Abstract:
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.
journal_name
Tob Controljournal_title
Tobacco controlauthors
Max WB,Sung HY,Lightwood J,Wang Y,Yao Tdoi
10.1136/tobaccocontrol-2018-054572subject
Has Abstractpub_date
2018-11-01 00:00:00pages
s82-s86issue
Suppl 1eissn
0964-4563issn
1468-3318pii
tobaccocontrol-2018-054572journal_volume
27pub_type
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