All of this has been absolutely fascinating. Personally, I've not smoked in over two months. I've ordered some cotinine tests. I'm curious. Do I have nicotine in me or not? Can't wait to find out!
Last edited:
From CNN.com Today/Eissenberg study with feedback
- Thread starter lager
- Start date
- th_trl_thread_readers 0
- Status
I've gone looking for similar testing of nicotine nasal spray. There is a very interesting (to me at least) study by N.L. Benowitz, S. Zevin & P. Jacob, III at Sources of variability in nicotine and cotinine levels with use of nicotine nasal spray, transdermal nicotine, and cigarette smoking.
Although the study doesn't have direct bearing on e-cigs I did find one paragraph to be an interesting contrast to the study currently being discussed:
"Treatment for 5 days in each condition is relevant because 5 days allows adequate time to achieve steady daily levels of nicotine and its metabolites (as confirmed by comparing the 08.00 h values at the beginning and the end of the blood sampling day, seen in Figure 1) and to allow time to become practiced in the use of nicotine nasal spray. Initially, nicotine nasal spray was very irritating to the nose and throat and caused watery eyes, coughing and/or sneezing. However, tolerance developed quickly to these noxious effects, so that by day 2 or 3 all doses could be taken without difficulty. By day 5, nicotine nasal spray was easily and consistently dosed by all subjects."
Although the study doesn't have direct bearing on e-cigs I did find one paragraph to be an interesting contrast to the study currently being discussed:
"Treatment for 5 days in each condition is relevant because 5 days allows adequate time to achieve steady daily levels of nicotine and its metabolites (as confirmed by comparing the 08.00 h values at the beginning and the end of the blood sampling day, seen in Figure 1) and to allow time to become practiced in the use of nicotine nasal spray. Initially, nicotine nasal spray was very irritating to the nose and throat and caused watery eyes, coughing and/or sneezing. However, tolerance developed quickly to these noxious effects, so that by day 2 or 3 all doses could be taken without difficulty. By day 5, nicotine nasal spray was easily and consistently dosed by all subjects."
Definitely a valid point Mister. I certainly don't use a PV today in the way that I did on day one. (Good thing) This isn't smoking, it doesn't work quite the same. You do have to learn your device.
Dr E, would you elaborate on the statement above?
What is an "abuse liability assessment"?
and what and how would data be collected ? (in short -not asking for great detail)
- and once again mahalos - these forums are a bit like a roman coliseum event sometimes!
kai
Personally, after observing heads 15 times in a row, I would ask myself "what factor(s) could bias a coin-toss the most severely?"
If it were my job to determine this, I would put it down to center of mass and experimentally determine the center of mass to see that the center of mass indeed corresponds to the center of volume.
To conclude a bias without proving a bias might be viewable as a bias unto itself.
But just to make sure I'm not misunderstood, 15 in a row would make me suspect a biased coin (pending experimentation to PROVE a biased coin). The odds of this with an unbiased coin are quite low but still non-zero.
Having had time to read and digest the study, and in particular, the discussion section of the study, there is nothing I find particularly objectionable.
The discussion does acknowledge the need to investigate different conditions, E.G. more puffs, greater puff volume, as well as the need to investigate user behavior over time (seems to suggest a more experienced vaper). The only definite statement of ineffectiveness was that nicotine isn't effectively delivered acutely by the ecigs in the study (with "acute" being, of course, heavily influenced by the study parameters such as user inexperience, equipment selected, puff count, and cartridge nicotine level).
I do find myself having to comment that with studies such as this, the author of the study has the luxury of having to defend only what the study specifically states. The study does carefully qualify it's conclusions, but the author is free to informally make much less guarded statements that may be easily interpreted by a sadly uncritical media. The takeaway from this study, whether it be the author's intention or not, is "Ecigs equal zero nicotine", and in my mind, I see nothing from the study author outside the study itself (which most will never bother to read) to qualify this. Even if an informal statement with implications beyond the carefully stated study conclusion were to be revisited and carefully qualified, with the state of the media, it's too late, the media is onto the next story and too often show no interest in digging any deeper than a casual scratch at the surface.
