Category: Science

  • Crossing the Divide

    Crossing the Divide

    Photo: es0lex

    When scientists work for a tobacco company

    By Cheryl K. Olson

    Carlista Moore Conde never expected to work for Big Tobacco. A chemical engineer by training and a former NASA scholar, her career had focused on R&D for multibillion-dollar brands of household name consumer goods at Procter & Gamble.

    “I spent 20 years working on products that improved people’s lives,” she told me soon after we’d met at the 2021 Global Tobacco and Nicotine Forum in London. “Now I’m working on products that can save lives.”

    Carlista Moore Conde

    As group head of new sciences at BAT, Conde is part of a trend among tobacco companies to hire from outside the fold—industries that often have nothing to do with nicotine, as well as academia and government—to work on reduced-harm products that lower the health risks to people who are already addicted to combustible cigarettes.

    “I have family members, dear aunts and uncles, who spent a lifetime smoking and suffered the [health] consequences,” she continued. “So I never even considered working for a tobacco company, honestly. I misperceived the harm of alternative nicotine products as being the same as traditional smoking.”

    Mohamadi Sarkar took a different path to working in the industry. He’d been a professor of clinical pharmacology at the Medical College of Virginia at Virginia Commonwealth University where he’d done research on smoking-related diseases. He was approached by scientists from Altria about joining them after he’d presented at a conference run by the Society for Research on Nicotine and Tobacco.

    “And my first reaction was ‘Heck no!’” he said. “I was a tenured professor. Never in my wildest dreams had I thought I’d work for corporate America, let alone work for a tobacco company!” He’s now a fellow in scientific strategy at Altria Client Services. Sarkar has been at the company and its predecessors for 19 years. He maintains a faculty appointment at VCU and teaches three courses there per year.

    Brian Erkkila was a neuroscientist at the National Institutes of Health before joining the then-new FDA Center for Tobacco Products in 2011. He was a lead toxicologist there for more than six years. After a three-year stint at the Foundation for a Smoke-Free World, he moved to Swedish Match in 2021, where he is director of regulatory science.

    “It was certainly comforting to see how ‘all-in’ everyone I work with at Swedish Match is about tobacco harm reduction,” he said. “Looking out from inside the industry, there is a magnified sense of uncertainty concerning the regulatory environment. It’s very difficult to know what the nicotine marketplace will look like even one or two years from now.”

    Looking past the cliches: While the tobacco industry engaged in questionable and even spurious research a generation or two ago, its recent approach has been quite different.
    (Photo: Seventyfour)

    New Scientists, Old Beliefs

    Mohamadi Sarkar

    A generation ago, the tobacco industry was largely an old boys’ network. Tobacco was “in your blood.” As the health effects of combustible cigarettes became apparent, many scientists from outside that industry saw joining it as a career killer.

    But Big Tobacco has moved on. In response to public health findings, combined with social, regulatory, and economic pressures, it’s shifting away from combustible tobacco and focusing on alternative, less harmful nicotine-delivery systems. Still, scientists who are recruited from outside the industry often respond with healthy skepticism about whether this new focus is sincere. Conde shared that skepticism until she spoke with BAT employees who had come from outside tobacco and took a close look at the company’s operations.

    “You hear stories about big bad tobacco from the past,” she added. “But what I found is that the science done here is done in a very transparent and rigorous way and is shared, even with our competitors.”

    Erkkila added, “Sadly, I feel that some former colleagues will simply write me off for joining [the] industry. However, they need to understand that this is not the same industry from decades ago. FDA regulation of tobacco products has ensured that the research being done by companies is vetted and carried out in a robust manner.”

    Sarkar admits that he struggled a bit with the reactions of some people at his university when he started at what was then Philip Morris USA. “Folks I knew from my past experience in academia who were my friends and colleagues started distancing themselves,” he recalled. “They were not happy with my decision to work for a tobacco company. But we do good science with the right rigor. I take great pride in the work we do.”

    For Sarkar, as well as other scientists who’ve worked previously as professors, one of the strong advantages of corporate research is the consistency of funding. Another is the speed with which a novel idea can be pursued. Research grants to university laboratories often require months of detailed paperwork. The success rate of scientific research grant applications to the federal government—the largest funder of such research—is notoriously low. (In 2020, the National Cancer Institute rejected six grant applications for every grant that it funded.)

    “At PMUSA, I was just amazed at the resources available to do the research, and the commitment not only to conduct the research but to publish and share it with the scientific community,” Sarkar continued. “Unfortunately while we are keen on publishing and sharing our research, some journals don’t accept industry funded research for peer-review consideration. In this situation, nobody wins—not science, not good policy, and certainly not adult smokers.”

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    A Caste System for Researchers?

    Brian Erkkila

    There’s a paradox to the resurgence of suspicion and even outright rejection of industry-conducted science on tobacco harm reduction and alternative nicotine products. While the tobacco industry engaged in questionable and even spurious research a generation or two ago, its recent approach has been quite different.

    “In this age of rampant misinformation, certain groups ignoring quality science because they don’t like the source strikes me as a hindrance to public health,” said Erkkila.

    Recently, the editorial board of Nicotine & Tobacco Research, the journal published by the Society for Research on Nicotine and Tobacco, announced that “In order to continue the journal’s policy of alignment with the SRNT, which owns the Journal, N&TR will no longer allow tobacco industry (TI) employees to submit work to the journal in any format. TI employees include those individuals who work for companies owned in part or in whole by manufacturers of commercial tobacco products.”

