From CNN.com Today/Eissenberg study with feedback

[DC2]

Although I obviously don't support regulation as a drug delivery device, and think that would be silly, that is NOT the same thing as banned.

No, you are of course correct, but I contend that it is ESSENTIALLY the same thing.

If regulated as a drug delivery device, which is apparently what Dr. Eissenberg is hoping for, and lobbying for if I may be so bold, then everybody who sells either juice or equipment would be subject to a very lengthy (many years) and very expensive FDA approval process.

That in my view is the exact same thing, for all intents and purposes, as a ban.
Although I suppose it might be more fair to call it a long-term temporary ban.

 

[DC2]

I am sorry to go to this length, but it is fact, and needs to be said...

Dr. Eissenberg has been viewing this thread for much of the day, and he has not countered any of the assertions that claim that he is in favor of electronic cigarettes being classified as drug delivery devices, just as Mr. Godshall has implied.

How much more time do we give him to tell us that he is in our corner?

Tell us good doctor, WHERE DO YOU STAND?

 

[voltaire]

No, you are of course correct, but I contend that it is ESSENTIALLY the same thing.

If regulated as a drug delivery device, which is apparently what Dr. Eissenberg is hoping for, and lobbying for if I may be so bold, then everybody who sells either juice or equipment would be subject to a very lengthy (many years) and very expensive FDA approval process.

That in my view is the exact same thing, for all intents and purposes, as a ban.
Although I suppose it might be more fair to call it a long-term temporary ban.

If it should come to that, I'll be right there with you demanding that analog cigarettes be subject to the same process (in which case it will never happen), particularly since not only are they much more harmful, but they also contain much more psychoactive compounds (drugs) than mere nicotine. A cigarette is simply WAY more of a drug than an ecig is, by ANY measure.

And if they do somehow manage to effectively ban ecigs, I'll be right there with you in the new black market! Which probably won't be much different than our current gray market, and may even be better in some ways.

 

[deewal]

(edit)

So you see, I lost nothing, except for the time it took to respond to your worthless post.

Well if my post was pointless at least i've only made one.
What are the worth of your posts in this thread. What do you hope to achieve with all your quibbling and point scoring. In fact what is the worth of this whole thread. The FDA and BP and BT want E-cigs banned. Gone. Extinct.
What are You actively doing to oppose their ACTIONS.
Nothing. You are just pontificating on a Web Forum which suits them fine.
The only people you are addressing here are people who are Vaper's and do not wan't their E-Cigs taken away.
Every Word you write Here means Nothing to the FDA or the Media.
It just satisfies your ego.
It's about time everbody wakes up and realises that the FDA are SERIOUS.

 

[teissenb]

Actually, I haven't been viewing this thread at all until tonight. I have been busy at work and I also had a tournament squash match to play.

As for where I stand on the question you ask, I don't think I know enough about the ramifications of either option (or if there is a third option) to have a firm position. If I understand current affairs correctly, the decision will be made by the courts. If the courts are to make the decision then I am not sure how my position matters -- I won't be in the courtroom and I won't be doing the regulating. Is it so hard to believe that someone who has been testing, for more than 10 years, the nicotine delivery and other effects of potential reduced exposure products for tobacco users is motivated by a scientific interest in the nicotine delivery and other effects of electronic cigarettes?

A moment ago I was reading Bill's post that seems to imply that others scientists are soon going to be reporting results similar to my own, and that some of them are also going to report that cartridges labeled as containing nicotine do not in fact contain nicotine (do I have that right or am I misreading it?). If that is correct, surely everyone here should favor regulation so that everyone can be sure that they are getting/inhaling what a package says they are getting/inhaling?

 

[voltaire]

I am sorry to go to this length, but it is fact, and needs to be said...

Dr. Eissenberg has been viewing this thread for much of the day, and he has not countered any of the assertions that claim that he is in favor of electronic cigarettes being classified as drug delivery devices, just as Mr. Godshall has implied.

How much more time do we give him to tell us that he is in our corner?

Tell us good doctor, WHERE DO YOU STAND?

