Chantix And Suicide: The Latest Numbers
74 CommentsBy Ed Silverman // February 1st, 2008 // 4:09 pm
The FDA has announced a public health advisory about abnormal behavior, agitation, depressed mood, suicidal ideation, and actual suicidal behavior with Pfizer’s anti-smoking drug. And has provided updated numbers - 491 cases of suicidal thinking or behavior, including 420 in the US. And of those, there were 39 suicides, including 34 in the US.
“We’ve become increasingly concerned as we see a number of cases that truly look like exposure to the drug and not other causes,” says Bob Rappaport, director of the FDA’s division of anesthesia, analgesia and rheumatology products, in a briefing this afternoon with reporters.
As of now, he adds, “there’s no definitive evidence there’s a causal relationship” between Pfizer and the abnormal and suicidal behaviors. Although, the agency notes that “it appears increasingly likely that there may be an association between Chantix and serious neuropsychiatric symptoms.”
Pfizer has contended that “some reports may have been complicated by the symptoms of nicotine withdrawal in patients who stopped smoking, but not all patients with these symptoms had quit smoking.” Rappaport says that it remains unclear whether the adverse events are related to withdrawal symptoms. “We’re not yet absolutely sure it’s related to stopping the drug.” The FDA found evidence some Chantix patients experienced psychiatric problems even though they were still smoking.
The agency, which began reviewing cases last November, announced new changes to the Chantix product labeling, although Pfizer updated the labeling two weeks ago.
The issue that seems to have focused national attention on Chantix was the case of Carter Albrecht. While in a drunken rage, the Texas musician banged on the door of a homeowner, who feared an intruder, and shot and killed the young man. Although Albrecht was later found to have tested for a high level of alcohol, he’d also begun taking Chantix, the smoking-cessation drug, a week earlier and complained of vivid dreams. Hallucinations are noted as only a rare psychiatric disorder, but “Chantix dreams” were cited by Albrecht’s family and girlfriend as possibly contributing to his outburst.
Matt
And somehow people will consider the side effects acceptable… Stupid humans.
Dan
Perhaps I’m missing something, but I find it hard to believe such side effects were not observed during trials to get the drug approved. And if so, why was it approved?
It seems the FDA needs new ownership besides the industry that it is suppose to monitor to protect us.
Atlex
Look at the numbers–34 suicides out of 4 million users. While the data does suggest that there is a link of some sort, there would likely have been some number of suicides without the drug. (Remember, that the mentally ill smoke at a much higher rate than the rest of society; moreover, smoking cessation by any means is associated with depression.) So the increased risk, at this point, is likely very small and would have probably not shown up in a study of 1000 or 10000 patients. The FDA may also realize that smoking is the number 1 cause of premature death and that the risk to benefit ratio is still quite positive.
By the way, in the trials, there was 1 suicide (out of a few thousand patients) which was deemed at the time as unrelated to drug treatment.
Jane
Atlex,
If the mentally ill smoked at a much higher rate, wouldn’t they have been represented in the trials? With your theory then the drug companies manipulated the study design and somehow only found the unmentally ill smokers. Give us a break.
Ernest
Pfizer, Eli Lilly, GlaxoSmithKline, etc. are rapidly eroding the world’s confidence in pharmaceutical medications. How are we to trust any drug we take. Antidepresants cause suicide and homicide and drug companies are still defending these drugs by claiming that this is what depressed people do. Now we have Chantix, which may be no more than Zoloft combined with something to ease nicotine withdrawal. Whatever it is, Chantix has psychiatric side-effects similar or worse than Zoloft and Prozac. Now a person who just wants to quit smoking is put into the category of a mental patient by virtue of taking this drug. Anyone experiencing strong suicidal ideas or attempting suicide while on this drug will never be able to undue that experience. Smoking is beginning to look like a much better and safer choice than taking the anti-depressant Zyban or Chantix.
Mike M
No one should use this agent, bottom line. It is actually not much more effective than any other modality utilized for smoking cessation. Quitting is hard, and the key is good follow up, as well as adequate social support; on top of these core components, add traditional nicotine replacement therapy if necessary, and move the “quick fix pill of the moment” to the back burner due to the minor fact that you may be more likely to KILL YOURSELF on the drug
Diane
There are many factors to consider, including the smoking, mental illness connection, smoking and associated poor health habits and esteem issues, as well as the number of people in the sample who would have killed themselves anyway. “Sucidal thinking” is very hard to evaluate and is not standerized. Most drug withdrawls are associated with agitation and significant discomfort. In term of Zyban-it is a new name for a well established anti-depressant, which has not been connected to the symptoms reported. I think this needs a lot more study and clarity.
Laurie
” In term of Zyban-it is a new name for a well established anti-depressant, which has not been connected to the symptoms reported. I think this needs a lot more study and clarity.”
Zyban/Wellbutrin has an FDA suicide warning on it with a mandatory Black Box. Making the jump from a large portion of the mentally ill smoke to all smokers are mentally ill is one of the worst examples of “spin” that I’ve seen yet.
http://www.fda.gov/medwatch/SAFETY/2004/Wellbutrin_hcp.pdf
Truthman
If Chantix is a similar type of drug to Zyban, then it is also similar to SSRI’s and possibly acts on dopamine and serotonin .. The fact that it is quite clearly linked to abnormal behaviours, suicide etc also backs up the evidence that SSRI’s can induce these side effects too..