    This concern flies in the face of one of the fundamental tenets of scientific research: that it should be judged solely on its rigor not on the provenance of the researchers. That is the purpose of anonymous peer review. Preemptively excluding all research from the industry (or academia or government or pharmaceutical companies) is naive at best and will likely do harm to the public health.

    All researchers who publish should cite both their affiliations and their sources of funding as well as other potential conflicts of interest. This encourages readers to employ a gimlet eye when considering conclusions and recommendations. It’s a pretty safe bet what the National Pork Producers’ Council will recommend for dinner. But does that mean I should automatically reject its nutritional analyses or its studies of African Swine Fever risk and prevention?

    The new policy draws some bizarre distinctions. I’m a former academic researcher. During my career, I’ve worked on tobacco harm reduction and youth smoking prevention projects that were funded by government, nonprofits and industry. Am I a “good guy” or a “bad guy?” Is there a formula by which a certain amount of government-funded research cancels the stigma of industry-funded research, the academic equivalent of buying carbon offsets? (I’m only being slightly facetious.)

    Note that the SRNT definition of “tobacco industry” does not include e-cigarette makers, except those linked to traditional tobacco product companies. (It also does not exclude consultants to tobacco companies from its conferences or journal, only industry employees.)

    We run the risk that some of the “bad actors”—companies that have shown scant interest in harm reduction and youth use prevention—will have access to communications channels being denied to “good actors” that currently or have previously manufactured tobacco products. Under these rules, researchers for companies side-stepping Food and Drug Administration regulation by using synthetic nicotine could have their work considered for publication while scientists who crossed from government and academic posts to Juul (which is partially owned by Altria) would have their work summarily dismissed.

    Simplistic approaches such as this may feel righteous, but they elevate form over function. We lose sight of the ultimate goal—a goal more likely to be achieved by sharing data and resources. Many scientists who have entered the industry believe that they can do more to block the dangers of combustible tobacco from the inside than from the outside.              

    “My moves from regulator to the Foundation and ultimately to Swedish Match have all been about reducing the public’s harms from tobacco,” said Erkkila. “Others’ view of me may have changed, but these moves have allowed me to appreciate the issue from many sides.”

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  • Stepping Up

    Stepping Up

    Tim Liddicoat
    (Photo: Hall Analytical)

    Hall Analytical is investing in reduced-risk product analysis to meet growing demand driven by innovations and regulatory requirements.

    By George Gay

    Hall Analytical’s sponsorship of the recent GTNF in London represented the company’s first participation in this annual conference, and Tobacco Reporter was keen to discover why it had decided to take part this year. Did its participation represent, for instance, a vote of confidence in the future of the nicotine industry?

    Given the chance of an email exchange with managing director Tim Liddicoat, Tobacco Reporter started off by asking whether he believed Hall Analytical’s nicotine industry business would increase or decrease in the future.

    Tim Liddicoat: We are convinced that our nicotine industry business will significantly increase in the next five years. With our investment in reduced-risk product analysis at Hall Analytical, we believe that client requirements for our analytical expertise will substantially increase in the next several years. The recent report in Research and Markets predicts the global ENDS [electronic nicotine-delivery systems] market to reach $84.43 billion in 2025, and we have the infrastructure and expertise to service this market with high-quality scientific data.

    Tobacco Reporter: Why this optimism? Do you believe the nicotine industry regulatory environment will become more demanding in the future?

    As the burden of proof required to prove APPH [appropriate for the protection of public health] increases incrementally in the U.S. and as European legislation develops, along with the need to support new innovations in the space, we see the analytical testing requirements becoming more demanding. This drives us to develop even more sensitive, precise, accurate and robust analytical methods.

    In addition, as regulatory frameworks continue to be strengthened in established markets around the world and client demand for high-quality product characterization, emission analysis, stability and E&L [extractable and leachable] studies will only increase. The recent publication of the U.S. FDA’s final rule for the PMTA [premarket tobacco product application] pathway has established the minimum data requirements for a deemed tobacco product to enter substantive review. This certainty has been welcomed by the RRP [reduced-risk product] sector, enabling product regulatory compliance strategies to be reviewed and re-engaged. The published final rule, and limited market authorizations of tobacco-flavored ENDS to date, strongly suggest the agency’s burden of proof to demonstrate APPH is substantial. The European TPD [Tobacco Products Directive] regulatory review is imminent, and there’s every indication that a tightening of regulation around flavored ENDS products is favored by the majority of member states. This will potentially increase the requirements for analytical services from our European TPD clients.        

    Client requirement for our services will not only be fueled by regulatory compliance but rapid innovation in product technology with safety and user experience at the heart of new product development.  

    ENDS clients are also looking to emerging markets for growth, with national regulators examining established markets for guidance on appropriate regulatory frameworks. Tobacco companies traditionally focused on combustible cigarettes are rapidly diversifying their product portfolios toward reduced-risk alternatives for a sustainable business future. Growth in global markets for the next generation of nicotine-containing products will progress rapidly, and our ability to respond to clients’ needs will enable Hall Analytical to attract new business servicing the RRP sector.   

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    Who owns Hall Analytical?

    Hall Analytical is owned by Element Material Technology, a leading global provider of testing, inspection and certification services on a wide range of products, materials, processes and services for a diverse set of end markets, where failure in service is simply not an option.

