Tag: Special Innovation Issue

  • 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.
  • The Virtuous Weed

    The Virtuous Weed

    Artwork: Dan Kurtz

    When tobacco heals instead of hurts

    By Taco Tuinstra

    The health consequences of tobacco use have been well documented. According to the World Health Organization, more than 8 million people worldwide succumb to tobacco-related illnesses, such as lung cancer, heart disease and chronic obstructive pulmonary disease, every year. For every person who dies due to tobacco, at least 30 people live with a serious tobacco-related illness, according to a 2019 policy brief by Tobacconomics.

    Tobacco also carries a significant economic toll. A report prepared by the World Bank Group Global Tobacco Program expected the worldwide economic cost of smoking to reach $1.4 trillion in 2017, equivalent to 1.8 percent of the world’s gross domestic product that year. Little wonder, then, that many view the tobacco plant as evil.

    Yet there is another, decidedly more benign, side to the Wicked Weed. When dried, set on fire and inhaled, the tobacco plant wreaks havoc; when deployed as a “green bioreactor,” the golden leaf has the potential to help address some of the world’s most vexing public health challenges, including, ironically, certain respiratory afflictions.

    Baiya Phytopharm is currently developing a new generation of its vaccine for the omicron variant of Covid-19 and expects to conduct Phase 1 trials in April 2022.
    (Photo: Baiya Phytopharm).

    Among the most striking examples of tobacco’s potential to heal rather than hurt are recent endeavors to develop an inoculation against the novel coronavirus. In February, Health Canada approved Covifenz, a tobacco plant-based Covid-19 vaccination developed by pharmaceutical giant GlaxoSmithKline and Medicago, a biopharmaceutical company backed by Philip Morris International. According to Health Canada, Covifenz is the world’s first vaccine approved for human use that utilizes a plant-based protein technology.

    As it turns out, plants—and especially tobacco plants (see sidebar)—lend themselves exceptionally well to developing pharmaceutical compounds. In many ways, they are better suited to the task than the man-made bioreactors used in traditional vaccine development.

    To create a vaccine, scientists must produce antigens—molecules that trigger an immune response to a specific virus or bacteria. Antigens for conventional vaccines are made by infecting cells from insects, monkeys, hamsters or other sources in the laboratory with a virus or a bit of viral genetic code that tricks the cells into making copies of the virus or antigen. The cells incubate in bioreactors for extended periods of time and then undergo a complex purification process before being packaged into vials.

    Bioreactors are expensive, however, and their operation requires trained personnel. They are also susceptible to contamination, forcing vaccine developers to keep bioreactors growing different types of antigens far apart and under sterile conditions.

    Dahlia Garwe

    Plants are natural bioreactors, according to Dahlia Garwe, the former CEO of the Kutsaga Tobacco Research Station in Zimbabwe. “They are able to perform eukaryotic post-translational modifications that are often essential for biological activity of many mammalian proteins,” she explains. When infected with DNA from Covid-19 or other viruses, plant cells will make millions of copies of virus-like particles that can serve as antigens without being infectious.

    Using plants instead of mechanical bioreactors offers many benefits, notes Garwe. Plants are cheap to grow, easy to manipulate and resistant to contaminations that could present problems for humans. “Green bioreactors do not suffer the same risk of pathogen contamination as seen in mammalian cell culture as there are no known cross-kingdom pathogens,” she says.

    With light as their primary energy source, plants are less expensive to work with than traditional cell culture systems, allowing for inexpensive and nearly unlimited scalability. Because plant systems are robust and inert, they are also easier to handle and purify than other systems.

    Medicago is not the only company that has grasped the promise of plants in the development of vaccines and therapeutics. At least three other organizations are using Nicotiana benthamiana, a close relative of the tobacco plant used in cigarettes, to develop Covid-19 vaccines. In December 2020, the U.S. Food and Drug Administration approved an investigational new drug application for a Covid-19 vaccine by BAT subsidiary Kentucky Bioprocessing (KBP, now part of KBio). The company is currently conducting Phase I clinical trials, which are the first steps in testing the safety and side effects of a pharmaceutical in humans.

    According to BAT, plant-based vaccines have several advantages over serums developed with conventional technologies, including speed and thermostability. Whereas traditional methods can take months to yield the desired vaccine ingredients, KBP’s tobacco plants do so within six weeks. And unlike some of the existing Covid-19 vaccines, KBP’s vaccine candidate has the potential to be stable at room temperature, an important benefit, especially for public health networks in countries with warm climates and few refrigerated trucks and warehouses.

    Fearing supply constraints and “vaccine nationalism” at the start of the pandemic, scientists in Thailand have joined the race as well. Baiya Phytopharm, a plant-produced biologics company, is working with tobacco in part because that crop can be easily and inexpensively cultivated domestically, thus reducing Thailand’s reliance on foreign-made vaccines. According to the Bangkok Post, Thailand has more than 10,000 tobacco growers.

    Waranyoo Phoolcharoen

    In an email exchange, Baiya Phytopharm co-founder Waranyoo Phoolcharoen told Tobacco Reporter that the company had finished Phase 1 clinical trials and was happy with the data. Baiya Phytopharm is currently developing a new generation of its vaccine for the omicron variant of Covid-19 and expects to conduct Phase 1 trials this month (April). If the vaccine candidate does well in subsequent trials, it could be available in Thailand by the end of the year, according to Phoolcharoen.

    Meanwhile, Akdeniz University in Turkey is using a protein produced by tobacco plants to develop a Covid-19 vaccine. Its technology is based on an angiotensin-converting enzyme 2 and can be administered as an injection or through a spray. According to an April 2021 report in Hurriyet Daily News, tests on mice have demonstrated a high level of inhibition of the Covid-19 virus from entering the cell. At the time of publication, Akdeniz University was seeking funding to conduct clinical trials in humans.

    In addition to Covid-19, scientists have sought to tackle many other diseases with the help of tobacco. In response to concerns about bioterrorism following the September 11 attacks in the United States, researchers at the University of Central Florida used tobacco plants to create a protective antigen against anthrax. According to an article published in Environmental Health Perspectives, mice immunized with the agent survived anthrax injections of 1.5 times the deadly dose.

    In 2014, KBP, working in cooperation with the U.S. Biomedical Advanced Research and Development Authority, developed, tested and used ZMapp, an antibody cocktail to treat infection from the Ebola virus, which was raging in west Africa at the time. In under six weeks, KBP completed cGMP manufacturing of each of the three monoclonal antibodies comprising the ZMapp cocktail, which received temporary emergency authorization from the FDA.

    Pushing the envelope further still, Collplant of Israel is using tobacco to generate human tissue and organs. Collplant’s technology allows for the production of large quantities of medical grade human collagen, which is a primary building block for the human body and essential for tissue repair. Physicians use collagen products to treat chronic wounds, burns and other afflictions. Deriving collagen from tobacco rather than from traditional sources, such as cadavers, cows or pigs, offers several advantages, including stable fibrillates, pure molecular structures and no immunogenic responses, according to Collplant.

    While the endeavors described above are only a sample of the many ways in which tobacco is deployed to produce pharmaceutical and other useful compounds, they vividly illustrate the potential of the golden leaf to help solve rather than create problems—a side that is often overlooked due to the health toll extracted by smoking.

    The Green Bioreactor

    While despised in the court of public opinion, tobacco is highly valued among plant scientists.

    For starters, the species has good physiology for research. “Seeds are easily sterilized, and germination is very quick, so generating experimental material is easy,” says David Norman, senior scientist at Demeetra AgBio, a company that is using gene editing for crop trait development and that also works with tobacco (see “Genetic Scissors,” Tobacco Reporter, August 2021). “Tobacco grows fairly fast compared to many plants, to where flowering and mature seeds can be attained in just a couple months.”

    The soft tobacco leaf is ideal for transfection, allowing researchers to easily introduce DNA or RNA into its cells. What’s more, regeneration mechanisms from callus in tobacco are extremely efficient. In addition to allowing genetic modifications on leaf material, tobacco is also easily propagated as a cell culture or protoplast culture. 

    The fact that tobacco is neither a food nor a feed crop makes it even more attractive as a plant for conducting research, according to Dahlia Garwe, the former CEO of the Kutsaga Tobacco Research Station in Zimbabwe. Using tobacco, she says, reduces the likelihood of transgenic material contaminating food or feed supply chains—an important consideration when many consumers remain wary of genetically manipulated foods.

    Tobacco is also well understood from a genetic engineering and molecular biology standpoint; it has been more characterized than any other plant system. Scientists have been researching and genetically modifying tobacco since the early 20th century.

    Meanwhile, biochemists have been able to produce many recombinant proteins in tobacco, with the plants serving as bioreactors for largescale production of pharmaceutical and industrial compounds. “Tobacco can easily take in DNA to produce these compounds when injected into the leaf or through vacuum infiltration of whole plants,” says Norman.

    The vacuum infiltration method, in particular, can be scaled up to infect many plants at one time, according to Norman. “After infiltration, tobacco transiently expresses the DNA introduced for a short while and makes the protein of interest in the leaves.

    “While the protein production in plants may not be that impressive on a per plant scale, up to a few percent depending on the protein of interest, you have to consider the yield per acre for tobacco. On an average acre of tobacco, the yield can be several tons of leaf material. With that scale of leaf material per acre, suddenly those small protein yields add up to being significant and potentially economically viable.”–T.T.

    The Plant-Based Vaccine: A Late Bloomer?

    In February, Medicago’s Covifenz Covid-19 vaccine received the green light from Health Canada, making it the world’s first plant-based vaccine approved for human use. Considering how long scientists have known about the potential of plant-based vaccines—the proof of concept dates back some 30 years—it may seem surprising that the first regulatory approval for such a product was granted only this year.

    While the U.S. Department of Agriculture in 2006 gave the thumbs-up to a plant-derived vaccine to inoculate chickens against the lethal Newcastle disease, most of the projects targeted at human vaccines never even made it to end-stage clinical trials. The FDA did approve Protalix’s plant-based drug to treat Gaucher’s disease in humans in 2012 and in 2014 gave emergency authorization to ZMapp, a plant-based biological medicine manufactured by KBP (now part of KBio) to treat Ebola, but the first was not a vaccine, and the second was approved under special conditions.

