Talk:Varenicline

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[edit] Removal of alcohol dependance

I'd appreciate a link to the official statement regarding the use of phase 3 human test studies being the minimum quality standard for citation in medical articles on wikipedia. In my opinion, citation of an article released by the National Institute of Health of the United States Federal Government should constitute notable and reliable enough information to meet inclusion standards. --Linkinlogs 00:10, 4 November 2007 (UTC)


About the link to alcohol consumption: Regarding the fact that was an animal study... The study was mentioned all over mainstream media. I know that's not the most reliable place for medical information, but since the pill is already used on humans I thought it was relevant. A lot of times animal studies are about substances that end up not being effective in humans, but this one works with nicotine. I figured that means that there is a reasonable chance this will mean something in humans, and at the very least it will bring about more research. Maybe it was a stretch to say it may be effective against alcoholism, but it's definitely made a buzz in the mainstream media and I got the impression that it's getting a lot of attention. But I'm no expert in medicine, nor am I an experienced editor here (this was my first one). But that was my thinking behind it. --SlamboS 00:45, 12 July 2007 (UTC)

Someone keeps putting chantixresources.com in the resource link. It appears to be spammish. 68.169.183.172 15:23, 15 August 2006 (UTC)Zylo

JAMA this weeks contains four trials all demonstrating effectivity against placebo and even bupropion.

An editorial raises some concerns about inclusion bias and generalisibility of the results[1]. I've hesitated to cite the first three studies without taking a closer look at these writers' objections. JFW | T@lk 22:27, 4 July 2006 (UTC)


This drug I believe is now available in the UK on prescription. This I feel should be added to the article.

[edit] In the news:

http://www.sciam.com/article.cfm?chanId=sa013&articleId=ACE9FF1E-E7F2-99DF-31F26EC00AA05F4A&modsrc=most_popular

http://abcnews.go.com/GMA/OnCall/story?id=3623085&page=1 Jayedwards5 18:02, 20 September 2007 (UTC)

Perhaps a bit more detail and discussion? Most of this seems to amount to heavy speculation. JFW | T@lk 23:44, 19 September 2007 (UTC)

Agreed that it is speculation, but as someone who is actually using it and watching the message boards, I've seen enough people mention aggression and psychosis as a potential problem [2] (as an example). As stated, I've cited reliable sources in an effort to fairly inform. In fairness, I have put Pfizer's response in as well. And in fact, I've come out in defense of Chantix on several of these boards attempting to avert panic. However, the fact that it is so often discussed makes it relevant. Jayedwards5 00:04, 20 September 2007 (UTC)JayEdwards5

I wish you'd discussed this first before reinserting it again. Speculation on message boards is NOT a reliable source, even if you balance it with some information from Pfizer that is not actually a response to that speculation. The best way of averting panic is being selective in what enters article spice on Wikipedia. You could consider WP:RFC to see if other users agree with your view, but please do not reinsert the material in question until my concerns have been addressed. JFW | T@lk 16:55, 20 September 2007 (UTC)

The fact that the unsettling side effects are discussed on message boards alone would perhaps constitute speculation; the fact that these effects are listed on Pfizer's own web site[3] combined with the heavy play they receive from people actually taking this medicine takes it to another level and makes it relevant. The fact that it has made national news by definition makes it newsworthy. I included links to sources (NOT message boards) which discuss both sides to the story (the abcnews article contains Pfizer's response in detail). And the best way to avoid panic is not censorship; it is to keep people well-informed. Arbitrarily deleting information that is relevant, newsworthy, as neutral as possible, cited, and significant to those considering taking a new medication, even though it may be inflammatory, suggests a hidden agenda. Jayedwards5 17:14, 20 September 2007 (UTC)

I've asked you to stop reinserting this until we've arrived at consensus. It's a shame you're in such a rush. Now which effects from Pfizer's website are you interested in? Why do we need an ABC news article with uninformed speculation if there is a website from the manufacturer? I'm displeased at your reference to "censorship"; that is not a fair description of my objections; please remain civil. Think of WP:RFC instead of reverting. JFW | T@lk 19:12, 20 September 2007 (UTC)

If what you mean by "consensus" is that only you agree with what is posted, then you have not only sabotaged the spirit of Wikipedia, but have taken on the role of censor. The news article cites "reports"; the statement notes that reports have been made. No conclusions are proffered. What was inserted would not be considered controversial except by those who would have a vested interest in whether inflammatory reports reached the public. There would be no other reason for the removal of said statements other than that. Pfizer's website is merely their side; if Wikipedia merely allowed what a manufacturer states, WP would simply be a search engine. What would Brown & Williamson's page look like? What was inserted was properly cited and informative, and included facts, not speculation. You are not the final arbiter of what constitutes facts. If statements are cited, are relevant, and are important, they belong. So rather than deleting, why not put in a subsection that deals with these reports instead of attempting to sweep them under the rug? That way the general public, armed with ALL the information, can draw their own conclusions. Jayedwards5 19:31, 20 September 2007 (UTC)

