Who said the FDA is a Tool of BP?

[Mazinny]

If Chantix poses No Elevated Risk of Adverse Effects, why does something like this Bother Me?


Doctors Downplaying Drug’s Suicide Risks Attract FDA’s Scrutiny

I consider myself a relatively intelligent man, but i'm afraid it's beyond me to determine why this ( or anything else for that matter ) bothers you

Kidding aside, i'm not sure why this happened, especially since, " James Rusnak, chief development officer for Pfizer’s cardiovascular and metabolic unit, said the Chantix study was blinded, meaning that doctors who helped conduct it didn’t know whether patients were getting a drug or a placebo. Any doctors who might have downplayed side effects would have done so across the board and thus wouldn’t affect the final outcome, he said."

“The idea of blinded study is to remove bias,” Rusnak said in an interview. “Even if you have payments and even if those payments bias the investigators in favor of your drug, the investigator has no idea which is your drug. They can only guess.”

This is the same FDA btw that you are implying strongly is bought and paid for by BP !

The agency wasn’t immediately able to provide exact details on what all of the payments were for, and the FDA staff report doesn’t name the doctors who received payments.


All i ask is to read the literature ( pro and con ) with an open mind. I know you are able to since i have seen you go against the conventional group-think on other issues. Don't you find it curious why all the " suicidal thought " reports are either self reported online or through the FDA adverse effects reporting system ? Why there hasn't been a single documented case of causal effect ? Why dozens of follow up controlled, double blind studies failed to show a link ?

It’s disturbing to read through hundreds of cold, clinical reports dotted with terms like “nightmare,” “hallucination, auditory,” and “completed suicide.” But it’s important to view these reports in context: these are anecdotal, unproven associations. They can’t be taken as proof of a causal relationship. Just as an anti-vaxxer could report autism as a side-effect of the MMR vaccine, anyone can report any symptom and attribute it to Chantix.


“It’s completely uncontrolled and anyone can call in and say ‘I had this effect while taking Chantix,’” said Suzanne Colby, a tobacco researcher and the associate director of the center for alcohol and addiction studies at Brown University. Colby has no affiliation with Pfizer and none of her research has ever been funded by Pfizer (nor any other drug company, she noted).


Being pro-vaping doesn't mean we should have a knee-jerk reaction ( not saying you do ) to other cessation methods. I am grateful to vaping, it is what worked for me, but i believe there are other methods that could work for others, and they should be judged based on a benefit vs. risk assessment.

 

[Mazinny]

Well shoot, Mazinny. Caught me, for sure. But severely reduced doesn't mean done away with.......and now that I read your above info, am wondering how in the heck the class action suit was won in 2014. I do have two immediate neighbors who took Chantix and took themselves off because of the weird dreams and suicidal thoughts and have read too many on ECF that have had the same response to the drug.......Not "scientific info" at all. OTH, there's a won lawsuit and all those warnings in the ads. I suppose because of all the tainted research on vaping that's been pushed on the public, I've become really, really skeptical about anything the drug companies OR researchers have tested/researched.

I don't think the suit was won, i believe it was settled. Companies settle suits for strategic reasons routinely. Even if it is won, it's not proof that Chantix caused the suicides, only that a jury determined so.

I too have heard first hand from people who have had adverse reactions to Chantix ( not suicidal thoughts though ). I have also heard first hand from many people who have successfully quit using chantix, and there are thousands of testimonials on line as well. Keep in mind also that 22 million ( 11 million in U.S. ) unique people have used Chantix, and it has a 23 % one year quit rate.

 

[pennysmalls]

My hubs smoked more on Chantix. Said he wasn't getting any satisfaction from his cigarettes while on Chantix so smoked more trying to make up for it. He finally said to hell with it and quit both cold turkey lol!