    Headquartered in London, U.K., Element’s scientists, engineers and technologists, working in its global network of over 200 laboratories, support customers from early R&D, through complex regulatory approvals and into production ensuring that their products, materials, processes and services are safe, compliant and fit for purpose.

    Is ownership about to change?

    Hall Analytical was acquired (along with VR Analytical, Crawford Scientific, Anatune and APEX Scientific) in July 2021, and ownership is not about to change again.

    What, in layman’s terms, are the main methods you use and the main pieces of equipment you use, especially in respect of testing e-cigarette and heat-not-burn products and vapors?

    When testing ENDS products, we focus on the analysis (testing) of the e-liquid and resultant vapor emissions, which are inhaled by the user. E-liquid testing can be more straightforward than analyzing ENDS vapor. The e-liquid samples received from clients are prepared in the laboratory and tested using analytical instruments, which employ either liquid chromatography (LC) or gas chromatography (GC) to separate the complex mixture of chemicals. The LC or GC is connected to a detector, such as a mass spectrometer, which can detect, identify and accurately quantify trace levels of chemical compounds. To unequivocally quantify trace chemicals in complex e-liquids and vapor emissions, we use tandem mass spectrometry for extremely sensitive and specific chemical detection. Trace metal quantities in e-liquid and vapor emissions are determined using a technique called inductively coupled plasma mass spectrometry.

    For vapor emission analysis of both ENDS and heated-tobacco products (HTPs), we employ the same analytical instruments but need to generate vapor emissions from the test devices in a standardized procedure. To do this, we use an automated e-cigarette/HTP vaping machine specifically designed to be compliant with international testing standards. The test device emissions are generated by the machine, collected, prepared in the laboratory and then analyzed by the techniques previously discussed. 

    You mention above quantifying “trace chemicals in complex e-liquids.” How would you explain to a layman what complex trace analytical chemistry is?

    Many chemicals can be found in complex mixtures at very low “trace” concentrations in different matrices, such as pharmaceutical products, environmental samples, physiological samples (blood, urine, etc.) and e-liquids used in e-cigarettes. Most of these trace chemicals were not detectable for many years due to limitations in analytical instruments and methods. With modern advances in instrumentation and techniques, laboratories can detect and precisely determine the amount of trace chemical present in a complex test sample. 

    What are the main services you offer, apart from those already mentioned?

    Hall Analytical delivers industry-leading scientific expertise that supports our customers’ ability to ensure product safety. We do this in support of a number of industries: tobacco (to support both product development and regulatory submission for reduced-risk products) and pharmaceutical and medical device supply chain and manufacturers. Our main services are in support of chemical analysis of RRPs and E&L testing for all aforementioned industries.

    Do you offer any services in respect of traditional tobacco products?

    We have recently moved into analytical testing of HTPs but currently do not analyze traditional tobacco products.

    Where is your company based?

    Hall Analytical is based at a 25,000-square-foot facility in Wythenshawe, Manchester, [U.K.]. This is the only Hall site, but the wider Element organization has a global network of over 200 laboratories, some of which support reduced-risk product testing similar to that carried out at Hall Analytical.

    How many people work for Hall Analytical?

    Hall Analytical currently has 50 staff. There are about 200 people in the wider Element Life Sciences EMEAA [Europe, Middle East and Africa] organization split over five companies (Hall Analytical, VR Analytical, Crawford Scientific, Anatune and APEX Scientific), with the Element Material Technology business working in a global network of over 200 laboratories.

    Are they mainly chemists and technicians?

    Hall Analytical employees are split between the operational team, quality, science (study direction, R&D and subject matter experts, E&L specialists), commercial and supporting functions (project management, HR, HSE [health and safety], admin and IT) with the majority directly supporting our customers by delivering industry-leading scientific expertise that supports our customers’ ability to ensure product safety.

    In which countries are your main customers based?

    Our customer base is primarily European and North America[n], but we have customers based worldwide. Many customers are large multinational organizations, and we have supported them from Australia to South America and beyond.

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    Which industries provide the bulk of your business?

    Tobacco companies, pharmaceutical companies, medical device organizations and their supply chain partners make up the bulk of our business.

    You expressed confidence earlier, so would it be fair to say that your business is growing?

    We have a strong business that is well placed for future support of all of our customers. We fully expect the business to sustainably grow in the coming years and to further expand its services and offerings in tobacco RRPs, pharmaceutical E&L and medical device E&L. We see fantastic opportunities with our acquisition by Element and will continue to work in partnership with our customers to meet their needs as their businesses develop.

    Does this mean you invest significantly in the business?

    In recent years, we have been well supported with significant investment in infrastructure (£2 million), instrumentation and data systems (£1 million), business leadership and our quality management system to reflect changing customer needs and maintain our commitment to state-of-the-art, high-quality analytical services.

    Has your business been affected by Brexit and, if so, how?

    The only impact we have had from Brexit has been with supply of chemicals from the EU. With changing REACH [Registration, Evaluation, Authorization and Restriction of Chemicals] regulations, it has become more difficult to predict which reagents and standards will be available, but we have mitigated well with increased stock of hard-to-get chemicals.

    Has your business been affected by the Covid-19 pandemic and, if so, how?

    Covid has impacted our business in ways that we would not have predicted. On the one hand, we saw a slowdown in the responsiveness of the FMCG [fast-moving consumer goods] markets we serve due to the restrictions of working on-site for many of our customers, but, in contrast, supporting vaccine development, ventilator production and a general acceleration of pharmaceutical and medical device projects accelerated. 

