Category: Derek Yach

  • Regulators Urged to Embrace THR

    Regulators Urged to Embrace THR

    More than 1.8 million lives could be saved within the next 40 years by replacing World Health Organization-directed tobacco control efforts with products like vapes and e-cigarettes, snus and nicotine pouches, a new study has found. Urgent action is required to tackle continuing prevalence of smoking as global efforts to end smoking have stalled and current approaches to tobacco control have proven insufficient, the researchers said.

    Instead of current measures, researchers found that tobacco harm reduction (THR) products that replace smoking with nicotine alternatives promise to make a significant improvement in health outcomes in the Middle East and save millions of lives.

    The researchers studied the impact of tobacco use in seven countries in the Middle East including Pakistan, Egypt, Lebanon, Jordan, Kuwait, Saudi Arabia and the UAE, and determined that more than 384,000 die prematurely annually due to tobacco use. Tobacco use contributes to several major causes of death in these countries including lung and oral cancer, COPD, heart disease, and stroke, which are all set to increase in prevalence over the next few decades.

    The ideal means of reducing this burden is through THR products which use nicotine without the deadly byproducts that cause disease. THR products like e-cigarettes/vapes, heated tobacco products, snus, nicotine pouches and charcoal free shisha are rapidly gaining traction among consumers in the Middle East and are considerably safer than smoking. However, these innovations have not yet been embraced by physicians and governments as means of cutting premature deaths. 

    Embracing THR, cessation, and improved lung cancer treatment represents a major opportunity for the Middle East to dramatically improve the health of its populations.

    Derek Yach, lead author

    The report comes as the quality of evidence on the benefits of smoking cessation and THR has strengthened. Stopping tobacco use at any age is associated with longer survival, and switching to THR products is almost twice as effective for cessation as nicotine replacement therapies. While long-term studies on the health benefits of switching to THR are still needed, results of studies using biomarkers of future diseases are promising.

    The report comes at a critical time as many Middle East countries’ reverse bans on some THR products and liberalize their approach to tobacco alternatives. Meanwhile, new and innovative THR products are being developed for the Middle East signaling the growing acceptance of the value of THR and the demand for them by consumers.

    To benefit from the promise of these products the authors recommend educating physicians to communicate the benefits of THR to patients in all clinical encounters, countering disinformation about nicotine and the value of THR, and developing a regional equivalent of the Royal College of Physicians report on THR and vapes. The authors also recommend that policymakers revise regulations to improve access to THR products and invest in national science and research to replace tobacco with THR and establishing independent science-based consumer groups to advocate for their needs. The authors  encourage religious leaders to guide their communities to quit smoking and support tobacco harm reduction.

    “Embracing THR, cessation, and improved lung cancer treatment represents a major opportunity for the Middle East to dramatically improve the health of its populations,” said Derek Yach, lead author of the report, global health consultant and former senior WHO official. “The prevalence of smoking is projected to only decrease by less than 2 percentage, from 33.3 percent in 2020 to 31 percent in 2025. This preventable disaster should engender outrage and immediate action. This report aims to provide an alternative vision of what is possible.”

    Figure: Projected deaths from tobacco in 2060

    This figure shows the number of tobacco deaths expected to occur in 2060 using three scenarios: WHO projections using FCTC and MPOWER measures; WHO projections adding THR products; and WHO projection adding THR, smoking cessation and, lung cancer innovations.
  • The Takeaways

    The Takeaways

    REDPIXEL

    What did we learn from the E-Cig Summit in Washington, D.C.?

    By Derek Yach

    The E-Cig Summit comes at a time of change in how tobacco harm reduction (THR) products are regarded by those who oppose or support their use as a means of ending smoking. In recent months, new reports, editorials and comments in leading medical journals have highlighted the benefits of vapes for smoking cessation.1,2,3,4 Further, calls for medically licensed vapes have increased from academics who rarely agree on THR policies.5

    Robin Mermelstein, director of the Institute for Health Research and Policy at the University of Illinois, opened the meeting by noting that diverse perspectives are needed for innovations required to end combustible use. With no scientists from the private sector allowed to present research (except for former Center for Tobacco Products [CTP] Director Mitch Zeller, who is currently an advisor to Qnovia), this goal was tough to achieve. And it comes shortly after an editorial in Nicotine and Tobacco Research, the lead journal of the Society for Research on Nicotine and Tobacco, calling for complete exclusion of industry scientists.6 One wonders how widely supported this view is.

    I summarize key inputs from the Summit that address six questions:

    1. What are the major trends in cigarettes and vape use in the United States?

    Rafael Meza of the BC Cancer Research Institute showed that smoking and vaping prevalence in youth has declined. Frequent use (20 days or more over 30 days) is about 6 percent for smoking and vaping in both boys and girls. Among adults in middle age, cigarette consumption has declined in tandem with vaping increasing. Smoking rates, however, have not declined among people over 65 and remain highest among those with the lowest incomes and education. Meza’s projections of future trends are flawed by excluding probable impacts of heated-tobacco products and nicotine pounces joining vapes as providing alternatives to combustibles over the next few years.

    Only 4 percent of all smokers live in the U.S. Resources and debate about global policies are shaped heavily by U.S. federal, academic, nonprofit, philanthropic and private sector perspectives. Global realities need to be brought into summits. To mention two. First, smoking rates exceed 40 percent in men across most Middle East and Eastern European countries and in China and Indonesia. Smoking rates exceed 20 percent in women across Eastern Europe and small island states. These were rates in the U.S. 40 years to 50 years ago. THR provides a route to leapfrog over the road taken by the USA.

    Second, toxic smokeless tobacco products are commonly used, especially across South Asia, and cause about 350,000 oral cancer deaths. Nicotine pouches could well be the route to eliminating this dreadful cancer. A global perspective would place this as an achievable goal.

    1. Is there greater balance in addressing the needs of adults who smoke and those who have early disease compared to what has been a dominant focus in past summits on youth?

    CTP Director Brian King stressed that youth issues remain his priority. In response to Mermelstein, he could not explain why this remains a priority, given extremely low vape use in youth and the absence of convincing evidence that vapes are a gateway to combustibles. In contrast, both the U.K. and New Zealand give priority to ending combustible use in adults.

    King repeated his advice to adults who smoke: first use Food and Drug Administration-approved cessation medications and only then FDA-authorized reduced-risk products. Dual use is not supported. This advice is not in line with current evidence presented at the conference or multiple reports.1,2,3,4,5 Vapes are the most effective means to quit. Dual use lowers overall risks.

    Scott Sherman of New York University stressed that the ultimate goals of tobacco control are to prevent the burden of tobacco-related disease. About 70 percent of people smoke when diagnosed with chronic obstructive pulmonary disease, peripheral vascular disease, schizophrenia, alcohol use disorders and several cancers, to name some major outcomes. The majority are still smoking years after their diagnosis. Sherman believes such patients would benefit from trying vapes. There are few studies in this area. He outlined a small pilot study of patients with chronic diseases comparing vape use to nicotine-replacement therapy (NRT) use that motivates for larger studies. Patients with early-stage chronic diseases who are between 40 years and 55 years of age who quit are likely to yield major health benefits.

    1. Is there evidence of the benefits of nicotine pouches, snus and heated-tobacco products as cessation interventions to complement studies of vapes? And are there studies comparing these products to NRTs and medicated solutions?

    There are few such studies. Jamie Hartmann-Boyce of the University of Massachusetts and the Cochrane Collaboration presented a Cochrane review using indirect methods to compare a range of interventions. Vapes, NRTs and cytosine showed the strongest evidence of cessation effectiveness compared to other medications and interventions. She stressed the need for more high-quality studies. Public, philanthropic and industry funders should invest in such research among populations and countries where smoking and toxic smokeless tobacco rates are extremely high.

    1. Were the benefits of using biomarkers to demonstrate the effects of switching from tobacco products to THR options on proxy health outcomes discussed?

    Zeller mentioned new real-world evidence using biomarkers that suggest benefits of dual use (of vapes and combustibles) in terms of proxy health outcomes. Mike Cummings briefly mentioned the need to use biomarkers of exposure and outcome to accelerate knowledge about THR impact on health outcomes. As an epidemiologist, I have long felt that we need to complement self-reporting and mortality-based studies with use of 21st century biomarkers that allow for more accurate assessment of exposure and earlier determination of outcomes. Tobacco industry scientists currently lead in developing and using biomarkers. Their extensive list of peer-reviewed publications should be cited and used by academics.

    1. There have been important discussions recently in the New England Journal of Medicine (NEJM) and JAMA about the benefits of medical licensing THR products. What are the views of the regulators, industry and academics in going this route and, more broadly, in supporting vapes as an effective way to quit?