I need not be lectured on the spirit of Wikipedia; people try to insert all sorts of nonsense in the name of the "spirit of Wikipedia". I also resent being called a "censor".
If the "reports" you talk about cannot be cited independently (e.g. FDA notifications), how notable are they? That's not sweeping under the rug, that's being deliberately selective to distinguish high-quality (e.g. scientific research) from low-quality (message boards) sources.
Please be mindful of the three revert rule. JFW | T@lk 20:12, 20 September 2007 (UTC)

The sentence in the article, "There have been reports of people experiencing mood and behavior changes while taking Varenicline, including psychosis, depression and suicide", is not backed up by the ABC news article, and is misleading. According to the ABC News report, it states that there were isolated incidents of psychotic and suicidal behavior, but it occurred in patients taking both the drug as well as placebo, so I don't think this is very strong evidence at all. I'm not disputing the reliability of ABC News here; in this case, they seem to be providing reasonable information, although the article in question deals more with one person instead of the study or clinical trial itself, so if we're talking about actual facts, it's better to use information from the manufacturer or clinical trial here. The ABC News source seems to focus more on one musician's case than the study on the drug itself. Dr. Cash 20:14, 20 September 2007 (UTC)

It looks to me like the most you can claim from the above abc news article is that a girlfriend of a famous person has stated that she believes that she thinks side effects from this drug caused her boyfriend to act irrationally which subsequently resulting in him being shot. Remember 20:26, 20 September 2007 (UTC)

