June 20, 2018

Stanton A. Glantz, PhD

PMI releases new data purporting to show how healthy IQOS is

In November, 2017 I published “Philip Morris hides data in plain sight on dangers of new heat-not-burn product” in The Conversation that pointed out that the results from 24 clinical medical tests that PMI submitted to the FDA actually showed that IQOS was not detectably less dangerous than conventional cigarettes.

In reviewing all the information that PMI submitted to the FDA, the FDA’s Tobacco Products Scientific Advisory Committee voted unanimously (with one abstention) against approving PMI’s reduced risk claim.

I was surprised that PMI did not immediately have a come back.

Now, they (sort of, but not really) do.  On June 15, 2018 PMI put out a press release, “Philip Morris (PM) Announces Positive Results from New Clinical Study on IQOS,” that says “all eight of the primary clinical risk endpoints moved in the same direction as observed for smoking cessation in the group who switched to IQOS, with statistically significant changes in five of the eight endpoints compared with on-going smoking.”

This sound pretty good until you note that this study only examined 8 clinical measures, compared to the 24 in the earlier study submitted to the FDA.  Moreover, when I went and looked up the protocol on ClinicalTrials.gov, I found that of the 8, only 6 were clinical endpoints.  (The other 2 were measures of exposure, which were not in the 24 endpoints they previously presented to FDA.)  They don’t say which of the changes were statistically significant, so this looks a lot like cherry picking to avoid unpleasant findings.

Of course, if public health talked about risks for tobacco products that “moved in the right direction” without reaching statistical significance, PMI and the other tobacco companies would jump on us for junk science.   Moreover, PMI increased the sample size from 88 in the original US study to 984.  While bigger studies are better, the fact is also if you make the sample size big enough almost any difference will reach statistical significance.

While PMI does not present any more details, they do say that the work will be submitted to a peer reviewed journal.  My guess is that it will be Regulatory Toxicology and Pharmacology, which consistently publishes pro-industry results.

The bottom line:  Without the details, this statement does not substantively change our state of knowledge about IQOS.  There is still not good evidence publicly available that they are safer than cigarettes.  This particular study also raises questions about manipulating the experimental design, something Philip Morris and other tobacco companies have a long history of doing.

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