Who said the FDA is a Tool of BP?

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OldBatty

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When it comes to tobacco, nothing can be trusted from the FDA.

The FDA has lost all credibility when it comes to tobacco and nicotine.

The FDA has lost all trust and credibility about anything as far as I am concerned. Only difference between tobacco and everything else is those lies are not as blatant and usually mixed with enough truth to make them harder to spot.
 

zoiDman

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The FDA has lost all trust and credibility about anything as far as I am concerned. Only difference between tobacco and everything else is those lies are not as blatant and usually mixed with enough truth to make them harder to spot.

Now lets not be Too Hasty in Judging the FDA. I'm sure that they are Monitoring this Issue Closely.

In fact, I know they are. And have been doing so for a Long Time.

Over 5,000 Chantix Complaints Filed in One Week
 
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Stubby

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The FDA has lost all trust and credibility about anything as far as I am concerned. Only difference between tobacco and everything else is those lies are not as blatant and usually mixed with enough truth to make them harder to spot.
I am not going to take it that far, and it would likely be a mistake to do so. The tobacco devision of the FDA really is uniq in it's bias. I am not at all sure that carries over into other parts of the FDA.
 

zoiDman

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I am not going to take it that far, and it would likely be a mistake to do so. The tobacco devision of the FDA really is uniq in it's bias. I am not at all sure that carries over into other parts of the FDA.

Oh I am Sure if someone with the High Ethical Standards as Margaret Hamburg was aware of any Wrong Doings or Overt Biases occurring at the FDA, that she would have put an Immediate stop to it.

Former FDA Commissioner Charged in RICO Lawsuit
 

Rickb119

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I am not going to take it that far, and it would likely be a mistake to do so. The tobacco devision of the FDA really is uniq in it's bias. I am not at all sure that carries over into other parts of the FDA.
Only the parts where their bias (or lack thereof) would make no difference in their funding, or political agenda. :sneaky:
 

Mazinny

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You missed the point.

Respectfully, i don't believe i have. I was merely pointing out the fallacious parts of your argument in respect to Chantix and Chantix alone.

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.

I have read it. The mindset you describe does not automatically prove that the FDA is wrong re Chantix.

The FDA rejected the modified risk designation of snus because of extreme anti-tobacco bias.

We are in agreement here.

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.

This is where we disagree. They mandated the black box warning in 2009 and kept it for 7 years despite Pfizer presenting them with study after study showing no link between increased suicidal tendencies and chantix. They only removed it after being presented the results of a study that FDA insisted on and helped design, looking for neuropsychiatric adverse effects, on otherwise healthy and people with existing mental health issues. Double blind, placebo controlled, 8000 participants in 16 countries. Doesn't seem like they were looking for an excuse to remove the black box warning to me. All the so called "evidence" you are talking about is anecdotal. All of it. Not a single study, whether funded by Pfizer, or independent, and there have been dozens over a ten year period, have shown a link to increased suicides.



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.

Sorry, to state that the FDA has lost all credibility, is not nearly enough to prove your case against Chantix. You need to do a lot better than that.

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.

This is the most flabbergasting and unscientific part of your post. Real word observations and anecdotal evidence have their place. When they show a pattern, they are useful in dictating what direction new studies should take, but they are not a substitute for double blind, controlled studies, let alone superior to them.

Anecdotal evidence are prone to biases, don't account for other important factors, are based on casual observations in uncontrolled environments, and result in causal connections being made way too easily, among many other flaws.


I am a big proponent of THR and it's what helped me quit smoking. But i also support cessation efforts for those who would rather chose that approach. The fact that the FDA has an anti THR bias does not prove anything re chantix. Different strokes for different folks
 

Stubby

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This is the most flabbergasting and unscientific part of your post. Real word observations and anecdotal evidence have their place. When they show a pattern, they are useful in dictating what direction new studies should take, but they are not a substitute for double blind, controlled studies, let alone superior to them.

Anecdotal evidence are prone to biases, don't account for other important factors, are based on casual observations in uncontrolled environments, and result in causal connections being made way too easily, among many other flaws.

You are caught in your own circular logic. It is a huge mistake to ignore real world issues and brush them off as unscientific (though not perfect, only a fool ignores them), and putting all your cookies in clinical trials. That is exactly what the FDA has done and is the only way they can rationalize the removal of the warning.

