FOR IMMEDIATE RELEASE - June 4, 2004
Charleston, South Carolina
Contact: John R. Polito (843) 797-3234
Widespread Blinding Failures Put Validity of Nicotine Replacement Studies in Serious Question
Does NRT really double a smoker's chances? While real-world quitting surveys find no advantage, their simplicity has been attacked as unscientific by double-blind clinical trial NRT researchers. Now the clinical trial's integrity is in question as a new study reports blinding failures in 71% of NRT studies assessing blindness.
Charleston, SC June 4, 2004 -- Imagine deeply believing the "double your chances" NRT marketing slogan and hearing about a study offering a 50/50 chance of receiving three months of free nicotine patches. Once in the study, imagine being able to sense that the flow of nicotine to your brain had ended, as you grew confident that the patch on your arm was empty when placed there. Would frustrated expectations have destroyed your resolve to continue?
NRT'S BLIND SPOT
A study in the June 2004 edition of Addictive Behaviors identified 73 double-blind placebo controlled NRT trials and found that only 17 had conducted blinding assessments. During assessments participants were asked to surmise whether they had been using a real nicotine delivery device or an empty placebo.
According to the authors, 12 of the 17 studies (71%) reported blinding failures as "subjects accurately judged treatment assignment at a rate significantly above chance."
Entitled "The blind spot in the nicotine replacement therapy literature: Assessment of the double-blind in clinical trials," the study was led by Marc Mooney at the University of Minnesota's Tobacco Use Research Center. It found that almost two-thirds of placebo patch quitters were "confident" that they had not received the real nicotine patch.
The study lists a number of prior studies foreshadowing that attempts to use placebo controls in clinical NRT trials might not produce accurate assessments of NRT's true merits.
The authors assert that nicotine is a psychoactive drug providing cues making it easier to discriminate and cite a 1996 study in which smokers were "trained to reliably distinguish various doses of nicotine from placebo."
It cites a series of studies indicating that using nicotine will "reliably reduce withdrawal symptoms," that "most have quit several times before entering clinical trials, and many are only too familiar with the syndrome," and that "the use of a double-blind design provides no guarantee that ... participants remain blind to their treatment assignment."
BLIND TO MISSING TURKEYS
Although current NRT marketing asserts that NRT "doubles a smoker's chances of quitting versus cold turkey," smokers might be surprised to learn that "real" cold turkey quitters were not invited to formal NRT studies to compete against NRT quitters.
Instead, the industry's "double your chances" assertion is based entirely upon clinical odds ratio victories generated by performance of quitters receiving months of free nicotine products, over those who wanted to receive months of free nicotine products but were instead randomly assigned to receive placebo products.
Does cutting back on nicotine intake prior to ending its use alter any quitter's underlying dream of freedom? Instead, could frustrated expectations and rewarded expectations have handed NRT an unearned victory? Could a billion dollar nicotine replacement industry have been built almost entirely upon known blinding failures?
CLUES THE BLIND COULD FOLLOW
Aside from "real-world" quitting surveys in California, London and Quebec in which those choosing to quit cold turkey performed just as well as those using a growing array of expensive NRT products, a March 2003 meta-analysis that combined and averaged all seven over-the-counter (OTC) patch and gum studies provides highly visible evidence that the merits of NRT may have been vastly overstated.
The study found that only 7% of OTC patch and gum users and 3% of placebo group quitters were still not smoking at six months. Although it again provided NRT with its much heralded "double your chances" victory margin, according to June 2000 U.S. Clinical Practice Guideline evidence tables, the 3% placebo rate is at least three times lower than historic six-month "on-your-own" quitting rates.
The authors of the March 2003 study speculate that the extremely low rate could be due to less dependent smokers having already successfully quit, with remaining smokers comprising a "hardened" heavily dependent population. But the hardening argument is in obvious conflict with real-world findings.
The Journal of the American Medical Association published the results of the California smoker survey on September 11, 2002. It contains graphs indicating absolutely no long-term NRT advantage for light smokers (less than 15 cigarettes per day) or heavy smokers (more than 15 per day).
