Deeming Regulations have been released!!!!

[wiredlove]

next time she rants about how dangerous your vaping/equipment is,, look her straight in the face and calmly inform her that hate and ignorance has killed far more people.. and maybe she should actually read up on the subject.

If the power of my hate could kill ignorant people that would be awesome. -evil laughter-

 

[Mazinny]

I wonder if the FDA has done the Same Thing for Varenicline?

They actually have, not that they have done anything about it . The Institute for Safe Medication Practices stated that 988 serious incidents were reported to the FDA linked to Chantix use in the U.S. during the fourth quarter of 2007 alone ! the most for any medication in that period. Sorry, couldn't immediately find a more recent report.

Chantix Problems

 

[bigdancehawk]

Exactly what I have been trying to say.... the stats are there, but I guess the FDA can't be bother to do their jobs.
-sigh-

Their idea of their job and your idea of it are quite different. They live in a different world and don't think like you do.

 

[crxess]

The one I submitted for the preposed deeming was really long. I think they just skipped over the comments that didn't apply to the answers they had already prepared.

The FDA used Testimonials for ONE SINGLE PURPOSE - To shore up Loopholes in an Already written Deeming Document. Information was used in majority for Inclusion of Supplies of all types as Product or accessories for use of Product.

Nothing in the Open Comment Period was for adjustment to allow, due to public opinion or industry documented safety.

*** On a Brighter note:

There have been a lot of meetings over the past 48 hours about what color plate do we deliver Debbie Wasserman Schultz’s head on,” said one pro-Clinton Democratic senator.

 

[zoiDman]

They actually have, not that they have done anything about it . The Institute for Safe Medication Practices reported 988 serious incidents linked to Chantix in the U.S. during the fourth quarter of 2007 alone ! the most for any medication in that period. Sorry, couldn't immediately find a more recent report.

I also wonder what "Weighting Factor" the FDA places on a Problem.

ie:

Throat Irritation (e-Cigarette)
Strong Desire to Jump Out of a 14th Floor Window (Chantix)

 

[Lessifer]

I also wonder what "Weighting Factor" the FDA places on a Problem.

ie:

Throat Irritation (e-Cigarette)
Strong Desire to Jump Out of a 14th Floor Window (Chantix)

Well, one could turn into a long term health concern, potentially costing the sufferer thousands of dollars in health care costs.
The other is an isolated event with no further associated medical costs.

 

[crxess]

I also wonder what "Weighting Factor" the FDA places on a Problem.

ie:

Throat Irritation (e-Cigarette)
Strong Desire to Jump Out of a 14th Floor Window (Chantix)

E-cigarette - $100, and for the casual user, another $100 or so for a 1 year supplement.

Chantix(no insurance) $900 for a 3 month prescription(plus Dr.s expenses) With no Guarantee of Effectiveness or Safety in Use.

Both have possibility of long term effects!

 

[Sugar_and_Spice]

I wonder if the FDA has done the Same Thing for Varenicline?

You could check. Those links
I just went and looked and could not find anything. I may just be tired. Dunno.

 

[beckdg]

Exactly what I have been trying to say.... the stats are there, but I guess the FDA can't be bother to do their jobs.
-sigh-

They're doing a fine job at their actual jobs.

They're getting plenty of funding and protecting the share holders of their biggest interests like nobody's business.

Just not doing much of a job of protecting public health as we're led to believe is their job.

Tapatyped

 

[zoiDman]

Well, one could turn into a long term health concern, potentially costing the sufferer thousands of dollars in health care costs.
The other is an isolated event with no further associated medical costs.

True.

And a Chantix induced Suicide did stop someone from Smoking. So those Data Points can be used to statistically bolster Chantix's effectiveness claim.

 

[Sugar_and_Spice]

They actually have, not that they have done anything about it . The Institute for Safe Medication Practices stated that 988 serious incidents were reported to the FDA linked to Chantix use in the U.S. during the fourth quarter of 2007 alone ! the most for any medication in that period. Sorry, couldn't immediately find a more recent report.

Chantix Problems

That' why I didn't find it. I only went back to 2009. Thanks for posting this.

 

[Lessifer]

True.

And a Chantix induced Suicide did stop someone from Smoking. So the those Data Points can be used to statistically bolster Chantix's effectiveness claim.

I believe that's a point in both the pharma cessation column, and the smoking related death column.

 

[beckdg]

It's not up to you to provide them with names. It's up to them to do the research.

Good luck with that.

FDA isn't a research facility.

Nearly all their research comes from their big industry not-so-silent partners.

Been that way for nearly 60 years.

Tapatyped

 

[Iron Molly]

That's so much nicer than keying her car.

I actually did get "revenge" of a sorts. I'm now a faster cyclist than she is, despite vaping. She tried to keep up with me on the last ride, but had to turn around and go back less than halfway. If she hadn't, I'm pretty sure she would have been dropped. To me, that's the best revenge ever!

 

[The Ocelot]

*** On a Brighter note:

There have been a lot of meetings over the past 48 hours about what color plate do we deliver Debbie Wasserman Schultz’s head on,” said one pro-Clinton Democratic senator.

Red China?

 

[zoiDman]

You could check. Those links
I just went and looked and could not find anything. I may just be tired. Dunno.

It was More of a Rhetorical Question.

And to make a Comparison between some of the other Products that the FDA seems fine with.

---

BTW - I Don't know how the Discussion with the FDA about e-Cigarettes somehow got Shifted from Harm Reduction over Smoking to what it is Today? But isn't that what it Should be?

 

[Sugar_and_Spice]

Good luck with that.

FDA isn't a research facility.

Nearly all their research comes from their big industry not-so-silent partners.

Been that way for nearly 60 years.

Tapatyped

That is taken out of context. The research he was referring to was the stats on ecig business and importers not the medical research.

 

[beckdg]

That's true, but if most manufacturers and shops register, it will prove that their economic impact estimates are completely wrong and that might provide a further basis for legal attack.

Meh...

I think it would further prove a negative economic impact on govt through tobacco bonds, BT, BP, CDC, AHA, ALA, W.H.O., etc through special interest appropriations via monies gained by BT & BP through their "non-profits".

Though that WOULD expose their actual intents.

Tapatyped

 

[bigdancehawk]

I also wonder what "Weighting Factor" the FDA places on a Problem.

ie:

Throat Irritation (e-Cigarette)
Strong Desire to Jump Out of a 14th Floor Window (Chantix)

Why do people keep saying things like this about Chantix, a product which the FDA has determined to be both safe and effective for smoking cessation? Just yesterday I was reading about a study showing that Chantix does not cause thought of suicide or other adverse neuro-psychological effects. The study was initiated and paid for by Pfizer, a neutral and independent source of funding.

 

[beckdg]

That is taken out of context. The research he was referring to was the stats on ecig business and importers not the medical research.

No

No it wasn't.

Who's interest did they protect by the "research" they did "do"... errr... accept?

Isn't it obvious they weren't interested in doing the actual work?

What's different enough to take out of context?

They don't "do" their own actual research. Period.

Now to misconstrue or depend on someone else's research for financial gain. That's another story.

Tapatyped