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Chapter 6: Common Hazards & Pitfalls

Topics:  Alcohol | Co-Dependency | Blood Sugar | Caffeine | Crutches | NRT | Placebo Fraud | Pharma Secrets | Chantix/Champix | E-cigs | Negative Support | Second-Hand Smoke | Bad Days & Disturbing Dreams | Weight Gain | Weight Control | Menstrual Concerns | Pregnancy



Placebo Isn't a Quitting Method

Placebo isn't a nicotine dependency recovery method and it certainly isn't cold turkey.

Webster's defines "placebo" as "1. usually pharmacologically inert preparation prescribed more for the mental relief of the patient than for its actual effect on a disorder. 2. an inert or innocuous substance used especially in controlled experiments testing the efficacy of another substance (as a drug)."

Placebos have historically served as the gold standard in research studies that compare a new treatment to no treatment. The objective is to "blind" participants as to the type of treatment they've received, so that assignment awareness doesn't affect their response to it.

Falsehood #4: Placebo-controlled clinical trials were blind

The blinding problem with smoking cessation studies is two-fold. Assignment awareness within the active NRT group can be revealed by the fact that nicotine is a psychoactive drug which stimulates the nervous system via the release of adrenaline. This makes the heart pound 10 to 20 beats per minute quicker while elevating blood pressure.

Even more noticable, nicotine causes release of dopamine which, at least briefly, satisfies the addict's wanting and desire for more.

Punished wanting satisfaction expectations, assignment awareness within the study's placebo group (the study's control arm) is even greater than in the NRT group.

Expecting to sense diminished urge or crave intensity, the vast majority will instead endure their full withdrawal syndrome: a rising tide of anxieties, anger, dysphoria, concentration difficulty and sleep fragmentation, all within 24 hours of ending nicotine use.

Imagine being handed a piece of nicotine gum or a nicotine lozenge while experiencing strong urges to smoke, dip, vape or chew. How long would it take you to tell whether or not it contained nicotine, or was instead a nicotine-free placebo look-a-like?

Not all of us can do it. However, 3 to 4 times as many will correctly state that they received a placebo as declare wrong, and that's within one week of attempting to stop smoking.[1].

Pretend for a moment that you're still hooked, using, wanting to stop, and curious about NRT but not wanting to spend any money. You hear about a new 4-session nicotine gum stop smoking study at a nearby medical school.

The study is offering a free three month's supply of nicotine gum, counseling, plus travel expense reimbursement. There's just one catch. Half signing up for the study will be randomly assigned to receive nicotine-free placebo gum instead.

Would you stick around and allow yourself to be toyed with for the next 3 months if convinced that you'd been given placebo gum instead of the real thing? Neither did many of them.

In study after study, 80 to 90 percent of participants reported a history of prior stop smoking attempts. Those attempts taught them to recognize the onset of their withdrawal syndrome. The more prior attempts they'd made, the more expert they became at recognizing it.

But the remaining placebo group members received the exact same counseling, correct? True, but the primary counseling objective in every nicotine replacement study was to foster successful nicotine dependency transfer to an alternative form of delivery, not the lessons and advice needed to minimize the effects of abrupt nicotine cessation (the focus of this book).

If true, what validity would there be if the NRT study found that twice as many nicotine gum users succeeded in stopping smoking as those chewing placebo gum?

Imagine the lack of intellectual integrity required to label victory by default - results rooted in frustrated expectations among a group of smokers who went to great lengths to receive free NRT - as having been "science-based."

It's why use of placebo controls in smoking cessation studies have served as a license to rob, defeat and kill.

As I wrote in a letter published in the Canadian Medical Association Journal in November 2008, "pharmacologic treatment of chemical dependency may be the only known research area in which blinding is impossible."[2]

We cannot fool cessation savvy nicotine addicts as to whether or not wanting and urges flowing from their brain dopamine pathways have been satisfied.

A June 2004 study was entitled "The blind spot in the nicotine replacement therapy literature: Assessment of the double-blind in clinical trials."[3] It teaches that anyone asserting that NRT studies were blind is not being honest, as far more study participants are able to correctly declare their assignment than couldn't.

Falsehood #5: NRT defeated cold turkey in clinical studies

This might surprise you, but those wanting to stop smoking cold turkey have never been invited to compete in clinical trials against self-selecting smokers seeking months of free replacement nicotine, bupropion or varenicline.[4]

Unlike those going cold turkey, those seeking free "medicine" joined the study in hopes of diminishing their withdrawal syndrome, not quickly meeting, greeting and defeating it.

