on its seventh CEO since the 1994 congressional testimony (at which, so far as I can tell after watching four hours of testimony, only Andrew Tisch of Lorillard actually denied the health risks of smoking); its current CEO was born well after health warnings appeared on US packs. If you can’t stop mentioning the (tobacco) war, does that create its own barriers to dialogue and progress?

    “The recent Federal Trade Commission complaint regarding the Juul-Altria deal reinforces the need for extreme skepticism in accepting at face-value claims made by the cigarette manufacturers to transform their core cigarette business.” Why? It might be one of the most calamitous deals I’ve ever seen, but did Altria really blow $13bn without any intention of transforming its business? Where is the evidence that the FTC understands any of the public health issues at stake here?

    Does an insistent focus on industry behaviour hinder consideration of other reasons why smokers still smoke or use other tobacco / nicotine products?
    Implicit throughout the paper is the idea that smokers only smoke because they are addicted. “Progress with smoking cessation has been painfully slow” because “1) nicotine addiction makes it very hard to stop smoking; and 2) current treatments for nicotine addiction have limited effectiveness.” Are all smokers victims or patients who need to be treated? Is there no room for discussion of pleasure as distinct from the mere satisfying of a craving? What other motivations are important for tobacco and nicotine consumers? How is the centuries-long societal use of nicotine, recognised in Clive’s article, explained?

    If smokers are patients, does that make e-cigarette users patients too? Where is the room to ‘rethink nicotine’?
    I wonder to what extent resistance to the idea of tobacco harm reduction is driven by the same attitude towards the industry that much of this paper conveys. If you insist that cigarettes are addictive because they’re engineered that way, does that hamper your attempts to persuade sceptics that e-cigarettes, oral tobacco or other novel products are any different? Youth vaping is said to be “an unintended consequence of aggressive industry behaviour in an unfettered marketplace.” Is it that simple? “Lifestyle advertising” is mentioned disapprovingly, and contrasted with “health-related messaging which would be appealing to current adult smokers”. What if something smokers enjoy about these novel products, that they apparently don’t with NRT therapies, is that they’re recreational rather than medicinal?

    Two years ago FDA CTP’s Dr Zeller posed some challenging questions, including “How comfortable are we with long-term, or possibly permanent, use of less harmful nicotine delivery mechanisms by adults, if they help keep currently addicted smokers from relapsing to combustible tobacco products?” This paper seems to steer clear of this and other questions posed by Dr Zeller, and touch only in the most tentative fashion on the idea that use of lower-risk nicotine products should be acceptable for anyone other than “current addicted smokers”. Could there be any benefits to the use of nicotine in a clean form?

    Regarding the paper’s 4 proposals:
    1. The concept of mandating the removal of essentially all nicotine from cigarettes is accepted uncritically throughout the paper, without consideration of the practical or ethical challenges involved. If the alternatives to cigarettes are attractive enough to consumers, then smokers will switch to them anyway.
    2. I agree with Clive that opening up the TCA for redesign might currently run the risk of an even worse outcome than we have already.
    3. Dialogue is a good idea, but I worry that the views expressed in this paper actually help to cement attitudes which make constructive dialogue harder. Rather than arguing that adolescent use of nicotine products should be “a major topic of concern” I would frame it differently: concern over youth use of nicotine products shouldn’t let us lose sight of the major gains to be made for overall population heath from a much wider uptake of these products by people who would otherwise smoke.
    4. My impression is that product manufacturers can and do seek to share their research and market data widely, but are often met with an attitude that anything coming from them is tainted. Very large sums of money seem currently to be allocated in US research budgets to projects trying to prove that this is the case. Changing that dynamic probably needs a fundamental reset.

    Important disclosure: I worked as a tobacco industry analyst for various international investment banks from the early 1990s. I now work as a fund manager, and that fund – in which I invest myself – has holdings in several tobacco stocks. These are my own personal views, not those of my firm.

  • Bill Godshall

    I agree with virtually everything Clive wrote and said.

    But tobacco controllers and FDA regulators couldn’t have achieved their two key anti-THR tobacco policies in the US without help by large cigarette companies.

    To protect its Marlboro monopoly from future market competition by other brands (and by far less harmful smokeless tobacco products), Altria negotiated and aggressively lobbied (in collaboration with tobacco controllers) for eight years to attain the necessary votes in Congress to enact the 2009 TCA.