Also if suicidal ideation occurred in both the control and experimental arm of the clinical trials it suggests that deprivation of smoking causes suicidal ideation, not varenicline. Remember 20:28, 20 September 2007 (UTC)
One last note, it appears that suicidal ideation is higher for smokers in general so it may not be a surprise that suicidal ideation would occur in a clinical trial of smokers in both the active and control arms. Also smokers tend to be schizophrenic, which may be more responsible for the irrational behavior than the barenicline. See [4] ("Comorbidity of schizophrenia and smoking is extremely common.[4] Multiple studies have shown the incidence of smoking among schizophrenics to range from 75% to 90%, compared with an incidence in the general population of approximately 25% to 30%. Ninety percent of schizophrenic smokers started smoking before they became symptomatic from schizophrenia. No association has been found between smoking in schizophrenia and medication. Smoking increases the risk of suicide. The odds ratio of making a suicide attempt for a smoker is 2.0 compared with that of a nonsmoker. The odds ratio for having suicidal ideation as a smoker is 1.4 compared with a nonsmoker. This relative risk is less than that for depression but greater than that for schizophrenia.")Remember 20:34, 20 September 2007 (UTC)
wow...there seems to be some confusion here. First, 'smokers tend to be schizophrenic'? Ummm...no; remember the direction the relationship is taking -- if some studies have shown that up to 90% of schizophrenics smoke, that is *not* the same as saying smokers 'tend' to be schizophrenic, or even that 'a lot' of smokers are schizophrenic. Saying that smokers tend to be schizophrenic is like reading a study that says most Hollywood actors wear mascara when on camera and then claiming that mascara wearers tend to be working actors. Just because a generalised statement can be made in one direction (and we aren't even sure that is correct!) does not mean that another statement can be made in the opposite direction.
One might safely say 'many schizophrenics are smokers', and depending upon how much faith one places in the studies one has read, might even be willing the place a bet that the next person who walks into the rec room of a mental hospital for schizophrenics is a smoker. But it does not work the other way around; I cannot sit in the park watching people smoking all day long and think I have seen a single schizophrenic, diagnosed or not.
Additionally, although the comorbidity of smoking and schizophrenia is common, no relationship can be assumed from this fact alone. Correlation does not imply causation -- IN ANY DIRECTION. There is a direct correlation between ice cream sales and drownings -- as ice cream sales rise, drownings also increase. Does chocolate cherry chip *cause* drownings? No. Does being about to drown *cause* people to eat ice cream? No. It could just be that more people swim and eat ice cream in the summer.  :-) Sometimes 'facts' are just coincidences, or there is a mediating variable in there that is difficult (or less intuitive than the mis-identified relationship) to discern, or there is a good potential avenue for further study, but a correlational relationship alone does not cement (or even imply) a necessary and sufficient condition.
Also, the 'fact' that '[n]inety percent of schizophrenic smokers started smoking before they became symptomatic from schizophrenia.' and attempting to make meaningful fact out of that statement alone is leaning towards being an example of the post hoc ergo prompter hoc fallacy. Someday a relationship may be able to be drawn (e.g., self-medication in the form of nicotine to replace Substance X which is being depleted) based upon empirical research (not reasoning and relationships), but at this time no such relationship can be honestly stated, and so this fact is only an interesting tidbit of trivia. Hold it in your mind in case other indicators of a relationship arise, but one would be wrong to base action upon it. Considering that the average age of diagnosis as a schizophrenic (for men per Wikipedia is appx 20 - 28 yrs) -- just statistically -- is higher than the average age of starting to smoke (17.8 years; Kavari, 2005), it is not surprising that the majority of people start to smoke before the average age of diagnosis, period...including those who don't have schizophrenia, and therefore aren't diagnosed with it. The average age of first sexual intercourse (16.5 years; Rotermann, 2005) precedes schizophrenia dx as well; is there a relationship there? How about one between sex and smoking?  ;-)
Ok, so I am being facetious a bit now, but I hope you get my points. Smoking is bad for you, but it does not have to be paired with schizophrenia to be a bad thing; it is a bad thing all on its own. Someone who smokes should not be alarmed that they may be schizophrenic, or suicidal. Someone who is schizophrenic is not *destined* to commit suicide, they are only more likely statistically. We have to remember that *people* are statistics, but a person is an *individual*. In other words, YMMV.  :-)
Lastly, 'Also if suicidal ideation occurred in both the control and experimental arm of the clinical trials it suggests that deprivation of smoking causes suicidal ideation, not varenicline.' gets another ummm...no. If you are studying the effects of Varenicline (or smoking cessation, which would be different, yes?) and have just the treatment and control groups, Varenicline is as much responsible for their suicidal ideation as it is for their thinking about what to eat for dinner, because both groups are doing that as well. Hopefully if one were actually studying the effects of Varenicline on suicidal ideation, they would have a more rigourous experimental framework in order to establish a link. I cannot decide to study whether or not Varenicline helps people quit smoking, gather my participants and assign them to groups, then notice at the end that 50% of one group killed themselves and try to put forth any intelligent explanation as to why (other than educated musings, but those are largely meaningless). I was studying VARENICLINE and SMOKING CESSATION. PERIOD. Although it is really exciting to have ideas about all kinds of things, as a researcher I should use caution as to what I have opinions about (especially what with all the attrition in my studies! ;-) ), when I am making my opinions publicly known. Sadly, these days, between 'science writers' and corporate shills put forth as experts, most people are as confused as ever about the difference between fact and opinion, especially once statistics, empirical research, and/or logic come into play.
You might want to check out these links before further speculation: http://en.wikipedia.org/wiki/Questionable_cause http://en.wikipedia.org/wiki/Data_dredging
And, honestly, I am *not* saying that I favour smoking. I don't. I am just concerned over some of the comments having the cloak of facts when I differ with that opinion, and worry that someone might take some of it to heart. Ancodia 17:55, 3 October 2007 (UTC)

[edit] NICE

Technology appraisal: http://guidance.nice.org.uk/TA123 JFW | T@lk 08:51, 27 July 2007 (UTC)

[edit] Please Add...

It would be nice if someone could explain in layman terms how this drug works, what it does, etc. —Preceding unsigned comment added by 69.3.229.197 (talk) 14:30, 10 October 2007 (UTC)

In layman's terms, nicotine changes the brain by growing receptors to a particular pleasure center. When nicotine is withheld, these receptors begin to get agitated, sending out the message "time to light up".

I may not understand the above description because I am not a layman. But the effects of nicotine are a bit more complex than that. It is true that one effect of chronic nicotine treatment is the increase of high affinity binding sites in the brain. This is different to "growing receptors". We do not know what it means actually. For a long time, it has been assumed to be an increase of alpha4beta2 nicotinic receptors. Then other explanations came up, like a shift between different isoforms of receptors, an effect on receptor folding etc. But in any case, this is not, as far as I am aware, involved in nicotine addiction. Or let's say not in nicotine dependence. I just could not understand what "When nicotine is withheld, these receptors begin to get agitated, sending out the message "time to light up" means.Nicolas Le Novere (talk) 17:27, 1 January 2008 (UTC)

Chantix works by blocking messages involving the pleasure center effected by nicotine, both incoming and outgoing. It first works by dulling the message that says it's time to light another cigarette (feed the addiction), so one doesn't want to smoke as many. Second, when one does light up, it just won't taste good. There's no satisfaction. Because these messages are blocked and the receptors not used, the receptors slowly go away, lessening the desire to smoke a great deal.