    Zeller believes improved medically approved tobacco harm reduction products are part of increasing access for adults to reduced-risk products. Nancy Rigotti of Mass General Hospital stated that a medical pathway is needed despite no medically approved products being available. Her views are based on knowledge that physician practices have widespread impact on their patients and on policies. She is concerned that the U.S. Preventive Services Task Force, the American Cancer Society, the Centers for Disease Control and Prevention, and the American Heart Association are still unclear about the benefits of vapes as being the most cost-effective means of achieving cessation. Their statements are either ambiguous or explicitly oppose vape use for cessation. She restated her NEJM call for clinicians to strongly advise patients who smoke to try vapes.2

    King did not address this, and he deflected issues related to cessation to the FDA’s Center for Drug Evaluation and Research (CDER). The lead FDA tobacco chief should have an integrated approach to ending smoking that involved the CTP and the CDER. That is the spirit of the messages in recent influential journals by leading academics and former FDA heads.3,5 Further, the FDA 2015 CDER guidance on alcohol shows how it accepts abstinence and harm reduction endpoints used for drug approvals. It seems time that the CTP and the CDER could learn how well this is working to end the harm of tobacco use.

    Both Neal Benowitz and Clive Bates of Counterfactual Consulting said we need to address the benefits of nicotine as a range of new products become available. This has implications for future medical licensing and recreational use. We need innovative ways to tease nicotine effects from combustible smoke effects to make progress on the regulatory front and to inform messaging to health professionals and smokers. A recent paper by Jasmine Khouja and her colleagues that used biobank data and multivariable Mendelian Randomization elegantly showed that most harms of smoking are unrelated to nicotine.8 Hopefully, work looking at the benefits of nicotine for Parkinson’s disease will follow. I recommend readers watch this space.

    1. Can THR practices outside of the U.S. inform U.S. policy?

    Like the U.S., adult smoking rates in the U.K. and New Zealand have declined as vaping has increased. Deborah Arnott of Action on Smoking and Health (ASH) U.K. indicated that dual use has followed the path seen years ago when NRTs were introduced and regarded this as a transitional route to eventual cessation. This is an important insight for U.S. policymakers to acknowledge.

    The U.K.-proposed legislation includes a ban on disposables, a new tax on e-liquid (which may reduce illicit trade from China and will maintain a differential tax relative to cigarettes) and measures to reduce the appeal of vaping to children in ways that allow adults to have continued access. Arnott supports vape promotion approaches that have more clinical and fact-based features and other policies that regulate proportionate to risk.

    Ben Youdan of ASH New Zealand showed that for years, New Zealand and Australia had similar rates of decline in adult smoking. Over five years, however, adult rates have diverged, with New Zealand rates falling faster. He believes this is based on differences in vape policies and messaging. New Zealand media and policies support vaping to quit, especially among the Indigenous population. Martin Dockrell of the U.K. Department of Health and Social Care described U.K. government-funded programs to provide vapes to homeless people, people with mental illness and other groups with high smoking rates. The hope is that these initiatives will lower social class inequalities in chronic diseases that are strongly driven by differences in smoking rates.

    Ben Youdan stated that Australia “treats people who vape as criminals or as sick people incapable of self-determination.” The result of this is that 90 percent of vapes on the Australian market are illicit while cigarette access is universal. The opposite is true in New Zealand.

    King mentioned that the FDA is committed to health equity. The FDA should learn from the U.K.’s and New Zealand’s vape policies.Concluding Comments

    The extent of misinformation was a topic that pervaded sessions. Alex Clark of the Consumer Advocates for Smoke Free Alternatives Association gave examples of how the FDA’s youth education campaigns have contributed to negatives views about vapes and nicotine. This could accelerate with the deployment of Chatbots that are explicitly programmed to spread misinformation about vapes and nicotine, the latest WHO one being a notable worrying example.9 Researchers need to rapidly engage computer scientists in building AI-driven ways to address misinformation continuously and at scale before the digital space is dominated by those who oppose harm reduction. This could draw upon the promising results of correcting misbeliefs about nicotine causing cancer and about vapes reported by Andrea Villanti of Rutgers.

    For several years, E-Cig Summits and related standalone vape meetings have led thought leadership about the value of tobacco harm reduction. With the growth of a spectrum of reduced-risk products now available, is it time to consider transitioning such meetings into opportunities to address emerging ways to end smoking and the use of toxic smokeless tobacco products through a wider range of products? That would encourage comparative studies and for a deeper examination of how consumers use products throughout the day. It would also allow for policy discussions that focus more on harnessing a wider community of users and innovative companies to compete to accelerate an end to smoking.

    David Levy of Georgetown University and Bates both made these point very strongly by placing the needs and interests of consumers first and seeing competition between companies and products as beneficial to meeting consumer needs to improve their health.

    For that to succeed, future conferences will need to adopt Mermelstein’s opening words in practice and end boycotts and bans of industry scientists so that all actively developing innovative ways to make progress can debate the best ways forward together.

     

     

     

    A global health expert and anti-smoking advocate for more than 30 years, Derek Yach is the owner of Global Health Strategies. Previously, Yach was the director of the Foundation for a Smoke-Free World and a World Health Organization cabinet director and executive director for noncommunicable diseases and mental health. He was deeply involved with the development of the Framework Convention on Tobacco Control.

    References

    1. Electronic cigarettes for smoking cessation – Lindson, N – 2024 | Cochrane Library
    2. Electronic Cigarettes for Smoking Cessation — Have We Reached a Tipping Point? | New England Journal of Medicine (nejm.org)
    3. Bolstering FDA Pathways for Reducing Death and Disease from Tobacco | JAMA Health Forum | JAMA Network
    4. E-cigarettes and harm reduction: An evidence review | RCP London
    5. How the FDA Can Improve Public Health — Helping People Stop Smoking | New England Journal of Medicine (nejm.org)
    6. Commercial Tobacco and Nicotine Industry-Funded Research Has No Place in SRNT and Nicotine & Tobacco Research | Nicotine & Tobacco Research | Oxford Academic (oup.com)
    7. https://www.fda.gov/files/drugs/published/Alcoholism—Developing-Drugs-for-Treatment.pdf
    8. Estimating the health impact of nicotine exposure by dissecting the effects of nicotine versus non-nicotine constituents of tobacco smoke: A multivariable Mendelian randomisation study – PubMed (nih.gov)
    9. Philanthro-colonialism: Bloomberg and the WHO — Marc Gunther
  • The Promise of Synthetic Nicotine

    The Promise of Synthetic Nicotine

    Photo: Oksana Fedorchuk

    As consumer demand for healthier and more environmentally friendly alternatives to combustible cigarettes increases, we should expect greater focus on the benefits of this man-made alternative.

    By Derek Yach

    Tobacco-derived nicotine has been the sole source of nicotine used by pharmaceutical and tobacco companies until recently. The naming of the sector (tobacco sector), the naming of companies (British American Tobacco for example) and the framing of public health policies as tobacco control all show how pervasive and deeply embedded the word tobacco has become despite its scientific name being Nicotiana.

    The dominance of tobacco plants started to wane when pharmaceutical companies developed nicotine-replacement therapies (NRTs) as cessation products. That highlighted the fact that while nicotine is addictive, it is not the source of death and disease caused by the products of combustion. The advent of a wide range of consumer-facing products that also use nicotine (especially e-cigarettes and nicotine pouches) to help smokers switch and/or quit has further increased the focus on nicotine.

    Initially, there was no debate about the source of nicotine since it was assumed to come from the plant. In recent years, several companies have started using patented laboratory processes to develop nicotine from scratch. Many, like Zanoprima, use green chemistry to convert plant-based molecules into synthetic nicotine. Other companies, such as Contraf-Nicotex-Tobacco (CNT), begin with plant-based molecules used in cosmetics and derived from vitamin B.

    Nicotine, like many molecules, exists in two orientations: S-nicotine and R-nicotine; however, nicotine that occurs naturally in the tobacco plant is entirely S-nicotine. Prior to the popularization of synthetic nicotine, this distinction had not been of great practical importance due to its naturally occurring form. Pharmaceutical-grade synthetic nicotine manufacturers such as CNT and Njoy therefore treat R-nicotine as a byproduct of the S-nicotine manufacturing process while Zanoprima’s patented process does not produce R-nicotine at all. Other manufacturers may use methods that may well not meet the high-quality standards of the pharmaceutical industry.

    What Benefits Does It Bring to Consumers and the Environment?