Smokers, tobacco users, vapers.. etc. We're all a cranky lot, because we're a besieged lot weary of hearing from authority and/or busybodies what ought to be imposed upon us ostensibly on our behalf. It bears repeating again, agree or not, I respect Dr. E very much now as he has demonstrated his possession of a ten-pound pair via his willingness to wade into this hornet's nest of besieged crankiness.
The discussion does acknowledge the need to investigate different conditions, E.G. more puffs, greater puff volume, as well as the need to investigate user behavior over time (seems to suggest a more experienced vaper). The only definite statement of ineffectiveness was that nicotine isn't effectively delivered acutely by the ecigs in the study (with "acute" being, of course, heavily influenced by the study parameters such as user inexperience, equipment selected, puff count, and cartridge nicotine level).
I do find myself having to comment that with studies such as this, the author of the study has the luxury of having to defend only what the study specifically states. The study does carefully qualify it's conclusions, but the author is free to informally make much less guarded statements that may be easily interpreted by a sadly uncritical media. The takeaway from this study, whether it be the author's intention or not, is "Ecigs equal zero nicotine", and in my mind, I see nothing from the study author outside the study itself (which most will never bother to read) to qualify this. Even if an informal statement with implications beyond the carefully stated study conclusion were to be revisited and carefully qualified, with the state of the media, it's too late, the media is onto the next story and too often show no interest in digging any deeper than a casual scratch at the surface.
Smokers, tobacco users, vapers.. etc. We're all a cranky lot, because we're a besieged lot weary of hearing from authority and/or busybodies what ought to be imposed upon us ostensibly on our behalf. It bears repeating again, agree or not, I respect Dr. E very much now as he has demonstrated his possession of a ten-pound pair via his willingness to wade into this hornet's nest of besieged crankiness.
Last edited:
Some of the media had a field day with the research results. As is typical, the British press had the most sensationalist headlines and story. I've grabbed a few graphs from two stories today:
and this
Shameful reporting, to be sure.
and this
Shameful reporting, to be sure.
Now that we know that there is no nicotine delivered from e-cigarettes then the FDA will have nothing to regulate. I say good job, and let us keep inhaling nothing.
i gotta +1 this.
as for the media... well. i expect no more and no less. unfortunately.
Terrible TBob, your absolutely correct
Can someone point out the word Urgent in the Discussion Section of the report ?
Though i do wish he had not used the word Regulated.
I've only briefly read through the last couple of pages of this thread but it occured to me that we were all New to Vaping when we started and i did'nt know anything about Primer and strangely enough i did'nt taste a weird taste from my first E-Cig which was a cheapie Mini. Even so within two day's i was able to stop Smoking even if i did'nt know the "Correct" way to puff (whatever that is) and this after Smoking 2 Packs of High Nic Cgarettes for over 50 years. Also for at least a year i used prefilled 16mg Carts and never "dripped" and only in the last 4-5 months have started to mix my own flavoured liquid and that was only because my favourite flavour was becoming harder to find.
Now I read the report last night and if as it say "there is virtualy no Nic" this makes it a Placebo and not only that but quite possibly the best Placebo ever invented and should not need evaluated or regulated at all.
Why ? Because it works as i still have been vaping today and have no desire for Tobacco Cigarettes even though i now know it's a Placebo.
Which is still the reason that the FDA and the MHRA want them banned.
We are Not Buying Cigarettes. They do not like that and must Stamp out this Healthy Behaviour
Last edited:
The obvious conclusion to be drawn, by the FDA, from these two studies is that they should regulate E Cigs. Since the nicotine has not been consumed in the body, it is being exhaled onto the carpets creating the third hand smoke threat.
The obvious conclusion to be drawn, by the FDA, from these two studies is that they should regulate E Cigs. Since the nicotine has not been consumed in the body, it is being exhaled onto the carpets creating the third hand smoke threat.
The only problem they have there is that the E-Cig creates Vapour not Smoke so there is'nt even any first hand smoke. Also the Vapour exhaled could only leave a tiny amount of Nicotine which does NOT cause Cancer.
It's Tobacco which causes Cancer. If these California Profs are only Educated to the level of 14 year old's then God help Science.
