Wednesday, July 08, 2009

Pharmaceutical Money-Related Bias in Smoking Cessation Research is Now Readily Apparent; New Article Demonstrates How This Bias Pushes Medication

An article published in the current issue of Nicotine and Tobacco Research concludes that spontaneous quit attempts are more than twice as likely to be successful as planned quit attempts (see: Ferguson SG, Shiffman S, Gitchell JG, Sembower MA, West R. Unplanned quit attempts -- results from a U.S. sample of smokers and ex-smokers. Nicotine and Tobacco Research 2009; 11:827-832).

An online survey was conducted with 900 current smokers and 800 ex-smokers. The odds of a spontaneous quit attempt being successful (defined as lasting longer than 6 months) were found to be about 2.6 times greater than the odds of a planned quit attempt being successful. The paper also found that, as expected, planned quit attempts were much more likely to involve the use of pharmacotherapy than unplanned quit attempts.

Thus, these results support the conclusion that cold turkey cessation remains the most effective means of quitting smoking. Cessation attempts that involve pharmacotherapy are substantially less likely to be successful than quit attempts that do not involve the use of pharmacotherapy.

Of course, these findings are in direct contradiction to the recommendations of a national panel of smoking cessation experts, which recommends that pharmacotherapy be used in every quit attempt.

Interestingly, although the authors find that the use of pharmacotherapy is not particularly effective in smoking cessation on a population level, their major conclusion from the study is as follows: "The results suggest, similar to previous research, that a substantial proportion of quit attempts are unplanned and that such attempts can be a successful route to cessation. Given the frequency of such attempts, methods of making treatment available to assist unplanned quitting should be considered."

The Rest of the Story

When I read this paper, I found the conclusion particularly odd. The findings of the study were that planned quit attempts are not the way to go, and that the use of pharmacotherapy is not particularly effective on a population level. The study confirmed previous evidence that unplanned quit attempts are more successful, probably because they involve a much higher level of motivation. But the major conclusion of the study was that methods of making pharmacotherapy available to those making unplanned quit attempts be developed.

I teach my students that in a scientific manuscript, the conclusion of the paper should follow directly from the study findings. And the conclusion should not be one that could have been made in the absence of the study findings. In other words, the conclusion should be directly related to the study findings.

In this case, the conclusion has no direct relationship to the study findings. It does not follow at all from the findings. Those findings do nothing to support the conclusion. In fact, if anything, the study findings are at odds with the conclusion.

The assertion that pharmaceuticals be made available to smokers making spontaneous quit attempts is one which is based on a particular opinion, not one that is based on any specific findings of this study. In fact, such a conclusion could have been asserted prior to even beginning the study. This research did not even test the effectiveness of the use of pharmacotherapy in unplanned quit attempts. There is no evidence presented that pharmacotherapy would be effective in aiding such quit attempts. In fact, it is perfectly plausible that pharmacotherapy would hinder such quit attempts as it would keep the smoker addicted to nicotine while a large proportion of these smokers are getting themselves off of nicotine entirely.

This conclusion seemed quite mystifying to me until I read the fine print at the end of the paper.

The following information is revealed:

1. "This study was funded by GlaxoSmithKline Consumer Healthcare."

2. "Through their work at PinneyAssociates, Dr. Ferguson, Mr. Gitchell, Dr. Shiffman, and Mr. Sembower serve as consultants to GlaxoSmithKline Consumer Healthcare on an exclusive basis
on matters relating to smoking cessation. Dr. Shiffman and Mr. Gitchell also have an interest in a venture to develop a new nicotine replacement medication. Dr. West undertakes research and consultancy for manufacturers of cessation medications and has a share of a patent in a novel nicotine delivery device."

Aha! We suddenly have an explanation for the very odd, contradictory, and out of place conclusion of this study. The pharmaceutical funding of the study and of its authors has created an exceptionally strong bias that is leading to the study pushing drugs when it should probably be doing just the opposite: pushing cold turkey quit attempts without the use of pharmacotherapy.

This is an excellent example of the way in which financial conflicts of interest create significant bias in scientific studies and lead to biased conclusions that do not fairly and objectively present and interpret the scientific findings of a particular study and the overall literature on the topic. The bias is most readily apparent in the recommendations that are made in the study, which do not follow directly from the study findings, but instead, serve the interests of the study sponsor and the financial interests of the investigators.

I want to make it clear that this is no minor issue. It has substantial public health implications. I believe that the obsession with pharmaceuticals is severely hindering the tobacco control movement and the effort to enhance smoking cessation in the population. My own work and experience and that presented in the published literature support the conclusion that the most effective way to enhance smoking cessation is to put resources into aggressive anti-smoking media campaigns that give smokers a major jolt and spur them to make spontaneous quit attempts. The California anti-tobacco media campaign in particular has been documented to have produced exactly such an effect.

But instead of providing further support for the implementation of such interventions, this study is basically trying to support the status quo by merely suggesting that pharmacotherapy be made available to those making spontaneous quit attempts. To be honest, I believe that such an intervention could well do more harm than good. More importantly, to focus on the pharmacotherapy aspect of the intervention takes the attention from where it needs to be: on the need for more aggressive efforts to try to create the motivation necessary for smokers to accomplish the Herculean task of quitting smoking, as demonstrated beautifully in this study.

In some ways, that's the shame of the whole situation. Here is what I consider to be a beautifully conducted, insightful study that brilliantly examines a major research question and makes a huge and rather earth-shaking contribution to the existing literature on smoking cessation. However, what is the conclusion that comes from the study? Merely that the products made by a company with which the authors have a financial conflict of interest be marketed to the smokers who are currently having the most success without pharmaceuticals.

God forbid that a smoker succeeds in quitting without providing profits to Big Pharma, is essentially what this study is concluding.

I don't believe we're that far from a rational and science-based policy regarding the promotion of smoking cessation in this country. But the one thing which is keeping us from getting there is the prostitution of the tobacco control movement to pharmaceutical company financial interests.

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