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Abstinence from smoking eight years after participation in randomised controlled trial of nicotine patch

BMJ 2003; 327 doi: https://doi.org/10.1136/bmj.327.7405.28 (Published 03 July 2003) Cite this as: BMJ 2003;327:28

Rapid Response:

Re: Does nicotine replacement therapy help smokers quit?

To see Butcher criticized for pointing out that the study's authors
presented selected data in a manner designed to enhance the "apparent"
effectiveness of NRT is nothing new. Here it's asserted that "[u]se of
the nicotine patch conferred a 39% increase in the odds of continuous
abstinence compared with placebo" when the big and hidden news is that
while 12.8% of the placebo group were quit at 8 years (104 out of 810),
only 11.9% of patch users remained abstinent (97 out of 815).

Would that message sell NRT? I don't think so. It's why Butcher was
slammed.

OTC NRT is not just a bad joke among those surveyed in California,
Minnesota and London, it's 93% midyear relapse rate, as found in the March
2003 Hughes and Shiffman meta-analysis,[1] is likely costing thousand upon
thousands their lives. To pretend that it's not being marketed and used
almost exclusively as a stand alone cessation tool is intellectual fraud,
and so is clothing it in effective behavioral interventions having decades
of proven efficacy.

On July 24, 2003, we watched as NHS issued a press release declaring
a massive nationwide cessation program victory at one month [2] while
asserting that 75% of successful quitters used NRT.[3] Imagine being so
ethically bankrupt that a government health agency would assert to the
world that heroin addicts who were one month into a three month heroin
weaning program (with a two month supply in-hand) had already "kicked the
habit."[2] Where is the NHS midyear and one year NRT performance data?
What is NHS hiding?

Where are the one year OCT NRT performance rates and just how bad are
they? Do you really think the pharmaceutical industry doesn't know? Are
they less than 3%?

Was 1 to 3 mg. of nicotine used as a placebo device masking agent in
this study as it was in many others?[4] If so, did it alter the intensity
and/or duration of normal abrupt cessation? Would it be ethical to
proclaim to the world that a 20 mg. a-day nicotine addict who relapsed
while being fed 1 to 3 mg. of nicotine a-day via placebo, had engaged in
and failed at cold turkey quitting experience?

Did 18% or less of the placebo group believe it had been wearing the
active patch at study's end, as was the case in the 1997 Sonderskov OTC
patch study where the authors stated that "the effect of such a blinding
failure would probably be a reduction of the placebo effect"?[5]

Why continue the charade that those wanting 12 weeks of free NRT so
badly that they'd be willing to participate in a medical study for a 50/50
chance of receiving it, had the exact same mind-set as the 91.2% of all
successful long-term quitters who had the expectation of quitting entirely
on their own? (see American Cancer Society's Cancer Facts 2002)

Why continue to pretend that a 20 mg. a-day nicotine addict who is
totally denied their addictive substance isn't quitting earlier than a
20mg. a-day nicotine addict being fed 21 mg. of nicotine a-day via NRT?
The Shiffman lozenge study declared victory at six-weeks while the lozenge
group received all the lozenge nicotine they wanted for up to six full
months. If true, wouldn't we have been more honest to compare the 6 month
placebo group performance rate to the 12 month lozenge rate?

Why continue to pretend that behavioral study interventions such as
group support, nurse interviews, pep-rallies, education programs,
telephone contact, and counseling, that were offered beyond week-two of
any NRT study, didn't unfairly benefit the greater numbers of well-fed
nicotine addicts as opposed to the often 50 to 80% in the nicotine starved
placebo group who had already relapsed?

Smokers only muster serious cessation confidence about once every
three years. Have we improved recycling results for second time NRT
users above the ZERO (0%) percent success rate generated in the 1993
Tonnesen study entitled "Recycling with Nicotine Patches in Smoking
Cessation"?[6] If so, where is the study? If not, how many priceless
cessation opportunities have been squandered in the name of greed and how
many needlessly died because we failed to warn them that their odds
dropped to zero following their initial NRT relapse? Secrets?

Why are we still allowing marketing of NRT to youth while failing to
advise those dependent upon 20 mg. or less of nicotine per day that NRT
has proven ineffective in helping them quit (5% at six months).[7] Why
isn't more being made of the June 2003 Memphis student NRT survey finding
that 18% of student NRT users were never-smokers?
http://whyquit.com/whyquit/A_NRT_teens.html

If the medical study industry is not willing to police itself then it
should fully expect the legal system to arrive and make corrections. At
least Big Tobacco never labeled nicotine medicine, defined toying with it
therapy, pronounced those permanently hooked on NRT as having
successfully quit, or spent hundreds of millions conditioning smokers to
believe that weaning with costly clean-nicotine devices was twice as
effective as anything they could do on their own. They're coming, they
should, and so are the shreadders.

[1] 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.
http://tc.bmjjournals.com/cgi/content/full/12/1/21

[2] NHS Press Release, 07/24/03 - Continuing Success of NHS Services
to Help Smokers Quit
http://tap.ukwebhost.eds.com/doh/Intpress.nsf/page/2003-0276?OpenDocument

[3] UTV, July 24, 2003, “NHS helps 120,000 quit the habit”
http://u.tv/newsroom/indepth.asp?pt=n&id=35061

[4] 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.
http://www.ncbi.nlm.nih.gov/entrez/query.fcgi?cmd=Retrieve&db=PubMed&lis...

[5] 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.
http://www.ncbi.nlm.nih.gov/entrez/query.fcgi?cmd=Retrieve&db=PubMed&lis...

[6] Tonnesen P, et al., Recycling with nicotine patches in smoking
cessation. Addiction. 1993 Apr;88(4):533-9
http://www.ncbi.nlm.nih.gov/entrez/query.fcgi?cmd=Retrieve&db=PubMed&lis...

[7] Hurt, RD et al., Nicotine Patch Therapy in 101 Adolescent
Smokers , Arch Pediatr Adolesc Med. 2000;154:31-37. http://archpedi.ama-
assn.org/cgi/content/abstract/154/1/31

Competing interests:  
Founder www.WhyQuit.com, a free online abrupt nicotine cessation education and support forum

Competing interests: No competing interests

30 July 2003
John R. Polito
Nicotine Cessation Educator
Summerville, SC 29485