Federal Surveys Demonstrate E-Cigarettes Have Been Successful Quit-Smoking Aids For a Decade

 

New research based on U.S. government survey data shows, “The most popular methods used to stop smoking were nicotine products (53.9%; 1.5 million adults), especially e-cigarettes in combination with other methods (40.8%; 1.2 million) and e-cigarettes alone (26.0%; 0.7 million)” [confidence intervals removed by me]. Additionally, “Prescription drug products (8.1%; 0.2 million) and non-nicotine, non-prescription drug methods (6.3%; 0.2 million) were less popular.”

Tobacco researchers Floe Foxon (Pinney Associates) and Ray Niaura (New York University) made those observations in their new report, “Use of nicotine products, prescription drug products, and other methods to stop smoking by US adults in the 2022 National Health Interview Survey,” appearing in the journal Internal and Emergency Medicine (abstract here).

Foxon and Niaura analyzed “U.S. adults who self-reported having stopped smoking cigarettes for 6 months or longer in the last year and the methods they used, or who did not stop smoking but tried in the last year.”  The survey that supplied the raw data is the standard instrument used by the Centers for Disease Control and Prevention to count 29 million adult current and 56 million former U.S. smokers each year. 

The researchers note that their results are similar to those in an earlier analysis of adult smokers in the FDA’s Population Assessment of Tobacco and Health (PATH) Survey.  I conducted that study along with Nantaporn Plurphanswat and noted in a blog post, “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.”

Now we have definitive population-level evidence, provided by the federal government, that e-cigarettes have been the most popular and among the most successful quit-smoking aids for almost a decade.  It is long past time for government officials to acknowledge these facts.

 

E-Cigarettes = Nicotine Medicines = Prescription Medicines = Cold Turkey: All Help Some Smokers Quit

 

Thirty-six co-authors, peer review, and they still got it wrong.

Dr. John Pierce and 35 colleagues have published a study in the journal PLoS One analyzing data from FDA Population Assessment of Tobacco and Health (PATH) surveys.  Their work was touted in a University of California San Diego press release titled, “E-cigarettes Don’t Help Smokers Quit and They May Become Addicted to Vaping.”  But their study actually proved that e-cigarettes are as helpful as medicines promoted by anti-tobacco crusaders.

The study followed participants in all three waves of the PATH – one year apart in 2014, 2015 and 2016.  I will describe how Pierce and colleagues conducted this complicated analysis. 

Pierce et al. selected participants who were smoking every day when they enrolled in PATH Wave 1 (n= 9,021).  They then selected those who had tried to quit smoking “in the past 12 months” between Waves 1 and 2, but who were still smoking daily (n= 2,443).  In other words, those daily smokers had tried, but did not quit, during the year between the first two waves.  Daily smokers who had not tried quitting were excluded.

Pierce divided those 2,443 daily smokers who had failed to quit between Waves 1 and 2 into three groups: those who had tried stop-smoking medicines (a prescription and/or over-the-counter medicinal nicotine, n=442); those who had tried e-cigarettes (n=566, 116 of whom had also used stop-smoking medicines); and those who had used neither (i.e., had gone cold turkey, n=1,435).

After the three groups of smokers had failed between Waves 1 and 2, Pierce compared them at Wave 3 (one year after Wave 2) with respect to three outcomes: abstinent from cigarettes for 12+ months; abstinent from cigarettes for 30+ days; and abstinent from all tobacco. 

The researchers found that the first two outcomes for all groups were similar: “Twelve-month cigarette abstinence was ~10% and comparable across all methods used to quit… There was no net risk difference in 30+ days cigarette abstinence at W[ave]3 between the e-cigarette group and either the no e-cigarette control, the no [cold turkey group] or the [medicine group].”     

While the authors apparently approved their press release headline – “E-cigarettes Don’t Help Smokers Quit” – they failed to note that e-cigarettes had helped people quit as often as medicinal nicotine, other medicines or going cold turkey.  In fact, all of the quit aids helped some smokers.  The headline should have read: “E-cigarettes, Nicotine Medicines, Prescription Medicines and Cold Turkey All Help Some Smokers Quit.”

Another red flag with this study is that it focused only on 2,443 “daily smokers” at Wave 1 who had tried to quit between Waves 1 and 2, but were also daily smokers at Wave 2 and additionally had information at Wave 3.  That number represents a remarkably narrow subset of all daily smokers at Wave 1 (about 27% of the 9,021 daily smokers at Wave 1).

Even more important, the authors completely ignored former smokers at both Waves 1 and 2 who had already used e-cigarettes (and other aids) to quit in the year before.  The Wave 1 former smokers were documented by my research group in a 2017 research study.  It is entirely inappropriate for Pierce et al. to issue a press release claiming that “E-cigarettes don’t help smokers quit” when they produced results only for a select population of daily smokers who remained daily smokers after trying to quit. 