    Consumers increasingly demand information about the supply chain of end products. Leading food companies have led in being transparent about the source of all ingredients in their products with a shift toward those where labor conditions on the farm are known, addition of chemicals are reported, water and greenhouse gas use associated with products are made public and the traceability of food product ingredients is independently audited. Investors are more likely to invest in companies with sound records on these issues.

    So it will be for all future nicotine products.

    For many combustible users, the incentive to switch to a reduced-risk product usually starts with a desire to lower health risks. But for a considerable number, environmental issues are fast becoming reasons to switch, often independent of their health concerns. Again, this has its analogy in the food sector, where companies like Whole Foods have built their main value proposition on an environmental benefit, with health credentials being dubious.

    The tobacco industry emits 84 million metric tons of carbon dioxide (CO2) a year, which is equivalent to 0.2 percent of global CO2 emissions, according to researchers at Imperial College London. Of the total, 20.87 million tons of CO2 come from cultivation, and 44.65 million tons of CO2 come from curing, together amounting to 78 percent of all tobacco industry emissions. Synthetic nicotine has the potential to virtually eliminate these.

    Synthetic nicotine brings tangible benefits to consumers: A better sensorial experience, assurances about the absence of contaminants and a stamp of quality good enough for pharmaceutical companies, to name a few.

    The recent World Health Organization report Tobacco: Poisoning Our Planet paints a vivid picture of the harms of tobacco farming, curing and processing for the environment. More recently, the Foundation for a Smoke-Free World provided a qualitative summary of the potential sources of environmental harm associated with reduced-risk products. Both the WHO and the foundation advocate for the reduction in global tobacco farming, outlining the harms caused by tobacco growth and cultivation on arable land, workers’ rights and malnutrition. It is likely that products created with synthetic nicotine can mitigate many concerns in the product lifecycle. And as companies selling clean nicotine push harder to ensure their products are recyclable and/or reusable, the overall negative environmental footprint will decline further.

    Where Is It Likely to Grow Fastest?

    Today, synthetic nicotine is used in next-generation nicotine products by emerging nicotine pouch companies like NIIN and by mainstream vape companies like Njoy. This trend is set to continue and will gain traction as e-cigarettes and nicotine pouch companies seek medical licensing using synthetic nicotine.

    One example is SMOOD, an up-and-coming next-generation e-cigarette and NRT company based in New York City. SMOOD creates its products as a comprehensive approach to address both health and environmental issues simultaneously. Synthetic nicotine, recyclable hardware and design features to support smokers to quit may well be a signal of what is to come. “We always used nontobacco nicotine due to the absence of minor tobacco alkaloids and metals, both of which are inherent in agricultural production,” says Martin Steinbauer, chief engineer of SMOOD. “Together with repeatable pharmaceutical production processes, nontobacco nicotine improves the toxicological safety of our devices and eliminates carbon emissions, water use and deforestation from tobacco growing. Most importantly, it offers a clean break of nicotine from tobacco finally.”

    Snus and heated-tobacco products are unlikely to shift away from tobacco in the medium term but are lowering the health risks of the tobacco they use through processing changes in the case of snus and by eliminating combustion in the case of heated-tobacco products. For decades to come, tobacco plants will be used in these products as well as in combustibles like cigarettes and cigars where a significant demand from consumers is likely to remain even as overall demand declines.

    Most major tobacco companies already support farmers to diversify. It will be interesting to watch the dynamic within companies with large and growing reduced-risk portfolios who will continue to sell combustibles even as they shift to reduced-risk products to a greater extent in later numbers for several decades. Altria’s purchase of Njoy, Philip Morris International’s acquisition of Swedish Match and BAT’s dominance in the U.S. vape space all signal that these companies will take a twin track approach to nicotine sourcing.

    Who Makes It and How Do They See the Future?

    CNT has stated that synthetic nicotine is currently a niche product with enormous potential. “We see enormous demand there and the capacity for the synthesis of chemical is unlimited.”

    Zanoprima, the only company to use myosmine as the starting material believe that in time synthetic nicotine will become the main source of nicotine in pharmaceutical products as well as in products likely to be sold as both medically approved cessation products, and as recreational products for ex-smokers to use.

    Isn’t It Expensive To Use?

    No—prices have been dropping recently and will continue to do so as demand increases.

    Conclusion

    Health and environmental consumer demand combined with benefits in terms of quality and safety, suggest that synthetic nicotine is set to meet its potential in the coming years.

    A global health expert and anti-smoking advocate for more than 30 years, Derek Yach is the owner of Global Health Strategies. Previously, Yach was the director of the Foundation for a Smoke-Free World and a World Health Organization cabinet director and executive director for noncommunicable diseases and mental health. He was deeply involved with the development of the Framework Convention on Tobacco Control.
  • Derek Yach

    Derek Yach

    A global health expert and anti-smoking advocate for more than 30 years, Derek Yach is the owner of Global Health Strategies. Previously, Yach was the director of the Foundation for a Smoke-Free World and a World Health Organization cabinet director and executive director for noncommunicable diseases and mental health. He was deeply involved with the development of the Framework Convention on Tobacco Control. On this page we feature a selection of Yach’s contributions to Tobacco Reporter.

    The Takeaways

    Tobacco harm reduction advocate Derek Yach reflects on the lessons from the recent Ecig Summit in Washington, DC.

    Derek Yach

    Read a selection of articles from our special contributor Derek Yach.

    Doctor’s Orders

    Medical licensing of e-cigarettes and nicotine pouches should be an urgent priority, writes Derek Yach.

  • Doctor’s Orders

    Doctor’s Orders

    Photo: Minerva Studio

    Medical licensing of e-cigarettes and nicotine pouches should be an urgent priority.

    By Derek Yach

    The alarm about the risks of products to health is usually first sounded by physicians. That was certainly the case with tobacco and health. The 1962 Royal College of Physicians (RCP) Report on Smoking as well as the 1964 Surgeon General’s (SG) Report on the same topic were led by physicians and drew upon the best epidemiological evidence available. The reports’ statement that “smoking kills” led to rapid changes in physicians’ smoking behavior well before regulators took up the challenge. The world had to wait eight years before the World Health Organization passed its first modest resolution on smoking. Only then did modest public health policies emerge.

    Internationally, the evidence is clear: No country experiences a serious decline in their smoking rates before it declines among physicians. And it takes about a decade before the population benefits start appearing. Globally, smoking rates among men approach 40 percent to 50 percent in countries as diverse as China, Bulgaria, Jordan and Bangladesh—or 50 years behind where the U.K. is today. Smoking rates among the physicians in these countries are about the same. There are few examples of physician-led reports like those of the RCP or SG from middle-income or lower middle-income countries. In such settings, we cannot expect to see substantial progress in ending smoking if we stick with the status quo.

    Physician Leadership Is Crucial for the Introduction of Innovative Interventions

    Innovations in healthcare are usually led by physicians armed with solid epidemiological and clinical data showing the benefits of new interventions for patients and the population. Physician leadership gives credibility to new products. The opposite is also true. Products that are not endorsed or approved by physicians rarely achieve population benefits and may face stiff regulatory approval.

    Sluggish Progress on Improving Cessation Outcomes

    For decades, physicians have followed a “medicalization” path to cessation, so it is not surprising that they have neglected tobacco harm reduction (THR) options. The basic advice given by physicians has changed little. Quit cold turkey, counseling, nicotine-replacement therapies (NRTs) and a few other pharmaceutical and behavioral services remain the mainstay of cessation. None have success rates that exceed 15 percent over the year, and most are associated with repeated relapses. The World Health Organization’s own reports to the World Health Assembly this year pointed to slow progress in addressing cessation. Numerous reports, such as those issued by the Foundation for a Smoke-Free World, have pointed to the failure of the pharmaceutical industry to bring better cessation tools to the market despite advances in behavioral and neuroscience that have led to new therapies for a range of diseases.

    It is long overdue that physicians have access to far more efficacious and effective ways of ending smoking. We now have a full range of feasible options that have been authorized by the U.S. Food and Drug Administration as “appropriate for the protection of public health”: heated-tobacco products, e-cigarettes, snus and most recently nicotine pouches. E-cigarettes and nicotine pouches are well placed to form the basis of a new approach to cessation and harm reduction.

    How Do We Engage Physicians in Scaling up Access to These Lifesaving Products?

    Recent experience shows that physicians have been resistant to these products for several reasons. They fear these are a new tactic by the tobacco industry to keep the next generation addicted. They seek data on long-term benefits. They are bamboozled daily by well-funded nonprofits and WHO messages about the dangers of these products for kids, and the impact of them on cancer or heart disease. The fact that none of this is based on science has not stopped the opposition.

    Could Medically Licensed Products Break Through and Reach Physicians?

    I strongly believe that they could.

