(CBS New York) E-Cigarettes: The Good, The Bad, & The Smoky

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Our House

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...the #1 whopper of the decade, "They're being sold to children."
Which is why all the States (and their 3 letter group reps) who tried to ban ecigs were so anxious to settle for a bill prohibiting sale to minors. Oh wait, they weren't? That's right. Because it has NOTHING to do with the Children!...Because these people KNOW that kids don't want ecigs!

A stance like that speaks volumes. All it takes is about 2-3 seconds of thought to realize what the ban attempts in Maryland, NY, Illinois, Cali and Utah were all about. Banning sale to adults is what they really wanted -- and if they can't get that, **** the children.
 

MoonRose

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Vocalek

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To smoke or not to smoke? New technology for an old addiction - News - Suntrap: Electronic Cigarette Manufacturer

“Health care professionals and consumers may report serious adverse events [side effects] or product quality problems with the use of e-cigarettes to the FDA's MedWatch Adverse Event Reporting program either online, by regular mail, fax or phone.”

Maybe we should start sending our Adverse Event Report ...

My adverse event is improved health. :p

No, no, no. Do NOT do that. That will be used against us.

The dirty, rotton scoundrals will ignore the content of your report and instead say "We received a million calls to our serious adverse events line."
8-o
 

kristin

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To smoke or not to smoke? New technology for an old addiction - News - Suntrap: Electronic Cigarette Manufacturer

“Health care professionals and consumers may report serious adverse events [side effects] or product quality problems with the use of e-cigarettes to the FDA's MedWatch Adverse Event Reporting program either online, by regular mail, fax or phone.”

Maybe we should start sending our Adverse Event Report ...

My adverse event is improved health. :p

I actually went to MedWatch a couple of weeks ago and counted the reports on e-cigs since July 2009 (after the FDA press statement) to March 2010 (the last report posted.) There were 7 reports. Four reported "no adverse reaction." One reported "equipment failure." One reported "blurred vision" and the last one reported "depression."

I then compared that to the 100+ reports on Chantix (43), Nicotrol (16), Nicorette & Nicoderm (lost count) and other NRT products. And I only looked at January 2010 - March 2010, because it took hours to get through just that one report, there were so many!
 
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Vocalek

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Is it correct that the FDA refused to allow someone to put their product forward for trials etc? I thought i'd read that somewhere on the Forum.

I heard something like that, too. I recall hearing that one company approached the FDA about being approved as a modified risk tobacco product and were told that the FDA doesn't have the process set up yet.

I do know at one point, there was a study set up to test the air in a room full of people vaping at a Vaper's Club meeting. It had approval of the Institutional Review Board.

IRB approval is required for any study that will use human subjects. Since the only people being exposed would be people who are regularly exposed to vapor, the study seemed safe enough.

All of a sudden, the IRB withdrew its approval, with no explanation. The study was dead in the water.

In both these cases, what I have just reported above is "hear-say". I have no first-hand knowledge.


BTW, an IRB is usually a committee set up at a university or research facility to approve and review any studies that will be done by their employees, a subcontractor, or a client. The person who was organizing the study suspects that the IRB had some type of political pressure applied to them to quash the approval for the study.
 
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rothenbj

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I actually went to MedWatch a couple of weeks ago and counted the reports on e-cigs since July 2009 (after the FDA press statement) to March 2010 (the last report posted.) There were 7 reports. Four reported "no adverse reaction." One reported "equipment failure." One reported "blurred vision" and the last one reported "depression."

I then compared that to the 100+ reports on Chantix (43), Nicotrol (16), Nicorette & Nicoderm (lost count) and other NRT products. And I only looked at January 2010 - March 2010, because it took hours to get through just that one report, there were so many!

Did you happen to notice if the person reporting the depression happened to be the same person reporting "equipment failure". That would get a lot of people depressed. ;)
 

rothenbj

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I heard something like that, too........

BTW, an IRB is usually a committee set up at a university or research facility to approve and review any studies that will be done by their employees, a subcontractor, or a client. The person who was organizing the study suspects that the IRB had some type of political pressure applied to them to quash the approval for the study.

The research probably was probably "not aligned with the department's mission". That seems to be a popular direction these days. Just sayin
 
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