Who said the FDA is a Tool of BP?

[Lessifer]

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?

I don't necessarily believe the warning should be removed, personally I think the warning should be different and that it and other drugs in its class should be treated differently/have tighter controls. I'm wary of that though because tighter controls on medications tend to make things harder for people who actually need them. I'd love a culture shift when it comes to mental health. I don't know if I agree with PCP's prescribing anti-depressants or other medications in that wheel house.

 

[Lessifer]

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 ?

my
It's an incredibly rare occurrence, not statistically significant, which is not the same as "it doesn't happen." The numbers would also be lower depending on the criteria used for "history of depression/mental health problems."

 

[zoiDman]

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 ?

You know what, You're Right.

And I'm sure (now) that if the Pfizer and the FDA says that Chantix is Fine, that it has to be.

Because Studies Don't Lie. And neither do people like Pfizer. Or someone with a Exemplary Record of Providing Accurate/Non-Biased Information about tobacco Control like the FDA.

 

[zoiDman]

I don't necessarily believe the warning should be removed, personally I think the warning should be different and that it and other drugs in its class should be treated differently/have tighter controls. I'm wary of that though because tighter controls on medications tend to make things harder for people who actually need them. I'd love a culture shift when it comes to mental health. I don't know if I agree with PCP's prescribing anti-depressants or other medications in that wheel house.

But the Pfizer funded study shows that the Black Box Warning Isn't Necessary. I say we Take it Off.

 

[Mazinny]

You know what, You're Right.

And I'm sure (now) that if the Pfizer and the FDA says that Chantix is Fine, that it has to be.

Because Studies Don't Lie. And neither do people like Pfizer. Or someone with a Exemplary Record of Providing Accurate/Non-Biased Information about tobacco Control like the FDA.

Appeals to emotion, ad-hominems and sarcasm, is not an adequate replacement for a well structured argument.

 

[zoiDman]

Appeals to emotion, ad-hominems and sarcasm, is not a replacement for a well structured argument.

No. Nothing of the Sort. With all that was Posted here, You convinced me.

Wasn't that the Point?

To convince me that there was No Credible Link between Chantix and all those People Flipping Out.

 

[Rossum]

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 wasn't aware that removing it from the market was being considered. I thought this was all about a warning on the label and/or how much patient monitoring is done.

 

[mcclintock]

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 ?

From this I'm left wondering if the sugar pill users with suicidal ideas were the ones that actually stopped smoking despite it only being a placebo. Maybe the problem with Chantix is it's too effective? You might stop smoking even if your body isn't ready. Peoples' need for nicotine and tobacco alkaloids is highly variable. There are some that have reported here that they cannot function properly without these things, didn't function properly before they started smoking either.

 

[zoiDman]

From this I'm left wondering if the sugar pill users with suicidal ideas were the ones that actually stopped smoking despite it only being a placebo. Maybe the problem with Chantix is it's too effective? You might stop smoking even if your body isn't ready. Peoples' need for nicotine and tobacco alkaloids is highly variable. There are some that have reported here that they cannot function properly without these things, didn't function properly before they started smoking either.

Or if a Study was Done where they gave Chantix to Non-Smokers, and if previously Normal people wanted to Jump out of 7th Story windows, that would Rule Out the Nicotine Deprivation thing?

Maybe Pfizer will Fund a Study to show that this Doesn't Happen.

 

[Stubby]

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.

Perhaps you are missing some important views on the FDA and the mindset that runs freely though those halls.

This is a bit of a clue
Tobacco Truth: FDA Rejects Plea to Correct Smokeless Tobacco Warnings; A Closer Look at Flawed Interpretations

The FDA has essentially rejected the modified risk designation for Swedish snus. This is a product that has a huge amount of solid evidence that shows it is about a harmful as a cup of coffee. It is likely less risky then vaping, though that would be splitting hairs. Yet in a complete perversion of science it has been rejected.

You have to understand the mindset we are dealing with. To them, all tobacco is evil (and let's now include nicotine). It doesn't matter how low the risk, or how beneficial to public health. Not only that, but all tobacco/nicotine users are in desperate need of being reformed. God forbid they actually offer them a way of using tobacco and nicotine that lets them lead a long healthy life.

