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New Eissenberg study vindicates e-cigarettes

Discussion in 'Medical Research' started by Bill Godshall, Jul 22, 2010.

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  1. Bill Godshall

    Bill Godshall Executive Director
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    Tom Eissenberg et al have published a new study comparing e-cigarette usage to cigarette usage. The results vindicate e-cigarettes.

    I've tried to attach a PDF of the article, but don't know if it worked.
     

    Attached Files:

  2. SudokuGal

    SudokuGal Ultra Member ECF Veteran

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    Yep, it works...good news...thanks for posting!
     
  3. mini_art

    mini_art Vaping Master ECF Veteran

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    So basically its saying that e cigs really dont deliver nicotene.
    Well ok , if that is true, then we can all quit today right? Hmmm.
    Either way, it is a good report for the industry.
     
  4. Windsage

    Windsage Senior Member ECF Veteran

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    Very interesting find. They show almost no nicotine elevation with the e-cigs, but show a slight trending of heart rate change. Since they say the "sham" product was the persons own brand, I assume this was simply puffing on an unlit cig.

    I wonder how much of the satisfaction effect is simply caused by the appearance of a smoke like product. I know it seems to me that vapor production effects my personal opinions. Whenever I have a juice or cartridge with low vapor production it does not seem as satisfying to me. Similarly, I can change from 18 mg to 12 mg and they both seem fine as long as the vapor production is good.

    Thanks for sharing the report.
     
  5. D103

    D103 Super Member ECF Veteran

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    Very interesting study and I am glad that Dr. Eissenberg continued this work and obviously did a much better job of it this time. I am particularly interested in the finding that the e-cigs did not, according to his tests, provide a 'signifcant' amount of nicotine to the user, yet still had obvious beneficial results. This poses many more questions than it answers but I am certainly heartened by the fact that studies are being done and more accurate information is being collected. I firmly believe that the science will inevitably show what so many have already been saying and that is, that this technology is, in fact, "safer" than traditional tobacco smoking and is unequivocally a viable tobacco harm reduction alternative.
     
  6. rolygate

    rolygate Forum Manager Admin Verified Member ECF Veteran

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    Thanks Bill.

    Briefly, this trial confirms my previous statement that:

    If a new ecigarette user, with a new ecigarette, is deliberately isolated from expert advice as to how to specify the correct materials, how to set up the product correctly, and how to use it correctly, then they will get little or no nicotine in the bloodstream as a result of using it.

    This is my conclusion from the results of three clinical trials which all agree on this result (Bullen / Laugesen, Siegel, Eissenberg).

    Difference from tobacco cigarettes
    The most important fact that an experienced user would be aware of is that there is no comparison with a tobacco cigarette whatsoever in either the purchase procedure for e-cigarette hardware or refills [1], the product preparation [2], or the use of the product [3]. The single common factor is that both are placed in the mouth. Apart from that, there are no similarities between a tobacco cigarette and an e-cigarette.

    [1] The strongest retail e-liquid available is needed for a new user - 36mg. It is proven (by these three trials) that medium or low-strength liquid does not work. This high-strength liquid needs to be ordered specifically as it will not be included in standard retail packs. In contrast, a cigarette buyer just buys their preferred brand over the counter and it will deliver exactly the result they need.
    [2] A new unit needs the zero-nic transport liquid removed, and some high-strength refill liquid dripped onto the atomizer. This sort of procedure is unknown to a cigarette smoker, who simply extracts the product from a pack and lights it up.
    [3] Inhalation technique is of a completely different type from that used with a tobacco cigarette. For example an experienced user, given one of these low-power units loaded with medium or low-strength liquid, would inhale lightly, direct to the lungs, for between 6 and 10 seconds. Of course, this cannot be achieved by a first-time user without expert instruction. In addition, a standard e-cigarette must be used for between three and four times as long as a tobacco cigarette in order to acquire sufficient nicotine input (ie around fifteen minutes). In contrast a cigarette smoker automatically inhales strongly, for a brief period of around one second, and the cigarette is finished in about five minutes. Thus there is no similarity in the way the two products are used. An e-cigarette is bought, prepared and used as differently from a tobacco cigarette as a power drill is. There are no similarities at all.