 

[zoiDman]

I consider myself a relatively intelligent man, but i'm afraid it's beyond me to determine why this ( or anything else for that matter ) bothers you

Kidding aside, i'm not sure why this happened, especially since, " James Rusnak, chief development officer for Pfizer’s cardiovascular and metabolic unit, said the Chantix study was blinded, meaning that doctors who helped conduct it didn’t know whether patients were getting a drug or a placebo. Any doctors who might have downplayed side effects would have done so across the board and thus wouldn’t affect the final outcome, he said."

“The idea of blinded study is to remove bias,” Rusnak said in an interview. “Even if you have payments and even if those payments bias the investigators in favor of your drug, the investigator has no idea which is your drug. They can only guess.”

This is the same FDA btw that you are implying strongly is bought and paid for by BP !

The agency wasn’t immediately able to provide exact details on what all of the payments were for, and the FDA staff report doesn’t name the doctors who received payments.


All i ask is to read the literature ( pro and con ) with an open mind. I know you are able to since i have seen you go against the conventional group-think on other issues. Don't you find it curious why all the " suicidal thought " reports are either self reported online or through the FDA adverse effects reporting system ? Why there hasn't been a single documented case of causal effect ? Why dozens of follow up controlled, double blind studies failed to show a link ?

It’s disturbing to read through hundreds of cold, clinical reports dotted with terms like “nightmare,” “hallucination, auditory,” and “completed suicide.” But it’s important to view these reports in context: these are anecdotal, unproven associations. They can’t be taken as proof of a causal relationship. Just as an anti-vaxxer could report autism as a side-effect of the MMR vaccine, anyone can report any symptom and attribute it to Chantix.


“It’s completely uncontrolled and anyone can call in and say ‘I had this effect while taking Chantix,’” said Suzanne Colby, a tobacco researcher and the associate director of the center for alcohol and addiction studies at Brown University. Colby has no affiliation with Pfizer and none of her research has ever been funded by Pfizer (nor any other drug company, she noted).


Being pro-vaping doesn't mean we should have a knee-jerk reaction ( not saying you do ) to other cessation methods. I am grateful to vaping, it is what worked for me, but i believe there are other methods that could work for others, and they should be judged based on a benefit vs. risk assessment.

When TinFoilHat.com reports that someone like Pfizer is Influencing Doctors/Study Researchers with Indirect Payments, I Don't get Excited.

But what Bothers Me is when there are People inside the FDA that are raising Very Serious Questions about Ethical Practices and Clear-Cut Financial Conflicts of Interests.

If this was some Hay Fever med and the Side Effect was an Itchy Rash on some Body Part that I probably shouldn't mention, it would be One Thing.

But it Isn't. Were Talking about People Flipping Out. And Too Many Chantix related Suicides of otherwise Normal People to Ignore.

If you think Chantix is Hunky Dory. That's Cool. Or if you want to Site Studies that say Chantix doesn't cause what Many People have Seen First Hand...

Hi Jasjas. Welcome to the ECF.

Good to Hear that e-Cigarettes are Helping You. They helped me Kick a 20 Year Pack-a-Day Habit.

I have known 3 People who have used Chantix.

One tried it and it Didn't Work.
One tried it and Cut Down. But felt Strange and Stopped. And Started Smoking Again.
One tried it and after 4 Days decided that Jumping out of a 7th Story Window at 3:30am was a Good Idea.

Thank God she woke up her boyfriend as she started to climb out the widow. And he was able to Stop Her.

... That's Cool Too.

I would just Hope that Anyone who has seen as Many e-Cigarette Studies that have been so Overtly Biased would keep an Open Mind to the Concept that sometimes a Study does Not Reflect what is Actually Going On at the Individual or Population Level.

 

[Mazinny]

When TinFoilHat.com reports that someone like Pfizer is Influencing Doctors/Study Researchers with Indirect Payments, I Don't get Excited.

But what Bothers Me is when there are People inside the FDA that are raising Very Serious Questions about Ethical Practices and Clear-Cut Financial Conflicts of Interests.

If this was some Hay Fever med and the Side Effect was an Itchy Rash on some Body Part that I probably shouldn't mention, it would be One Thing.

But it Isn't. Were Talking about People Flipping Out. And Too Many Chantix related Suicides of otherwise Normal People to Ignore.