If chantix had been marketed as an pscyhiatric drug and not a quit smoking drug then I bet the side effects would have been blamed on the patients as did happen with Paxil, Zoloft , effexor, Zyprexa, Risperdal etc…
Atlex
Jane, actually as I believe the label mentions or the FDA has mentioned, the clinical studies for Chantix were designed to screen out those with known mental illness. It is fairly typical for pre-approval studies to screen out those with co-morbidities. Other illnesses or conditions can make it difficult to interpret results. However, if if the studies didn’t screen thesm out, it is fairly likely that a clinical study of a few thousand participants wouldn’t demonstrate the increase in neuropsychiatric conditions. Even with more than 4 million users in the US, the FDA doesn’t have enough data to be sure of this effect.
By the way for all others, Chantix is not in the same class as Zyban or SSRIs. It has a different mechanism of action. That doesn’t mean it doesn’t cause neuropsychiatric problems, it just means that you can’t directly related any class effects of antidepressants to Chantix.
Chris
Aside from the tedious ‘Pharma companies are evil’ comments someone asked if this is similar to Zoloft, that is, is it an antidepressant hence the SSRI like side effects. I googled Chantix (chemical name varenicline) and found some info. I’m not a scientist so if any pharmacologists out there could comment it would help, but it seems to me that the drug is not an antidepressant but has more similarities with the class used to treat Alzheimer’s disease.
“Varenicline, produced by Pfizer, is unusual as it both stimulates and blocks specific nicotinic receptors in the brain. It is thought that by stimulating the receptor it mimics the effects of nicotine to reduce cravings. At the same time, it partially blocks the receptor preventing nicotine from binding to it, resulting in a weaker response in people who give in to temptation and have a cigarette.”
I know that deficiencies in nicotinic receptors seem to play a role in Alzheimer’s disease and that Pfizer is in that area. Was this a drug originally developed for AD and re-directed to smoking cessation? If so I don’t think that is wrong. The rates of mortality associated with smoking are very significant and far greater than the suicide rates associated with this drug, as sad as any suicide is. I don’t smoke but know people who do and some just can’t quit. If this or any other drug, patch etc helps them, then great. It’s worth seeing that side of the picture too.
Nathan
This is from a post I made back in December on this same topic:
Here’s a few numbers to consider:
(Note: these are very rough numbers, I’m not a statistician and the numbers are off of web sites that may or may not be accurate — but will hopefully give us a “ballpark”)
Based on numbers that I’ve seen, somewhere in the range of 400,000 prescriptions for Chantix have been filled this year. Since the course of treatment is several weeks, let’s assume that number represents 200,000 people. There are approximately 10 MILLION attempted suicides in the US every year. That means that 1 in 300 people (0.3%) in the US attempt suicide annually. That also means that a whooping 330 (0.3% of 200000) people taking Chantix are likely to attempt suicide this year.
———-
For those of you who think that Chantix has some similarity to SSRIs: the only similarity is that Chantix is a CNS active drug. (i.e. both drugs get into the brain) It acts as a partial agonist of the nicotinic receptor. This acts to partly block the effect of nicotine to the brain (so smoking isn’t as pleasurable) as well as to very slightly stimulate the nicotinic receptors (so that cravings aren’t so intense).
Any drug that gets into the brain should be treated with caution and respect. However, smoking is estimated to cause more that 400,000 premature deaths per year in the US alone. Which do you think is a more serious risk?
Laurie
“However, smoking is estimated to cause more that 400,000 premature deaths per year in the US alone. Which do you think is a more serious risk?”
Oh, I agree that smoking is a huge health problem, but not recognizing the potential downside of Chantix is irresponsible. The warning is appropriate and needed. I don’t believe that a patient who takes Chantix expects to have a possible suicide reaction. The patient needs to know this possibility, regardless of how small the numbers are.
My reference to Zyban/Wellbutrin was not meant to connect Chantix to antidepressants. It was the clarify Diane’s comment that Zyban had no known psychiatric side effects, which was inaccurate.
Atlex
Laurie, I don’t think anyone is saying that the warning is not appropriate, just that it has to be put into context. Many of the posters here don’t do that; they look at the raw numbers and make outlandish statements (see above…Mike M; Truthman; Ernest, Jane).
Laurie
I’m just thrilled that a warning is up. Now it’s up to the consumer to decide if the risks are worth the benefit. That’s always been my goal in this fight. Full disclosure.
Jane
No, what I’m looking at Atlex is how a drug company is taking a population of people (smokers),easily disliked by hugh part of society, to make a profit on a dangerous drug. When some pretty serious side effects have arisen all the sudden this population of people are being labeled mentally ill. Why? because they can as it is pretty easy for people to associate someone who would smoke has to have some type of mental imbalance.
Justice in Michigan
If I’m following events rightly, there is an important preemption-related issue here.
A few weeks ago, we “congratulated” Pfizer for updating the Chantix label. That seemed appropriate. If I read the post correctly, FDA is now confirming that update was, indeed, called for.
What this shows is that a company _can_, if it is inclined, update the label unilaterally, and without prior FDA approval. Indeed, most of us would conclude that a company is obliged to do so at the time they become aware of potential new risks, or understated warnings.
A central argument of the preemptors - perhaps _the_ central argument - is that such unilateral label-change is not allowed unless there is a proven causal relationship and the AE is newly discovered. The Bush FDA itself recently posted another of its “rules” to that effect.
So here we have a clear case that should drown that argument for good. Good riddance!
Lisa Van S
Justice in Michigan,.
Since you brought up Preemption,.. Have you seen that GSK just won a case using preemption in the death of a 13 year old paxil victim (O Neal vs GSK) GSK put out a press release, I personally believe it was a case they shouldnt have bragged about.
Truthman
Atlex..
I noticed you accused me of making outlandish statements…
I would be interested to know what you were refering to..
Could my so called outlandish statements possibly compare to some created by the pharmaceutical industry?..