    E-cigs don't work
    Therefore, three carefully conducted and valid clinical trials have effectively proved that e-cigarettes don't work.

    This is an interesting conclusion because:
    a) It creates a very strong legal definition. Ecigarettes are proven not to deliver nicotine to the user, or in such insignificant amounts that they cannot constitute in any way a drug delivery system. Both the amounts observed, or lack of them, plus the carefully observed metabolic effects (none), prove this.

    b) In order to challenge this result, more trials would need to be conducted that strongly contradicted these results.

    c) If e-cigarettes are to be regulated on the basis they actually do something, as against being claimed to do something, then this third trial which again confirms the results of previous trials destroys any possibility that such an attempt at regulation could succeed at law. In effect, e-cigarettes are proven not to do anything, and this could not now be challenged in court (without further trials that produced directly contradictory results).

    The fact that we know different is neither here nor there - it certainly has no legal significance.

    It should be noted here that the results of Intellicig's recent trial appear to conflict. However, the full trial results have not been published, and they appear unwilling to publish the precise levels of serum nicotine, which may also be insignificant, although one would doubt this as they should at least know how to use an e-cigarette.

    Notes on the PDF content
    The phrase 'own brand' is initially confusing as it is not explained. It means the subject's preferred cigarette brand.

    The trial was conducted in accordance with:
    '.....package instructions [that] state that electronic cigarettes should be used similarly to a tobacco cigarette, .....'
    Any experienced user would know that any such instruction is incorrect and will lead to sub-optimal results.

    Repeated here:
    'Consistent with product instructions, participants were instructed to puff from the electronic cigarette devices as they would a normal cigarette.....'
    As stated, this instruction is incorrect.

    '...unlike puffing from a tobacco cigarette, two 10-puff bouts with the two electronic cigarettes described here expose users to no measurable nicotine or CO...'
    So, e-cigarettes don't work. In addition they don't poison the user with carbon monoxide, which is useful to know.

    And repeated:
    ' Despite the failure to deliver nicotine, .....'


    And again:
    'In spite of delivering no measurable nicotine, .....'

    So we can be quite sure that electronic cigarettes don't work.

    With regard to CO intake:
    'Importantly, neither of the electronic cigarettes tested in this study was associated with any measurable CO exposure. Long-term CO exposure has been linked to cardio vascular disease caused by tobacco cigarette smoking.....'
    Apparently, they are unlikely to cause heart disease either - again, useful to know.

    An interesting statement:
    ' Clinical laboratory methods have an important role to play in this empirical examination, ...... These methods will likely be extremely important to any future regulation of electronic cigarettes either as tobacco products or drug delivery devices in the United States (i.e., by the Food and Drug Administration) and elsewhere.'
    Although it's not possible to know exactly what the author had in mind, one reading of this statement is: "If e-cigarettes are to be regulated on their efficacy or otherwise as drug delivery devices, then as such they are proven not to deliver". This statement therefore appears sympathetic to us.

    On the topic of using beginners instead of experienced users:
    '...and inclusion of electronic cigarette-naïve participants who may be representative of cigarette smokers sampling an electronic cigarette for the first time, but not of a more experienced electronic cigarette user population.'
    The author admits that beginners may not be the best subjects, experienced users might produce a different result.

    He notes that the results of other trials concur:
    'It is noted that the nicotine delivery results are similar to another clinical trial (the Bullen/Laugesen Ruyan trial).'

    And sums up by stating:
    'In sum, this study revealed that two electronic cigarette brands do not expose electronic cigarette-naïve users to nicotine or carbon monoxide under the acute testing procedures described here, .....'

    Conclusion
    So there we have it: ecigs don't work - and if they are to be regulated on the basis that they deliver a drug or have some form of effect on the human body, we now have three trials that say there is no such delivery and no such effect.

