In a must-read commentary for all tobacco control practitioners, John Polito explains in easy-to-understand terms why there is such a discrepancy between clinical trial research - which has shown a clear benefit of nicotine replacement therapy (NRT) and other pharmaceutical smoking cessation aids - and population-based research, which demonstrates that NRT is not particularly effective and that cold turkey quitting remains the most effective cessation method.
Polito explains that NRT clinical trials essentially equate receiving a placebo with quitting cold turkey. In other words, in comparing the use of NRT to quitting without pharmaceutical aids, these clinical trials provide nicotine replacement medication to some subjects and a complete dud of a pill to other subjects. It is quite clear to many receiving the placebo that they are taking a dud, since the physiologic effects of nicotine are quite easy to detect. Subjects who are disappointed that they are receiving placebo are discouraged and more likely to return to smoking, simply because of their disappointment that they were not randomized to receive a real medication.
In a brilliant exposition of the limitations of NRT clinical trial research, Polito writes: "The only way to have honest comparisons is to invite and fairly service the nicotine dependency recovery needs of those having an expectation of abruptly ending all nicotine use. To experience the current study format farce in all its glory we'd need to actively recruit smokers who want to quit cold turkey and then randomly assign half to wear a patch. If that sounds strange, remember it is just the mirror image of the clinical trials done to date."
In other words, NRT clinical trials are essentially comparing smoking cessation rates among those who are highly motivated to quit and receive nicotine with cessation rates among those who are highly motivated to quit and then given the disappointment of not receiving the nicotine that they were hoping for.
The Rest of the Story
This explains why the clinical trials have shown a benefit for NRT, while population-based studies, which Polito reviews, have confirmed that cold turkey quitting remains the most effective cessation method. For example, as Dr. John Pierce of the University of California San Diego concluded, the use of NRT "is not associated with any increase in successful quitting in the population."
Interestingly, Pierce was viciously attacked, not for shoddy science but for even daring to suggest that NRT may not be effective. Tobacco control is so firmly entrenched in the hands (and money) of Big Pharma that it simply does not want to hear that pharmaceutical smoking cessation aids are not the panacea that the public has been told they are.
The attacks on Dr. Pierce are not a surprise to me anymore, as I have learned from my own experience that dissent is not allowed in tobacco control and that one cannot challenge the established wisdom of the movement without being personally attacked. The movement is unable to respond substantively to critics, and thus resorts to ad-hominem attacks.
The truth is, however, that Pierce's study was not in any way unique. It simply confirms the results of at least 7 other population-based studies which also found that NRT offers no long-term abstinence benefits when compared to quitting cold turkey.
Fortunately, the limitations of the NRT clinical trials and the pharmaceutical ties of those who are setting national smoking cessation treatment guidelines are starting to be publicly exposed. A February 8 article in the Wall Street Journal noted the financial conflict of interest of the chair of the federal panel that is revising the smoking cessation guidelines:
"Michael Fiore is in charge of revising federal guidelines on how to get smokers to quit. He also runs an academic research center funded in part by drug companies that make quit-smoking aids, and he personally has received tens of thousands of dollars in speaking and consulting fees from those companies. Conflict of interest? No, says Dr. Fiore, who has consistently declared that doctors ought to use stop-smoking medicine. He says his opinion -- reflected in current federal guidelines -- is based on scientific evidence from hundreds of studies. Now debate is growing about that evidence, and about who should be entrusted to interpret it. Some public-health officials say industry-funded doctors are ignoring other studies that suggest cold turkey is just as effective or even superior to nicotine patches and other pharmaceuticals over the long run, not to mention cheaper. "
"The Public Health Service, part of the Department of Health and Human Services, issued guidelines in 2000 calling for smokers to use nicotine patches, gums and other pharmaceutical aids to quit, with a few exceptions such as pregnant women. Dr. Fiore, a University of Wisconsin professor of medicine, headed the 18-member panel that created those guidelines. He and at least eight others on it had ties to the makers of stop-smoking products."
My own opinion, based on my years of experience in the field, is that the almost singular focus on NRT and other pharmaceutical treatments for smoking dependence are more of an impediment to smokers quitting than a help. This focus is obscuring the real problem - which is that smokers must be highly motivated if they are going to quit successfully and long-term.
In other words, smokers are not going to quit unless they really want to quit. You can try cold turkey, with NRT, or with accupuncture or hypnosis, but if you are not highly motivated to quit and do not really feel a deep, emotional desire to rid yourself of the addiction, it's not going to happen. In my experience, the desire to quit cold turkey indicates a much higher level of motivation to quit than simply the desire to take a drug.
Our smoking cessation plan should focus on motivating smokers to quit, not on getting doctors to prescribe pharmaceutical products and making smokers think that quitting smoking is as easy as popping a pill or applying a patch.
This past Tuesday, Ken Millstone of the Columbia News Service highlighted John Polito's and my concerns that cold turkey quitting is being slighted because of the tobacco control movement's singular pre-occupation with pharmaceutical cessation treatment.
"With nicotine replacement therapy, 'the levels of long-term success are dismal,' said Dr. Michael Siegel, a physician and professor at Boston University's School of Public Health. 'More important, I think the role of nicotine replacement therapy as part of a national policy to address smoking cessation has been over emphasized.... Quitting cold turkey has been the most effective way of quitting smoking.'"
Countering my comments and those of John Polito was Dr. Saul Shiffman, "a professor of psychology at the University of Pittsburgh who has studied smoking cessation for 30 years."
Interestingly, what the article does not disclose is that Shiffman has an enormous financial conflict of interest. Far from merely being a professor (like I am), he is also a senior scientific advisor for Pinney Associates, a for-profit business which is funded primarily by...
... you guessed it ------> pharmaceutical companies.
Dr. Shiffman is a consultant to GlaxoSmithKline, maker of NiQuitin, Nicoderm CQ, Nicabate, and Nicorette. He has been paid by GlaxoSmithKline to conduct research with them, and has received funding from the pharmaceutical company for this research. According to his disclosure in another article, he "also has an interest in a new smoking cessation product."
If I'm interpreting this correctly, not only has Dr. Shiffman been funded by GlaxoSmithKline or his research and received consulting income from GlaxoSmithKline, and not only does his company consult primarily for pharmaceutical companies, but he actually has his own financial interest in a new smoking cessation pharmaceutical product.
If I had such extensive financial interests in smoking cessation pharmaceutical products, I'm sure I would also have a much more positive appraisal of the effectiveness and role of these products.