Friday, April 03, 2009

New Study Demonstrates How Conflicts of Interest with Big Pharma Influence Reporting of the Effectiveness of Smoking Cessation Drug Treatment

A new study published online ahead of print in BMJ reviews the evidence on the effectiveness of nicotine replacement therapy (NRT) in smoking cessation and concludes that: "Available trials indicate that nicotine replacement therapy is an effective intervention in achieving sustained smoking abstinence for smokers who have no intention or are unable to attempt an abrupt quit." (Moore D, Aveyard P, Connock M, Wang D, Fry-Smith A, Barton P. Effectiveness and safety of nicotine replacement therapy assisted reduction to stop smoking: systematic review and meta-analysis. BMJ 2009;338:b1024 doi:10.1136/bmj.b1024).

The article is based on a review and meta-analysis or nicotine replacement therapy treatment of smokers who were unable or unwilling to stop smoking abruptly. The outcome was continuous abstinence from smoking which was generally measured at six month and twelve month follow-up. A secondary outcome was sustained smoking reduction, which was defined as reducing cigarette consumption by more than 50%.

The results were as follows:

The proportion of smokers achieving sustained abstinence at six months with nicotine replacement therapy was 6.75%, compared to 3.28% for placebo, yielding a significant relative risk of 2.06.

The proportion of smokers achieving sustained abstinence at final follow-up (generally one year) was 1.6% for the nicotine replacement therapy group, compared to 0.4% for the placebo group.

The proportion of smokers achieving sustained reduction at six months was 21.8% in the intervention group compared to 16.5% in the placebo group.

The proportion of smokers achieving sustained reduction at final follow-up was 6.3% for the NRT group and 1.6% for the placebo group.

The Rest of the Story

As you can from the actual study results, the conclusions of this paper are highly slanted. With a long-term smoking cessation percentage of only 1.6%, one can hardly call NRT treatment an "effective" intervention. Even though the 1.6% abstinence rate is better than the 0.4% achieved with placebo, no one in their right mind would consider a 1.6% success rate with NRT to be "effective."

In fact, the logical conclusion from this paper is that NRT was a dismal intervention. The overwhelming majority of smokers - 98.4% - failed to achieve long-term sustained abstinence with NRT treatment.

The slanting of the paper's conclusions is also evident with the smoking reduction findings. While getting 6.3% of smokers to reduce their cigarette consumption is a dismal result indicating that NRT is quite ineffective for this purpose, the study authors use the fact that 6.3% is greater than 1.6% to argue that the intervention is effective. That's quite a job of "spinning" the results.

When I read this paper and saw how slanted the study conclusions are in light of the actual data presented, my first thought was: I wonder what the chances are that one of the study authors has a financial conflict of interest with Big Pharma?

Lo and behold, the rest of the story is that study author Paul Aveyard acknowledges that he has been paid by McNeil, a pharmaceutical company located in Sweden that is associated with the Johnson & Johnson family of companies. According to the paper, Aveyard "has accepted hospitality and money from McNeil (Helsinborg, Sweden), which sponsored the trials in the report."

Among other things, McNeil is the manufacturer of Nicorette tablets, Nicorette nasal spray, Nicorette gum, Nicorette inhalator cartridges, and Nicotrol.

Clearly, McNeil has a huge stake in the nicotine replacement therapy market and so there is the appearance that the financial conflict of interest of one of the study authors by virtue of his funding by McNeil affected the slanted way in which the results of this article were reported.

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