How to quit smoking cigarettes

Users Encouraged to Report All Adverse Events

All Chantix or Champix users experiencing significant adverse events are strongly encouraged to report them to your government’s adverse event reporting agency. Varenicline is a new drug and without user feedback, medication safety officials may remain in relative darkness regarding some risks for years or even decades. The following are links to online reporting forms: Australia | Canada | New Zealand | United Kingdom | United States

Pfizer Giving Refunds

I am receiving reports of Pfizer giving purchase price refunds to users experiencing reactions and unable to continue taking varenicline. Rachael from Tennessee had used Chantix for 5 days before developing a rash on her face. She contacted Pfizer and they sent her a refund request form which she completed and returned.

On February 14, 2008 I telephoned Pfizer to verify the refund process and was told that, Rachael is correct. Patients experiencing adverse reactions could receive refunds either by calling and requesting a refund form or by sending Pfizer a copy of their pharmacy purchase receipt, accompanied by a short letter requesting a refund and explaining why. I requested the proper mailing address but they would not release it and I was told that the actual user, not a cessation educator, would need to call 1-800-533-4535 to obtain it. This link is to Pfizer’s Customer Service page.

Dependency and withdrawal concerns

Can Chantix users get hooked on it, or more accurately, permanently transfer their nicotine dependency to it? Chantix users visiting Topix.net are sharing stories of withdrawal syndrome type symptoms when attempting to end varenicline use. But how common is this?

Varenicline is a partial agonist that produces up to 60% of the dopamine release generated by nicotine, while actually blocking nicotine molecules from occupying nicotinic acetylcholine receptors (the alpha 4, beta 2 subtype), thereby preventing nicotine from releasing dopamine. Is 60% of the dopamine production generated with nicotine sufficient to foster or maintain chemical dependency?

When nicotine gum was first introduced in ‘84 there was no mention of the possibility of getting hooked on the cure. Today GlaxoSmithKline consultants estimate that nearly 40% of nicotine gum “users” are dependent upon it, or as the consultants put it, “are persistent users.”

The varenicline studies make no mention of possible dependency transfer concerns. A November 2003 study found that as many as 6.7% of nicotine gum “quitters” were still chronic users at six months, three months beyond FDA use guidelines. Although two completely different studies but conducted in the same year and involving the same authors, if only 7% of OTC gum users are able to quit smoking for six months but 6.7% are then hooked on it, then what percentage actually breaks free from nicotine by chewing it? It has been a major defect of pharmacology studies.

Rarely have any clinical trials (including Chantix & Champix) examined and reported body fluid nicotine, bupropion and varenicline levels (from saliva, urine or blood) at long-term follow-up, to see if participants had actually arrested their chemical dependency or simply transferred it. It’s as if researchers don’t care.

Is there a similar dependency transfer concern with varenicline but possibly to some lesser degree? If so, why wouldn’t Pfizer want to fully disclose those concerns up front so that smokers can make fully informed decisions. If none, in light of nicotine gum, patch, lozenge and inhaler dependency issues, why wouldn’t Pfizer want to reassure smokers?

A related question, arising from what may be the sloppiest portion of the Chantix studies, is how widespread was NRT use within the five studies and how much of Chantix’s 22% one-year rate is attributable to elevated dopamine output generated by NRT, once Chantix’s elevated dopamine output ceased at the end of the 12-week treatment period?

We know that records were kept of “use of nicotine containing products.” We also know, from the Oncken study, that once Chantix treatment ended after twelve weeks that “use of nicotine replacement therapy did not disqualify subjects from being considered abstinent.” The obvious questions becomes, how many actively feeding nicotine addicts did Pfizer count among the cured and why was the NRT use data not published or released?

Chantix and Champix studies were not blind as Pfizer continues to assert

It’s hard to imagine any smoker who has not heard the NRT marketing assertion that it “doubles” their chances of quitting. If Pfizer and Chantix follow the path taken in marketing NRT, regardless of how low Chantix’s quitting rate eventually becomes, smokers will only be told its victory margin over the study’s placebo group, not the actual percentage of users succeeding.

In fact, it’s already happening. Pfizer’s May 11, 2006 Chantix press release fails to disclose that nearly 4 out of 5 Chantix clinical study participants relapsed to smoking. Instead it boasts, “In two identically designed studies, patients receiving a 12-week course of Chantix therapy (1 mg twice daily) nearly quadrupled the likelihood of quitting than those taking placebo.”

Let’s examine these massive Chantix placebo victories. In Pfizer’s Chantix (varenicline) clinical trials those screened and not excluded were randomly assigned into at least one of two study arms: the active group which would receive Chantix and the control group which would receive an identical looking placebo pill.

Each of the five Chantix studies represents that it was double blind. If true, neither participants nor researchers should have been able to determine participant assignment to receive either a placebo pill or the active chemical varenicline. Surprisingly, the studies do not mention whether or not researchers actually conducted blinding assessments to test and validate the study’s blind.

