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Heated tobacco products: the example of IQOS
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    PMI's response to this paper comes up short

    NOT PEER REVIEWED
    PMI finally responded to my paper in Tobacco Control1 showing that the data submitted in their MRTP application to the FDA to market IQOS with reduced risk claims did not actually support claims of reduced risks.

    Specifically, PMI’s MRTP application included their 3-month study of 24 non-cancer biomarkers of potential harm (which PMI calls “clinical risk endpoints,” CRE) in humans using IQOS compared to conventional cigarettes. These biomarkers include measures of inflammation, oxidative stress, lipids, blood pressure, and lung function. (PMI did separate studies of biomarkers of exposure, several of which are carcinogens.) While PMI’s application emphasizes that these biomarkers generally changed in positive directions, my examination of the data revealed no statistically detectable difference between IQOS and conventional cigarettes for 23 of the 24 BOPH in Americans and 10 of 13 in Japanese. Moreover, it is likely that the few significant differences were false positives. Thus, despite delivering lower levels of some toxicants, PMI’s own data failed to show consistently lower risks of harm in humans using IQOS compared to conventional cigarettes.

    Their undated response, “The Difference between IQOS and Continued Smoking,”2 presents two arguments:

    • The original study submitted to FDA was “NOT DESIGNED to serve as the sole pivotal evidence with regards to CRE’s and to show statistically significant changes in the CREs.”...

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    Conflict of Interest:
    None declared.