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March 2003 OTC NRT Meta-Analysis
Finds 93% Midyear
Relapse Rate

by John R. Polito, March 5, 2003

Link to full text copy of OTC NRT Meta-Analysis

Link to online exchange with the study's authors

A September 2002 a "real-world" quitting survey published in the Journal of the American Medical Association boldly declares that NRT appears no longer effective in increasing long-term successful cessation in California smokers.  A November 2002 quitting survey found that NRT benefits provided under Minnesota's two largest health insurance plans did not result in higher quit smoking rates. [also see a March 2005 Maryland survey which found that NRT quitters were less likely to succeed than those quitting on their own].

Now, a March 2003 study combines the results of almost all over-the-counter (OTC) nicotine replacement therapy (NRT) studies conducted to date and declares that the odds ratio (OR) of quitting for six months while using OTC NRT as part of a medical study was just seven (7%) percent.  Yes, even for those involved in the actual OTC medical studies themselves, studies that sought to prove the worth of quitting by gradual nicotine weaning while using a clean delivery device, the odds of relapse by midyear were 93%

Entitled "A meta-analysis of the efficacy of over-the-counter nicotine replacement," the study was published in the March, 2003 edition of the journal of Tobacco Control at pages 21 to 27.  If you think there may have been some kind of negative NRT bias involved, forget it.  The study's primary author was Dr. John R. Hughes, a paid consultant to GlaxoSmithKline, the maker of Nicorette, Nicoderm CQ, and NiQuitin CQ, and also a consultant to Pharmacia, the maker of Nicotrol.  The study's secondary author was Dr. Saul Shiffman who is also a paid consultant to GlaxoSmithKline.

One of the eight OTC studies reviewed by Dr. Hughes and Dr. Shiffman was the Korberly nicotine patch study presented at the March 1999 SNRT (Society for Research on Nicotine and Tobacco) conference in New Orleans.  In the Koberly study only 1 out of 149 OTC nicotine patch users was still not smoking at the six month mark.  That's less than one percent (0.67 out of 100).

Dr. Hughes and Dr. Shiffman also cite the Hays OTC patch study that was published in 1999 in the American Journal of Public Health. In it only 18 of 326 nicotine patch users - just 5.6 percent - were still not smoking at six months.

As for bias, Table 4 of the study included a prescription nicotine patch study whose primary author was Dr. Shiffman himself. Although not used to compute the overall OTC NRT performance rating, it's noteworthy in that only 8 of 269 Rx nicotine patch users - 2.97 percent - were still not smoking at six months.

In all, seven different OTC NRT trials were combined by Dr. Hughes and Shiffman using a random effects model.  The mean six month quit smoking rate was only seven (7%) percent.

Dr. Hughes and Shiffman do their academic best within the article to try and convince those making worldwide smoking cessation policy that after 20 years of NRT research - research that consumed the lion's share of all cessation research dollars - a 93% midyear relapse rate demonstrates an "effective" means for smokers to quit.

Will smokers continue to spend their hard earned dollars - and more importantly those limited and priceless periods of confidence where they muster sufficient courage to make yet another mad dash for freedom - on expensive gradual nicotine weaning products, or will they at last begin to explore, in search of more effective means of quitting?

What Hughes, Shiffman and almost all other NRT researchers continue to refuse to study is the amazing performance of pre-NRT abrupt nicotine cessation programs that combined varying forms of education, skills development, counseling, group support and long term reinforcement follow-up while achieving midyear rates of 30%, 40% and in a few cases even 50%.

Maybe NRT researchers can be forgiven for not taking the time to search-out and study the world's finest programs before embarking upon their gradual nicotine weaning magic bullet quest, but how could they ignore the amazing performance of many of the placebo groups within their own published NRT studies.  How could they fail to notice that the NRT studies in which the abrupt cessation placebo group excelled were often caked in layers and layers of education, skills development, counseling, group support and reinforcement protocols?

It was not unusual to see large percentages of "real" nicotine-free quitters actually standing on their own two feet late into many of the NRT studies.  Why did NRT researchers remain silent as hundreds of millions in NRT marketing were spent in an attempt to undermine the credibility of abrupt nicotine cessation quitting in the minds of smokers? What impact has years of cold turkey bashing had on national cessation rates?

Why do tobacco control policymakers and researchers independent of pharmaceutical interests remain silent as Hughes and Shiffman push 7% at six months, when 21% of the cold turkey quitters (the placebo group) in the 1994 Fiore NRT study remained nicotine free at six months, 22% in the 1995 Herrera study were free at one year, and when 37% in the 1988 Areechon study, 43% in the 1987 Hall study, and 45% in the 1982 Fagerströöm study were all still standing tall at six months? Profits? At what cost in terms of lives?

If the NRT study industry's above figures are accurate then Hughes and Shiffman are arguing that we should continue spending billions on NRT's 7% midyear performance promise instead of refining, developing, deploying and encouraging the use of proven tools that we know can deliver at least a 600% greater chance of midyear freedom.

Keep in mind that actual rates are likely lower than 7% at midyear as: (1) all study participants received free NRT products while "real-world" quitters must pay from their own pockets; (2) the average study involved the indirect motivational support associated with an average of 5.9 "visits," during which participants interacted with researchers to varying degrees; and, (3) the 7% midyear rate counts those still hooked on receiving nicotine from NRT products at six months as having successfully quit.  In other words, all NRT studies to date have measured smoking cessation and not nicotine cessation.

Friends, this is not some game.  Those we love are buying into NRT's slick sales pitch and relapsing at shameful rates.  How many of the 4.9 million tobacco graves filled during 2002 should still be empty?  Picture 40 U.S. cities of 100,000 inhabitants being emptied every year.  It's time to speak up!

We don't have to be NRT researchers to take our own poll of all quitters who we know have been off of all nicotine for over one year.  How did they do it?  We listened to those marketing NRT for over two decades.  Isn't it time to listen and trust in the evidence around us and believe the feedback we hear and see? Tobacco companies now openly admit that nicotine is addictive. If true, why no addiction warnings by those pushing replacement nicotine?

All pharmaceutical grade nicotine comes from tobacco plants. Its use is not therapy and it is not medicine. It is a powerful natural insecticide which has no business inside the human brain. Isn't it time for responsible health policymakers to dig deeper and begin asking the obvious questions?

I, John R. Polito, am 100% solely responsible for the content of this article and assume full responsibility for its Internet publication.  It had not been reviewed by any other person prior its Internet publication on March 5, 2003, nor had any other person had any input upon its content.  The views expressed are my own, in my individual capacity, as a concerned nicotine cessation and control advocate.

John R. Polito
Nicotine Cessation Educator

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