Last week the FDA authorized the sale of RJ Reynolds’ (BAT’s US subsidiary) Vuse e-cigarette despite heavy use by kids because “the manufacturer’s data demonstrates its tobacco-flavored products could benefit addicted adult smokers who switch to these products – either completely or with a significant reduction in cigarette consumption – by reducing their exposure to harmful chemicals.” This conclusion depends heavily on the assumption that e-cigarettes help smokers stop smoking.
A new paper from John Pierce and his colleagues at UCSD, “Incidence of Cigarette Smoking Relapse Among Quitters Who Switched to E-Cigarettes or Other Tobacco Products: A Cohort Study,” provides the best evidence to date that this assumption is wrong. Until now research on the effect of e-cigarettes on smoking cessation have focused on the effect of e-cigarette use on quitting either at one point in time of with relatively short follow up.
Rather than consider the short-term effect on e-cigarette use on whether or not smokers quit cigarettes (“switching”), Pierce and colleagues started with people who were current smokers at baseline that had quit a year later, then followed them for another year to see who relapsed and how that related to whether they were using e-cigarettes or other tobacco products.
Rather than helping them remain smokefree (harm reduction), former smokers who switched to e-cigarettes (as well as any other form of tobacco use) were more likely to relapse compared to former smokers who had quit all tobacco, by a total of 8.5 percentage points.
While individuals who switched were more likely to relapse to smoking, they were also more likely to attempt to quit again and be off cigarettes for at least three months at the second follow up. A further follow-up survey is needed to identify whether this is evidence of a pattern of chronic quitting and relapsing to cigarette smoking, or whether it is part of progress toward success.
In any event, based on what we know as of now, the purported cessation benefit that forms the foundation for the FDA’s decision to allow Vuse Solo to be sold in the USA melts away over time.
While it may be too soon to reverse the Vuse Solo order, FDA needs to incorporate this important new research before they authorize the sale of any more e-cigarettes.
The study is based on 4 years for the FDA/NIH PATH dataset, a large nationally representative dataset, which makes the results even stronger and more relevant to regulatory decision making.
John Pierce published a op-ed in MedPage Today based on the study that does a nice job of putting it into the context of the larger literature. The overall conclusion is
Over the past 14 years, e-cigarettes have become popular among smokers who are trying to quit as well as teenagers experimenting with nicotine. The PATH Study offers excellent longitudinal evidence with 5 years of data already publicly available and at least 2 more years currently being prepared for release. So far, this population study has found no evidence that e-cigarettes are helping smokers quit successfully, and the evidence on teen initiation is troubling. While all the evidence is not in yet, the data we have to date suggests we should not embrace the harm reduction hypothesis, but stay the course on promoting abstinence from all nicotine. After all, in the past 20 years, there has been a major reduction in cigarette smoking in the U.S., little to none of which is attributable to e-cigarette use.
Here is the UCSD press release on the study:
UC San Diego Study: E-cigarettes Don’t Help Smokers Stay Off Cigarettes
Cigarette smokers who quit smoking but substitute e-cigarettes, or other tobacco product, are more likely to relapse
The United States Centers for Disease Control and Prevention have suggested that smokers who are unable to quit smoking may benefit by switching from smoking cigarettes to vaping e-cigarettes if they switch completely and are able to avoid relapsing to cigarette smoking.
However, there have been few studies on whether smokers are able to transition to e-cigarettes—battery-operated devices that heat a liquid made of nicotine, flavorings and other chemicals to make an aerosol that users inhale into their lungs—without relapsing back to cigarette smoking.
Published in the Oct. 19, 2021 online issue of JAMA Network Open, an analysis by the Herbert Wertheim School of Public Health and Human Longevity Science at University of California San Diego and UC San Diego Moores Cancer Center reports that e-cigarette use—even on a daily basis—did not help smokers successfully stay off cigarettes.
“Our findings suggest that individuals who quit smoking and switched to e-cigarettes or other tobacco products actually increased their risk of a relapse back to smoking over the next year by 8.5 percentage points compared to those who quit using all tobacco products,” said first author John P. Pierce, Ph.D., Distinguished Professor at the Herbert Wertheim School of Public Health and UC San Diego Moores Cancer Center.
“Quitting is the most important thing a smoker can do to improve their health, but the evidence indicates that switching to e-cigarettes made it less likely, not more likely, to stay off of cigarettes.”
Researchers used data from the nationally representative Population Assessment of Tobacco and Health (PATH) longitudinal study, undertaken by the National Institute on Drug Abuse (NIDA) and the FDA Center for Tobacco Products under contract with Westat. The team identified 13,604 smokers between in 2013 and 2015 who were followed over two sequential annual surveys to explore changes in use of 12 tobacco products.
At the first annual follow up, 9.4% of these established smokers had quit. Now considered “former smokers,” 62.9% of these individuals remained tobacco free, while 37.1% had switched to another form of tobacco use. Of these recent smokers who switched to another product, 22.8% used e-cigarettes, with 17.6% of switchers using e-cigarettes daily.
Recent former smokers who switched to e-cigarettes were more likely to be non-Hispanic white, have higher incomes, have higher tobacco dependence scores and view e-cigarettes as less harmful than traditional cigarettes.
“Our goal in this study was to assess whether recent former smokers who had switched to e-cigarettes or another tobacco product were less likely to relapse to cigarette smoking compared to those who remained tobacco free,” said senior author Karen Messer, Ph.D., professor and chief of the Division of Biostatistics at the Herbert Wertheim School of Public Health.
