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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?" 
I do hope...
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
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
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
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.
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
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.
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. 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
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
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. 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
 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 -
 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-
 Polito, JR, Does the Over-the-counter Nicotine Patch Really
Double Your Chances of Quitting? Link to online article -
 Polito, JR, Are nicotine weaning products a bad joke? Link to
online press release -
 Tonnesen P, et al., Recycling with nicotine patches in smoking
cessation. Addiction. 1993 Apr;88(4):533. Link to 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.
Jump to comment:
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?" 
I do hope...