Statements about Paxil , such as…
“restores a chemcial imbalance”
“safe and effective”
“is not linked to suicide”
“is not linked to an increased rate of self harm”
“is not linked to aggression”
“is not addictive”
“could work in children”
“remarkable efficacy”
All these statements were advertised as facts in marketing campaigns and press by GSK…
And all of these claims have proven to be untrue and false ..
Even GSK does not make these claims anymore
In fact they have admitted most of them were not true…
My statements are based on 4 years experience of paxil and psychiatry.. And 6 years experience of researching and campaigning about Seroxat(paxil)… Actually I would say I (along with other campaigners) have read much more information about Paxil than any GSK employee ever has or ever will…
And i have every right to bring this knowledge to public attention…
Is that outlandish enough for ya?…
Truthman
Have you seen that GSK just won a case using preemption in the death of a 13 year old paxil victim (O Neal vs GSK) GSK put out a press release, I personally believe it was a case they shouldnt have bragged about.
I agree absoultely Lisa..
This case was struck out on a loophole and pathetic technicality.. If GSK wants good PR , it would be wiser for them not to brag about this..
Kinda reminded me of when OJ Simpson was aquitted .. know what i mean?…
Atlex
Truthman (sic), did I miss something? Did I in any way mention Paxil? Why are you babbling about Paxil when the discussion here is about an unrelated drug?
As a side note for Justice in Michigan…it’s not clear that Pfizer unilaterally made the label change. I believe that Pfizer stated that they were in discussions with the FDA on this issue and the label change was likely a result of a “negotiation”.
Justice in Michigan
Lisa - I haven’t followed that particular case, but - overall - roughly half the cases in which preemption has figured have been won by manufacturers.
Needless to say, politics figures in a lot of this on every level. For anti-preemption people, that does not bode well for the cases that the Supreme Ct. will hear.
On the other side, major media are beginning to pick up on the issue. If it becomes a major issue in every Congressional district (they’re all up for grabs), we might be hearing quite a bit.
At core, Congress (both parties) have balked at stating their intent explicitly. That includes folks like Dingell, Waxman, Kennedy, Dodd, et. al., as well as those you might expect to be more preemption-friendly.
Personally, I could not vote for anyone (again, either party) who continued to balk on this issue. NEJM called its consequences “momentous” for the future of healthcare. “Momentous” is big enough for me.
Justice in Michigan
Atlex, fair point which we’ve visited before. It would be good to know what the process actually was between Pfizer and FDA - who proposed what; when; etc.
Anyone have some inside scoop?
Ed Silverman
Hello Justice,
I listened to the FDA teleconference on Friday afternoon and, if I recall correctly, the agency and the drugmaker did review this together. Pfizer chose to act before the FDA issued its advisory. However, at the moment, I don’t have the level of detail you’re seeking. Sorry about that.
ed
Lisa Van S
Justice in Michigan,
I agree, numerous cases have been won when Industry invokes preemption, with exception,.. Child cases involving SSRI’s. Manufacturer’s have filed preemption and then backed off. One case comes to mind; Woodward vs Pfizer!! Like I said, GSK should have refrained from bragging IE press release. Paxil and Kids; a pretty touchy issue w/many members of Congress. Big Mistake & GSK shouldnt have gone there. I also wouldnt be surprised if GSK privately settles this case before it goes for appeal, like they had done in Tobin vs GSK…. Just a thought!
Truthman
Atlex
Truthman (sic), did I miss something? Did I in any way mention Paxil? Why are you babbling about Paxil when the discussion here is about an unrelated drug?”
I mentioned Paxil, because you said i was making outlandish statements , and i was presenting you with outlandish statements made by the pharma industry…
It’s called Irony.. Ever hear of it?
…oh an i just love your use of the old latin (sic) ..
How so very subtle and cleverly sarcastic…
It must be wonderful (barf) to work (whore) in the pharmaceutical (snake oil) industry (killing machine)…
jr.
The company did not test people that had behavioral disorders in there study so the company is at fault cause the study is false it may help you stop smoking and you may think that you are ok but then you find out that you can’t leave your house because they company did test or do their job to protect us and give us the info that could have saved or live or a family members live. I DO BELIEVE THAT THIS DRUG SHOULD DO MORE STUDIES AND TAKING OFF THE MARKET DUE TO THE RISING SUICIDES
psingpsych
re: Atlex and Jane’s comments about how the studies are done: I’m involved in many studies of drugs in development and, believe me, these studies are designed so carefully in terms of who is allowed as a subject that it’s hard to get anyone who is an “ordinary” representative patient. It is very easy to exclude people with serious mental illnesses and with substance abuse.
Smokefree newbie
As a current Chantix user and newly reformed smoker, the side effects are so minimal. Especially considering smoking and it’s alternatives. As far as “the dreams” dreams are bizarre anyways. Typically, I don’t remember my dreams. On Chantix, I remember everything. They are just extremely vivid. That’s a weird way to awaken, but great for breakfast conversation.
pg
39 deaths from suicide - what are the rest of the deaths so far from then?
http://www.news.com.au/heraldsun/story/0,21985,22988603-2862,00.html
“ANTI-SMOKING “wonder drug” Champix will hit shelves in Australia tomorrow, even after being linked to more than 62 deaths and thousands of cases of suicidal thoughts and depression in the US and Britain.”
The rest might be to do with health problems such as cardiovascular disease that they EXCLUDED from the trials, so therefore the risks / dangers are ‘unknown’ when chatix is given to those people:
http://www.news.com.au/heraldsun/story/0,21985,22988603-2862,00.html
pg
Second url should have been http://whyquit.com/pr/082506.html
where it explains what health conditions Pfizer excluded from Chantix trials (mental and various physical conditions) and much more.
