Electronic letters to:

Letters:
Kristian B. Filion, MSc, Patrick Bélisle, MSc, Lawrence Joseph, PhD, Gilles Paradis, MD MSc, Stéphane Rinfret, MD MSc, and Mark J. Eisenberg, MD MPH
Smoking cessation trials
CMAJ 2008; 179: 1038 [Full text] [PDF]
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Electronic letters published:

[Read eLetter] Why cessation blinding concerns differ from other clinical trials
John R. Polito   (13 November 2008)

Why cessation blinding concerns differ from other clinical trials 13 November 2008
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John R. Polito
Editor WhyQuit.com

Send letter to journal:
Re: Why cessation blinding concerns differ from other clinical trials

john{at}whyquit.com John R. Polito

My sincere thanks to CMAJ for publishing my letter contending that "chemical dependency may be the only known research area in which blinding is impossible," that drug addicts with lengthy quitting histories cannot be fooled by randomization as to the absence or presence of full-blown withdrawal. My thanks to the authors for replying. They suggest that the proper time to assess blinding is prior to formation of efficacy beliefs. I fully agree. Ideally, it would occur roughly 8 hours into cessation. But the authors close by dismissing my blinding concerns as concerns shared in "most clinical trials."

Most clinical trials do not involve an attempt to improve a syndrome (chemical withdrawal) that was non-existent when the trial commenced. Cessation pharmacology's unique objective isn't treatment of some ongoing pre-existing condition but reduction or elimination of insula driven withdrawal anxieties that arise after randomization, after the trial commands participants to commence cessation.

Nicotine withdrawal agony is a study induced (or attenuated) event which peaks within 24 to 72 hours of cessation. This raises unique, profound and obvious blinding concerns which demand unbiased scrutiny due to extremely dismal real-world pharmacology performance results contrary to the authors' efficacy conclusions.

The World Medical Association (WMA) Declaration of Helsinki commands that the "benefits, risks, burdens and effectiveness of a new intervention must be tested against those of the best current proven intervention" and that placebos should not be used unless "compelling and scientifically sound methodological reasons" are demonstrated.

The authors identified 170 placebo controlled smoking cessation trails that did not involve smokers with chronic disease. Clearly, placebo is not a real-world quitting method, nor are the expectations of those joining pharmacology trials shared by cold turkey quitters who fully expect to endure withdrawal. It is time to either validate that those 170 trials deserve to be considered science based or cease using them as a marketing tool. It's time to either adhere to WMA placebo use standards or accept full responsibility for the premature demise of those deprived of their human rights.

Respectfully,

John R. Polito

Conflict of Interest:

Editor WhyQuit.com