I don't think anybody ever expected him to be in our corner, and he never claimed to be. It's clear he thinks they should be regulated, and I agree that it would be nice to know what form he thinks that regulation should take. But maybe, just maybe, he hasn't fully formed a firm opinion on that yet, or maybe he simply wants to avoid as much of the politics as possible. (Tough line to walk, but I can't blame him.) In any case, there's no reason we can't have a civil discussion with someone whom we disagree - those are usually the most enlightening kind of discussions for everyone involved.

 

[Mister]

surely everyone here should favor regulation so that everyone can be sure that they are getting/inhaling what a package says they are getting/inhaling?

Some regulation makes obvious sense, for example no sales to minors. (The e-cig industry is already mostly doing that.)

But in no circumstances should there be any regulation affecting e-cigs which are more onerous on manufacturers than the regulations applied to cigarettes, nor which are more onerous on consumers than regulations applied to cigarettes. All evidence to date indicates that e-cigs are vastly less harmful than cigarettes and that many smokers find them an acceptable alternative. To regulate them more stringently than cigarettes flies in the face of reason. It would be regulation which directly causes harm by favoring use of a much more harmful product (cigarettes) over e-cigs.

Regulating e-cigs as drug delivery devices would subject them to far more expensive and stringent rules than cigarettes and should not be considered. This is why people on this forum are particularly sensitive to the term "drug delivery" - that's a term with specific meaning to the FDA which implies stringent regulation.

As to the specific case of regulating demonstrably accurate nicotine content, why? Cigarettes are well known to deliver vastly different levels of nicotine to users than what the approved testing processes measure and what is thus on the labels. If some e-liquid manufacturer is inconsistent in the levels of nicotine or tries to save pennies by shorting consumers, the free market will take care of that problem by itself.

 

[Brewster 59]

Well if my post was pointless at least i've only made one.
What are the worth of your posts in this thread. What do you hope to achieve with all your quibbling and point scoring. In fact what is the worth of this whole thread. The FDA and BP and BT want E-cigs banned. Gone. Extinct.
What are You actively doing to oppose their ACTIONS.
Nothing. You are just pontificating on a Web Forum which suits them fine.
The only people you are addressing here are people who are Vaper's and do not wan't their E-Cigs taken away.
Every Word you write Here means Nothing to the FDA or the Media.
It just satisfies your ego.
It's about time everbody wakes up and realises that the FDA are SERIOUS.

Well you are right but what do we do about it? Ill tell you what Im doing about it I am stockpiling and can care less what these air bags have to say.

 

[voltaire]

Well if my post was pointless at least i've only made one.

Now two.

What are the worth of your posts in this thread. What do you hope to achieve with all your quibbling and point scoring. In fact what is the worth of this whole thread.

Should be self-evident, but to give you the cliff notes, my efforts have been toward keeping open discussion going. Your previous post was the exact opposite of that.

The FDA and BP and BT want E-cigs banned. Gone. Extinct.
What are You actively doing to oppose their ACTIONS.
Nothing. You are just pontificating on a Web Forum which suits them fine.

See above.

The only people you are addressing here are people who are Vaper's and do not wan't their E-Cigs taken away.

I somehow doubt Dr. Eissenburg is a vaper - and he has a hell of a lot more chance of making a difference than any of us do. In fact, I believe the best chance I'll personally ever have to make a difference is by participating in a discussion with him.

Every Word you write Here means Nothing to the FDA or the Media.
It just satisfies your ego. It's about time everbody wakes up and realises that the FDA are SERIOUS.

See mirror.

P.S. I think I've made my points, and I am done for now. Get your last dig in if you must. I'll respond only to posts of substance, or when I feel I might contribute to the discussion, if any remains.

P.P.S. Mister: Very good point in your last paragraph!

 

[DC2]

I don't think anybody ever expected him to be in our corner, and he never claimed to be. It's clear he thinks they should be regulated, and I agree that it would be nice to know what form he thinks that regulation should take. But maybe, just maybe, he hasn't fully formed a firm opinion on that yet, or maybe he simply wants to avoid as much of the politics as possible. (Tough line to walk, but I can't blame him.) In any case, there's no reason we can't have a civil discussion with someone whom we disagree - those are usually the most enlightening kind of discussions for everyone involved.

