More Productive and Effective Than
Nicotine Replacement Therapy?
Written July 18, 2003, updated August 28, 2009
In 1987, free cold turkey quitting spent zero dollars on marketing while producing 88.7% of all successful ex-smokers (see, Table 6, .PDF pg. 27 of 1987 U.S. Health Survey). The Nicotine Replacement Therapy (NRT) industry knew then that billions in profits were possible if it could only find a way to destroy the perceived credibility of quitting on your own.
For almost two decades the NRT industry blasted cold turkey quitting at every opportunity, while using its economic muscle to erase abrupt nicotine cessation quitting recommendations around the globe. Although the industry made billions, but when it came to quitting, recovered nicotine addicts were a bit smarter than the burning plant-matter between their lips made them appear.
According to the American Cancer Society (ACS), 91.2% of all successful long-term quitters are quitting entirely on their own. Let me say that again, 91.2% of successful quitters did not purchase or use the nicotine patch, Zyban, nicotine gum, Wellbutrin, the nicotine lozenge, hypnosis, the nicotine spray , acupuncture, nicotine inhalers, magic herbs, laser therapy, or attend any formal quit smoking program. They did it entirely on their own! 1
But don't trust the ACS's 2003 Cancer Facts & Figures report indicating that cold turkey is by far the most productive form of quitting on earth, or a May 2006 Australian study that followed smoking patients of 1,000 family practice physicians and found that successful cold turkey quitters accounted for 1,942 of 2,207 former smokers, a whopping 88% of all success stories. Instead take your own poll of all those who’ve been off of all nicotine for at least a year. 1 Believe your own ears. How did they do it? Shouldn't we be teaching their method, lessons and secrets to smokers?
Contrast the fact that 91.2% of successful long term quitters quit on their own, with the fact that 93% of nicotine patch and gum users relapse to smoking within six months. 2 The few who do manage to break free while toying with pharmaceutical grade nicotine don't do so because of it. They do so in spite of it.
Yes, I am obviously comparing a productivity rate to an effectiveness rate but shouldn't both factors cause pause and reflection upon the math behind deadly insanity that elevates an unproductive and ineffective means of cessation above the method responsible for producing almost all ex-smokers?
Health advocates have unwittingly assisted the pharmaceutical industry in undermining the credibility of earth's most productive quitting technique and in suppressing life-saving information on how to take the sting out of quitting cold. Most are honest and dedicated health professionals who were duped by profit driven agendas and misled by sham research which pretends that NRT studies were blind, that nicotine addicts with lengthy quitting histories will not quickly notice the presence or absence of full-blown withdrawal. . They wanted to believe in the marketing and hype of clean-nicotine weaning just as badly as those of us hooked.
The difference is that millions of us did believe in NRT's promises while repeatedly relapsing. Millions of us did so over and over and over again, until feeding our brain's chemical addiction permanently damaged, impaired or destroyed our bodies.
Hundreds of millions have been spent conditioning smokers to believe that NRT doubles their chances of quitting. The theme has generated billions in NRT profits. The "double your chances" slogan is the cornerstone of NRT marketing around the globe. But it's a stone that's gradually crumbling under the weight of new studies, study reviews, surveys and researcher admissions. Today, some of us are convinced that this two decade era of cessation pharmacology research will eventually be recognized by historians as the most widespread and deadly instance of clinical trial study fraud in research history. Let's look at one glaring 2003 example of conflicting cold turkey efficacy assertions.
In July 2003 GlaxoSmithKline's (GSK) Australia website was engaged in marketing NicabateCQ. 3 There you would have seen the attached graph, indicating what looks like a bit less than 10% of cold turkey quitters still not smoking at six-months. You would have read GSK's assertion that "in one study over 90% of cold turkey quitters were smoking again after six-months."
Contrast GSK's 10% cold turkey six-month quitting-rate acknowledgment to the March 2003 meta-analysis which combined and averaged all seven OTC NRT studies and found that only 7% of patch and gum users were still not smoking at six months. 3
Cold turkey 10% vs. NRT 7% at six months? Could it be that GSK had not yet then seen or heard about the March 2003 seven (7%) percent finding?