It you think I am exaggerating then you are likely living in a naive bubble. That really is there mindset. They are on a holy mission, and with any holy mission, lets not let facts get in the way, and if they do, they can just make up there own. They have completely rejected science with snus and vaping, and now we are supposed to believe them when it comes to Chantix. They have removed the black box warning not because it is not risky (it clearly is), but because it fits there ideology. This is not science, its religion. When it comes to tobacco, nothing can be trusted from the FDA.

 

[Stubby]

double post

 

[bobwho77]

What are you talking about, the side effects are so mild

Taken from their website on 12/26/2015


Chantix side effects
Abnormal Dreams
Chronic Trouble Sleeping
Feel Like Throwing Up
Gas
Head Pain
Incomplete or Infrequent Bowel Movements
Throwing Up
Angina
Trouble Breathing
Acute Infection of the Nose, Throat or Sinus
Condition in which Stomach Acid is Pushed Into the Esophagus
Drowsiness
Dry Mouth
Excessive Sweating
Feeling Weak
Increased Hunger
Indigestion
Itching
Loss of Appetite
Low Energy
Nightmares
Not Feeling Well
Rash
Runny Nose
Sluggishness
Stomach Cramps
Abnormal Heart Rhythm
Abnormal Liver Function Tests
Anemia
Anxious
Behaving with Excessive Cheerfulness and Activity
Chest Pain
Delusions
Depression
Diabetes
Erythema Multiforme
Giant Hives
Hallucination
Having Thoughts of Suicide
Heart Attack
High Blood Pressure
Injury
Mental Disorder with Loss of Normal Personality & Reality
Panic Disorder
Paranoia
Problems Metabolizing Alcohol
Seizures
Stevens-Johnson Syndrome
Stroke
Suicidal
Thoughts of Hurting or Killing Others
Transient Ischemic Attack
Unconscious
Aggressive Behavior
Backache
Cannot Focus Thoughts
Cramps
........
Disturbance of Attention
Dizzy
Excess Urination
Feeling Anger Toward Something
Feeling Restless
Flu-Like Symptoms
Heart Throbbing or Pounding
Hives
Joint Pain
Mood Changes
Muscle Pain
Nosebleed
Peripheral Vascular Disease
Problem Behavior
Problem with Periods
Problems with Eyesight
Reaction due to an Allergy
Ringing in the Ears
Sensation of Spinning or Whirling
Sleep Disorder
Swollen Lymph Nodes
Taste Problems
Temporary Redness of Face and Neck
Visible Water Retention
Weight Gain

Nausea, headache, vomiting, drowsiness, gas, constipation, trouble sleeping, unusual dreams, or changes in taste may occur. If any of these effects last or get worse, tell your doctor or pharmacist promptly.

Remember that your doctor has prescribed this medication because he or she has judged that the benefit to you is greater than the risk of side effects. Many people using this medication do not have serious side effects.

Tell your doctor right away if you have any serious side effects, including: burning feeling in feet/toes, unusual pain in the legs when walking.

Stop taking varenicline and get medical help right away if you have any very serious side effects, including: seizure, symptoms of a heart attack (such as chest/jaw/left arm pain, shortness of breath, unusual sweating), signs of a stroke (such as weakness on one side of the body, trouble speaking, sudden vision changes, confusion).

A very serious allergic reaction to this drug is rare. However, get medical help right away if you notice any symptoms of a serious allergic reaction, including: rash, itching/swelling (especially of the face/tongue/throat), severe dizziness, trouble breathing.

And they want us to believe that VAPING is bad for us

 

[bobwho77]

Perhaps you are missing some important views on the FDA and the mindset that runs freely though those halls.

This is a bit of a clue
Tobacco Truth: FDA Rejects Plea to Correct Smokeless Tobacco Warnings; A Closer Look at Flawed Interpretations

The FDA has essentially rejected the modified risk designation for Swedish snus. This is a product that has a huge amount of solid evidence that shows it is about a harmful as a cup of coffee. It is likely less risky then vaping, though that would be splitting hairs. Yet in a complete perversion of science it has been rejected.