Franklin
Isn’t smoking in and of itself a suicidal tendency… there’s really nothing here to discuss, and Nathan’s figures attest to this furor as “much about nothing”.
pg
Yes there IS something to discuss. Pfizer have taken over Tobacco, selling a drug under the banner of science to allegedly help get off nicotine - with about as much ’science’ as the tobacco industry used to promote smoking.
Smoking kills, we all KNOW that. Chantix kills too.
Millions of people have given up smoking without drugs and have survived. Pfizer are making a profit on convincing people to USE THEIR DRUG to survive but its already killing more people than tobacco did in THEIR first couple of years.
Pfizer is an industry that makes ‘MEDICINES’, tobacco never was.
THAT IS FRAUD.
pg
One thing Pfizer’s drug is NOT, is SCIENCE.
pg
Trial data: Chantix works for only “one in five” people ergo FOUR OUT OF FIVE relapsed in a year. But the side effects, many of which are yet unknown due to the exclusions of mental illness, cardiac disorders, etc, can affect any number of people.
http://whyquit.com/pr/082506.html
“Does Chantix really work?” “Tell me the truth, what are my chances?” Frankly, if long-term results from clinical trials hold, your actual chances of quitting smoking with Chantix (whose chemical name is varenicline) are not promising. According to boasts by Pfizer, the drug’s maker, “approximately one-in-five” users quit smoking for a year. Yet sadly, Pfizer is today marketing varenicline as having a 44% success rate at 12 weeks, when that figure is really rather meaningless. In clinical trials the treatment period was 12 weeks and users were still under the chemical’s rather amazing influence. If addicted to using an external chemical to steal dopamine, how significant is a boast about successfully substituting another chemical that allows continued stealing?…”
So whats the difference between tobacco and chantix? What is the difference between the Tobacco Industry with its cigarettes and a ‘Pharmaceutical Industry’ with its drugs, both aiming for the same section of society, both using false statistics and fraudulent science?
pg
The difference is: People already know tobacco kills but TRUST their GP and the FDA when they want to get off tobacco. They will believe Chantix is an evidence based scientific medicine and so must be beneficial, unaware that it MOST DEFINITELY is NOT.
Brian
pg
I think it is reasonable to warn people that quitting smoking may make them depressed and suicidal. Quitting smoking is not something to be taken lightly. The change in one’s homeostasis is dramatic as it is not simply a habit. Once you make the choice you should understand that no one knows whether you will come out the other side in good shape.
I think people who smoke ignore the fact that their brain has been physically changed by nicotine and that they may suffer, some more than others, while trying to quit. Nicotine threatens your life and it is not unreasonable that people can’t live without it!
pg
Isn’t trying to STOP a clear indication of NOT being suicidal? Isn’t that why millions of people across the world have given up (successfully without drugs and of course without side effects)?
Not to forget that mental health disorders were EXCLUDED from trials.
All in all it doesn’t take a rocket scientist to understand that Pfizer are making fraudulent attempts to blame adverse CHANTIX drug events on the person taking them.
A 10 year old child would understand that. But then, children don’t see the world through pharma-tainted glasses.
pg
Millions of people have done it, Brian.
Millions of people have succeeded over the years, without a drug to replace it.
pg
All Pfizer are doing here is making a profit on something the tobacco industry used to make a profit on, using fraudulent science.
There is no way out of that. Its clear, its obvious, people did it without Chantix before, people who were ON CHANTIX BUT HAD NOT GIVEN UP SMOKING have become suicidal.
Its a profit making exercise by Pfizer. No more, No less.
pg
http://www.fda.gov/cder/drug/InfoSheets/HCP/v...
“…Serious neuropsychiatric symptoms have occurred in patients taking Chantix. These symptoms include changes in behavior, agitation, depressed mood, suicidal ideation, and attempted and completed suicide. While some patients may have experienced these types of symptoms and events as a result of nicotine withdrawal, some patients taking Chantix who experienced serious neuropsychiatric symptoms and events had not yet discontinued smoking. In most cases, neuropsychiatric symptoms developed during Chantix treatment, but in others, symptoms developed following withdrawal of Chantix therapy…”
John
I think it’s fantastic to see such informed discussion. I too am intrigued by the fact that Pfizer changed all labeling prior to the FDA announcing it was requiring change. As shown in the article I wrote linked above, my greatest concern initially wasn’t adverse events but effectivenss as many of the early nicotine gum studies in the 80s showed signiicantly higher one year rates than varenicle but in real world use the gum’s rate is now recognized as about 7% at six months.
After having read the full text of all NRT studies published in English I’m absolutely convinced that using the double blid study format in drug addiction pharmacology studies has been a license to steal, and that both GSK and Pfizer have long been aware of this fact. It is the only study area where those assigned to the placebo group are actually punished and made worse by throwing them into full blown drug withdrawal. I keep waiting for some health journalist to wrap their brain around this shell game but as yet it hasn’t happened.
John R. Polito
Brian
John,pg
As you know the cold turkey approach works in patients with low levels of nicotine exposure due to high metabolism by cyp2E6.. Don’t oversimplify the problem. All those extra nicotine receptors in a smokers brain demand stimulation..Most people don’t quit by any means….so all the tools in the shed need to be accessed
pg
Brian, I’m offline in a minute, but would ask you before going why it would be seen necessary to include a drug that has already seen 62 deaths of which 39 were suicide therefore 23 were due to other causes, and thousands of reported side effects - in such a relatively short period.
Do you actually BELIEVE that tools that kill people who have not even yet gone into withdrawal from nicotine, and people who are simply trying to give up as millions have done before the emergence of Chantix, is useful?
