Link to webcast of Dec. 17 FDA Public Hearing on NRT & Innovative Products

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rothenbj

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The final presentation has to get them thinking, at least on a superficial level, but the bottom line always seems so important to these people and BP provides that bottom line. Who was that sweet voiced ANTZ that you'd like to shut up? She didn't have much of an agenda much.

Of course their final question to the Dr. signed my death warrant since 20 pack years was the scientifically proven cutoff. Considering my 43 years and 2-3 PAD for at least the last 10, I figure I must be in the 70 pack year group. At 65, I must already be dead. It was nice not meeting you all today, but I feel alright.
 
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nchamber68

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Interestingly, after watching the video, I now think the only thing the FDA believes in is lengthy and costly studies that usually seem, to me and imho, biased to whomever is giving or paying for the studies. I especially liked the comparison to the first 6 years of vaping vs the first 6 years of smoking...like they were saying that people who vaped, have not vaped long enough or there was a possibility that vaping is somehow as bad as smoking or the lack of statistical information there is insurmountable.:blush:

It's like if their isn't a study then they are unable to think or draw intellectual conclusions.

You are dead on right about those studies. My husband used to work at Eli-Lilly and you would not believe the kind of money they have to drop into useless and pointless studies (which always seem to say what they want them to anyway) in order to get FDA approval. Additionally years are spent testing compounds on rats only to find out in the end that the compounds have entirely unexpected effects when used on humans.
 

nchamber68

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The final presentation has to get them thinking, at least on a superficial, but the bottom line always seems so important to these people and BP provides that bottom line. Who was that sweet voiced ANTZ that you'd like to shut up? She didn't have much of an agenda much.

Of course their final question to the Dr. signed my death warrant since 20 pack years was the scientifically proven cutoff. Considering my 43 years and 2-3 PAD for at least the last 10, I figure I must be in the 70 pack year group. At 65, I must already be dead. It was nice not meeting you all today, but I feel alright.

LOL...me too. I smoked for 32+ years and the last ten were around 2 PAD...so according to his math I should have had lung cancer 5 or 6 years ago and I have been lucky enough to not even get bronchitis since before I started smoking. :)
 
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Drumonron

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LOL...me too. I smoked for 32+ years and the last ten were around 2 PAD...so according to his math I should have had lung cancer 5 or 6 years ago. :)

I thought that was a provocative statement too...it was like if you've smoked for 20 plus....it simply isn't worth quitting...."stay with us"....there is no longer a benefit so....keep on lighting up.....sad...really sad.
 

j4mmin42

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Interestingly, after watching the video, I now think the only thing the FDA believes in is lengthy and costly studies that usually seem, to me and imho, biased to whomever is giving or paying for the studies. I especially liked the comparison to the first 6 years of vaping vs the first 6 years of smoking...like they were saying that people who vaped, have not vaped long enough or there was a possibility that vaping is somehow as bad as smoking or the lack of statistical information there is insurmountable.:blush:

It's like if their isn't a study then they are unable to think or draw intellectual conclusions.

That's part of the game. They're a regulatory body, and here in the West, we (on the whole, anyway) believe that hard science is the key to our understanding of things we don't know (except for religion). I personally agree with the need for more statistical info, and that the relatively short time period that these devices have been around is not going to help our cause at all. On top of that, these people have the health of hundreds of millions weighing on them- so the thought of them allowing something like e-cigarettes to remain unregulated forever is just not likely.

On top of all of that, there is big business and money involved (against our cause, for the most part). So this is going to be a long road, and us vapers are going to need to stay strong.
 

kwalka

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I definitely do not want to start a debate in this direction, but I just have to mention about all the vapers who were screaming about how AEMSA was going to be bad for us and wanted to blast them upon their inception. It sure was nice to see Link up there representing his interests yet speaking for all of us.
 

nchamber68

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I thought that was a provocative statement too...it was like if you've smoked for 20 plus....it simply isn't worth quitting...."stay with us"....there is no longer a benefit so....keep on lighting up.....sad...really sad.

Actually, that woman was the one who was being provocative and saying long term smokers shouldn't use NRT. The Dr. was careful to emphasize that it was even more important for the long term smokers to use NRT instead of smoking because the harm caused to them by smoking would be even worse...at least that's how I heard it.
 