Blinding is extremely important to the study’s core validity. If randomized participants can determine their group assignment then the study’s final odds ratio victory (if any) may reflect frustrated and/or fulfilled expectations rather then the actual merits of the chemical tested. Blinding failures actually occurred in NRT studies and it is almost impossible to believe that they didn’t happen in Chantix studies too.

Nicotine is a psychoactive chemical that generates a potent dopamine/adrenaline high. The pharmaceutical industry has known since at least a 1994 study that smokers can quickly be trained to reliably distinguish various doses of nicotine from placebo. Smokers with any quitting history have experienced their own withdrawal syndrome and should be expected to recognize both its onset and intensity.

The Chantix studies found that varenicline significantly diminished a smoker’s withdrawal syndrome. Cravings were consistently reduced when varenicline, 1.0 mg twice daily, was compared with placebo. All three comparable studies found that varenicline significantly reduced the urge to smoke compared to placebo.

Approximately 90% of participants in the Chantix studies had previously attempted quitting, failed and had some degree of memory of what it felt like to sense the onset of the anxieties and craves associated with their withdrawal syndrome.

A June 2004 study by Mooney reviewed 73 allegedly double-blind NRT studies and declared that the limited number of studies assessing blindness were not generally blind as claimed in that “subjects accurately judged treatment assignment at a rate significantly above chance.”

Mooney warned researchers that, “To determine the prevalence of failure, clinical trials of NRT should uniformly test the integrity of study blinds. Moreover, if blindness failure is observed, subsequent efforts should be made to determine if blindness failure is related to study outcome and, if so, to provide an estimate of treatment outcome adjusted for blindness bias. Without these methods and analyses, the validity of NRT clinical trial results could be questioned.”

The blinding analysis in a 2005 study by Dar found that 3.3 times as many placebo group members correctly guessed that they had received placebo (54.5%) as guess nicotine (16.4%). Although the Dar study focused on smoking reduction, Tonnesen’s 1993 nicotine inhaler quitting study produced strikingly similar placebo group findings in that 3.8 times as many in the placebo group correctly guessed placebo (58%) as guessed nicotine (15%). Among inhaler users, Tonnesen found that 3.5 times more correctly guessed inhaler (46%) as guessed placebo (13%), while 42% on active and 27% on placebo did not know which treatment they had received.

Participants were recruited to the Chantix studies by being told that the study involved evaluation of a medication. Most seeking participation knew their withdrawal syndrome and clearly hoped the medication would diminish the rising tide of anxieties and craves they now associated with withdrawal.

Pfizer knew that NRT studies were plagued by blinding failures and that frustrated and rewarded expectations likely played a substantial role in both relapse and cessation. Pfizer also knew that Chantix placebo group members would not receive anything different than received by NRT placebo group members - an inert placebo. For them, the exact same set of elements was in play - the expectation of relief, the onset of withdrawal and frustrated expectations. It knew that the active group would sense a “significant” reduction in their withdrawal syndrome and thus likely be more inclined to remain and take advantage of the study’s heavy and lengthy support structure.

Mooney warned researchers more than two years ago that a study’s core validity could be questioned if full blinding assessments were not conducted. If the Chantix studies failed to stop and assess blinding, why? Did Pfizer know in advance that its varenicline studies would not be blind and that blinding bias would impact performance?

Quoting from the Dar 2005 study, “The present secondary analysis of the data elucidates these placebo effects by showing that reduction of smoking was strongly related to participants beliefs about their drug assignment. Smoking reduction was larger in those who believed that they had received nicotine compared with those who believed they had received placebo, regardless of actual drug assignment. Moreover, after adjustment to perceived drug assignment, the association between actual drug assignment and smoking reduction was no longer statistically significant.”

Approximately 80% of the placebo group members in the varenicline studies relapsed to smoking within two weeks. A brief blinding assessment within two weeks could have quickly and easily revealed each participant’s assignment belief. Where is it? As far as we know, no blinding assessment was conducted. Why?

It makes one wonder who at the FDA is actually reading studies like Mooney and demanding quality cessation study design prior to drug approval. In fact, the FDA’s May 11, 2006 press release suggests that the studies were in fact blind. Also noteworthy is the FDA’s failure to mention that 4 out of 5 Chantix users relapsed.

The above paragraphs on study blinding were written on August 25, 2006, prior to trading correspondence with scores of varenicline users and learning how smoking between days 4 through 7 of varenicline use (as directed by Pfizer) was strange in that the normal and expected dopamine “aaah” sensation that had occurred within seconds 10 seconds of every cigarette they’d ever smoked no longer occurred. Thus, it would seem that many or possibly most assigned to the active varenicline group in Pfizer’s clinical trials had “actual” knowledge of their assignment prior to ever quitting.

