Category: Research

  • ‘Switchers’ See Improved Respiratory Health

    ‘Switchers’ See Improved Respiratory Health

    Image: leszekglasner

    People who switch from smoking to vaping see improved respiratory health, but people who begin consuming electronic cigarettes while continuing to smoke regular cigarettes do not report improved respiratory symptoms, according to a new paper in Nicotine and Tobacco Research, published by Oxford University Press.

    Adults increasingly use electronic cigarettes to try to quit smoking because of the perceived reduced risk. But while vaping reduces exposure to toxic chemicals, it has been unclear whether switching from cigarettes to e-cigarettes results in a reduction of the respiratory problems—like wheezing and coughing—common in regular cigarette smokers.

    Researchers used data from the Population Assessment of Tobacco and Health (PATH) study, a national longitudinal measure of tobacco use in the United States performed by the National Institutes of Health. The investigators here observed adult participants between 2013 and 2019 who reported smoking cigarettes exclusively at the beginning of the investigation and reported a baseline cough or wheeze.

    The researchers divided the subjects into four groups: those who transitioned from exclusive cigarette smoking to quitting nicotine altogether, those who switched from cigarette smoking to vaping exclusively, those who continued to smoke cigarettes only, and those who kept smoking and also began vaping. 

    Completely switching from cigarettes to e-cigarettes led to a moderate increase in the resolution of wheeze symptoms compared with persistent smoking. However, there were lower rates of respiratory symptom resolution among those transitioning to vaping while maintaining or increasing their smoking.

    Among 5,210 subjects with a baseline cough, 3,362 (65 percent) saw their coughs go away. Of the 5,367 people who reported a baseline wheeze, the researchers observed that 2,862 (53 percent) saw improvements. Switching from cigarettes to e-cigarettes exclusively resulted in significantly reduced wheezing but not cough resolution. Transitioning to both smoking and vaping (versus just continuing to smoke cigarettes) was not associated with respiratory improvement overall or even among participants who reduced their cigarette smoking intensity.

    The researchers note that the rates of symptom resolution were 14 percent lower (for cough) and 15 percent lower (for wheeze) among those who switched to dual use and maintained or increased their smoking intensity; those who started using electronic cigarettes while continuing to smoke the same number of regular cigarettes saw their wheeze and coughing get worse.

    Switching from smoking cigarettes to quitting nicotine altogether was, perhaps unsurprisingly, associated with the best improvements in both coughs and wheezing.

  • Boredom, Relaxation Top Drivers of Teen Vaping

    Boredom, Relaxation Top Drivers of Teen Vaping

    Boredom, relaxation and experimentation are the key drivers of teen vaping, according to new research from University of Michigan (U-M).

    Published in Pediatrics, the study “Reasons for Vaping Among U.S. Adolescents” examined data from in-school surveys of U.S. students in eighth, 10th and 12th grades.

    “Vaping has become the primary way that adolescents use nicotine,” said author Megan Patrick of U-M’s Institute for Social Research. “Understanding why adolescents vape is important for figuring out how to reduce and prevent nicotine use among teenagers.”

    Of the 5,082 respondents, data showed relaxation was the most common reason cited, no matter the grade or frequency of vaping. Boredom landed in the top three reasons across frequency groups as well.  

    Among 12th graders who reported vaping near-daily, a third said they vaped to feel good or because it is more convenient than cigarettes. Less than 10 percent of that same group said vaping helped them quit smoking cigarettes.

    Near-daily vaping in the past 30 days was reported by 1.7 percent of eighth graders, 4.2 percent of 10th graders and 7.8 percent of 12th graders. “Relaxation” emerged as the top reason for vaping, cited by nearly half of adolescents who vaped in the past year and over 70 percent of near-daily vapers.  

    The study stresses the importance of understanding the diverse reasons behind teen vaping, particularly the significant role of stress relief. Given that a large proportion of near-daily vapers use vaping to relax, incorporating mental health support into prevention programs is crucial.

    “Our findings illustrate a shift over the past decade in the reasons adolescents vape, moving from experimentation to stress relief and relaxation, highlighting key areas for intervention,” Patrick said.

    Other frequently mentioned reasons include “experimentation” and “boredom,” with “taste” also ranking high. Among near-daily vapers, significant numbers noted they vaped to “feel good” or because it is “more convenient than cigarettes,” with a smaller percentage aiming to “help quit cigarettes.”

    “Among the adolescents who vape near-daily, 43 percent report that they vape because they are hooked or have to have it,” Patrick said. “The fact that so many adolescents feel addicted to nicotine is concerning. Another reason, reported by almost one in five near-daily vapers, was to manage their weight. Additional research is needed on this, but parents and health care professionals should be aware that many adolescents are vaping to try to lose weight or control their weight.”

    The authors of the study argue that screening for stress and anxiety should be conducted alongside nicotine screenings to provide early intervention. These experts also noted a shift in why adolescents are vaping, as 2015 data listed relaxation as only the fifth most common reason.

