I love reading intelligent, thoughtful discussion and appreciate Dr. Eissenberg taking the time to join us and post. Thank you sir.
From CNN.com Today/Eissenberg study with feedback
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I think you are misunderstanding Dr. Chaouachi's claim. He does not say MY work is funded by Pfizer. He writes: "All of them are also members of Globalink, the world antismoking network of about 6,000 activists around the world, sponsored by the pharmaceutical industry (Pfizer laboratories among others)..." He means that Globalink, which is a listserv for tobacco control researchers, is funded by Pfizer. I am a member of Globalink, and I do not know but would not be surprised if it were funded by Pfizer. I have never received any support from Pfizer and my research has never been funded by them.
As an aside, Dr. Chaouachi spends a great deal of time attacking me and any other researcher who presents data that suggest that smoking tobacco using a waterpipe (hookah, narghile, shisha) might pose health risks. I am sorry he does this, and cannot control his behavior. As with the data on e-cigarettes, I do not control the waterpipe data, I merely report them.
As an aside, Dr. Chaouachi spends a great deal of time attacking me and any other researcher who presents data that suggest that smoking tobacco using a waterpipe (hookah, narghile, shisha) might pose health risks. I am sorry he does this, and cannot control his behavior. As with the data on e-cigarettes, I do not control the waterpipe data, I merely report them.
The copyright to a scientific paper is held by the journal. Posting it to a forum lke this would violate copyright law and I cannot do it. I again ask Tropical Bob to please e-mail me at my vcu.edu and I can share copy with him for his personal use. If he chooses, he may share it with each of you for your personal use.
Note: As stated, for copyright reasons, this PDF cannot just be posted. I have sent a link to it to Sun Vaporer, BigJimW, and Dvap. If you get a "page not found", add .PDF to the link I sent you. Anyone can pass it along one to one, so ask a friend. It is technical, scientific, not easy reading. Anyone who has read this thread has digested the gist of the study.
I am going to further send this to the two doctors internationally who are conducting trials of e-smoking.
I am going to further send this to the two doctors internationally who are conducting trials of e-smoking.
There is the Doctirine of Fair Use but since it is not helpful, it makes no difference.
Sun
Sun
No offense to Dr. Esseinberg (and much appreciation for his comments in the forum), but after reading the pdf I'm a bit confused and disturbed.
(not that I'm not usually disturbed ...
... who me, I'm an angel 
) .... on to my point ...
The datapoints at 45 minutes are not included except in the graph, and I located an older study on nic-gum that was quite clear that nic absorption through the mucosa of the mouth and throat is substantially slower than that of a combustion cigarette. Was this difference in absorption time and manner accounted for within the study ... it doesn't appear so from the limited information in the pdf. In fact the different absorption mechanism isn't even identified as far as I can see.
But most disturbing is the last sentence: "At the least, consumers should be aware that, unlike several regulated nicotine products (eg, gum, patch), these putative drug delivery systems do not delivery nicotine effectively after acute administration." (emphasis mine ... cue title of post.)
Just sayin'
Jan
(not that I'm not usually disturbed ...
... who me, I'm an angel ) .... on to my point ...The datapoints at 45 minutes are not included except in the graph, and I located an older study on nic-gum that was quite clear that nic absorption through the mucosa of the mouth and throat is substantially slower than that of a combustion cigarette. Was this difference in absorption time and manner accounted for within the study ... it doesn't appear so from the limited information in the pdf. In fact the different absorption mechanism isn't even identified as far as I can see.
But most disturbing is the last sentence: "At the least, consumers should be aware that, unlike several regulated nicotine products (eg, gum, patch), these putative drug delivery systems do not delivery nicotine effectively after acute administration." (emphasis mine ... cue title of post.)
Just sayin'
Jan
Sometimes even researchers themselves lose sight of the fact that you cannot know for sure if the results you observed for a given set of circumstances will be observed for all sets of circumstances. In other words, you can't prove what you didn't test.
I would feel more comfortable with what Dr. Eissenberg said to CNN if it had been more specific, pointing out the boundaries of the testing. Without this specificity, the take-home message is on par with the FDA's implication that electronic cigarettes are more likely to cause cancer than smoking tobacco.