    At a recent Keller and Heckman meeting, Ian Fearon, chief scientific officer at McKinney Scientific Advisors, described the “halo” effect of having medically licensed e-cigarettes on the market. To get medically licensed requires proof of quality, safety and efficacy. Once achieved, this could legitimize the category and open the doors to widespread physician acceptance of the products. The same could happen with nicotine pouches.

     This could start to erode distrust of these products by physicians as they use them and advise their patients to use them. The predictable positive outcomes would accelerate adoptions and use.

    Recall that almost 50 percent of male doctors in many low-income and middle-income countries and countries across the Middle East smoke. Helping them to switch first deserves concerted effort. And having a new medically licensed e-cigarette or nicotine pouch could well trigger the desired cascading impacts on their patients and then among the general population.

    The process to obtain a medical license has been well outlined by the FDA’s Center for Drug Evaluation and Research (CDER) and the U.K.’s Medicines and Healthcare products Regulatory Agency (MHRA). Neil Benowitz et al. (see below) and Fearon have stressed that CDER requirements are particularly onerous. The MHRA process is more “encouraging.” According to them, a major benefit of the MHRA is that studies required can be conducted in any country whereas only U.S. studies are accepted by the CDER.

    A unique authoring partnership between people who usually disagree about the value of THR concluded that the CDER should “reach out to companies that may be interested in developing smoking cessation products” and indicated that that could include medically approved vapes. Authors included Benowitz and Ken Warner, known supporters of THR, and Matt Myers and Joanne Cohen, who until now have opposed THR.

    They commented that “the deadliest form of nicotine delivery has been subject to limited oversight whereas products marketed to help people quit face far more regulatory barriers.” The fact that agreement can be reached on the value of THR in the context of medically licensed products should be taken as a signal to how broader acceptance might happen.

    Mitch Zeller, previous head of the FDA’s Center for Tobacco Products, jumped into this field recently and urged action on medical licensing when he announced that he had joined a company aiming to bring a medically licensable vape to market.

    Why Has Industry Not Led the Way?

    There can be little doubt that the pharmaceutical industry and leaders in the tobacco industry have long had the scientific knowledge and technical capabilities to develop medically licensed equivalents to e-cigarettes and nicotine pouches. So why has there been no progress? Are short-term commercial interests taking precedent over health needs? I suspect this is a major factor delaying progress by large companies. But thankfully, smaller entrepreneurial companies are pursuing medical licenses at considerable cost to them.

    In addition to commercial interests, industry leaders and analysts have mentioned three other issues as hampering to progress:

    1. Concern that the WHO and anti-harm reduction activists would mount campaigns against them.
    2. Tobacco companies fear that a medically licensed product would reach a small part of the market—people with early symptoms of disease or those deeply concerned about their health. That might turn off other smokers seeking to use safer products for recreation and pleasure. They do not want to be stigmatized as being “patients.”
    3. Any innovation or improvement to a medically licensed reduced-risk product needs costly, lengthy and comprehensive re-appraisals by the regulating body with no guarantee of consumer acceptance. For industries specializing in fast-moving consumer goods, this can be a deterrent.

    What Is the Size of the Market?

    Companies need to look at data on the burden of disease and at data they have showing that an extremely high percentage of e-cigarette users switched from combustibles for health reasons. Global burden of disease data shows that 8 million people die annually from tobacco use. That figure hides the fact that hundreds of millions of tobacco users have early symptoms or signs of cancers, heart and lung disease or tuberculosis. It hides the fact that over 50 percent of people with serious mental illness smoke, that about 60 percent to 70 percent of people with early chronic obstructive pulmonary disease, tuberculosis and schizophrenia smoke at the point they are diagnosed. And that figure does not change much during their treatment, suggesting physicians’ failure to help their patients end smoking.

    It is not surprising that a recent Bloomberg analysis suggests that the size of the nicotine-replacement market could reach $100 billion by 2028. That should stimulate companies to invest in medically licensed options that consumers demand and enjoy in unprecedent numbers.

    How Would These Products Be Marketed?

    Marketing strategies would need to distinguish between products that are medically approved versus others. There are many precedents for designing marketing plans to reach two different audiences using the same basic product. The most recent being how Ozempic addresses the needs of people with diabetes while Wegovy (both made by Novo Nordisk) addresses obesity. Two brands, one set of active ingredients. In an analogous way, initially NRTs were prescription-only in most countries but were changed to “over the counter” use to improve access to “essential medicine,” and NRTs are noted as such in the WHO Model List of Essential Medicines.

    I could see this developing a comparable way for e-cigarettes and nicotine pouches.

    Conclusion

    There is a massive untapped need to get more efficacious cessation products on the market. Medically licensed e-cigarettes and nicotine pouches could well be the key to gaining widespread and critically needed physician support for the categories. That could unblock deep opposition to THR as it has happened with so many innovations that benefit health.

    A global health expert and anti-smoking advocate for more than 30 years, Derek Yach is the owner of Global Health Strategies. Previously, Yach was the director of the Foundation for a Smoke-Free World and a World Health Organization cabinet director and executive director for noncommunicable diseases and mental health. He was deeply involved with the development of the Framework Convention on Tobacco Control.
  • Time to Rethink the FCTC

    Time to Rethink the FCTC

    When the World Health Organization drafted the Framework Convention on Tobacco Control (FCTC), global tobacco sales were dominated by combustible cigarettes. The emergence of new technologies, such as e-cigarettes and tobacco-heating products, along with a deterioration in attitudes toward global cooperation have rendered many of the assumptions on which the treaty is based obsolete. During Keller and Heckman’s recent E-Vapor and Tobacco Law Symposium in California, public health expert Derek Yach, who was instrumental in the creation of the FCTC, argued that it is time to update the treaty and bring its stipulations in line with the realities of a radically different context. Below is the text of his presentation, gently edited to fit Tobacco Reporter’s style format.

    Derek Yach

    Active work on the WHO FCTC began with  Gro Harlem Brundtland’s appointment as WHO director general in 1998. I was tasked with creating the Tobacco Free Initiative that would develop a treaty to address tobacco control as its primary goal. Substantial work over decades and many resolutions of the World Health Assembly adopted by consensus provided the elements of the treaty. Each element was based on taxes or regulations that were in place in some countries that had contributed to measurable declines in cigarette consumption by 1998. It was the first time the WHO had used its treaty-making provisions provided by the Constitution.

    I will briefly reflect on several geopolitical realities that allowed us to make rapid progress on the treaty. I will then highlight several assumptions that governments and academics made at the time about what was needed before considering what is needed now.

    Brundtland had been prime minister of Norway and before that minister of health and the environment. She led development of the early round of environmental treaties through the 1980s and 1990s and strongly believed then that multilateralism through the United Nations’ system was the best means to tackle transnational threats to health, the environment and security. Our FCTC advisory team reflected those views and included experts from the worlds of disarmament, diplomacy and international law.

    The content of the treaty was supposed to highlight issues of a transnational nature, leaving purely domestic policies for individual countries to decide. Some examples of transnational issues that appeared in the final text included illicit trade (now a protocol), cross-border marketing and scientific exchange. Pretty soon, the negotiations dropped that distinction and included national tobacco control policies that had weak or no transnational dimension. Some examples include tax policies, bans on smoking in public places, cessation programs and youth access initiatives.

    The WHO inquiry into the tobacco industry’s decades of so-called “interference” in tobacco control policy and research settings was released early in the negotiating process and served as a constant reminder to governments about the need to address industry interference in policy and research processes.

    At the start of the formal negotiations, but separate from the WHO process, several leading multinationals and attorneys general in the United States signed up to the Master Settlement Agreement that imposed penalties on U.S.-based companies and funded a massive nonprofit (the Orwellian sounding Truth Initiative) to tackle youth smoking.

    The FCTC reflected these developments and the underlying negative sentiment toward multinationals. Paragraph 5.3 of the FCTC addressing industry interference and the article that addresses litigation against the industry are the best examples of this sentiment. They are unique features of this treaty compared to other UN treaties.

    A whole cadre of tobacco control advocates and policymakers were groomed by the FCTC process to follow a set of actions that were felt to be most appropriate at the time. In fact, many called the several FCTC negotiating sessions carried out over a five-year period the “University of Tobacco Control.” Diplomats and health leaders from many countries took part. Few had prior knowledge of tobacco control. Many are still active today. Most have stuck with the “demonize don’t engage” industry mantra. As we will see later, this is because it is the easiest option but not the best option. It requires no intellectual effort.

