Who said the FDA is a Tool of BP?

[zoiDman]

US drops bold warning from anti-smoking pills Chantix, Zyban

"The FDA decision stems from an 8,000-patient study of smokers that found no elevated risk of psychiatric problems among Chantix users who had no prior history of mental illness. European regulators previously removed their own warning from the drug based on the same data.

The study was jointly funded by Pfizer and GlaxoSmithKline PLC, which markets a competing smoking-cessation drug, Zyban. The FDA also removed similar warning language about psychiatric events from Zyban's label, according to an agency statement."

 

[Rossum]

 

[zoiDman]

It is Interesting the way the CDC collects data for something like this.

Ya see, when that Dude blows his brains out with that .357, the CDC categorizes him as an Ex-Smoker who Successfully Quit using Chantix.

And the Chances of Relapse is almost Zero.

 

[celticluvr]

 

[Jumpin' In...]

It is Interesting the way the CDC collects data for something like this.

Ya see, when that Dude blows his brains out with that .357, the CDC categorizes him as an Ex-Smoker who Successfully Quit using Chantix.

And the Chances of Relapse is almost Zero.

Yuk yuk yuk..."almost zero".

 

[sonicbomb]

 

[DrMA]

It is Interesting the way the CDC collects data for something like this.

Ya see, when that Dude blows his brains out with that .357, the CDC categorizes him as an Ex-Smoker who Successfully Quit using Chantix.

And the Chances of Relapse is almost Zero.

Actually that guy is a double win: both a successful quit with Chantix & a "smoking-related" death for the tally that brings more $ to tobacco ConTrol

 

[anavidfan]

 

[zoiDman]

Well... The Important thing is that the FDA Doesn't see any Conflict of Interests in using a Study Result when the Study was Funded by the Manufacture of the Drug.

And the Side Effects like Itching, Dry Mouth and Jumping out of 7th Story Windows are Minor.

 

[Marc411]

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.

 

[zoiDman]

Call me Old Fashion, but I would think if a Drug designed to help someone stop Smoking could/can cause these Side Effects...

Hallucination
Having Thoughts of Suicide
Thoughts of Hurting or Killing Others

... that at the Very Least, study date should be Collected for an Independent Source. And not from the People who want to get Rich selling the Drug.

 

[Mazinny]

Well... The Important thing is that the FDA Doesn't see any Conflict of Interests in using a Study Result when the Study was Funded by the Manufacture of the Drug.

Call me Old Fashion, but I would think if a Drug designed to help someone stop Smoking could/can cause these Side Effects...

Hallucination
Having Thoughts of Suicide
Thoughts of Hurting or Killing Others

... that at the Very Least, study date should be Collected for an Independent Source. And not from the People who want to get Rich selling the Drug.

That's the way the system works. Always has been. The overwhelming majority of clinical trials are sponsored by manufacturers, including all those that failed, and all those that were submitted to the FDA in support of a drug that was not approved.

The FDA did not agree to remove the warning when Pfizer first went to the FDA with the results of a meta study analyzing dozens of clinical studies. They insisted instead on a study that they recommended and helped design called EAGLES. Yes the study was funded by Pfizer and Glaxo, but that is the case with nearly every clinical study.

http://thelancet.com/journals/lancet/article/PIIS0140-6736(16)30272-0/fulltext

 

[Nermal]

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

Well, there is that, I suppose.

 

[choochoogranny]

A successful class action lawsuit settled in 2014 against Pfizer because of the serious side effects of Chantix (over 500 deaths among other.....um-m-m-m, injuries). How can the FDA, in light of the information brought forth in this suit, consider NOT removing this product from the market and now removing the "black box" warning? Right after the lawsuit settlement it was reported briefly that the FDA was considering a second black box warning.......Whatever happened to that? I am so ready for these "controlling" agencies to be severely reduced!

 

[dobroeutro]

The "system" sucks...

 

[Mazinny]

A successful class action lawsuit settled in 2014 against Pfizer because of the serious side effects of Chantix (over 500 deaths among other.....um-m-m-m, injuries). How can the FDA, in light of the information brought forth in this suit, consider NOT removing this product from the market and now removing the "black box" warning? Right after the lawsuit settlement it was reported briefly that the FDA was considering a second black box warning.......Whatever happened to that? I am so ready for these "controlling" agencies to be severely reduced!

You want Chantix banned, yet you are ready for the " controlling agencies who do the banning to be severely reduced ". Who is going to do the banning ?

 

[zoiDman]

That's the way the system works. Always has been. ...

I would Hope, at some time in the Near Future, that we could get Leadership at the level of the HHS Secretary and the FDA Commissioner that when there is a Problem with an FDA Approved Drug (like people Jumping Out of Windows) that an Independent Review of the Drug could be Performed.

And we Need a Few more Frances Kelsey's working at the FDA.