By the way, my post DIRECTLY beneath yours - it landed a couple of minutes after your - was not aimed at you, I was still writing it when you posted yours. I only saw your comment after I’d posted it, hence the next one addressing you by name :-)
Jane
Brain,
Of the millions and millions of smokers who quit smoking before Chantix came on the market, not once did I hear of one person killing themself because of the lack of nicotine. Spin this drug any way you want but people are dying, people are suffering, and guess what, they aren’t mentally ill. 69 people would be alive today had they not taken this drug.
Laurie
“I think it is reasonable to warn people that quitting smoking may make them depressed and suicidal.”
You have made this claim many times. Do you have any data to back this up? I have looked and found nothing. On a google search the only association between nicotine and suicide is when Chantix is in the mix. I would love to see any data you have.
Theresa
I think it’s pretty clear that Atlex is a Pharma “troll”–a pro-pharma poster who lurks in chat rooms and listservs and posts to sites like this one, promulgating a pro-pharma point of view while masquerading as a neutral voice of reason. Regarding Chantix, one item that I read (http://www.wfaa.com/sharedcontent/dws/wfaa/latestnews/stories/wfaa071120_mo_chantixfda.229fea93.html) indicated that Chantix plus alcohol, in particular, may cause suicidal thoughts and behavior, and that Pfizer never tested the drug in combination with alcohol. To me, this seems an odd decision.
John R. Polito
“Most people don’t quit by any means”
Although you did not address my comment at all, which is fine, if “most” means greater than 50%, then your statement is incorrect as the CDC, ACS and nearly every major health non-profit contends that roughly 90% of all long-term ex-smokers quit smoking cold turkey.
I’ve personally worked with thousands of quitters, Brain, and it’s been my experience that the heaviest smokers are often the most motivated. Like any endeavor in life, including nicotine dependency recovery, key to enhancing the prospects of success are education, understanding and rock solid support.
But I’d be curious hearing your thoughts regarding whether or not using a double blind study format in drug addiction studies constitutes a license to steal. Most varenicline users I’ve spoken with tell me that by day 5 or 6 that smoking a cigarette is like smoking a carrot as the expected dopamine “aaah” sensation does not arrive 8 seconds later, as it did thousands of times before. Keep in mind that this is prior to day 8 when Pfizer advises them to quit smoking. It isn’t a matter of guessing whether or not a foreign chemical is at work inside their brain, they knew it with a degree of certainty, and prior to ever quitting.
Is it an unfair and deceptive trade practice for Pfizer to proclaim to the world that these studies were blind when it knows with absolutely certainty that they were not?
Diglebe
Now imagine how many suicides there would be for all the people who quit cold turkey. A lot more. You people have to understand that its not just chantix that is making mental alterations to the brain. Its also the other stimulants smoking creates that your body is weening its self off of. So to say its purly chantix and suicides are a resilt of this purly is bad science.
Nathan
John says:
“Most varenicline users I’ve spoken with tell me that by day 5 or 6 that smoking a cigarette is like smoking a carrot as the expected dopamine “aaah” sensation does not arrive 8 seconds later, as it did thousands of times before. Keep in mind that this is prior to day 8 when Pfizer advises them to quit smoking.”
John, that is EXACTLY the point! What are you missing here? That IS the drugs effect! Varenicline makes smoking less pleasurable. It’s easy to stop smoking once smoking a cigarette gives you the same pleasure that smoking a carrot does.
You say:
“the CDC, ACS and nearly every major health non-profit contends that roughly 90% of all long-term ex-smokers quit smoking cold turkey.”
That’s irrelevant. The point is, how many people quit LONG TERM. I’m sure that it’s not 90%. I talked to a smoker yesterday who said that she is very getting very good at quitting smoking: she’s quitting for her 9th time.
I do agree with you on one point: Pfizer choose to compare Chantix to placebo. Quiting cold-turkey on placebo is probably not the “standard of care” for smoking cessation. They should have done an NON-BLIND study comparing Chantix to nicotine patches or something similar. However, as most people are aware, there is a significant placebo effect for most diseases — especially ones involving the brain. Therefore, Pfizer would have likely been heavily critisized by the FDA if that had done a non-blind study comparing Chantix to nicotine patches. It’s possible a study like that is underway now, as a followup up (post-marketing) study.
John, I’m still left confused: What are you claiming about Chantix? Are you claiming that its unsafe? Unneeded? Ineffective? All three?
Based on what I’ve seen it is safe (when compared to the very dangerous condition that it is treating), needed (due to the high number of people that fail to quit with standard therapy), and effective (not 100% effective, but if I could take a drug and have a 20% chance of being “cured” from a life-threatening illness, I would gladly due so).
Nathan
Jane says:
“Of the millions and millions of smokers who quit smoking before Chantix came on the market, not once did I hear of one person killing themself because of the lack of nicotine. Spin this drug any way you want but people are dying, people are suffering, and guess what, they aren’t mentally ill. 69 people would be alive today had they not taken this drug.”
You are fooling yourself. People die every day. We all will die sooner or later. We don’t report those deaths to the FDA. As soon as someone starts taking a new drug and then dies, it’s going to be reported to the FDA. The question is this: Did MORE people die taking the drug than would be expected to “randomly” die due to natural causes? That’s partly what my number crunching (post #12 or so) was trying to point out.
Here’s a litany of things that could happen when about 200,000 people take Chantix:
1) Smokers sometimes have heart attacks. Did people using Chatix have a disporportionally higher (or lower) number of heart attacks?
2) Smokers sometimes get cancer. Did people using Chatix have a disporportionally higher (or lower) number of cancer victims?
3) Smokers (and nonsmokers) sometimes commit suicide. Did people using Chatix have a disporportionally higher (or lower) number of suicides?