    Then, after I helped convince the large tobacco companies to begin marketing e-cigarettes and revealed the FDA Deeming Rule would ban virtually all of the tens of thousands of vapor products and let FDA give one or several tobacco companies a multi billion dollar e-cigarette monopoly/oligopoly, all of the tobacco companies endorsed and lobbied for FDA’s 2014 Deeming Rule (which also protects their cigarettes from further market erosion by vapor products).

    Some of the large e-cigarette manufacturers also endorsed and lobbied for the cigarette protecting Deeming Rule (in hopes of FDA approving their PMTA).

    Per Judge Grimm’s order, all nicotine vapor sales will be banned by FDA’s Deeming Rule on September 9 (in two months), although FDA almost certainly will allow at least several vapor products to remain legal on the market (as the agency reviews their PMTAs).

    Hopefully, FDA officials will sober up quickly and allow hundreds of different nicotine vapor products to remain legal (including open system products and dozens/hundreds of flavored e-liquids) as FDA reviews their PMTAs.

    Otherwise, the black market for nicotine vapor products will skyrocket in the US.

  • I think your analyses, while mostly exact, are excessively (almost exclusively) centered on the US. The resistance to the anti-thr approach, mostly fueled by US philanthrocapitalists can be best organized at the world level (including for WHO) by increasing the organizing efforts in other countries, especially the EU where there are significant states that could make a diffwrence and refuse to follow the US prohibitionist push: Italy, France, Germany, Spain could already constitute a veto block at the EU level and impact the WHO as well. Such organizing will require a higher level of $ resources than presently available. On that score, one elephant in the room is the Foundation for a Smoke-Free World: what could be usefully done with $80 million per year? Not seriously and persistently engaging/challenging Derek Yach about how those funds are used is giving up having any say/influence on the largest private funding that exists. Just saying publicly what ‘you’ think/wish should be done with such a budget, what is lacking, would hopefully be an incentive for a better use of the funds ultimately provided by PMI customers. More than welcoming the traditional tobacco industry, there should be an effort to engage the many still independent e-cig entrepreneurs, who create flavors, the so many devoted vape shop owners who help so many people to quit, and of course the millions of vapers. It’s a new type of coalition and international network to build. Without forgetting the elephant…

  • Jon Fell

    Very interesting post, as usual Clive. I can see what Cummings et al are trying to do with their paper but I find the whole thing quite odd and in itself a good illustration of the problems which hamper progress on these issues. Still piecing my thoughts together, but planning to follow up with more in the next few days!

  • Irish Lass

    I agree that there is more going on than a misunderstanding between factions with the same goals.

    I think Robert Harvey has already made most of the points that I would make.

    I also agree with your comments on the first paper, Clive.

    I hope that your ongoing attempts get somewhere, but I have become sceptical because it seems as though most governments still listen to the WHO and tobacco control, exclusively. I do admire you for not throwing in the towel. What you are doing is right, and deserves to succeed.

  • robert harvey

    1- better then lowering the nicotine make it illegal to add chemical components to cigarettes that make them more addictive in the first place.
    In recent decades, more and more additives have been introduced, and current cigarettes may contain up to 10 per cent additives by weight. Nearly 600 different additives have been documented.
    2- tobacco endgame is just fancy words that make it look like regulators are trying to end tobacco use.
    in truth government rely too much on the income from tobacco sales to phase tobacco out otherwise they would support reduced risk products such as e-cigs and snus that could replace tobacco use within a generation.
    3- the points here only support my conclusions on the myth that is ‘tobacco end game’.

  • Paul Mitchell Johnson

    As usual, you’re spot on, Clive. The war on vaping is not a science based public health concern. It is an ideological war on a “perceived problem” without concern for the unintended consequences. It is driven by smugness & arrogance and is funded by those who wish to mold the world into their vision of what is right and good. A “my size fits all” approach. Sadly, too few are paying attention to what you have exposed and too many are hearing and believing what they want to hear. That vaping is as bad or worse than cigarettes and Congress is putting an end to those evil things. In short, they are winning. The Senate just passed a USPS ban on product delivery, no doubt it will pass the House in two weeks with little if any debate on the subject. Meanwhile, the Wuhan Corona Virus pandemic rages on in this country. Interesting timing, wouldn’t you say. Don’t we have bigger fish to fry? Not for them, a nicotine free world is their goal. A snob free world is ours.

  • […] The past is not the future – what lies ahead for tobacco and nicotine? […]

  • […] The past is not the future – what lies ahead for tobacco and nicotine? […]

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