Drumonron

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That's part of the game. They're a regulatory body, and here in the West, we (on the whole, anyway) believe that hard science is the key to our understanding of things we don't know (except for religion). I personally agree with the need for more statistical info, and that the relatively short time period that these devices have been around is not going to help our cause at all. On top of that, these people have the health of hundreds of millions weighing on them- so the thought of them allowing something like e-cigarettes to remain unregulated forever is just not likely.

On top of all of that, there is big business and money involved (against our cause, for the most part). So this is going to be a long road, and us vapers are going to need to stay strong.

I understand the need for scientific evidence in support of vaping but one needs a study that shows vaping vs smoking....which one is more deadly...this would be a precursor and the statistics are there that support the toxicity of smoking already so this should be a positive for ecigs(hate that they are called this)....NRT is the future for ex-smokers....they need to get involved with AEMSA and CASAA and the DRS that can assist now....before more youths become addicted to Tobacco.
 
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rothenbj

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Well if you think about it, if too many people are successful quitting with NRT and they don't get the diseases that BP wants to treat later in your life their bottom line gets seriously impacted. The NRT product works as designed as the most efficient marketing tool available. Inspire purchase over an over again of the latest and greatest stop smoking product thus insuring a continual stream of income. Then later, sell the drugs to treat the illnesses.

When you think about it, most people don't seriously work at quitting smoking until they've smoked at least 10 years and if it takes 8-10 quit attempts to actually be successful, you're probably at or close to that 20 pack year line in the sand. Marketing genius.
 

alank

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Actually, that woman was the one who was being provocative and saying long term smokers shouldn't use NRT. The Dr. was careful to emphasize that it was even more important for the long term smokers to use NRT instead of smoking because the harm caused to them by smoking would be even worse...at least that's how I heard it.
Me too, he never seemed to reference nor exclude vaping as NRT. Maybe I missed that???

PS: I have 40 years of analogs under my belt and moderate COPD. I haven't got too many choices beyond vaping or quiting, my target is quiting and no vaping.
 
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s§sZAN

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Interestingly, after watching the video, I now think the only thing the FDA believes in is lengthy and costly studies that usually seem, to me and imho, biased to whomever is giving or paying for the studies. I especially liked the comparison to the first 6 years of vaping vs the first 6 years of smoking...like they were saying that people who vaped, have not vaped long enough or there was a possibility that vaping is somehow as bad as smoking or the lack of statistical information there is insurmountable.:blush:

It's like if their isn't a study then they are unable to think or draw intellectual conclusions.

I am glad I wasn't the only one who picked up on that.
 

Kibbster

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I don't really see why millions have to be spent on research to find out if there are long term affects for e-cigs and NRT.
It wastes time and allows more smokers to die for their habit.
It's no secret what smoking does, research, experiments and medical knowledge knows exactly what smoking does to your health and they know that cigarettes are one of the biggest killers in the modern world.
How can anything in e-cigs with it's fairly benign chemicals be anywhere near the ball park of the dangers of smoking.

It's possible that if there are no known dangers maybe there are no dangers, why wait forever for the other shoe that might not drop.

Smoking on the other hand is taking people every second of everyday round the world (almost.)
 

RosaJ

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Me too, he never seemed to reference nor exclude vaping as NRT. Maybe I missed that???

PS: I have 40 years of analogs under my belt and moderate COPD. I haven't got too many choices beyond vaping or quiting, my target is quiting and no vaping.

You're right. We don't want the FDA to decide that ecigs are NRT's. We would be held to the same rigorous studies as the Pharmaceutical Companies. We're trying to convince the FDA that ecigs are part of the Tobacco Harm Reduction (THR). We don't claim that ecigs' purpose is to stop our addiction to nicotine, only replace the delivery of the nicotine.

Yes, some of us cut out all nicotine if we so want to, but if we push to make the claim that we vape because we want to cut out nicotine altogehter, the FDA will consider it to be a medical device just like the gum, patches, Chantix, etc. We (I'm not a spokesperson for CASAA, just a vaper) want ecigs to be considered on par with smokeless tobacco products such as snus.

This is my understanding.
 
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