If you think Chantix is Hunky Dory. That's Cool. Or if you want to Site Studies that say Chantix doesn't cause what Many People have Seen First Hand...



... That's Cool Too.

I would just Hope that Anyone who has seen as Many e-Cigarette Studies that have been so Overtly Biased would keep an Open Mind to the Concept that sometimes a Study does Not Reflect what is Actually Going On at the Individual or Population Level.

I must admit, i didn't expect such an emotional response, without addressing any of the questions i asked.

Note that i didn't say unequivocally that there aren't " too many chantix related suicides of otherwise normal people " , only that i haven't seen any credible evidence. Kind of like an atheist can't prove there is no god, only that he hasn't seen any evidence of his existence.

I can see my notes of caution against anti-Chantix hysteria won't find a receptive audience in this thread, which is somewhat surprising for a group routinely faced with anti-vaping hysteria

I'm out, carry on !

 

[zoiDman]

I must admit, i didn't expect such an emotional response, without addressing any of the questions i asked.

Note that i didn't say unequivocally that there aren't " too many chantix related suicides of otherwise normal people " , only that i haven't seen any credible evidence. Kind of like an atheist can't prove there is no god, only that he hasn't seen any evidence of his existence.

I can see my notes of caution against anti-Chantix hysteria won't find a receptive audience in this thread, which is somewhat surprising for a group routinely faced with anti-vaping hysteria

I'm out, carry on !

I think where the Disconnect is between us is that I do Not See that there is an Acceptable Percentage of People who can Attempt Suicide as a Side Effect of using a Drug such as Chantix with the Hopes of Quitting Smoking.

Sorry. The Risk just Does Not Justify the Potential Benefit.

What is the Acceptable Amount of People who will attempt Suicide (or perhaps Try to Kill Someone Else) for a 1 in 4 Chance of Quitting Smoking for You?

 

[BuGlen]

I think where the Disconnect is between us is that I do Not See that there is an Expectable Percentage of People who can Attempt Suicide as a Side Effect of using a Drug such as Chantix with the Hopes of Quitting Smoking.

Sorry. The Risk just Does Not Justify the Potential Benefit.

What is the Expectable Amount of People who will attempt Suicide (or perhaps Try to Kill Someone Else) for a 1 in 4 Chance of Quitting Smoking for You?

I would actually go further and say that, regardless of the suicidal / homicidal effects, using any brain altering pharma product should only be considered for patients who display very distinct psychological disorders. The "take a pill for whatever ails you" social norm needs to be challenged, and Chantix is as good a place as any to start.

 

[zoiDman]

I would actually go further and say that, regardless of the suicidal / homicidal effects, using any brain altering pharma product should only be considered for patients who display very distinct psychological disorders. The "take a pill for whatever ails you" social norm needs to be challenged, and Chantix is as good a place as any to start.

I do agree that it seems we as a Society have in some ways moved towards the attitude that there is a Pill for Everything. But when it comes to Smoking, if a Non-Major Side Effects drug could be Designed, I would be All For It.

Because Quitting Smoking is the Single Greatest thing that a Smoker can to Improve the Quality of their Life.

Unfortunately, such a Drug does Not Exist. And Chantix is not even a Reasonable Approximation of what Risk/Benefit should be All About.

 

[DC2]

After witnessing and participating in the journey my father went through...

I wouldn't take any pill unless I absolutely had to.
And had already explored any alternatives that made sense.

I've seen what increasing regimens of pill after pill can do to a person.
Leave them an incoherent, drooling pile of flesh in some cases.

And I've seen the remarkable recovery that can be made when you reverse that process.
Removing pills instead of adding more and more and more.

My father used to take Zyprexa, Celexa, Trazadone, and Depakote, among others.
Now he takes NONE of those, at my direction, and he's around 90% better.

It's a scary world out there.

 

[schatz]

After witnessing and participating in the journey my father went through...

I wouldn't take any pill unless I absolutely had to.
And had already explored any alternatives that made sense.

