Wednesday, November 29, 2017

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 MarkerIQOS Versus SmokingIQOS Versus Complete Quitting*



Inflammation

White blood cell countIQOS significantly lowerNS
C-reactive proteinNSNS
Soluble ICAMIQOS significantly lowerNS
FibrinogenNSNS



Oxidative Stress

Prostaglandin F2 alphaIQOS significantly lowerNS
11-DTX-B2NSNS



Cholesterol, Triglycerides

High density lipoproteinIQOS significantly higherNS
Low density lipoproteinNSNS
Total cholesterolNSNS
TriglyceridesNSIQOS significantly lower



Blood pressure

SystolicNSNS
DiastolicNSNS



Lung function

Forced expiratory vol, 1 sec.NSNS



Carbon monoxideIQOS significantly lowerNS
CarboxyhemoglobinIQOS significantly lowerNS



NicotineNS*IQOS significantly higher



Carcinogens**

Nicotine-derived nitrosamine ketone (NNK)IQOS significantly lowerQuitting significantly lower
Butadiene (MHBMA)IQOS significantly lowerNS
Acrolein (3-HPMA)IQOS significantly lowerQuitting significantly lower
Acrolein (HMPMA)IQOS significantly lowerNS
Benzene (S-PMA)IQOS significantly lowerNS
Polycyclic aromatic hydrocarbons (1-OHP)IQOS significantly lowerNS
Polycyclic aromatic hydrocarbons (CYP 1A2)IQOS significantly lowerNS
N-nitrosonornicotineIQOS significantly lowerQuitting significantly lower
4-aminobiphenylIQOS significantly lowerNS
1-aminonaphthaleneIQOS significantly lowerNS
2-aminonaphthaleneIQOS significantly lowerNS
o-toluidineIQOS significantly lowerNS
Acrylonitrile (CEMA)IQOS significantly lowerNS
Styrene (HEMA)IQOS significantly lowerNS
Benzo(a)pyreneIQOS significantly lowerNS
Toluene (S-BMA)NSNS



NS, No significant difference
* IQOS results in nicotine levels that are similar to smoking
** carcinogen (chemical metabolites)


2 comments:

Roberto Sussman Livovsky said...

Do you have the primary source on the FDA latest release. That is "The agency’s latest release provides further evidence that toxin levels three months after switching to IQOS look more like complete quitting". Thanks

Brad Rodu said...

The FDA website contains enormous amounts of information and is very difficult to navigate. After much investigation I found the information, but it does not have an accessible link. So I make the specific report that is the source of this blog available here: https://drive.google.com/file/d/1hwxwRFYNYVoyApljayXvRVU03nNnBdpa/view?usp=sharing

Brad Rodu