    Dahlia Garwe, the former CEO of the Kutsaga Tobacco Research Board in Zimbabwe, suspects the “delay” in approving plant-based vaccines is due to regulatory issues and public perceptions of genetically modified organisms (GMOs). “Most vaccines produced in plants would most likely be classified as GMOs, which automatically makes them ‘undesirables,’” she ventures.

    Kathleen Hefferon, who teaches microbiology at Cornell University, acknowledges that public perception may be part of the problem but believes that many consumers would accept plant-made vaccines just as they have accepted vaccines produced in eggs and mammalian cells. “They are familiar with the GM technology when used for medical purposes,” she says. “It is when it comes to genetic modification in food products that some people seem to raise concerns.”

    Hefferon suspects that the absence of a clear regulatory path represents the greatest obstacle as it may have made pharmaceutical companies wary of investing in this technology. The carrot suspension cell culture that Protalix used for its Gaucher’s disease drug somewhat resembles Chinese hamster ovary cell culture, she notes. “That made it a little easier for regulators.”

    Patrick Doyle, CEO of KBio Holdings, a company set up by BAT to accelerate the development and production of novel treatments with plant-based technology, says it is important to remember that in a normal R&D cycle, medicines and vaccines on average take over 10 years, even when using a proven technology or approach.

    “In fact, as a result of the global health crisis presented by Covid[-19], development, regulatory review and approval timelines were accelerated to support the delivery of much-needed vaccines,” he says. “Before gaining approval for any vaccine, manufacturers must generate sufficient data to demonstrate the efficacy and safety of the candidate and technology, which takes time. For example, the mRNA platform, first discovered in the early 1960s, was a genetic technology that had long held huge promise but only received the first FDA [Food and Drug Administration] emergency use authorization for the prevention of Covid-19 disease in individuals 16 years of age and older on  Dec. 20.”

    According to Doyle, the positive data generated and the subsequent approval of Medicago’s vaccine is both a positive in terms of creating another approved treatment option for Covid-19 and reinforcing the potential of plant-based vaccines.

    Hefferon agrees that Medicago’s success could set the stage for plant-made pharmaceutical commercialization in future years, and her optimism appears to be shared by others. Research and Markets expects the value of the global plant-based vaccines market to reach $2.62 billion by 2028—more than double the 2021 figure. Tobacco companies seem well attuned to the potential as evidenced by PMI’s investment in Medicago and by BAT’s creation of KBio. Doyle says KBio will explore new opportunities to develop its plant-based production system, which has the potential to offer greater speed, thermostability and scale-up opportunity and.

    Hefferon says she’s very happy about the growing momentum for plant-based vaccines. “Too bad it took a pandemic to make it happen.” –T.T.

    Uphill Battle: Tobacco-Backed Vaccines Continue To Face Skepticism From Health Authorities

    While tobacco plants lend themselves exceptionally well to the creation of pharmaceutical compounds, vaccinations and treatments developed by tobacco-backed organizations still face an uphill battle as demonstrated by recent World Health Organization actions.

    During a March 16 media briefing, the WHO’s assistant director-general for drug access, vaccines and pharmaceuticals, Mariangela Simao, said the global health body had paused the process for pre-qualification of Medicago’s new Covifenz Covid-19 shot due to the biopharmaceutical firm’s link to Philip Morris International, which owns about one-third of the Canadian company.

    “The WHO and the U.N. have a very strict policy regarding engagement with the tobacco and arms [industries], so it’s very likely it won’t be accepted for emergency use listing,” said Simao. The WHO persists in its opposition despite Health Canada’s February approval of Covifenz for adults between the ages of 18 and 64.

    In a statement published by the CBC, Medicago said it believes authorization decisions should be based on the quality, efficiency and safety of the vaccine, not who owns shares in the manufacturer.

    “It is our understanding that the WHO has made a decision to pause the approval of the vaccine and that this decision is related to Medicago’s minority shareholder and not to the efficacy and safety of the vaccine, which was demonstrated with the approval by Health Canada,” the statement reads.

    Derek Yach, a global health consultant, was aghast by the WHO’s suggestion that it might reject Medicago’s vaccine based on the company’s relationship with PMI.

    “‘Pikuach nefesh’ is the ethical principle in Jewish law that the preservation of human life overrides virtually any other religious rule,” he said. “Most other religions support a variant of this. WHO violates this ethical principle when it denies people access to a lifesaving vaccine.”

    If the WHO follows through, the vaccine would be the first Western-manufactured Covid-19 shot to be rejected by the global health body, according to Bloomberg. —T.T.

    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.
  • In the Pipeline

    In the Pipeline

    Photo: Imperial Brands

    A glimpse at patent registrations shows what the future of tobacco harm reduction may look like.

    By Stefanie Rossel

    Since the first filter cigarette was manufactured in 1934, the cigarette has stayed more or less the same. Despite some tweaks to filters, papers and tobacco blends over the decades, innovation was not exactly the word that came to mind in the context of combustible cigarettes. So it’s little wonder that when the World Health Organization Framework Convention on Tobacco Control (FCTC) was drafted in the late 1990s, its authors could not imagine a future product much different from the familiar tobacco column wrapped in paper. As a consequence, the FCTC makes little to no reference to intellectual property or technology.

    The past two decades have proven the FCTC creators—and many other observers—wrong. While the WHO was trying to cut down tobacco consumption with classic strategies, such as tax hikes, smoking bans and health warnings, a new generation of reduced-risk products, including e-cigarettes and tobacco-heating devices, entered the market. Many of these products bore little resemblance to the combustible cigarette that the FCTC was designed to tackle.

    Developed by independent entrepreneurs, the first vapor products surprised the tobacco industry as much as they did their WHO counterparts. After realizing the potential, however, cigarette manufacturers redirected some of their formidable resources at developing the sector, creating a multitude of new reduced-risk technologies.

    In recent years, the leading tobacco companies have pumped billions into research and development to offer their customers smoke-free alternatives. Philip Morris International alone had invested $9 billion in R&D by 2019. Median R&D expenses stood at $495 million for the fiscal years ending December 2017 to December 2021. They peaked in December 2021 at $617 million.

    BAT has spent more than $2.6 billion on R&D investment since 2012. In a preliminary statement in February 2022, the company said that it had further increased next-generation products investment by £496 million ($653.44 million) in 2021.

    Japan Tobacco International invested $2 billion between 2015 and 2020. The efforts are likely to pay off not just in terms of having less risky products available but also financially. Euromonitor expects the global retail value of the reduced-risk category to exceed $100 billion by 2025, up from $40 million in 2020.

    Developed by indpendent entrepreneurs, the first vapor products surprised the tobacco industry as much as they did their WHO counterparts (Illustration: VPR Brands)

    A Different Strategy

    As technology investments increase, intellectual property is becoming more valuable—and contested, as demonstrated by the recent PMI/Reynolds American Inc. dispute. In September 2021, the U.S. International Trade Commission (ITC) ruled that PMI’s IQOS heated-tobacco product (HTP) infringes on two RAI patents. After the Biden administration failed to intervene, PMI and its U.S. partner, Altria Group, were barred from importing IQOS devices in the U.S.

    The case is charged because IQOS is currently the only electronic nicotine product with a modified-risk tobacco product (MRTP) designation from the U.S. Food and Drug Administration, which allows Altria to market the product with reduced exposure information. Among other things, the company may tell consumers that its heating system significantly reduces the production of harmful and potentially harmful chemicals compared to conventional cigarettes. The ITC ruling means that American smokers currently don’t have access to IQOS. PMI is now looking at manufacturing IQOS in the U.S.

    Unlike the WHO, the FDA, which was authorized to regulate tobacco products by the 2009 Family Smoking Prevention and Control Act, acknowledges that electronic nicotine-delivery system products are fundamentally different from combustible cigarettes, and the agency has provisions to accommodate reduced-risk products.

    To receive MRTP designation, a manufacturer must provide scientific evidence showing that its product is “appropriate to promote the public health” as defined by the FDA. Although criticized as a long-winded and costly pathway—PMI handed in more than a million pages of documentation to support its IQOS application—the process at least offers a prospect for reduced-risk products, which is more promising than the WHO’s “quit-or-die” attitude.

    Roya Ghafale at the 2021 GTNF conference in London

    Innovation in the Making

    Tobacco and vapor companies’ substantial R&D spending is reflected in the number of tobacco harm reduction (THR) patents. Between 2010 and 2020, an estimated 73,758 patents were published globally in the areas of nicotine vapor products, smokeless nicotine products and HTPs, according to the 2021 Patent Landscape Report, a study prepared by Oxfirst Managing Director Roya Ghafele for the Foundation for a Smoke-Free World.

    Established tobacco companies, such as PMI, BAT and the China National Tobacco Corp. (CNTC), hold the largest patent portfolios in the THR space, showing that the development of less hazardous nicotine-delivery systems is a priority in their strategies. In terms of patents published, nicotine vapor technology is the fastest-growing THR technology, with a compound annual growth rate of 9.1 percent. It is followed by heated-tobacco technology, which has been growing 4.1 percent per year, and smokeless tobacco technology, which has a 1.1 percent annual growth rate.

    Geographically, patent publications are concentrated in high-income or upper-middle-income countries. Companies operating in the tobacco and cannabis sectors dominate patent activity: In tobacco-heating technology, CNTC, PMI and BAT account for 15 percent of patents published in the past 10 years. China leads with an estimated 22,956 patent publications followed by the U.S. with an estimated 14,344 publications. In the Africa and Middle East region, patent activity remains limited to Israel, Morocco and South Africa, according to the report. In nicotine vapor technology, the picture is similar: About 10 percent of all patents granted during the past decade are held by CNTC, PMI and Kimree Hi-Tech, a Chinese e-cigarette manufacturer.