In fact God help the Planet.
The United States conducted around 1,054 nuclear tests (by official count) between 1945 and 1992. Most of the tests took place at the Nevada Test Site and the Pacific Proving Grounds in the Marshall Islands. Ten other tests took place at various locations in the United States, including Alaska, Colorado, Mississippi, and New Mexico.
I suspect that this may possibly have caused Cancer in a couple of people also. Could'nt have done the Planet much good either.
We are still breathing in the results of that radiation.
Hi all:
Sorry for the slow responses.
Tom09 asks what sort of results we might expect in our acute testing model if we used a nicotine inhaler. I have never worked with the inhaler and so have no experience with it. In looking at the Bullen et al (2009) SRNT report, it appears to deliver a very slow and low but statistically significant nicotine dose. I'd have to say that would be my prediction, but doing the experiment would be the only way to know. FYI, we HAVE tested the nicotine lozenge (2 mg) in this acute model, and it also failed to increase plasma nicotine levels significantly (Cobb et al., in press).
Mister is interested, I think, in seeing the results if folks used these products over 5 days. It might interest you to learn, therefore, that my work on evaluating novel products for tobacco users has always focused on studies with one of two exposure periods, acute and chronic, where acute (as you've seen) is brief laboratory exposure and chronic is defined as 5-days use outside the laboratory. The references (you can find them on PubMed) are: Breland et al., 2006; Breland et al., 2002; and Gray et al., 2008 (study 2 is the relevant one in the Gray et al., paper). We always do the acute testing first, so we know what we are dealing with and can be sure the longer-term model is safe for participants. So, are we considering a longer-term study for e-cigs? Of course! You need to realize, however, that these studies are not at all cheap, and I need to convince unbiased funding sources to provide the necessary resources. It is on my "to do" list, I promise you. I have found many of the suggestions on this thread very useful on planning that and other studies. I will continue to listen.
KK asked about abuse liability. Short answer: When a new drug is considered for FDA approval, the question is asked (by the FDA) how likely is this drug to be abused instead of used therapeutically? In many cases where the drug produces no central nervous system effects there is no reason to anticipate abuse (think antibiotics). In other cases, like a novel stimulant or narcotic, there is reason to anticipate it (think oxycodone or methylphenidate). When FDA anticipate some chance of abuse, they ask the company that wants to market the drug to produce data relevant to abuse liability. The basic question is, does the drug produce pleasant enough effects that someone would be interested in using it just for fun? Abuse liability assessment usually involves more than one study and, in humans, the methods are ideally behavioral (e.g., will the person work to attain the drug) and subjective (e.g., do questionnaire results indicate that the drug makes them feel good). I won't bore you with more methodological detail. Regulators use the results of such studies to determine how easy it will be for people to obtain the drug (i.e., over-the-counter, by prescription, etc.).
DVap makes some very cogent remarks about reporters. I think we need to be cognizant of a reporters job, which is (at least in part) to help sell their paper/magazine/TV station/website. They need to bring people in, which will help generate advertising revenue. To do that, they need to write interesting stories. Now, when I meet with a reporter (like the CNN reporter) we can spend anywhere from 5 to 60 minutes talking about my research. You'll have to trust me that I try very hard to detail the methods and all of the caveats. But you know what? I've found after 10 years of speaking to reporters that, as interesting as I think I am, the details of science must be very boring, because they rarely make it into the paper/magazine/TV spot/website. What gets in are the few sound bites. So I might explain all the conditions of the study in 10 sentences and then say, "Under these conditions these products delivered no measurable nicotine." and you can guess which of those 11 sentences makes it into the story.
So why talk to the media? Because the citizens of this country support my research, and they have the right to know the results of the work they are funding. I do my best (as I am here) to communicate the details whenever I can.
Thanks for listening,
Tom E.
PS: My research nurse was out sick yesterday but she is in today and verifies that the atomizer/vaporizer ARE wet when new. She also brought me the Crown7 "How to use" pamphlet that gives NO information about removing primer fluid (never mentions it at all) and recommends that users stop inhaling after 14-16 puffs. Recall that participants in the Tobacco Control study took 20 puffs total.