This quotation have been more accurately worded something like this:
I would feel more comfortable with what Dr. Eissenberg said to CNN if it had been more specific, pointing out the boundaries of the testing. Without this specificity, the take-home message is on par with the FDA's implication that electronic cigarettes are more likely to cause cancer than smoking tobacco.
...gives the take-home message that anyone who uses electronic cigarettes is being bamboozled because nobody gets any nicotine from any brand, model, or dosage level of this product.
This quotation have been more accurately worded something like this:
There is also the point that the atomisers may well have been seeing their first use, and that the volunteers may well have been only inhaling primer fluid vapour.
Again, without sight of the full documentation, it's difficult to draw solid conclusions, but the testing, in my opinion, the test regimen appears to have been flawed., and the quote used by CNN is dangerously erroneous.
It's also worth examining whether or not the fluid in the cartridges was tested for nicotine content, and what the assay results showed (if there were any). Had the good doctor naiively taken NJoy or Crown's word for it. or did he test?
Again, without sight of the full documentation, it's difficult to draw solid conclusions, but the testing, in my opinion, the test regimen appears to have been flawed., and the quote used by CNN is dangerously erroneous.
It's also worth examining whether or not the fluid in the cartridges was tested for nicotine content, and what the assay results showed (if there were any). Had the good doctor naiively taken NJoy or Crown's word for it. or did he test?
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There will be more tests. Dr. Eissenberg is reading this forum and others, and will take into consideration valid points made about testing protocol.
Here's a paragraph from an email exchange we had:
Everyone who e-smokes should welcome research. After all, what we don't know about e-smoking is .. virtually everything, and that fact is being used against us by the anti's. We need knowledge. And if that knowledge smudges our rose-tinted glasses, then take off the glasses and recognize reality.
And as Dr. Siegel suggests in his column, delivering no significant nicotine could be a blessing in disguise for e-smoking. No nicotine = no problem.
Here's a paragraph from an email exchange we had:
Everyone who e-smokes should welcome research. After all, what we don't know about e-smoking is .. virtually everything, and that fact is being used against us by the anti's. We need knowledge. And if that knowledge smudges our rose-tinted glasses, then take off the glasses and recognize reality.
And as Dr. Siegel suggests in his column, delivering no significant nicotine could be a blessing in disguise for e-smoking. No nicotine = no problem.
two very good points, the atomizers very well could have been brand new and coated in primer fluid. also, just because NJOY or Crown7 SAY that their cartridges are 16mg, doesn't mean they actually are. They could have been mislabeled 0mg carts for all we know! Unless the study actually did test the carts beforehand and failed to mention that to us..
The PDF did have some mention that they are aware that different PV models will have different results. The PDF states that there is an "ongoing need to evaluate nicotine delivery devices[PVs]. These evaluations should be conducted in a manner that takes into account variability in design(including cartridge nicotine content)....."
I'm hoping for future studies with a wider range of PVs considering all the variables.
To CuriousJan:
Benowitz et al (1988) showed that, while chewing 4 mg nicotine gum for 30 minutes, plasma nicotine concentrations gradually increased throughout the 30 minute gum chewing period and then peaked (at 10 ng/ml) at 30 minutes. If you are hypothesizing that the e-cig is using the same (buccal) route of absorption as the nicotine gum, then the prediction would be that, after 30 minutes, we should have seen some increase in plasma nicotine level. We did not. Even if it were some slower route (I know of none), we would have expected to see an increase from the first bout sometime after the second bout: please note that, when both bouts are taken together, we sampled blood for over 90 minutes in total. We did not see any reliable increase in plasma nicotine level at all.
The study was not designed to identify an "absorption mechanism" but since, under the conditions tested there clearly was not any absorption, the point is moot.
I am unsure why the word "putative" strikes you as biased. The first definition of "putative" in my Shorter OED is "That is believed to be such" and the second is "reputed". E-cigarettes are reputed or believed to be drug delivery systems (that is, systems that deliver the drug nicotine). They have not been demonstrated to be that, but they are believed to be that. The data I present show that, under the conditions tested, these two e-cigarettes that are believed to deliver nicotine do not deliver nicotine. Why is the word "putative" less than appropriate in this context?
