1. Re: Re: OTC NRT 93% Midyear Relapse Rate

    The authors concede that programs offering cessation education, skills development, counseling and/or group support "on average" produce quit rates more than double (15%) their meta-analysis OTC NRT finding of 7% at midyear. Although most of us are aware of at least one short term abrupt cessation program consistently achieving midyear rates in the 30 to 50% range, I thought that confronting the authors with midyear placebo group performance rates of 37%, 43% 45%, from their own NRT studies, would cause them to reflect upon just how ineffective OTC NRT really is. I was wrong. Instead, they ignore placebo performance when clothed in behavioral protocols while telling us that 30 to 50% "vastly overstates" behavioral intervention's realities.

    Assume for the sake of argument that there are scores of abrupt cessation programs around the globe that are today consistently achieving midyear rates in the 30 to 50% range. Further assume that those conducting them are willing to share their content, allow us to borrow their most effective elements, and that we can combine, refine, present and consistently produce 30 to 50% midyear nicotine cessation using a laptop, PowerPoint and a scripted presentation. Would the current 5% behavioral program attendance rate cited by the authors be the best we should hope for when the product being offered is at least 428% as effective as OTC NRT?

    The authors conclude that the vast majority of smokers [do] not want and will not use behavioral treatment. I encourage readers to visit the "how to quit smoking" pages of government web sites or of those health organizations that you know are receiving large annual NRT pharmaceutical industry contributions. I submit that smokers cannot want or even be curious about interventions or effectiveness ratings that are intentionally hidden from view. I submit that if NRT commercials were up- front in disclosing OTC NRT's 93% midyear relapse rate that sales would decline dramatically, and quitters would immediately begin searching for more effective tools.

    Remember when NRT didn't have 5% participation? Imagine the potential of a government-sponsored cessation marketing campaign that could honestly declare that a short twelve-hour behavioral program was affording those in attendance a 428% greater chance of quitting than OTC NRT products requiring weeks or even months of dedicated use. Could participation increase to 20%? Imagine teaming up with local businesses and health care providers to offer donated attendance incentives such as free temporary fitness center passes, pulmonary function exams, cardiovascular exams, or tickets to local health related attractions.

    Forget about the possibilities for now. Accepting the authors' 15% behavioral program efficacy concession, in what T.V. commercial are those pushing the concept of gradual nicotine weaning telling smokers that their neighborhood abrupt cessation programs are, on average, twice as effective as OTC NRT? Instead, they condition viewers to believe that attempting cessation without OTC NRT doubles their chances of relapse.

    The authors argue that behavioral programs are more expensive than NRT. I just visited where an eight-week supply of Nicoderm CQ was $192 (U.S.) and Nicotrol was $200. Twenty-four patch quitters would spend $4,608 on patches while producing just 1.7 midyear quitters, at a cost of $2,711 per successful quitter. The same funds spent on a twelve-hour behavioral clinic generating a 30% midyear rate would produce 7.2 success stories, at a cost of $640 per quitter.

    My next free two-week clinic commences on the 25th at the College of Charleston. As usual, there is no pay, and I, along with scores of other skilled facilitators, would gladly fly anywhere in the world for the opportunity to help smokers break free while at the same time being compensated at a rate less than what it costs to produce a single midyear NRT quitter $2,711).

    I know that many researchers have devoted substantial portions of their lives to the development of NRT only to end up, here, acknowledging a 93% midyear relapse rate. This isn't a good day for any of us. I apologize if any researcher feels their integrity is being impugned by my continuing to seek answers to such questions as the extent of the practice of placebo nicotine doctoring. But in that the authors declare odds ratio victories over placebos known to have been doctored, and both authors are paid consultants for NRT pharmaceutical companies and clearly have access to those who provided placebo devices for most NRT studies, I must again ask, how many OTC NRT studies employed placebo nicotine doctoring, what amounts of nicotine were used in each study's placebo device, and what studies were undertaken to verify that the practice does not extend the intensity and/or duration of normal abrupt cessation?

    Dr. Pierce's NRT survey published in JAMA on September 11, 2002 concluded that "NRT appears no longer effective in increasing long-term successful cessation in California smokers." In November 2002, Dr. Boyle's Minnesota insurance benefit review published in Health Affairs concluded that the use of NRT did not ....."result in higher rates of quitting smoking." Is it just possible that out in the "real world" where surveyed smokers know whether or not they successfully quit last year, where they have their own understanding of what it means to be quit, and where they know whether or not they bought and used OTC NRT, that NRT truly is showing zero value as a cessation tool?

    Is it just possible that the study practice of "declaring" someone still receiving a steady diet of nicotine from the NRT device, as having already successfully "quit," allowed NRT a natural short-term advantage when competing against "real" nicotine quitters, that just doesn't get acknowledged by those being surveyed in the real-world?

    Have you ever stopped to reflect upon how the odds ratios in the 2002 lozenge studies would have turned out if abstinence was defined to commence upon the cessation of all nicotine intake? It's amazing how one simple study definition - cessation - can create billions worth of efficacy. Imagine such definitions being used with alcohol replacement therapy (ART) where you know you're drunk but the researchers keep telling you that you've already quit.