    They argue further research is needed to understand those adolescents vaping for weight management—reported by nearly a fifth of 12th graders who vaped near-daily.  

    The research was funded by the National Institute on Alcohol Abuse and Alcoholism and the National Institute on Drug Abuse.

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  • Ensuring Excellence

    Ensuring Excellence

    The critical role of site visits and quality controls in behavioral science research

    By Elizabeth DeMartini

    In the ever-evolving field of behavioral science research, ensuring the integrity and reliability of data is a critical aspect of quality research. This article details the importance of study site visits and quality controls in maintaining high research standards and ethical conduct for direct interactions between study site staff and participants when conducting behavioral studies, such as in-person consumer perception and intentions, label comprehension and human factors, actual use and switching, product use patterns, and abuse liability.

    Study site staff are directly engaging with participants during recruitment and screening for eligibility, explaining and gathering signatures for the informed consent forms, study product administration, data collection and general communication with participants. There are times prior to or during study conduct where important study execution information, which may seem clear to researchers intimate to a project, may be missed or unclear to study site staff. This could lead to issues with data quality and compliance.

    This potential knowledge gap can be alleviated by having a regular on-site and virtual presence and directly collaborating with the study site staff throughout the study with increased oversight during key study milestones. With this, stakeholders can ensure successful project implementation while maintaining the integrity of each individual research project.

    The Role of Site Visits in Research Integrity

    Study site visits are a fundamental aspect of research oversight, serving multiple functions that collectively uphold the integrity of research studies. These visits facilitate direct interaction and collaboration between the research team and study site staff, allowing for real-time monitoring and support. Here are key reasons why site visits are indispensable:

    • Training and Support—Study site staff play a vital role in the successful execution of studies. The study site’s proper understanding of the study outcomes and methods enhances the quality of the data collection processes, communication between all parties, compliance requirements and overall health of the study. The study site staff will be intimately involved in the project from start to finish, and it is of utmost importance that they are well versed in study protocol, data collection methods and ethical considerations. Being on-site allows researchers to educate the study site staff through each step of the study. Many projects involve study products that participants are trained to use. For study site leaders to train these participants, researchers must feel confident that they have trained each research site well. Being on-site at these trainings allows for a hands-on approach, enhancing the competency of the study site staff and fostering a collaborative environment where questions and concerns can be addressed promptly.
    • Ensuring Protocol Compliance—Adherence to institutional review board-approved study protocols is crucial for the validity and reliability of research findings. Site visits oversee and verify that study procedures are being followed as outlined. This helps identify deviations or noncompliance issues early, allowing for timely corrective actions. Researchers’ presence on-site throughout project milestones ensures that the study site staff feels confident in implementing these critical study procedures. Remote monitoring of adverse events and clinical assessments of side effect severity related to research study product use is a critical responsibility. It is good practice to have a medical monitoring team on call for this service. Consistent with the informed consent form, participants should be educated on what adverse events may be and when to call, and encouraged to always err on the side of caution. By providing this surveillance, researchers can detect any potential safety concerns and address the next steps promptly.
    • Building Relationships—Face-to-face interactions during site visits strengthen the relationship between the central research team and site personnel. This is essential for effective communication and coordination throughout the study. A strong relationship facilitates smoother operations and encourages site staff to proactively report issues and seek guidance when needed.
      Many contract research organizations view study sites mainly as a transactional engagement, often with limited oversight. However, this approach is fundamentally short-sighted. The strength and integrity of a study’s data hinge on the meticulous execution of the research protocol, which can only be achieved through genuine, trusted partnerships with study sites. By fostering collaborative relationships and investing in mutual trust, organizations should ensure that the research is conducted with the highest level of precision and dedication. This partnership-based approach not only enhances the quality of data but also drives successful outcomes that meet both regulatory standards and the nuanced needs of clients.
    • Assessing Facility Capabilities—Evaluating the layout of the research sites infrastructure and assessing their capabilities is a necessary component of site visits. Research protocols include standards for product storage, document storage, product disposal, and in some cases survey administration. By being on-site, research organizations can assess the facility’s capabilities and preparedness to ensure they are complying with all regulations. Site visits can also help the research team work with the study site staff to create a comfortable flow and environment for participants engaging in the research. A proper study environment is necessary to produce high-quality data.