    An increasing number of vapor patent applications cover technologies for therapeutic purposes.
    (Photo: Respira Technologies)

    Toward Therapeutic Uses

    The patent filings provide a glimpse into what the future of THR might hold. Interestingly, the number of patents for nicotine vapor technologies that could result in medical smoking cessation devices or be applied to other therapeutic purposes has increased substantially over the studied period. Between 2010 and 2020, 48 percent of patents were filed under classifications related to medical or veterinary science. According to the report, this indicates a shift from recreational technology toward more therapeutically oriented technology. While many patents currently focus on the vaporization of cannabinoids instead of nicotine, there is also mention of other therapeutic drugs, including those targeted at relieving pain, fever, inflammation and disorders of the nervous system.

    As far as the hardware is concerned, the number of patents referring to sprayers or atomizers adapted for therapeutic purposes ranks second behind those for inhaling appliances shaped like cigars, cigarettes or pipes.

    Patents relating to electrical heating or constructional details, such as the connection of cartridges and battery parts, also represent a large part of publications. BAT’s Pure Tech development is an example of this trend. The ultra-slim, micro-engineered stainless steel distiller plate acts as both the heater and wick, replacing the traditional coil and wick system and thus optimizing the aerosol process so that there is less risk of thermal breakdown in products. In its Science & Innovation Report 2020–21, the company calls Pure Tech a game-changer. Laboratory tests show that the vapor generated by this technology contains around 99 percent fewer and lower levels of certain toxicants compared to cigarette smoke, according to BAT. In biological tests, cells exposed to this vapor exhibited a much lower response or no response at all compared to cigarette smoke, a result that strongly suggested that this technology could contribute to the reduced-risk profile of its vapor products, BAT said.

    PMI has filed patents for vaping technology that includes sensors that are designed to monitor the characteristics of their users and provide therapeutic data, according to the Patent Landscape Report. Should these devices make their way into consumer nicotine products, Ghafele concludes, this would shift the purpose of these products from purely recreational to therapeutic, making nicotine businesses potential partners for insurance companies, public health authorities and other related industries. It could also further normalize—and improve access to—reduced-risk product technologies.

    While the patent publications by nicotine companies indicate a “pharmaceuticalizaton” of these industries, patent filings by pharmaceutical companies active in nicotine-replacement therapies suggest that these players remained focused on pharmaceutical uses for nicotine and are uninterested in entering the recreational nicotine space.

    To make headway in global tobacco harm reduction, critics say tobacco companies should make their innovations more accessible to customers in low- and middle-income countries. (Photo: BAT)

    Reserved for High-Income Countries

    In heated-tobacco technology, Ghafele found, most patents related to the design and manufacture of devices with an emphasis on the heating element, which tobacco companies seek to improve to increase the efficiency of their technology. BAT’s current Glo HTP range is heated by induction technology, thus avoiding direct contact between the electronics and the heating element. JTI’s Ploom S and Ploom X HTP models, by contrast, work with the company’s proprietary HeatFlow technology, where a ribbed heat chamber heats the tobacco stick from the outside for minimal charring.

    Following the blade-heating technology employed in initial generations of IQOS, PMI has added induction to heat the tobacco in its latest generation of HTP devices, IQOS ILUMA, which launched in 2021. The company’s TEEPS HTP platform, meanwhile, uses carbon-heating technology. The device works without electronics. It features a charcoal tip that is lit to produce heat. In the charcoal tip, oxygen reacts with the carbon in a combustion process, producing heat and carbon dioxide. An aluminum disk separates the charcoal from the tobacco, transferring the heat but blocking the airflow, thus preventing the tobacco from reaching the ignition point.

    Of the HTP patents analyzed by Ghafele, 38 percent were filed under therapy-related codes. The frequent mention of antineoplastic agents, which are medications used for cancer treatment, could indicate that companies are researching these agents to reduce the health risks of their products, she notes. There was also high patent activity relating to the therapeutic use of nicotine for neurological disorders, such as Parkinson’s disease or Alzheimer’s disease.

    While the report suggests that the once-staid tobacco industry has evolved into a highly innovative sector, it also reveals a shortcoming: Few of the patent applications are filed in the developing world, where intellectual property protections tend to be weak. Given that most smokers live in low-income and middle-income countries, this represents a missed opportunity for tobacco harm reduction.

    To bridge the gap, says Ghafele, stakeholders should explore ways to better integrate the needs of developing countries and motivate tobacco companies to offer potentially less harmful products outside of the wealthy world.

    Stefanie Rossel is Tobacco Reporter’s editorial contributor. An experienced trade journalist, she combines sharp reporting skills with in-depth knowledge of the tobacco and vapor industries. Prior to joining Tobacco Reporter, Stefanie was editor-in-chief at Tobacco Journal International, where she worked for a decade. Fluent in English, German and French, Stefanie covers tobacco news around the world. She is based in Germany.
  • Major Milestones

    Major Milestones

    Photo: Uwell

    Vaping technology has come a long way. Here are the most impactful breakthroughs from the past 15 years.

    By Mike Huml

    The e-cigarette, which may very well be the most effective harm reduction device ever conceived to address preventable diseases, is built upon the simplest circuit possible. In essence, an e-cigarette is a resistor, a switch and a power source. From this simple circuit, thousands of variations arose over the course of about 15 years. During this Golden Age of regulatory limbo, the vapor industry exploded, and with that came endless innovation and constant refinement, transforming that little cig-a-like into all the products vapers enjoy today. Throughout this process, several innovations stand out as milestones. These innovations would improve the quality, consistency or convenience of the vaping experience. The nature of these changes necessarily contributed to reduced risk and increased uptake among populations.

    The Cig-a-Like

    Photo: Wabeno

    While more an invention than an innovation, the e-cigarettes that were available circa 2008 were not based on a revolutionary concept. Patents for similar but rudimentary e-cigarettes date back as far as the 1930s, but it wasn’t until the new millennium that all the pieces came together into a marketable product. Early adopters of the technology readily admit that first-generation e-cigarettes left much to be desired. What these pioneers agreed on, however, was the potential of these products. By improving the hardware and e-liquids—which could be accomplished with relatively inexpensive and readily available components—those early e-cigarettes could be turned into truly viable alternatives to their combustible counterparts.

    Cig-a-likes provided brutally short battery lives, weak but perceptible vapor, questionable flavor reproduction and a penchant for leaking and “spitback.” Almost immediately, e-cigarette users began tinkering with modifications to these products to mitigate the negative aspects. Cartridge “polyfill” was replaced with aquarium filter to increase absorption and prevent stray fibers from sticking to the bridge of the atomizer. Some wouldn’t be bothered with cartridges at all, nor the inconsistent draw and spitback associated with them, and replaced the cartridge with a “drip tip.” With one or two drops of e-liquid applied directly to the atomizer, the experience became more consistent at the cost of convenience. Longer batteries were soon made available to increase battery life, but it wasn’t until an increase in girth was an option that vapers and manufacturers collectively had an epiphany that would change everything: E-cigarettes don’t need to look like cigarettes.

    The eGo

    Photo: Joyetech

    The eGo, and other similar variations like the Riva, resembled a cigar more than anything. As battery life was a primary turnoff to curious parties, the idea that a battery could last a full day jump-started an entire era of e-cigarette popularity. The eGo could be found in affordable kits at almost every e-cigarette retailer, and it was available in different colors with different atomizers to match. Cartomizers and clearomizers largely replaced the old cartridge-plus-atomizer combination, and with inconvenience slowly becoming alleviated and customization increasing, the e-cigarette market saw a remarkable boom. There was still work to be done, however, as each starter kit required a tutorial and a certain degree of patience. Investment in new technology was still minimal and mostly took the form of variety instead of quality. Customization of appearance was great, but there was still hardly any customization of the vape experience itself. Atomizers of varying resistances were available, and small batch “modding” filled a niche need for higher power with different voltages by stacking batteries in series, but the gap between these two progressions was still wide.

    The Provari and Variable Voltage

    Photo: onVaping

    The Provari from Provape was in a class of its own. Coveted by all vapers, this device was the Cadillac of vaping. It single-handedly popularized the concept of variable voltage. Instead of trying and buying atomizers of multiple resistances, the Provari provided a range of output voltages, effectively allowing the user to adjust the amount of vapor and heat generated by atomizers of most any resistance available at the time. Unfortunately, the Provari was expensive, rare and much larger than the eGo. However, the Provari was rugged, durable and made in America—all features in high demand and low supply. Any mod from the variable voltage era took its cues from the Provari in terms of both performance and aesthetic. Eventually, variable voltage technology worked its way all the way down to the eGo in a new variation known mainly as the eGo Twist. Rampant cloning and intellectual property theft became a real issue during this time, but for better or worse, it led to countless variations of variable voltage devices, including the eGo Twist, eGo Spinner, eGo VV and many others.

    The Tank

    Photo: Uwell

    Up until this point, e-liquid was dripped directly onto an atomizer or absorbed by some type of filler. As power and performance increased, e-liquid was being consumed at a faster rate, and a larger supply was required in order to avoid constant refilling and dry hits. By modifying cartomizers by punching a hole in the casing and inserting it into a clear plastic cylinder, the “carto tank” was born. Early versions had trouble with both leaking and dry hits due to wicking inconsistencies, but again, there was potential. The idea of free-floating liquid in a reservoir changed how innovators thought about e-liquid delivery, leading to popular products such as the clearomizer, which was smaller than a tank but paired perfectly with the eGo’s size, came in a variety of fun colors and could be filled up much faster than a standard cartomizer. At this time, sides were chosen. Team Cartomizer enjoyed more vapor production and a draw that more closely resembled that of a traditional cigarette at the cost of convenience while Team Clearomizer had a range of colors to choose from and a smooth draw at the cost of leaking and dry hits. As time went on, the technologies and methods used to create these early tanks improved into the sub-ohm tanks that we enjoy today. Almost all common sub-ohm tanks take inspiration from both camps, with a vertically oriented coil surrounded by a filler material (cartomizer) housed in a clear tank with free-floating e-liquid. Although a range of preset resistances were available to pair with variable voltage devices during this time, due to generally poor quality-assurance standards, even multiple coils with the same advertised resistances could perform drastically differently from one another, even when fired at the same voltage. To combat this, a new technology had to emerge.