I've seen what increasing regimens of pill after pill can do to a person.
Leave them an incoherent, drooling pile of flesh in some cases.

And I've seen the remarkable recovery that can be made when you reverse that process.
Removing pills instead of adding more and more and more.

My father used to take Zyprexa, Celexa, Trazadone, and Depakote, among others.
Now he takes NONE of those, at my direction, and he's around 90% better.

It's a scary world out there.

Is there a good chinese medical practitioner in your area? I highly recommend them.

 

[Mazinny]

I think where the Disconnect is between us is that I do Not See that there is an Expectable Percentage of People who can Attempt Suicide as a Side Effect of using a Drug such as Chantix with the Hopes of Quitting Smoking.

Sorry. The Risk just Does Not Justify the Potential Benefit.

What is the Expectable Amount of People who will attempt Suicide (or perhaps Try to Kill Someone Else) for a 1 in 4 Chance of Quitting Smoking for You?

 

[Mazinny]

I think where the Disconnect is between us is that I do Not See that there is an Expectable Percentage of People who can Attempt Suicide as a Side Effect of using a Drug such as Chantix with the Hopes of Quitting Smoking.

If you really meant to say "expectable", you and i actually don't disagree at all

If you meant to say "acceptable", and typing "expectable" was a freudian slip, i'm not even there yet. I first need to be convinced that there is a link, before deciding what the acceptable rate is. Jenny McCarthy is convinced that her sons autism was caused by childhood vaccinations. I'm not convinced of that either.

The real "disconnect" between us may be that despite the fact i personally quit using e-cigarettes ( as have millions of others ), i'm not chauvinistic about vaping, and don't believe it's a panacea. I'm convinced others can and have had success quitting, using other methods. I also believe there could be other methods in the future that could do the job even better than vaping, and (gasp) they could even be developed by BP and/or BT. I support all methods of smoking cessation and tobacco harm reduction, and my ultimate goal is that all smokers who want to quit smoking are able to, not that they all turn into vapers.

Sorry. The Risk just Does Not Justify the Potential Benefit.

1- I suspect the hundreds of thousands, if not millions who have quit using Chantix would disagree with you.
2- I respect your opinion, but would prefer every adult be able to make their own decision in that regard.

What is the Expectable Amount of People who will attempt Suicide (or perhaps Try to Kill Someone Else) for a 1 in 4 Chance of Quitting Smoking for You?

Again, don't you think there should be evidence of a "causal effect", before we get to talk about acceptable rates ? Not even one of the dozens of studies, whether funded by Pfizer, or independent, has shown this. These include observational studies, meta analyses, and double blind, placebo control studies.

 

[Verb]

After witnessing and participating in the journey my father went through...

I wouldn't take any pill unless I absolutely had to.
And had already explored any alternatives that made sense.

I've seen what increasing regimens of pill after pill can do to a person.
Leave them an incoherent, drooling pile of flesh in some cases.

And I've seen the remarkable recovery that can be made when you reverse that process.
Removing pills instead of adding more and more and more.

My father used to take Zyprexa, Celexa, Trazadone, and Depakote, among others.
Now he takes NONE of those, at my direction, and he's around 90% better.

It's a scary world out there.

My wife was put on Depakote after a TBI. Caused way more problems than help. Many side effects were similar/same as TBI symptoms. Eventually, I was able to convince my wife some of her symptoms could be the med. Very difficult to stop once started meds should have a required disclosure and consent form. When the only safe way to stop a pharmacutical is to start another, I think something should be clearly stated before starting the first.

 

[zoiDman]

...

Again, don't you think there should be evidence of a "causal effect", before we get to talk about acceptable rates ? Not even one of the dozens of studies, whether funded by Pfizer, or independent, has shown this. These include observational studies, meta analyses, and double blind, placebo control studies.

What Evidence of Causality would you consider Valid?