"We're getting a bit short on Hero's Lately"

 

[Mazinny]

I would Hope, at some time in the Near Future, that we could get Leadership at the level of the HHS Secretary and the FDA Commissioner that when there is a Problem with an FDA Approved Drug (like people Jumping Out of Windows) that an Independent Review of the Drug could be Performed.

And we Need a Few more Frances Kelsey's working at the FDA.

"We're getting a bit short on Hero's Lately"

There actually has been plenty of independent reviews of this specific drug. A lot more than most drugs. I'm not particularly pro-chantix mind you, in fact i wouldn't be surprised if i have anti-chantix posts in this forum in the past, but i am beginning to have a change of mind as i read the literature.

A massive study published in last month’s issue of The Lancet: Respiratory Medicine pulled data from the National Health Service in the UK to look for evidence of a link between Chantix and neuropsychiatric risks as well as cardiovascular risks. Looking at more than 160,000 patients, the researchers found no increased risk of neuropsychiatric events when compared to bupropion (the other popular stop smoking drug) or nicotine replacement therapy (things like the patch and gum). (Two out of the six study authors have received grants from Pfizer, though those grants were not used on this study.)


Earlier this year, a review of the current scientific literature on varenicline was published in Nicotine & Tobacco Research. The review was written by Dr. John Hughes, who has previously received funding from Pfizer, but is also considered one of the foremost experts on nicotine. Hughes looked at 46 studies, 41 of which were not funded by Pfizer, specifically looking at suicidal outcomes. He found the studies consistently showed no increased risk of suicide with varenicline, and in the handful where there was an increased risk, it was very low.


And if the Pfizer affiliations are making you suspicious, there are plenty of examples of completely independent studies finding the same results. A study published in the February issue of BMJ reviewed 39 trials involving 5,817 patients who were taking Chantix and 4,944 patients taking placebos. The researchers found “no increased risk of suicide or attempted suicide, suicidal ideation, depression, or death in individuals treated with varenicline.” None of the study authors have any affiliation with Pfizer or have received any funding from Pfizer. A study from 2013, also with no ties to Pfizer, looked at 120,000 patients undergoing some form of smoking cessation treatment and found no evidence of association between varenicline and an increased risk of suicide or depression.


There are also studies that focus on specific groups, like people with schizophrenia or bipolar disorder. Even with pre-existing neuropsychiatric issues, researchers found no risk of adverse effects linked to Chantix.

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

 

[zoiDman]

There actually has been plenty of independent reviews of this specific drug. A lot more than most drugs. I'm not particularly pro-chantix mind you, in fact i wouldn't be surprised if i have anti-chantix posts in this forum in the past, but i am beginning to have a change of mind as i read the literature.

A massive study published in last month’s issue of The Lancet: Respiratory Medicine pulled data from the National Health Service in the UK to look for evidence of a link between Chantix and neuropsychiatric risks as well as cardiovascular risks. Looking at more than 160,000 patients, the researchers found no increased risk of neuropsychiatric events when compared to bupropion (the other popular stop smoking drug) or nicotine replacement therapy (things like the patch and gum). (Two out of the six study authors have received grants from Pfizer, though those grants were not used on this study.)


Earlier this year, a review of the current scientific literature on varenicline was published in Nicotine & Tobacco Research. The review was written by Dr. John Hughes, who has previously received funding from Pfizer, but is also considered one of the foremost experts on nicotine. Hughes looked at 46 studies, 41 of which were not funded by Pfizer, specifically looking at suicidal outcomes. He found the studies consistently showed no increased risk of suicide with varenicline, and in the handful where there was an increased risk, it was very low.


And if the Pfizer affiliations are making you suspicious, there are plenty of examples of completely independent studies finding the same results. A study published in the February issue of BMJ reviewed 39 trials involving 5,817 patients who were taking Chantix and 4,944 patients taking placebos. The researchers found “no increased risk of suicide or attempted suicide, suicidal ideation, depression, or death in individuals treated with varenicline.” None of the study authors have any affiliation with Pfizer or have received any funding from Pfizer. A study from 2013, also with no ties to Pfizer, looked at 120,000 patients undergoing some form of smoking cessation treatment and found no evidence of association between varenicline and an increased risk of suicide or depression.


There are also studies that focus on specific groups, like people with schizophrenia or bipolar disorder. Even with pre-existing neuropsychiatric issues, researchers found no risk of adverse effects linked to Chantix.

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

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

"...

In the FDA staff report, the agency offered an unusually pointed assessment of the payments and their relationship to doctors’ findings in the study. At two sites, the agency reported that doctors got “as many as 60 separate honoraria for speaking engagements and consulting fees.”

In sites where doctors received $25,000 or more from Pfizer, according to the FDA, only 1.8 percent of patients who had already been diagnosed with a psychiatric disorder were reported to have side effects, such as anxiety, agitation, hostility or suicidal thoughts, during the study. At locations where physicians received less money or none at all, 6.4 percent of patients reported such problems.

..."

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

 

[choochoogranny]

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.