The list could go on, and on, and on. My number crunching was attemping to answer question #3. Based on the numbers I found, people using Chantix may have a slightly higher risk of suicide than the general population. However, people using Chantix are NOT the general population: they are smokers. I have yet to see any statistics showing that smokers have a higher (or lower) suicide rate than the general population. Its possible (though I think unlikely) that smokers have a LOWER suicide risk than the general population. If this were the case, then the numbers of suicides with Chantix could be a real problem. But again, this risk has to be weighed against the very significant health risks posed by smoking itself.
For those of you (pg) and others who think this drug is so dangerous, I really want to see some number crunching SHOWING that death rates are higher with this drug than in the general population (or placebo). Numbers without a reference point mean NOTHING.
truthman
Considering we know at least one of our regular pro pharma brigade is associated with Pfizer, I sometimes wonder if the pro-pharma people who post on Pharmlot have been planted for damage limitation purposes… But anyhow, would anyone here really be that suprised if this was the case?
pg
I’m not sure about your number crunching in your comment Nathan(the one about 12 down from the top) - you may be right but without finding the source of what you describe as “somewhere” you could also be totally off keel either way.
Using the figures from the extract below, Page 15 of this LINK:
“He [Khan] found a rate of 757 suicides for every
100,000 participant year or 715 per 100,000
participants. That is 68 times the population rate, enormous.”
that (by rough estimate) the “population rate” of completed suicides is around 11 in 100,000, though I’m not a mathemetician or statistician either, so I’m not sure of that.
As far as attempted AND completed suicides are concerned, the statistics should become clearer as GPs become aware from the warnings given that Chantix can cause suicidality, and they assess whether or not their patients that came in with a wish to stop smoking had shown any prior signs of suicidality, instead of assuming that the person had suddenly for no discernable reason become depressed and suicidal.
The FDA warning has come relatively early re Chantix and that in itself rings alarm bells, not to mention Bob Rappaport’s statement:
“We’ve become increasingly concerned as we see a number of cases that truly look like exposure to the drug and not other causes”
Before wishing you a good weekend, I would add that I would never knowingly try to break a bad habit by taking a drug that has an 80% failure rate, a list of drug adverse effects that could curtail my longevity quicker than tobacco, and where trials were limited and included excluding health problems although being marketed to the population at large - thus preventing my GP to even assess what conditions might make the drug a more obvious risk to life. But we’re all different.
[Rushed message, apologies for any grammatical or typo errors]
pg
See, rushed and haven’t closed a link somewhere. Sorry!
pg
See, rushed and haven’t closed a link somewhere. Sorry! Only takes a minute to close a link, maybe Ed will remove the last one:
I’m not sure about your number crunching in your comment Nathan(the one about 12 down from the top) - you may be right but without finding the source of what you describe as “somewhere” you could also be totally off keel either way.
Using the figures from the extract below, Page 15 of this LINK:
“He [Khan] found a rate of 757 suicides for every
100,000 participant year or 715 per 100,000
participants. That is 68 times the population rate, enormous.”
that (by rough estimate) the “population rate” of completed suicides is around 11 in 100,000, though I’m not a mathemetician or statistician either, so I’m not sure of that.
As far as attempted AND completed suicides are concerned, the statistics should become clearer as GPs become aware from the warnings given that Chantix can cause suicidality, and they assess whether or not their patients that came in with a wish to stop smoking had shown any prior signs of suicidality, instead of assuming that the person had suddenly for no discernable reason become depressed and suicidal.
The FDA warning has come relatively early re Chantix and that in itself rings alarm bells, not to mention Bob Rappaport’s statement:
“We’ve become increasingly concerned as we see a number of cases that truly look like exposure to the drug and not other causes”
Before wishing you a good weekend, I would add that I would never knowingly try to break a bad habit by taking a drug that has an 80% failure rate, a list of drug adverse effects that could curtail my longevity quicker than tobacco, and where trials were limited and included excluding health problems although being marketed to the population at large - thus preventing my GP to even assess what conditions might make the drug a more obvious risk to life. But we’re all different.
[Rushed message, apologies for any grammatical or typo errors]
pg
The link by the way is there as reference for working out COMPLETED SUICIDE RATES for population, its not about Chantix. That was the quickest I could find under key words I used.
Nathan
pg,
Let’s assume that your numbers are correct (ie. 11 comleted suicides per 100,000 population per year). The number of people that have taken Chantix since it was introduced is approximately 300,000. That would mean that you would expect about 33 suicides if Chantix had no effect on the suicide rate. The FDA advisory says that there were 39 suicides reported (worldwide). Given that numbers are probably a bit underreported, it is plausible that Chatix does have an effect on the rate of suicide. However, again, I content that the effect is insignificant when compared to the very well-documented risks of smoking.
——————–
Here’s where I came up with the 300,000 number:
2007 Chantix worldwide revinue (SEC filing) was $883 million. A weekly dose of Chantix costs ~$120 wholesale. That equals 7.4 million “weeks” of dosage. Typically, patients use Chantix for 12 weeks. 7.4 million divided by 12 is 613,000. However, I’ve read that people typically have to use two courses of Chantix (on average) before actually quiting. That comes to roughly 300,000 people having taken Chantix in 2007. I think you’ll agree based on those numbers that 300,000 is actually a rather conservative estimate.
Nathan
Truthman says:
“Considering we know at least one of our regular pro pharma brigade is associated with Pfizer, I sometimes wonder if the pro-pharma people who post on Pharmlot have been planted for damage limitation purposes… ”
I’m flattered Truthman. I work for Wyeth. I have no interest what-so-ever in Pfizer, except in-so-far as it influences the health of the pharmaceutical industry as a whole. I’d appreciate in the future if you would attempt to refute the facts and opinions in my posts rather than simply attack my profession.
