FDA Releases More Positive Results for IQOS; British Medical Association Supports E-Cigs

I earlier reported (here) that Stanton Glantz, a University of California, San Francisco professor, urged the FDA to deny Philip Morris International’s application to market its IQOS heat-not-burn cigarette as a modified risk tobacco product, based on his comparison of lab results for IQOS users versus continuing smokers.  I noted that Glantz ignored data for IQOS users versus complete quitters, although that statistical comparison was not in the documents released by the FDA.

Additional data released by the FDA yesterday shows that PMI had submitted considerably more information from its Japanese study.  PMI reported data on exposure to carcinogens, carbon monoxide and nicotine, and, importantly, analyses for all of these results, including IQOS versus smoking, and IQOS versus quitting.

The following table shows all results after three months.  Differences in the table are described positively with respect to health (e.g., IQOS significantly lower).  “NS” indicates no significant difference between groups for that test.  The primary carcinogens are listed, with lengthy chemical metabolites abbreviated in parentheses.  

IQOS users were not significantly different than quitters with respect to inflammation, oxidative stress, blood pressure, lung function and carbon monoxide levels.  Compared with continuing smokers, IQOS users had significantly lower levels of 15 out of 16 carcinogen markers after 90 days of use.  There were no differences between IQOS and quitting for 13 of 16 markers.

My previous blog post was based on partial results released by FDA.  The agency’s latest release provides further evidence that toxin levels three months after switching to IQOS look more like complete quitting.

No one is claiming that IQOS is perfectly safe.  However, exposure to toxic agents among IQOS users is substantially lower than exposure among smokers, and very close to that associated with complete quitting.

In breaking news, the British Medical Association Board of Science has just issued a positive report on e-cigarettes (here).  Their findings, which likely apply to IQOS, appear below verbatim.

Is it safe to use an e-cigarette in the long-term?

In the absence of long-term studies it is not possible to be certain about the long-term health risks, but there is growing consensus that use of e-cigarettes is significantly safer than smoking.

Unlike cigarette smoking, e-cigarette use does not expose users to the products of combustion, and most of the toxicants causing smoking-related disease are absent or significantly reduced in e-cigarette vapour.

Indications to date are that complete switching can lead to improvements in the levels of toxins and carcinogens in urine similar to that in smokers who switch completely to NRT (nicotine replacement therapies).

Comparison of Laboratory Values: IQOS Users Versus Continuing Smokers and Versus Complete Quitters After 3 Months
Lab Marker	IQOS Versus Smoking	IQOS Versus Complete Quitting*
Inflammation
White blood cell count	IQOS significantly lower	NS
C-reactive protein	NS	NS
Soluble ICAM	IQOS significantly lower	NS
Fibrinogen	NS	NS
Oxidative Stress
Prostaglandin F2 alpha	IQOS significantly lower	NS
11-DTX-B2	NS	NS
Cholesterol, Triglycerides
High density lipoprotein	IQOS significantly higher	NS
Low density lipoprotein	NS	NS
Total cholesterol	NS	NS
Triglycerides	NS	IQOS significantly lower
Blood pressure
Systolic	NS	NS
Diastolic	NS	NS
Lung function
Forced expiratory vol, 1 sec.	NS	NS
Carbon monoxide	IQOS significantly lower	NS
Carboxyhemoglobin	IQOS significantly lower	NS
Nicotine	NS*	IQOS significantly higher
Carcinogens**
Nicotine-derived nitrosamine ketone (NNK)	IQOS significantly lower	Quitting significantly lower
Butadiene (MHBMA)	IQOS significantly lower	NS
Acrolein (3-HPMA)	IQOS significantly lower	Quitting significantly lower
Acrolein (HMPMA)	IQOS significantly lower	NS
Benzene (S-PMA)	IQOS significantly lower	NS
Polycyclic aromatic hydrocarbons (1-OHP)	IQOS significantly lower	NS
Polycyclic aromatic hydrocarbons (CYP 1A2)	IQOS significantly lower	NS
N-nitrosonornicotine	IQOS significantly lower	Quitting significantly lower
4-aminobiphenyl	IQOS significantly lower	NS
1-aminonaphthalene	IQOS significantly lower	NS
2-aminonaphthalene	IQOS significantly lower	NS
o-toluidine	IQOS significantly lower	NS
Acrylonitrile (CEMA)	IQOS significantly lower	NS
Styrene (HEMA)	IQOS significantly lower	NS
Benzo(a)pyrene	IQOS significantly lower	NS
Toluene (S-BMA)	NS	NS

NS, No significant difference

* IQOS results in nicotine levels that are similar to smoking

** carcinogen (chemical metabolites)