"... Varenicline is the primary suspect drug in 17,900 serious injuries from psychiatric adverse events that were reported to the FDA, 43% by health professionals. The cases describe suicidal behaviors, bizarre and reckless aggression, delusions, and homicidal and suicidal thoughts. The effects are documented in peer-reviewed studies and FDA surveillance reports that were written independently by different teams of investigators using data from different countries. More than 2,500 varenicline victims have been paid an estimated $300 million in compensation by Pfizer for serious injuries that occurred before the Boxed Warning was required.

..."

https://www.ismp.org/quarterwatch/pdfs/20160912.pdf


"... These new data show varenicline continues to account for more cases of suicidal, self-injurious or homicidal thoughts than any other therapeutic drug during the period 2007 through 2013 Q3. The ranking is shown in Table 1. The findings were robust and the differences between varenicline and other drugs were large. Varenicline ranked first in both suicidal/self-injurious thoughts as well as homicidal thoughts. Varenicline cases outnumbered those for any other drug by more than 3-fold difference. For homicidal ideation cases the margin was a 5-fold difference. Excluding foreign reports did not alter the findings. Examining the most recent reports since 2011 reduced the margin by which varenicline cases outnumbered all others, but was consistent with a 73% decline in dispensed outpatient prescriptions since the peak in 2008.

[See Table 1]

https://www.ismp.org/quarterwatch/pdfs/2013Q3.pdf


I think at some point, a person starts to Question how well of a Statistical Based study conclusion accurately represents what is Actually Occurring in the Real World.

 

[zoiDman]

BTW - Thank you for pointing out the Typo(s) in my previous Post.

Auto-Correct is usually my Friend. But Not this time.

 

[Mazinny]

What Evidence of Causality would you consider Valid?

Double blind, placebo controlled studies ( none of which, whether funded by Pfizer or independent have shown a link ), and certainly not the FDA's 'adverse effects reporting system', which your link relied on. This system is used to require follow up scientific studies ( and it was, dozens of new studies were conducted over numerous years and no link was detected ), it's not in and of itself proof of anything. The link you provided just counted the number of reports made to the FDA. This system is completely uncontrolled and anyone can report anything and link it to anything they want anonymously.

Care to read the reports made to the FDA adverse effects reporting system about vaping btw !

 

[Lessifer]

If you really meant to say "expectable", you and i actually don't disagree at all

If you meant to say "acceptable", and typing "expectable" was a freudian slip, i'm not even there yet. I first need to be convinced that there is a link, before deciding what the acceptable rate is. Jenny McCarthy is convinced that her sons autism was caused by childhood vaccinations. I'm not convinced of that either.

The real "disconnect" between us may be that despite the fact i personally quit using e-cigarettes ( as have millions of others ), i'm not chauvinistic about vaping, and don't believe it's a panacea. I'm convinced others can and have had success quitting, using other methods. I also believe there could be other methods in the future that could do the job even better than vaping, and (gasp) they could even be developed by BP and/or BT. I support all methods of smoking cessation and tobacco harm reduction, and my ultimate goal is that all smokers who want to quit smoking are able to, not that they all turn into vapers.





1- I suspect the hundreds of thousands, if not millions who have quit using Chantix would disagree with you.
2- I respect your opinion, but would prefer every adult be able to make their own decision in that regard.




Again, don't you think there should be evidence of a "causal effect", before we get to talk about acceptable rates ? Not even one of the dozens of studies, whether funded by Pfizer, or independent, has shown this. These include observational studies, meta analyses, and double blind, placebo control studies.

What Evidence of Causality would you consider Valid?

"... Varenicline is the primary suspect drug in 17,900 serious injuries from psychiatric adverse events that were reported to the FDA, 43% by health professionals. The cases describe suicidal behaviors, bizarre and reckless aggression, delusions, and homicidal and suicidal thoughts. The effects are documented in peer-reviewed studies and FDA surveillance reports that were written independently by different teams of investigators using data from different countries. More than 2,500 varenicline victims have been paid an estimated $300 million in compensation by Pfizer for serious injuries that occurred before the Boxed Warning was required.