    Operationally, we flexed well to a hybrid work model where some activities could be done remotely, and there was little impact. We also moved facility at this time, and this was delayed a little.

  • Study: Thousands of Unknown Chemicals in E-Cigarettes

    Study: Thousands of Unknown Chemicals in E-Cigarettes

    Photo: pavelkant

    E-cigarettes and other vapor products contain thousands of unknown chemicals and substances not disclosed by manufacturers, according to a study published on Oct. 6 by Chemical Research in Toxicology.

    The authors noted that the aerosols produced by vapor products contain more than 2,000 chemicals, the vast majority of which are unidentified. The researchers, who are from Johns Hopkins University, reported that the findings suggest people who vape are using a product whose risks have yet to be fully determined and could be exposing themselves to chemicals with adverse health effects.

    The researchers used a chemical fingerprinting technique based on liquid chromatography and high-resolution mass spectrometry, which can identify organic compounds in wastewater, food and blood. The team evaluated four popular products: Mi-Salt, Vuse, Juul and Blu, testing only tobacco-flavored products.

    The examined e-liquids contained hydrocarbon-like compounds, typically associated with combustion, which manufacturers claim are not produced during vaping. “More and more young people are using these e-cigarettes, and they need to know what they’re being exposed to,” study co-author Carsten Prasse was quoted as saying by Johns Hopkins Magazine. “E-cigarette aerosols contain other completely uncharacterized chemicals that might have health risks that we don’t yet know about. People just need to know that they’re inhaling a very complex mixture of chemicals when they vape. And for a lot of these compounds, we have no idea what they actually are.”

  • Taming the Moral Panic

    Taming the Moral Panic

    Photo: romankosolapov

    A recent landmark article offers a rare balanced look at vaping in the U.S.  

    By Cheryl K. Olson

    In the 1930s, there was considerable handwringing among politicians and academics about how gangster films would turn an entire generation of teenagers into thugs and thieves. After a few years, film scholars recognized that it was a moral panic—a widespread and irrational fear supported by emotions rather than by scientific data. They moved on.

    In the 1950s, sociologists feared that crime and horror comic books would destroy the morals of that era’s youth. There were U.S. Senate hearings on whether they should be published as well as mass comic book burnings around the country. After a few years, sociologists recognized that it was a moral panic. They moved on.

    In the early 21st century, a popular London-based tabloid claimed that video games are as addictive as heroin and that “Britain is in the grip of a gaming addiction, which poses as big a health risk as alcohol and drug abuse.” On the other side of the Atlantic, then-Senator Hillary Clinton claimed that “violent video games increase aggressive behavior as much as lead exposure decreases children’s IQ scores.” It was, psychologists have largely concluded, another moral panic with echoes that remain in today’s public policy.

    We may have just seen the turning point on the moral panic surrounding vaping. Writing in the August issue of the American Journal of Public Health (AJPH), 15 former presidents of the Society for Research on Nicotine and Tobacco (SRNT), the world’s leading scientific organization for the study of smoking, concluded that concerns about youth vaping are overblown and may be undermining attempts to get current combustible tobacco users to quit. The much-touted fears are simply not supported by the data.

    Rebalancing the Conversation on Vaping

    As the title—“Balancing Consideration of the Risks and Benefits of E-Cigarettes”—suggests, the authors were particularly concerned about the public’s misunderstanding of the products’ relative risks.

    “Of respondents to a 2019 national survey, nearly half considered vaping nicotine just as harmful as or more harmful than cigarette smoking,” they wrote. “Only one in eight considered vaping less harmful. (The rest responded, ‘I don’t know.’) By contrast, the U.S. National Academies of Sciences, Engineering and Medicine and the British Royal College of Physicians have concluded that vaping is likely far less hazardous than smoking cigarettes.”

    In the U.S., youth vaping prevention programs have done their work too well. In recent years, the tone of coverage of vaping, in academic journals and news media, has gone from a mix of curious, skeptical and optimistic to a presumption of acute danger. A 2018 content analysis of 2015 news coverage of e-cigarettes, published in Nicotine & Tobacco Research (the SRNT’s journal), noted that “quoted physicians, researchers and government representatives were more likely to refer to e-cigarette risks than benefits” in the run-up to U.S. Food and Drug Administration regulation.

    They presciently cited concerns about harm from this increasingly negative media coverage: “While the news media is an important vehicle for informing the public about the potential risks of these new products, it has also been argued that news stories that focus only on risks without contextualizing their risks relative to cigarettes or discussing their harm reduction benefits may contribute to misperceptions about the risks of these products.”

    “Contextualizing the risks”—in other words, framing the issue affects the terms of the debate. For example, we’ve seen the framing of flavored vapes shift as public opinion on vaping soured. The initial focus on eliminating child-attracting names, imagery and packaging (sugary breakfast cereals, cartoons, baby bottle shapes) morphed into suspicion of fruit flavors in general and then to all nontobacco flavors. This gradual shift masks the absurdity of mandating that nicotine stay linked to the taste of cigarettes, when the goal is to wean people off them.