Did confidence in actual assignment combine with varenicline elevated dopamine levels to allow a greater percentage of the varenicline group to relax, take advantage of, and benefit from, what may have been the most intense counseling and support format offered in any quitting study to date? This factor worked to create distance between frustrated placebo group quitters whose assignment actually punished them by throwing them into full blown drug withdrawal.

Employing the double-blind study format in drug addiction studies, the only area of pharmacology research where assignment to the placebo group actually punishes participation by throwing quitters into full blown chemical withdrawal, is a licence to steal. Think about medication studies for headaches, high blood pressure or cholesterol. Would it be fair to make those assigned to the placebo group suffer far more than when you found them, to add full-blown nicotine withdrawal to whatever condition with which they arrived?

Pfizer’s assault upon cold turkey and the smoker’s natural instincts

The U.S. Federal Trade Commission (FTC), charged with enforcing truth in advertising, has allowed the NRT industry to make outlandish marketing claims and distort NRT’s true effectiveness (if any). One of the worst offenses was the assertion that NRT competed against and defeated cold turkey quitters within NRT randomized clinical trails. The representation is false and deceptive, as it simply did not happen.

The only subjects applying for these studies are a population that is self-seeking medication, medication they hope will somehow diminish their withdrawal symptoms and syndrome, the exact opposite of a quitter who fully expects to meet, greet and overcome full blown withdrawal. There were no cold turkey quitters in NRT clinical studies. There were no cold turkey quitters in any clinical Chantix study, just a frustrated placebo group whose expectations that medication would diminish their withdrawal syndrome went totally unfulfilled.

A key industry marketing tactic has been a two-decade campaign that bashes and trashes confidence in abrupt nicotine cessation quitting by suggesting that it’s almost impossible, that “few” cold turkey quitters succeed. What motivation is there for Pfizer to be honest with smokers when teaching them the truth about their own natural cessation instincts? It is extremely rare when any journalist exposes the pharmaceutical industry for the ongoing falsehood that roughly 40 million U.S. cold turkey success stories is “few.”

Pfizer needs to remember two important facts. First, as suggested by the these two tables, during 2006 80-90% of all successful long-term quitters are again expected to be cold turkey quitters (see American Cancer Society Cancer Facts & Figures 2003, Table 3; and Doran, May 2006).

Second, long-term NRT quitters have never once prevailed over those quitting without it in any real-world quitting method survey published to date (see the California JAMA survey, Quebec Quit & Win, Minnesota Insurance Survey, London, Western Maryland, Ferguson’s UK NHS Smoking Cessation Services survey, Australia Family Practice Survey, U.S. National Cancer Institute).

Maybe real-world Chantix evaluation will someday prove superior to those quitting without it. Let’s hope so. But if cessation pharmacology study history is any indication, we shouldn’t hold our breath. Until then, what is certain is that the pharmaceutical cessation industry will continue to work study design to its economic advantage, spinning results to foster unrealistic expectations, hiding each study’s actual relapse rates, ignoring obvious blinding failures, boasting about odds ratio victories flowing from them, and proclaiming victory over foes who were not present.

If Pfizer wanted to design and recruit for a study that fairly compares a cold turkey quitting program such as WhyQuit’s to its varenicline quitting program it would have to: (1) limit creating pharmacology use expectations by advertising only that it was recruiting for a “quitting program” without any mention of “medicine” or “quitting products,” (2) randomise participants to either the varenicline or cold turkey arm of the study without blinding (and only then conduct face-to-face informed consent); and (3) fairly acknowledge the differences in the two cessation methods by allowing the cold turkey program to devote the bulk of its education, skills development and support time to the first two weeks of cessation, while allowing varenicline users needed guidance and support in both learning to adapt to using it and adjusting to ending use at treatment’s end. But don’t expect to ever see this happen as billions in profits are at stake and it’s far more profitable for the pharmaceutical industry to “pretend” that the expectations of frustrated placebo participants were identical to those of real cold turkey quitters.

The next time you hear a pharmaceutical industry commercial suggest that quitting cold turkey is nearly impossible, take your own survey of all long-term ex-smokers who have been off of all sources of nicotine and all cessation dopamine enhancing chemicals for at least one year. Once you complete your own survey we invite you to explore WhyQuit and the wonderful world of educated and supported abrupt nicotine cessation. Quitting need not be a life threatening event. There is still only one rule that if followed offers a 100% guarantee of success to all … no nicotine, just one day at a time … Never Take Another Puff, Dip or Chew!

1 Response to “Chantix - To Quit Smoking Medication”.

1. healthranker.com :

   Chantix - To Quit Smoking > How to quit smoking cigarettes…

   All Chantix or Champix users experiencing significant adverse events are strongly encouraged to report them to your government’s adverse event reporting agency. Varenicline is a new drug and without user feedback, medication safety officials may rema…

   January 31st, 2009 at 5:01 am

Leave a comment.