The two primary authors of the March 2003 OTC NRT meta-analysis were John Hughes and Saul Shiffman. The study's financial disclosure states that "Dr. Hughes has received speaking and consulting fees and grants from Glaxo-SmithKline and Pharmacia, both of whom market nicotine replacement products [and] ... Dr Shiffman serves as a consultant to GlaxoSmithKline Consumer Healthcare (GSKCH) on an exclusive basis regarding matters relating to smoking cessation." 3 How could GSK not know?
Could the title to this article be accurate? Are an unschooled, unskilled and unassisted cold turkey quitter's natural abilities to quit on their own, higher than those purchasing and using expensive nicotine weaning products? U.S. government historical placebo and control group performance data supports GSK's 10% midyear "cold turkey" quitting figure as being accurate. 4
A review of placebo and control group performance rates from 210 study arms presented in "Evidence Tables" of the U.S. Clinical Practice Guideline (June 2000)produces an average six-month placebo/control group rate of 11.53% 5 . Keep in mind that the U.S. Guideline’s "Evidence Tables" were compiled by a panel of experts on which 11 of 18 members disclosed prior financial ties to the NRT industry. 6
In that on July 15, 2003, GSK’s own website openly acknowledged that cold turkey's midyear quitting rate was in the 10% range, how, after the March 2003 OTC NRT meta-analysis finding of a 7% midyear NRT quitting rate, can the NRT industry continue to represent that NRT doubles a smoker’s chances of quitting? Have medical ethics deteriorated to the point that massive profits associated with marketing an inferior quitting method, producing inferior numbers, are being elevated above life itself?
If our morals allowed us to put profits ahead of lives, how could we hide the 10% rate and continue making billions in profits by selling a means of quitting generating only 7% abstinence at midyear? Sadly, the 10% part is easy. It's my firm belief that GSK's Australia web site, and other such references, will be quickly "amended" or deleted once this article comes to GSK's attention. 3 But once the visible factual landscape has again been groomed, what magic and mirrors could possibly allow NRT to continue to claim victory over cold turkey quitting?
It will be, and is being done, by ignoring or condemning inexpensive and simple smoker quitting surveys being taken in those jurisdictions where NRT's influence isn't sufficient to extinguish efforts to conduct them [ see the September 2002 JAMA survey finding that NRT is ineffective in helping California smokers quit ]. 7
Instead, the industry's ploy is to direct all focus inward to battles being waged and victories being declared over those using placebo devices that the industry knows will continue to produce 3 to 4% midyear quitting rates. Just three percent? But how? What factors could possibly cause placebo group quitters in NRT studies to relapse at rates roughly three times higher than real-world rates?
As best I can tell, the trick in generating OTC placebo group performance rates in the 3 to 4% range involves two primary factors: (1) frustration of a study participant’s expectations of receiving free NRT products by being able to tell that they were not receiving the “real thing”; and (2) using placebo devices that are not true inert placebos but instead laced with 1 to 3mg. of nicotine - not enough to satisfy a smoker’s crave anxieties but possibly enough to grind their spirit and resolve into the ground.
Frustrated Expectations - Let’s look at the expectations issue first. Imagine having been bombarded with almost two decades of NRT marketing that falsely led you to believe that NRT was twice as effective as quitting without it. Imagine signing-up for an NRT drug study on the promise of a 50% chance of receiving 12 weeks of free NRT products. Alternatively, imagine being so convinced in the merits of NRT that you walk into your local drugstore, plop your hard-earned money down on the counter, only to be told that you've just won a 50/50 chance of getting free NRT if you'll only agree to participate in a study.
Accepted into the study, instead of receiving the “real” NRT device you are instead randomized into the group assigned to receive the placebo device. Would you be able to tell that your patch was the placebo? If so, how would it effect your thinking and your resolve to continue?