    The Framework Convention on Tobacco Control was developed at a time when combustible tobacco products ruled supreme. (Photo: Nopphon)

    A Diversion into Adam Grant’s Book, Think Again

    Adam Grant is a Wharton professor and noted author. His latest book describes how we are blinded by confirmation and desirability biases. We see what we expect to see, and we see what you want to see. Of course, most people will say, “I’m not biased!” Unfortunately, and to quote Charles Darwin, “ignorance more often begets confidence than does knowledge.” The greater the knowledge, the more likely we acknowledge humility, our doubt and demonstrate curiosity for new insights. Too few people believe what Daniel Kahneman, a Nobel Prize winner for behavioral economics, does. He enjoys discovering he was wrong because it means he is now less wrong than before.

    What does this mean for the FCTC today?

    I believe that the WHO and leadership of tobacco control are trapped in 1998 thinking and driven by 1970s solutions.

    Let me explain the latter first.

    Most tobacco control policies were developed in the 1970s and led by a small group of countries: Canada, Norway, New Zealand, the United Kingdom and Singapore. They all had strong regulatory enforcement capacity, elevated levels of local science competence and high levels of education and income. The case studies from these countries formed the basis of global norms. In doing so, the weaknesses within many other countries, especially low-income and middle-income countries (LMICs), in terms of regulatory competence, scientific and medical insights, became impediments to progress.

    While physicians led tobacco control policy development and science in the core countries until 2000, this has not happened to a great extent in most LMICs and especially those in Asia, the Middle East and Africa.

    Policies have rarely been adapted to the development reality of LMICs. Sitting in Geneva, few understand that “law on the books is not law on the streets.”

    Just one example from the WHO’s own review: Cessation services and even nicotine-replacement therapies (NRTs) are not available to most smokers in LMICs. This is despite NRTs having been on the WHO Essential Medicine’s Formulary for years.

    All these factors have meant that tobacco control has moved slowly globally—leading the WHO in its latest update (January 2023) to state that by 2025, there will be 1.27 billion tobacco users in the world—a quarter of a billion more than a few years ago. Not a sign of success. The WHO data also shows that smoking rates exceed 50 percent for men in many countries, including Indonesia, China and Jordan.

    Geopolitics have become messy and unpredictable. (Image: the_lightwriter)

    Two Aspects of 1998 Thinking that Persist Today Despite Profound Changes Underway

    Geopolitics has become messy and unpredictable. Paul Tucker describes this in detail in his latest book, Global Discord. Multilateralism as we knew it even a decade ago has eroded fast. The major political and military powers are in a heightened state of tension. Geopolitical threats like pandemics and climate change are not being addressed in the spirit of a common future as was the norm in earlier periods. It is very unlikely that we could have had the degree of agreement negotiated for the FCTC today as was achieved 20 years ago. Brundtland confirmed this was the case in our discussions a few years ago. Going forward, this will have implications for future efforts to update the FCTC or to adjust in the light of new evidence.

    The FCTC ignored innovation. The FCTC does not mention intellectual property nor does it tackle the complex issues of patents. Why? Recall that the late 1990s was a period of major activity at the World Trade Organization and the WHO in relation to HIV/AIDS treatments. The question was: How could LMICs access the best treatments at affordable prices? So why is there no focus on innovation, science and modern technologies within the FCTC?

    Back then, there was a group sense among the leadership of tobacco control that the tobacco industry was a dirty old legacy industry. They would never innovate their way toward safer and less damaging products. Their last efforts to do this with “lights” were seen as a ruse.

    I hosted a meeting of leading tobacco industry scientists and public health experts in the WHO headquarters in 1999 during the negotiations. The aim was to give industry a platform to show whether they had plans to develop truly reduced-risk products. Unfortunately, they did not. No follow-up meetings ever happened.

    Article 5.3 in the FCTC got misinterpreted as a rationale to ban engagement with industry—especially their scientists. It was intended to be a warning to government to be vigilant in managing engagement with industry. It addressed common sense conflicts of interest concerns. Since adoption of the FCTC, Bloomberg Philanthropies has invested substantial funding to maintain the view that all industry science cannot be trusted and that so-called industry interference is the biggest threat to progress in ending smoking.

    A schism grew and deepened between the companies that have invested billions of dollars in transformative research on the one hand and public health leaders advising the WHO and their governments on how best to end smoking on the other hand.

    The U.S. Food and Drug Administration’s $150 million invested recently through the Tobacco Product Scientific Advisory Committee expanded the schism in the U.S. Recall that the U.S. funds 90 percent of all so-called tobacco harm reduction research in the world. U.S. scientists dominate global policy settings and media with their content. Skewed U.S. content skews global debates. How skewed is it?

    A content analysis of FDA research spending shows that academics in the U.S., including the American Heart Association, give priority to research that aims to show how dangerous vaping is to kids and, more recently, adults. It scantily addresses the best ways to accelerate an end to adult smoking. It is dismissive of technology innovation—and hence has avoided patent considerations. And it does not attempt to find solutions, for example, for people with schizophrenia or chronic obstructive pulmonary disease (COPD).

    In sharp contrast, tobacco and vaping industry research addresses benefits and risks as they are required to by the FDA if they seek authorization of their products to be deemed “appropriate for the protection of public health.”

    These two groups of researchers need to engage in scientific debate. Yet opportunities to do so have diminished as journals and conferences have banned scientists funded directly or indirectly by industry. This is leading to a serious bias with implications for public policy. How can we expect to make fundamental change without involving those who hold such a major stake in potential changes? In no other sector—energy, food, pharma—is this tolerated.

    While the FCTC remains mute on patents, today, they are a source of intercompany friction and litigation. A recent review of patent filings in China, the U.S. and Europe showed that tobacco harm reduction is one of the most dynamic areas of activity being filed. The review showed that while a small percentage of submissions addressed combustibles, the vast majority were in areas of innovation that are driving safer reduced-risk nicotine products. And a growing number were in areas of pharmaceutical and medical applications.

    This fundamental shift by leading tobacco companies to invest in solutions for health has been joined by newer and often smaller separate vape, synthetic nicotine, inhalant and related companies. Entrepreneurs backed by investors are now highly active in this space.

    The industry is moving toward a world where nicotine, freed from its damaging links to tobacco, could end millions of tobacco deaths and, in time, prevent a range of neurological and brain disorders associated with aging.

    Grant’s call for us to rethink in the light of new realities applies directly to our field.

    Grant’s call for a rethink applies to our leading public health agencies. And some progress is underway. The Reagan-Udall Foundation review of the FDA is a good start. The recent Center for Strategic and International Studies’ review of the Centers for Disease Control and Prevention (CDC) and the Lancet Commission and other reviews of the WHO all represent a chance to take a fresh look at how agencies failed to yield the desired results during the pandemic. Sadly, many of these agencies and their leaders are characterized by the opposite of rethinking. This is well summarized in a wonderful-sounding word: mumpsimus, or “a person who obstinately adheres to old customs or ideas in spite of evidence that they are wrong or unreasonable.”

    Last month, the WHO’s executive board reviewed progress in tackling global health. Its conclusion was that we are wildly off track in terms of reaching agreed goals for cancer, heart disease, lung disease and mental health. The worst pandemic in a century has played a key role in these trends. More of the same will not get us back on track. It’s time the WHO recognized that technology and innovation, led by private sector innovation, is the fastest way to make progress. They know that to be the case for most of biomedicine.

    Embracing tobacco harm reduction represents such innovation in our sector. It is the only way to cut tobacco deaths within a decade or so. And it is consistent with the FCTC. Recall that the very definition of tobacco control includes “tobacco harm reduction.” Article 1(d) of the FCTC explicitly states that “tobacco control” means a range of supply, demand and harm reduction strategies that aim to improve the health of a population by eliminating or reducing their consumption of tobacco products and exposure to tobacco smoke.” Unfortunately, these “harm reduction strategies” have never been elaborated and defined. One could argue that this has led and will continue to lead to unnecessary tobacco-related disease and premature death.

    Governments are being encouraged and supported to ban or restrict many products that could cut deaths and disease. This is not acceptable. The science has strengthened in favor of vapes, nicotine pouches, snus and heated-tobacco products. The FDA authorizations of these products start with them passing the FDA test as being “appropriate for the protection of public health.”

    Tobacco and vaping industry research today addresses benefits and risks as they are required by regulators. (Photo: BAT)

    What are the Components of a Rethink?

