October 1, 2018

Stanton A. Glantz, PhD

PMI tweaks the numbers to make IQOS look better than it is (at a population level)

Wendy Max and her colleagues at UCSF just published “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” in Tobacco Control.  This paper uses the information published in Philip Morris International’s Modified Risk Tobacco Product (MRTP) application that was submitted to the FDA to assess the confidence that one can have in PMI’s prediction that, on balance, IQOS would have net population benefits.

They find many biases in the construction of the model and the assumptions behind it, all of which tend to overstate benefits and understate risks, which make PMI’s economic model inappropriate for public health decision making.

Another more general contribution of the paper are extensive supplementary tables that describe all the available models and their strengths and weaknesses.    

Here is the 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.

The full citation is  Max WB, Sung H, Lightwood J, et al.  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.  Tobacco Control Published Online First: 01 October 2018. doi: 10.1136/tobaccocontrol-2018-054572.  The paper is available for free here.

 

 

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