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Original articles: S Shiffman, J R Hughes, J L Pillitteri, and S L Burton Persistent use of nicotine replacement therapy: an analysis of actual purchase patterns in a population based sample Tob Control 2003; 12: 310-316 [Abstract] [Full text] [PDF]

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No nicotine gum users nicotine free at six months?

John R. Polito   (6 November 2003)

No nicotine gum users nicotine free at six months? 6 November 2003
John R. Polito, Nicotine Cessation Educator Founder WhyQuit.com Send letter to journal: Re: No nicotine gum users nicotine free at six months? john{at}whyquit.com John R. Polito	The abstract's conclusion that persistent use of nicotine gum is "very rare" casts serious doubt upon the authors' objectivity. How can they here describe a 6.7% chronic nicotine gum use rate at six months as reflecting a 'very rare' condition while their March 2003 OTC NRT meta- analysis - published in this same journal - embraced a 7% six-month smoking abstinence rate finding as "effective?" [1] I do hope the FDA will lay the authors' March 2003 meta-analysis beside this study's findings as the shocking news is that almost 100% of nicotine gum users who were declared to have quit smoking for six months (7%) appear to have still been hooked on the nicotine gum at six months (6.7%). The big news is that one-quarter (24%) of nicotine patch users (1.7% of the 7%) who were previously reported to have successfully quit at six months were likely still using the nicotine patch. If almost 100% of gum and 95% of patch users are still hooked on nicotine at six months and success is "very rare" then doesn't some rather serious life threatening NRT marketing deception need to be immediately addressed and corrected? The authors apparently want us to believe that those spending hundreds of dollars violating FDA use guidelines were not chemically dependent. Yes, I'm clearly using Table 1 "one month gap"findings. But if this study is to be taken seriously, after the authors discarded all purchase data reflecting multiple same day scans on the assumption that they were scanning errors, some of which obviously evidenced purchases of multiple month supplies, I think we must. It also brings the authors selective data "estimates" closer to historical study findings. What I find interesting is that there was zero analysis of any nicotine purchases except for NRT when every nicotine product sold has UPC codes and participants were required to scan all purchases. Why would their NRT scans be anymore reliable than other nicotine product scans? Wouldn't that have provided data on the number of smokers in each household, their brands, and whether or not they attempted cessation? In single smoker households the nicotine use picture should be amazingly clear. It would be interesting to see this data analyzed by researchers who are not acknowledged NRT industry consultants and who do not feel compelled to disclose within the study that they have a personal financial stake in the development and marketing of new NRT products. The patterns of NRT use interlaced with cigarette and other nicotine purchases should produce some rather fascinating info on just how well "therapy" was actually going. I just don't know if it would be in the pharmaceutical industry's financial interests to share such details. If the real agenda of this study - and reflecting back there seems to have been an overabundance of marketing objectives - is to get the FDA to double the OTC NRT use recommendation period from three to six months, thus substantially enhancing profits, the FDA would be well advised to attack the pharmaceutical industry's hiding of nicotine’s addictive properties with the same vigor it would if allowed to regulate tobacco product warnings and a failure to have any U.S. dependency disclosures. The authors assert that "the literature has seldom examined dependence upon NRT." Is there any wonder why? Imagine having to put nicotine addiction warning labels on all nicotine weaning products. They are badly needed too. The 2003 Memphis youth NRT use survey finding that teens who have never taken a single puff off of any cigarette are now daily NRT users should have set off major alarms at the FDA.[2] Is one of the objectives of this study to diminish growing concern that NRT products are the new gateway to a lifetime of nicotine dependency for tens of thousands of youth? If so, is it just possible that a bit of "real" dependency science may at some point be in order? In reading this study it's almost as if the authors want us to believe that the brain's dopamine, adrenaline and serotonin neurons are somehow able to discriminate between nicotine from a cigarette and nicotine from NRT products. How are such shell games and nonsense any different from the tobacco industry's nonsense? This study's intro and discussion read like decades of tobacco industry spin on the issues of addiction and safer cigarettes while again totally ignoring all nicotine dependency biochemistry or studies raising legitimate nicotine health risks. Nicotine addiction isn't about getting high but about how the mind and body have redefined "normal." Our bodies rebelled against those first few puffs but quickly adjusted to inhaling thousands of chemicals. Amazingly, nicotine crossed the blood-brain barrier and was a chemical key that snugly fit the acetylcholine locks responsible for fine tuning a host of brain neurochemical pathways including select dopamine, adrenaline and serotonin circuits, and through cascading indirectly controlling more than 200 neurochemicals. The mind's adjustments to being constantly bombarded with nicotine were gradual yet constant. But eventually the brain ran out of tricks as it could no longer keep up with the smoker smoking more nicotine in order to achieve remembered prior performance. It did everything possible to protect its reward, mood and anxiety circuits from overload and burnout. It some areas it reduced the number of receptors for nicotine, in others the number of transporters were diminished, while in some regions of the brain millions of additional neurons were grown. Through disbursal and turning down the brain's receptiveness to nicotine, normal brain chemistry was altered as a new sense of normal emerged and an addiction was born. It was a sense of normal now completely dependent upon nicotine's two-hour chemical half-life. Successful dependency recovery is being willing to allow the brain the time needed to readjust to again functioning without nicotine, and the quitter time to adjust to the brain's adjustments. It is impossible for the brain, body and consciousness to adjust to functioning and living without nicotine until its arrival stops. If true, how can NRT claim responsibility for a 7% midyear nicotine cessation rate? It can't. As shown by superimposing this study upon the authors' March 2003 finding, within six months zero gum users and only five in one hundred patch users are nicotine free. But what about the 5% who transdermal nicotine seemed able to help escape? I submit that they did not quit nicotine while engaged in using it but only after pulling off that last patch. There is a substantial body of non-NRT study evidence strongly suggesting that almost twice as many patch users (10%) would have succeeded if they had not toyed with months of nicotine weaning.