    1. The WHO should acknowledge the imperative to tackle the health of adults who smoke as the main way it can get global health sustainable development goals on track. Most adults who have early COPD stage or cardiovascular disease or pre-cancerous signs of oral cancer or schizophrenia or tuberculosis are smokers. That is why people with schizophrenia die 10 years to 15 years younger than the general population—a fact ignored by most policymakers. Well over half of all patients with COPD smoke at diagnosis, and 90 percent smoke a year post diagnosis. A true failure of health systems.
    2. The WHO should appoint an independent commission to have the same terms of reference the British government gave to Javed Kahn. Define better ways to end smoking by 2030. And this should be in part funded by Michael Bloomberg’s latest grant to strengthen tobacco control. There is no loss of face in doing this. Simply a recognition that the science has advanced and policy needs to catch up. Article 5.3 assumed that there is an “irreconcilable difference between the interests of public health and the tobacco industry.” That was true in 1998. Today, the reality is more complex. The FDA deeming of reduced-risk products as being “appropriate for the protection of public health” calls into question the continuation of the irreconcilable conflict principle and suggests more nuance is required about who, how and when to engage. A commission is required to explore this new reality.
    3. The negotiations on a pandemic treaty have just started in Geneva. The central focus is on solidarity and equity. In the draft zero that was just released, 11 of the 49 paragraphs deal in some way with intellectual property and related issues like strengthening national research capacity. A few years ago, I asked a CEO of a leading tobacco company if he would consider licensing some of their most important innovations to companies in LMICs or state monopolies to help them accelerate their exit from combustibles. He gave an emphatic yes. It is time we pushed leading multinationals to do this.
    4. Governments that include harm reduction in their tobacco control programs or have solid evidence of the contribution harm reduction plays to their decreased smoking rates should actively share their experiences with governments during the World Health Assembly and at the upcoming FCTC Conference of the Parties in Panama later this year. More specifically, the U.S. government’s FDA representative should outline the rationale and progress made in authorizing several snus, vape, nicotine pouch and heated-tobacco products. The world’s most sophisticated regulatory body has decided harm reduction products benefit smokers but has done nothing to share this knowledge globally. This is exactly the opposite of what it does in relation to new drugs, vaccines or health interventions unrelated to tobacco. There is a little-known amendment to an appropriation resolution going back decades, the Doggett Amendment, which compels U.S. embassies around the world to not provide support to U.S. tobacco companies in foreign countries. The FDA authorizations now demand that this be adjusted to permit and encourage embassies and companies with authorized products to explain their benefits to health and science leaders around the world. The Chinese government holds the key to full transformation of the global tobacco industry. Its state monopoly sells more than half of all cigarettes sold worldwide, and this percent is increasing. To date, it has been slow to adopt tobacco harm reduction despite being the home to the most innovative e-cigarette and related technology companies in the world. Two years ago, the government announced a goal of having all new car sales in 2035 be electric vehicles. Imagine the power of a similar commitment to end combustibles.
    5. Over the last decade, leading tobacco multinationals have made progress in getting a range of reduced-risk products to market. In some cases, revenue from such products is approaching 50 percent of total revenue. The recent report from the Foundation for a Smoke-Free World shows, however, that little progress has been made in LMICs where reduced-risk products are legal. BAT has made the most progress with its reduced-risk products now available in Egypt, Indonesia, Pakistan and Saudi Arabia, among others; PMI sells in Saudi Arabia, Egypt and the Philippines. Other multinationals are absent from most of these countries, and no multinational sells in Nigeria or Bangladesh. Note that 80 percent of all smokers reside in LMICs, and a similar proportion of deaths from tobacco occur there. Industry could do more, faster and through partnerships with state monopolies and smaller companies.
    6. Tobacco and vape companies need to urgently prepare submissions for medical licensing of vapes and nicotine pouches. The FDA and the U.K. Medicines and Healthcare products Regulatory Agency have called for this. It could reverse the increasing resistance of the health professionals to these products—opening the door to wider use with major population health gains.
    7. It’s time we took on disinformation within tobacco harm reduction more seriously. In February, FDA Commissioner Robert Califf called for urgent action related to Covid-19 misinformation. It’s time the FDA tackled massive disinformation related to tobacco harm reduction. I am sure he knows—as you know; as FDA tobacco chief Brian King knows; as 15 past presidents of the Society for Research on Nicotine and Tobacco know—that nicotine is not the problem or the cause of cancer. But despite this, the CDC, the Campaign for Tobacco-Free Kids, the WHO and, yes, the FDA fund campaigns that propagate false, misleading and deceptive messages about harm reduction and nicotine. The stream of retractions of fake science they cite grows. Vaping does not cause cancer or heart disease or e-cigarette or vaping product use-associated lung injury (EVALI.) The original lies, though, live on in policy briefs worldwide and are seen by many as fact.

    Kahneman inspired Grant to remind us that it is much easier to follow in the paths of the status quo. For the sake of global health, it is time we took the path least taken—to real progress.

    A global health expert and anti-smoking advocate for more than 30 years, Derek Yach is the owner of Global Health Strategies. Previously, Yach was the director of the Foundation for a Smoke-Free World and a World Health Organization cabinet director and executive director for noncommunicable diseases and mental health. He was deeply involved with the development of the Framework Convention on Tobacco Control.
  • Ukraine is Opportunity to Transform Tobacco

    Ukraine is Opportunity to Transform Tobacco

    Photo: Hugo

    The crisis in Ukraine offers an opportunity to transform tobacco use across eastern and central Europe.

    By Derek Yach

    Vladimir Vorotnikov, writing in Tobacco Reporter’s August 2022 issue, outlined how Russia’s invasion of Ukraine has upended well-established supply chain and business relationships that have been in effect for decades. In fact, a careful read of Balkan Smoke by Mary C. Neuberger traces the roots of these relationships way back to Bulgaria in the 1920s. Vorotnikov discussed the impact of sanctions on Russian tobacco production, the emergence of illicit trade in the region, and more recently, the reestablishment of cigarette production in Ukraine.

    He does not discuss the massive growth over the past few years in new reduced-risk nicotine products—led by IQOS—across eastern and central Europe. The editor makes the point that Russia is (was) one the largest markets for IQOS. My own observations during a visit to Kyiv in late October 2021 were that a range of vape products and heated-tobacco products were readily available across the city despite posters funded by Bloomberg Philanthropies near the Parliament proclaiming that they were dangerous.

    An anti-vaping poster in Kyiv
    (Photo courtesy of Derek Yach)

    This is a time of profound transition for the region. Amid the horrors of war and the human tragedies it continues to bring to the people of Ukraine are opportunities to reduce future deaths from the single largest cause of premature death in the region—and especially among men—combustible tobacco products. As rebuilding begins—as it inevitably will—government, business and health professionals need to grasp the chance to avoid rebuilding the tobacco industry in the image of the past and rather take the high ground of health and make reduced-risk products the easily available option while phasing out combustible sales.

    For governments, this means adopting risk-proportionate regulations that build on the approaches proposed by the recent Javed Khan report for the United Kingdom, and on the authorizations of a range of reduced-risk products by the U.S. Food and Drug Administration. Ukraine and the neighboring countries relied on FDA guidance in relation to Covid vaccine advice—now is the time to draw upon their guidance to accelerate access to reduced-risk products, citing the FDA’s comments that they are deemed “appropriate for the protection of public health.”

    Tax and other regulatory approaches could be applied to accelerate the transition. Further, governments of the region need to step up investments in customs and excise oversight to stop large-scale illicit trade taking hold—as it has in the occupied territories of Georgia following Russian invasion in 2008.

    The Russian government also has an obligation to protect the health of its people and take regulatory steps to ensure that the progress made by Philip Morris International, Japan Tobacco International and BAT is increasing their revenue from heated-tobacco products at the cost of combustibles. Slippage with regard to these gains will translate into a return to the very high smoking rates, and associated death rates, of the past.

    Government actions will be limited, though, unless the three leading tobacco companies (PMI, JTI and BAT) active in the region commit to take concerted efforts to accelerate their transition out of combustibles and publicly clarify what “withdrawing from Russia” means. Are they continuing to profit from Russian cigarette sales albeit through local companies? Are those companies obliged to push ahead with reduced-risk products, or will they revert to cigarettes?

    Outside of Russia, leading tobacco companies could communicate the benefits of switching, take measures to clamp down on illicit trade and tighten youth access to all nicotine products, through joint action. Such bold actions would give them a chance to show their seriousness to transformation—something investors should reward.

    United Nations agencies have a role to play at this time. Evidence emerging from inside Ukraine suggests that smoking rates have increased among those in the military and possibly among displaced peoples. This is understandable given the unprecedented stress to which people are exposed. The current U.N. response has been to ignore this reality and simply continue to support policies that ban cigarette sales during conflicts—something that is probably ignored. A far better way forward is to support people who smoke or seek nicotine to have ready access to nicotine-replacement products and approved reduced-risk nicotine products. This would mean that a generation of people may well emerge from the war with lower overall risks to their health.

