A new study by Swedish epidemiologists asserts that their Markov model shows that providing smokers with free government-subsidized nicotine replacement therapy (NRT) would likely be cost-effective to both the government, as payer, and to society.

Published on June 27, 2023 in Nicotine & Tobacco Research, there’s just one rather glaring concern. The foundation of their analysis rests upon the conclusion that the use of NRT increases the likelihood of successfully quitting smoking by 55% when data from nearly all population-level effectiveness findings suggest that NRT is ineffective.

Entitled “Should nicotine replacement therapy be provided free of charge? A cost-utility analysis in Sweden,” the paper’s foundation conclusion regarding NRT’s benefit is derived by multiplying an NRT versus placebo risk ratio clinical trial meta-analysis efficacy finding of 1.55, by a Swedish survey effectiveness estimate that 7.7% of unaided quitters successfully quit. The authors declare that the result (11.9) reflects 4.2% “absolute effectiveness” of NRT over “current practice.”

According to the authors, they resorted to comparing NRT clinical efficacy to real-world unaided effectiveness because they “did not find effectiveness studies that compared treatment with NRT to the current Swedish practice...”

Let that soak in for a minute. Researchers are recommending that government pay for free replacement nicotine for all smokers without direct evidence of population-level effectiveness.

Sweden aside, worldwide, scores of studies have documented real-world quitting method productivity and effectiveness. What's missing is that, as yet, no researcher has collected, pooled, published, and established an effectiveness evidence base.

Most smokers have a finite number of priceless periods of cessation confidence before bad news strikes. Here’s a sampling of data and findings suggesting that the tease of free replacement nicotine could actually undermine the smoker's ability to break inhaled nicotine's grip upon them, ultimately costing them their life:

2002 JAMA: "Conclusion: Since becoming available over the counter, NRT appears no longer effective in increasing long-term successful cessation in California smokers."

2006 NCI: A National Cancer Institute study examined 8,200 quitters and found that at 9 months those quitting without use of approved products had a slightly higher rate of success than those using the nicotine gum, patch, lozenge or Zyban.

2006 Addictive Behaviors: Australian family practice patient data indicated that 88% had quit cold turkey and that it was roughly twice as effective as NRT.

2014 Mayo Clinic Proceedings: A prospective population-level study found that "Compared with smokers using none of the cessation aids" at 6-month follow-up ... "use of NRT bought over the counter was associated with a lower odds of abstinence (odds ratio, 0.68; 95% CI, 0.49-0.94)."

2017 JNCI: Among 2,129 TUS-CPS (survey) quitters, “there was no evidence that use of varenicline … bupropion … or nicotine replacement … increased the probability of 30 days or more smoking abstinence at one-year follow-up.”

According to the authors, “The lack of effectiveness of pharmaceutical aids in increasing long-term cessation in population samples is not an artifact caused by confounded analyses. A possible explanation is that counseling and support interventions provided in efficacy trials are rarely delivered in the general population.”

2018 PLoS One: Table 7 data from this prospective population-based study indicates that quitting smoking cold turkey was 3.3 times more effective than NRT.

2019 Addiction: England Smoking Toolkit Study compared 8,348 unassisted quitters to 5,206 OTC NRT quitters and found an unadjusted smoking abstinence rate of 16.8% for unassisted and 11.6% for NRT.

2020 PLoS One: Table 1 data from a PATH survey involving 2,443 US smokers who reported a quit attempt at annual follow-up indicates that smokers quitting without the use of any pharmaceutical aid were 24% more likely to be abstinent from all forms of tobacco after 12 months, including e-cigs, than those using FDA-approved quitting products.

2022 Addictive Behaviors: Among 1,045 adult smokers in England who provided data at baseline and reported a serious past-year quitting attempt at 12-month follow-up, the study's raw data indicates that quitting without use of any quitting aid was 43 percent more likely to succeed than use of over-the-counter NRT (odds ratio, 0.57, 95% CI, 0.39–0.84) and 40 percent more likely than prescription NRT (odds ratio, 0.60; 95% CI, 0.37–0.98).

2022 Preventive Medicine Reports: Table 2 data indicates that among 2,783 French quitters, unassisted quitters were 27% more likely than NRT quitters to have successfully quit smoking for 6 months, were 38% more likely to succeed for a year, and 43% more likely to quit for 2 years.

2023 BMC Pregnancy and Childbirth: Among 3,154 women smoking at conception, 1,414 self-reported being smoking abstinent during late pregnancy. Among them, 64.8% who quit cold turkey reported not smoking during the final 3 months of pregnancy, roughly twice the effectiveness of women who turned to vaping e-cigarettes (31.3%) or for a pooled group of all remaining quitting methods, including NRT and prescription medications (35.7%).

As noted by the authors, "Our findings highlight the opportunity for presenting the positive message about unassisted cessation as the most common and successful quitting method to pregnant smokers who are ready to try to quit."

That raises the most egregious smoking cessation research neglect issue of all. If observational studies consistently evidence that the vast majority who fully arrest their chemical dependence upon nicotine do so by going cold turkey, what is the key or keys to successful abrupt nicotine cessation and could they have been discovered and easily, cheaply, and widely shared long, long ago?

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John R. Polito received his JD from the University of South Carolina School of Law in 1985, where he graduated Wig & Robe. He is a former 3-pack-a-day thirty-year smoker and the 1999 founder of WhyQuit. A nicotine cessation educator since 2000, John mentored under Joel Spitzer for two decades, presenting more than 100 live nicotine dependency recovery programs modeled after Joel's programs. He is the author of "Freedom from Nicotine - The Journey Home," "Smart Turkey," 6 peer-reviewed journal articles, and founder and director of Turkeyville, a 17,000-member Facebook support group exclusively for cold turkey quitters. Email: johnpolito54@gmail.com

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