    John R. Polito

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  2. Re: OTC NRT 93% Midyear Relapse Rate

    Over-the-counter nicotine replacement: Rhetoric vs. Reality

    Mr. Polito has criticized our recent meta-analysis of over-the- counter (OTC) nicotine replacement (NRT) that appeared in Tobacco Control (Vol 12, p 21). Our brief response is below. Readers wishing to respond to us or obtain citations for our assertions can email or ).

    The major assumption of Mr Polito’s comments appears to be that tobacco control is better off sticking solely with intensive behavioral therapy programs. Both of us helped develop such programs and agree that they can produce higher quit rates than OTC NRT. (Though Mr. Polito vastly overstates their efficacy: For example, he USPHS and Cochrane meta -analyses of such programs report a quit rate of about 15% - not the 50% cited by Mr. Polito.) Indeed, the highest rates of success are obtained when smokers combine both behavioral and pharmacological treatment.

    The problem is that the vast majority of smokers does not want and will not use intensive behavioral treatment. Many surveys have shown that among smokers who try to quit, less than 5% of smokers will attend these programs. We, like Mr. Polito, would prefer that smokers get all the treatment they can, including behavioral treatment, but have come to recognize that smokers do not use intensive behavioral treatment, even in the developed countries, where it can be made available. In addition, these programs are costly, which will limit their feasibility in developing nations.

    Thus, we believe a less effective treatment used by more smokers would do more good than a more effective treatment used by fewer smokers. For example, in the US, among 1000 smokers trying to quit, about 200 will use OTC NRT, resulting in about 14 quitters. However, at most 50 will use behavior therapy, resulting in 7 quitters. In summary, we believe it is irresponsible to hold out, as a sole remedy, a treatment that only 5% of smokers will use and assume that this fulfills responsibility to help smokers who want to quit.

    Finally, we would point out that making OTC NRT available does not mean one should give up on group behavioral therapy. It simply gives smokers another option for dealing with life-threatening tobacco use.

    Some other errors in Mr. Polito’s statements:

    Neither of us has suggested that now that we have OTC we do not need "to explore more effective means of quitting." In fact we have authored articles urging the development of better behavioral techniques and critical of the current state of affairs.

    Both our own audits and those of the National Cancer Institute indicate NRT research does not "consume the lions share of all cessation research dollars;" For example, we estimate less than 10% of US National Institutes of Health funding for smoking cessation research goes to testing NRT.

    NRT ads are said to "bash… quitting via self-reliance," to convey that self-quitting is "hard and painful," that quitting with NRT is "painless" and that OTC NRT is "highly effective." In fact, our view is that the ads have emphasized the realistic difficulty and discomfort of quitting without overstating the relief provided by NRT, and have emphasized the importance of the smoker’s efforts in the quit process; .e.g, “only for those committed to quitting,” and “You can do it – Nicorette can help”

    Mr. Polito also questions whether it has been getting harder to quit. Interested parties may want to review two recent meta-analyses by Irvin and colleagues, which show that success rates have been dropping, for both behavioral and pharmacological treatments. Many students of this issue believe that, as smokers who can quit easily do quit, the smokers remaining are those who have the hardest time achieving success.

    Finally, we would note our response above does not a) use comparisons across studies differing in methods, timing, etc., which are notoriously misleading b) impugn the motives of the author or c) use ridicule or sarcasm.

    John Hughes and Saul Shiffman

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  3. OTC NRT 93% Midyear Relapse Rate

    Dr. Hughes and Shiffman do their academic best to try and convince those making worldwide cessation policy decisions that, after 20 years of NRT 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. Rubbish! It's a sad day indeed when NRT researchers celebrate a 93% failure rate by declaring odds ratio victories over nicotine doctored placebos. 1

    Does anyone truly think it's harder to quit today than it was twenty years ago or have those marketing NRT simply conditioned smokers into believing it is? Why have NRT researchers remained silent as millions upon millions was spent in an attempt to undermine the credibility of cold turkey (abrupt cessation) quitting in the minds of smokers? Is it possible that years of bashing self-reliance has had a negative impact upon cessation expectations?

    What Dr. Hughes, Dr. Shiffman and most other NRT researchers continue to refuse to study is the amazing performance of pre-NRT abrupt 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 even 50%. Are smokers needlessly dying because pharmaceutical companies won't profit from behavioral programs? Have we spent 90% of our research dollars on 10% of the problem - chemical dependency?

    Maybe NRT researchers can be forgiven for not taking the time to 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 studies in which the placebo group excelled were often caked in layers and layers of education, skills development, counseling, group support and reinforcement protocols?

    How can Dr. Hughes and Dr. Shiffman sell 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 Fagerström study were all still standing tall at six months?

    Should we continue to keep OTC NRT on center stage and continue to neglect research into refining, developing, deploying and encouraging the use of proven behavioral programs that we know are capable of delivering at least a 600% greater chance of midyear freedom?

    We don't have to be NRT experts 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? Isn't it time to listen and trust in the long term cessation evidence surrounding each of us?

    John R. Polito

    1. Sanderskov J, Olsen J, Sabroe S, et al. Nicotine patches in smoking cessation, a randomized trial among over-the-counter customers in Denmark. Am J Epidemiol 1997; 145: 309-18, at 312 "...placebo patches contained a pharmacologically negligible amount of nicotine."

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