Wednesday, November 30, 2011

New Study Calls Nicotine Sampling Therapy a Promising Strategy for Smoking Cessation, Even Though Study Itself Found No Effect on Six-Month Abstinence

A study published this week in the Archives of Internal Medicine concludes that nicotine sampling therapy (giving smokers samples of nicotine replacement therapy [NRT] to promote NRT use) is a promising strategy to promote smoking cessation.

The study involved a randomized clinical trial which compared a practice quit attempt intervention with or without the provision of nicotine lozenges to promote the use of NRT among a sample of smokers who were unmotivated to quit.

The methods, as describe in the study abstract, were as follows: "Within a nationwide randomized clinical trial (N = 849) to induce further quit attempts and cessation, smokers currently unmotivated to quit were randomized to a practice quit attempt (PQA) alone or to nicotine replacement therapy (hereafter referred to as nicotine therapy), sampling within the context of a PQA. Following a 6-week intervention period, participants were followed up for 6 months to assess outcomes. The PQA intervention was designed to increase motivation, confidence, and coping skills. The combination of a PQA plus nicotine therapy sampling added samples of nicotine lozenges to enhance attitudes toward pharmacotherapy and to promote the use of additional cessation resources. Primary outcomes included the incidence of any ever occurring self-defined quit attempt and 24-hour quit attempt. Secondary measures included 7-day point prevalence abstinence at any time during the study (ie, floating abstinence) and at the final follow-up assessment."

The intervention was successful in getting smokers to make quit attempts and to use NRT (presumably in those quit attempts). While only 12.5% of those in the control group used NRT in the post-intervention follow-up period, 69.0% of those in the nicotine sampling therapy group used NRT (presumably to try to quit) during the post-intervention follow-up period.

The study concludes that the use of nicotine sampling therapy increases quit attempts and enhances NRT use and is therefore a promising strategy to promote smoking cessation.

The Rest of the Story

It might surprise readers to find out that the study actually found that nicotine sampling therapy was ultimately ineffective. At six months follow-up, there was no significant difference in the point prevalence of abstinence between the NRT group (16%) and the control group (14%).

Because the intervention had no effect on 6-month smoking cessation rates, it clearly had no effect on the bottom line: sustained cessation. For this reason, I disagree with the study conclusion. I do not conclude that NRT sampling is a promising strategy. I think this study demonstrates that it is a failed strategy. The bottom line is this: it didn't work. At six months, those in the intervention group were just as likely to be smoking as those in the control group. To me, that's a failure.

In fact, I believe the study provides strong evidence that NRT is quite ineffective in promoting smoking cessation, at least among smokers who are not motivated to quit. Since 69% of the smokers in the intervention group tried NRT and only 12.5% of smokers in the control group used NRT, the failure to find any difference in cessation at six months suggests that the use of NRT had no effect on smoking cessation.

The paper spins the results in an entirely different direction, calling NRT sampling a promising approach.

This at first seemed odd to me. However, it then occurred to me that what I see as an apparent bias in the interpretation of the study results could perhaps be a result of a financial conflict of interest, something I have observed time and again in the NRT literature. And in fact, in turns out that two of the study authors have or have had significant conflicts of interest with Big Pharma.

One author discloses the following: "Since January 1, 2008, Dr Hughes has received research grants from ... the National Institutes of Health and from Pfizer Pharmaceuticals; the latter
develops and sells smoking cessation medications. During this time, he has accepted honoraria or consulting fees from the following nonprofit and for-profit organizations and companies that develop, sell, or promote smoking cessation products or services or educate or advocate about smoking cessation: Abbott Pharmaceuticals, Aradigm, ... DLA Piper, EPI-Q, ... Evotec, Free and Clear, GlaxoSmithKline, Golin Harris, Healthwise, Integrated Communication, Invivodata, ... McNeil Pharmaceuticals, Novartis Pharmaceuticals, ... Pfizer Pharmaceuticals, Pinney Associates, Propagate Pharmaceuticals, Reckner Associates, Scientia."

Thus, this author has substantial financial conflicts of interest by virtue of his research funding and consulting income from a number of pharmaceutical companies that develop, sell, or promote smoking cessation medications.

A second author does not have any current conflict of interest, but previously, he reports having consulted for and received consulting payments from GlaxoSmithKline for helping the company market its Nicorette Fruit Chill gum. Though this financial relationship with the pharmaceutical company occurred in 2006, I explained earlier why I believe it is still very much relevant for the reader of the present study.

This is another example of a research study where I come to a very different conclusion than the article does about the effectiveness of NRT. And once again, the difference in interpretation has at least the appearance of potentially resulting from bias associated with a financial conflict of interest with Big Pharma.

I think this is a very serious issue because in my opinion, the obsession with NRT in smoking cessation treatment has been the greatest obstacle to finding an effective approach to helping smokers quit. Thus, it is an obsession that in my opinion has cost lives by diverting attention and resources from more effective potential approaches. I find it particularly unfortunate, therefore, that what I see as a skewed presentation of the science on NRT's effectiveness has the appearance of being influenced by financial conflicts of interest with pharmaceutical companies.


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