    Quality Controls in Research: A Multidimensional Approach

    Quality controls are the backbone of any research endeavor, ensuring that the data collection is accurate, reliable, robust and valid. In the case of social and behavioral science research, quality controls encompass a range of activities designed to maintain high standards and ethical conduct. Key aspects of quality control include:

    • Data Integrity—Maintaining the integrity of data collected during a research study is essential for producing credible results. Professional research organizations employ an in-house survey methodologist who is responsible for a multitude of quality control measures surrounding data integrity, including validation checks built into the survey and real-time data audits with daily reports on any data that would reflect any discrepancies. The survey methodologist works closely with the team and sites throughout each step of the entirety of the research process and especially during the first days of study implementation, confirming correct participant eligibility, assignment and data quality.
    • Ethical Conduct—Upholding ethical standards in research is a fundamental principle. Quality assurance processes are designed to ensure that all study activities are conducted with a focus on human subject protections. This includes obtaining informed consent, ensuring confidentiality and conducting research in a way that respects participants’ rights and dignity, which the study site staff are trained prior to and on the same day as first-participant-in.

    Challenges and Solutions in Implementing Site Visits and Quality Controls

    Despite the clear benefits, implementing site visits and quality controls can present challenges. Addressing these challenges requires a proactive and adaptive approach.

    • Resource Constraints—Conducting site visits and maintaining rigorous quality controls are essential components of any successful study, but they can be resource-intensive endeavors. Adequate funding, staffing and logistical support are crucial to carrying out these activities effectively. Medical monitoring teams play a pivotal role in this process, ensuring that every site adheres to the highest standards of patient care and protocol compliance.
      To address these challenges, research organizations should focus on optimizing resource allocation, ensuring that their teams are well supported and strategically deployed geographically. Leveraging technology for remote monitoring allows organizations to maintain oversight without the need for constant physical presence, which not only conserves resources but also increases agility in responding to emerging issues.
    • Geographical Barriers—Research studies often involve multiple sites across diverse geographic regions, making the logistics of conducting frequent site visits a significant challenge. To address this, it is advisable to employ a risk-based approach to site selection, prioritizing visits based on project timeline milestones and the specific needs of each study. This strategic approach ensures that resources are directed toward the most critical sites where oversight can have the greatest impact.
      Professional contract research organizations place a strong emphasis on rigorous project management across multiple geographic regions. This involves close collaboration with the institutional review board, whose oversight and guidance should be integral to the organization’s approach. Oversight plans should involve initial site evaluations, frequent and transparent communication between sites and the research team, and ongoing supervision to uphold protocol integrity and data quality. By integrating these elements into the project management plan, organizations can maintain consistency, compliance and excellence across all study sites, no matter where they are located.
    • Standardization Across Sites—Ensuring consistency in study conduct across multiple sites is crucial for data comparability. Developing comprehensive procedures and conducting training sessions can help standardize procedures. Regular communication and site support also play a vital role in maintaining consistency. For example, with the research team’s presence on-site during first-participant-in, the research team can provide oversight and intervene to correct any errors in study administration, and the study site staff are able to discuss any questions they may have in real time. This allows for high-quality compliance to be achieved. It also allows the research team to address reoccurring issues and modify their site training materials to be more comprehensive for all study sites.
    • Evolving Regulatory Requirements—Regulatory landscapes are dynamic, with frequent updates and changes. Staying abreast of regulatory requirements and ensuring compliance can be challenging. Engaging with regulatory bodies, participating in industry forums, and continuous education for study site staff are effective strategies to navigate regulatory complexities.

    Conclusion

    The importance of site visits and quality controls in behavioral research cannot be overstated. These practices are essential for ensuring the integrity, reliability and ethical conduct of research studies. By fostering close collaboration between the central research team and study sites, providing thorough training, support, availability, strong relationships, as well as implementing robust monitoring and quality assurance processes, contract research organizations can ensure that their research endeavors produce credible, high-quality data that advance innovation and regulatory compliance in the nicotine industry. Ultimately, these efforts contribute to the overarching goal of protecting human subjects, quality data collection and enhancing public health outcomes.

    Elizabeth DeMartini is a medical monitor and researcher at Applied Research and Analysis Co. (ARAC). She brings a wealth of experience from diverse roles in the healthcare and wellness sectors spanning the last two decades.

    An alumna of James Madison University, DeMartini holds a Bachelor of Science degree in nursing. Demartini is a licensed registered nurse through the Virginia Board of Nursing and is authorized to practice in 38 additional U.S. states. Together with Brianne Becht, DeMartini initiated ARAC’s medical monitoring team, enhancing standardization with on-site facility trainings, clinical assessments and compliance oversight.

    ARAC is a social and behavioral sciences research firm known for designing, executing and presenting creative, customizable Module 5 and 6 studies to support manufacturers, regulatory agencies and industry consultants. The fully staffed contract research organization employs in-house psychologists, behavioral scientists, statisticians and survey methodologists.

    ARAC’s data-driven approach ensures rigorous, evidence-based insights to support innovation and regulatory compliance in the nicotine industry.

    The ARAC team services clients worldwide in product development and consumer research supporting innovation and “next-generation” products, with focused expertise on the regulatory sciences for U.S. applications, including ITPs, premarket tobacco product applications, modified-risk tobacco product applications and substantial equivalence applications.
  • Playing with Numbers

    Playing with Numbers

    Photo: Hafiez Razali

    How research methods distort nicotine effects and risks

    By Cheryl K. Olson

    “The paper seems like a joke.” That’s what Harvard researcher Miguel Hernan said recently to the journal Science about a report linking e-cigarettes and strokes.