You have to understand the mindset we are dealing with. To them, all tobacco is evil (and let's now include nicotine). It doesn't matter how low the risk, or how beneficial to public health. Not only that, but all tobacco/nicotine users are in desperate need of being reformed. God forbid they actually offer them a way of using tobacco and nicotine that lets them lead a long healthy life.

It you think I am exaggerating then you are likely living in a naive bubble. That really is there mindset. They are on a holy mission, and with any holy mission, lets not let facts get in the way, and if they do, they can just make up there own. They have completely rejected science with snus and vaping, and now we are supposed to believe them when it comes to Chantix. They have removed the black box warning not because it is not risky (it clearly is), but because it fits there ideology. This is not science, its religion. When it comes to tobacco, nothing can be trusted from the FDA.

America's busy bodied puritan streak HAS led to some pretty bone-headed policy

 

[Marc411]

Funny that a commercial recently published in the US still states that suicide is one of the side effects.

How do you debate something that comes directly from their own mouth

This one aired last night during the Giants/Philly game

Chantix TV Commercial, 'Thomas'

 

[Mazinny]

I wasn't aware that removing it from the market was being considered. I thought this was all about a warning on the label and/or how much patient monitoring is done.

Sorry, i didn't mean to give the impression that the FDA decision was about removing the product ( or not ).

I was having a discussion with Zoid, and i assumed that's his position. Going back in the thread i saw that he never explicitly called for the products removal ( it was another member ), so, yeah you're right , in the context of my discussion with Zoid, the sentence you posted was clearly a " straw man " on my part. Apologies to Zoidman, if that is not his position !

 

[zoiDman]

Sorry, i didn't mean to give the impression that the FDA decision was about removing the product ( or not ).

I was having a discussion with Zoid, and i assumed that's his position. Going back in the thread i saw that he never explicitly called for the products removal ( it was another member ), so, yeah you're right , in the context of my discussion with Zoid, the sentence you posted was clearly a " straw man " on my part. Apologies to Zoidman, if that is not his position !

Whereas if Chantix was taken Off the Market, I wouldn't Loose any Sleep over it. But that Wasn't why I started this Thread.

 

[Mazinny]

Perhaps you are missing some important views on the FDA and the mindset that runs freely though those halls.

This is a bit of a clue
Tobacco Truth: FDA Rejects Plea to Correct Smokeless Tobacco Warnings; A Closer Look at Flawed Interpretations

The FDA has essentially rejected the modified risk designation for Swedish snus. This is a product that has a huge amount of solid evidence that shows it is about a harmful as a cup of coffee. It is likely less risky then vaping, though that would be splitting hairs. Yet in a complete perversion of science it has been rejected.

You have to understand the mindset we are dealing with. To them, all tobacco is evil (and let's now include nicotine). It doesn't matter how low the risk, or how beneficial to public health. Not only that, but all tobacco/nicotine users are in desperate need of being reformed. God forbid they actually offer them a way of using tobacco and nicotine that lets them lead a long healthy life.

It you think I am exaggerating then you are likely living in a naive bubble. That really is there mindset. They are on a holy mission, and with any holy mission, lets not let facts get in the way, and if they do, they can just make up there own. They have completely rejected science with snus and vaping, and now we are supposed to believe them when it comes to Chantix. They have removed the black box warning not because it is not risky (it clearly is), but because it fits there ideology. This is not science, its religion. When it comes to tobacco, nothing can be trusted from the FDA.

When did i ever give the impression ( in this thread or anywhere else in this forum ), that i agree with the FDA's position on tobacco, nicotine, and tobacco harm reduction ?

As far as Snus specifically, i agree, the evidence of it's reduced risk is compelling as far as i can read. I am under the impression that Snus PMTA has been approved, but it's MRTP application has not, but that they are in continued discussion with Swedish Match over the MRTP as well, according to Match. Please correct me if i am wrong, as i don't follow the news about Smokeless Tobacco as closely as you do.

We weren't discussing other forms of cessation and harm reduction in this thread though. We were only discussing Chantix.

Where i have a problem with your analysis is the following :

They have completely rejected science with snus and vaping, and now we are supposed to believe them when it comes to Chantix.

This is a logical fallacy. The merits ( or lack thereof ) and relative risk to benefit raatio of Chantix should be judged independently of FDA's position on Snus and E-cigarettes. It's not enough to claim they are wrong about Chantix, just because they have been wrong on THR. One has nothing to do with the other.

