The FDA Center for Tobacco Products concern about balancing potential benefits of e-cigs with demonstrated risks to youth presumes that adults using e-cigarettes will switch completely to e-cigs and that e-cigs are substantially less risky than cigarettes. Bekir Kaplan and colleagues’ new paper Effectiveness of ENDS, NRT and medication for smoking cessation among cigarette-only users: a longitudinal analysis of PATH Study wave 3 (2015-2016) and 4 (2016-2017), adult data contributes important information that contradicts this presumption.
They used the FDA/NIH PATH study to examine 6704 people who were just smoking cigarettes in 2015-6 to identify people who were trying to quit, what products they used in their quit attempts (e-cigs, NRT or other FDA-approved prescription medication [varenicline and bupropion]), and what happened a year later (2016-7). Most people used NRT (58.5%) followed by NRT in combination with FDA-approved medications (17.4%), with about the same numbers using e-cigs (12.3%), medications alone (11.8%). (The small number of people who used e-cigs in combination with NRT or medications were excluded.)
All these cessation aids worked about as well with around 16.1% having stopped smoking a year later (p=0.97). This compares with 5.3% quitting among people who did not use any of these aids. The authors do not report if this 5.3% is significantly different from 16.1%. Our meta-analysis of e-cig use and smoking cessation did not find a significant difference in quitting between smokers who used e-cigs compared to those who did not among people motivated to quit (OR = 0.851; 95% CI = 0.684, 1.057),
The lack of a difference between the different smoking cessation aids remained non-significant after controlling for a range of demographic factors and measures of nicotine dependence.
As discussed in the paper, these results are consistent with several earlier longitudinal studies. The value of the new study is that it is based on more recent data that reflects use of products that are closer in time to current product use patterns.
Of particular relevance to the FDA’s deliberations none of the smokers who used e-cigarettes to quit switched completely to e-cigarettes. 37.4% became dual users in which they continued to use e-cigs and smoke cigarettes at the same time. (52.8% went back to just smoking cigarettes and 9.6% stopped using any tobacco products.) This high level of dual use is harm enhancing because dual use is more dangerous than smoking alone (lung disease: link1, link2, link3; heart disease: link4, link5, link6).
As far as I know, none of FDA’s publicly released analyses consider the risks of dual use. Indeed, they have ignored dual use by focusing on the assumption that people would “switch completely.” The Kaplan paper directly contradicts that assumption.
It is also important to emphasize that Kaplan and colleagues studied smokers who were actively trying to quit and using e-cigs and the other products as explicit cessation aids. The FDA Center for Tobacco Products is required to consider the effects on all smokers and nonsmokers.
Kaplan and colleagues conclude “Given uncertainty about the long-term health effect of ENDS and the likelihood of becoming dual users, people who smoke and need assistance quitting should be encouraged to use current Food and Drug Administration-approved cessation methods until more effective methods are developed.“
Here is the abstract:
Background: Research is inconclusive on the effectiveness of electronic nicotine delivery systems (ENDS) as cigarette cessation aids compared with nicotine replacement therapy (NRT) or non-NRT medication. This study compared the cigarette cessation rates for ENDS, NRT and non-NRT medication.
Method: Population Assessment of Tobacco and Health Study wave 3 cigarette-only users who used ENDS, NRT or non-NRT medication (varenicline and bupropion) to quit smoking between wave 3 and 4 were included. ‘Cessation’ was defined as being a former cigarette smoker in wave 4. χ2, logistic regression, and a sensitivity analysis with Bayes factor assessed the association between quitting smoking and method used.
Results: Among 6794 cigarette-only users, 532 used ENDS (n=75), NRT (n=289), non-NRT medication (n=68), or a combination of NRT and non-NRT medication (n=100) to quit smoking between wave 3 and 4. The percentages of quitting smoking among those who used ENDS, NRT, non-NRT medication, and a combination of NRT and non-NRT medication were 16.2% (n=14), 16.1% (n=47), 17.7% (n=13), and 14.8% (n=12), respectively (p=0.97). None of the cigarette-only users who used ENDS to quit smoking became ENDS-only users in wave 4; 37.6% became dual users of ENDS and cigarettes.
Conclusion: No differences were found when cessation rates of ENDS, NRT or non-NRT medication were compared. Given uncertainty about the long-term health effect of ENDS and the likelihood of becoming dual users, people who smoke and need assistance quitting should be encouraged to use current Food and Drug Administration-approved cessation methods until more effective methods are developed.
The full citation is Kaplan B, Galiatsatos P, Breland A, Eissenberg T, Cohen JE. Effectiveness of ENDS, NRT and medication for smoking cessation among cigarette-only users: a longitudinal analysis of PATH Study wave 3 (2015-2016) and 4 (2016-2017), adult data. Tob Control. 2021 Sep 15:tobaccocontrol-2020-056448. doi: 10.1136/tobaccocontrol-2020-056448. Epub ahead of print. PMID: 34526410. It is available here.