I would agree with you if I didn't see so much evidence that his mind is made up already.

 

[DC2]

Is it so hard to believe that someone who has been testing, for more than 10 years, the nicotine delivery and other effects of potential reduced exposure products for tobacco users is motivated by a scientific interest in the nicotine delivery and other effects of electronic cigarettes?

It's only hard to believe based on your quotes in the media.

 

[Brewster 59]

Actually, I haven't been viewing this thread at all until tonight. I have been busy at work and I also had a tournament squash match to play.

As for where I stand on the question you ask, I don't think I know enough about the ramifications of either option (or if there is a third option) to have a firm position. If I understand current affairs correctly, the decision will be made by the courts. If the courts are to make the decision then I am not sure how my position matters -- I won't be in the courtroom and I won't be doing the regulating. Is it so hard to believe that someone who has been testing, for more than 10 years, the nicotine delivery and other effects of potential reduced exposure products for tobacco users is motivated by a scientific interest in the nicotine delivery and other effects of electronic cigarettes?

A moment ago I was reading Bill's post that seems to imply that others scientists are soon going to be reporting results similar to my own, and that some of them are also going to report that cartridges labeled as containing nicotine do not in fact contain nicotine (do I have that right or am I misreading it?). If that is correct, surely everyone here should favor regulation so that everyone can be sure that they are getting/inhaling what a package says they are getting/inhaling?

So are you saying that every cig delivers the exact amount of nic, tar and 4000 extra chems with the same amount and no variance whatso ever?

I will ask you this, name one FDA approved nrt that has better than a 10% success rate and no side effects?

You seem to assume that we would want regulation, while standards would be great and regulations to processing would be most welcome I dont think anyone would welcome a 4mg max or a flavor restriction.

The funnist argument I have ever seen is that ecigs are a gateway to real cigs the truth is almost all ecig users are former smokers. Ecigs are a pain with charging batts, failing componets, they just are better than the useless nrts.

As for getting what we are paying for, well we are paying for a subsitute to smoking, one that works not like those crappy nrts, and if the ecig does not work for a person they are free to keep buying cigs, or trying useless nrts, or whatever they decide is right for them.

 

[ChipCurtis]

I want to make 2 statements about e-cigs, and I don't think there is a person on this forum who would disagree that both statements are plausibly true.

1. E-cigarettes are a nicotine delivery device.
2. E-cigarettes are an electronic replacement for smoking real cigarettes.

You will notice that statement #2 has no intrinsic medical meaning to it. Both statements represent the cleavage point where e-cigs will have to follow one path or the other when it comes to eventual regulation. Statement #1 has medical meaning and would place e-cigs squarely in pharmaceutical turf. Statement #2 has no medical meaning and would place e-cigs squarely in tobacco product turf. Both statements are the crux of what is being argued in FDA vs. SmokingEverywhere.

Knowing this, Dr. E's tests, all other tests, and all conclusions being reached by those tests, represent only 50% of the entire weight of legal argument on this subject. The other 50% consists of marketing representation and marketing jargon, all of which play an equal functioning role in legal interpretation.

If Judge Leon's ruling is of any indication, the 50% power of the medical arguments may not even have to come into play when a court decision is made. This should give people here some indication as to how much power a single clinician can wield with regard to the e-cig's fate. Not a lot, if certain lawyers and/or judges see fit.

 

[anim8r]

I think that he satisfactorily explained why the study had to be designed the way that it was. Not having a baseline to go by, he simply had to proceed with caution while testing an unknown product on people. Otherwise, he would have had problems getting the study approved to begin with. The study "is what it is" - and unfortunately that's not what we wanted it to be. (BTW, I say this even though I think I was the first person in this thread to be critical of the study's design, rather than being critical of CNN for reporting on it.)