Idle Observer
Nathan, you’re dealing with the lunatic fringe and/or Scientologists hiding behind the noble goal of protecting the public from dangerous CNS drugs.
Brian
Sorry John but you are a Neanderthal in the world of addiction. The key point your are missing is that the brain changes physically when nicotine is introduced. The less it is changed the easier it is to quit. The level of free nicotine in the brain stimulates and then deactivates nAcCh receptors. Over time nAcCh receptors up regulate and suddenly you need more stimulation to keep your self sane. Folks with a high metabolic rate for nicotine clear it prior to CNS penetration. The end result for those heavily addicted is an increase in receptor number. I would posit that those who have really quit cold turkey (god bless them), were not that far down the addiction road as far as receptor number goes. The fact that there are many laryngectomies smoking through their stoma shows that fear of smoking death is not a great motivator but fear of being deprived of nicotine is a potential suicide risk for a very few. Remember varenicline is just a nAcCh P.A. so it sits on the same exact receptors that nicotine wants to use. For a very very few people the loss of their friend nicotine is just too much.
truthman
“I’m flattered Truthman. I work for Wyeth. I have no interest what-so-ever in Pfizer, except in-so-far as it influences the health of the pharmaceutical industry as a whole. I’d appreciate in the future if you would attempt to refute the facts and opinions in my posts rather than simply attack my profession ” Says Nathan …
I was far from trying to flatter you Nathan..
I have consistently refuted (with evidence) all the facts and opinions of yours which i have disagreed with thus far…
It’s a shame that you back out of the debate when your limp arguements fall to pieces..
truthman
So Nathan, You work for Wyeth.. (manufacturors of the poisonous Effexor)
You must be proud to work for a company which destroys peoples lives with bogus drugs…
http://www.petitiononline.com/mod_perl/signed.cgi?effexor
Check out the 16,000 signatures on The Effexor Petition..
(And no Nathan, they are not 16,000 happy customers..)
I bet you wouldn’t dare get into a debate with 16,000 people who have been severly damaged by Effexor would you? ..
Oh and on the same subject..
The Paxil online petition has almost 10,000 signatures..
http://www.petitiononline.com/mod_perl/signed.cgi?oky71
And yourself and Brian (who works for Pfizer no doubt) continue to claim that people are helped by these drugs..
It seems to me that the defunct reputation of the pharmaceutical industry is somehow connected to its continual faliure to address the voices of it’s customers (the patients).. Maybe Yourself and Brian should begin to recognise that ..
addicted
The elephant in the room is cigarettes and nicotine addiction. It’s like heroin and our government gets 52% of the profits for each pack sold. It kills over 400,000 people a year. Genocide for profit. I’m a smoker who finds it very very difficult to quite. My fear is for the next generation of addicts. It needs to stop at some point.
Brian
Truthman,
Point out what is incorrect about what I have said in the post above? BTW you are wrong in your attribution about me. Don’t forget let’s keep this post on the up and up. The moral high ground now belongs to me. You are one nasty guy. You don’t mind watching addicts continue to suffer and die
Lori
I have been on Chantix for 5 weeks now, with success.
It’s not a miracle pill, urges do creep up. Withdrawl s/s are easier, BUT I have some of the same adverse reactions that most of you have, the one that comes to mind the most is, I got really angry at my husband for not suggesting where we went to lunch, (yeah stupid) but at the time it didn’t seem that way. I just recognized it, and relaxed and tried to calm myself down. But here’s a thought…………. could taking the pills mixed with withdrawl symptoms and lack of sleep (from vivid dreams) and not using smoking as a coping mechanism for anxiety, (and I could probally go on) like a Domino effect be causing the adverse reactions? But then again it’s working directly on our brain receptors? On ONLY the smoking ones or is it affecting others that it shouldn’t be.
Adam
Lori- 5 weeks? wait another month
Here’s the thing. People are not just making this up. I’m not making up any of the symptoms I had or the ones I still battle - sometimes day by day. Something did happen and is happening to people who are using this drug. The real issue is what do we do now that we are ‘affected’ by this drug. Sit around and squable about how bad smoking really is or how the drug company lied or what the numbers tell us. People are hurting- some are being driven to the point of losing jobs and families and lives- I don’t know the answer but I’m pretty sure it’s not calling my Dr and getting another drug to help me with this problem. You can say you didn’t have a bad reaction and life is wonderful- good for you- not for the rest of us- I just don’t know what to do now. By the way- I smoked for 25 years- have now been off for 6 months, am a pretty normal married man with three great kids, no history of violence, stable job, go to church…etc….. just last week I sat in my office chair and thought about how great it would be to blow my head off while sitting in my chair…….. Oh and it’s not because I read through all your wonderfully insightful and charming witty comments– I just thought it would be great……. and I end this the same way I started……. I just need to know what I do next
Lacey
I must say that all of the above comments that you all have posted have some great points. We are all entitled to our own opinions and have our own experiences. I am not going to go through and give you my opinions or past experiences.
All i want to say is that I am tired of smoking… I have been smoking for over 8 years. I feel old and unhealthy and I am only 25. I take 20mg of PAXIL a day for the past 2 months and have been perfectly fine. At first it made my feel really energetic as if i consumed 5 cups of coffee and then after 1.5 weeks that subsided and I am doing great. Starting tomorrow I am going to start taking CHANTIX at a lower dose than directed and feel it out from there. I have tried quitting in the past and get way to moody, anxious, craving for food and a smoke, i feel like I am going to go insane…then I smoke and i feel better. So….My point is, I am going to do a self study: 25 y.o female witha history of depression and axiety, smoking x10 years, taking no meds other than 20mg PAXIL by mouth with the first initial dose of .25mg of CHANTIX once a day for 4 days then increase to .25mg CHANTIX twice a day for 4 days…I will continue prescription therapy and icreasing dosage every 4 days. I will keep you all updated on my hopeful progress. I HAVE DONE ALOT OF RESEARCH ON CHANTIX PRIOR TO MY CHOICE TO START WITH THE PRESCRIPTION THERAPY. I will keep you all updated daily online for your own research and so that Ican use this online post as a resource to track my daily symptoms.