    While no one who looks at the data would claim that vaping is safe or that nonsmokers should start, the 15 AJPH authors put our concerns into perspective. The melodramatic public service announcements implying that vaping will disfigure your face and send eel-like creatures to invade your brain or that it “can escalate teen mood swings” are as irrelevant as the much-mocked Partnership for a Drug-Free America’s series of “This is your brain on drugs” public service announcements from the 1980s featuring sizzling fried eggs.

    Smokers Are Still Here

    Smoking remains a massive and challenging public health problem. In the United States alone, nearly a half-million people will die this year from smoking-related illness. The headlines and health campaigns about smoking may be gone, but smoking is not.

    In the AJPH authors’ eloquent phrasing, “To the more privileged members of society, today’s smokers may be nearly invisible. Indeed, many affluent, educated U.S. persons may believe the problem of smoking has been largely ‘solved.’ They do not smoke. Their friends and colleagues do not smoke. There is no smoking in their workplaces nor in the restaurants and bars they frequent. Yet one of every seven U.S. adults remains a smoker today.”

    The stalled decline in adult smoking rates gets little attention in academic journals. One 2017 study (Zhu S et al. – “Smoking prevalence in Medicaid has been declining at a negligible rate.”) found that about a third of people on Medicaid (who must have incomes below a certain threshold and often deal with chronic physical or mental illnesses) are smokers; their quit rates were basically flat from 1997 to 2013.

    As part of restoring balance between vaping’s youth risks and adult smoker benefits, the 15 AJPH authors bring up smoking as a social justice concern. For example, “African Americans suffer disproportionately from smoking-related deaths, a disparity that, a new clinical trial shows, vaping could reduce.”

    Further, “Smoking accounts for a significant proportion of the large life expectancy difference between affluent and poorer Americans. For smokers with serious psychological distress, two-thirds of their 15-year loss of life expectancy compared with nonsmokers without serious psychological distress may be attributable to their smoking. Vaping might assist more of these smokers to quit.”

    I shared the AJPH article and related material with someone whose business is specially designed e-cigarettes for incarcerated persons, replacing various types of dangerous contraband combustible tobacco. Watching the short video that accompanies the article, produced by the University of Michigan School of Public Health and featuring study co-author Kenneth Warner, made her staff literally stand up and cheer. 

    The 15 researchers’ conclusions bode well for helping those who are addicted to combustible tobacco and who will not or cannot yet quit. Vaping provides a reduced harm pathway for providing the nicotine that smokers’ brains crave without most of the extremely dangerous combusted byproducts of tobacco. The contents and existence of this landmark article are a reason to celebrate—not for us but for the smokers whose lives may be saved.

    Why is it important that these authors are past presidents of the Society for Research on Nicotine and Tobacco? Because this is not an organization known for friendly relations with the nicotine product industry. But they looked at the data and are moving on.

    The New Merchants of Doubt

    An interesting commentary accompanied that American Journal of Public Health consensus statement by 15 respected experts. In it, Martin Dockrell and John N. Newton worry that the drumbeat of concern about vaping’s risk “leads to cognitive bias” that makes us discount evidence of benefits. For this mindset, they use an interesting and potentially stinging turn of phrase: “Public health risks stealing the [tobacco] industry’s clothes, becoming the new merchants of doubt.” This references the famous 2010 book Merchants of Doubt: How a Handful of Scientists Obscured the Truth on Issues from Tobacco Smoke to Global Warming.*

    Dockrell and Newton are not the first to label e-cigarette critics as merchants of doubt (just as I’m far from the only person to call moral panic on youth vaping). But it’s quite another thing to sling that history-laden insult in the editorial pages of the venerable American Journal of Public Health.

    Merchants of Doubt tells the story of how the tobacco industry pioneered the creation of controversy and uncertainty in the face of general scientific consensus. “How could the industry possibly defend itself when the vast majority of independent experts agreed that tobacco was harmful and their own documents showed that they knew this?” asked authors Naomi Oreskes and Erik M. Conway. “The answer was to continue to market doubt.”

    This approach of creating controversy and marketing doubt was copied by other industries, including to deny global warming. They describe the industry’s “key insight: that you could use normal scientific uncertainty to undermine the status of actual scientific knowledge. As in jujitsu, you could use science against itself.”

    For example, longitudinal studies may well uncover yet-unknown health risks of vaping for certain types of products or use patterns or people with certain genetic makeups. Because vaping is new and the technologies are still evolving, it will take decades to collect the kinds of evidence we have now about smoking. The new merchants of doubt take advantage of that to play up the inevitable uncertainty about risks, blowing smoke to obscure the fact that today, the “vast majority of independent experts” agree that vaping is a far less dangerous alternative.

    For decades, the hero’s narrative was public health against Big Tobacco, charging ahead, the good guys beating back lies from the bad guys promoting disease and death. Now, 15 Society for Research on Nicotine and Tobacco past presidents invite us to look up from the haze of that long battle and consider how positions have altered. Some public health advocates may now be engaged in the wrong fight. Or worse, we may be fighting on the wrong side. —C.K.O.

    *Oreskes N, Conway EM. Merchants of Doubt: How a Handful of Scientists Obscured the Truth on Issues from Tobacco Smoke to Global Warming, Bloomsbury Press, 2010.

  • BAT Announces Innovation Hub in Italy

    BAT Announces Innovation Hub in Italy

    Photo: BAT

    BAT will be opening an innovation hub in Trieste, Italy. The company will invest €500 million ($582.2 million) over the next five years in the project.

