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Introduction Heated tobacco products (HTPs) are marketed as less harmful alternatives to cigarettes, but the lung cancer risk of HTPs is unknown. In the absence of epidemiological data, assessing the risks of HTPs relies on biomarker data from clinical trials. This study examined existing biomarker data to determine what it tells us about the lung cancer risk posed by HTPs. Aims and Methods We identified all biomarkers of exposure and potential harm measured in HTP trials and evaluated their appropriateness based on ideal characteristics for measuring lung cancer risk and tobacco use. The effects of HTPs on the most appropriate biomarkers within cigarette smokers switched to HTPs and compared to continued cigarette smoking or cessation were synthesized. Results Sixteen out of eighty-two biomarkers (7 exposure and 9 potential harm) measured in HTP trials have been associated with tobacco use and lung cancer, dose-dependently correlated with smoking, modifiable upon cessation, measured within an appropriate timeframe, and had results published. Three of the exposure biomarkers significantly improved in smokers who switched to HTPs and were not significantly different from cessation. The remaining 13 biomarkers did not improve—in some instances worsening upon switching to HTPs—or were inconsistently affected across studies. There were no appropriate data to estimate the lung cancer risk of HTPs in non-smokers. Conclusions The appropriateness of existing biomarker data in assessing lung cancer risk of HTPs, both relative to cigarettes and their absolute risk, is limited. Furthermore, findings on the most appropriate biomarkers were conflicting across studies and largely showed no improvement following a switch to HTPs. Implications Biomarker data are fundamental to assessing the reduced risk potential of HTPs. Our evaluation suggests much of the existing biomarker data on HTPs is inappropriate for determining the risk of lung cancer posed by HTPs. In particular, there is a paucity of data on the absolute lung cancer risk of HTPs, which could be obtained from comparisons to smokers who quit and never smokers exposed to or using HTPs. There is an urgent need for further exploration of the lung cancer risks posed by HTPs, via clinical trials and, in the long-term, confirmation of these risks via epidemiological studies. However, careful consideration should be given to biomarker selection and study design to ensure both are appropriate and will provide valuable data. [ABSTRACT FROM AUTHOR]

Introduction: The tobacco industry has a long history of manipulating science to conceal the harms of its products. As part of its proclaimed transformation, the world's largest tobacco company, Philip Morris International (PMI), states it conducts "transparent science". This paper uses recently leaked documents from PMI and its Japanese affiliate, Philip Morris Japan (PMJ), to examine its contemporary scientific practices., Methods: 23 documents dating 2012 through 2020 available from Truth Tobacco Industry Documents Library were examined using Forster's hermeneutic approach to analysing corporate documentation. Thematic analysis using the Science for Profit Model was conducted to assess whether PMI/PMJ employed known corporate strategies to influence science in their interests., Results: PMJ contracted a third-party external research organisation, CMIC, to covertly fund a study on smoking cessation conducted by Kyoto University academics. No public record of PMJ's funding or involvement in this study was found. PMJ paid life sciences consultancy, FTI-Innovations, ¥3,000,000 (approx. £20,000) a month between 2014 and 2019 to undertake extensive science-adjacent work, including building relationships with key scientific opinion leaders and using academic events to promote PMI's science, products and messaging. FTI-Innovation's work was hidden internally and externally. These activities resemble known strategies to influence the conduct, publication and reach of science, and conceal scientific activities., Conclusions: The documents reveal PMI/PMJ's recent activities mirror past practices to manipulate science, undermining PMI's proclaimed transformation. Tobacco industry scientific practices remain a threat to public health, highlighting the urgent need for reform to protect science from the tobacco industry's vested interests.Implications: Japan is a key market for PMI, being a launch market for IQOS and having the highest heated tobacco product use globally. Our findings, in conjunction with other recent evidence, challenge PMI's assertion that it is a source of credible science and cast doubt on the quality and ethical defensibility of its research, especially its studies conducted in Japan. This, in turn, brings into question the true public health impacts of its products. There is urgent need to reform the way tobacco-related science is funded and conducted. Implementation of models through which research can be funded using the industry's profits while minimising its influence should be explored., (© The Author(s) 2024. Published by Oxford University Press on behalf of the Society for Research on Nicotine and Tobacco.)