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Fact check of FDA cold turkey fact check

April 4, 2019   John R. Polito
Can the FDA be trusted to tell smokers the truth about which quitting method is the most advantageous, productive, and effective in generating real-world ex-smokers?

The FDA's new cold turkey fact or fiction page suggests that the FDA is unable to be honest with smokers about cold turkey performing better than NRT.

On March 28, 2019 the U.S. Food & Drug Administration (FDA) unveiled a webpage and companion video entitled “Fact or Fiction: What to Know About Smoking Cessation and Medications.”

What’s the first and apparently most important factual “misperception” the FDA sought to correct? The title reads:

“The best way to quit is ‘cold turkey.' Fiction!”

As if saying “trust us,” the FDA provides no citation or reference for any cold turkey assertion.

What does the FDA mean by “best”? Obviously, its definition excludes such factors as the cheapest method, the safest, or the quickest.

Merriam-Webster defines the adjective “best” as 1: excelling all others // the best student in the class; 2: most productive of good: offering or producing the greatest advantage, utility, or satisfaction.

FDA’s Cold Turkey Representation


The FDA’s “cold turkey” fact check opens by stating:

“There is no ‘right way’ to quit smoking, but many smokers try to quit ‘cold turkey’ and are not successful.”

Although nested in ambiguity, is it fair to say that the FDA wants smokers reading this sentence to walk away believing that smokers who attempt to quit smoking cold turkey are not successful?

Fact Check: Cold Turkey “Most Productive” Method


Discussing what “many smokers try,” the FDA is clearly referring to what happens in real-world quitting. There were two population-level quitting method studies published in 2018, the July Weaver et al study in PLoS One[1] and the November Benmarhnia et al paper in the American Journal of Epidemiology.[2]

According to Table 7 data from the Weaver 2018 study, among successful quitters not switching to e-cigarettes, 67% of ex-smokers (56 of 83) quit smoking cold turkey. When the 27 smokers who switched to e-cigarettes are added to the denominator, cold turkey’s share declines to 50.9 percent.[1]

Table 5 data from the Benmarhnia 2018 study indicates that 76.5 percent of the study’s 283 smokers who successfully ended all tobacco use, did so without resort to any approved stop smoking aid or e-cigarettes.[2]

Weaver and Benmarhnia aren’t the only real-world studies where more smokers quit cold turkey than by all other methods combined.

Roughly half of ex-smokers questioned in a 2013 Gallup Poll succeeded via abrupt nicotine cessation. Ironically, the article lead chosen by Gallup News reads, “Former smokers say best way to quit is just to stop ‘cold turkey.’"[3]

Doran 2006, an Australian study, examined the smoking histories of patients of family practice physicians. It found that cold turkey accounted for 1,942 of 2,207 former smokers, or 88% of success stories.[4]

Examining 19 unassisted quitting articles, Smith 2015 provides a more recent and comprehensive look at Australian quitting. “Data from these studies indicated 54% to 69% of ex-smokers quit unassisted.”[5]

What about government real-world studies? Do Department of Health and Human Services (DHHS) findings support the FDA’s assertion that cold turkey quitters are unsuccessful? No, again, the exact opposite.

Featured in a February 8, 2007 front-page Wall Street Journal article originally titled "Nicotine Fix," the only known DHHS study is Hartman 2006, an unpublished National Cancer Institute survey. There, 5,428 smokers out of 8,499 (66%) quit without using any approved quitting aid. In that these unaided quitters also generated the highest quitting rate of any method (16%), they accounted for the vast majority of successful quitters.[6]

As with all studies referenced in this article, none, including Hartman 2006, are referenced in any known DHHS article or webpage.

FDA’s “Proven Methods” Representations


The balance of the FDA’s cold turkey fact check attempts to motivate smokers to purchase and use FDA approved quitting products.

“The good news is that there are several proven methods to help you quit smoking,” smokers are told.

The truth chasm between none and most smokers quitting cold turkey is massive, glaring, consistent and proven. Now, after hiding America’s ex-smoker production champion behind impossible and failure, the FDA tells smokers that:

“There are many ways to get help and there are multiple options proven to be safe and effective when trying to quit. Over-the-counter nicotine replacement therapy products and prescription medications can help minimize the withdrawal symptoms and cravings when trying to quit. Studies show that using cessation medicines can double your chances of successfully quitting…”

Is it fair to say that the phrase “can double your chances” refers to "your" chances under real-world conditions?

But if referring to clinical trial efficacy findings, ask yourself, how many smokers who plan on quitting cold turkey join studies dangling free NRT, Zyban or Chantix as study recruiting bait?

And how fair is it to suggest that smokers wanting and seeking free study "medication," who instead end up chewing, wearing or swallowing a placebo look-a-like, have the same quitting mindset as the average cold turkey quitter?

Cold turkey quitters hope to move beyond withdrawal, whereas "medication" quitters seek to diminish or eliminate it.

Productivity aside, is it true that real-world use of FDA approved "quitting aids" double success rates? No. In some studies it's the exact opposite.

