How to use behavorial findings to sell NRT
28 January 2006
Professor West, your presentation was pure science until you decided to taint and transform a stages of change rebuke into an NRT sales pitch, based upon beliefs that are very likely as erroneous as those you just debunked.
I am at a loss to understand why you felt the need to convert a behavioral finding into a nicotine patch commercial. Such boldness and tenacity after openly declaring your pharmaceutical financial ties is disburbing. I submit that this study should have stood on its own.
Professor West, the following issues beg research attention but it is not in the pharmaceutical industry's financial interests to do so. I submit that the following six conclusions are correct and challenge you to disprove them.
1. Almost all successful UK and US quitters who have remained 100% nicotine free for at least six months quit smoking cold turkey (80 to 90%). Conclusion: Pharmaceutical industry commercials and literature which continue to suggest that quitting cold is nearly impossible are both false and deceptive.
2. Conclusion: Placebo controlled NRT clinical studies were not "blind" as claimed and their conclusions simply cannot be accepted as science-based, especially in light of the fact that NRT has failed to show any advantage whatsoever in all real-world surveys to date (see Mooney M, et al, The blind spot in the nicotine replacement therapy literature: Assessment of the double-blind in clinical trials. Addict Behav. 2004 June;29(4):673-84 and http://whyquit.com/pr/051904.html ). Nicotine is a psychoactive chemical producing alert dopamine/adrenaline intoxication. Any smoker with a quitting history has some degree of awareness of what it feels like to have their nicotine removed and returned.
3. Conclusion: NRT clinical odds ratio victories over placebos were not earned but by default. A significant percentage of the active group had its expectations fulfilled and remained to benefit from study behavioral elements that ranged from telephone contact, evaluation visits, counseling, education and group or individual support, each of which have their own proven efficacy. A significant segment of the placebo group had its expectations of receiving weeks or months of free nicotine products shattered and "most" placebo group quitters dropped out within the first two weeks. In no clinical NRT study did researchers ever interview the majority of placebo group which relapsed within the first two weeks, while this group's assignment beliefs and relapse motivation memories were still fresh and accurate (within the first month).
4. Nearly half of all smokers have now attempted quitting with over -the-counter NRT products. Acknowledged GSK consultants conducted a meta- analysis of OTC patch and gum studies and found that 93% of users had relapsed to smoking within six months (see Hughes, JR, Shiffman, S, et al.,A meta-analysis of the efficacy of over-the-counter nicotine replacement. Tobacco Control, March 2003;12:21-27 ). Conclusion: Athough one year OTC NRT cessation rates are a well kept industry secret, if historic rates from 1 year clinical studies hold, roughly 96% of those using OTC NRT as a stand alone quitting tool relapse to smoking within one year.
5. Only two nicotine patch studies have examined the odds of success of second-time nicotine patch users, Tonnesen (April 1993, Addiciton) and Gourlay (1995 August BMJ). In Tonnesen 100% of second-time users relapsed within 6 months and in Tonnesen the rate was 98.4%. As the NRT quitter use rate continues to climb this factor grows even more critical, yet remains undisclosed by the pharmaceutical industry or its army of consultants. Conclusion: Unlike with cold turkey quitting where the odds of success increase with each subsequent attempt, the repeat NRT user's odds of success dramatically decline.
6. One last NRT point relating to the December 2005 report to the UK government that you co-authored, which led to a government brochure for pregnant mothers which advises "Ideally you should try to give up smoking without the use of NRT but if you can't manage this, you can use NRT. The risks to your unborn baby are far less than from continuing to smoke. If you have sickness or nausea NRT patches may be preferable to gum, lozenges, tablets or inhalers."
According to Dr. Theodore Slotkin, one of the leading nicotine toxicologists, "there is abundant evidence that the major problem for fetal development is exposure to nicotine rather than other components of cigarette smoke." Dr. Slotkin pointed me to the Sarasin study which found fetal rat brain nicotine concentrations 2.5 times higher than the mother's blood nicotine level when on continuous nicotine feed, such as would be the case with the nicotine patch (see Reproductive Toxicology, 2003, 17: 153–162 ). Conclusion: UK fetal development is about to experience its darkest era ever. Oh how I pray that you are right and that the world's leading nicotine research toxicologists are wrong.
In closing I ask you to ponder the impression this study leaf with readers. You identified 996 successful ex-smokers and your lead closing recommendation was the nicotine patch. What would you expect them to believe? If you have survey data indicating how the 996 quit I challenge you to share it here. I submit that it will show that more than 900 of them succeeded without resort to replacement nicotine.
John R. Polito Nicotine Cessation Educator
Competing interests: Editor of www.WhyQuit.com, the Internet's leading abrupt nicotine cessation resource.
Competing interests: None declared
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