IMO, The only thing that I think can be reasonably criticized are some of the comments he chose to give to the media. I do find many of them hard to swallow, and some of them just seem downright misleading to me. But then again, scientists tend to speak from what they themselves can prove in the lab, which is not necessarily an accurate reflection of reality in the real-world. Knowing the limitations of his study, it would have been nice if he had spoke to the media in a way that could not be so easily misinterpreted. The way I see it though, he probably has to play the "catchy sound-bite" game to get the kind of press and reputation that will make it easier to get funding for subsequent studies. If that's true at all, it doesn't really make it right - but sadly, that's just the world we all live in these days.

But, if he was nothing but a minion of Big P. and/or Big T, as some seem to be implying, I'm sure that he (and they) could have come up with something MUCH worse than "ecigs don't deliver nicotine". Also, as others have pointed out, if that were the case, he would have nothing to gain from posting here and engaging us in discussion. He has admitted that the study had limitations and has seemed genuinely interested and willing to consider reasonable suggestions about how he might change the structure and details of future studies. The way I see it, complaining about the study or assailing his character or motivations can't possibly do anybody any good. The only productive discussion at this point, is that which addresses how to design future studies to more accurately reflect the real-world usage of ecigs. (though, that discussion may be over now)

The bolded statement is exactly why I'm irritated with Dr E. I don't fault someone for designing an ineffective test on a technology he is completely unfamiliar with. I fault the baseless huge bullets he gave to lawmakers to speed anti-ecig legislature through our states.

 

[Tampa2]

I posted twice on that article. The last count I seen was 286 comments. You may have to go to their actual site, register, then post. Refresh, then post again. It is BS, isn't it!

 

[DC2]

If I understand current affairs correctly, the decision will be made by the courts. If the courts are to make the decision then I am not sure how my position matters -- I won't be in the courtroom and I won't be doing the regulating.

In a country where the government is supposed to guided by the will of the people, the opinions of those who help shape the will of the people matters quite a bit. Of course, we could certainly argue whether or not that is the kind of country we live in.

 

[kristin]

Dr. Eissenberg,

If you are concerned that these device deliver to consumers as promised, then consider this. The vast majority of the consumers of this product are former smokers and it's NOT purchased as a smoking cessation - only a smoking replacement. (See these two surveys for reference:
http://www.e-cigarette-forum.com/forum/polls/71248-why-did-you-start-vaping.html

http://www.e-cigarette-forum.com/fo...please-follow-instructions-before-taking.html)

Safety is relative in light of that fact. If this product was intended for the majority of consumers, I can see having higher standards of safety, but to smokers, safer than smoking is a HUGE improvement.

Once people understand that this product is not intended for non-smokers, it changes the perspective. We may be choosing a lesser of two evils, but it's OUR choice.

 

[wader2k]

But don't you know that we live in a society where it is widely thought that the Government's job is to protect us from ourselves.

 

[Brewster 59]

But don't you know that we live in a society where it is widely thought that the Government's job is to protect us from ourselves.

Why cant these people worry about their own lives I sure they all have things they can improve on. Why do they have the need to push what they think is right on me? I really dont want their help in making my decisions these people cant even balance their budgets. Seems to me there must be something better to spend our tax dollars on then going after ecigs, gee maybe spending on education might be better.

 

[Aunt Cranky]

My immediate reaction to that CNN article was "BS!" and was wondering who was funding the study. There is a long history of Big Pharma (and I would imagine Big Tobacco as well) creating studies with specific outcomes in mind, and then creating experiments that cause those outcomes. I'm thinking specifically about the use of natural supplements (vitamins, herbs) to treat maladies that are also treated by expensive man-made drugs that make Big Pharma tons of money.

For example, there are plenty of folks out there who will swear that taking SAM-e supplements, or St. Johns Wort helps them "feel better", lessens their depression or pain symptoms. There will be a ton of studies that say these supplements have "no effect" and that the relief people experience is all placebo (but what does it matter if even 10% of the people taking the supplement are experiencing relief from symptoms without having to shell out $xx for a prescription that trashes your liver)?

If vaping can get heavy smokers to give up their analogs without the use of a (very potent nicotine receptor inhibitor drug), or other nicotine delivery methods (which for smokers like my bf, proved unpleasant), then you have a positve outcome.