The California survey review boldly concludes that, "NRT appears no longer effective in increasing long-term successful cessation in California smokers."
GRASPING FOR BLINDNESS
How long were the pharmaceutical industry and researchers aware of serious blinding concerns? According to the "Blind Spot" study they began toying with trying to fool placebo group quitters by putting small amounts of nicotine (.5 or 1 mg.) into pieces of placebo gum as early as 1982.
The study indicates that the practice was also used in a number of nicotine patch studies where patches worn by placebo group members released up to 3 mg. of nicotine, the nicotine equivalent of smoking three cigarettes a day. No formal clinical study can be found testing the effects upon placebo group cessation rates of using nicotine as a masking agent.
Although the new study asserts that a dozen failures are not sufficient in number, depth of analysis or uniformity to allow definitive conclusions about their "consequences," it warns researches that "the validity of NRT clinical trial results could be questioned" if future studies fail to make proper blinding assessments.
In that the pharmaceutical industry funded a large percentage of NRT studies, what the "Blind Spot" study leaves unaddressed is why the 71% failure rate would be any lower in the 56 studies that chose not to conduct blinding assessments or, at least, to not publish their results.
1. Blind Spot Study: 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 (link to full-text copy in PDF format)
2. Fact: Pharmaceutical industry "double your chances over cold turkey" assertions: GlaxoSmithKline May 3, 2004 Press Release; Pfizer January 16, 2004 Press Release
3. Fact: Four real-world quitting surveys finding no advantage for NRT: (1) Pierce, JP, et al., Impact of Over-the-Counter Sales on Effectiveness of Pharmaceutical Aids for Smoking Cessation. Journal of the American Medical Association, September 11, 2002;288:1260-1264 (link to full text in PDF format); (2) Boyle, RG, et al, Does insurance coverage for drug therapy affect smoking cessation? Health Affairs 2002 Nov-Dec;21:162-8 (link is to study abstract);(3) SmokeFree London, Tobacco in London - Facts and Issues, June 2003, Figure 14, PDF page 17 (link is to report in PDF format); (4)Gomez-Zamudio, M, et al, Role of pharmacological aids and social supports in smoking cessation associated with Quebec's 2000 Quit and Win campaign, Preventive Medicine 2004 May;38(5):662-7 (link to study abstract).
4. Fact: 7% OTC NRT six-month quit smoking rate, 3% placebo rate: 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 (link to full text copy)
5. Fact: 3% OTC NRT meta-analysis placebo rate at least three times lower than historic rates: USDHHS Clinical Practice Guideline, June 2000 (link to 196 page PDF document - . Also see Polito, JR, Does the Over-the-counter Nicotine Patch Really Double Your Chances of Quitting?, WhyQuit, April 2002 (link to online article averaging Guideline evidence tables)
Related Links and Articles
- Nicotine cessation: lost in the deserts of Abu Dhabi, Polito, JR, 03/16/15
- 10 studies screaming "leave replacement nicotine alone!" Polito, JR, 01/01/15
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- The Great American quit smoking sham, Polito, JR, Nov. 18, 2013
- BMJ's non-publication policy should extend to pharma's nicotine, Polito JR, Oct. 19, 2013
- A letter to Obama: one nicotine addict to another, Polito JR, Sept. 26, 2013
- Gallup Poll: cold turkey 48 times smarter than Nicorette, Polito JR, Aug. 26, 2013
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- Pharma bias destroys ITC quit smoking medication study, Polito JR, Aug. 20, 2012