I have heard testimonial after testimonial about the negative effects of Chantix. Some of that could well be exaggerated, but to completely ignore real world issues, and simply claim they are not valid because they didn't occur in a laboratory under controlled conditions is a perversion of science.

Of course a discussion with someone who thinks clinical trials are where the only true science occurs, and is all to willing to ignore first hand accounts is pretty much a dead end road. Clinical trials are just the beginning of the process. The rest is observations in the real world. In the end the latter carries much more weight.
 
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englishmick

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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.

I know there are zealots and ideologues around this issue, but I always assumed the main driver for the FDA was money. Pressure from politicians who are worried about their donors, and their own desire to have well paid consultancy jobs to go to after they leave the FDA, and so forth. Would they really put their beliefs ahead of their personal financial interest.

Do you think ideology is a major factor in the behavior of the FDA? Or maybe just with a handful of senior leadership.
 

Petrodus

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1-2Cents_zps377c9a55.gif

Just my 2 cents

For years I would say ...
If you peel back the onion far enough you will find money at the core.

Today, I would say you will find "politics" at the core.
 
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balance

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Chantix is a kind of a big deal here in my house. Because in late 2008/early 2009, my husband used Chantix to quit smoking. It worked well in that he found it easy to quit smoking after some 30 years. It did not work well in that he had a seizure in 2009, and it changed our lives.

Back then, seizures were not part of the warnings on the label. Even if it had been, he probably would have tried it, just as many folks ignored the "strange dreams" and suicidal thoughts things to give it a whirl. What is sad, to me, is that after the seizure, we mentioned the "possibly Chantix" cause to our doctor -- a doctor who had not prescribed it. And he said, oh, no, Chantix couldn't possibly have caused the seizure - it's been well studied.

Imagine our surprise when nowadays, Chantix advertisements mentions seizures as a possible outcome.

Meanwhile, what does a seizure do to your life? If you need to drive to see clients for work, you're out of work, because you can't drive for six months. When you apply for new jobs, they think you were DUI unless you feel like telling them about your exciting adventure in the Emergency Room. Of course, if you do that, you've revealed a pre-existing condition, which was not covered by most healthcare in 2009, and might not be covered in the future. Suffice it to say: it was really hard to get a job during the first six months after a seizure.

During those first six months, you're on anti-seizure medications. But in many states, including mine, after six months seizure-free, you can go off medication. Which made no sense to me, since the six months kinda proved that the medication was working. But whatever.

After my husband's second seizure in 2011, he was again prescribed medication, medication that he will be taking for the rest of his life. But of course, the second seizure included another six months without pay, along with a modest amount of depression - due, I think to the no-work thing, rather than the psychotropic affects of Chantix earlier.

Adult onset seizures are kinda rare, and usually indicate a brain tumor. No brain tumor here. But, so far, a year of lost wages due to the two seizures, and a never-ending prescription cost.

Vaping seems way easier, cheaper, and safer.
 

somdcomputerguy

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    ..what does a seizure do to your life?
    I have epilespsy. I know just what can happen to ones (and those in their) life..
    ..exciting adventure in the Emergency Room.
    Getting stitches and staples in my scalp is exciting for me, but not exciting enough for SSA. To this day, they continue to deny me SSI, saying my 'condition' isn't serious enough, or occur frequently enough..
    Of course,
    My story is way to long to type out the whole thing. I am extremely sorry for you and yours troubles.
     
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    schatz

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    WE all need to look deeper into herbals and plant based medicine before we go running to these docs for our meds. Just my advice, did the chantix and had alot of the bad side effects also and used to believe in these pharmaceuticals like everyone else. Just look around and maybe Google you might be surprised at what can work.
     

    balance

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    I have epilespsy. I know just what can happen to ones (and those in their) life..
    Getting stitches and staples in my scalp is exciting for me, but not exciting enough for SSA. To this day, they continue to deny me SSI, saying my 'condition' isn't serious enough, or occur frequently enough..
    My story is way to long to type out the whole thing. I am extremely sorry for you and yours troubles.
    Thanks much for your thoughts.
    Sorry to hear about your troubles with SSI.

    Fortunately, after a return to our home town, hubby went back to his former employer and a job he is dang good at, and is working now. But yeah, still taking meds for the rest of his life. I work with folks with disabilities, and I can testify that the system kinda sucks.
     
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