Friday, December 8, 2017

Population-Level Proof: E-Cigarettes Are Popular & Successful Quit-Smoking Aids



Tobacco harm reduction opponents have belittled reported use of e-cigarettes as smoking cessation aids, dismissing case studies as mere “anecdotes” (here) and claiming a lack of population evidence to support a quit-smoking claim. 

Now that evidence exists.

In a just published study, my colleague Nantaporn Plurphanswat and I use federal government data to demonstrate that e-cigarettes were one of the most commonly used quit aids by American smokers in 2013-2014, and that they were the only aid more likely to make one a former smoker (i.e., a successful quitter) than quitting cold-turkey

Our study, appearing in the International Journal of Environmental Research and Public Health (open access, available here), analyzed data in the Population Assessment of Tobacco and Health (PATH) Survey, a combined project of the U.S. Food and Drug Administration and the National Institutes of Health. 

The PATH survey asked current smokers which aids they used when they tried to quit, and former smokers which aids they used to quit, in the past 12 months.  Participants could pick from the following: (1) no aid, (2) support from friends and family, (3) other aids (counseling, quit line, books, pamphlets, videos, clinic, class, web program), (4) e-cigarettes, (5) other combustible tobacco (cigars, cigarillos, filtered cigars, pipe tobacco, hookah), (6) smokeless tobacco (dip, chew, or snuff, and dissolvable tobacco), (7) pharmaceutical nicotine (NRT: patch, gum, inhaler, nasal spray, lozenge or pill), and (8) prescription drugs (Chantix, varenicline, Wellbutrin, Zyban, or bupropion).

Here is a summary of the results for smokers using a single quit aid:


Single Quit Aids Used By American Smokers, 2013-2014
AidCurrent Smokers*Former Smokers*All*% FormerOdds Ratio** (95% Confidence Interval






No aid5,546,0001,429,0006,975,00020.5Referent
Support, friends family1,992,000446,0002,438,00018.30.98 (0.75-1.28)
Other aids139,00037,000176,00021.00.89 (0.36-2.17)
E-cigarettes1,652,000540,0002,192,00024.61.43 (1.12-1.83)
Other combustible91,00024,000115,00020.91.43 (0.78-2.63)***
Smokeless tobacco92,00032,000124,00025.81.43 (0.78-2.63)***
NRT1,190,000284,0001,474,00019.30.89 (0.61-1.28)
Prescription drug347,00070,000417,00016.80.97 (0.55-1.71)
All aids11,049,0002,862,00013,911,00020.6
*estimated from PATH survey weighting.  Some numbers do not appear in the peer-reviewed publication.
**Odds ratio of being a former smoker, adjusted for number of quit attempts, age, sex, race/ethnicity, education, income and region
***categories combined to produce a single OR



Overall, nearly 14 million smokers tried to or did quit using a single quit aid in 2013-2014.  As we note, “E-cigarettes were used…by 2.2 million smokers…, NRT by 1.47 million, prescription drugs by 418,000 and smokeless tobacco by 124,000.” 

While NRT and prescription drugs, combined, helped some 354,000 smokers quit, it was e-cigarettes, which are routinely condemned by many public health institutions, that produced the greater success, helping 540,000 smokers quit.  Given the government’s own evidence, it’s time to acknowledge the scientific legitimacy, value and benefit of e-cigarettes with respect to the health of the population.

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)


Tuesday, November 21, 2017

Tobacco Harm Reduction Is Science, Not Conspiracy



Technology newsmonger The Verge should stick to covering cell phones and earbuds.  Last week it published a fantastical tale of e-cigarette intrigue, suggesting the existence of an international tobacco and vaping industry conspiracy.  The article by Liza Gross (here), richly sourced, linked my work to this imagined scheme.

I have always been entirely transparent about my research sponsors.   
I have publicly reported that my research at the University of Alabama at Birmingham, from 1999 to 2005, and since at the University of Louisville, has been supported by unrestricted grants to those institutions. The funds are managed according to the institutions’ policies to assure that grantors have no influence on my research products or activities. 

Since my first publication in tobacco harm reduction (THR) in 1994, I have been interested in all THR products, regardless of manufacturer.  The Verge cited an “unsolicited” email from me to claim a connection to Reynolds, the marketer of Eclipse, but I had submitted my note via a blind "Talk to RJR" email account, as I had no relationship with anyone at the company.  The purpose of my email was to challenge Reynolds for positioning Eclipse as a lower risk product for smokers.  I objected that it was not lower risk, but rather “a tobacco product which delivers only xx% of (specific toxins) when compared with currently available products because the tobacco is heated rather than burned.”  I was correcting Reynolds, suggesting they make a reduced exposure claim rather than a reduced risk claim.  Note that when Congress gave the FDA regulatory authority over tobacco nine years later, it included both reduced risk and reduced exposure as pathways for Modified Risk Tobacco Product approval by FDA for product claims by tobacco manufacturers.

As a result of my email to Reynolds, the company provided a senior scientist to give a well- received public seminar at the UAB School of Public Health describing the company’s research and resulting peer-reviewed articles on Eclipse (here). 

Elsewhere in its story, The Verge used half-truths to besmirch me and others with regards to contact with tobacco companies.  For 23 years I have worked with a wide range of organizations interested in tobacco harm reduction.  I generated peer-reviewed articles and other reports as a scientific advisor for the American Council for Science and Health, and as a fellow of the Heartland and R Street Institutes, all without financial remuneration.  These activities fall within my responsibilities as Professor of Medicine and Endowed Chair of Tobacco Harm Reduction Research at the University of Louisville.

The dictionary defines “verge” as the edge, rim, or margin of something.  Ms. Gross’s article espouses a conspiracy theory that, in my case, is well beyond the margin of accuracy.  Had the author contacted me, I would have provided the Tobacco Truth.