Not at all. Varenicline is a nicotinic agonist. It imitates nicotine effect. Yes it is "dulling the message that says it's time to light another cigarette" exactly like nicotine would do. It does not cause the receptors to go away. Even if it would, it would not lessen the desire to smoke a great deal. Nicolas Le Novere (talk) 17:27, 1 January 2008 (UTC)

It is not a vehicle for nicotine, so it doesn't prolong the addiction, unlike patches and inhalers.

Varenicline works exactly like nicotine, and we could perfectly do patches and inhalers of varenicline. The difference between varenicline and nicotine, is that the former affects only some nicotinic receptors, and affect them partially. Since nicotine has many effects on the brain, positive and negative, it is better.Nicolas Le Novere (talk) 17:27, 1 January 2008 (UTC)

Smokers still need to pick a quit day (because they smoke not just to kill the craving, but out of habit, from stress, in celebration...) and they'll still have occasional cravings, some coming out of nowhere long after the smoker has quit, so online support is also provided. There is at least one free self-hypnosis resource that many, many people have used to help in ending their addiction to nicotine (google: quit smoking online and select the first result).

The success rate for Chantix appears to be about 44% after three months, far above other products on the market. The one year success rate is about 22%, still far higher than other methods of quitting. The reason for this drop is because Chantix is a tool, not a magic pill, and nicotine is an insidious addiction.

The reason is first that tobacco is not just nicotine. For instance, tobacco smoke contains inhibitors of monoamine oxidase, that certainly participate to addiction and explain that chewed tobacco is far less addictive than smoked one. Second, tobacco smoking is more than a pharmacological addiction. Social and environmental cues are very important (otherwise noone would start to smoke. The first effect of tobacco smoke is to make you puke. One start to smoke mainly to comply with social rules). Third although varenicline is better than nicotine, it missed its target. It does not target the right receptors. For various reasons, that would be far to complicated to explain here (but that have to do mainly with social structure of scientific research, including stiffness of the opinion, power of simplistic explanations, lack of understanding of basic pharmacology by molecular biologists, but also with the slowness of drug development) most of the current clinical trials are targeting alpha4beta2 receptors, while the scientific community is now focussing on alpha7, alpha6beta2beta3 and alpha4alpha6beta2beta3 receptors. Nicolas Le Novere (talk) 17:27, 1 January 2008 (UTC)

[edit] Carter Albrecht

Albrecht's girlfriend is convinced that Chantix contributed to his tragic death; fine, nevermind Albrecht's blood alcohol content of 0.29 mg/dl, three times the legal driving limit in Texas. Albrecht's girlfriend isn't a medical or pharmaceutical expert, and since the ABC News article doesn't have a byline, I have serious doubts about the credibility, reliability, and accuracy of the source. The neurological side effects are no different from diphenhydramine, which is available OTC in the states. —Viriditas | Talk 11:56, 31 December 2007 (UTC)

You are reading too much into the note on Albrecht. The FDA said that it is aware of that case (without mentioning the name though) and asked Pfizer if there have been anything similar. The fact that he took varenicline with a high dose of alcohol is mentioned in the article and by the FDA. The description of the incident is taken from ABC only to give some background to the somewhat cryptic FDA announcement. Nowhere it is stated that varenicline is to blame, and Albrecht's girlfriend is not mentioned as a source or any kind of authority at all. It is up to the FDA to decide, and the article clearly states that. My guess is that the FDA will come up with a stronger language regarding taking alcohol with varenicline. Paul gene (talk) 19:48, 31 December 2007 (UTC)

