Who should smokers believe when it comes to choosing the best way to stop smoking? Real-world experience or nicotine replacement therapy (NRT) industry claims? The industry says that NRT "doubles your chances," based on results from studies that were placebo-controlled and allegedly double-blind. Real-world evidence continues to mount that billions of dollars is being made selling NRT products that offer no advantage over quitting without them. The latest news from Quebec is another case in point.

A September 2002 review of California quitter survey data concluded that "NRT appears no longer effective in increasing long-term successful cessation in California smokers." Published in the Journal of the American Medical Association, the California finding was soon reinforced by real-world survey data from Minnesota (November 2002) and London (June 2003). Now, data from a Canadian quitting contest, published in the May 2004 edition of Preventive Medicine, joins the rising chorus.

THE QUEBEC CONTEST

A flood of "Quebec 2000 Quit and Win" contest marketing attracted 20,400 smokers. Quebec 2000 Quit and Win participants completing the six-week contest had the added incentive of competing for cash awards, trips and gift certificates. Each participant was allowed to select his or her own method of quitting and required to partner-up with a non-smoker who was to provide on-going social support. The sampling of results proved the combination to be extremely effective.

At six weeks, 65% of cold turkey quitters were still not smoking compared to 64% of nicotine gum and patch users. At the six month mark, 34% of cold turkey quitters and 34% of nicotine gum users and patch users were still smoke-free. Again, cold turkey performed as well as NRT.

As in the California, Minnesota, and London surveys, the NRT industry's cornerstone marketing assertion that it "doubles a quitter's chances" proved false. What the Quebec experiment may evidence is that adding economic incentive and social support to any cessation method can quadruple the six-month odds of quitting. It also found that bupropion users (Zyban and Wellbutrin) performed best at 43%.

WHAT'S WRONG WITH THE INDUSTRY STUDIES?

Unlike lab-based, formal studies, smoker quitting surveys like Quebec allow experts to make head-to-head performance comparisons between those who decide to abruptly end all nicotine use (quitting cold turkey) and those who desire to continue receiving nicotine via a growing assortment of nicotine replacement products.

In lab-based NRT studies participants often sign up because they want the products; they have a 50% chance of not being assigned to the placebo group, thus receiving weeks or even months of free nicotine.

A key element for a valid double-blind study is that participants cannot tell whether they are getting the drug or a placebo. Blinding surveys conducted during formal NRT studies suggest that a substantial percentage of smokers may have been able to sense that they were no longer receiving nicotine.

In a Denmark patch study published in the February 1997 edition of the American Journal of Epidemiology, at study's end only 18.3% of those in the placebo patch group believed that they had received the real nicotine patch. The authors openly admit that "the effect of such a blinding failure would probably be a reduction of the placebo effect."

If people sign up for formal NRT studies because they want the free product, and they are able to tell that they are not getting it, could their frustrated expectations have caused a significant percentage of placebo group quitters to throw in the towel early, thus providing the industry with its ballyhooed "twice as effective" odds ratio victory?

In light of the real-world comparisons of people who choose cold turkey versus people who choose NRT, it's a question worth considering.

CONCLUSION

According to the American Cancer Society's 2003 Cancer Facts & Figures report, 91.2% of all successful long-term quitters quit entirely on their own without using any product, service, or produce. If true, it would seem that cold turkey quitting is alive and well despite a twenty year bashing by NRT marketing that refuses to acknowledge "real-world" performance.

Meanwhile, NRT marketing continues to suggest that only superheros are capable of quitting cold and that NRT doubles a quitter's chances. The FDA is apparently ignoring actual product performance -- the real world data -- in allowing such claims to continue.

Fact References:

1. Pierce, JP, et al., Impact of Over-the-Counter Sales on Effectiveness of Pharmaceutical Aids for Smoking Cessation. Journal of the American Medical Association, September 11, 2002;288:1260-1264 - link to free full text in PDF format: http://www.fchn.org/fmh/wmchh/articles/sept/otc_smk_cess_aids.pdf

2. Boyle, RG, et al, Does insurance coverage for drug therapy affect smoking cessation? Health Affairs 2002 Nov-Dec;21:162-8 - link to study abstract: https://whyquit.com/studies/2002_Boyle_Insurance_Drug_Cessation.pdf

3. SmokeFree London, Tobacco in London - Facts and Issues, June 2003, Figure 14, PDF page 17 - link to report in PDF format: Original link: http://www.lho.org.uk/HIL/Lifestyle_and_Behaviour/Attachments/PDF_Files/SmFeeFactsIssues.pdf

4. Gomez-Zamudio, M, et al, Role of pharmacological aids and social supports in smoking cessation associated with Quebec's 2000 Quit and Win campaign, Preventive Medicine 2004 May;38(5):662-7 - link to study abstract: http://www.ncbi.nlm.nih.gov/pubmed/15066370

5. Sonderskov J, et al. Nicotine patches in smoking cessation: a randomized trial among over-the-counter customers in Denmark. American Journal of Epidemiology 1997 February;145: 309 to 318 - link to study abstract: http://www.ncbi.nlm.nih.gov/pubmed/9054234

6. American Cancer Society, Cancer Facts and Figures 2003, Table 3, report page 25, PDF page 27 - link to report in PDF format: https://whyquit.com/studies/2003_ACS_Cancer_Facts.pdf

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