    Covering an area of 20,000 square meters, the hub will host a manufacturing site for BAT’s “new category” products, a digital boutique, an innovation lab and a center of excellence for digital transformation and digital marketing. It will be dedicated to research, development and production of reduced-risk product lines.

    The building will be constructed to minimize its environmental impact with the objective of being carbon neutral, with a particular focus on energy efficiency and the use of renewable sources. The facility will also produce energy using a photovoltaic system that converts light into electricity using semiconducting materials.

    BAT expects to develop multiple production lines at the facility for the export of reduced-risk products, including Vuse (vapor), Velo (modern oral) and Glo (tobacco-heating products).

    The innovation hub will play a key role in our ‘A Better Tomorrow’ transformation as we strive to reduce the health impact of our business.

    “The innovation hub in Trieste will play a key role in our ‘A Better Tomorrow’ transformation as we strive to reduce the health impact of our business,” said BAT Chief Marketing Officer Kingsley Wheaton in a statement. “Our goal is to create new products, backed by science, that provide adult smokers with enjoyable, less risky alternatives.”

    “We are proud to announce the opening of our A Better Tomorrow Innovation Hub, a fundamental part of our transformation goals to reduce the health impact of our business,” said Roberta Palazzetti, president and CEO of BAT Italy and area director for southern Europe. “As a leading center for innovation, Trieste in Italy has been chosen as the home of the project, which demonstrates the capabilities of our country.”

    Construction of the structure will begin in mid-November, with the first module scheduled to be completed and activated in May.

  • The Credibility Gap

    The Credibility Gap

    Photo: ia_64

    What tobacco industry scientists wish they could say to physicians and public health researchers about their work

    Cheryl K. Olson

    “I was an ardent antismoker who believed that the tobacco industry was a bunch of evil scientists just working out how they could addict children,” said Justine Shaw Jackson, who is also known as Justine Williamson. Her grandfather, a smoker, died of COPD; her father’s smoking was likely linked to his heart attack and cancer.

    She simply didn’t believe anything that tobacco industry scientists said. “I thought they wanted to make their products even more harmful,” she added.

    So, how did she end up working for Big Tobacco?

    Scientists employed by most industries face predictable concerns about the independence and credibility of their work and even whether they’re “real” scientists. After all, we have a pretty good idea what the Egg Board will be recommending we eat for breakfast. This problem is particularly acute for scientists who work in the tobacco industry.

    Despite their detailed and sophisticated knowledge about harm reduction for smokers, they’re sometimes excluded from professional interactions with nonindustry researchers in which that expertise would be of benefit. The history of Big Tobacco from decades ago has stripped them of their credibility.

    Current employees of tobacco companies are constrained by a combination of government regulations and corporate nondisclosure rules. I spoke with several scientists who had recently left positions at tobacco companies about what they wished they could say to physicians and public health researchers about the work they’d been doing. Some agreed to speak on the record; others agreed to provide background information.

    Twenty years ago, Jackson was finishing her doctorate in genetic technology at Swansea University. British American Tobacco was funding a project in a professor’s laboratory. She met some of their scientists. “These guys were working incredibly hard on understanding what in smoke was causing problems and on reducing the harm of tobacco products,” she added.

    Across the pond in the U.S., Willie McKinney, a toxicologist, had a similar start to his career at Philip Morris USA. He had finished his doctorate in toxicology at the University of North Carolina, met with industry scientists and was impressed with their honest assessment of tobacco’s health effects.

    “They told me that they were out of alignment with society and that their products cause harm,” he said. “That alignment with society means modifying products to be less harmful or selling products that do not cause harm. They can’t make money if they’re shut down. So for 20 years, that was my focus: testing and evaluating potentially reduced-risk products.”

    They both became experts in harm reduction for smokers. Yet because of their association with Big Tobacco, they were frustrated that public health practitioners, medical professionals and government policymakers left researchers like them out of the conversation when it came to helping smokers stay healthier or quit smoking.

    Both recently left industry positions. Jackson is now an executive coach; McKinney formed his own consulting company. (Full disclosure: I’ve worked and written articles with McKinney.)

    One of the concerns I heard from them and others was being unable to respond to the rampant misinformation on the relative risks of nicotine products, especially when that misinformation comes from well-intended government sources or nonprofit organizations. Like epidemiologists facing anti-vax propaganda, industry scientists watch in frustration as facts lose ground to uninformed beliefs and outright lies—information that could interfere with smokers quitting combustible cigarettes.

    I asked them to imagine a long plane flight. Their seatmate, whom they had never met before, is a public health researcher. Upon discovering that they work in the tobacco industry, the public health person starts peppering them with questions. If they could have spoken freely, how would they have responded?

    Why can’t you just stop selling cigarettes? That would solve the problem!

    Unfortunately, it wouldn’t. In an ideal world, there would be no cigarettes. There would be no nicotine. But the world we inhabit includes 1.14 billion smokers.

    This number may startle the seatmate, who probably doesn’t know many current smokers. Smoking is not evenly distributed among the population nowadays. In North America, it’s relatively rare among the highly educated and well-to-do, for example. It’s banned in most workplaces. Anti-smoking ad campaigns have waned. But the deaths continue—nearly 8 million a year. Yet many smokers cannot or will not quit, even with all the available information on how smoking kills. That’s an incredible challenge that won’t respond to simplistic solutions.

    “We know from past experience with prohibition of alcohol and opioids that simply banning something doesn’t work,” noted Jackson.

