In all, how does it change the picture of Chantix users' safety - or risks - when all these adverse health effects hidden in its "Full Prescription Information Sheet", as published by Pfizer for the eyes of medical practitioners only, are included?

Statistically, your chances of being affected by any one of its "frequent" adverse effects are roughly 2 in 5. Also, there is so many "infrequent" possible adverse effects that your statistical chances of being affected by any one of them are roughly 3 in 10. Combined, your chances to suffer one of these side effects - most of them quite serious -

could be as high as 1 in 2, or even worse.

Why did Pfizer hide this from the consumer?

The rationale might be, as expressed by one of its doctors, that these side effects were reported during the trials, but "aren't necessarily associated with the drug".

There could be some logic in it...or not. If you think this is bad enough, wait - it gets worse. The three comparable pre-marketing Chantix trials by the manufacturer had carefully selected participants - over 4,000 total - with the rejection rate between 25% and 34%. Among those rejected from participating in the trials were those with "clinically significant medical disease" - including mental health problems - those at high risk of developing one (alcoholism, hypertension, overweight, underweight), those younger than 18 and older than 75, and those known to have recently relapsed in trials with other smoking-cessation drugs.

Put plainly, the participants were generally healthy. This leads to three conclusions:

(1) most of the reported adverse effects are likely caused by Chantix,

(2) Chantix trial results are not representative of what can be expected with the general population, and

(3) safety of the drug for those with existing medical condition, or at a high risk of developing one, is virtually unknown.

Is "accomplice" to strong a word to use for the FDA, whose duty is to verify that a drug is safe before giving it its approval? A simple overview of how these pre-marketing studies have been conducted reveals both, a plethora of serious adverse effects possible with Chantix, as well as a

complete lack of data concerning possible consequences of the drug when used by others than generally healthy.

Yet, the FDA not only allowed Chantix to enter the market, it allows it to go to the consumer with only 5 minor adverse effects listed on the Patient's Information sheet. Is that how it fulfills its "mission to enhance the health and well-being of Americans"?

Does this have something to do with nearly 1/4 of the FDA budget coming from "user fees", the lion's share of which are those paid by pharmaceutical industry? Or even more that the projected increase in FDA's 2008 "salaries and expenses" - some $140 million - is effectively covered by the hefty increase in these same "user fees"? Draw your own conclusions. What is rather obvious is that the FDA can be expected to do its job properly only if it is financially independent of those who it is supposed to be overseeing.

It isn't that the possibility of serious adverse health effects of Chantix were not to expect. The drug acts by attaching to a specific nicotinic-type acetylcholine receptors, with dual effect: it prevents nicotine from binding to those same receptors (thus acting as nicotine antagonist), while at the same time causing release of roughly half as much of dopamine as nicotine would (thus acting as a partial nicotine agonist). The former diminishes pleasurable effects of smoking, while the latter reduces craving for nicotine. Almost a magic formula - except that it works by replacing one foreign chemical by another, and that it

interferes with the body function of acetylcholine,

a key neurotransmitter needed for proper functioning of the brain, muscles - including, of course, the heart - and the entire body.

The importance of acetylcholine function is well known. In fact, it is the very first neurotransmitter discovered, back in 1914; Henry Hallett Dale and Otto Loewi received the Nobel Prize for this discovery in 1936. For quite a while now, it is not even a higher-science domain, rather a common knowledge. Yet, a drug interfering with the function of this crucial neurotransmitter was given an instant "go" by the FDA, apparently without it even bothering to take a closer look of how the trial studies were conducted.

Apparently, it did cost some lives and caused great deal of suffering in a short period of time.

On the other hand, with over 40 millions smokers in the U.S. alone - and up to 2/3 likely to attempt to quit - the drug does have a great profit potential.

Does Chantix also have the potential to help those wanting to quit smoking? The final article will try to answer that question.

CONTINUES: Chantix' efficacy

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