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10 studies screaming
"leave replacement nicotine alone!"

Updated August 4, 2018 by John R. Polito

BMJ image of Polito's quit smoking article How is a nicotine addict attempting to wean themselves off of nicotine any different than the alcoholic toying with alcohol weaning?

Imagine an alcohol replacement therapy clinical trial. Imagine the accomplishment of alcoholics who successfully transferred their dependency from a bottle or beer can to an IV drip bag being compared to alcoholics who had abruptly ended alcohol use weeks or months earlier, when given IV bags containing sugar water (the placebo group). How long would it be before someone shouted fraud?

Why do nicotine replacement therapy products (NRT) - the nicotine patch, gum and lozenge - prevail inside randomized clinical trials yet fail miserably in real-world use?

The loser within clinical trials was a placebo group using look-a-like NRT products. What the pharmaceutical industry would rather you not know is that the placebo gum (1982) or placebo patch (1996, 1997, 2002) was often spiked with just enough nicotine to keep users in the tease and throws of withdrawal: not delivering enough to satisfy cravings, nor allowing them to get clean, begin re-sensitizing, and move beyond peak withdrawal.

Studies not using active placebos were not blind as claimed. It's why active placebos were needed. Researchers knew that if participants were aware of their assignment, that the outcome would reflect expectations, not product worth.

Smokers with lengthy quitting histories become experts at recognizing the onset of withdrawal. The few quality blinding integrity assessments shared in clinical studies show that three (1997, 2005) to four (2009) times as many placebo group members could correctly declare their randomized assignment as declared wrong, and could do so within 24-48 hours of quitting (peak withdrawal).

Would you have become frustrated if you'd joined a study hoping to receive weeks or months of free NRT, only to realize that you'd been given a placebo instead? So did many of them.

Aside from frustration handing NRT victory by default, counseling, support and other study contacts were designed to at first foster successful dependency transfer from smoking to NRT, and then to gradually weaning NRT users off of nicotine. What the inactive placebo group needed and was deprived of was counseling, guidance and support tailored to the needs of someone abruptly ending nicotine use.

Real-world NRT quitters are not trained, counseled and supported by NRT experts. But then, neither are real-world cold turkey quitters. World-wide, relatively few cold turkey quitters study at cold turkey quitting schools such as WhyQuit.com.

That's what makes the below 10 real-world studies so critical, the fact that unassisted cold turkey quitters generate substantially higher long-term success rates than unassisted NRT quitters.

What NRT stakeholders will never do is to conduct fair studies which pit quitters educated and schooled in successful abrupt nicotine cessation against quitters educated and schooled in nicotine dependency transfer and weaning. Why? Because, as shown below, even with delayed nicotine cessation, NRT gets clobbered in "almost" fair fights.

Truth is, all long-term independent real-world population level quitting method studies since 2002 have found that NRT simply doesn't work. As I suggested in a 2012 British Medical Journal letter, NRT has undercut successful quitting and is costing lives.

NRT's Killing FieldsSo, how does pharma get away with selling products that don't work? It relies upon an army of paid academic consultants to help hide, suppress or dismiss as non-science-based any and all evidence of NRT ineffectiveness. It then markets NRT by knowingly pretending the fiction that efficacy and effectiveness are one in the same.

NRT marketing often includes the assertion that NRT doubles "your" chances. The word "your" clearly suggests population effectiveness, not efficacy victories over placebo.

Common sense shouts that smokers wishing to quit cold turkey do not join NRT studies. Nor do they use placebo NRT products laced with small amounts of nicotine. The only time NRT has gone head-to-head with cold turkey is out in the street.

And what happens there? Nicotine's half-life inside the body is two hours. It means that within 72 hours of ending all use, that the cold turkey quitter will become 100 percent nicotine-free. Their brain receptors will begin re-sensitizing and they'll have no choice but to move beyond peak withdrawal within the first 3 days.

The pharmaceutical industry's economic muscle and influence is massive, as evidenced by the millions it annually hands to researchers, consultants, universities, medical journals, and to both government and public health organizations.

Could that muscle be why a former Nicorette salesman now heads the Food and Drug Administration's new Center for Tobacco Products, or why the nation's telephone quitline nicotine patch give-a-way champion was appointed director of the Centers for Disease Control's Office on Smoking and Health?

Could it also be why quitters will not find reference to any of the following 10 population level studies on any website advocating NRT use? Could it be that the CDC and FDA are on the wrong side in the war against smoking (pharma's)?