    The article was concocted by a dubious research group, founded to help young international medical school graduates get coveted authorship credits. Its analysis of U.S. government survey data claimed that respondents who vaped had a higher risk of stroke, at younger ages, than those who smoked. Its glaring flaws included inflating the number of survey takers by tens of thousands and failing to correct for the relative youth of vapers.

    Despite this, the 2022 paper’s findings found their way into media headlines and anti-vaping advertising. The Science article credits Gal Cohen and Floe Foxon with sounding the alarm on this appalling study.

    Subtler issues that affect research quality, and how research is perceived by the public, are harder to spot. Research methods may seem a dull or arcane topic. But a peek at how the research sausage is made reveals some simple yet surprising ways that the process can go wrong.

    Sometimes old habits or unquestioned assumptions are to blame. Just as typewriters affect how we text on our mobiles, legacy cigarette research methods and mindsets influence how we study noncombustible nicotine products.

    Hours of Vaping?

    Everyone understands cigarettes. When it comes to totting up use, cigarettes are easy. They come in standard units. You light, puff and extinguish. Not so for products such as vapes. How, then, do researchers compare smoking with these new nicotine-delivery systems?

    “There’s a lot of research showing that people who use e-cigarettes graze throughout the day,” says Arielle Selya, who conducts nicotine product research at Pinney Associates. “Unlike cigarettes, there’s no defined stopping and starting. They don’t have to finish a discrete unit; they just puff on and off.” Measuring this kind of variable, intermittent activity is a challenge.

    This problem is not unique to vaping. Studying nicotine pouch use, I found unexpectedly wide variations in what people did and what they thought was normal. Some tossed a pouch in the trash after 10 minutes or 15 minutes. Others kept one in their mouth for a couple of hours. A few sometimes reused a pouch they’d started earlier or cheeked pouches of two different flavors at once.

    As an example of what can go wrong, Selya pointed to a recent study of vaping and respiratory symptoms. To the authors’ credit, they tried to measure heaviness of e-cigarette use. The problem was the poor fit between their question and the behavior. They asked, “How many hours did you use electronic cigarettes per day?”

    “I’m not a vaper, but that seems like such a strange question,” says Selya. “Like asking how many hours do you spend drinking water?”

    Better approaches to measuring nicotine product use include writing down what you’re doing whenever a device pings you (ecological momentary assessment) or in a daily diary.

    Twisted Terminology

    Another holdover from cigarettes is the way tobacco is seen as the default flavor for all nicotine-containing products. “With e-cigarettes, you have to add a tobacco flavor,” notes Selya. “But researchers often say ‘flavored’ when they mean ‘non-tobacco flavored’–in some communications even the NYTS team does this–but tobacco itself is a flavor! This generates misunderstandings.”

    Nicotine research terminology can defy common sense. Consider the concept of “abuse liability.” In everyday English, abuse implies harm. When the U.S. Food and Drug Administration assesses new drugs, stricter regulation may be required if there’s abuse potential, defined as “intentional, nontherapeutic use” to “achieve a desired psychological or physical effect.” An effect like euphoria, hallucinations or distorted thoughts or perceptions. 

    When it comes to reduced-harm nicotine products, abuse potential becomes, weirdly, a plus. A backhanded compliment. If you want to attract someone away from cigarettes, features like rapid nicotine absorption, relaxation and relief of withdrawal encourage that transition.

    Abuse liability also illustrates another nicotine methodology vexation: there is no agreed-on way to measure it. One article looked at comments made by the FDA on manufacturers’ submissions for multiple types of nicotine products. Regulators considered a whole range of measures related to abuse liability, from product chemistry and pharmacokinetics to subjective factors. Of the latter, “liking” the product turned out to be the most reliable and sensitive abuse liability measure!

    Misleading Measures

    Again, cigarettes are simple and familiar. Novel nicotine products, by contrast, come in ever-evolving variations. U.S. government surveys, such as the Population Assessment of Tobacco and Health (PATH) and National Youth Tobacco Survey (NYTS), measure trends in who is using what products. The results are widely used and reported. However, for survey results to make sense, people must understand the questions.

    Discrepancies in results suggest that research participants often misunderstand nicotine products and/or the terms being used to describe them. For example, answers about vaping brands and device types often don’t match. In the NYTS, just two-thirds of teens who said they “usually” used a pod/cartridge brand of e-cigarette (such as Juul, Logic or Vuse) also said they “most often” used a pod/cartridge device. Almost one in five adults in the PATH study had these kinds of mismatched answers about their vaping behavior. 

    Some questions have even larger errors. “The NYTS asks whether your e-cigarette product contains nicotine salts,” says Selya. “And overall, about 50 percent said they don’t know.”