The average nicotine smoker inhales roughly 1 mg. of nicotine from each cigarette smoked. 8 The average 20 cigarette-a-day smoker receives about 20 mg. of nicotine. It's no coincidence that a 21 mg. nicotine patch provides 21 mg. of nicotine over 24 hours. It's also no coincidence that the 21 mg patch is the recommended starting point for those whose brains are chemically dependent upon smoking 20 mg. of nicotine per day. 9
If you were a 20 mg. a day nicotine addict, would you be able to tell whether or not you were getting your 20 mg. of nicotine? GSK sponsored research indicates that you would notice a big difference in crave intensity but not in withdrawal symptoms. 10 This 2002 GSK study found that “craving intensity was significantly lower ... with NRT patches than with placebo.” Not surprisingly, it also found no difference in craving levels between those who continued smoking nicotine and those receiving nicotine from transdermal nicotine patches. 10
What would your reaction have been if your primary motivations for joining the study were a deeply conditioned belief in NRT's ability to double your chances of quitting and the hope of receiving 12 weeks of free nicotine patches, and you were now convinced that you had been assigned to the placebo group instead? Should others within the placebo group have been able to tell the difference too? If so, could their combined frustrated expectations have been at least partly responsible for generating a relapse rate that is roughly three time higher than for “real-world” quitters who quit while having zero expectations of receiving 12 weeks of free and clean nicotine?
In one of the seven OTC NRT studies that was combined and averaged to produce the dismal 3% placebo group rate in the March 2003 OTC NRT meta-analysis, when placebo group members were questioned at the end of the study only 18.3% believed that they had received the “Real McCoy” (the active patch). 11 Although the study’s authors declare that “the effect of such a blinding failure would probably be a reduction of the placebo effect” 11 the NRT industry is today knowingly relying upon such flawed studies in order to continue claiming odds ratio (OR) victories and keep the nicotine profits flowing.
To watch the NRT industry defy common sense, fairness and medical ethics by equating placebo patch user performance to real-world cold turkey performance is heartbreaking. The only common thread between a smoker willing to give up all nicotine while quitting cold turkey and one wanting free nicotine so badly that they were willing to participate in an OTC NRT study in hopes of getting it, is that the brain reward pathways of both are chemically dependent upon it.
Placebos Not Placebos - What is a placebo? American Heritage defines it as “an inactive substance or preparation used as a control in an experiment or test to determine the effectiveness of a medicinal drug.” Merriam-Webster defines it as “an inert or innocuous substance used especially in controlled experiments testing the efficacy of another substance.”
Is nicotine an inactive, inert and innocuous substance? Would putting 1 to 3 mg. of what many consider earth’s most chemically captivating substance 12 into an NRT delivery vehicle fit the definition of a true placebo?
Have you ever heard of a medical study where 5 to 15% of the active chemical being tested was put into an identical delivery device and labeled a placebo? Would it be honest advertising to later go on television and proclaim that studies had shown NRT to be twice as effective as quitting cold turkey if those making such representations knew that the study’s quitters were never allowed to engage in and experience true cold turkey abrupt nicotine cessation?
The first time I had a placebo nicotine doctoring discussion with some of the world’s leading NRT authorities I was shocked when they failed to reference any study showing that the practice had no effect on outcomes but instead said that its use was based on “feelings” and “beliefs” that up to 3 mg. of nicotine over a 24 hour period would not alter the intensity or duration of normal abrupt nicotine cessation. Their “feeling” sentiments are even expressed in a 1996 patch study:
Patients in the P [placebo] group received a transdermal formulation with a very low content of nicotine (13% of the active form), a dose which is conventionally felt to be too low to affect outcome. " 13
Conventionally felt? I wonder how many successful quitters would agree that they could have consumed the nicotine equivalent of smoking up to three cigarettes a day, each and every day, and it would not have affected their ability to quit.
The 1997 Sonderskov OTC NRT study was one of the seven OTC NRT studies used to compute the 7% midyear NRT cessation rate in the March 2003 Hughes and Shiffman OTC meta-analysis. In it we are told that “the placebo patches contained a pharmacologically negligible amount of nicotine.” 14 What the study fails to disclose is how much nicotine was used or what standards were applied to determine how negligible it was.
Nicotine’s half-life in the bloodstream is about two-hours: an average of 122 minutes in Latinos, 134 minutes in whites, and 152 minutes in Chinese-Americans. 15 Within 72 hours of ending all nicotine use a cold turkey quitter's blood serum will test nicotine-free and more than 90% of nicotine's major metabolites will have passed through their urine. 16 It is then, by the three day mark, that true cold turkey quitters have no choice but to begin sensing the underlying current of anxieties associated with chemical withdrawal begin easing off.