At the second annual follow up, the authors compared the former smokers who were tobacco free to those who had switched to e-cigarettes or other tobacco products. Individuals who switched to any other form of tobacco use, including e-cigarettes, were more likely to relapse compared to former smokers who had quit all tobacco, by a total of 8.5 percentage points.
Among recent former smokers who abstained from all tobacco products, 50% were 12 or more months off cigarettes at the second follow up and were considered to have successfully quit smoking; this compared to 41.5% of recent former smokers who switched to any other form of tobacco use, including e-cigarettes.
While individuals who switched were more likely to relapse to smoking, they were also more likely to attempt to quit again and be off cigarettes for at least three months at the second follow up. A further follow-up survey is needed to identify whether this is evidence of a pattern of chronic quitting and relapsing to cigarette smoking, or whether it is part of progress toward successful quitting, said the researchers.
“This is the first study to take a deep look at whether switching to a less harmful nicotine source can be maintained over time without relapsing to cigarette smoking,” said Pierce. “If switching to e-cigarettes was a viable way to quit cigarette smoking, then those who switched to e-cigarettes should have much lower relapse rates to cigarette smoking. We found no evidence of this.”
Co-authors include: Ruifeng Chen, Sheila Kealey, Eric C. Leas, Martha M. White, Matthew D. Stone, Sara B. McMenamin, Dennis R. Trinidad, David R. Strong and Tarik Benmarhnia, all of UC San Diego.
This research was funded, in part, by the National Institutes of Health (1R01CA234539) and the Tobacco-Related Disease Research Program of the University of California Office of the President (28IR-0066).
Disclosures: The authors report no conflicts of interest.
Full study available after embargo at: http://jamanetwork.com/journals/jamanetworkopen/fullarticle/10.1001/jamanetworkopen.2021.28810?utm_source=For_The_Media&utm_medium=referral&utm_campaign=ftm_links&utm_term=101921
Here are the key points (from the paper):
Question: Does switching to e-cigarettes prevent former cigarette smokers from relapsing to cigarettes?
Findings: In a US-representative sample, 9.4% of smokers became recent former smokers one year later. While 22.8% reported switching to e-cigarettes, 17.6% reported daily e-cigarette use. Switching to any tobacco product including e-cigarettes was associated with an 8.5% increase in relapse to smoking over the next year. This increase in relapse was similar to that seen in those who switched to other tobacco products.
Meaning: Switching to e-cigarettes has not prevented relapse to cigarette smoking in the US smokers.
Here is the abstract:
Importance: Although e-cigarettes are not approved as a cessation device, many smokers believe that e-cigarettes will help them quit cigarette smoking successfully.
Objective: To assess whether recent former smokers who had switched to e-cigarettes or another tobacco product were less likely to relapse to cigarette smoking compared to those who remained tobacco free.
Design: We analyzed 4 Waves of the Population Assessment of Tobacco and Health Study (2013-2017), combining 2 independent cohorts each with 3 annual surveys: Cohort 1: W1-W3; Cohort 2: W2-W4.
Setting: Nationally representative in-household annual surveys.
Participants: Current established smokers at Baseline (n=13,604) who were recent former smokers at Follow-up 1 and who completed Follow-up 2 (n=1228).
Exposure: Use of e-cigarettes or alternate tobacco product assessed at Follow-up 1 when a recent former smoker.
Main Outcome(s) and Measure(s): 12+months abstinence by Follow-up 2.
Results: At Follow-up 1, 9.4% (95% CI: 8.7%, 10.0%) of previous-year smokers were recent former smokers (mean age 41.9 years, 43.2% females) Of these, 22.8% (95% CI: 19.7%, 26.0%) had switched to e-cigarettes with 17.6% (14.8%, 20.5%) using them daily. A total of 37.1% (95% CI: 33.7%, 40.4%) used a non-cigarette tobacco product and 62.9% (95% CI: 59.6%, 66.3%) were tobacco free. Switching to e-cigarettes was highest (31.3%) for those who were in the top tertile of tobacco dependence, were Non-Hispanic White (26.4%), and had higher incomes (27.5%). At Follow-up 2, unadjusted relapse rates were similar among those who switched to different tobacco products (41.5% successfully quit, 17.0% relapsed with significant re-quit, and 36.2% current smokers).. Controlled for potential confounders, switching to any tobacco product was associated with higher relapse rate than being tobacco free (adjusted Risk Difference (aRD)=8.5%, [95% CI: 0.3%-16.6%]). Estimates were similar for those who switched to e-cigarettes, whether daily or not, although confidence intervals crossed zero. While switchers were more likely to relapse, they appeared more likely to make a requit and be abstinent for 3 months at Follow-up 2.
Conclusions and Relevance: This large US nationally representative study does not support the hypothesis that switching to e-cigarettes will prevent relapse to cigarette smoking.
The full citation for the paper is Pierce JP, Chen R, Kealey S, Leas EC, White MM, Stone MD, McMenamin SB, Trinidad DR, Strong DR, Benmarhnia T, Messer K. Incidence of Cigarette Smoking Relapse Among Individuals Who Switched to e-Cigarettes or Other Tobacco Products. JAMA Netw Open. 2021 Oct 1;4(10):e2128810. doi: 10.1001/jamanetworkopen.2021.28810. PMID: 34665239. It is available for free here,