    This is also true for so-called “concept” flavors, she notes. “Not strawberry-banana, but something like cosmic fusion. When youth are asked about concept or ice flavors, they don’t know the characteristics of their product, or maybe don’t understand those words.”

    NYTS first asked youth about tobacco-free nicotine pouches in 2021. That year, just 1.9 percent of teens reported ever using one. Checking the details, I found a flaw: The questionnaire defined nicotine pouches as “flavored.” However, over a third of teen ever-users said the pouch product they used was unflavored. (Perhaps they confused pouches and snus?) 

    A further example: the 2023 NYTS found that 1 percent of youth—an estimated 370,000—had ever used a heated-tobacco product. At the time, that product category was not sold in the United States.

    As Ray Niaura of New York University told me, “That can’t be right. Literally, it’s impossible. So that means it’s measurement error.”

    This suggests young survey takers were befuddled. “Kids aren’t going to know,” says Niaura. “‘Heated tobacco: Yeah. I smoked a cigarette. It’s heated. I light it on fire.’”

    Yet the Centers for Disease Control and Prevention reported the result without comment or explanation.

    If a product is only used by a small percentage of people, these sorts of errors could create unreal changes in year-to-year trends. The reporting of those potentially misleading trends affect the perceptions of academics, regulators and the public. “With that amount of uncertainty and some of the low numbers, it’s hard to figure out what’s the signal versus the noise,” notes Selya.

    Questionable Choices

    Another seemingly simple but complicated issue: Who counts as a current product user? Youth surveys typically ask “have you used e-cigarettes at all, even a puff, in the last 30 days?” Surveys aimed at adults commonly ask, “Do you currently use e-cigarettes some days, every day or not at all?”

    If you assume capturing any youth e-cigarette use is important, then “even a puff” makes sense. But it also makes it difficult to separate teens who are briefly experimenting from teens at risk for problematic ongoing use.

    In studies that look at how using nicotine products affect some aspect of health, researchers choose what outcomes to measure. Their choices can suggest biases or suspicious holes in what’s reported.

    A recent study using PATH data tried to compare e-cigarette use and the age at which people developed asthma. “Why age of asthma onset rather than whether they developed asthma at all?” says Selya. “Often, I read a study and think, did you look at these other related outcomes? If so, why weren’t they published?” This issue of results that may exist but aren’t reported are known as the “file drawer problem.” Preregistering study plans would avoid this issue.

    Researchers, Meet Users

    Before I dove deeply into tobacco harm reduction, my research focused on the effects of violent video games on youth. Finding discrepancies between research reports and what teens told me, I realized that many of the field’s most-cited “experts” had never actually played or even observed the games they studied.

    Similarly, many nicotine researchers seem to have never held or used the noncombusted products they study. This leads to findings that don’t reflect real-world situations. One example is an article by Sebastien Soulet and Roberto Sussman on metal contents of e-cigarette aerosols. They found that researchers were overheating tank vaping devices, generating aerosols that would be “likely repellent to human users.”

    “I think there’s a big disconnect and abysmally low involvement of actual consumers, the people affected by policies,” says Selya. Partnering with people who actually know and use novel nicotine products would be a giant step toward improved research quality.  

    References

    Foxon F. (2023). Discordant device/brand reporting among adolescents who used e-cigarettes in the National Youth Tobacco Survey. Nicotine and Tobacco Research. https://doi.org/10.1093/ntr/ntad228

    Joelving F. (2024). Prescription for controversy. Science. https://www.science.org/content/article/questionable-firms-tempt-young-doctors-with-easy-publications

    Selya A, Ruggieri M, Polosa R. (2024). Measures of youth e-cigarette use: strengths, weaknesses and recommendations. Frontiers in Public Health. https://doi.org/10.3389/fpubh.2024.1412406

    Soulet S, Sussman RA. (2022). A critical review of recent literature on metal contents in e-cigarette aerosol. Toxics. https://www.mdpi.com/2305-6304/10/9/510

    Vansickel A et al. (2022). Human abuse liability assessment of tobacco and nicotine products: approaches for meeting current regulatory recommendations. Nicotine and Tobacco Research. https://doi.org/10.1093/ntr/ntab183

    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 Advisors. She spent 15 years on the faculty of Harvard Medical School.
  • PMI Accused of ‘Manipulating Science’

    PMI Accused of ‘Manipulating Science’

    Image: Xistudio

    Philip Morris International has been accused of “manipulating science for profit” through funding research and advocacy work with scientists, according to The Guardian.

    Leaked documents from PMI and its Japanese affiliate revealed plans to target politicians, doctors and the 2020 Tokyo Olympics as part of the company’s marketing strategy to attract nonsmokers to its IQOS heated-tobacco product. Japan is a launch market for IQOS.

