A nicotine-free smoking cessation drug has been launched
on the Scottish public, prior to its approval in
England.
The Product's success rate is claimed to
be 44 per cent (and 18 per cent in a control group using a
placebo).
The drug is available on prescription. The
Scotsman heralds its arrival with glowing confidence and an
endorsement from Maureen Moore of ASH Scotland, who revels in
all the pharmaceutical treatments available for smokers to
give up smoking. The notion of not wanting to give up smoking
does not figure in this report – and it is taken for granted
that the smoking cessation treatments available on
prescription invariably make quitting easier – in Moore's
words, 'raise people's chances of quitting smoking'.
Portraying smokers as victims unable to give up as a
result of their own volition gives pharmaceutical companies
like Pfizer, the manufacturers of Champix, a glow of altruism
– they are there to help people. Readers commenting on this
report include former smokers who have given up without
expensive 'crutches' as well as those resenting the cost to
the public purse of putting smoking cessation drugs on
prescription.
Enter John Polito of
whyquit.com and author of a
study on Champix. Polito left this report on the
discussion
thread. It reports that Pfizer was forbidden by the FDA to
use the name Champix in the States because of its exaggerated
connotations of success, so it is known there as Chantix.
Polito's article points out the aberrations in the trials
process, such as their ecxlusion of test subjects who were
considered hard to treat, or the absence of any comparison
with cold turkey quitters.
Interim success rates
between the test group and control group varied considerably
between the different centres where the tests were carried
out, ranging from a 0 per cent success rate in San Francisco,
Kentucky and Tulane in the placebo group up to 46 per cent in
Massachussets. The test subjects on Champix achieved success
rates at 12 weeks between 6 per cent in New York and 69 per
cent in Mayo Clinic. The results point to enormous variability
in the quality of support services available.
The
longer-term success rate of test subjects compared with
placebo subjects is significantly affected by the placebo
group's awareness of their status, during or after the study.
This results in a high relapse rate among placebo users,
'handing the active group victory by default'.
Exclusion of would-be quitters who want to go cold
turkey allows companies like Pfizer to say that their products
offer a high success rate compared with cold turkey quitters.
Polito claims that differing expectations of the experience of
quitting reflects directly on any comparison between cold
turkey and drug-supported quitting, and companies should not
make claims for their products without including cold turkey
quitters in their comparison studies.
The result of
distortions in described in this study should sound warnings.
The European Commission and FDA owe it to the public to set
stringent standards in this area.