..."

https://www.ismp.org/quarterwatch/pdfs/20160912.pdf


"... These new data show varenicline continues to account for more cases of suicidal, self-injurious or homicidal thoughts than any other therapeutic drug during the period 2007 through 2013 Q3. The ranking is shown in Table 1. The findings were robust and the differences between varenicline and other drugs were large. Varenicline ranked first in both suicidal/self-injurious thoughts as well as homicidal thoughts. Varenicline cases outnumbered those for any other drug by more than 3-fold difference. For homicidal ideation cases the margin was a 5-fold difference. Excluding foreign reports did not alter the findings. Examining the most recent reports since 2011 reduced the margin by which varenicline cases outnumbered all others, but was consistent with a 73% decline in dispensed outpatient prescriptions since the peak in 2008.

[See Table 1]

https://www.ismp.org/quarterwatch/pdfs/2013Q3.pdf


I think at some point, a person starts to Question how well of a Statistical Based study conclusion accurately represents what is Actually Occurring in the Real World.

Just because I feel like throwing my personal thoughts into the mix...

Chantix can and certainly has helped people quit smoking.

My belief is that many of the issues arise because people, doctors and patients, do not understand/respect what chantix and wellbutrin actually are. Mood altering pharmaceuticals should not be taken lightly. People should take the same precautions when starting chantix as they would when beginning an anti-depressant. If you have a history of psychological symptoms they can get worse, if you have no history but have an underlying condition, it can be brought out.

Imagine if, instead of getting a prescription with 3 refills and a note to call if you have any problems, people got a 2 week prescription with a scheduled follow up appointment before the medication could be continued.

Of course that would cost people more and take up more of the doctor's time.

 

[zoiDman]

Double blind, placebo controlled studies ( none of which, whether funded by Pfizer or independent have shown a link ), and certainly not the FDA's 'adverse effects reporting system', which your link relied on. This system is used to require follow up scientific studies ( and it was, dozens of new studies were conducted over numerous years and no link was detected ), it's not in and of itself proof of anything. The link you provided just counted the number of reports made to the FDA. This system is completely uncontrolled and anyone can report anything and link it to anything they want anonymously.

Care to read the reports made to the FDA adverse effects reporting system about vaping btw !

I'll throw out the Consumer Reporting for the Sake of Narrowing this Discussion.

But are you saying that we should summarily discount the Reporting to the FDA by Prescribing Physicians?

Doctor Prescribes Chantix to a Patient.
Patient has Psychotic Episode and attempts to Hurt Themselves or Another (or Succeeds!)
Doctor Reports Event to the FDA.

This is Not Meaningful ?

 

[zoiDman]

...

My belief is that many of the issues arise because people, doctors and patients, do not understand/respect what chantix and wellbutrin actually are. Mood altering pharmaceuticals should not be taken lightly. People should take the same precautions when starting chantix as they would when beginning an anti-depressant. If you have a history of psychological symptoms they can get worse, if you have no history but have an underlying condition, it can be brought out.

...

So how would this Fit In with Relaxing the Warnings afforded to potential Users of this Mood Altering Drug?

While at the Same Time Ramping Up a Multi-Million Dollar Nation Wide Prime Time TV Ad Campaign?

 

[Mazinny]

I'll throw out the Consumer Reporting for the Sake of Narrowing this Discussion.

But are you saying that we should summarily discount the Reporting to the FDA by Prescribing Physicians?

Doctor Prescribes Chantix to a Patient.
Patient has Psychotic Episode and attempts to Hurt Themselves or Another (or Succeeds!)
Doctor Reports Event to the FDA.

This is Not Meaningful ?

No i'm not saying they aren't meaningful, i'm saying they are cause for follow up studies, real double blind, placebo controlled studies. These studies were conducted, and no link was found. In some of them the people using the sugar pills reported higher rates of suicidal ideations than those actually using chantix !

I have no objection to the system Lessifer proscribes btw, i just don't think an important and successful tool of smoking cessation should be removed from the market on the basis of these reports alone.

I will repeat the question i asked previously Zoid, why do you think there were no links detected in any of the real studies, even those by independent sources ?