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- Replacement Nicotine's Killing Fields, Polito JR, Feb. 11, 2012
- Dying truths about quitting smoking methods, Polito JR, Nov. 14, 2011
- Bias against cold turkey quitting apparent in literature, Siegel, M, Nov. 3, 2011
- Suicidal behavior and depression in smoking cessation treatments, Moore TJ et al, Nov. 3, 2011
- Study finds cold turkey quitting more effective but concludes opposite, Siegel, M, Nov. 1, 2011
- Tar wars over smoking cessation, BMJ Link, Chapman, S, Aug. 8, 2011
- Is a 14% Chantix success rate worth risking death?, Polito JR, June 14, 2011
- Chantix fails to defeat nicotine patch, Polito JR, March 30, 2011
- Chantix serious injuries exceed 8,500, Polito JR, Jan. 29, 2011
- Chantix - Champix worth questioned, Polito JR, Jan. 6, 2011
- How to quit smoking, Polito JR, Dec. 18, 2010
- GlaxoSmithKline continues defrauding smokers, Polito JR, Nov. 2, 2010
- Little communication in failed war against smoking, Polito JR, August 8, 2010
- Addiction to Smoking Nicotine a Mental Illness and Disease, Polito JR, April 12, 2010
- Smokefree.gov really Buymeds.now, Polito JR, March 24, 2010
- American Association of Public Health Physicians Calls for End to Cold Turkey Discrimination, Nitzkin, JL, March 21, 2010
- CDC Ignores Cold Turkey Quitters, Polito JR, March 11, 2010
- New Study Shows That Even Extended Nicotine Replacement Therapy is Extremely Ineffective; Unaided Quitting Rates are Far Better , Siegel M, March 4, 2010
- Four Members of FDA Tobacco Products Scientific Advisory Committee Have Received Pharmaceutical Money; Influence of Industry on FDA Grows, Siegel M, March 2, 2010
- GlaxoSmithKline Given a Seat on FDA Tobacco Products Scientific Advisory Committee, Siegel M, March 1, 2010
- The Global Research Neglect of Unassisted Smoking Cessation: Causes and Consequences, Chapman S and MacKenzie R. PLOS Medicine, February 2010
- Smoking Racket, ABC.net, Chapman S, February 10, 2010
- Five facts Chantix ads keep hidden, Polito JR, December 29, 2009
- UW-CTRI's Holiday Health Media Manipulation, Polito JR, December 16, 2009
- Petition for Honest Quit Smoking Studies, Polito JR, December 2, 2009
- University of Wisconsin: World's Pharm Nicotine Sales Center, Polito JRWhyQuit, November 12, 2009
- Free quit smoking ebook's 2 millionth download, Polito JR, October 12, 2009
- ALA's Not-On-Tobacco school quit smoking program not effective, Polito JR, September 7, 2009
- Tobacco control integrity champ demands review of U.S. cessation policyPolito JR, July 18, 2009
- IN MY VIEW: Effectiveness of Nicotine Replacement Therapy Needs to Be Re-Examined, Siegel M, July 17, 2009
- Nicotine patch inventor fudges patch study findings, Polito JR, July 12, 2009
- Cold turkey trounces pharmacology in GlaxoSmithKline quitting study, Polito JR, July 9, 2009
- Pharmaceutical Money-Related Bias in Smoking Cessation Research is Now Readily Apparent; New Article Demonstrates How This Bias Pushes Medication, Siegel M, July 8, 2009
- Initial National Expert Panel on Smoking Cessation Also Had Severe Conflicts of Interest with Big Pharma; Repeating the Mistake: Inexcusable , Siegel M, April 7, 2009
- New Study Shows that Nicotine Replacement Therapy is Ineffective for Gradual Smoking Cessation, But Concludes the Opposite, Siegel M, January 13, 2009
- Have smokers been hoodwinked and bamboozled by placebos?, Polito JR, Nov. 14, 2008
- Smoking cessation trials, Canadian Medical Association Journal, Polito JR, February 29, 2008
- Pfizer's Chantix Continues Killing Quitters, Polito JR, October 22, 2008