Perhaps you attribute my desire for proof to be a bias? But we all want proof that are drugs/medical devices performed as claimed, do we not? If I presented you with a device that I believed to be able to deliver an antibiotic to your sick family member, I hope that you would not believe that it actually delivered the antibiotic unless it had been tested either by you or some other reputable person/group. That is the way medical science works and that is why the drugs and devices that we use today are the ones that we use: someone tested them and demonstrated that they work they way they are reputed to work. This state of affairs was unfortunately not present in the age of "patent medicines" and many people consumed useless or even harmful "laudanums" instead of proven cures.
Benowitz et al (1988) showed that, while chewing 4 mg nicotine gum for 30 minutes, plasma nicotine concentrations gradually increased throughout the 30 minute gum chewing period and then peaked (at 10 ng/ml) at 30 minutes. If you are hypothesizing that the e-cig is using the same (buccal) route of absorption as the nicotine gum, then the prediction would be that, after 30 minutes, we should have seen some increase in plasma nicotine level. We did not. Even if it were some slower route (I know of none), we would have expected to see an increase from the first bout sometime after the second bout: please note that, when both bouts are taken together, we sampled blood for over 90 minutes in total. We did not see any reliable increase in plasma nicotine level at all.
The study was not designed to identify an "absorption mechanism" but since, under the conditions tested there clearly was not any absorption, the point is moot.
I am unsure why the word "putative" strikes you as biased. The first definition of "putative" in my Shorter OED is "That is believed to be such" and the second is "reputed". E-cigarettes are reputed or believed to be drug delivery systems (that is, systems that deliver the drug nicotine). They have not been demonstrated to be that, but they are believed to be that. The data I present show that, under the conditions tested, these two e-cigarettes that are believed to deliver nicotine do not deliver nicotine. Why is the word "putative" less than appropriate in this context?
Perhaps you attribute my desire for proof to be a bias? But we all want proof that are drugs/medical devices performed as claimed, do we not? If I presented you with a device that I believed to be able to deliver an antibiotic to your sick family member, I hope that you would not believe that it actually delivered the antibiotic unless it had been tested either by you or some other reputable person/group. That is the way medical science works and that is why the drugs and devices that we use today are the ones that we use: someone tested them and demonstrated that they work they way they are reputed to work. This state of affairs was unfortunately not present in the age of "patent medicines" and many people consumed useless or even harmful "laudanums" instead of proven cures.
i hope this doesn't violate copyright, but i am going to post the graph from the PDF. To be clear, this graph is for educational purposes only.
I did notice that plasma nicotine levels DID in fact raise while using the e-cigarette, albeit only slightly and not nearly as significantly as when using their own brand. Although the increase in plasma nicotine wasn't VERY significant(not even 5ng/ml), it was still an increase in nicotine. Unlit (sham) cigarette's plasma nicotine levels stayed stagnant at 0ng/ml the entire time.
So the statement that "They are as effective at nicotine delivery as puffing on an unlit cigarette" is misleading, since there IS some(though small) increase in nicotine while using an e-cigarette. This quote made it appear as if we were getting ZERO levels of nicotine from both e-smoking and 'sham' smoking(puffing on an unlit cigarette).
This rather meager increase in nicotine is most certainly due to the fact that 1 e-cig puff does NOT = 1 cigarette puff. 10 puffs from an e-cigarette(especially an NJOY or Crown7), isn't very significant, and results in a not very significant increase in nicotine....but there still IS a small increase in nicotine.
I did notice that plasma nicotine levels DID in fact raise while using the e-cigarette, albeit only slightly and not nearly as significantly as when using their own brand. Although the increase in plasma nicotine wasn't VERY significant(not even 5ng/ml), it was still an increase in nicotine. Unlit (sham) cigarette's plasma nicotine levels stayed stagnant at 0ng/ml the entire time.
So the statement that "They are as effective at nicotine delivery as puffing on an unlit cigarette" is misleading, since there IS some(though small) increase in nicotine while using an e-cigarette. This quote made it appear as if we were getting ZERO levels of nicotine from both e-smoking and 'sham' smoking(puffing on an unlit cigarette).