And this :

They have removed the black box warning not because it is not risky (it clearly is), but because it fits there ideology.

And according to this logic, are we to believe that from 2009 through 2016, where the black box warning was mandatory, the FDA had a different ideology ? Was there a complete overhaul of FDA personnel in 2016, that i am not aware of ?

 

[Mazinny]

From this I'm left wondering if the sugar pill users with suicidal ideas were the ones that actually stopped smoking despite it only being a placebo. Maybe the problem with Chantix is it's too effective? You might stop smoking even if your body isn't ready. Peoples' need for nicotine and tobacco alkaloids is highly variable. There are some that have reported here that they cannot function properly without these things, didn't function properly before they started smoking either.

That's an astute observation. You may very well be on to something. The article i cited earlier in the thread touches upon this issue as well :

Colby suspects there are a number of factors that could be leading to the reports of negative side effects, ranging from fodder for courtroom defenses to the very real side effects of nicotine withdrawal. The fact is that Chantix is a pretty effective stop-smoking aid, so many people who report scary side effects have recently kicked two or three-pack-a-day habits, and that takes a toll on the brain, Colby said.


“The most common things are cravings, irritability, frustration, sleep disturbance, difficulty concentrating, negative affect generally, depression,” Colby said. “For people who have various forms of mental illness, maybe those are exacerbated. These things that happen very idiosyncratically, how do we know that it’s the Chantix versus something that would have happened anyway? The only way to answer that question is with clinical trials.”

The Best Drug for Quitting Smoking Can't Shake Its Suicide Stigma

 

[Rickb119]

Or if a Study was Done where they gave Chantix to Non-Smokers, and if previously Normal people wanted to Jump out of 7th Story windows, that would Rule Out the Nicotine Deprivation thing?

Maybe Pfizer will Fund a Study to show that this Doesn't Happen.

And I thought my fantasies were far fetched.

 

[Stubby]

When did i ever give the impression ( in this thread or anywhere else in this forum ), that i agree with the FDA's position on tobacco, nicotine, and tobacco harm reduction ?

As far as Snus specifically, i agree, the evidence of it's reduced risk is compelling as far as i can read. I am under the impression that Snus PMTA has been approved, but it's MRTP application has not, but that they are in continued discussion with Swedish Match over the MRTP as well, according to Match. Please correct me if i am wrong, as i don't follow the news about Smokeless Tobacco as closely as you do.

We weren't discussing other forms of cessation and harm reduction in this thread though. We were only discussing Chantix.

Where i have a problem with your analysis is the following :

They have completely rejected science with snus and vaping, and now we are supposed to believe them when it comes to Chantix.

This is a logical fallacy. The merits ( or lack thereof ) and relative risk to benefit raatio of Chantix should be judged independently of FDA's position on Snus and E-cigarettes. It's not enough to claim they are wrong about Chantix, just because they have been wrong on THR. One has nothing to do with the other.

And this :

They have removed the black box warning not because it is not risky (it clearly is), but because it fits there ideology.

And according to this logic, are we to believe that from 2009 through 2016, where the black box warning was mandatory, the FDA had a different ideology ? Was there a complete overhaul of FDA personnel in 2016, that i am not aware of ?

You missed the point. Go read the link to Brad Rodu's analysis of why the snus application was rejected. It is the mindset that dominates the FDA when it comes to tobacco and nicotine that I was getting at.

The FDA rejected the modified risk designation of snus because of extreme anti-tobacco bias. They are also removing the black box warning on Chantix because of the same bias. They will look for any excuse to remove it, despite lots of evidence showing how dangerous it is.

You keep thinking they are actually dealing with science, but when it comes to anything related to tobacco, it is all driven by ideology and extreme bias. The mindset is the same whether it be snus, vaping, or Chantix. They are not separate issues. The FDA has lost all credibility when it comes to tobacco and nicotine.

Another point you are missing is that you are hung up on clinical trials as the be all end all. It is not. Observations in the real world are a far better indicator of reality then the artificial environment of a clinical trial. Clinical trials have there place, but also there limitations. What the real world observations tell us is that a lot of people have a hard time with Chantix and it has to often lead to some very bad results.