[3] An unsupported and uneducated quitter's core motivations and nicotine cessation desires appear unaffected by cessation method unless that method deprives them of some of their own natural recovery abilities. NRT appears to do just that by prolonging the up to 72 hours needed for 100% of nicotine and 90% of nicotine metabolites to be removed from the body and the brain to begin sensing the arrival of and adjusting to nicotine- free blood serum. One of NRT's biggest fictions is that real world 'on-your-own' quitting rates are the same as those being generated in OTC NRT studies trying to cope with admitted blinding failures or even employing nicotine as a placebo device masking agent.[4] It's why the authors continue to take stabs at the 2002 Pierce JAMA survey conclusion that NRT is no longer effective, and ignore London and Minnesota surveys with similar findings. Nicotine is the natural chemical defense that keeps the roots, leaves and seeds of the tobacco plant from being eaten by bugs. Drop for drop it's more deadly that strychnine and three times deadlier than arsenic. Amazingly, the FDA allowed the pharmaceutical industry to redefine and market an insecticide as medicine and label its use therapy. It also stood by while new tortured definitions of quitting, cessation, and abstinence were created allowing NRT to hide nicotine and addictiveness concerns while making billions in profits by claiming meaningless odds ratio victories. It watched as researchers kept straight faces while pretending that those still using nicotine had accomplished some great feat that was then compared to those who truly had ended all nicotine use. What FDA officials should not sweep under the rug or allow studies such as this to redefine, ignore or minimize is the growing awareness of the destructive potential of this amazing pesticide. The authors' assertion that "prolonged use of NRT is not thought to be harmful" is simply untrue as it flies in the face of a growing list of study concerns produced by real experts engaged in real science. The U.S. National Cancer Institute has raised cancer concerns over the nicotine-derived nitrosamine NKK on normal lung epithelial cells. The Paris National Institute of Health recently found evidence that nicotine causes a major fall in production of PSA-NCAM, a protein with a vital role in the plasticity of the brain with apparent impairment of learning and memorization. A 2001 Stanford study concluded that nicotine tremendously accelerates tumor growth rates and atherosclerosis through angiogenesis. And an October 2000 study in Pediatrics that followed 8,000 teenagers has depression experts rethinking why so many nicotine dependent Americans suffer from chronic depression and other mental health concerns. But I want to mention one more risk that harm reduction oriented NRT experts just can't seem to grasp. I'm talking about an entire life being chemically dependent upon nicotine's two-hour chemical half-life. I'm referring to again sensing the full glory of our own reward pathway releases that flow from accomplishment, a big hug, or even a nice cool glass of water. About handling our own adrenaline releases, our own anxieties and anger, determining when it's time to eat, dealing with real hunger pains for the first time in decades, or even something as simple as the circumstances under which we'll feel our fingers grow cold. Not only does the brain adapt to the chemical world of nicotine normal, the new addict quickly forgets who they really were and the amazing sense of calmness that existed inside their mind prior to climbing aboard the nicotine, dopamine/adrenaline/serotonin roller-coaster ride of endless highs and lows. Natural regulation of mood, flight or flight, and reward is life itself, something more nicotine cannot return. Big brother health policy has unforgivably used nicotine cessation as a practice arena for someday going head-to-head with big tobacco in supplying the daily nicotine needs of a billion addicts. Smokers trusted us "science" to help arrest their dependency and it lied to them. It not only knew that "their" definition of quitting included nicotine, NRT marketing knowingly played upon it by constantly undermining their natural inclination to want to give up all nicotine by quitting cold. The white-coat ceremony vow was to do no harm yet physician science remains silent while knowing that the dismal 5.3% six-month nicotine patch quitting rate (derived by subtracting persistent purchasers rate of 1.7% from the OTC NRT finding of 7%) drops to almost zero percent during a second or subsequent patch attempt.[5] If true, how can those calling themselves addiction scientists sleep at night knowing that there is no lesson to be learned from repeated NRT use but that relapse is 100% guaranteed as dependency, destruction, decay and disease continue bringing forth vastly increased odds of early demise. John R. Polito Nicotine Cessation Educator [1] Hughes JR, Shiffman S. et al, A meta-analysis of the efficacy of over-the-counter nicotine replacement, Tobacco Control. 2003 March;12(1):21-7. Full text link - http://tc.bmjjournals.com/cgi/content/full/12/1/21 [2] Klesges, L. et al, Use of Nicotine Replacement Therapy in Adolescent Smokers and Nonsmokers, Arch Pediatr Adolesc Med. 2003;157:517- 522. Abstract link - http://archpedi.ama- assn.org/cgi/content/abstract/157/6/517 [3] Polito, JR, Does the Over-the-counter Nicotine Patch Really Double Your Chances of Quitting? Link to online article - http://whyquit.com/whyquit/A_OTCPatch.html [4] Polito, JR, Are nicotine weaning products a bad joke? Link to online press release - http://www.emediawire.com/releases/2003/10/prweb84809.htm [5] Tonnesen P, et al., Recycling with nicotine patches in smoking cessation. Addiction. 1993 Apr;88(4):533. Link to abstract - http://www.ncbi.nlm.nih.gov/entrez/query.fcgi?cmd=Retrieve&db=PubMed&list_uids=8485431&dopt=Abstract . Also note references to unpublished studies such as the Korberly nicotine patch study presented at the March 1999 Society for Research on Nicotine and Tobacco conference in New Orleans in which only 1 out of 149 OTC nicotine patch users was still not smoking at the six month mark.