    This creates a firm legal position that would be impossible to challenge without further, conflicting trials. If such trials were conducted by or funded by an organisation with a vested interest in producing conflicting results (such as the FDA), such results would not have the necessary stature to provide any proof.

    And my viewpoint...
    As an ecigarette user, I know these trials are, shall we say, 'flawed', but am very pleased indeed by the results.

    We all know that an experienced user, by correct specification / preparation / user technique, can derive so much nicotine that O/D is possible*. But that doesn't matter: legally, e-cigarettes are now proven not to work and that's a great result :)
    * This statement is simply an opinion; compared to the identical results of three independent trials it has no importance whatsoever.

    You should remember that we are venturing into lala land when we enter the world of government regulation and legal dispute. Truth, fact, morals, ethics, human life or any other considerations important to the individual or even the population at large have no significance here. We now have incontrovertible proof that ecigarettes don't work and we should be very glad of it indeed.
     
  7. DC2

    DC2 Tootie Puffer Verified Member ECF Veteran

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    Looking forward to following this discussion...
     
  8. rothenbj

    rothenbj Vaping Master Verified Member ECF Veteran

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    I am in complete concurrence with what you wrote and the results of the monumental studies.

    The FDA should immediately drop their embargo and stop their appeal of the verdict and let the E-cig rise and fall on the merits of being a smoking simulator that may give the smoker enough of an impression of smoking to overcome an addiction to the most addictive substance known to man- nicotine.

    This gimmick has proven to be successful in getting millions to stop smoking those deadly analogs without continuing their nicotine addiction. For those truly addicted to nicotine or other tobacco alkaloids, there is always snus and the theater prop to get them off the really deadly products. Win win in my mind.

    I just spent a brief time with some new Blu users that it is not working for. I'm going to have to educate them in how to get more vapor output so they are fooled into believing they are not smoking so they can become un-addicted. :vapor: :vapor: Smokescreens are us.
     
  9. ezmoose

    ezmoose Guest

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    Interesting, I've added it to my research library.

    Thanks for posting!
     
  10. D103

    D103 Super Member ECF Veteran

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    I totally agree with Roly in that participants were not "accurately instructed" as to "optimum e-cig use/technique" that an experienced user would be familiar with - thus likely accounting for the little to no nicotine level increase results and yet benefits were still derived. But hey, this study is part of the 'record' now, as it were, so what the h***, let them think/believe we are not getting any or very little nicotine - it's merely "pretend smoking" and a very clever psychological gimmick - so it helps to dismiss the whole "drug delivery device" argument as well as any "second-hand vapor" danger since if there is little to no nicotine 'going in' certainly no more can be "going out" /exhaled into the air. This study also really throws a wrench into the addiction argument
     
  11. CJsKee

    CJsKee Super Member Verified Member ECF Veteran

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  12. kinabaloo

    kinabaloo Vaping Master ECF Veteran

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    "Truth, fact, morals, ethics, human life or any other considerations important to the individual or even the population at large have no significance here."

    Exactly. So whether e-cigs 'work' or not will likely make no difference to ensuing political nonsense. Endemic corruption, Alice in Wonderland ...
     
  13. Mister

    Mister Super Member ECF Veteran

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    This is not a new study. It is the very same Eissenberg study as was already discussed at length and discredited in this thread: http://www.e-cigarette-forum.com/forum/e-cigarette-news/69409-cnn-com-today.html.

    This appears to be the final report, which was mentioned as coming in future when the first report was released. The writeup is different and more extensive than the original report. Data from 16 more subjects is supposedly included this time but a note says that there were no significant differences in these subjects, and as far as I can tell the graphs which were in the first report were not regenerated, the graphs in both reports appear identical.

    The good news in this report is that the comments under "Discussion" are far more carefully worded and take into account some of the issues we raised in the thread mentioned above. (Issues we raised which reflect badly on the experiment, e.g. the possibility that the subjects only vaped primer fluid, are of course not mentioned ;) )

    In particular the "Discussion" notes includes "Methodologic considerations of the current study include ... and inclusion of electronic cigarette–naïve participants who may be representative of cigarette smokers sampling an electronic cigarette for the first time, but not of a more experienced electronic cigarette user population."