But what if their brain reward pathways were never allowed to sense the arrival of and bathe in 100% nicotine clean blood serum? What if instead they were forced to continuously sense the results of wearing, chewing or sucking on placebo devices delivering the nicotine equivalent of smoking 1 to 3 cigarettes a day? Would it alter the intensity and/or duration of the normal cold turkey quitting experience or even destroy their resolve to continue?
Even more disturbing, would it be ethical to proclaim to the world that a 20 mg. a day nicotine addict who was fed 1 to 3 mg. of nicotine a day had engaged in and failed at a cold turkey quitting experience?
Where do we go from here? - Let's not forget that tobacco related diseases kill half of all adult smokers. 17 In that the average smoker only musters the confidence to attempt quitting about once every three years, how many serious quitting opportunities do they have to squander before bad news arrives? For almost two decades, NRT advocates have enticed smokers to spend those precious limited opportunities on the latest and greatest new weaning device containing the exact same active substance responsible for each and every relapse the smoker has ever experienced in their entire quitting history - the exact same chemical responsible for generating the 93% midyear relapse rate in the March 2003 OTC NRT meta-analysis. 18
Today it's the lozenge. Called medicine in television and radio commercials while almost hiding the fact that it's simply more nicotine, 19 the lozenge is yet another ploy to separate those addicted to nicotine from their money, hope, dreams and another priceless opportunity to focus upon and master the lessons learned by the 91.2% of successful quitters who figured things out on their own.
Is it time to be honest with those addicted to smoking nicotine? Should those making NRT use recommendations begin revealing the truth about just how ineffective NRT has proven these past few years? Is it time to stop the practice of giving meaningless odds ratio victory data over placebos that don't qualify to be defined as placebos, or pretending that NRT study participants - often using nicotine laced placebo devices - have the same odds of quitting as real-world quitters?
Is it time to begin sharing the March 2003 OTC NRT meta-analysis results of 7% at midyear, something no site recommending NRT has yet done? Is it time to tell smokers how productive abrupt nicotine cessation quitting is out in the "real-world" and to teach its most important lesson of all, that just one powerful puff of nicotine all but assures full and complete nicotine relapse?
Is it also time for nicotine smokers to learn the truth about education and support programs existing prior to the birth of NRT - the ones that gradual nicotine weaning invaded, made laughable and destroyed? For example, the 1983 Raw and Heller review of all 55 British stop-smoking clinics then found that their pre-NRT one year quitting rates ranged from 14% to 43% for the 19 clinics that maintained sufficient records to determine performance.
Yes, one year quitting rates! Instead of pushing 7% midyear NRT down their throats, what if the key elements from the 1983 UK clinic that generated the 43% one year rate could be made available for free inside the homes and public libraries of millions of smokers, simply by hitting a computer power switch and making a few clicks of a mouse? But who would tell them about this free and highly effective opportunity? Who would work to make it freely available to every nicotine addict - an NRT industry that stands to lose billions in profits?
Public health officials are quick to note that the lessons learned from school-of-hard-knocks quitting, derived after “three to four previous unsuccessful attempts,” eventually allow “in excess of 90% of ex-smokers [to] quit alone and without recourse to any professional help whatsoever,” but their analysis stops short. What lessons were learned? Could those lessons be imparted as part of a massive smoker education campaign reaching out to the 15 to 20% of our population that appears unresponsive to coerced cessation via tobacco tax increases, social controls limiting smoking locations, and name calling intended to foster leprosy status? Absolutely !
But what lessons are learned from the school-of-hard- NRT -knocks? Yes, over 90% of all successful on-your-own quitters eventually do quit on their own, and, yes, we can accelerate their learning, but isn't the more important question whether or not NRT quitters can eventually learn how to properly gradually wean themselves off of all nicotine by repeated use of NRT following relapse? Sadly, the answer appears to be no!
One of the most disturbing NRT marketing omissions is the horrific number of websites failing to advise smokers that if they have previously relapsed while using NRT that their odds of quitting during any subsequent NRT attempt drop to almost zero. In a 1993 study entitled “ Recycling with Nicotine Patches in Smoking Cessation ,” failed patch users from a patch study one year earlier were recycled and given a second attempt at quitting with the patch. By the six-month mark " all subjects had relapsed in the group previously treated with active nicotine patch ." 20 All of them! Did NRT deprive them of their own natural abilities to quit?
