Wednesday, July 12, 2006

World Conference on Tobacco and Health Sponsorship by Big Pharma Precludes it From Being Objective Scientific Symposium

The 13th World Conference on Tobacco and Health convenes today in Washington, D.C. As John Polito argues in a must-read piece, the sponsorship of this conference by two major pharmaceutical companies that market nicotine replacement products (Pfizer and GlaxoSmithKline) precludes the conference from being an objective scientific symposium that can freely consider the appropriate role of nicotine replacement therapy (NRT) as part of an effective national or international smoking cessation strategy.

Polito's piece is perhaps the best, most insightful, and most enlightening article I have ever read during my years in tobacco control. It is must reading for anyone in tobacco control or anyone interested in the issue of smoking cessation. In fact, the piece is so nicely put together and well-argued that I'm afraid I can offer readers little better than simply referring them to the piece.

According to Polito: "Keenly aware of smoking's massive annual slaughter and in search of help, government health officials from around the globe will descend upon Washington DC from July 12-15 for the 13th World Conference on Tobacco or Health. What they'll find instead is that the conference's two corporate sponsors -- GlaxoSmithKline and Pfizer -- have produced a well orchestrated commercial designed to convince them that government subsidized nicotine is the answer - replacement nicotine or NRT. What they won't hear is the truth, that replacement nicotine has never proven effective in any real-world setting and likely never will.

The California tobacco survey, the Minnesota insurance survey, Quebec Quit and Win, the Tobacco in London survey, Western Maryland, UK NHS Smoking Cessation Services, Australia family practice survey, two decades after its 1984 introduction NRT does not have a single real-world performance victory, none. ...

The reason NRT will never be effective in head-to-head real-world competition is that the expectations of cold turkey quitters to abruptly end all nicotine use are beyond the ability of the pharmaceutical industry to exclude, redefine, tease, torment, play upon, frustrate, defeat or destroy. The clinical lesson kept quiet by the pharmaceutical industry and its army of loyal research consultants is that clinical efficacy studies were an expectations nightmare. Study participants joined in hopes of receiving weeks or months of free replacement nicotine. Instead of NRT clinical odds ratio victories evidencing NRT efficacy they reflect the frustration and fulfillment of the nicotine addict's nicotine expectations. ...

Clinical efficacy and community effectiveness are two entirely different standards. According to an August 2004 article by Dr. Lois Biener, PhD, Senior Research Fellow, University of Massachusetts, "the effectiveness of NRT in the general population has not been established. In spite of the fact that NRT and other drugs are included in the Public Health Service guidelines, their efficacy has only been demonstrated in carefully controlled clinical trials. Evidence of their effectiveness in general population has been difficult to find."

Dr. [John] Pierce analyzed seven years of data from the California Smoker's Survey, one of the world's largest. His study, published in the September 11, 2002 issue of the Journal of the American Medical Association, concluded that "NRT appears no longer effective in increasing long-term successful cessation in California smokers."

The Rest of the Story

Polito makes several critical points. First, the failure of blinding in just about every NRT clinical trial casts doubt on the validity of these studies. Smokers entering a trial and hoping to receive nicotine replacement are likely to be able to detect whether they are indeed receiving it. And if they aren't, what are the chances that they are going to maintain their enthusiasm and motivation to remain cigarette-free? Is NRT truly being compared to placebo, or is this essentially a one-arm study, with NRT being compared to a population of disappointed research subjects?

Second, demonstrating the effectiveness of NRT in clinical trials is a far cry from proving that NRT is an effective smoking cessation aid in actual practice. The fact that despite positive clinical trials, NRT has generally not been found to be an effective method for smoking cessation in the general population is discouraging.

Yet, these results are consistent with the data showing that the overwhelming majority of smokers who quit successfully do so cold turkey, without the aid of NRT products.

Third, claims that NRT doubles a smoker's chances of quitting versus "cold turkey" methods are invalid, because the clinical trials do not compare those who are randomized to receive NRT with those who are highly motivated to quit such that they want to do it "cold turkey." As Polito astutely points out, NRT has never gone head-to-head against those wanting to quit "cold turkey" in any cessation trial. Without such a study, can it accurately be claimed that NRT is twice as effective as quitting "cold turkey?"

Fourth, population-based data on smoking cessation methods do not support the contention that NRT is an effective smoking cessation strategy. In 2000, only 6.8% of former smokers stated that they had used drug therapy to help them quit, while a whopping 91.4% of successful quitters stated that they had quit "cold turkey" or by gradually decreasing the amount smoked (ACS Cancer Facts and Figures 2003).

Fifth, the actual quit rates achieved using NRT are dismally low, even if they are a modest improvement over quit rates of those who are randomized not to receive replacement nicotine. A review of over-the-counter nicotine patch and gum studies reported that 93% of participants relapsed to smoking within six months. Moreover, quit rates are even lower for those who fail once on NRT, but improve for those who fail on "cold turkey" attempts.

Finally, some studies have suggested that NRT may be more hazardous than smoking for pregnant women, because more nicotine is delivered to the fetus from NRT than through smoking. This is one example where the use of NRT may actually be hazardous, rather than merely ineffective.

With Pfizer and GlaxoSmithKline serving as two of the largest corporate sponsors of the 13th World Conference, there is simply no way that this can be an objective scientific symposium, especially when it comes to a discussion of the appropriate role (if any) of NRT in a national and international strategy to promote and enhance smoking cessation.

As I noted when I first learned of the sponsorship of this conference by Big Pharma: "the upshot [of this sponsorship] is that the World Conference on Tobacco or Health will not offer an objective consideration of the potential role of nicotine replacement products in a national and global smoking cessation strategy. This is particularly unfortunate given the problems that the tobacco control movement seems to be having these days with its scientific integrity. And it is at least slightly ironic, I think, given that one of the topics to be discussed at the conference is research sponsored by the tobacco industry and how the fox was apparently guarding the hen house. In some ways, having Pfizer and GlaxoSmithKline sponsor this conference is kind of like inviting the fox into the hen house. One thing is for sure. A truly objective consideration of the appropriate role of nicotine replacement therapy in a national and global smoking cessation strategy is desperately needed. But such an objective review cannot and will not come out of the 2006 World Conference on Tobacco or Health, specifically because the chief sponsors of the conference are none other than the foxes themselves."

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