Why are there no head-to-head clinical studies pitting "medicine" against cold turkey? Because if honest competition had occurred, NRT, bupropion and varenicline would have lost, would have never been approved for sale, and there would have been no need for this explanation.

Smoking cessation studies in which the senior researcher has no history of having accepted funding and/or personal payments from the pharmaceutical industry are rare.

Is it reasonable to expect financially conflicted researchers to bite the hand that feeds them? If they did, they know that they'd never receive any pharma money or pharma research project again.

The industry cannot allow its paid army of researchers to conduct intellectually honest studies. They'd cost it billions in lost profits. It's why smoking cessation clinical trial research is nearly void of scientific integrity. It's why most calling themselves researchers are little more than glorified nicotine salesmen.

We've now seen more than 200 placebo-controlled smoking cessation NRT, bupropion and varenicline studies, when nearly all agree that placebo affords study participants the worst possible odds of success.

Last time I looked, the National Institute of Health's clinical trials registry identified more than 200 new smoking studies that are expected to use placebo controls.[5]

Why? Industry research is about the quest for corporate profits and satisfied shareholders. Pharma is fully aware of the facts I've just shared and exploits them.

How many participants assigned to placebo in upcoming studies are facing their final cessation opportunity before experiencing a smoking induced heart attack, stroke, or being diagnosed with terminal cancer or emphysema?

Instead of subjecting them to the worst method known (placebo), why not instead offer them the best proven treatment as the study's control, and then see how the new method being evaluated compares to the best?

Principle 32 of the World Medical Association's (WMA) Declaration of Helsinki commands that the "benefits, risks, burdens and effectiveness of a new intervention must be tested against those of the best current proven intervention" and that placebos should not be used unless "compelling and scientifically sound methodological reasons" are demonstrated.[6]

Let's not forget that WMA Principle 32 is totally meaningless when the credibility of cessation's "best current proven intervention" is totally rooted in fraud. Still, how many desperate addicts down to their final confidence opportunity before bad news will cessation researchers rob and sentence to death?

The primary reason researchers continue to use placebo instead of pharma's "best current proven intervention" is that placebo promises the greatest margin of victory possible and the biggest news headlines.

Also, in pitting cessation products against each other, unless a tie, one product must win and the other lose.

Think about GlaxoSmithKline, maker of Nicorette gum, the Commit nicotine lozenge, the Nicoderm CQ patch and Zyban. If in their shoes, would you want any of your products losing to another?

Pharmaceutical companies avoid risk of defeat in head-to-head product competition by use of a control that isn't a real cessation method. That way, no company economic interest gets harmed.

Unfortunately, the lives of clinical trial participants are being sacrificed by a near ethic-less smoking cessation research industry, researchers driven by the quest for personal pharma income, study funding, news headlines, and university tenure.



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References:

1. Dar R, et al, Assigned versus perceived placebo effects in nicotine replacement therapy for smoking reduction in Swiss smokers, Journal of Consulting and Clinical Psychology, April 2005, Volume 73(2), Pages 350-353 (3.3 times as many correctly determined assignment); also see Rose JE, Precessation treatment with nicotine patch significantly increases abstinence rates relative to conventional treatment, Nicotine & Tobacco Research, June 30, 2009, where 4 times as many placebo patch users correctly determined their placebo assignment as guessed wrong, and did so within one week of quitting.
2. Polito JR, Smoking cessation trials, Canadian Medical Association Journal, November 2008, Volume 179, Pages 1037-1038; also see original online e-letter selected for publication, Polito JR, Meta-analysis rooted in expectations not science, E-Letter, Canadian Medical Association Journal, July 17, 2008; and a follow-up e-letter rebutting pharmacology meta-analysis editors' suggestion that blinding issues in drug addiction studies are no different than concerns seen in other studies, Polito JR, Why cessation blinding concerns differ from other clinical trials, E-Letter, Canadian Medical Association Journal, November 9, 2008.
3. Mooney M, et al, The blind spot in the nicotine replacement therapy literature: Assessment of the double-blind in clinical trials, Addictive Behaviors, June 2004, Volume 29(4), Pages 673-684.
4. Polito, JR, Flawed research equates placebo to cold turkey, WhyQuit.com, March 12, 2007.
5. National Institute of Health, www.ClinicalTrials.gov, visited December 2008, search: placebo + smoking.
6. World Medical Association, Declaration of Helsinki, Ethical Principles for Medical Research Involving Human Subjects, Adopted by the 18th WMA General Assembly, Helsinki, Finland, June 1964, and last amended by the 59th WMA General Assembly, Seoul, October 2008.



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