Stephanie
even though there were “only” 39 suicides i’d like to see you tell that to those 39 persons families who would have done anything to save there loved one, you obviously don’t know the seriousness of depression and how much it can ruin an innocent persons life.
Kris
Chantix has only begin to show its ugly head. There are 34+ suicides documented. That is by no means at all a real number. How about the people who were driving and suddenly felt like plowing into a brick wall? - That would be called an (Accident) not suicide.
This is a drug to stop smoking. Literally in the direct relationship to stop killing yourself; quite funny, isn’t it, like something you’d see in Monty Python…
Smokers are already paying for somebody (big tobacco) to kill themselves, just a little bit slower. Maybe this is a new game called “Lets pay someone else to do if faster” … hmmm I know a perfect name., ‘chance to kill’… no that work work, howabout to off yourself., ie NIX… yeah.. take this drug, and you will have a chance to NIX yourself… CHANTIX… perfect., —
By the way, isn’t Big Tobacco, RJ and Phillip still saying ” smoking cigrettes are not causing cancer”
Its all a bunch of Bull…
Casual Reader
that was a very interesting conversation to read through. it seems though that very few of you are actual smokers, and few posters have used it, or no someone that has. i just wanted to add that i have three friends who have used Chantix and all 3 have been tobacco free for at least a year. i’ve talked extensively to all 3 of them about using Chantix and the only constant was the fact of “the dreams”. none of the 3 said anything about deep depression (in fact, i would call it opposite as they were all excited to finally quit smoking). and as for the dreams, i experienced the same thing when using the nicotine patch.
HorusCat
Jane,
The mentally ill are routinely disqualified from trials except in the case of a study for the particular disease state they manifest. As are pregnancy-age women. The mentally ill cannot give informed consent.
HorusCat
Brian,
Don’t get into it with Truthman. He will out-ugly you and it will just make you tired. My mom had smoked for 58 years when her doc Rxed Chantix. She didn’t even want to quit! But, she did. I’ll have to ask her about the dreams.
I think people should have access to Chantix after being apprised of the risk of depression. This is surely a case of the absolute risk reduction being worth it for many people.
Leah
I began taking Chantix to quit smoking at the end of February. I read the warnings, which included a range of side-effects, but none being increased depression or suicidal ideation. The drug worked miracles, smoking was horribe, and I successfully quit after about 1 1/2 weeks. The directions are to contine taking it for 12 weeks to be sure you’ve kicked the habit.
I started getting extermely irritable and “down”. I’ve always suffered from exterme PMS symptoms (and here in Minnesota many of us get the end-of-winter-blues, awaiting more daylight and nice weather.) I chalked the blues as those two reasons. I began having bad nightmares, and this began to concern me. I was having dreams of things I would never even think about, things that have never crossed my mind. For example: I dreamt of shadows coming out of my legs that were some sort of deamon or devilish thing. I knew that the only way to get rid of these shadows was to cut my legs off. I woke up the next morning panicked, thinking what if I wasn’t in a deep enough sleep and I actually went into the garage and fired up the chainsaw. This was my final straw, I thought it must be the Chantix. At this point I stopped taking it and began hearing people talk about their crazy dreams while taking it too.
A few days went by and my craving for cigarettes returned. I thought, well I’ll give it another try, maybe it was a fluke. Five days later I got into an argument with my mother, which for us is no surprise. But this time I just snapped.
I decided to take a drive to clear my head. I ended up driving about 70 miles from my home. I was frustrated that I had gotten lost (at this time it was 4am). I pulled off the road after passing the same farmer’s field 5 times. At this point it’s like I completely gave up. I took a pocket knife from my car, went into the woods and slit my wrists. I was in a remote location on an unmarked road in a field not very visible from the dirt road. I severed the main artery, 3 tendons and 2 nerves in my left hand and 1 tendon in my right. By the grace of God someone saw my car in the field and called 911. A police officer got to me at 1pm, I had been unconscious for approx. 9 hours. It is a miracle I am alive.
I’ve never been one who wanted to hurt myself. I have the most amazing and supportive friends and family, whom are all baffled. I have psych. doctors telling me they have no idea, I seem to be “normal” and had a random, intense impulse. I’m a very strong and have never considered suicide an option. This leads me to believe one thing…the Chantix.
I apologize if the story got long…but I’m just now realizing I should really share my story. I will be the first to say it did it’s job, I quit smoking. BUT I remind every person I talk with to watch your friends and loved ones who are taking it. Be aware of strange behavior! Please send me a message if I can be of any help to anyone with questions. It is now almost 3 months since I tried to end my life…and I still do not understand!
Sorry this is so late (I just began typing well again).
marcie
I just want to say that i have been smoking for 12 yrs and have not been able to quit with any patches or anything. But i tried chantix and quit, but i stopped taking the meds and started back up. Key is to stay taking the meds for at least 2 months after you quit. About the dreams, YES, i have the most vivid dreams and most are bad ones. About the deppression, the first week i start taking the meds i feel or my friends say i sound down. But no suicide feelings, just prolly down cause the cigarettes start tasting like crap and i want them to taste better ;). No, but the meds work so good, i wish everyone that is baddly addicted would try it cause it works for sure. Id say 90% is the pill and it takes 10% of you trying to quit.