Nicotine Gum Maker's Concern Raises Concerns
The maker of Nicorette gum - GlaxoSmithKline (GSK) - issued a May 3rd press release in response to a May 2nd N.Y. Times article entitled "A Quitter's Dilemma: Hooked on the Cure." The Times piece quotes a GSK consultant as saying, "We estimate 36.6 percent of current gum users are engaged in persistent use." Concerns over a rising tide of chemically captive customers may be secondary to a more fundamental concern indirectly raised by the GSK press release: do "any" quitters using nicotine gum as a stand-alone tool actually break free from nicotine?
(PRWEB) May 13, 2004 -- Last year two GSK consultants combined and averaged
all seven over-the-counter nicotine patch and gum studies. The shocking results
were published in the March 2003 edition of Tobacco Control. They found that
only 7% were successful in quitting smoking for six months. Amazingly, GSK’s May
3rd press release includes the admission that among those who quit smoking, "7%
used the gum for 6 months or more." Correct me if wrong but isn't seven minus
seven still zero?
Upon discovering how to abstract pure nicotine from
the tobacco plant the pharmaceutical industry actually rewrote the definition
for quitting. Prior to that moment all methods of quitting included breaking
free from nicotine too, the sine qua non of smoking.
The modern quitter
now has four important considerations in comparing and picking cessation
products, procedures or programs: the smoking cessation rate, the nicotine
cessation rate, the length of time they quit (for purposes of making accurate
comparisons), and how results were verified.
As for verifying results,
self reporting relies entirely upon the honor system, expired carbon monoxide
levels test for smoking but do not test for the presence of nicotine, and blood
cotinine testing (a long-lasting nicotine metabolite) is the common method for
detecting recent nicotine use.
Few NRT studies examine cotinine levels
but for those concerned about continuing dependency upon nicotine it can be a
rather important piece of information. In a 2002 nicotine lozenge study by GSK
consultants, victory in quitting smoking was declared at six weeks while study
participants were offered up to 20 lozenges a day for six full
months.
GSK's press release also asserts that NRT "doubles a smoker's
chances of quitting versus cold turkey." We now have four large real-world
quitting surveys in which performance of smokers quitting cold turkey is
directly compared against those quitting with NRT -- California, Minnesota,
London and Quebec. In each case cold turkey quitters performed as well as NRT
quitters at six months - zero advantage.
Not only has the pharmaceutical
industry redefined quitting, amazingly, it has taken the liberty of redefining
who is and isn't a cold turkey quitter. It's fully aware that "real" cold turkey
quitters - those actually motivated to quit cold turkey - were not invited to
compete in formal NRT studies.
In almost all NRT studies, participants
were recruited by being promised a 50/50 chance of receiving weeks or months of
free NRT products. When assigned to the placebo group instead, a significant
percentage were somehow able to sense that the flow of nicotine to their brain
had ended.
In one of the seven OTC NRT studies - Sonderskov 1997 - at
study's end only 18.3% of those in the placebo patch group believed that they
had received the real nicotine patch. The authors openly admit that "the effect
of such a blinding failure would probably be a reduction of the placebo
effect."
Chance? Coincidence? Apparently not. A new study in the June
2004 edition of Addictive Behaviors identified 17 NRT studies which assessed
blindness. The authors assert that "12 studies found that subjects accurately
judged treatment assignment at a rate significantly above chance."
Has a
billion dollar industry been built entirely upon meaningless odds ratio
victories that reflect little more than high placebo group dropout rates due to
seriously frustrated expectations? If so, at what cost in terms of quitting
opportunities, time, and lives needlessly lost? At what cost in terms of the
integrity of science?
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Source : http://www.prweb.com/releases/2004/5/prweb125542.htm