Are nicotine weaning products a bad joke?

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Nicotine gum, patch and lozenge marketing continues to assert that clean nicotine weaning products double a smoker's chances of quitting. Recent findings raise serious concern over whether they benefit or are a barrier to those seeking freedom from nicotine.

Do over-the-counter (OTC) nicotine replacement therapy (NRT) products like the nicotine gum, patch and lozenge really help smokers quit? "Double your chances" has been the cornerstone of NRT marketing for almost two decades but just how useless must a product become before warranting a close examination of what's being doubled?

A March 2003 study review published in Tobacco Control combined and averaged all OTC NRT studies and found that 93% of nicotine patch and gum study participants relapsed to smoking within six months.

The study's financial disclosure indicates that the primary authors were NRT industry consultants. Despite seven months since the study's release and despite reflecting the combined results of all seven OTC studies, the CDC, NIH, FDA, state health departments, and all major health organizations have chosen not to share this horrific 7% midyear abstinence finding with smokers. But why?

Could pharmaceutical industry government influence possibly have become so strong? Could major health non-profits have themselves become addicted to large annual NRT industry contributions for allowing their trusted influence and websites to be used as storefronts to sell nicotine products to nicotine addicts?

NRT use recommendations also fail to warn youth about their chances and risks. After generating a dismal 5% six-month quitting rate among 101 adolescent smokers, a study published in the January 2000 edition of Archives of Pediatrics & Adolescent Medicine (APAM) concluded that the patch was ineffective in helping youth smokers quit.

A June 2003 youth NRT use survey, also published in APAM, raises the additional concern that teenage never-smokers are possibly becoming chemical slaves to the daily use of NRT products. Among the 216 surveyed youth who asserted they had used NRT, 40 represented that they had "never smoked a cigarette, not even a few puffs" and 7 of the 40 reported using NRT every day.

Aside from the almost secret treatment accorded NRT's adult and youth six-month relapse rates, smokers have long been kept in the dark regarding one other critical NRT shortcoming. How are the 7% adult and 5% youth midyear quitting rates impacted by a second or subsequent NRT attempt?

The study experts call it "recycling" and the only known study was published in a journal entitled Addiction in April 1993. Sadly, practice does make perfect with NRT in perfecting the odds of defeat. Not a single nicotine patch user who relapsed in a patch study a year earlier was still quit six months into their second patch attempt - zero, none.

Deprived of their natural odds of recovery, how many smokers may have believed in and toyed with NRT for so long that they actually ran out of time and chances?

Recent studies are not the only bearers of bad NRT news. Smoker survey findings published in the September 11, 2002 edition of the Journal of the American Medical Association concluded that "NRT appears no longer effective in increasing long-term successful cessation in California smokers." London and Minnesota smoker surveys also found no benefit.

If so, why continue depriving smokers of basic performance info that would empower them to make meaningful decisions in how to spend their priceless periods of confidence, in trying to break nicotine's grip upon their brain's dopamine, adrenaline and serotonin pathways? And how can the industry continue asserting that NRT is twice as effective as quitting on your own?

According to evidence table data presented in the June 2000 U.S. Clinical Practice Guideline, the historical on-your-own success rate for those not using any products or programs is roughly 10% at six months.

Those marketing NRT ignore a quitter's 10% natural recovery ability and instead look inward to declare victory over a group of placebo device users within the study, where, amazingly, only 3 to 4% succeed in quitting for six-months. But why three times lower?

What if you so deeply believed in the NRT marketing hype that you agreed to participate in a study in hopes of receiving 12 weeks of free patches? What if you were quickly able to sense or detect that you were not getting your regular dose of nicotine but had instead been randomly assigned to receive the placebo patch? Would frustrated expectations cause you to find an excuse to relapse?

In one of the studies used to compute the March 2003 OTC NRT findings, at study's end only 18.3% of those in the placebo patch group believed that they had received the "Real McCoy." Although the authors clearly state that "the effect of such a blinding failure would probably be a reduction of the placebo effect," it didn't stop the industry from relying upon it in claiming yet another internal "double your chances" odds ratio victory.

Aside from blinding failures, the placebo devices in a number of studies did not meet the classic definition of "placebo" as, supposedly for masking purposes, they contained from 1 to 3 mg. of nicotine.

The average smoker receives 1 mg. of nicotine from each cigarette smoked. The average pack-a-day smoker inhales roughly 20 mg. daily. In NRT studies they are routinely assigned to the 21 mg. patch where they are expected to engage in weeks or months of gradual stepped-down weaning.

By contrast, the blood-serum of a cold turkey quitter is 100% nicotine free by day three and 90% of nicotine's metabolites have passed through their urine. It's then that withdrawal normally peaks in intensity and begins to gradually subside.

