From CNN.com Today

[Thulium]

Originally Posted by teissenb

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?

The "third option" is an official recognition that tobacco products CAN be made safer. After decades of the FDA and Surgeon General telling us there is "no such thing as a safe cigarette", people tend to believe this. However, in the Tobacco Act of 2009, Congress gave the reins of control over tobacco to the FDA and asked (or at least implied, IMO) that they create regulations to make tobacco products safer. (Perhaps not "safe" in absolute terms, but certainly "safer" in relative terms)

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?

I'm sure Bill will give you a better answer, but when I read his post I thought he was implying that he'd heard through the grapevine about your research in particular. Your work showed that an e-cig neophyte taking 10 short puffs on a new PV shows little or no increase in nicotine plasma levels (as if this is a surprise), but you acknowledge that you would not be surprised to find statistically significant nicotine delivery under other conditions (even though your quotes to the media do NOT reflect that acknowledgement). Therefore, I really doubt that there are other researchers attempting to duplicate your work.

Considering that you have done research on tobacco and nicotine products in the past, I'm a little surprised (disappointed?) that your work does not seem to acknowledge the phenomenon of self-titration: When given enough options, tobacco users seem to have an uncanny ability to get themselves just as much nicotine as they crave by whatever means. They'll take longer or shorter "puffs", they'll take more or less frequent puffs, they'll inhale deeply or shallow, etc. That phenomenon is what really invalidates this study: In "real world" conditions, if a neophyte user doesn't get a statistically significant amount of nicotine from their first 10 "puffs" he/she will simply continue puffing until they are satisfied (unless, that is, your suggestion that these products are as effective as puffing on an unlit cigarette is just plain wrong)

Dr. E., if your intentions regarding these products are truly investigational (rather than based on an "anti" agenda) I would suggest that future studies investigate the habituation factor of these products in comparison to traditional tobacco use. Due to the habit forming ingredients present in smoke that are not in PV (specifically, Monoamine oxidase inhibitors), I suspect that the amount of nicotine absorbed will tend to trend upward with traditional tobacco use and level off or trend down with "cleaner" nicotine delivery systems. If my hypothesis is correct, this could help debunk the "What about the Children?!?" claims by providing evidence that using an electronic cigarette does not cause nicotine addiction or gateway into traditional tobacco use. Alternately, if there is no difference or a tendency for PV users to increase their nicotine intake, that could suggest that manufacturers should consider including other tobacco alkaloids in their formulations.

[Bill Godshall]

On post 665 of this thread, Tom Eissenberg wrote:

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?

If the federal court upholds Judge Leon's ruling (that the FDA can't regulate SE and NJOY e-cigarettes as drug devices, and that the "claims" made about tobacco/nicotine products are the primary determinant whether the product is a "tobacco" or "drug device"), the FDA will have no alternative but to reclassify and regulate e-cigarettes as tobacco products.

But the FDA also has had the authority (since June) to declare e-cigarette as tobacco products and to begin regulating them as such (which is what I urged Congress to require the FDA to do (via amending the tobacco legislation) and what I've urged the FDA to do since June (after Obama signed the FDA tobacco law). The AAPHP also has just filed a Citizens Petition with the FDA to do so (more on that campaign next week).

Due to the SE v FDA lawsuit, and due to the FDA's current policy of regulating drug devices (which basically bans the products unless/until after clinical trials are conducted) the only practicle way for the FDA to quickly adopt many of Tom Eissenberg's product regulation suggestions (some of which I agree with) is to reclassify and regulate them as tobacco products.

But if/when the FDA chooses to regulate e-cigarettes as tobacco, there would be no requirement for manufacturers to prove the products are "safe and effective", which are only required for "drug devices", and which Tom also has insisted upon.

Tom needs to decide if he wants e-cigarettes to be regulated by the FDA as "safe and effective drug devices" or if he wants the FDA to adopt reasonable and responsible labelling and marketing regulations for e-cigarettes (as tobacco products). That said, the FDA tobacco law doesn't require any other tobacco product to list its nicotine content, and the FTC has discouraged/prohibited cigarette companies from listing nicotine/tar contents on cigarettes for the past three decades (due to the "light cigarette" scandal).

Regarding my posing from October, I don't know how many e-cigarette studies are ongoing, and its quite possible that all of my sources were referring to Eissenberg's new study.

I'm pleased that Tom pointed out that he designed his study back in 2008, and Tom should know that I have only minor concerns about his very important published study.

What I'm extremely disappointed with are the news headlines, stories and quotes that Tom generated, which grossly misrepresent and are inconsistent with the findings of his study. Tom's refusal to address these concerns indicate to me that he fully supports and stands behind those headlines, stories and quotes.

[teissenb]

I didn’t realize that the post from Bill Godshall was from last fall. My apologies.