    War and tobacco use are intimately linked and currently interacting in dangerous ways to the health of populations. We should not wait for the transition to peace and health to begin before taking steps to accelerate the transition of smokers away from combustibles.

    A global health expert and anti-smoking advocate for more than 30 years, Derek Yach is the owner of Global Health Strategies. Previously, Yach was the director of the Foundation for a Smoke-Free World and a World Health Organization cabinet director and executive director for noncommunicable diseases and mental health. He was deeply involved with the development of the Framework Convention on Tobacco Control.
  • Derek Yach on TR’s Special Innovation Issue

    Derek Yach on TR’s Special Innovation Issue

    The renowned global health expert explains how innovation represents the single biggest opportunity to lower the health toll of tobacco use.

    By Taco Tuinstra

    Until recently, few people would have mentioned the words “tobacco” and “innovation” in the same sentence. Even as other legacy industries started disrupting their respective operations, the tobacco industry remained content to milk its tried-and-tested business model and count on the habit-forming properties of nicotine to sustain its business.

    That has changed dramatically over the past 15 years. Advances in technology, together with shifting attitudes, have turned the once-staid nicotine business into a cutting-edge innovator. The modern e-cigarette was not invented by the tobacco industry, but when it started making inroads around 2008, the industry recognized its potential and devoted considerable resources to its perfection. The ensuing disruption to the nicotine business prompted one major financial institution to rank the impact of e-cigarettes in the same league as that of 3D printing.

    And it didn’t stop there. Tobacco companies went on to develop a host of additional reduced-risk technologies, such as tobacco-heating devices. Some even began applying their expertise in agronomy, product development and substance delivery to create nonrecreational products, such as vaccines, pharmaceuticals and therapeutic devices.

    The topic of innovation has always been dear to Tobacco Reporter’s heart. Not only have we covered it frequently in our columns; we have also created a competition dedicated to industry innovation—the Golden Leaf Awards.

    Astonished by the radical transition taking place in the industry, and excited about what it promises for the future, Tobacco Reporter decided to devote an entire issue to the topic of innovation.

    To ensure the topic would be treated with the breadth and depth it deserves, we partnered with one of the world’s most prominent advocates for public health progress through innovation: Derek Yach. Formerly with the World Health Organization and the Foundation for a Smoke-Free World, Derek was deeply involved in the creation of the Framework Convention for Tobacco Control—a document that was prepared when King Combustible still ruled supreme.

    Since leaving the WHO, Derek has spent much of his time encouraging health authorities to recognize the unique public health opportunity presented by innovation, urging them to accommodate, rather than frustrate, new technologies.

    Tobacco Reporter spoke with Derek about Tobacco Reporter’s special issue and the importance of innovation.

    Taco Tuinstra is Tobacco Reporter’s editorial director.Based in Raleigh, North Carolina, USA, he coordinates the work of staff writers and contributors.On his watch, Tobacco Reporter has won several awards for editorial excellence.Since joining the magazine in 1997, Taco has visited more than 75 countries to meet industry representatives in their markets and to report tobacco news firsthand.
  • The Promise of Innovation

    The Promise of Innovation

    Photo: Lezinav

    Nicotine companies are helping tobacco users move from deadly combustible cigarettes to substantially reduced-risk products.

    By Derek Yach 

    Over the past few decades, we have seen unprecedented progress across a wide range of technologies—digital and info tech, biotech, AgroSciences, material sciences and more. These are transforming many sectors considered “legacy,” “dirty” and simply out of fashion. The tobacco sector epitomizes many of the changes underway. The April 2022 edition of Tobacco Reporter highlights the diversity and speed of the change. From finding new uses for the tobacco plant, to ending exposure to toxic substances linked to combustion in cigarettes, to finding ways to design the emerging products to be biodegradable or recyclable, to limiting youth access—innovation pervades this classic, dirty legacy sector.

    Evolution of THR Technologies

    In an insightful article, Mike Huml outlines the role of hobbyists and smokers in seeking solutions to cutting toxic exposures (see “Major Milestones”). Driven by their passion, an entire new set of products with myriad components, a new language and, later, vape stores have arisen. Their role has been crucial in showing what is possible, what is desired and what can be achieved when advances in electronics, aerosolization, batteries and coils are combined into new consumer products.

    Thousands of miles away from where the first large groups of users of these new products live in Shenzhen, China, new companies have taken up the opportunity and drawn on the Silicon Valley-like spirit that pervades the city to develop core components and completed products now at the heart of the e-cigarette and heated-tobacco revolutions. Until recently, companies like Shenzhen Smoore Technology, ALD and other vapor hardware suppliers were unknown in Europe and the United States; today, they are household names in the nicotine business. Their investments in research will increasingly become visible as future products emerge.

    As with any successful innovation, the larger established tobacco companies have invested billions of dollars to create tobacco harm reduction (THR) products that appeal to smokers and pass the muster of regulators, such as the  U.S. Food and Drug Administration. Their continued investment in research, patent filings and product launches mean that we now have over 100 million users of reduced-risk products—but that is less than 10 percent of the real target! More progress requires that state monopolies, who together account for one in two cigarettes sold globally, join the innovators.

    Next Frontiers for Farmers and the Environment?

    Farmers. Advances in our understanding of plant genomics initially helped to produce more environmentally resilient and productive tobacco plants and the ability to adjust nicotine levels. This has now given way to using the tobacco plant to develop a Covid-19 vaccine, a range of pharmaceuticals, wound-healing products and a range of domestic products for clothing, skin care and more! In his article “The Virtuous Weed,” Taco Tuinstra gives a hint of what is to come. These advances, however, will provide only a few tobacco farmers with alternative livelihoods. The speed of switching away from combustibles and high levels of quitting combined with the growth of demand for synthetic nicotine come together to make it more urgent to support the most vulnerable tobacco farmers’ transition to alternative livelihoods.

    THR and the Environment. The growing concern about the impact of plastic pollution on the environment has led to the start of negotiations of a new United Nations resolution on greening plastics. The initiative will take two years to three years, will be legally binding and will push the pace of change in addressing alternatives to plastics like never before. Electronic cigarettes and heated-tobacco products will not escape scrutiny. They contain a wide range of nonbiodegradable components, including plastics, batteries and heavy metals. The rapid increase in disposable vapes and pods has not been accompanied by serious efforts to tackle this problem—until now!

    ALD Group, a Shenzhen-based company, has been actively reviewing various studies and found from the Truth Initiative that 51 percent of e-cigarette users throw their empty pods or disposable devices in the regular trash, 43 percent do the same with their empty batteries, about 17 percent put both in the regular recycling bin, and about the same percentage throw them away or send them for recycling.

    ALD Group’s response is to use biodegradable materials whenever possible and to develop recycling solutions within an integrated environmental management approach based on international standards, such as ISO 14001. The company appears to be adapting best practices from Nespresso on pod design, recycling and disposal as well as from leading beverage companies that have shifted almost exclusively to biodegradable products in the sale of their beverages.

    ALD’s investments in research and development in biodegradability are beginning to pay off. This comes at a time when consumer and regulatory concerns about the environmental impact of risk-reducing product waste have increased.

    Continued Progress on the Transformation Road Demands More Private-Public Partnerships

     In a recent editorial, Nature highlighted the value of industry- academic collaboration in the context of Covid-19 vaccines. This edition shows how massive investments by nicotine companies—large and small—in research, technology development and consumer  insights are delivering alternatives to deadly combustibles and displacing them faster than ever before.

    THR advocate David Sweanor mentions several areas that require additional attention if private-public collaboration is to be achieved: mechanisms for researchers to access industry data and how to apportion intellectual property (see “From Coercion to Empowerment”) None of these are impossible. All require individual companies to find ways to work together on issues of public health and environmental benefit.

    The Nature editorial calls for barriers to collaboration to be dismantled as much as possible. That lesson has yet to penetrate the walls of leading groups like the World Health Organization, academic and research bodies and scientific journals in relation to THR. Bans, prohibitions and ad hominem attacks of tobacco industry and related scientists chills dialogue, slows innovation and seriously hampers progress toward ending smoking and the death and disease it causes.

    This edition shows that despite these barriers, substantial, unstoppable progress is underway—that progress could accelerate if engagement replaced these barriers. The beneficiaries would be millions of smokers seeking better solutions and longer, healthier lives.

    Derek Yach has been a global health expert and anti-smoking advocate for more than 30 years. Throughout his career, he has supported and led smoking cessation research and policy development and has been a strong proponent of harm reduction policies,

    Previously, Yach was the director of the Foundation for a Smoke-Free World, and a World Health Organization cabinet director and executive director for noncommunicable diseases and mental health. He was deeply involved with the development of the Framework Convention on Tobacco Control.
  • ‘Vuse Authorization a Positive for Harm Reduction’

    ‘Vuse Authorization a Positive for Harm Reduction’

    Photo: R.J. Reynolds Vapor Co.