    A Tobacco Control Research Group paper from the University of Bath stated that Philip Morris Japan (PMJ) funded a Kyoto University study into smoking cessation via a third-party organization. The researchers found no public record of PMJ’s involvement, however. According to a PMI spokesperson, the company’s involvement was attributed when the results were presented at a scientific conference in Greece in 2021.

    PMJ reportedly paid £20,000 ($25,287.48) a month to FTI-Innovations, which is a life sciences consultancy run by a professor from Tokyo University. The payments were for tasks like promoting PMI’s science and products at academic events, which, according to an internal email, a PMJ employee claimed they had been told “to keep it a secret.”

    The paper, which was published in Nicotine & Tobacco Research, is based on 24 leaked company documents from between 2012 and 2020.

    “These activities resemble known strategies to influence the conduct, publication and reach of science and conceal scientific activities,” the researchers said.

    “The manipulation of science for profit harms us all, especially policymakers and consumers trying to make potentially life-changing decisions,” said Sophie Braznell, one of the paper’s authors. “It slows down and undermines public health policies while encouraging the widespread use of harmful products.”

    The leaked documents undermined PMI’s claims to conduct “transparent science,” according to Braznell, who called for reforms to funding and governance of tobacco research “to protect science from vested corporate interests.”

    In a different report from Stopping Tobacco Organizations and Products (STOP), also based on leaked documents, PMJ appeared to lobby for IQOS to be permitted in places where smoking was banned.

    Entities like medical and hospitality groups and Japan’s Fire and Disaster Management Agency were targeted for endorsements, “which, if secured, could give the appearance of organic, widespread acceptance of IQOS,” said STOP.

    Moreover, the report stated that aiming for a presence at the Tokyo Olympics “echoes a known industry tactic of advertising addictive, harmful tobacco products at sports events—associating these products with health, misleading consumers and reaching children and young people.”

    “PMI’s intentions with IQOS seem to extend far beyond what they’ve stated,” said Jorge Alday, director of STOP. “This revelation adds weight to the mounting evidence questioning the credibility of PMI’s claims about their intentions and their products.

    “Disturbingly, it hints at a broader pattern of deceptive tactics, potentially laying the groundwork for a new chapter in the tobacco epidemic,” he said.

    “This is yet another specious story from an organization more interested in criticizing our company than helping reduce the harm from cigarettes,” said a PMI spokesperson. “Like any highly regulated multinational company, PMI regularly seeks to share our positions on issues that affect our consumers, our company and our communities. Not only is this type of engagement entirely legal and appropriate, [but] it is essential to the type of inclusive policymaking that will lead to better outcomes for the people affected by those policies.”

  • Similar DNA Changes in Smokers and Vapers

    Similar DNA Changes in Smokers and Vapers

    Image: tonaquatic

    A new study from University College London (UCL) and the University of Innsbruck shows that e-cigarette users with limited smoking history have similar DNA changes to specific cheek cells as smokers, reports Medical Xpress.

    The study was published in Cancer Research. It analyzed epigenetic effects of tobacco and e-cigarettes on DNA methylation in more than 3,500 samples to determine the impact on cells directly exposed to tobacco (e.g., cells in the mouth) and cells that are not directly exposed to tobacco (e.g., blood cells or cervical cells).

    Data showed that epithelial cells in the mouth had substantial epigenomic changes in smokers. Similar epigenetic changes were seen in epithelial cells in the mouths of e-cigarette users who had smoked fewer than 100 tobacco cigarettes in their lifetime.

    “This is the first study to investigate the impact of smoking and vaping on different kinds of cells—rather than just blood—and we’ve also strived to consider the longer term health implications of using e-cigarettes,” said Chiara Herzog, first author of the study. 

    “We cannot say that e-cigarettes cause cancer based on our study, but we do observe e-cigarette users exhibit some similar epigenetic changes in buccal cells as smokers, and these changes are associated with future lung cancer development in smokers,” Herzog said. “Further studies will be required to investigate whether these features could be used to individually predict cancer in smokers and e-cigarette users.”

    “While the scientific consensus is that e-cigarettes are safer than smoking tobacco, we cannot assume they are completely safe to use, and it is important to explore their potential long-term risks and links to cancer,” said Herzog. “We hope this study may help form part of a wider discussion into e-cigarette usage—especially in people who have never previously smoked tobacco.”

    The study also showed that some smoking-related epigenetic changes remained more stable than others after quitting smoking, including smoking-related epigenetic changes in cervical samples.

    “The epigenome allows us, on one side, to look back,” said Martin Widschwendter, senior author of the study. “It tells us about how our body responded to a previous environmental exposure like smoking. Likewise, exploring the epigenome may also enable us to predict future health and disease. Changes that are observed in lung cancer tissue can also be measured in cheek cells from smokers who have not (yet) developed a cancer.

    “Importantly, our research points to the fact that e-cigarette users exhibit the same changes, and these devices might not be as harmless as originally thought. Long-term studies of e-cigarettes are needed. We are grateful for the support the European Commission has provided to obtain these data.”