    The Darwin and Variable Wattage

    The Darwin from Evolv flew under the radar, mostly due to its boxy appearance, unique design that favored cartomizers specifically and a general lack of electrical knowledge among nonhobbyist vapers. But make no mistake, the Darwin was a game-changer, and its technology was enthusiastically copied by other manufacturers. To simplify: With a variable wattage device, atomizer resistance no longer mattered. Once a user decided that they enjoyed vaping at 10 watts, an atomizer of any resistance could be attached, and it would always vape the same way. Even minor inconsistencies between atomizers of the same resistance had no noticeable impact on the vaping experience. As variable wattage technology slowly made variable voltage obsolete, stores no longer had to carry extensive varieties of identical cartomizers, clearomizers or other atomizers with different resistances. Vapers no longer had to stalk their favorite retailer in the hopes that their favorite 2.5-ohm cartomizer would finally be restocked. Most importantly, variable wattage directly led to a blanket increase in overall consistency of vapor products.

    The Road Less Traveled—Mechanical Mods, Rebuildable Atomizers and Sub-Ohm Vaping

    Photo: Bedya

    While mainstream vaping was evolving, another phenomenon was taking place. While features, gadgets and color variety appealed to the mainstream, technology simply wasn’t moving fast enough for the hobbyist vaper. They wanted one thing: vapor. Nothing else mattered. Convenience? Safety? What are these words? By removing the internals from the mod formula in order to provide the cleanest, most direct pathway for electricity to flow from the battery to the coil and dropping coil resistance to below 1 ohm, sub-ohm vaping was born. The chips used to regulate mainstream mods provided too many amperage limitations, and hobbyist vapers spent ludicrous amounts of money because they favored craftmanship over new gizmos and pure performance over convenience. Of course, no premade atomizer was available at a resistance below even 1.25 ohms, so the DIY crowd began to, in fact, DIY. Small operations began manufacturing limited runs of solid metal mods and large atomizers in which the coil could be built by the end user. This allowed for maximum performance customization but minimal convenience. Additionally, this setup inherently presented the highest risk potential as there was no board to protect from pulling too many amps from a battery that wasn’t designed with vaping in mind. As such, surprisingly large leaps in battery efficiency and safety resulted from a spike in the demand for high-amperage batteries.

    The DNA Board

    Seeing multiple factions form in the vaping community, Evolv recognized a need. Some mainstream vapers wanted to “chuck clouds” safely and without the hassle of rebuilding and using a mechanical mod, which could be prohibitively expensive. Conversely, some hobbyist vapers ashamedly admitted that it would be nice to be able to enjoy some of the conveniences of “normie” mods without sacrificing too much performance. The DNA20 board finally proved that it was possible to vape sub-ohm coils on a regulated device and to do it safely. Any atomizer with a resistance down to 0.8 ohms could be used up to a maximum power of 20 watts—a far cry from the triple-digit wattages some mechanical mod users were accustomed to, but the DNA20 was a successful first step toward uniting a community that was just beginning to coalesce.

    Around this same time, vaping could no longer be ignored by the media and health officials. Partly exaggeration and partially due to the uptick in the popularity of vaping, reports of varying credibility started making headlines, with media outlets reporting on battery explosions, “popcorn lung” and heavy metal toxicity. Some of those health concerns turned out to be spurious, often due to flawed study designs.

    “This study was conducted by firing a two-ohm clearomizer from three years ago at six volts and measuring the levels of heavy metals and other pollutants,” researchers of such materials might write. “The results show an abundance of heavy metals, formaldehyde and silica particulates.”

    Yes, all vapers knew that dry hits were bad, but they were also repulsive to experience, and so these studies didn’t accurately reflect how users were using vapor products in the real world. However, it brought up a decent point. Vaping was regarded as safer than smoking, but it could always be safer. Having gone through a couple iterations of their DNA board, Evolv released their newest chipset that would change the industry yet again.

    Temperature Control

    Photo: EcigaretteDirect

    The DNA40 was an improvement over the DNA20 and the DNA30 in terms of power output and other functionality, but more than that, it was the progenitor of every temperature control device available today. When using a coil comprised of nickel, the DNA40 could calculate the temperature of the coil by measuring the change in resistance due to heat. Since it could calculate the temperature, it could maintain said temperature by adjusting the wattage by way of voltage in order to effectively eliminate dry hits. The chemical changes caused by overheating e-liquid, wire and wicking material now had a safeguard in the form of temperature control. This technology was naturally copied and can be found on almost every modern vaping device. Even pod systems use a simple version of temperature control technology. Several years after the release of the DNA40 and seeing an increase in demand for high-wattage devices, the DNA200 was released with a refined version of temperature control that could use additional wire types but that also included a revolutionary piece of software called eScribe.

    eScribe Software

    Available for free to anyone with a PC or Mac, eScribe provides not only the most comprehensive suite of features and customization options for vapers who use devices with a DNA board but also tools for researchers and scientists studying the health effects of vaping, allowing them to plot and record data with ease. The user features include custom screens, easy firmware updates, additional profiles and more. However, with more and more attention being brought upon vaping, particularly the health element, eScribe is the perfect tool for anyone to conduct their own studies and experiments. Everybody from the curious hobbyist vaper to large health institutions can access the features in eScribe and easily troubleshoot their device or go as far as to conduct large-scale studies.

    Pod Systems and Nicotine Salt

    Photo: Bantham

    Sometimes, things come full circle. With vaping technology reaching a plateau due to an overall increase in quality across the board, becoming more affordable and accessible on beginner-focused devices and inevitably facing government regulations, it became easy to provide a small device that delivered on the promise that cig-a-likes made years before. Although pod systems generally still don’t resemble analog cigarettes in appearance, the vape experience has never been closer to feeling like smoking. Years of trial and error, innovation and refinement led to the widespread popularity of these inexpensive, simple devices. Additionally, while liquid nicotine had been the standard prior to the existence of pod systems, nicotine salts provide a level of nicotine comparable to smoking but without the overly harsh throat hit and pungent flavor of e-liquid that contains a large percentage of liquid nicotine solution. Together, pod systems and nicotine salt e-liquid provide a foolproof package that anybody can pick up at a local retailer, fill up and begin using immediately and with no prior knowledge of vaping or its underlying electrical concepts. Meanwhile, synthetic nicotine is presenting new opportunities given its lower levels of contaminants and its suitability for standardization of safety and quality.

    Thanks to years of innovation, we are inundated with vaping products that not only provide a consistent, convenient and enjoyable alternative to smoking but that are also safer, more so than vaping used to be. As vapers looking back on the past decade, it’s clear that every technological innovation for the sake of a better vaping experience was also an innovation in harm reduction. The original cig-a-like was a proof-of-concept that demonstrated immense potential and got innovators excited for future prospects. The eGo addressed pressing needs of users but also directly led to a decrease in smoking, a net positive for public health. Moving from fixed voltage to variable voltage to variable wattage saw a directly linked connection to increased consistency and overall product quality while continuing to appeal to more and more people. Mechanical mods and sub-ohm vaping sparked a demand for safer and more efficient battery technology, which has huge implications for many other technological industries. With temperature control technology and eScribe, we see an answer to the health concerns, warranted or not, from health agencies and others. Pod systems bring everything full circle, utilizing all the advances in vapor technology while maintaining a simple, no-hassle design reminiscent of the original e-cigarette—where it all started.

    Vaping technology has come a long way in a short 15 years. What started as a hobby of passionate vapers triggered a wave of innovations, first pursued by independent entrepreneurs and later turbocharged by the investments of well-resourced traditional tobacco companies. This has resulted in mass production of safer nicotine products, giving smokers a welcome alternative to deadly combustibles. While the majority of consumers are now embracing standardized products, the hobbyists will likely continue innovating, further pushing the boundaries of technology in what was once considered a staid business.

    Mike Huml is a professional vapor hardware reviewer. An enthusiast vaper since 2009, he is always trying to get his hands on the newest, shiniest mod. Huml has evaluated countless vaping devices over the years, but you’ll usually find him with a mechanical mod and RDA in-hand, surrounded by an aura of fog. His personal motto: “Happiness is a warm coil.”
  • Preventative Measures

    Preventative Measures

    Photo: Metamorworks

    Innovations in technology and regulation could help ease the concerns surrounding youth access to vaping products.

    By Timothy S. Donahue

    Most tobacco control experts agree that vaping is safer than smoking combustible cigarettes. The primary concern for anti-vaping groups, legislators and regulatory officials isn’t where e-cigarettes fall on the continuum of risk; it’s about preventing youth access to nicotine products, whether underage is defined as under age 21, as it is in the United States, or as under age 18, as it is in many other markets. The best way to prevent youth access is through innovative technology, according to vapor industry experts. Technology and regulatory policies will both be required for the vaping industry to satisfy its skeptics.

    Technological innovations have been the vaping industry’s primary contribution to battling youth access. Several companies have developed devices that use biometrics, such as fingerprint and facial recognition. The OBS Cube FP Kit, for example, uses fingerprint recognition to prevent unauthorized use. However, a 2020 review by ecigclick.com found the fingerprinting function complicated to configure. “The instruction manual is total pants … it really is,” the reviewer wrote. “So far, I haven’t worked out how to use the fingerprint stuff; there are diagrams in the book which relate to bugger all on the actual device.”

    Juul Labs launched its C1 in Canada in 2019. The device paired with an Android smartphone to limit who could use it and to provide monitoring of what and how often the user vaped. Juul says the C1 could only be used if people passed age verification and facial recognition checks. The C1 also had a system that could be set to automatically lock when it was not being used or was away from the phone to which it was linked.

    Juul Labs then launched the Juul2, which had many of the same child safety features as the now discontinued C1. The Juul2 can also recognize and authenticate proprietary Juul2 pods when they’re attached, limiting the ability to use counterfeit pods or refill pods with other substances, such as THC.