    The discussion is also cautiously optimistic that electronic cigarettes may have potential for tobacco harm reduction use.

    I think we had a significant impact in Dr. Eissenberg's new slant on the same data.

    Unfortunately none of this rework of the report will undo the damage caused by the original release of this report and the associated comments Eissenberg made to the press. They won't pay attention to this final version. My feeling is that Dr. Eissenberg has both been swayed by us to view his data more correctly, and has also used what he learned from us to clean up the report so that this final version (probably the only version which will be acknowledged to exist in future since the damaging first release was preliminary) won't reflect as badly on him in future.
     
  14. Debs63

    Debs63 Full Member

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    which means the states will still try to make it illegal because if everyone were to quit analogs they'd get no revenue from the taxes that they charge.
     
  15. rolygate

    rolygate Forum Manager Admin Verified Member ECF Veteran

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    Well, this is very true. Dr E. has certainly made progress. However I don't see his report or his comments as damaging. There is a lot of kerfuffle all around ecigs but it doesn't seem to slow the uptake down much - if that's what you are referring to. People tend not to believe what they read now as it's just so much junk. Lies, damn lies and PR.

    And the key thing is that the report adds to a strong legal position that ecigs don't do anything medicinally. This is very useful to us indeed since that position cannot now be legally challenged. Personally I'm grateful to Dr E and colleagues as they've done us a favor. Perhaps it wasn't the intended result but that doesn't matter. The situation now is that no matter what anyone says or whatever other factors exist:

    Electronic cigarettes are proven not to have any medicinal function or effect


    That position cannot possibly be legally challenged at this point in time. It would require a substantial number of clinical trials with conflicting results, to enable any challenge to be made to that position.

    Therefore if there is an attempt to regulate ecigarettes based on the premise that they deliver a drug, or have some effect on the human body, then that attempt to regulate must fail at law (it won't stand up in court). Three independent clinical trials that show conclusively that there is no drug delivery and there is no effect on the subjects constitutes incontrovertible proof.

    This is why the FDA doesn't want any clinical trials of ecigarettes and has done everything possible to stop them. The results, whatever they might be, will not be good news for them.
     
  16. JollyRogers

    JollyRogers Ultra Member Verified Member ECF Veteran

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    I find his results interesting. Three to four days into switching from analogs to my ecigarette and using 30mg smoke juice, I went into definite nicotine withdrawals plus probably some other type of withdrawals from what ever is in Marlboro lights. I got through them after a few days. Recently I have been battling a terrible summer cold, now twice recurring thanks to my son. At the onset of the cold, I could not vape for two days! Not a single withdrawal symptom other then I kind of wanted to vape. I have never tested for nicotine, though I would like to, so I have no idea if I really am ingesting any nicotine. I think I am, but now I question it. I know that another poster went through the effort of self testing and was positive for nic. So that also makes me think I am ingesting nicotine. But this doctor's report says that my ecigarette is not delivering nicotine to my body!? So it definitely isn't a drug delivery system. I think I'll go mix some 0mg and vape that awhile and see how I do...
     
  17. rolygate

    rolygate Forum Manager Admin Verified Member ECF Veteran

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    Exactly. Of course, it all comes down to money and power in the end - nothing else is of any significance.

    In the case of e-cigarettes we should entirely forget about any objections made on health grounds or other such matters. These points are merely a smokescreen. It's all about the money, and only about the money. If you want to know who is doing what and why, then follow the money.

    From a personal point of view, I do think there is an argument to be made that ecigarettes will eventually cause severe problems for national tax revenues. Smokers fund the country, or at least a valuable proportion of its services, and we ignore this at our peril.

    You're talking about billions of dollars lost tax revenue and it it has to be found somewhere. My fear is that when tax departments wake up to this, they will join the anti-ecig brigades - and their power is considerable. Look at it this way: where will the money come from when 10% of smokers have switched? How about when 25% of smokers have switched?