Key Studies Warnings Against NRT Use

  1. July 2018 - PLoS One (free full-text): Taken at face value, Table 7 of this prospective population-based study indicates that quitting smoking cold turkey was not only 11 times more productive than nicotine replacement therapy (NRT) in producing successful quitters (56 cold turkey quitters vs. 5 NRT quitters), it was also 3.3 times more effective (43.4% vs. 13.1%). Unfortunately, as my official comments regarding the study indicate, the study's definition of "cold turkey" was abrupt smoking cessation, not abrupt nicotine cessation. Thus, quitting method crossover would likely change the above figures somewhat but probably not much.

    July 2018 PLoS One quit smoking method effectiveness chart
  2. October 2014 - Mayo Clinic Proceedings: A prospective population level study involving the UK's previously most driven and dedicated NRT advocate (Robert West, PhD) found that "Compared with smokers using none of the cessation aids" at 6-month follow-up" ... "use of NRT bought over the counter was associated with a lower odds of abstinence (odds ratio, 0.68; 95% CI, 0.49-0.94)."
  3. July 2013 - Gallup Poll: After 3 decades of heavy nicotine gum marketing, this national survey found that only 1 in 100 successful ex-smokers credit nicotine gum for their success, that only a tiny fraction quit by use of any approved product (just 8%), and that more quit smoking cold turkey than by all other methods combined.
  4. January 2012 - Annual Review of Public Health: This study reviewed U.S. government survey data and found that, whether a light smoker (less than 15 cigarettes per day) or a heavy smoker (greater than 15 per day), that replacement nicotine is ineffective when compared to smokers quitting unassisted.
  5. July 2009 - Nicotine & Tobacco Research: By definition, purchase of nicotine patches, gum or lozenges requires planning. This study involved one of the leading U.S. NRT advocates, Saul Shiffman, PhD. Nearly identical results to an earlier 2006 UK study, it found that unplanned quit smoking attempts were 2.6 times more likely to succeed for 6 months than planned attempts. It's why any website asserting that planning is "key" to success is a quitting product storefront (a claim being made by both Philip Morris USA and the CDC).
  6. May 2006 - Addictive Behaviors: Patient smoking and quitting data of 1,000 Australian family practice physicians was gathered and analyzed. Not only was cold turkey quitting by far the most effective method - doubling the success rate of nicotine gum, nicotine patch and nicotine inhaler quitters - it was by far the most productive method. Successful cold turkey quitters accounted for 1,942 of 2,207 former smokers, a whopping 88% of all success stories.
  7. 2006 - National Cancer Institute - A February 8, 2007 front-page Wall Street Journal article by a Pulitzer Prize winning author featured a study by the National Cancer Institute. The Institute's study examined 8,200 quitters and found that at 9 months those quitting without use of approved products had a slightly higher rate of success than those using the nicotine gum, patch, lozenge or Zyban. Unpublished and not available on any government website, the study evidences actual government awareness and cover-up of NRT ineffectiveness.
  8. 2005 - Journal of Addictive Disorders: Among 1,954 questionnaire respondents, "when NRT use was assessed in relation to smoking status in 1998, 30% of NRT ever users compared to 39% of nonusers had quit smoking."
  9. June 2004 - Addictive Behaviors: This study reviewed NRT blinding integrity assessments. It should have alerted both the FDA and CDC to the fact that NRT studies were not blind as claimed in that 12 of 17 studies "found that subjects accurately judged treatment assignment at a rate significantly above chance. U.S. health officials should have immediately demanded that all future studies funded by taxpayers include a blinding integrity assessment."
  10. March 2003 - Tobacco Control: A study by GlaxoSmithKline paid consultants combined and averaged all U.S. over-the-counter nicotine patch and gum studies. It found that 93 percent of OTC NRT quitters had relapsed to smoking within 6 months.
  11. 2003 - Cancer Facts & Figures 2003: Table 3 on page 25 of this American Cancer Society report shares data findings from the 2000 national surveys. It indicates that 91.2% of former U.S. smokers quit smoking cold turkey. This was 16 years after nicotine gum became a cornerstone of U.S. cessation policy.
  12. September 2002 - Journal of the American Medical Association: This study involved a large population level quit smoking survey sampling. It concluded that "Since becoming available over the counter, NRT appears no longer effective in increasing long-term successful cessation in California smokers."

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Written 01/01/15 and page reformatted 08/04/18 by John R. Polito