If NRT has no validity as a quitting tool that smokers can eventually succeed at figuring out how to adapt to in achieving permanent abstinence, why are we keeping that fact secret and what credible alternative is being offered to the more than 93% of NRT quitters who have already discovered that their ability to gradually wean themselves off of all nicotine is probably no greater than an alcoholic's ability to wean their way off of alcohol?
As an aside, a similar disturbing marketing omission is in not telling youth who smoke an average of 20 mg. (or less) of nicotine per day that NRT is not effective in helping them quit (5% at six months). 21
Whereas wearing, chewing, sucking or inhaling nicotine imparts no knowledge, we are fully capable of teaching all nicotine dependent humans the timing and sequencing of the natural withdrawal and recovery cycle. We have the ability to help them develop realistic recovery expectations , provide a cessation recovery philosophy , and teach basic coping skills . The tremendous potential of the Internet to serve as an inexpensive and widely available nicotine cessation education and support medium is just now beginning to be appreciated.
Unless OTC NRT's 93% midyear relapse rate is acceptable, policymakers have no choice but to add to the price of NRT the cost of behavioral and support programs lasting at least a week or two longer than the weaning process employed. Does it make sense to pay billions for NRT products that may be less effective than an uneducated and unsupported quitters own natural abilities? If not, why would spending additional money for weaning-oriented behavioral programs designed to coerce weeks or months of gradual stepped-down weaning compliance make economic sense?
Yes, smoking nicotine is highly captivating but breaking free need not be hard. In fact once properly motivated the majority of quitters are amazed at just how easy quitting becomes. The “Law of Addiction” can either be learned in the school-of-hard-quitting-knocks or in a few minutes of reading. The same for a multitude of other lessons associated with the dependency recovery process, including how to avoid unnecessary symptoms and common pitfalls like time distortion, unnecessary blood sugar swings associated with ending nicotine induced adrenaline releases, in avoiding development of unrealistic expectations, and in understanding and side-stepping the influence of mountains of conscious dependency memories and deeply engrained yet faulty thinking and reasoning.
Key is in breaking nicotine's grip and departing from active dependency with a profound appreciation for the fact that the true measure of nicotine's power isn't in how hard it is to quit but in how easy it is to relapse.
Regardless of how acquired, motivation, education, understanding, new skills, and quality support, if and when needed, have always been the tools of all human accomplishment. Contrary to the wishes of many, there still exists a wonderful body of abrupt nicotine cessation dependency understanding that is grounded in hundreds of studies and decades of clinic experience. It is a gift to all still enslaved by dedicated and caring researchers, facilitators scientists and health educators who devoted vast quantities of their time and lives to its creation.
It would be a dying shame to continue seeing it hidden, denied, maligned and/or intentionally suppressed for the sake of profits.
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 July 17, 2003, nor had any other person had any input upon its content. The views expressed here are my own, in my individual capacity, as a concerned nicotine cessation and control advocate.
