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首页> 外文期刊>Tobacco control >Modelling the impact of a new tobacco product: review of Philip Morris International's Population Health Impact Model as applied to the IQOS heated tobacco product
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Modelling the impact of a new tobacco product: review of Philip Morris International's Population Health Impact Model as applied to the IQOS heated tobacco product

机译：对新烟草产品的影响进行建模：回顾Philip Morris International的“人口健康影响模型”，该模型适用于IQOS加热的烟草产品

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Objectives We review the Population Health Impact Model (PHIM) developed by Philip Morris International and used in its application to the US Food and Drug Administration (FDA) to market its heated tobacco product (HTP), IQOS, as a modified-risk tobacco product (MRTP). We assess the model against FDA guidelines for MRTP applications and consider more general criteria for evaluating reduced-risk tobacco products.Methods In assessing the PHIM against FDA guidelines, we consider two key components of the model: the assumptions implicit in the model (outcomes included, relative harm of the new product vs cigarettes, tobacco-related diseases considered, whether dual or polyuse of the new product is modelled, and what other tobacco products are included) and data used to estimate and validate model parameters (transition rates between non-smoking, cigarette-only smoking, dual use of cigarettes and MRTP, and MRTP-only use; and starting tobacco use prevalence).Results The PHIM is a dynamic state transition model which models the impact of cigarette and MRTP use on mortality from four tobacco-attributable diseases. The PHIM excludes morbidity, underestimates mortality, excludes tobacco products other than cigarettes, does not include FDA-recommended impacts on non-users and underestimates the impact on other population groups.Conclusion The PHIM underestimates the health impact of HTP products and cannot be used to justify an MRTP claim. An assessment of the impact of a potential MRTP on population health should include a comprehensive measure of health impacts, consideration of all groups impacted, and documented and justifiable assumptions regarding model parameters.
机译：目标我们回顾了由菲利普莫里斯国际公司开发的“人口健康影响模型”（PHIM），该模型在美国食品和药物管理局（FDA）的应用中用于销售其经加热的烟草制品（HTP）IQOS，作为一种改良风险的烟草制品（MRTP）。我们根据MRTP应用的FDA指南评估模型，并考虑评估降低风险的烟草制品的更通用标准。方法在针对FDA指南评估PHIM时，我们考虑了模型的两个关键组成部分：模型中隐含的假设（包括结果） ，新产品相对于卷烟的相对危害，已考虑的与烟草相关的疾病，新产品是双重使用还是多次使用都经过建模，还包括其他哪些烟草产品）以及用于估算和验证模型参数（非烟草之间的转化率）的数据吸烟，仅吸烟，同时使用香烟和MRTP以及仅使用MRTP;以及开始使用烟草的患病率）结果PHIM是一个动态状态转换模型，该模型模拟了香烟和MRTP的使用对四种烟草死亡率的影响归因疾病。 PHIM不包括发病率，低估了死亡率，不包括卷烟以外的烟草产品，不包括FDA推荐的对非使用者的影响并且低估了对其他人群的影响。结论PHIM低估了HTP产品对健康的影响，不能用于为MRTP索赔辩护。对潜在的MRTP对人口健康的影响的评估应包括对健康影响的全面衡量，对所有受影响群体的考虑以及有关模型参数的成文和合理假设。

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