Friday, November 17, 2017

Smoke But No Fire: IQOS Opponent Misrepresents 3-Month Studies to FDA



Stanton Glantz, a University of California, San Francisco professor, this week urged the FDA to “…deny [Philip Morris Intermational’s] application to market IQOS [its heat-not-burn cigarette] as a modified risk tobacco product because PMI’s own data fails to support a modified risk claim in people who are actually using the product.”

Glantz’s declaration is based on his review of lab results from two groups of smokers three months after (1) continuing to smoke or (2) switching to IQOS.  The studies, from Japan and the U.S., were submitted by PMI in its application (available at the FDA website here ).

It is well known that individuals’ lab results do not improve instantly upon smoking cessation.  The PMI submission clearly indicated that many of the subjects’ lab values are not expected to change for 6-12 months or longer after quitting. 
Beyond that, Glantz completely ignored a third PMI study group: smokers who had quit completely for three months. 

In this post I present the comparison that Glantz emphasized – IQOS users versus continuing smokers – but I add an equally important comparison that Glantz ignored – IQOS users versus complete quitters.  Because the U.S. study had too few subjects in the latter group  (n=9) for stable comparisons, I will focus on the Japan study, which involved 70 IQOS users, 41 continuing smokers and 37 complete quitters.  I will also note one omission in Glantz’s comparison.

The comparisons of IQOS and continued smoking in the table below were calculated by PMI and presented in its application.  PMI also calculated differences for IQOS versus quitting, but I could not find them in the material released so far by the FDA.  So those comparisons in the table are from my assessment of point estimates and confidence intervals from the submission.  All 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.


Comparison of Laboratory Values After 3 Months: IQOS Users Versus Continuing Smokers and Versus Complete Quitters in Japan
Lab MarkerIQOS Versus SmokingIQOS Versus Complete Quitting*



Inflammation

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



Oxidative Stress

Prostaglandin F2 alphaIQOS significantly lowerIQOS possibly lower
11-DTX-B2NSQuitting possibly lower



Cholesterol, Triglycerides

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



Blood pressure

SystolicNSNS
SystolicNSNS



Lung function

Forced expiratory vol, 1 sec.NSNS
NS, No significant difference
* My assessment based on point estimates and confidence intervals in submission  
** Omitted by Glantz

The PMI calculations show that IQOS users had four statistically significant favorable comparisons at 3 months compared with smokers.  Other results show no differences.  My assessment of IQOS users versus complete quitters reveals no significant differences for ten lab results.  There were only two possibly significant results favoring IQOS and one favoring complete quitting. 

In summary, the results at three months do not prove anything definitive, which was emphasized in PMI’s application.  These results were not used by PMI to support any positive claims about IQOS; they should not have been used by Professor Glantz to make any counter claims.


 

Friday, November 10, 2017

More Vaper Insights Drawn from the FDA PATH Survey, 2013-14



Following are additional insights into smoking and vaping from my Nicotine & Tobacco Research study (abstract here), coauthored by my economist colleague Dr. Nantaporn Plurphanswat.  Earlier blog notes on this analysis of the 2013-14 FDA-funded Population Assessment of Tobacco and Health (PATH) Survey are here.

Flavors and Nicotine

Flavors are important to vapers, but the PATH questionnaire inquired about flavoring only by grouping them: “menthol, mint, clove, spice, candy, fruit, chocolate, alcohol (such as wine or cognac), or other sweets.”  Nevertheless, we report that flavors “were consumed by 7 out of 10 current users.  Never-smokers were significantly more likely to use them than current and former smokers (84% vs. 67% and 69%), and they were significantly less likely to use liquid containing nicotine (69% vs. 93% and 88%).  Notably, …5.2% of current smokers, 7.8% of former smokers, and 25.9% of never-smokers used e-cigarettes that contained flavor, but no nicotine.”

Buying E-Cigarettes

We found that “The majority of users bought e-cigarettes in person (81%).  Former smokers were significantly more likely to buy them from the internet than current and never-smokers (21% vs. 10.3% and 13.0%).  Never-smokers were the least likely to buy their own e-cigarettes.  Two-thirds of former smokers purchased their e-cigarettes in a smoke shop or vape shop, which was significantly higher than current or never-smokers (55% and 45%).”

Reasons for Vaping

The PATH Survey asked vapers why they used e-cigarettes.  The top five reasons among former smokers who vaped were:

1.     “less harmful to me” (94%),
2.     “less harmful to persons around me,” (88%)
3.     “help to quit smoking,” (86%)
4.     “don’t smell” (80%)
5.     “use when/where smoking not allowed” (78%).

Current smokers who vaped listed the same top five reasons in slightly different order.  Understandably, #5 moved to the #2 slot.  Notably, “E-cigarette use by other people (‘important to me’ or ‘in the media or other public figures’) and appealing advertising were the least popular
reasons for use among all groups.”

Perceptions of Nicotine and E-Cigarette Harm

Regardless of smoking status, most vapers were misinformed about nicotine: 84% of never smokers believed that nicotine causes most cancers, as did 77% of current smokers and 66% of former smokers.  There was better news with respect to relative risk of vaping versus smoking: “The majority of users thought that e-cigarettes were less harmful than cigarettes. Ninety-four percent of former smokers thought that e-cigarettes were less harmful, which was significantly higher than either current or never-smokers (78% and 77%).”

This is meaningful, as a 2015 National Cancer Institute survey showed that only 26% of U.S. adults believed that e-cigarettes were less harmful than traditional cigarettes (discussed here).  The PATH results show that, despite a tsunami of misinformation from government agencies and health organizations, e-cigarette users are much better informed than the general public about differential risks of vaping and smoking. 



Thursday, November 2, 2017

NY Wrongheadedly Bans Indoor Vaping



Saying that e-cigarettes “carry long-term risks to the health of users and those around them,” New York Governor Andrew Cuomo signed into law on October 23 a bill that bans indoor vaping.  

The governor got his facts wrong.  While e-cigarette usage rates have boomed over the past five years, there is no evidence that they have any significant short-, medium- or long-term health effects. 

Andrew Stuttaford in the National Review (here) labeled Cuomo’s action “an unscientific war,” citing the Royal College of Physicians’ 2016 report (here)(emphasis in original). 

The case for e-cigarettes can be summed up by four key recommendations from the RCP report:


·       E-cigarettes are marketed as consumer products and are proving much more popular than NRT [nicotine replacement therapy] as a substitute and competitor for tobacco cigarettes.
 
·       E-cigarettes appear to be effective when used by smokers as an aid to quitting smoking.


·       … the hazard to health arising from long-term vapour inhalation from the e-cigarettes available today is unlikely to exceed 5% of the harm from smoking tobacco.


·       in the interests of public health it is important to promote the use of e-cigarettes, NRT and other non-tobacco nicotine products as widely as possible as a substitute for smoking


Ignoring clear evidence of vapor’s relative safety and widespread use in smoking cessation, politicians and public health officials in New York and elsewhere support the deadly cigarette status quo.

Beyond science issues, vaping bans have little impact on consumer behavior.  E-cigarette vapor dissipates quickly, so while bans may stifle e-cigarette use in public settings, enthusiasts know that they can continue vaping indoors; if they are discreet, no one will know.

The biggest flaw in vaping bans is the false implication – if not the explicit false claim – that vapor is as dangerous as smoke.  In the war on vaping by Governor Cuomo and others, such deception misleads American tobacco users and denies them use of proven harm reduction aids. That is the denial, not the promotion, of public health.