    And they will - it's just a question of time. Therefore it is my belief that eventually we will see ecigs being taxed in some way, and personally I have no issue with that, as I prefer to see the roads repaired and the hospitals staffed. The money has to come from somewhere.

    One thing is for sure: in a few years time there will be a massive hole in state and national revenues, and to ignore that as a factor in ecigarette regulation is a mistake. If ecigarettes are allowed to be freely sold then they will be taxed - that is simply unescapable in the long run.
     
  18. North Shore

    North Shore Senior Member ECF Veteran

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    I disagree with the notion that anything other than federal and state income tax, as well as state sales tax (when bought in state) should ever be paid on the sale of these devices.

    Through taxes, government has been in bed with big tobacco, forever. In Massachusetts we have some of the highest taxes on cigarettes in the nation. Yet, our bloated and corrupt system gives us beat up roads and little money for local schools. If every convenience and liquor store sold these products, you would still get a decent revenue from local sales tax. In a short time there would be less people getting sick and burdening health care care resources.
     
  19. Bill Godshall

    Bill Godshall Executive Director
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    This newly published study contains the same laboratory findings cited in Eissenberg's two page letter published in February's Tobacco Control, as two of the seven charts (over 45 minutes following product administration) in this newly published study (plasma nicotine and cigarette craving) also appeared in Eissenberg's previously published letter.

    And while the new study similarly states that "no significant changes in plasma nicotine were observed" following use of the e-cigarettes, Eissenberg didn't issue a press release this time falsely claiming the e-cigarette don't deliver any nicotine. Unfortunately, the new study failed to point out that plasma nicotine increased slightly (just not at a statistically significant level) five minutes after e-cigarette usage and gradually decline thereafter (which mimics, but to a lower degree, plasma nicotine levels following cigarette usage).

    And of course, the new study failed to point out any of the information ECF posters informed Eissenberg about, including
    - 16mg and 18mg e-cigarettes emit less nicotine than other e-cigarettes and e-liquid,
    - participants had never used an e-cigarette before the study,
    - participants were instructed to use an e-cigarette exactly like smoking a cigarette,
    - the e-cigarettes used in the study were used for the very first time.

    The new study also found that e-cigarette usage resulted in only very slight (but not statistically significant) increases in heart rates, while cigarette smoking sharply increased heart rates within five minutes.

    But the newly published study did find that e-cigarettes resulted in NO increase in carbon monoxide in plasma (figure 2), which should be touted as evidence that e-cigarettes don't emit any carbon monoxide (in sharp contrast to cigarette smoke).

    And the new study also found that e-cigarettes helped to calm (figure 3C) and satisfy (figure 3D) users (not as much as smoking a cigarette, but more than inhaling an unlit cigarette). While figure 3A shows the QSU factor for e-cigarettes between that of smoking and inhaling an unlit cigarette, I couldn't find an explanation for or definition of QSU factor anywhere in the study.

    Overall, the most important findings of Eissenberg's study that should be touted include:
    - unlike cigarettes, e-cigarettes emit/deliver no poisonous carbon monoxide,
    - unlike cigarettes, e-cigarettes don't cause a significant increase in heart rate,
    - e-cigarettes reduce cigarette cravings and provide some satisfacton for smokers,
    - e-cigarettes emit/deliver significantly lower levels of nicotine to users than cigarettes,
    - first time users of low nicotine e-cigarettes may not experience the same benefits compared to experienced users of different e-cigarette products.
     
  20. Vicks Vap-oh-Yeah

    Vicks Vap-oh-Yeah Vaping Master ECF Veteran

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    The only thing I'm concerned about in this study, and the resultant storm of 'placebo effect' claims is:

    IF they get it through their heads that the PV doesn't deliver any nicotine when used, what's to stop the powers that be from only allowing nic-free juices - - - "if it doesn't deliver, why have it IN there in the first place, safety, dangers, poison, blah, blah, blah...."

    WE know that using PV's properly delivers a dose of nic, and like it or not, that dose is what keeps us using PV's and not going back to tobacco or switching to other alternatives... they remove the nic from nic juice, we're going to have a serious problem.
     
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