How to quit smoking cigarettes

“What’s it like using varenicline?”

On May 11, 2006 the U.S. Food and Drug Administration (FDA) announced approval of the prescription drug varenicline, to be sold under the trade name Chantix. Today it is marketed as Champix in 20 European nations (including England and Scotland), Australia, Korea, Brazil, Mexico and Japan, with 2007 worldwide sales of $883 million (see PDF page 37). Interestingly, in the U.S. the FDA refused to approve Pfizer’s use of the name “Champix” asserting that from a promotional perspective, “it is overly fanciful and overstates the efficacy of the product” .

Still, for some, varenicline does have potential to at least initially seem almost like a non-event quitting experience for those lucky enough to avoid, move past or endure one or more of the 165 potential side-effects listed on Pfizer’s “Full Prescribing Information” sheet. Prior to January 18, 2008 Pfizer’s Patient Information sheet only mentioned vomiting, nausea, abnormal dreams, sleep disturbance and constipation as “the most common side effects.” It failed to alert smokers to less frequent yet vastly more serious risks mentioned on varenicline’s Full Prescribing Information Sheet, including suicidal thoughts, hallucinations, psychotic events, kidney failure, joint pain, muscle pain and arthritis.

Varenicline is a partial agonist that activates release of 35 to 60% of the dopamine that nicotine would have caused to flow if sitting on the exact same acetylcholine receptors. But in that varenicline is in pill form, and if taken regularly, present and occupying these receptors 24 hours a day, within 4-5 days of taking it and achieving “therapeutic levels,” smoked bursts of nicotine arriving in the brain (which would normally generate a dopamine “aaah” explosion within 8-10 seconds of a puff) should find most acetylcholine receptors already occupied.

One user described the expected but missing dopamine “aaah” sensations as though “smoking a carrot.” It is why Pfizer asserting to the world that its varenicline studies were “blind,” claiming that varenicline users could not tell whether or not they had been assigned to the group receiving the real pill, instead of a group whose pill did not contain varenicline (the placebo group), would be laughable if such representations didn’t reflect such a serious breach and betrayal of basic scientific integrity. It is not a matter of “guessing” whether or not a foreign chemical is present and at work inside their brain. They knew it was there and most realized it before ever quitting smoking.

As with nicotine patch, gum or lozenge use, they will likely experience some degree of back-end withdrawal syndrome upon ending varenicline use. Users must adjust to living without chemically enhanced dopamine flow.

Pfizer, in its zeal to generate sales, is failing to adequately alert smokers to the fact that half of varenicline clinical trial users who successfully quit smoking for 12 weeks while using it had relapsed to smoking within a year. It fails to tell them that recent head to head competition with the nicotine patch suggests that without ongoing counseling and support possibly as few as 9 in 100 users will be smoke-free at 6 months. It also fails to disclose that its studies were not blind as claimed, making much heralded victories over placebo users rather meaningless.

While Pfizer does an outstanding job of explaining how varenicline occupies nicotine-type acetylcholine receptors, thereby blocking nicotine’s ability to occupy the same receptor, it makes no attempt to explain what will happen should they inhale just one powerful puff of nicotine once Chantix/Champix is no longer present and blocking those receptors. Pfizer product marketing treats the topic of continued smoking while taking varenicline far too lightly (what it candy-coats as a “slip up”), thus setting the stage for relapse.

The message Pfizer should be pounding home is that after ending varenicline use, that within 8-10 seconds of taking a puff, that up to 50% of their brain’s acetylcholine receptors will be occupied by nicotine. It will generate a powerful dopamine explosion that their mind’s pay-attention pathways will make nearly impossible, in the short term, to forget. Their entire Chantix experience will have been for naught, as their brain will soon be begging for more nicotine.

What Pfizer also keeps hidden is the fact that we have no credible study data showing that Chantix is safe and effective for smokers having any significant medical condition, including alcohol abuse, as Pfizer intentionally excluded them from its five initial studies. Profits have again been elevated above the time and expense needed to produce quality risk assessment data. Excluded groups truly are human Guinea pigs, rolling risk dice and now being experimented upon, most without any warning whatsoever.

This fact was first brought on November 20, 2007, when U.S. Food and Drug Administration (FDA) announced that it “has received reports of suicidal thoughts and aggressive and erratic behavior in patients who have taken Chantix” and was conducting an investigation. What the FDA didn’t disclose, but was documented by a November 29, 2007 news story, was that the FDA was aware that Chantix had been implicated in at least 55 suicides. By January 18, 2008, concerns over agitation, depression and suicide had grown so great that Pfizer announced that labeling had been changed to warn users.

As detailed below, Pfizer’s varenicline studies reflect junk science at its worst. Designed to generate the highest quitting rates possible, sadly, real world quit smoking rates won’t come close. It is my hope that after looking behind the study curtain, exploring reports of thousands of adverse reactions being attributed to varenicline, and reflecting on Public Citizen’s call for smokers to avoid varenicline until safety issues are settled, that smokers will grow motivated to want to learn more about how nicotine keeps them enslaved. Why? Because knowledge is power, knowledge is a quitting method.

Chemically captive and residing between insula driven craves, urges and anxieties when we went too long between nicotine feedings, and dopamine pathway “aaah” reward sensations when we obeyed and replenished constantly falling nicotine levels (that declined by about half every two hours), how could we not come to falsely believe that smoking nicotine defined who we were, gave us our edge, helped us cope and that life without it would be horrible? After years of beatings and rewards, how easy would it be to remember the beauty of our pre-addiction mind, of going days, weeks and months without once wanting to smoke nicotine? Should using a quit smoking product that, when used alone, likely has a six-month failure rate near 90% be a life risking event? Is it rational to risk our life before educating our mind as to why we feel the need to risk it?

Think about it, what learning takes place by swallowing a pill? We will never be stronger than nicotine but then we don’t need to be as it is only a chemical with an I.Q. of zero. It cannot plot, plan, think or conspire and is not some demon that dwells within. Our greatest nicotine dependency recovery weapon has always been our vastly superior intelligence but not if we continue to live in dependency ignorance and darkness. Education, understanding, coping skills and ongoing support truly are quitting methods, ones most smokers continue to overlook.

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