    More governments need to follow the science.

    By Derek Yach

    The evidence is in. For the first time, the U.S. Food and Drug Administration has authorized the marketing of an e-cigarette in the country because it determined the help it offers adult smokers outweighs the attraction such products may hold for youth.

    The decision to allow the sale of British American Tobacco’s Vuse Solo closed electronic nicotine-delivery system, along with three tobacco-flavored cartridges, marks the third time in less than two years that the agency, despite vociferous, emotion-driven opposition from politicians and interest groups, has used peer-reviewed scientific evidence to approve tobacco harm reduction (THR) products.

    With this latest move, the FDA has signaled a distinct turn in the oft-contentious debate surrounding e-cigarettes, in which opponents claim little is known about what toxic chemicals they contain and that the tobacco industry has a terrible track record when it comes to being forthcoming about its products.

    That was not the case here, indicated Mitch Zeller, the director of the agency’s Center for Tobacco Products. “Today’s authorizations are an important step toward ensuring all new tobacco products undergo the FDA’s robust scientific premarket evaluation,” he said in a statement. “The manufacturer’s data demonstrates its tobacco-flavored products could benefit adult smokers who switch to these products—either completely or with a significant reduction in cigarette consumption—by reducing their exposure to harmful chemicals.”

    We have said it before, and we’ll continue to say it again (and again and again) in the face of all this misinformed vitriol and distrust: THR products are effective tools to help smokers lessen their risk of developing diseases such as lung cancer and COPD. So says one study after the next, including a recent measured, sober look at the risks and benefits of e-cigarettes that is signed by no less than 15 former presidents of the Society for Research into Nicotine and Tobacco, a leading international proponent of evidence-based science.

    The key word here is “evidence.” Although e-cigarettes are not risk-free, they have been found to be up to 95 percent less harmful than combustible cigarettes because they contain no tar and significantly fewer chemicals that make up the toxic stew of smoke in combustible cigarettes.

    Evidence, carefully compiled, weighed and debated, is how the FDA reached its earlier decisions to provisionally authorize the sale of Swedish Match’s snus and Philip Morris International’s IQOS heat-not-burn sticks as modified-risk tobacco products (MRTPs), subject to regular review. And “evidence” is how it made its first decision to approve the marketing of Vuse.

    It reached its decision through dispassionate, rigorous diligence—a risk-proportionate, microscopic gauging of the potential harm e-cigarettes pose for young people versus their potential therapeutic uses for adults who smoke combustible cigarettes and would like a less damaging alternative. Indeed, the FDA’s approval process is so thorough, it is accepted as the international gold standard for vaccines, pharmaceuticals and medical devices. As Adam I. Muchmore, a Pennsylvania State University law professor, explained last month [August] in an interview with Newsweek about the wait for Covid-19 vaccine approval, “There are a lot of ‘i’s’ to be dotted and ‘t’s’ to be crossed, and these are not simple bureaucratic requirements. Both producing this data, and reviewing it, requires the work of multiple experts in a wide range of scientific fields.”

    We hope the FDA will continue to use scientific evidence to approve the sale of menthol-flavored e-cigarettes so that combustible menthol cigarette users, among them the majority of African-American smokers, also have the opportunity to reduce their health risk. And we hope it will consider that nicotine-replacement therapy gums and sprays are already marketed in menthol and other flavors, all to help smokers quit.

    One does not need to look far to see the effects of FDA decisions: Following its full approval last August of Pfizer-BioNTech’s Covid-19 vaccine, a “tidal wave” of people were expected to line up for their jabs, spurred by employers and businesses that have been waiting for the green light and at least some doubters who needed more reassurance it is safe.

    And the National Institutes of Health’s Anthony Fauci aptly summed up the FDA’s influence in a comment earlier this year about its approval for Aimmune Therapeutics’ Palforzia, the first drug to treat peanut allergy for children. “Science is showing us the path to a future in which new therapeutic options may provide both solutions as well as peace of mind that individuals with food allergies and their families deserve,” he said.

    Those words could well apply to the field of THR too, although the FDA’s policy of placing the onus solely on individual companies to prove they contribute to public health (to wit, the 2.3 million pages of evidence PMI submitted on behalf of its IQOS application) has already left some smaller, streamlined companies out in the cold.

    That said,  governments in lower and middle income countries (LMICs), where the vast majority of the world’s 1.14 billion smokers live, would do well to study all three of the FDA decisions regarding THR products as they work to strengthen their own national research and regulatory capabilities and to take note of the careful steps the agency continues to take as it examines the applications of other companies that manufacture e-cigarettes, including Juul.

    These governments and their public health authorities need to review the statistics from places such as the United Kingdom, which has supported e-cigarette use as an effective way to lessen health risks and even quit combustible smoking altogether. Or, conversely, they could take two minutes and 42 seconds to watch a graphic Public Health England demonstration of the viscous, oozing, sticky dark brown residue left in the lungs from the smoke from 16 packages of cigarettes over the period of one month compared to the barely discernible trace of vapor left by the equivalent number of e-cigarettes over the same period.

    Right now, a huge gap exists between research output in tobacco control by a few developed countries and LMICs, and when it comes to reduced-risk products, the gap is even greater, a reflection of both the lack of support for homegrown scientific research and a concomitant reliance on advanced industrialized countries for regulatory scientific advice and support. The Foundation is committed to playing its role in closing this gap to allow LMICs to have the scientists able to fully inform their policymakers about the potential benefits of THR.

    There appears to be no interest in tobacco harm reduction as a principle or a tendency to unquestioningly accept the warnings by bodies such as the World Health Organization, which itself is mired in a past overtaken by technological advancements and sounds like the proverbial Greek chorus as it points to the lack of long-term testing and the perils such products pose to youth.

    The most extreme example of this governmental attitude is in India, where, despite 1.3 million people dying each year from tobacco-related diseases, e-cigarettes were banned in haste by the government, which was urged to do so by The Union, a Bloomberg-funded NGO based in Paris that recommends such extreme measures for LMICs on the supposed grounds that youth in these countries are particularly vulnerable. In turn, this has led to a burgeoning black market that prices these products out of reach of many of the disadvantaged communities who could use them most.

    The fact is, the most favored tobacco control measure in India is tax increases, which only serves to exacerbate the difference between the rich and the poor, for the latter group must turn to cheaper, even more dangerous products such as bidis, thin cigarettes composed of unprocessed tobacco that are hand-rolled in leaves and contain higher concentrations of nicotine, tar and carbon monoxide than conventional cigarettes sold in the United States.

    In Indonesia, where more than a quarter of the population smokes, including 19.4 percent of young people between the ages of 13 to 15, the local—and significantly cheaper—cigarette of choice is the unfiltered kretek, made from a blend of tobacco, cloves and other additives. Yet, there is little government oversight, with children even exposed to lengthy tobacco advertisements before blockbuster Hollywood films.

    Still, the WHO refuses to apply the consequences of harm reduction always being part of the definition of tobacco control in the Framework Convention on Tobacco Control. A good start would be for the WHO to consider recent peer-reviewed research by leading scientists that underpins the FDA submission and not reject it simply because it has been funded by the tobacco industry. In its Report on the Global Tobacco Epidemic—2021, it does not waver from its position, stating that new and emerging products simply chart a “new threat to tobacco control.”

    “As they emerge and rapidly evolve, these products can be difficult to characterize and therefore bring with them many regulatory challenges,” it states. “At the same time, the tobacco and related industries behind these newer products pedal misinformation campaigns, marketing them as ‘clean,’ ‘smoke-free’ or ‘safer,’ and claim they are effective cessation aids. By doing so, these industries attempt to appear part of the solution to the tobacco epidemic as opposed to instigators and perpetrators of the epidemic.”

    How disheartening! Yes, the tobacco industry has acted unconscionably in the past, lying about the toxicity of cigarettes and shamelessly professing its primordial dedication to the health and welfare of smokers. But, to paraphrase the old saying, change—real change—starts from within. We are seeing signs of that in the tobacco industry, with the results recognized by the FDA, leading health experts and authorities in countries such as the U.K.  

    It is time for all of us to move on—together.

    To stop treating all nicotine products as the same.

    To acknowledge that we all have a stake in people’s health and well-being and in a healthy future for our children, their children and for generations to come.

    And to start saving up to 4 million lives a year in the interim as the battle—our battle—continues to eradicate combustible tobacco for good.

    Derek Yach is the president of the Foundation for a Smoke-Free World.