    In fact, one of the predictable consequences of prohibiting the sale of combustible cigarettes at the commissaries of state and federal prisons has been the growth of a resilient black market. That’s a reflection of how powerful the addiction to nicotine is.

    But combustible cigarettes, the most dangerous of nicotine products, are not the only option for people who are addicted. There’s growing evidence that e-cigarettes work better than nicotine gums or patches at helping people quit smoking.

    But isn’t vaping just as bad?

    Public service campaigns in the U.S. that are meant to keep youth from vaping have stoked fears. National surveys show that more and more people incorrectly view vaping as equal in harm to smoking. Reports of potential benefits get scant attention.

    It’s another example of a moral panic—a widespread and irrational feeling of fear that’s not supported by scientific data. (A moral panic in the 1920s was that motion pictures about gangsters would turn millions of innocent teenagers into hoodlums. We now refer to those films as “classics.”)

    By contrast, health authorities in Europe, such as Public Health England, the Royal College of Physicians and Cancer Research U.K. are taking a different approach than their North American counterparts. They’re educating adult smokers about the relative risks of smoking versus vaping and encouraging them to switch, ideally as a first step toward quitting nicotine altogether. Their experts say that e-cigarettes are about 95 percent less harmful than combustible cigarettes and doubt that vaping leads youth to take up smoking.

    But what about the flavors?

    Some e-cigarette flavors, unfortunately, are attractive to teens. That’s a legitimate concern. We need to have a combination of effective youth vaping prevention programs, buyer age verification protocols, responsible marketing and nicotine addiction treatment programs for those who get hooked.

    But this concern about flavors seems inappropriately focused on vaping. My local grocery store sells stacks of mango-flavored and watermelon-flavored White Claw fizzy alcohol drinks with no visible protest. Yet these types of “alcopops” are highly attractive to underage drinkers and have been linked to dangerously high blood alcohol concentrations.

    Also, banning flavored vapes may do more harm than good when it comes to public health. Grown-ups prefer flavors too. “Evidence shows that flavors are incredibly important for adult smokers to use e-cigarettes to switch with,” Jackson added. “So how do you responsibly market those flavors with age-appropriate adult names? In the U.K. and in Europe, we worry whether the levels of nicotine in these products are high enough for smokers to be able to switch satisfactorily.”

    In other words, adequate nicotine levels may be a critical variable in getting addicted smokers to switch to reduced-harm vaping.

    Can’t we just get rid of the nicotine?

    Not only does the proverbial “man on the street” wrongly point to nicotine as the health danger in smoking; new studies show that most physicians “strongly agree” (also incorrectly) that nicotine directly contributes to cancer and heart disease.

    “Yes, nicotine does have addictive properties; that’s beyond question,” said Jackson. “But it’s all the other stuff. There are 10,000 components in cigarette smoke, and a chunk of them contain the carcinogens and toxicants that do the damage.”

    That’s where harm reduction comes in. If nicotine is not the health danger, how can you improve the health of addicted smokers who don’t (or don’t yet) want to quit? We now have a variety of delivery systems, such as e-cigarettes, heat-not-burn products, pouches and snus that can give smokers the nicotine their brains crave “without all the nasties in the smoke,” as Jackson put it. Ideally, they’ll use those reduced-harm products as a bridge to quitting tobacco and then nicotine completely.

    How can you work for Big Tobacco?

    “I was hired to focus on harm reduction because the people at the company knew that their product caused harm,” said McKinney.

    Today’s industry scientists work under different assumptions than past generations and toward different goals. We know and can openly say that smoking is addictive, dangerous and deadly. From inside, we can work to save lives without being dependent on the vagaries of grant support.

    The flight is coming to an end. The seatbelt light is on. Your seatmate has one final question.

    What can we agree on?

    The development of Covid-19 vaccines has shown what can happen when industry, academia and government work together on solving a critical public health problem. The ongoing threat and lives lost from smoking is similar to that of the pandemic. Imagine what could be achieved with that same level of cooperation and transparency.

  • Study Debunks Vaping-Heart Attack Link

    Study Debunks Vaping-Heart Attack Link

    Photo: Blue Planet Studio

    Vaping products are not associated with increased heart attack incidence among people without a history of smoking combustible cigarettes, according to a new study. Published in the American Journal of Preventive Medicine, the paper also concludes that three previous studies claiming a link between e-cigarettes and heart disease wrongly included those who previously smoked cigarettes or were using both vaping products and combustible products. One paper even included participants who had heart attacks before they started vaping.

    “Previous researchers confused their own models’ assumptions that these risks were independent with the idea that their analyses validated the presence of independent risks,” the researchers wrote. “There is no reliable evidence that e-cigarette use is associated with ever having had a myocardial infarction among never-smokers.”

    Authored by Michael Siegel, a community health sciences professor at Boston University, and University of California, Berkeley, business professor Clayton Critcher, the study analyzed data from 175,546 respondents to the annual National Health Interview Survey from 2014 to 2019.

    The researchers found that daily e-cigarette use was associated only with higher heart attack incidence among people who were also currently smoking combustible cigarettes and that there was no evidence for increased risk among vapers who had never smoked combustible cigarettes.

    The authors say that the initial study had drawn its conclusions about a perceived cause (vaping) and effect (heart attack) without considering a key variable (smoking).

    A 2018 study, also published in the American Journal of Preventive Medicine, claimed that daily vapers increased their odds of heart attack. However, the study only included participants who used both e-cigarettes and combustible cigarettes—none who used e-cigarettes alone.

