Tuesday, June 14, 2011

NRT and Chantix Proving to Be Less and Less Effective as Studies Approach Real-Life Conditions

Most of the research leading anti-smoking advocates to view nicotine replacement therapy (NRT) and medications like Chantix as effective for smoking cessation involves clinical trials in which subjects received intensive interaction with research staff, including counseling, interviews, and repeat phone calls. However, in real life (outside of the setting of clinical trials), the situation is very different. Some have therefore questioned whether the effectiveness rates of NRT and Chantix in clinical trials is indicative of their likely actual effectiveness as they would be typically used on a population basis.

New research published online ahead of print in the journal Nicotine and Tobacco Research suggests that in more real-life settings, the effectiveness of Chantix is far below that which has been previously reported in clinical trials. While six-month abstinence rates with Chantix as high as 33.5% were reported in the drug's original FDA approval studies, the current study reports only a 14% six-month point-prevalence (7-day) abstinence rate with Chantix (compared to 7% for placebo).

The population in this study consisted of smokers who wanted to quit but had no quit attempt planned in the next month.

The Rest of the Story

In the current study, subjects were provided with just 8 support/counseling sessions compared to 19 in the original Chantix clinical trial. As John Polito points out, the real question is what the six-month abstinence rate would be for the use of Chantix without any support and counseling sessions, as is the case most typically with the population-based use of this drug for smoking cessation.

This research suggests that as the number of support sessions falls and the intervention approaches a real-life situation, the effectiveness of the medication falls quite drastically.

Of note, the same lead study author has previously reported a six-month abstinence rate of only 7% for over-the-counter use of nicotine replacement therapy. This is again much closer to the real-life situation than many clinical trials.

The rest of the story is that tobacco control advocates and researchers are grossly over-estimating the effectiveness of existing, FDA-approved pharmaceutical smoking cessation aids such as nicotine replacement therapy and Chantix because the clinical trial setting with intensive intervention, counseling, and support does not simulate the real-life situation in which most of the population is using these drugs.

It's quite interesting that many tobacco control researchers are questioning the use of electronic cigarettes because they have not been shown to be effective for smoking cessation, yet these same researchers have no problem recommending for widespread use an approach that appears to fail at least 93% of the time.

(Thanks to John Polito for the tip, and for the many insights that I incorporated into this post).

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