This rather meager increase in nicotine is most certainly due to the fact that 1 e-cig puff does NOT = 1 cigarette puff. 10 puffs from an e-cigarette(especially an NJOY or Crown7), isn't very significant, and results in a not very significant increase in nicotine....but there still IS a small increase in nicotine.
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Absolutely, no question. Agreed.
However, we must keep in mind what Vocalek has posted:
Vocalek said:
The tag line that, "They are as effective at nicotine delivery as puffing on an unlit cigarette," does not provide a clear and honest reflection of the actual testing (production of knowledge) that has been done here. That tag line reads as a very general conclusion based on a very specific set of limited circumstances -- it's the problem of induction magnified greatly -- and that's the opposite of the generation of knowledge.
And I've always maintained the position that the ecig delivers a fair bit less nicotine (although not zero) than what the regular cigarette smoker receives. So, I'm certainly not predisposed to be unsympathetic to a position that lies in that direction.
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Slybootz:
I am sorry but that interpretation of the data is not correct. In science we distinguish between a change or difference that is "statistically significant" and one that is not. I cannot go into the statistical theory/methods here, but the basic idea is that with every measurement taken there is an error, and we must distinguish between reliable differences that we would expect to see again if we did the same study, and unreliable differences that simply reflect error in measurement. In the top panel of the figure, the filled symbols are statistically different from the measurement taken before product use (-5). If the symbol is NOT filled, there was no statistically significant difference which means no difference at all. Many a graduate student has railed against them, but those are the rules: if the difference is not statistically significant, then it is no difference at all. It looks like a difference because of the influence of random measurement error.
In fact, due to the lower limit of the assay being 2 ng/ml, any measurement error *MUST* be a positive error (causing an upward blip in the graph) because the assay cannot return a value below 2 ng/ml.
I am sorry but that interpretation of the data is not correct. In science we distinguish between a change or difference that is "statistically significant" and one that is not. I cannot go into the statistical theory/methods here, but the basic idea is that with every measurement taken there is an error, and we must distinguish between reliable differences that we would expect to see again if we did the same study, and unreliable differences that simply reflect error in measurement. In the top panel of the figure, the filled symbols are statistically different from the measurement taken before product use (-5). If the symbol is NOT filled, there was no statistically significant difference which means no difference at all. Many a graduate student has railed against them, but those are the rules: if the difference is not statistically significant, then it is no difference at all. It looks like a difference because of the influence of random measurement error.
In fact, due to the lower limit of the assay being 2 ng/ml, any measurement error *MUST* be a positive error (causing an upward blip in the graph) because the assay cannot return a value below 2 ng/ml.
@teissenb:
With the greatest of respect, I have to say that your methodology seems to be flawed. To begin with, you have no data to show what the actual concentration of nicotine in the cartridges used was. Secondly, you have no data to show what concentrations of nicotine in the smoke/vapour/air drawn from any of your subjects' device de jour was prior to any absorption (by whatever route) - should these data not have been obtained?
Similarly, you make no mention of how the e-cigarettes were prepared for usage and testing. Are you aware that they ship with "primer fluid" which is not nicotine bearing, and that 20 short puffs would be barely enough to vapourise that off before allowing nicotine bearing liquid access to the coil? Were the e-cigs "primed" with nicotine-bearing liquid prior to use?
While your attempts are laudable, I'm afraid that a lack of understanding of how an e-cig works seems to have produced results that are, to say the least, questionable, and, with respect, unreliable.
With the greatest of respect, I have to say that your methodology seems to be flawed. To begin with, you have no data to show what the actual concentration of nicotine in the cartridges used was. Secondly, you have no data to show what concentrations of nicotine in the smoke/vapour/air drawn from any of your subjects' device de jour was prior to any absorption (by whatever route) - should these data not have been obtained?
Similarly, you make no mention of how the e-cigarettes were prepared for usage and testing. Are you aware that they ship with "primer fluid" which is not nicotine bearing, and that 20 short puffs would be barely enough to vapourise that off before allowing nicotine bearing liquid access to the coil? Were the e-cigs "primed" with nicotine-bearing liquid prior to use?
While your attempts are laudable, I'm afraid that a lack of understanding of how an e-cig works seems to have produced results that are, to say the least, questionable, and, with respect, unreliable.
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