    The OBS Cube FP Kit, for example, uses fingerprint recognition to prevent unauthorized use. (Photo: OSB)

    Steven Yang, senior director of FEELM R&D, says that FEELM has incorporated designs into its products that prevent misuse by children, for example, by requiring the user to follow a specific sequence of procedures to activate the device. 

    “With a number of [the] industry’s leading patents, FEELM is exploring ways to integrate Bluetooth, fingerprint, airflow switch, sensor and other electronic technologies to create a child lock on products,” Yang says, adding that many Chinese vaping industry leaders have already adopted ID verification and facial recognition technologies.

    “FEELM’s strategic partner and China’s leading vape brand, RELX, has initiated Sunflower System in 2019. Based on AI and big data, the Sunflower System is integrated into different scenarios, such as RELX chain stores and the RELX app to prevent minors from purchasing vaping products,” explains Yang. “The Sunflower System has been extended to all RELX chain stores in China to ensure each purchase order is traceable. Moreover, through big data and GPS, the Sunflower System can automatically filter the addresses that do not meet the legal requirements of opening a vape store—for example, near schools.”

    Project Sunflower consists of adopting ID and facial recognition technologies to ensure that only adults can purchase products in its Chinese stores, according to RELX. Minors are not allowed to enter RELX stores, and in-store face-scanning cameras send alerts to RELX store staff if a suspected minor enters the store. Any suspected minor that is not able to present legal, valid ID proving his or her age is asked to leave the RELX store.

    Upon purchasing a product, RELX customers also need to verify their age through a facial recognition process that matches the customer’s face with the photo on the customer’s Resident Identity Card,” says a RELX representative. “This process is to ensure that the person in the store is using their own valid identification and not attempting to impersonate an adult.”

    While facial recognition measures are widely used and accepted in China, they may encounter resistance elsewhere. Chris Howard, vice president, general counsel and chief compliance officer for E-Alternative Solutions, a U.S.-based e-cigarette manufacturer, says that consumers have generally accepted biometric controls in phones, tablets and other devices that use fingerprints or faces to unlock the screens.

    Those who are tech savvy would likely welcome such an alternative in their vaping products, he says. However, traditional cigarettes don’t have any electronic controls to prevent unlawful use, so if vaping regulations follow tobacco rules, that would limit these types of innovations. 

    RLX Technologies has deployed facial recognition technologies to ensure that only adults can purchase its products in the company’s Chinese stores. (Photo: RLX Technolgies)

    “The idea that such a requirement would be necessary for vapor products to receive marketing orders seems unlikely. It is important to remember that adult smokers may be unwilling to deal with an electronically locked tobacco product,” says Howard. “While some may enjoy the novelty, many may just use a tobacco product—likely higher risk—that is easier to use. Many questions surround the use of biometrics in products. There are legal privacy issues, which would increase the cost of such devices.”

    Manufacturers must also remain aware of regulatory restrictions in the markets they operate within, according to Yang. FEELM has developed protocols to help retailers and distributors comply with local guidelines. Yang says the company attaches clear warning labels on its closed-system vaping devices and includes language in user manuals stating that the products are intended for use only by adults.

    “We also focus to ensure that the retail stores in which our products are sold have mechanisms in place to verify the age of the consumers purchasing products manufactured by us so as to comply with local laws and regulations in relation to age restriction,” Yang says. “Moreover, our website and our major customers’ web stores require visitors to enter their age before entering the websites.”

    While technology is an important component of a comprehensive strategy to prevent youth access, experts note that the industry and its regulators should also acknowledge technology’s limitations. Having grown up with smartphones, online social networks and e-commerce, today’s youngsters are the most digitally savvy generation to date. While the technical solutions to deter underage access may deter some, sufficiently motivated young buyers are likely to overcome such measures with relatively little effort.

    Regulatory Response

    Taxation has long been the preferred deterrent to youth access by regulators. Studies suggest, however, that increasing taxes doesn’t always have the desired impact. Instead, these measures discourage combustible smokers from switching to a safer alternative, according to a study by Steve Pociask and Liam Sigaud for the American Consumer Institute Center for Citizen Research. The researchers state, “overzealous or poorly designed restrictions [like tax increases] on vaping, combined with misleading information about e-cigarettes’ actual health risks, are deterring smokers from pursuing a potentially life-saving alternative.”

    Tim Andrews, director of Consumer Issues for Americans for Tax Reform, says that increasing taxes on reduced-risk tobacco alternatives will not reduce youth access but punish adult vaping consumers, leading many back to deadly combustible cigarettes.

    “Paradoxically, by creating a booming black market, which, by definition, possesses none of the rigorous age verification processes required by legal retailers, vapor taxes may increase not decrease youth access,” he says. “Youth vaping has plummeted in recent years due to increased enforcement of existing law. [According to the U.S. Centers for Disease Control and Prevention, only 3.1 percent of high school students vape daily.] Adequate and appropriate enforcement of existing law—not increasing taxes—is what will continue to drive this number down.”

    Tobacco harm reduction advocates also stress the importance of risk-proportionate pricing along with proper education about the products available to encourage smokers who cannot or will not quit nicotine to consider alternatives that are less harmful than cigarettes. By taxing the most harmful products—combustible cigarettes—at significantly higher levels than reduced-risk alternatives, regulators can nudge consumers to the least unhealthy options.

    Chris Howard

    Other innovative regulatory responses to youth vaping have had mixed results. Outside taxation and Tobacco 21 laws in the U.S., any effectiveness seems hard to prove. Research suggests that there are few studies available that show what impact differing regulatory actions have on youth vaping. A study published in BMC Public Health, “Policies that limit youth access and exposure to tobacco: a scientific neglect of the first stages of the policy process,” examined 200 international peer-reviewed articles. The researchers found that scientific evidence on the policy process for youth prevention initiatives were scarce.

    “The processes influencing the adoption of youth access and exposure policies have been grossly understudied. A better understanding of the policy process is essential to understand country variations in tobacco control policy,” the researchers wrote. They then went on to suggest that “policymakers can adopt and implement various supply-side policies to limit youth access and exposure to tobacco, such as increasing the minimum age of sale, limiting the number or type of tobacco outlets or banning the display of tobacco products.”

    Howard questions whether regulations limiting the number of tobacco outlets/vape shops or display bans would materially impact youth access. “Which companies should lose their business licenses?  Should only major chains, with arguably more control over storefronts, be permitted to sell tobacco products?” Howard asks. “How will removal of businesses prevent youth from obtaining tobacco products? Yes, there will be [fewer] stores to find products [at], but that doesn’t mean youth vaping will decline. During the ‘youth vaping epidemic,’* Walmart, arguably the largest retail footprint in the U.S., removed vapor products from its stores—is there evidence of reduced youth vaping as a result? Finally, banning tobacco product displays may impact youth exposure to products but would also reduce adult smokers’ exposure to different, potentially less harmful products.”

    Incentivizing Success

    There may be more innovative options to consider in controlling youth access. Another potential avenue to curb youth access may be to require manufacturers to offer incentives to retailers to maintain good practices. B2B sales discounts or incentives for meeting certain standards is likely to go a long way toward limiting youth access, according to Howard.

    “Manufacturers can incentivize limiting the number of products in a transaction to prevent straw sales, passing compliance checks, tobacco sales training and participating in the We Card program to encourage retailers to ‘up their game’ in preventing youth access,” he says.

    States are slowly becoming more innovative in their regulatory approach to youth vaping. Hawaii, for example, is considering the passage of a law that would require its Department of Health (DOH) to coordinate with its Department of Education (DOE) to establish a “take back” program for students to “voluntarily dispose of electronic smoking devices, flavored tobacco or synthetic nicotine products, and tobacco products in their possession.” If passed, the rules would also require the DOH and DOE to coordinate quarterly meetings with students on addressing the youth vaping epidemic.

    Many industry experts agree that the vaping industry, tobacco control community and regulators should be working together to solve the problem of youth uptake. However, that seems unlikely. It could be argued that the world’s most prominent regulator, the U.S. Food and Drug Administration’s Center for Tobacco Products (CTP), should be bringing stakeholders together to seek out common solutions to these problems. That hasn’t happened, according to Howard.

    “It appears CTP felt compelled to use a club, as opposed to a scalpel, to excise youth vapor use. Banning flavored pods and blanket denials of millions of PMTAs [premarket tobacco product applications] for flavored products through sweeping MDOs [marketing denial orders] removed most industry stakeholders in just about a month,” says Howard. “While much of this was thrust upon CTP by outside forces, it is hard to imagine, when they can completely control the issue, why would CTP now resort to compromise solutions?

    “CTP and the tobacco control lobby both detest those bad actors that market their products without regard to this important issue. Companies that actively follow the rules detest these bad actors too.  CTP, tobacco control and the ethical side of the industry should join forces to root these bad actors out.”

    *The surge in U.S. teen vaping was mainly a U.S. phenomenon. The most recent Centers for Disease Control and Prevention data suggest that episode is largely over, with both youth smoking and vaping at low levels. See https://www.cdc.gov/mmwr/volumes/71/ss/ss7105a1.htm?s_cid=ss7105a1_w.
    Timothy Donahue is the assistant editor of Tobacco Reporter. Since joining our team in January 2013, he has become not only an expert on the traditional tobacco business but also a well-respected voice in the rapidly developing vapor industry. Tim spends much of his time on the road, attending conferences and interviewing industry representatives. His networking skills, work ethic and quick mind are valuable assets to our diverse audience.
  • Seeking Synergies

    Seeking Synergies

    Photo: Feelm

    Tobacco companies are applying the expertise gained with reduced-risk products to new business areas.

    By Stefanie Rossel

    In their journey of transforming their businesses away from combustible cigarettes toward reduced-risk alternatives, tobacco companies have invested billions of dollars into innovation and scientific research over the past two decades. In return, they have obtained a wealth of expertise in adjacent areas—the potential of which they have just started to explore. Today, their goal is no longer limited to merely lowering harm but also to advancing health.