    In response to the study, the U.K. Vaping Industry Association (UKVIA) released a statement.

    “While the study data—which one leading academic has described as ‘crude’—implies a link to changes in cheek cells, which could potentially cause cancer, the study authors said their findings did not prove that e-cigarettes caused cancer,” the statement read.

    “The study authors said their findings showed that vapes ‘might not be as harmless as originally thought,’ but it is important to make clear that nobody in the vape industry ever said that vaping was harmless. There are risks from vaping, but they are tiny compared to smoking,” the UKVIA said.

    “This latest study,” the UKVIA statement said, “is also questioned by leading experts such as Peter Shields, an emeritus professor of medical oncology at Ohio State University. He states that critical pieces of information are missing and calls the smoking and vaping data that they are working from as ‘crude.’ He points to the fact that there is no biochemical verification that the vapers are actually not also smokers. He concludes that ‘researchers are still a far distance from being able to show causality, and the data looks like vapers are actually more like never smokers—implying their risk of cancer is not increasing by vaping.”

  • New Study on Harm Reduction Public Policy

    New Study on Harm Reduction Public Policy

    Image: alexskopje

    R Street Institute has released a new report, “Progressive Except for Nicotine: A Discussion of States’ Inconsistent Adoption of Harm Reduction Public Policy.”

    The study examined the harm reduction policy landscape across tobacco, opioids and cannabis in all 50 U.S. states. Researchers identified several important harm reduction-related policies that have varying levels of acceptance/implementation across different states or are currently in legislative flux: tobacco: state and municipal restrictions on electronic nicotine-delivery systems, also known as e-cigarettes or vapes; opioids: states’ authorization of syringe services programs, decriminalization of drug checking equipment, and presence of state-imposed restrictions on methadone that go beyond federal regulations; and cannabis: the legal status of medical and recreational adult-use cannabis markets in each state.

    Researchers then used this information to rank states as “restrictive,” “moderate” or “permissive” on harm reduction with regard to each substance. These rankings were quantitatively compared for all states, and states deemed “restrictive” on at least one substance were qualitatively examined. 

    The report found that while some states support one type of harm reduction, those same states may actively oppose another type of harm reduction. The report also showed that the five states most restrictive of reduced-risk nicotine products in tobacco harm reduction are California, Massachusetts, New Jersey, New York and Rhode Island, and these states are relatively “permissive” when it comes to opioid harm reduction and cannabis use.

    The researchers have suggested that lawmakers reflect on the inconsistencies between harm reduction policies across substances and put political motivations aside to support harm reduction across all substances.

  • Lung Association Urges Menthol Ban

    Lung Association Urges Menthol Ban

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    The American Lung Association’s State of Tobacco Control 2024 Report highlights the impacts of tobacco use and urges the White House to finalize rules on the impending menthol ban.

    The 22nd annual State of Tobacco Control report evaluates state and federal efforts to eliminate tobacco use and save lives with proven-effective tobacco control laws and policies. This year’s report highlights the public health perils of menthol tobacco use and the failure of the White House to finalize the rules to end menthol cigarettes and flavored cigars in 2023, according to an American Lung Association press release.

    “It is unacceptable that after decades of research and proven tobacco control efforts, tobacco use is still the leading cause of preventable death and disease in the U.S. Tobacco use is responsible for 480,000 deaths each year, including 45,000 Black individuals,” said Harold Wimmer, president and CEO of the American Lung Association, in a statement.

    “Right now, President Biden can take action and save lives if he finalizes the rules to end the sale of menthol cigarettes and flavored cigars. Menthol cigarettes make it both easier to start and harder to quit by reducing the harshness of the smoke and cooling the throat. Once these rules are final, fewer people will start smoking, millions will begin their journey to quit, and lives will be saved.”

    The federal section of the report highlights the failure of the Biden White House to finalize rules to end the sale of menthol cigarettes and flavored cigars in December 2023, the continued delay of the U.S. Food and Drug Administration to complete its review of premarket tobacco product applications and the beginning of meaningful enforcement against illegal e-cigarette products.

    In the State of Tobacco Control report, the American Lung Association identified four key actions for the Biden administration and Congress to take in 2024 that will help ultimately eliminate the death and disease caused by tobacco use: The White House must finalize the rules to end the sale of menthol cigarettes and flavored cigars; the FDA must finalize premarket review and work with other federal agencies to remove all illegal e-cigarettes and other flavored products from the marketplace; Congress must maintain or increase current funding for the Centers for Disease Control and Prevention’s Office on Smoking and Health; and Congress must pass H.R. 4775, the Helping Tobacco Users Quit Act, bipartisan legislation giving more people access to the resources they need to quit tobacco.