John R. Polito Nicotine Cessation Educator
1325 Pherigo Street Mount Pleasant, SC 29464 email@example.com
1. American Cancer Society, Cancer Facts and Figures 2003 (PDF Document) , see Table 3. 2. See final sentence under results which reads Hughes, JR, Shiffman, S, et al., A meta-analysis of the efficacy of over-the-counter nicotine replacement . Tobacco Control, March 2003;12:21-27. 3. GlaxoSmithKline Australia Pty Ltd ("GSKA") "Cold Turkey." Graphic and content are the copyright of GlaxoSmithKline Group of Companies (Copyright© 2001). 4. Clinical Practice Guideline, Treating Tobacco Use and Dependence , U.S. Department of Health and Human Services, Public Health Service, June 2000 (PDF Document). 5. Polito, JR, Does the Over-the-counter Nicotine Patch Really Double Your Chances of Quitting? 6. Clinical Practice Guideline, Treating Tobacco Use and Dependence, Appendix C 7. Pierce, JP, et al., Impact of Over-the-Counter Sales on Effectiveness of Pharmaceutical Aids for Smoking Cessation. Journal of the American Medical Association (JAMA), September 11, 2002;288:1260-1264. [PDF Document]. 8. Henningfield, J E, et al., (1993). Psychopharmacology of nicotine. In C.T.Orleans & J. D. Slade (Eds.), Nicotine Addiction: Principles and Management (pp. 24-45). New York: Oxford University Press. Also see, Benowitz, N. L. (1988). Pharmacological aspects of cigarette smoking and nicotine addiction. New England Journal of Medicine, 319, 1318-1330. Feyerabend, C, et al., Nicotine pharmacokinetics and its application to intake from smoking , British Journal of Clinical Pharmacology 1985 Feb;19(2):239-247. 9. Drugstore.Com, Nicoderm CQ 10. Teneggi V, et al. Smokers deprived of cigarettes for 72 h: effect of nicotine patches on craving and withdrawal . Psychopharmacology (Berl). 2002 Nov;164(2):177-87. Epub 2002 Aug 27. 11. Sonderskov J, et al. Nicotine patches in smoking cessation: a randomized trial among over-the-counter customers in Denmark. Am J Epidemiol 1997;145: 309 to 318, at page 317. 12. Nicotine Addition 101 , WhyQuit.com 13. Campbell IA, et al. Transdermal nicotine plus support in patients attending hospital study . Respiratory Medicine 1996, Volume 90(1): pages 47-51, at page 48. 14. Sonderskov J, et al. Nicotine patches in smoking cessation: a randomized trial among over-the-counter customers in Denmark. Am J Epidemiol 1997;145: 309 to 318, at page 312. 15. Benowitz, N.L., et al. 2002. Slower metabolism and reduced intake of nicotine from cigarette smoking in Chinese-Americans . Journal of the National Cancer Institute 94(Jan. 16):108-115. 16. 1988 U.S. Surgeon General's Report, Chapter Two: Nicotine Pharmacokinetics, Metabolism. and Pharmacodynamics , Office on Smoking and Health, Center for Health Promotion and Education, Centers for Disease Control, Public Health Service of the U.S. Department of Health and Human Services ( PDF Document, see page 18 of 56). 17. American Cancer Society Cigarette Smoking 18. OTC NRT 93% Midyear Relapse Rate , Electronic Letters to: A meta-analysis of the efficacy of over-the-counter nicotine replacement, J R Hughes, S Shiffman, P Callas, and J Zhang Tob Control 2003; 12: 21-27. 19. Drugstore.Com, Commit, Stop Smoking Lozenges, 4mg each 20. Tonnesen P, et al., Recycling with nicotine patches in smoking cessation. Addiction. 1993 Apr;88(4):533-9 21. Hurt, RD et al., Nicotine Patch Therapy in 101 Adolescent Smokers , Arch Pediatr Adolesc Med. 2000;154:31-37.
Related Links and Articles
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- GlaxoSmithKline Attacks Cold Turkey Quitting - John R. Polito, 12/05
- UK Guidance for NRT use in pregnancy and by children - ASH London, 12/05
- June 2000 Guideline Chairman Michael Fiore's Testimony - see PDF pages 14 & 15, 05/05
- The Nicotine Patch, Gum and Lozenge - Mounting Evidence of a Sham - John R. Polito, 04/05
- 40 Years of Progress? - Joel Spitzer, 10/04
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- March 2003 OTC NRT Meta-Analysis Finds 93% Midyear Relapse Rate - John R. Polito, 03/03
- Quitting Methods - Who to Believe? - Joel Spitzer, 2003
- JAMA Study Concludes NRT is Ineffective - John R. Polito, 09/02
- Real-World Nicotine Patch and Gum Rates - John R. Polito, 06/02
- Does the OTC Nicotine Patch Really Double Your Chances of Quitting? - John R. Polito, 04/02
- Is Nicotine Replacement Therapy The Smoker's Last Best Hope? - John R. Polito, 11/00
- Financial Disclosures for June 2000 Guideline Panel - U.S. Public Health Service, 06/00
- June 2000 Guideline Recommendation 7 - pharmacotherapy use by all quitters - 06/00
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Last updated on January 29, 2009 by John R. Polito