- Chantix and Champix mental health safety assurances contrary to evidence, Polito JR, May 21, 2008
- U.S. quit smoking policy integrity drowns in pharmaceutical influence, Polito JR, May 13, 2008
- Press Release on Smoking Cessation Guidelines Fails to Disclose Financial Conflict of Interest of Expert Panelists , Siegel M, May 12, 2008
- NIH Expert Panel Recommends Smoking Cessation Pharmaceuticals for Every Smoking Patient; Panel Chair and 8 Members Have Financial Ties to Big Pharma , Siegel M, May 8, 2008
- Does updated tobacco treatment "Guideline" reflect sham science?, Polito JR, May 5, 2008
- FDA Chantix Handling Betrayed Public Health, Polito JR, February 29, 2008
- Is Receiving a Placebo the Same Thing as Trying to Quit Cold Turkey? The Limitations of NRT Clinical Trials, Siegel M, March 16, 2007
- Flawed research equates placebo to cold turkey, Polito JR, March 12, 2007
- Nixing the patch: Smokers quit cold turkey, Columbia University, Millstone K, March 7, 2007
- Wall Street Journal Article Highlights Financial Conflicts of Interest of Chair of Federal Smoking Cessation Guidelines Panel , Siegel M, February 8, 2007
- NICOTINE FIX - Behind Antismoking Policy, Influence of Drug Industry, Helliker, K, Wall Street Journal, February 8, 2007
- Financial Ties Between Guideline Panels and Big Pharma Run Deep - Michael Siegel, MD, 01/07
- Chantix - an 8 in 10 failure rate or worse? - John R. Polito, 12/06
- Do physician's have a legal duty to ignore Guideline Recommendation 7? - John R. Polito, 12/06
- Is the U.S. government's quitting policy killing smokers? - John R. Polito, 10/06
- Will Chantix really help me quit smoking? - John R. Polito, 08/06
- It's unlikely this NRT study was blind - John R. Polito, 08/06
- Conference Sponsorship by Pharma Precludes Objective Symposium - Michael Siegel, MD 07/06
- 13th World Conference on Tobacco or Health Drenched in Nicotine - John R. Polito, 07/06
- Cold Turkey Twice as Effective as NRT or Zyban - John R. Polito, 05/06
- Nicotine Not Medicine, Its Use Not Therapy - John R. Polito, 04/06
- How to use behavorial findings to sell NRT - John R. Polito, 01/06
- GlaxoSmithKline Attacks Cold Turkey Quitting - John R. Polito, 12/05
- UK Guidance for NRT use in pregnancy and by children - ASH London, 12/05
- June 2000 Guideline Chairman Michael Fiore's Testimony - see PDF pages 14 & 15, 05/05
- The Nicotine Patch, Gum and Lozenge - Mounting Evidence of a Sham - John R. Polito, 04/05
- 40 Years of Progress? - Joel Spitzer, 10/04
- Widespread Blinding Failures Put NRT Studies in Serious Question - John R. Polito, 06/04
- Nicotine Gum Maker's Concern Raises Concerns - John R. Polito, 05/04
- A Quitter's Dilemma: Hooked on the Cure - New York Times, 05/04
- Quebec CT Quitters Disprove "Double Your Chances" NRT Assertion - John R. Polito, 04/04
- Are nicotine weaning products a bad joke? - John R. Polito, 10/03
- Is CT Quitting More Productive & Effective than NRT? - John R. Polito, 07/03
- Are Teens Getting Hooked on NRT? - John R. Polito, 06/03
- March 2003 OTC NRT Meta-Analysis Finds 93% Midyear Relapse Rate - John R. Polito, 03/03
- Quitting Methods - Who to Believe? - Joel Spitzer, 2003
- JAMA Study Concludes NRT is Ineffective - John R. Polito, 09/02
- Real-World Nicotine Patch and Gum Rates - John R. Polito, 06/02
- Does the OTC Nicotine Patch Really Double Your Chances of Quitting? - John R. Polito, 04/02
- Is Nicotine Replacement Therapy The Smoker's Last Best Hope? - John R. Polito, 11/00
- Financial Disclosures for June 2000 Guideline Panel - U.S. Public Health Service, 06/00
- June 2000 Guideline Recommendation 7 - pharmacotherapy use by all quitters - 06/00
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