    The list of recent initiatives and moves illustrating this shift is impressive. In September 2021, BAT announced the construction of an innovation hub in Trieste, Italy. In addition to hosting a new manufacturing site for the company’s reduced-risk products (RRPs), the facility will house an innovation lab and center of excellence for digital transformation and marketing as well as a digital boutique. On an area of 20,000 square meters, BAT plans to develop multiple production lines for European and global export of its RRPs.

    According to BAT Chief Marketing Officer Kingsley Wheaton, the innovation hub, which involves an investment of up to €500 million ($549 million) over the next five years, will play a key role in the company’s transformation toward reducing the health impact of its business. Trieste was chosen as the location for the hub as it is already a globally recognized center of excellence in research and science, BAT said.

    Philip Morris International is demonstrating commitment to transformation with a change of location: In November 2021, the company announced it would relocate its headquarters to Stamford, Connecticut, USA, this summer. The new facility is intended to become a center of state-of-the-art innovation and serve PMI’s smoke-free ambitions, which now also include areas such as inhaled therapeutics. Occupying a 6,642-square-meter campus, the Stamford headquarters will house the PMI Americas region and other corporate functions. PMI’s operations center will remain in Lausanne, Switzerland.

    The transition of nicotine companies to adjacent business areas is evident in China as well. SmooreTech, the world’s largest vaping device maker in terms of revenue, recently established a fundamental research institute with three centers and hired a chief scientific officer with a deep background in respiratory medicine. Among other activities, the institute will perform physical and toxicology testing, data analysis and develop standards for vaping devices as they seem set to explore related areas in respiratory medicine. In 2020, SmooreTech became the first company in the Chinese vaping sector to get approval for conducting a national research program on vaping harm reduction, which it will conduct jointly with Tongji University.

    From Cigarettes to Pharma

    Tobacco companies have been aware of the medicinal potential of the tobacco plant for some time now (see “The Virtuous Weed”). In 2008, PMI acquired a stake in Medicago, a Canadian biopharmaceutical company. BAT purchased U.S.-based Kentucky BioProcessing (KBP) in 2014. Medicago and KBP have both been working on tobacco plant-based vaccines. In January, Health Canada approved Medicago’s Covifenz vaccination against Covid-19—the world’s first vaccine approved for human use that utilizes a plant-based protein technology. BAT has been performing clinical trials on its Covid-19 vaccine candidate. In January this year, BAT launched KBio, a new company that will leverage the existing and extensive plant-based technology capabilities of BAT and KBP and focus on delivering treatments for rare and infectious diseases.

    These developments are part of the tobacco industry’s desire to move “beyond nicotine.” PMI plans to generate at least $1 billion in revenues from such new business by 2025. Last summer, it acquired the Danish oral drug delivery specialist Fertin Pharma for $820 million and the U.K.-based asthma inhaler manufacturer Vectura for $1.2 billion. In August, the tobacco company took over U.S. respiratory drug company OtiTopic for an undisclosed sum.

    Fertin Pharma concentrates on research, creation and manufacturing of gums, pouches and liquefiable tablets as well as various solid oral systems to deliver active ingredients, such as nicotine. The takeover has given PMI access to Fertin Pharma’s technologies, expertise and talent, which includes almost 200 research and development specialists.

    While the Danish company can help PMI increase its footprint in the modern oral category, Fertin Pharma’s oral drug delivery platforms also complement PMI’s experience with inhalation technologies and could be used to develop scientifically proven self-care wellness products, such as over-the-counter solutions and supplements for better living.

    Commenting on the Fertin Pharma deal, PMI CEO Jacek Olczak said that his company’s future was “centered on health, science, technology and sustainable business practices to deliver innovative products and solutions that aim to improve people’s lives and create a net positive impact on society.”

    “PMI’s future is centered on health, science, technology, and sustainable business practices to deliver innovative products and solutions that aim to improve people’s lives and create a net positive impact on society.”

    Jacek Olczak, CEO, PMI

    Critical Role

    Vectura specializes in inhaled drug delivery solutions. At the time of the acquisition, the company had 13 inhaled and 11 noninhaled products in its portfolio. The new subsidiary will provide PMI with another 200 scientists who are knowledgeable about formulation, inhalation, devices, clinical manufacturing and regulatory issues. The company will also provide access to new technology and pharmaceutical development capabilities.

    PMI aims to develop a fully owned pipeline of inhaled therapeutics and respiratory drug delivery systems. Vectura, says PMI, will play a critical role in PMI’s beyond nicotine strategy, which the acquisition, together with the Fermin Pharma deal, is expected to accelerate.

    OtiTopic, PMI’s third recent acquisition in the pharmaceutical field, has developed an inhalable acetylsalicylic acid treatment for acute myocardial infarction that is currently undergoing clinical trials. The product comprises a novel, proprietary aspirin formulation that, delivered via a dry powder inhaler, enters the bloodstream faster than oral tablets. If approved by the U.S. Food and Drug Administration, the treatment can address the needs of more than 83 million people at risk for myocardial infarction in the U.S. alone, according to PMI.

    According to PMI Chief Life Sciences Officer Jorge Insuasty, PMI’s beyond nicotine initiatives will initially focus on respiratory delivery and botanical products addressing areas such as energy, sleep, calm and focus. While currently less developed than established tools, such as pills and syrups, respiratory delivery has advantages over traditional medication delivery methods, Insuasty explained in a recent edition of PMI’s Scientific Update. Medicines delivered via the respiratory tract allow a rapid onset of the drug effect and potentially reduce side effects due to the lower dose that might be needed compared to taking a pill, for example. The same holds true for botanicals, an area in which PMI has gained considerable expertise during its work with plant substrates and aerosolization.

    PMI healthcare ambitions are supported by its venture capital unit, PMI Equity Partners. The $150 million Swiss-based fund invests in companies that are involved in respiratory delivery, botanical sciences, health monitoring technologies, computational research methodologies and other innovations that have the potential to benefit health.

    Focus on Recreational Products

    BAT, meanwhile, has singled out personalized well-being as a starting point for developing opportunities beyond nicotine. In its annual report, the company said it was taking a “disciplined approach” to its beyond nicotine strategy as it expects continuous growth in the emerging market for well-being and “active” products, particularly for CBD. Fortune Business Insights estimates that the global CBD market, which stood at $3.68 billion in 2021, will increase to $55.79 billion in 2028, reflecting a compound annual growth rate of 47.49 percent.

    BAT says its strength is its superior understanding of consumers. By combining contextual information with biometric data sets, the company believes it can build a comprehensive model of moods, behaviors and rituals. In January 2021, BAT launched its first vapor CBD product, Vuse CBD Zone, in Manchester, U.K.

    The diversification drive is backed by BAT’s March 2021 £126 million ($165 million) acquisition of a 19.9 percent stake in the Canadian cannabis producer Organigram. Organigram grows cannabis and manufactures cannabis-derived products. The investment will provide BAT with access to research and development technologies, product innovation and cannabis expertise. The two companies will establish a center of excellence at Organigram’s New Brunswick site to develop next-generation cannabis products with an initial focus on CBD.

    Like PMI, BAT is supported by a corporate venture capital arm in its transformation effort. Established in 2020, Btomorrow Ventures seeks to invest in health and wellness, functional products, science, sustainability and technology sectors.

    The nicotine industry’s transformation has just begun. Slowly but surely, several of the companies that most people still identify as creators of health problems are becoming developers of health solutions. They will have to overcome many hurdles on their journey, including public skepticism and resistance from groups such as the World Health Organization, which recently indicated it would reject Medicago’s Covid-19 vaccine because of the biopharmaceutical firm’s link to PMI. If the nicotine companies succeed in their transformation, however, it would arguably represent one of the most remarkable metamorphoses in corporate history.

    Stefanie Rossel is Tobacco Reporter’s editorial contributor. An experienced trade journalist, she combines sharp reporting skills with in-depth knowledge of the tobacco and vapor industries. Prior to joining Tobacco Reporter, Stefanie was editor-in-chief at Tobacco Journal International, where she worked for a decade. Fluent in English, German and French, Stefanie covers tobacco news around the world. She is based in Germany.
  • Unlikely Bedfellows

    Unlikely Bedfellows

    Photo: Dmitry

    How free-flowing data streams can help advance public health goals for nicotine products.

    By Cheryl K. Olson

    How might new technologies engage public health in transforming the tobacco sector? Let’s take a look at three unlikely scientific bedfellows: sewage, Covid-19 and smoking harm reduction.

    Of the many innovations born from the Covid-19 pandemic, my favorite is the U.S. Centers for Disease Control and Prevention’s National Wastewater Surveillance System (NWSS). Since September 2020, the NWSS has tapped into underused data streams flowing through our communities to get early warnings of local disease spread. It’s not perfect; you can’t predict how many people are sick, and it misses people not hooked up to municipal collection systems. But the information is there for the taking. It doesn’t depend on persuading people to show up and get tested. 

    The smoking harm reduction parallel? Technology innovations can also help advance public health goals for nicotine products using the less malodorous but equally free-flowing data streams of search engines and social media. This is information people have already provided, with no need to persuade them to fill out surveys or file a report. We can systematically search those streams to look for evidence of product adverse experiences or youth misuse of tobacco products or to hunt for and counteract nicotine misinformation.

    I found a guide to some of these new methods in sociologist Navin Kumar, a postdoctoral associate at the Yale School of Medicine. He uses techniques like social computing, machine learning and natural language analysis to promote health, including tobacco harm reduction.

    Countering Misinformation

    Kumar’s research group has done several studies looking at how new technologies can identify and potentially counter health misinformation. As an example of how to study web-based narratives in tobacco control, the researchers tackled two controversial areas at once by mapping how misinformation spread about vaping (especially CBD from cannabis) to help treat Covid-19. This included collecting vaping-related text fragments from a wide range of web sources, including health provider forums, news articles and blogs as well as social media. They also generated word clouds (a fun and intuitive way to depict the most-used words) to see how the use of key terms changed before and after Covid-19 was reported to the World Health Organization. The results showed a shift from words related to vaping bans to positive mentions of CBD and CBD oil.