I haven't read anything into it; I was merely quoting the source used and summarizing the autopsy results. Since the FDA doesn't mention Albrecht by name, I fail to see why it is included in the article, as the report in ABC News is less than credible, and quotes Albrecht's girlfriend as a medical authority when she isn't. —Viriditas | Talk 21:41, 31 December 2007 (UTC)
Since the FDA does not mention Albrecht by name, it is nice to have the background. According to WP:RS, reliable source is a source known for careful fact-checking, and ABC as a major news organization, certainly qualifies. Their reporting is also balanced, since in addition to Albrechts' girlfriend they also quote Pfizer representative. ABC did not offer their own interpretations of the incident, they used experts to do that, they merely reported the facts Paul gene (talk) 22:33, 31 December 2007 (UTC)
Always consider the source. We do not use secondary and tertiary media sources to describe scientific or medical issues without also confirming authoritative sources, which in this case would be a peer-reviewed journal, an official press release from Pfizer, or a press release from the FDA; Neither apparently exists. Each source must be evaluated on its own merits, not as a group. This source in particular [5] has no byline, does not quote Pfizer in the context of the claim being reported, and posits original research ("Did Combination of Stop-Smoking Drug and Alcohol Contribute to Carter Albrecht's Bizarre Behavior?") without appealing to any named experts. You said they used experts; who are they? Looking at the article, there is a mention of a pharmacy handout for Chantix detailing the warnings, and a physician by the name of Richard Honaker. But none of these "experts" address the issue of Albrechts death, which is my point. The girlfriend is not a medical authority. —Viriditas | Talk 23:38, 31 December 2007 (UTC)
No, I did not use the ABC report for any kind of medical claims or interpretation, but only for the description of what actually happened, so it is a primary source. Primary sources can be used if they come from a reliable source (major news organization in this case) and used in a simple description. And the source does quote Pfizer, and it is in the context of Albrecht's death (note the mention of alcohol): "We are very committed to patient safety," Ponni Subbiah, a Pfizer representative, told ABC News. "We continually monitor adverse events. To date there is no evidence to suggest that Chantix is associated with violent behavior. And I think it's important to keep in perspective that alcohol use in itself is associated with violent behavior." ABC also quotes an MD who regularly prescribes varenicline, so he is an expert: "Richard Honaker prescribes Chantix to patients and while he urges caution with the drug, he believes the possible risks may still be worth the benefit."More patients by far are able to quit smoking with this drug than anything else we have," Honaker said." Still I was conservative and did not include any of this. The rest of the note is taken from the FDA announcement: " FDA is aware of a highly-publicized case of erratic behavior leading to the death of a patient using Chantix to attempt to quit smoking. Although other factors, including alcohol consumption, appear to have played a part in this specific case, FDA asked Pfizer for additional cases that might be similar. We are currently evaluating the material Pfizer submitted in response to our request."Paul gene (talk) 01:38, 1 January 2008 (UTC)
You selectively interepreted a primary source as I show below. —Viriditas | Talk 03:36, 1 January 2008 (UTC)

Instead of focusing on Albrecht, we should be focusing on the "vivid, often-frightening dreams" that are reported as a side-effect. This has occurred in Benadryl-users (at small doses) for more than five decades, and that drug is OTC. If this was as serious a problem as Albrecht's girlfriend claims, you would expect to hear more about it considering the length of time people have been taking allergy medication. —Viriditas | Talk 23:53, 31 December 2007 (UTC)

Well, this discussion is about varenicline, not about Benadryl. How are the side effects of Benadryl relevant? I believe that the awareness of the potential danger of combining varenicline with alcohol is important, particularly, since there is a promotion of an off-label use of varenicline for the treatment of alcoholism. I hope the Albrecht case will stop that.Paul gene (talk) 01:38, 1 January 2008 (UTC)
The side effects I describe are those of varenicline, not Benadryl. According to ABC, Albrecht's girlfriend, Ryann Rathbone said:
...that almost immediately after starting the drug, they started having vivid, often-frightening dreams known side effect of the medication..."Nightmare kind of, hallucination kind of dreams where you don't know if it's real or not," Rathbone said. About a week into taking Chantix, after an evening of cocktails, a hallucinating Albrecht started lashing out at his confused girlfriend physically and verbally. "And the things that he was saying did not make any sense. It was like he was in a nightmare," Rathbone said.
Again, these are the same side effects reported with Benadryl, an OTC allergy medicine. Rathbone does not discuss alcohol use, Pfizer does. Is there a reason Pfizer is not quoted in the article? This article states:
FDA is aware of a highly-publicized case of Carter Albrecht
And yet, the FDA does not mention his name. But this is sourced to the ABC news story, which does not mention the FDA.
who was shot to death by his neighbor after, in the apparent state of delirium, hitting his girlfriend and trying to force the entry in the neighbor's house.
That's an interpretation of a primary source and is not supported by relevant authorities. I have every right to remove it.
Although in this case the delirium appeared to be caused by taking varenicline with a high dose of alcohol
Sourced to FDA.
FDA asked Pfizer for additional cases that might be similar. The FDA also recommended that health care professionals and patients watch for behavioral and mood changes.
That is a selective statement that does not reflect the full passage and should be quoted for accuracy. —Viriditas | Talk 03:34, 1 January 2008 (UTC)