From CNN.com Today/Eissenberg study with feedback

[Thulium]

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]

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]

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.
8-o

 

[mpetva]

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.

I fully agree! Thank you Dr. E! for sticking it out here with us, though there are disagreements

 

[curiousJan]

Wow is right.

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.

Thank you for recognizing this sad truth about the state of society. The fact is a lot of people are too lazy or stupid to form their own opinion based upon research and thought, they blindly swallow the media spin of important issues.

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.

Bravo, Dr. E. I commend you for your perseverance throughout this conversation and your persistence and drive for knowledge and understanding with respect to these devices.

Thank You!

Jan

 

[Oliver]

I'd also like to chip in with my gratitude for Tom's last post.

There is a clear and ongoing problem with all sectors of the media and science reporting. This is extensively documented in the UK by Dr. Ben Goldacre at Bad Science.

I do think that scientists need to be very circumspect in their dealings with the press, and to recognise that the principals (and complexities) by which they operate in their own professional life are scarcely understood by reporters. I think it's the two cultures phenomenon plus the need for sensationalism in news journalism that makes this such an intractable problem.

Dr Eissenberg, thank you for your willingness to engage with the community on this - you've gone way beyond what most people would be prepared to do.

And thanks to ECF members for such an excellent and productive discussion. Let's hope this carries on in the same vain - It seems to me that much can be achieved.

 

[curiousJan]

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).

Quick question:

For how long after you began using the device did you monitor your HR? For what length of time after concluding your use did you monitor?

I'm just wondering if there may be a delay and/or a more gradual increase involved.

Jan

 

[Oliver]

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"

deewal, scientists' careers really are not made by their media appearances. They are made by the integrity of their research - Dr. Eissenberg's research does exactly what it set out to do - nothing more, nothing less. It has provided an empirical base which can now be built upon.

I'm not in any way saying that the media reports that came after are not important. I think they are extremely regretful (and I'm not apportioning any blame), but they are a separate issue entirely to the research itself, and one in which Tom has met square on in his last post.

I do think Tom has shown himself more than willing to be an excellent partner to us all in furthering the understanding of the issues that are inherent in e-cigarette use.

 

[anim8r]

...

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.

...

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.

First, I didn't read one response from anyone asking for you to apologize for wanting a safe product. I saw the exact opposite.

I'm pretty certain we are still up in arms about the "overdose" statement you made.


Secondly, it is always a rare thing to see a PHD admit the likelyhood that one of his tests had either flawed equipment and/or procedures. I find this response to be at least promising and for that, you should be commended.

I would like to see an addendum to your articles including this personal experience, but it is what it is. I can only hope this personal account makes it into future interviews and publications.

And I do hope you will give serious consideration to the various suggestions presented by the multitude of experienced vapers when researching and developing any future e-cig tests.

 

[Lithium1330]

And now this is a good turn Dr. E. I really appreciate that you now see that the way you talk to the media matters, not only in the US, but all over the world, this is a very sensitive issue, e-cigs (and I mean the concept of vaporized liquid that produce a visible vapor with or without nicotine) have a huge potential in improving public health.

What you say to the media will be replicated in several countries, just think about it, soon enough the CNN article will be translated to Spanish and served to Spain and latinamerica by the local media, I can assure you that the vast majority of people who will read the headlines will be unable to find, read and understand your study properly (specially because this studies are released only in English), but "anti" groups will use the headlines to attack the e-cig concept, this happened with the FDA's press release, all "anti" groups and a lot of common people in latinamerica and Spain used those headlines from the FDA to say that e-cigarettes produce cancer! Even Brazil, Panama and Uruguay banned the product due to those headlines!

I really hope that now you could be able to take into account that your words to the media will impact not only your country, but a lot of other countries that are unable to do research in the subject and jut follow what the media says in the US.

 

[Belletrist]

wow, wow, wow.

very cool, dr. e. those are some pretty freakin' intriguing results. i can only imagine the fuel for more inquiry and future research!

and... yeah, a little naive, on the press. but although you're certainly older and smarter than me in a lot of ways, a little work in the marketing and PR business may have jaded me some (a lot).

all conflicts aside, i think this thread has--gasp and shock, internets!--been a learning opportunity for the majority of us, PhDs and armchair analysts alike.

 

[TropicalBob]

I join others when I say that I really appreciate the post, Dr. Eissenberg. First, you tested what many here would consider inferior electronic cigarette products with 16mg strength on virgin e-smokers - and got a result most of the veterans here could have predicted: Grossly insufficient nicotine delivery in conflict with the purpose of the devices.