But what if their brain neurons were never allowed to sense and bathe in nicotine-free blood serum? What if instead they were forced to cope with from 1 to 3 mg. of nicotine contained in a placebo device?

How many pack-a-day smokers could sneak puffs from one to three cigarettes for weeks and still quit? Could it alter the intensity and/or duration of normal withdrawal, or even drive their spirit into the ground? Would it be honest to declare to the world that they had attempted to quit "on their own" and failed?

The average nicotine addict only musters the confidence to venture beyond their thick wall of protective denial and attempt a mad dash for freedom about once every three years. With smoking eventually claiming half of all adult smokers, each an average of about 14 years early, the number of attempts available to each of them is limited.

Prior to NRT's arrival local abrupt nicotine cessation programs in communities around the globe were routinely generating midyear rates of 20%, 30%, 40% and in some cases almost 50%.

In the 1990s the U.S. government invited eleven researchers with a history of financial ties to the pharmaceutical industry to join seven researchers with no known associations in rewriting and declaring U.S. cessation policy. In June 2000 the full panel published a revised U.S. Clinical Practice Guideline declaring NRT use a mandatory cessation recommendation.

The 2000 Guideline was a death sentence for many non-NRT quitting programs as they were no longer considered "science-based," were out-of-step with U.S. cessation policy, and, unless willing to play by new rules, no longer credible candidates for funding.

The pharmaceutical industry made billions while forcing short two to four-week cold turkey programs to accept quitters engaged in months of toying with nicotine weaning products. It made graduation day as disturbing as attending an AA meeting where everyone was drunk.

The American Cancer Society's 2003 Cancer Facts and Figures report indicates that 91.2% of all successful long-term quitters quit without the nicotine patch, gum, lozenge, inhaler, without Zyban or Wellbutrin, and without hypnosis or acupuncture. They did it entirely on their own. Shouldn't we be searching for and sharing their secrets?

The key to effective cessation isn't in renaming the addictive substance medicine, labeling its use therapy, pretending that those addicted to it can gradually wean themselves off, or in hiding true NRT performance rates while ignoring that the odds for second time users drop to near zero. It's in learning to fully and comfortably engage life without reaching for the addictive substance.

Education, understanding, new skills and solid support - the same tools enhancing success rates in all human endeavors - dramatically increase the prospects of nicotine dependency recovery. Isn't it time they regained center-stage and that pharmaceutical companies were sent back to the lab to find a magic cure with a bit lower failure rate than 93% for adults, 95% for youth and 100% for second time users?

About the Author: John R. Polito is a South Carolina nicotine cessation educator, a former thirty-year three pack-a-day smoker, and the founder of, a free online abrupt nicotine cessation forum offering motivation materials, a recovery education program and group peer support.

Fact References:

1. Facts: All seven OTC NRT studies to date were combined and averaged and produced a 7% six-month quitting rate and the study's disclosures acknowledge the authors to be NRT industry consultants. 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 [ .

2. Fact: NRT is now a mandatory cessation recommendation. Clinical Practice Guideline, Treating Tobacco Use and Dependence , U.S. Department of Health and Human Services, Public Health Service, June 2000 [PDF Document - .

3. Fact: The historical on-your-own quitting rate is in the range of 10 to 12% at midyear. Polito, JR, Does the Over-the-counter Nicotine Patch Really Double Your Chances of Quitting? [ .

4. Fact: California smoker survey finds NRT not effective in helping smokers quit. 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 - .

5. Facts: Nicotine is being used in placebo devices and authors admit to blinding failures. 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 pages 312 and 317 [ . Also see 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 [ .

6. Fact: No recycled patch users quit during a subsequent attempt. Tonnesen P, et al., Recycling with nicotine patches in smoking cessation. Addiction. 1993 Apr;88(4):533 [ .

7. Fact: Nicotine patch declared ineffective in helping youth smokers quit. Hurt, RD et al., Nicotine Patch Therapy in 101 Adolescent Smokers , Arch Pediatr Adolesc Med. 2000;154:31-37 [ .

8. Fact: Teen neversmokers are becoming daily users of NRT [ .

9. Fact: CDC continues to strongly push NRT without any reference to actual success rates, no warnings of reduced rates for subsequent attempts, and no youth warnings that NRT is ineffective. CDC's You Can Quit Smoking Consumer Guide [ .

10. Fact: Eleven of eighteen U.S. Guideline panel members had financial ties to the NRT industry. Clinical Practice Guideline, Treating Tobacco Use and Dependence, Appendix C [ .

11. Fact: 91.2% of all successful long-term quitters quit on their own. American Cancer Society, Cancer Facts and Figures 2003 [PDF Document, see Table 3 - .


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