Fact Check: Cold Turkey Offers the “Greatest Advantage”


The 2018 Weaver study paints the most comprehensive quitting methods effectiveness picture yet.[1] The success rate for each method listed below is followed by the number who succeeded by using it and the number who attempted it:

43%   Cold turkey without any e-cig use (56 of 129)
22%   Alternative forms of tobacco without e-cig use (2 of 9)
21%   Zyban or Chantix without any e-cig use (5 of 24)
20%   Gradually cut smoking without any e-cig use (20 of 99)
16%   Any e-cig use (29 of 177)
13%   Nicotine replacement therapy without e-cig use (5 of 38)

Compare Weaver to Table 3 effectiveness findings from the 2006 Doran study data for the period 2001 to 2003 (which includes Zyban attempts but is prior to Chantix or e-cigarettes).[4]

40%   Cold turkey (269 of 669)
22%   Nicotine inhaler (4 of 18)
21%   Nicotine patch (52 of 242)
21%   Zyban (30 of 144)
18%   Hypnotherapy (5 of 28)
11%   Nicotine gum (8 of 70)

Since 2000, UK Professor Robert West has arguably been the world's most influential NRT proponent. Co-author of a 2015 Mayo Clinic Proceedings paper entitled "Prospective Cohort Study of the Effectiveness of Smoking Cessation Treatments Used in the 'Real World'," he finds and shares a fact that no DHHS agency has yet had the courage to share, that "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)."

The FDA's response to overwhelming evidence that approved product clinical efficacy and real-world effectiveness are diametric opposites has been to pretend that the effectiveness evidence-base doesn’t exist.

The FDA's cold turkey fact check closes by claiming that the highest quitting rates are generated by approved products when used in conjunction with counseling and support. Twenty years and a mountain of empirical evidence from online cold turkey support groups such as Turkeyville and Freedom strongly suggest that the FDA is partially correct.

Counseling and support sessions and contact time have their own proven clinical efficacy and real-world effectiveness regardless of the method they accompany.

What’s badly needed are additional studies like Weaver and Doran, studies examining grassroots quitting in even greater detail. It’s what Professor Simon Chapman refers to as, “global research neglect of unassisted smoking cessation.”[7]

According to Chapman, “[h]ealth authorities should emphasise the positive message that the most successful method used by most ex-smokers is unassisted cessation.”

Unfortunately, doing so would damage or destroy the FDA’s 35-year smoking cessation drug approval reputation.

Boxed in, the FDA and the DHHS have no choice but to continue to ignore existing population findings, to suppress much needed research, to omit cold turkey questions from national tobacco use surveys, to pretend that placebo users fairly reflect cold turkey quitters, to use agency muscle to diminish the credibility and visibility of authorities and websites advocating, teaching and/or supporting abrupt nicotine cessation, and, as here, to lie to smokers.

References:

1. Weaver SR, Huang J, Pechacek TF, Heath JW, Ashley DL, Eriksen MP. Are electronic nicotine delivery systems helping cigarette smokers quit? Evidence from a prospective cohort study of U.S. adult smokers, 2015–2016. 2018 PLoS ONE 13(7): e0198047. https://www.ncbi.nlm.nih.gov/pubmed/29985948

2. Benmarhnia T, Pierce JP, Leas E, White MM, Strong DR, Noble ML, Trinidad DR. Can E-Cigarettes and Pharmaceutical Aids Increase Smoking Cessation and Reduce Cigarette Consumption? Findings From a Nationally Representative Cohort of American Smokers, Am J Epidemiol. 2018 Nov 1;187(11):2397-2404. https://academic.oup.com/aje/article/187/11/2397/5046037Tarik https://www.ncbi.nlm.nih.gov/pubmed/29955810

3. Newport F, Most U.S. Smokers Want to Quit, Have Tried Multiple Times. Former smokers say best way to quit is just to stop "cold turkey." Gallup, July 31, 2013. https://news.gallup.com/poll/163763/smokers-quit-tried-multiple-times.aspx

4. Doran CM, Valenti L, Robinson M, Britt H, Mattick RP. Smoking status of Australian general practice patients and their attempts to quit. Addict Behav. 2006 May;31(5):758-66. Epub 2005 Aug 31. https://www.ncbi.nlm.nih.gov/pubmed/16137834.

5. Smith AL, Chapman S, Dunlop SM. What do we know about unassisted smoking cessation in Australia? A systematic review, 2005-2012. Tobacco Control. 2015 Jan;24(1): Pages 18-27. https://www.ncbi.nlm.nih.gov/pubmed/24026163

6. Hartman AM, What Does U.S. National Population Survey Data Reveal About Effectiveness of Nicotine Replacement Therapy on Smoking Cessation? National Cancer Institute, 2006 https://whyquit.com/NRT/studies/Hartman_NCI_NRT.pdf

7. Chapman S, MacKenzie R. The global research neglect of unassisted smoking cessation: causes and consequences. PLoS Med. 2010 Feb 9;7(2) https://www.ncbi.nlm.nih.gov/pmc/articles/PMC2817714/

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Page created 04/04/19 and last revised 04/05/19 by John R. Polito