While Pierce et al. narrowly defined their study groups, another study of PATH Waves 1 to 3 has produced diametrically opposite results.  Investigators at New York University, Ohio State, Georgetown and Columbia, led by Allison Glasser, coauthored a study that concluded: “…consistent and frequent e-cigarette use and increasing use over time, as well as flavors and device type, are associated with smoking cessation among adult smokers.”  They also found that “flavors may play a facilitating role in cigarette smoking cessation among adults. Use of a rechargeable device consistently…was also associated with a higher likelihood of smoking cessation within the past year when compared with use of disposable devices, although this effect was only found among daily smokers.”

The Pierce study and its PR spin underscore the importance of critical analysis and fact-checking of all research reports, even when “co-written” by dozens of authors and ostensibly peer reviewed.

 

  

FDA Awards “Modified Risk” Status to General Brand Snus Products from Swedish Match

“The U.S. Food and Drug Administration announced [on October 22] that, for the first time, it has authorized the marketing of products through the modified risk tobacco product (MRTP) pathway. The authorizations are for eight Swedish Match USA, Inc. snus smokeless tobacco products sold under the ‘General’ brand name” (from the FDA press release). 

The FDA authorization allows Swedish Match to use this statement: “Using General Snus instead of cigarettes puts you at a lower risk of mouth cancer, heart disease, lung cancer, stroke, emphysema, and chronic bronchitis.”  The approval will be in place for five years, but the agency can remove it at any time if it decides that it “no longer benefits the health of the population as a whole.”

It took the FDA over five years (during which 2.56 million American smokers died prematurely) to approve this truthful statement that I have documented for 25 years.  Note, however, that the tobacco control act stacked the deck against harm reduction by mandating the term “modified risk” instead of the more accurate “reduced risk.”

The FDA announcement received favorable media attention, with one analyst calling it a “gamechanger.”  While that may be true, there are some important things to remember.

1. The company filed its original application in 2014 to change the FDA’s mandated but grossly inaccurate smokeless tobacco warning labels.  The FDA, using flawed analysis, rejected that application in December 2016, and signaled that it would not jettison the required warnings, “cause mouth cancer” and “not a safe alternative to cigarettes.”  Swedish Match then filed an amended application with the statement that was approved.

2. The approved warning refers to “lower” risk of disease, which implies that risks are still present, when, in fact, snus has no risk for mouth cancer, heart disease, lung cancer, stroke, emphysema, and chronic bronchitis.  Even worse, the FDA’s “not safe alternative” warning covering a large part of the package and advertisements annuls the “lower” risk statement from Swedish Match. 

3. Swedish Match’s success was supported by a wealth of published epidemiologic research demonstrating snus’s negative impact on smoking and smoking-related diseases among Swedish men.  While Swedish boys use snus just like their fathers, use among American youth is nearly nonexistent.  These factors set a high standard of evidence for other current MRTP applications from Philip Morris International (IQOS), Reynolds (Camel snus) and and US Tobacco (Copenhagen moist snuff).   

• IQOS heat-not-burn tobacco.  Years of extensive research demonstrate that IQOS vapor is vastly less hazardous than smoke.  However, there is no epidemiology on the health effects of IQOS use, and there won’t be any for at least two decades.  In other countries, PMI sells IQOS devices only to adult smokers in special stores, so youth don’t have access.  PMI’s FDA application is now almost three years old (corresponding to 1.44 million dead smokers).

• Camel snus.  Produced in the same manner as Swedish snus, Reynolds’s Camel product should qualify for MRTP status with similar labeling, but Reynolds has no epidemiology for a product introduced in the U.S. around 2005.  The MRTP application is two and a half years old (1.24 million dead smokers).

• Copenhagen moist snuff.  The U.S. Smokeless Tobacco Company took a minimalist approach in its FDA MRTP application for this statement: “Switching completely to this product from cigarettes reduces risk of lung cancer.”  Still, the FDA, concerned with under-age use of dip products, claims that 350,000 “youth under 18 years of age use smokeless tobacco for the first time” yearly.  The agency will likely cite the youth issue to deny any statement about vastly lower risks, including lung cancer.  The MRTP application is one year, seven months old (760,000 dead smokers).

• E-cigarettes and vapor products.  The chances of these products getting an MRTP are approximately zero.  Research at American universities funded by the federal government is focused only on risks, epidemiologic studies are nonexistent, and federal officials consider vape products to be the cause of an exaggerated teen epidemic and mischaracterize them as the cause of lung injuries and deaths.  Manufacturers must first navigate widespread flavor and product bans, and then complete Premarket Tobacco Product Applications, a feat accomplished only by Swedish Match for General Snus and PMI for IQOS. 

Swedish Match should be commended for establishing a precedent for successfully navigating the Reduced (not merely modified) Risk Tobacco Product Pathway.