I am not at all certain that I need to take a position on the drug device/tobacco product issue. There are many issues in today’s complex world about which I have no position. For example, I am uncertain whether the Federal Reserve Bank is a good or bad idea. The same for term limits for congress people. I am uncertain if the Swedish snus experience will generalize to the U.S., or if FDA regulation of tobacco will be the boon some folks promise, or the bust others swear to. In any case, I don’t see how having one position or another on this issue is going to help me design better studies or run them more competently. In fact, as some have suggested, having a position one way or another is likely to be seen by some folks here and elsewhere as compromising my objectivity.

That having been said, I will not apologize for wanting a product that people use to inhale a substance into their lungs to be “safe and effective” and I reject the notion that this desire puts me in the “drug delivery device” camp and that was not my intention when I used those words. Indeed, if those three words indicate that idea to some readers, then I am very happy to change the words: I would like electronic "cigarettes" to be not harmful and to perform as advertised.

Having addressed that issue to the best of my ability, I would like to acknowledge one of the many very important lessons that I have learned from this discussion. You may think me naïve, but when I have spoken to the media about my work (and I have done so regularly for several years) I have always thought that my appropriately qualified comments were an invitation for interested individuals to find the study and read it for themselves. And in that vein, I have always considered my publications, and *not my comments to the media* to be the message I am delivering. The following analogy may be poor, but think movie trailer/movie: the media reports tell you there is a story, but (in my mind) folks who want to know the story will go to the paper. So, what I’ve learned from this experience is that for many people, the media reports (well qualified or not) ARE the story. This lesson contradicts my expectation and is in opposition to my firm belief that there is very little meaningful information to be gleaned about a scientific study from a CNN report, or a Richmond Times Dispatch report, or a Time Magazine report. Science is complex, and these media outlets, by their nature, avoid complexity. I would argue that if people see a media report about a scientific study of interest, they should go and get the study to see what it says. However, regardless of my expectations, beliefs, or arguments, you have taught me that, with apologies to Marshall McLuhan, “the media report IS the message.” I’m thankful, and I’ll keep this lesson in mind when I speak to the press in the future.

I would also like to report some results from some personal experimentation. At the suggestion of some of you, I purchased a KR808D-1 with various strength cartridges (Cowboy flavor). I used it last night (18 mg cartomizer) and tested my urine with Nicalert strips this morning. Result? 5/6. Clearly, this result is consistent with recent nicotine exposure. The confusing thing is this: I used the device while hooked up to a heart rate monitor which an observer was watching and I was not. My heart rate showed negligible changes during my many puffs on the device (it was one with a manual switch, which I was pressing; I was using the USB pass through; yes I got vapor, and yes I inhaled – quite the throat hit, I can assure you). Obviously I am not going to write a paper about this single experience, and there is much to be learned, but I certainly agree with the many of you who suggested that these devices may very well behave differently than the ones that I tested.

Tom E.

[dk2]

Very nice Dr. E

[DC2]

Wow, I am rendered speechless.

Fool me once, shame on you.
Fool me twice, shame on me.

I would appreciate if Mr. Godshall would expand on his issues with Dr. Eissenberg.
That might help relieve some of my current cognitive dissonance.

[Getbusyliving]

Heartfelt thank you for the candour, Dr. E.

[Mister]

Thank you Dr. Eissenberg! I admire your action in ordering the new device, in testing it on yourself, and in reporting your personal experience with such candour! Very well and nicely done.

[deewal]

Originally Posted by teissenb

I would also like to report some results from some personal experimentation. At the suggestion of some of you, I purchased a KR808D-1 with various strength cartridges (Cowboy flavor). I used it last night (18 mg cartomizer) and tested my urine with Nicalert strips this morning. Result? 5/6. Clearly, this result is consistent with recent nicotine exposure. The confusing thing is this: I used the device while hooked up to a heart rate monitor which an observer was watching and I was not. My heart rate showed negligible changes during my many puffs on the device (it was one with a manual switch, which I was pressing; I was using the USB pass through; yes I got vapor, and yes I inhaled – quite the throat hit, I can assure you). Obviously I am not going to write a paper about this single experience, and there is much to be learned, but I certainly agree with the many of you who suggested that these devices may very well behave differently than the ones that I tested.

Tom E.

No of course not. You would'nt want the Media to get hold of that as it may read "Prof E admits he might have been wrong and his first Test might have been flawed."
That might damage your Career and that is much more important than the Health of a few million Smokers.
As we say in Britain Mr E "Pull the other one. It's got bells on"

[wader2k]

Well that is quite the surprising turn of events........

[DC2]

Originally Posted by wader2k

Well that is quite the surprising turn of events........

I guess this is why chicks dig soap operas.

Edit: Wait, I meant girls
Edit: No, wait, I meant ladies
Edit: Women?

Actually there must be some men watching soap operas, or almost all of the soap operas ever made would not be among the longest running shows in television history.

Strange fact, I know, but look it up.