    The 2024 State of Tobacco Control report grades the federal government in five areas: federal regulation of tobacco products—grade C; federal coverage of quit smoking treatments—grade D; level of federal tobacco taxes—grade F; federal mass media campaigns to prevent and reduce tobacco use—grade A; and federal minimum age of sale for tobacco products to 21—incomplete (the FDA is overdue in finalizing the Tobacco 21 regulations as required by statute, which is why it earns an “incomplete”).

    The 2024 State of Tobacco Control report grades states and the District of Columbia in five areas that have been proven to prevent and reduce tobacco use and save lives: strength of smoke-free workplace laws—16 states and Washington, D.C., earned “A” grades; ending the sale of all flavored tobacco products—45 states earned “F” grades; funding for state tobacco prevention programs—41 states and Washington, D.C., earned “F” grades; level of state tobacco taxes—31 states earned “F” grades; and coverage and access to services to quit tobacco—20 states and Washington, D.C., earned “A” or “B” grades.

  • WHO: Tobacco Use Continues to Decline

    WHO: Tobacco Use Continues to Decline

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    A new World Health Organization report shows that tobacco use continued to decline in 2022, with one in five adults consuming tobacco compared to one in three in 2000, according to the WHO.

    According to the report, 150 countries are successfully reducing tobacco use.

    “Good progress has been made in tobacco control in recent years, but there is no time for complacency,” said Ruediger Krech, director of the WHO Department of Health Promotion. “I’m astounded at the depths the tobacco industry will go to pursue profits at the expense of countless lives. We see that the minute a government thinks they have won the fight against tobacco, the tobacco industry seizes the opportunity to manipulate health policies and sell their deadly products.”

    The WHO report shows that six countries continue to see an increase in tobacco use: Congo, Egypt, Indonesia, Jordan, Oman and the Republic of Moldova. The WHO is urging countries to continue putting in place tobacco control policies and to continue fighting against tobacco industry interference.

    In February, countries are set to meet in Panama for the 10th session of the Conference of the Parties to the WHO Framework Convention on Tobacco Control, where the WHO claims the tobacco industry will attempt to influence countries’ tobacco control policies.

  • Teen Cigarette Use Declined Over 30 Years

    Teen Cigarette Use Declined Over 30 Years

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    Cigarette smoking among U.S. adolescents (grades nine to 12) from 1991 to 2021 significantly decreased, according to a new study from Florida Atlantic University’s (FAU) Schmidt College of Medicine published in Ochsner Journal online ahead of print.

    Study findings include:

    • Ever use cigarettes significantly decreased from 70.1 percent in 1991 to 17.8 percent in 2021, an almost fourfold decline.
    • Occasional cigarette use significantly decreased from 27.5 percent in 1991 to 3.8 percent in 2021, a greater than sevenfold decline.
    • Frequent cigarette use significantly decreased from 12.7 percent to 0.7 percent, a greater than eighteenfold decline.
    • Daily cigarette use declined from 9.8 percent in 1991 to 0.6 percent in 2021, a greater than sixteenfold decline.

    While all grades experienced a significant decline in cigarette use, 12th graders consistently reported the highest percentage of occasional smokers compared to the other school grades, even in 2021. This finding suggests that while smoking has decreased across all age groups, older adolescents might still be more prone to experimenting with cigarettes than their younger counterparts.

    “The substantial decrease in cigarette use among U.S. adolescents spanning three decades is an encouraging public health achievement,” said Panagiota “Yiota” Kitsantas, senior author, professor and chair for the Department of Population Health and Social Medicine at the FAU Schmidt College of Medicine. “This decrease underscores the importance of continued vigilance, research and intervention to further reduce tobacco use and its associated harms.”

    Overall, inequalities in cigarette use among adolescents by gender have been present for decades. However, by 2021, discrepancies in smoking cigarettes by gender were diminished.

    With respect to race/ethnicity, by 2021, the decreases in cigarette consumption were even more pronounced among Black and Asian adolescents while the rates among white and Hispanic/Latino youth remained higher but were still significantly lower than the 1997 rates.

    “These results show reassuring trends, but they also suggest residual clinical and public health challenges that will require targeted interventions,” said Charles H. Hennekens, co-author, First Sir Richard Doll Professor of Medicine and senior academic advisor at the FAU Schmidt College of Medicine.

    “Quitting smoking significantly reduces risks of cardiovascular disease beginning within a matter of months and reaching the nonsmoker status within a few years, even among older adults. However, for lung and other cancers, reductions do not even begin to emerge for years after quitting and even after 10 years remain midway between the continuing smoker and lifelong nonsmoker. Thus, for reducing cardiovascular disease risks, it’s never too late to quit, but to reduce risks of cancer, it’s never too early.”

    Study co-authors are Maria Mejia, first author and an associate professor at Baylor College of Medicine; Robert S. Levine, professor of family and community medicine at Baylor College of Medicine and an affiliate professor at the FAU Schmidt College of Medicine; and Adedamola Adele, a recent biomedical science graduate at the FAU Schmidt College of Medicine.