    There are many challenges in applying these techniques to counter nicotine misinformation. For a start, we need to understand how people talk about nicotine products in online conversations as opposed to formal news reports. A study by Kumar and colleagues analyzed the framing of vaping in social media and how words used to describe vaping and their meanings shifted over time. In earlier years, “happy” and “wonderful” were among the most frequent words associated with vaping. From 2017 on, these gave way to words like “ban,” “lung” and “teen.” The study vividly illustrates (with those wonderful word clouds) the social media shift from seeing vaping as an alternative to cigarettes to viewing vaping as about harm and regulation like the news media did.

    Another problem: It turns out it’s easier to get people to buy into twaddle than to stop them from doing so. Said Kumar, “People tend to believe new misinformation; it’s harder to remove misinformation such as ‘vaccines have microchips.’” One of Kumar’s recent studies was a randomized controlled trial to try to counter tobacco product misinformation. Results were promising, but the challenge is huge. How can a metaphorical cupful of accurate information received in a study counter the buckets of misinformation people get on a daily basis?

    That’s why researchers such as Kumar are working on automated ways to detect misinformation on social media using machine learning. If responsible parties can detect the latest mutation in tobacco product misinformation as it emerges, “They could respond before it has a chance to take hold. And go to Facebook and other outlets to counteract it,” said Kumar.

    New technologies, such as social computing, machine learning and natural language analysis, may help counter online misinformation about nicotine products. (Photo: Jo Panuwat D)

    Adverse Experiences 

    The goals of reporting are to identify safety risks, to share lessons learned so our mistakes are new instead of repeats of the past and to raise the cost to potential bad actors of disregarding customer safety. The U.S. Food and Drug Administration’s Center for Tobacco Products takes voluntary reports from anyone—including product users, researchers and health professionals—about “adverse experiences.” You can report a tobacco product concern through the FDA’s central safety reporting portal at www.safetyreporting.hhs.gov, which also takes reports about marketed human and animal drugs and biologics, foods and dietary supplements.

    Traditional ways of reporting adverse experiences to the FDA leave a lot to be desired. Since the system is primarily voluntary, a busy human must find the time and motivation to report the problem. Under-reporting is assumed, but no one knows by how much or how reporting may differ by product, user or symptom type. Important details may be left out of the report, making it hard to spot patterns (or creating misleading patterns as in the case of e-cigarette or vaping use-associated lung injury (EVALI)). Reporting can also be biased by things like news reports and litigation. The blossoming variety of reduced-harm nicotine products further complicates finding and addressing safety issues when market shares are small and issues are infrequent.

    If your company’s tobacco product gets a premarket tobacco product application (PMTA) marketing granted order from the FDA, postmarket reporting of adverse experiences is required as part of the deal. “Serious and unexpected” adverse experiences that companies are told about or discover must be reported through that FDA portal within 15 days. The FDA may also require other postmarket reporting to stay comfortable with keeping a new tobacco product on the market. It’s in your interest to avoid surprises.

    This approach is still untested for tobacco products, but publications are proliferating using these methods. I ran across articles that used machine learning and natural language processing to monitor for adverse effects of Covid-19 vaccines on Twitter and for health risks from the mood-altering plant kratom on Reddit and Twitter.

    As with our example of using wastewater to predict Covid-19 spread, Kumar notes that multiple data sources better predict outcomes. “So you can use reports on Twitter combined with YouTube and [the] news to predict adverse experiences,” he said. Look to computer science publications for the latest publications on nicotine products; they aren’t caught up in the tobacco harm reduction battles now raging in many public health journals.

    How do These Tech Innovations Look to Public Health Authorities?

    Are these promising innovations likely to percolate through into accepted practice? Will regulators look upon creative high-tech approaches with favor or scorn? To look for clues, I searched the abstracts (summaries) of studies accepted for the March 2022 meeting of the Society for Research on Nicotine and Tobacco (SRNT). (SRNT is not, at present, an industry-friendly organization and, therefore, is a useful gauge of sentiment among academics and regulators.) Over two dozen studies involved using social media data for research, most simply to gather information and look for patterns. Some involved lifting data from Reddit, Twitter or Instagram about descriptions or perceptions of particular tobacco products then using conventional qualitative methods (coding by human readers) to explore topics and feelings. Others used social network analysis to understand how information about products or policies spread. 

    Two studies supported the possibility of collecting adverse experiences through social media. One coded mentions of positive and negative health outcomes from vaping found on Twitter and Reddit. Another studied videos posted to the TikTok app (with hashtag #nicsick).

    One study combined old and new methods by using an age detection algorithm with Reddit metadata to sort posted comments on vaping and then hand-reviewing the most popular posts by each age group. A nicotine product company could potentially use an age detection algorithm to show regulators that their social media accounts don’t attract youth.

    Wearable sensors were used to detect smoking behavior as part of a smartphone-delivered smoking cessation program. Behavior studies documenting the transition from smoking to vaping might benefit from including wearable technologies. We might find, for example, that people who’ve completely transitioned to vaping have better sleep quality.

    New technologies bring new potential but also novel problems. For example, social media has been hailed as a new cost-effective, efficient way to recruit subjects for research, especially hard-to-find subgroups. My research team did have some success recently using social media platforms, such as Facebook, to locate a particular “vulnerable population” for PMTA behavioral studies. However, it also attracted responses from scammers, automated survey bots and professional survey takers, which took a lot of time and creativity to block or identify and remove.

     

    Cheryl K. Olson is a California-based public health researcher who specializes in behavioral health issues and consults on tobacco product behaviors via McKinney Regulatory Science Associates. She spent 15 years on the faculty of Harvard Medical School.

    Forewarned is Forearmed

    Derek Yach

    One example of using these advanced techniques to find early signals of both misinformation and potential health concerns is an e-cigarette or vaping use-associated lung injury (EVALI) monitoring and alerting platform developed by Skai (formerly Signals Analytics) for the Foundation for a Smoke-Free World.

    As a proof of concept, the platform retrospectively analyzed and compared vaping-related content from social media and news sources. In social media comments about specific symptoms and vape ingredients, Skai’s platform spotted signals of the direct link between seizures and vaping synthetic CBD nearly a year before official reports appeared. This kind of early information, while not definitive, would allow public health authorities and the industry to respond quickly to prevent harm and provide corrective facts in appropriate language.

    Disinformation on social media, from naive misunderstandings to deliberate manipulations, will be a fact of life for years to come. Taking advantage of these analytical techniques allows the industry to demonstrate socially responsible leadership in advancing public health. Why be blindsided by EVALI’s inevitable successor when there are tools to detect and respond to it? –Derek Yach

    *https://skai.io/reports-and-whitepapers/early-detection-of-pandemics-and-outbreaks/?msclkid=4ac806b7a95011ecb5d22adb0bd2b48e

  • All in the Mind

    All in the Mind

    Photo: andriano_cz

    A human-centric health ecosystem could unleash tobacco harm reduction’s full potential.

    By Stefanie Rossel

    In their efforts to end the era of combustible cigarettes, governments, public health authorities and other stakeholders today have a much larger toolkit at their disposal than they did at the turn of the millennium—at least in theory because only a fraction of available strategies are currently being employed.

    Due to increasing connectivity, the Fourth Industrial Revolution has brought rapid changes to technology, industries and society. It is also transforming the healthcare system—insurance companies seeking to promote a healthy lifestyle by asking their customers to use wearable devices that record physical activity and calorie intake are just one example.

    In order to better deal with today’s complex challenges, healthcare has in recent years become more human-centric, striving to understand human needs and how design—both the process of designing and the outcome of that process—can respond to these needs. “Design” in this context refers not only to products, services and procedures but also to strategies and policies.

    A human-centric health ecosystem (HCHE) involves understanding people and their needs, engaging stakeholders throughout the design process and systematically addressing interactions between the micro-level, meso-level and macro-level of sociotechnical care systems as well as the transition of individual interests to collective interests.

    This new approach to healthcare requires a holistic systemic approach, major organizational change and well-designed, dedicated interventions, such as products, services or procedures to be used by patients, caregivers and medical professionals to facilitate and implement the system.

    The role of the patient in this system changes accordingly: Instead of being a passive recipient of medical directions, he or she becomes a well-informed, responsible patient, intrinsically motivated to actively contribute to the success of his or her treatment. In contrast to the traditional approach, he or she doesn’t simply passively comply with instructions and wait for professionals to solve their problems but makes use of a technology-enabled ecosystem with an embedded choice architecture that encourages the desirable behavior and seeks support from a variety of sources.

    This healthcare model is shifting the focus from treatment toward prevention. Centralized, capital-intensive diagnostics facilities will be aided and perhaps even replaced by individual, on-demand or continuous inexpensive and readily available technologies, such as the mentioned wearables. Sensors in these devices generate data that enable disease prevention with the help of machine learning. Diagnostic and treatment data could be collected in a global database that practitioners can access but that is owned by the patients. Finally, instead of applying homogeneous therapies across groups of patients with similar health issues, treatments are likely to become more personalized.

    Behavioral Triggers

    The novel concept also holds promise for the prevention of noncommunicable diseases (NCDs), for which tobacco use is one of the greatest risk factors. The U.K.’s progressive tobacco harm reduction (THR) strategy, for example, incorporates many HCHE components. It has established a comprehensive infrastructure that includes institutions and healthcare professionals to help smokers to switch to less hazardous products or quit nicotine altogether. In 2017, the U.K. launched a Tobacco Control Plan that stresses the importance of innovation and less harmful alternatives. According to studies, the U.K.’s approach has been able to reduce smoking prevalence from around 20 percent in 2011 to between 13.8 percent and 16 percent in 2021.

    But the HCHE model offers further opportunities. Focusing on the individual and his or her perceptions, intentions and behaviors influencing personal health results, it is a demand-driven structure. Personal health outcomes, in turn, will ultimately influence population health. A fully developed HCHE environment uses a vast range of behavioral triggers that can encourage healthy decisions and eventually impact the incidence and prevalence of NCDs.

