In 1990s, four randomised, double blind trials with large sample sizes (n = 278–802) tested active versus placebo patch (table 1). The Davidson et al trial28 was similar to other studies except it was conducted in four shopping malls. The Hays et al study31 was conducted at five study sites including private offices or storefronts. The study first randomised subjects into one of two trials: (1) a randomised, two group OTC NRT versus OTC placebo trial in which subjects received free patches; or (2) a one group, open label trial in which subjects had to pay for patches. We did not use open label trial in meta-analysis because it did not have a control group.

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NRT industry consultants.

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

Aside from blinding failures, placebo devices in a number of studies did not meet 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 21 mg. patch where they are expected to engage in weeks or months of gradual stepped-down weaning.

By contrast, 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 intensity and/or duration of normal withdrawal, or even drive their spirit into ground? Would it be honest to declare to world that they had attempted to quit "on their own" and failed?

The average nicotine addict only musters 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, number of attempts available to each of them is limited.

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

In 1990s U.S. government invited eleven researchers with a history of financial ties to pharmaceutical industry to join seven researchers with no known associations in rewriting and declaring U.S. cessation policy. In June 2000 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 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 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 odds for second time users drop to near zero. It's in learning to fully and comfortably engage life without reaching for addictive substance.

Education, understanding, new skills and solid support - same tools enhancing success rates in all human endeavors - dramatically increase prospects of nicotine dependency recovery. Isn't it time they regained center-stage and that pharmaceutical companies were sent back to 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?

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