    When challenged by other researchers about their failure to study vapers who had never smoked combustible cigarettes, the authors argued that such a distinction was unnecessary.

    In the meantime, two other papers were published based on the original paper’s claims, lending further unwarranted legitimacy to the idea of a link between e-cigarettes and heart attacks, according to an article in Filter.

    The second of those two papers was retracted in 2020 for basing its claims on evidence that included heart attacks from before the participants started vaping.

  • ‘Focus on Youth Vaping Could Hinder Cessation’

    ‘Focus on Youth Vaping Could Hinder Cessation’

    Photo: andrian cz

    A new paper co-authored by U.S. tobacco control experts endorses the harm reduction benefits of vaping for adult smokers trying to quit combustible cigarettes. The paper suggests that the public image of vaping products must be improved, and electronic nicotine-delivery systems (ENDS) should be promoted as a safer alternative to combustible cigarettes.

    “Opponents focus on e-cigarettes’ risks for young people while supporters emphasize the potential for e-cigarettes to assist smokers in quitting smoking. Most U.S. health organizations, media coverage and policymakers have focused primarily on risks to youths,” the report states. “Because of their messaging, much of the public—including most smokers—now consider e-cigarette use as dangerous as or more dangerous than smoking. By contrast, the National Academies of Science, Engineering and Medicine concluded that e-cigarette use is likely far less hazardous than smoking. Policies intended to reduce adolescent vaping may also reduce adult smokers’ use of e-cigarettes in quit attempts.”

    Published Aug. 19 in The American Journal of Public Health, the study was led by Kenneth Warner, a professor emeritus of health management and policy at the University of Michigan and a distinguished tobacco control expert. Fifteen former presidents of the Society for Research on Nicotine and Tobacco co-authored the paper.

    The authors present four categories of evidence supporting vaping as a quit aid for combustible tobacco use: the results of randomized trials, which show e-cigarettes outperform other cessation methods like nicotine patches; population studies, the findings of which “are consistent with a near doubling of quit attempt success”; cigarette sales, which decrease rapidly as vaping sales increase; and the unintended consequences of policies restricting vaping, such as bans that unintentionally shot up cigarette smoking.

    “The major elements of the public health community that are concerned with tobacco have been singularly focused on the risk to kids,” Warner told Filter. “They seem to truly have no interest whatsoever in adult smokers. The other piece is that you’re seeing lots of allegedly scientific papers that are raising health concerns that are unwarranted.” One such paper, which claimed that vaping increased the likelihood of having a heart attack, was later retracted.

    The paper also presents “a sensible mix of policies” to boost ENDS use, including taxing traditional cigarettes higher than e-cigarettes to encourage adult smokers to switch, allowing flavored vaping products available only at vape shops, restricting advertising to limit youth initiation and reducing the nicotine levels in cigarettes while ensuring the availability of “consumer acceptable” reduced-risk nicotine products.

    “Because evidence indicates that e-cigarette use can increase the odds of quitting smoking, many scientists, including this essay’s authors, encourage the health community, media and policymakers to more carefully weigh vaping’s potential to reduce adult smoking-attributable mortality,” the paper states.

  • Scientists: EVALI Cases May Have Been Covid

    Scientists: EVALI Cases May Have Been Covid

    Photo: Nonwarit

    Some victims of the vaping-related lung disease that swept the U.S. in 2019 were in fact suffering from Covid-19, reports the Global Times, a tabloid newspaper associated with the Chinese communist party.

    After reviewing some 250 chest CT scans from published papers, a group of Chinese scientists and radiologists suspect that some patients were wrongly diagnosed with e-cigarette or vaping use-associated lung injury (EVALI). According to the Global Times, the scientists found that 16 EVALI patients suffered from viral infections, which indicates that they could have had Covid-19.

    Yang Zhanqiu, a virologist at Wuhan University, said that due to the similarity of symptoms between EVALI and Covid-19 patients and since no nucleic acid detection kits were available at the time, it’s highly likely that some Covid-19 patients were misdiagnosed as EVALI patients in 2019.

    The scientists are now urging U.S. officials to start screening for Covid-19 in patients who in 2019 were diagnosed with EVALI.

    Covid is generally believed to have originated in Wuhan, but the Chinese communist party has on several occasions suggested that Covid-19 originated outside of China.

  • Poda Commences Clinical Trials

    Poda Commences Clinical Trials

    Photo: Poda Lifestyle and Wellness

    Poda Lifestyle and Wellness has started setting up the first clinical trials for its smoking cessation products.

    “I have already initiated the process of setting up the first clinical trials related to the efficacy of Poda’s products as smoking cessation tools,” said Poda Chief Medical Officer Jagdeep Gupta, who joined the company in July, in a statement. “I am currently in the process of setting up a pilot study, which will give us a solid platform for developing strong and effective clinical trials.

    “These clinical trials will be designed to result in the publication of level 1 evidence in respected medical journals globally if the data provides evidence. The pilot studies will also be designed to establish a scientific basis for the efficacy of Poda’s products as smoking cessation tools and additionally may provide Poda with access to research grants and other funds that can be used for additional studies, clinical trials and validation research.”

    The company has also entered into an agreement with Command Marketing predominantly to develop Poda’s e-commerce platform and brand identity. As part of this branding campaign, Command Marketing will also provide investor relations services.