Then, you personally tested a much better e-cig with a manual switch and you got results many of us feel we get now (but if you keep researching nicotine addicts using e-cigs, you might discover there is "something missing" and it's likely the MAOIs of tobacco smoke). We have entire threads on this forum devoted to that topic.

If you see this research all the way through, you might contribute to the greatest successful stop-smoking measure ever discovered, and forever change the idea that we are addicted only to nicotine (we are not and that fact quickly explains the failure rate of all NRT products and the success rate of switching to Swedish snus). I can think of nothing more important to save millions of lives.

Let's get it right. Provably right.

Thank you for posting your personal experiment -- and for undertaking it.

 

[MaryMarcelle]

First of all, let me commend you for acknowledging and making yourself available to, what I feel is one of the best collective representative samples of electronic cigarette users available, the members of this forum.

I would like to address a few points of the article, give some of my personal opinions, and ask a few questions.

From the CNN article:

They are as effective at nicotine delivery as puffing on an unlit cigarette," said Dr. Thomas Eissenberg, at the school's Institute for Drug and Alcohol Studies.

The latest clinical evidence suggests users are not getting the addictive substance they get from smoking tobacco. "These e-cigs do not deliver nicotine," Eissenberg said of the findings he expects to publish in an upcoming issue Tobacco Control, a product of the British Medical Journal Group.


While it may be true that the tar, along with additional carcinogens, in traditional tobacco analog cigarettes are what lead to the extensive list of negative health effects from smoking cigarettes, nicotine itself is an addictive substance and can be considered a dangerous drug as well. While you have found that Electronic Cigarettes do not deliver an equivalent amount of nicotine as the traditional cigarette, I contend that this would actually be a good thing, wouldn’t you agree?

I can really only speak for myself, but anyone who takes the time to browse through the E-cigarrettes.com forum will easily find hundreds, if not thousands of similar personal experiences. I was a 22-year veteran of tobacco analog cigarettes and felt like a prisoner to its addictive properties. I tried, unsuccessfully, 10 times within those 22 years to quit smoking. The FDA approved Nicotine Replacement Therapies that I used to assist me in my attempts included a nicotine patch, Wellbutrin, nicotine gum, and recently Chantix. It was during my latest attempt at quitting (using the Chantix) that I became aware of the Electronic cigarette. I decided it was worth a try. I quit taking the Chantix (used for one week) and used only the electronic cigarette (KR808 from V4L) and it has DEFINITELY worked for me. I do not consider myself a particularly religious person, but even I am one to admit that if there is a God, this device was sent directly from the Heavens from him (or her) to me. I consider it a miracle that I was not only able to quit smoking, but I did so with incredible ease and lack of any cigarette cravings whatsoever.

The fact is, this device really DOES help a large number of people with the desire to quit smoking tobacco analog cigarettes, achieve that goal. I contend that it does so more effectively than any FDA approved nicotine replacement therapy available on the market today. I have no studies/facts/statistics to back that statement up, which is why I reiterate that this is just my personal opinion. I do hope that those who are in the business of doing studies and publishing scientific findings regarding electronic cigarettes however, would take the time to listen to those of us who are in fact using the product on a daily basis. I feel that our experiences qualify us as some of the best (test subjects) and experts available regarding the electronic cigarette device.

I guess the point I am trying to make is that, even if the electronic cigarette does not offer an equivalent amount of nicotine as a tobacco analog cigarette, isn’t that a positive attribute in the long run, as long as it succeeds in helping a person to quit smoking?

With all of that being said, my main concern about the effects and or health risks of using electronic cigarettes are more concentrated on the possible associated risks of the repeated inhalation of the propylene glycol and vegetable glycerin based liquids. The only literature I could find regarding studies on this topic was an article reporting research performed in the 1940’s by Dr. Oswald Hope Robertson (1886-1966)

Here is a link to the related Time Magazine article about the study:
Medicine: Air Germicide - TIME

Perhaps you could do another research study regarding the above? (I volunteer as a test candidate!)

I would have loved to have been one of the 16 test subjects in your previous study, because, after all ~ free E-cig supplies! I also would have definitely been a subject that discontinued analog cigarettes and replaced them with the electronic cigarette during your trial.

I would also like to know where I could find the results of your study. Will it be published in any peer-reviewed magazines? Will it be posted online somewhere? I would be very interested in reading the report.

Thank you for taking the time to read and post on this forum.

Mary