    At the 2017 World Economic Forum (WEF) in Davos, Willis Towers Watson published a white paper assessing the progress in preventing NCDs with the help of behavioral economics as part of the Human-Centric Health project. According to the white paper, mortality rates due to NCDs are projected to increase from 38 million to 62 million by 2040. While NCDs presently impact mostly high-income countries, they are growing fastest in low-income and middle-income countries.

    Participants in the Human-Centric Health project were tasked to develop and disseminate knowledge and tools for behavioral changes that would lead to long-term healthier lifestyles. The experts were also asked to identify public-private cooperation opportunities across nontraditional health and healthcare stakeholders, for which the WEF could provide a platform. The project touched upon smoking cessation but did not make use of the THR concept.

    Making Healthy Choices

    Human decision-making depends heavily on heuristics, mental shortcuts that can facilitate problem-solving in situations of limited knowledge and time. Heuristic processes are based on experience, thus enabling people to quickly make the thousands of decisions they must make every day. Not all precepts of behavioral economics, though, lead to choices that support good health. The WEF white paper reviews some of the more powerful principles in behavioral economics that may contribute to healthier behavior within the HCHE if being applied appropriately.

    “Present bias,” for example, is a strong motivator: Humans tend to assign greater value to payoffs that are closer to the present time than those that occur further in the future—if people want something, they want it immediately. A strategy for health improvement should thus present choices that combine a current pleasure with a behavior that will lead to better health in the future and emphasize the near-term advantages of healthy behavior rather than the benefits that might be achieved later. A case study described by the white paper suggested glycemic control in diabetes patients reliant on food banks could be improved by providing clients with diabetes-appropriate food, blood sugar monitoring, primary care referral and self-management support.

    Another behavioral trigger is loss aversion: People sense the pain of loss more deeply than the pleasure of gain. Recently, this insight has been used in initiatives to encourage smoking cessation: Smokers received a payment at the outset of the program, which they would be forced to pay back if they failed to keep their commitment to quit smoking.

    Health choices can also be influenced by framing—by expressing the consequences of disease in survival rates rather than mortality rates, for example—even if the results are equal. The HCHE system may emphasize benefits that can be achieved through a specific action or the ease of healthy behavior compared with other activities people voluntarily decide on.

    The HCHE system also takes advantage of the knowledge that humans respond better to narratives than logic or statistics. By telling compelling stories that people can relate to, health practitioners can drive healthier behaviors. Of course, facts must be given accurately, but data alone don’t necessarily drive change.

    Humans are also subject to social norms—a person married to or friendly with smokers is more likely to smoke than a person without such relationships, according to the white paper. Findings like this, however, can also be used to achieve a positive effect—for example, by incorporating social media and influencers into information campaigns or asking people to make public commitments to future change.

    Choice architecture and defaults can nudge people toward healthier decisions. In a realm of choices, humans tend to stay with a default as it takes less energy than making an active decision and allows them to focus on more important concerns. A prominent display of healthy food in shops, for example, can thus help people make healthier choices.

    Humans’ tendency toward “irrational optimism” and “depletion” are additional behavioral triggers that can be taken advantage of to stimulate desirable behaviors. Including a lottery element in health incentives will generate attention at low cost. As people only have a limited span of attention, health improvement efforts should focus on measures with the most potential benefit while requiring the least cognitive effort of the targeted population.

    Stakeholders

    A successful HCHE, the white paper argues, resembles a consumer purchase model in which informed buyers express demands that support their well-being and stakeholders succeed by recognizing and meeting those demands. The paper identifies three actors that can greatly impact NCDs—insurers, retailers and technology.

    Insurers can contribute to the HCHE by providing health assistance, for instance, through health coaching, paying healthcare claims and providing incentives, such as rewards to encourage smoking cessation. They can also provide information about achieving and maintaining health, including health risk assessments, biometric screening and education.

    Next to increasing their inventories of healthy items, retailers, who act as a principal source of consumer products and therefore exercise particularly powerful influence over dietary quality, can provide access to selected health services, such as vaccinations on-site, and work with policymakers to develop pricing policies that encourage consumption of healthier foods and beverages. In the case of tobacco, the white paper recommends a reduced inventory, citing the example of CVS Caremark, a U.S. retailer that in 2014 stopped selling cigarettes.

    While CVS Caremark’s sales declined during the following year, its decision reduced total cigarette sales by 1 percent across 13 U.S. states while nicotine patch purchases increased by 4 percent immediately after tobacco sales ended.

    Health-related technology, the third component mentioned in the report, refers to the application of organized knowledge and skills in the form of devices, medicines, vaccines, procedures and systems developed to solve or prevent a health problem and improve the quality of lives.

    For patients suffering from chronic obstructive pulmonary disease or asthma, for instance, tracking usage of inhalers that provide vital medication can be challenging. An estimated 70 percent to 90 percent of patients use their inhalers improperly, thus delivering insufficient levels of medication to their lungs. In late 2018, the U.S. Food and Drug Administration approved the first digital inhaler with built-in sensors that detect when the inhaler is used and measure breathing. The sensors connect to a smartphone app, recording data that can be shared with doctors who can evaluate a patient’s inhaler usage. There are many ways that these technologies could be adapted for e-cigarettes, heat-not-burn devices and related products.

    The technology sector is also where reduced-risk tobacco products (RRPs) come into play as the gap between recreational and therapeutic inhalers is narrowing. Among recently published patents for nicotine vapor devices and heated-tobacco products, most cover therapeutic innovations, including vaping products that employ sensors (see “In the Pipeline,” page 20).

    The combination of new technologies and behavioral economics allow for healthy choices to be the easier choices. Laws that regulate products proportionate to their risk compliment and support this.

    Properly integrated into the HCHE, RRPs could drive tremendous progress in public health. The private sector has already realized the potential of RRPs as a smoking cessation tool. It is time for regulators to follow their example.

     

    Stefanie Rossel is Tobacco Reporter’s editorial contributor. An experienced trade journalist, she combines sharp reporting skills with in-depth knowledge of the tobacco and vapor industries. Prior to joining Tobacco Reporter, Stefanie was editor-in-chief at Tobacco Journal International, where she worked for a decade. Fluent in English, German and French, Stefanie covers tobacco news around the world. She is based in Germany.
  • From Coercion to Empowerment

    From Coercion to Empowerment

    David Sweanor

    Tobacco harm reduction advocate David Sweanor describes the shift required to reduce the health toll of smoking.

    By Derek Yach

    David Sweanor has played a global role in steering the World Health Organization, governments and nongovernmental organizations to use the most powerful interventions they have to end smoking. His focus on policy measures to reduce the carnage from cigarette smoking, including a leading role on excise taxes, marketing restrictions and smoke-free policies, has long included tobacco harm reduction (THR). And in the process, Sweanor has highlighted the need to move from blunt approaches to all tobacco products to a system that regulates products proportionate to their risk. In a recent conversation, Sweanor discussed the origins of innovation in THR.

    “Hobbyists” and consumers seeking safer products have long tried to develop products that deliver nicotine without other toxic ingredients common in combustible cigarettes (see “Major Milestones”). Our conversation focused on transformation underway in leading tobacco companies.

    Sweanor believes that leading tobacco companies have a clear vision of the endgame for their transformation—addressing health, wellness and consumer needs profitably. This was largely forced upon them by advancements in technology, upstart competitors and consumer demand. In contrast, leaders in tobacco control, he believes, are trapped in a vision set in the 1970s that relies on coercion rather than empathy and empowerment and ignores the role of disruptive technologies.

    Sweanor laid out progress reported in the latest round of quarterly earnings by leading tobacco companies. Analysts highlighted the role of reduced-risk products as increasingly driving corporate profitability. Philip Morris International now gets 30 percent of total revenue from reduced-risk products and BAT gets 12 percent, with Altria and Imperial advancing through single digits. And Sweanor stressed the fundamental role that competition and investments in innovative research have played in driving this progress.

    The funding, volume, quality and diversity of industry research have accelerated over the past decade, and the nicotine business has attracted new and innovative players. Industry research is more interdisciplinary than most public-funded research and includes cutting-edge insights from toxicology, systems biology, epidemiology and pharmacology enhanced by clinical insights from respiratory medicine, oncology and cardiovascular disease.

    Sweanor is concerned that at a time when we need more engagement between industry and public health researchers, more barriers are being created that discourage debate, counterproductively protect the cigarette trade and prolong the epidemic of diseases and deaths caused by cigarette smoking. The Society for Research on Nicotine and Tobacco’s ban on tobacco industry participation in its conferences is only the latest example of industry exclusion.

    To demonstrate that they have truly embraced transformation, says Sweanor, tobacco companies and other players in the consumer nicotine market should:

    • push ahead with investments and the launch of healthier, safer products designed to end combustible use;
    • be more proactive in challenging misinformation and the laws that protect the cigarette business from competition;
    • share patents addressing core aspects of health and safety with smaller companies and state monopolies in low-income and middle-income countries—this could be done in many ways within World Trade Organization rules; and
    • place key data of public health policy relevance in the public domain. This includes, for example, conversion rates from combustibles to reduced-risk products and consumer research on the viability of reduced-risk alternatives to cigarettes. Sweanor stressed that all companies need to do this. Much could be learned from a related effort undertaken by food companies in the United States led by the Healthy Weight Foundation.

    Above all, he believes that this is the time for companies to work with governments to more aggressively end the sale of combustibles. “They should not await permission from unyielding anti-tobacco groups before fully engaging in efforts to protect the health of their consumers,” said Sweanor.

    Sweanor discussed the emergence of industry initiatives that build on their investments to end combustibles (see “In the Pipeline”). From Covid-19 vaccines derived from tobacco plants (see “The Virtuous Weed”) to deeper insights into medication aerosolization and what this might mean for new classes of pharmaceuticals delivered through 21st century delivery systems, Sweanor stated that it is clear that companies are not stopping their transformation journey. “There are no examples from across other sectors that when such profoundly disruptive change happens, it ever returns to the status quo,” he said. “The arrow of innovation points toward healthier and more environmentally sustainable products and services.”

    In time, the recent analyst views that some tobacco companies will become life sciences companies tackling major health issues may well come true!

    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.