Sorry for the slow responses.
Tom09 asks what sort of results we might expect in our acute testing model if we used a nicotine inhaler. I have never worked with the inhaler and so have no experience with it. In looking at the Bullen et al (2009) SRNT report, it appears to deliver a very slow and low but statistically significant nicotine dose. I'd have to say that would be my prediction, but doing the experiment would be the only way to know. FYI, we HAVE tested the nicotine lozenge (2 mg) in this acute model, and it also failed to increase plasma nicotine levels significantly (Cobb et al., in press).
Mister is interested, I think, in seeing the results if folks used these products over 5 days. It might interest you to learn, therefore, that my work on evaluating novel products for tobacco users has always focused on studies with one of two exposure periods, acute and chronic, where acute (as you've seen) is brief laboratory exposure and chronic is defined as 5-days use outside the laboratory. The references (you can find them on PubMed) are: Breland et al., 2006; Breland et al., 2002; and Gray et al., 2008 (study 2 is the relevant one in the Gray et al., paper). We always do the acute testing first, so we know what we are dealing with and can be sure the longer-term model is safe for participants. So, are we considering a longer-term study for e-cigs? Of course! You need to realize, however, that these studies are not at all cheap, and I need to convince unbiased funding sources to provide the necessary resources. It is on my "to do" list, I promise you. I have found many of the suggestions on this thread very useful on planning that and other studies. I will continue to listen.
KK asked about abuse liability. Short answer: When a new drug is considered for FDA approval, the question is asked (by the FDA) how likely is this drug to be abused instead of used therapeutically? In many cases where the drug produces no central nervous system effects there is no reason to anticipate abuse (think antibiotics). In other cases, like a novel stimulant or narcotic, there is reason to anticipate it (think oxycodone or methylphenidate). When FDA anticipate some chance of abuse, they ask the company that wants to market the drug to produce data relevant to abuse liability. The basic question is, does the drug produce pleasant enough effects that someone would be interested in using it just for fun? Abuse liability assessment usually involves more than one study and, in humans, the methods are ideally behavioral (e.g., will the person work to attain the drug) and subjective (e.g., do questionnaire results indicate that the drug makes them feel good). I won't bore you with more methodological detail. Regulators use the results of such studies to determine how easy it will be for people to obtain the drug (i.e., over-the-counter, by prescription, etc.).
DVap makes some very cogent remarks about reporters. I think we need to be cognizant of a reporters job, which is (at least in part) to help sell their paper/magazine/TV station/website. They need to bring people in, which will help generate advertising revenue. To do that, they need to write interesting stories. Now, when I meet with a reporter (like the CNN reporter) we can spend anywhere from 5 to 60 minutes talking about my research. You'll have to trust me that I try very hard to detail the methods and all of the caveats. But you know what? I've found after 10 years of speaking to reporters that, as interesting as I think I am, the details of science must be very boring, because they rarely make it into the paper/magazine/TV spot/website. What gets in are the few sound bites. So I might explain all the conditions of the study in 10 sentences and then say, "Under these conditions these products delivered no measurable nicotine." and you can guess which of those 11 sentences makes it into the story.
So why talk to the media? Because the citizens of this country support my research, and they have the right to know the results of the work they are funding. I do my best (as I am here) to communicate the details whenever I can.
Thanks for listening,
Tom E.
PS: My research nurse was out sick yesterday but she is in today and verifies that the atomizer/vaporizer ARE wet when new. She also brought me the Crown7 "How to use" pamphlet that gives NO information about removing primer fluid (never mentions it at all) and recommends that users stop inhaling after 14-16 puffs. Recall that participants in the Tobacco Control study took 20 puffs total.
Hello Tom E....Thats why many people use forums like this one to find out how to vape, and how to use PV's properly. Thanks for sharing.
Why would it? Not many customers are researchers who DEPEND on receiving consistent amounts of nicotine in the first ten puffs.
There's a possibility that everyone in this thread, along with other other members here, manufacturers of different products, and people from other forums and how-to sites are all wrong about non-nicotine primer fluid. Or there's also the much more likely possibility that mainstream brands are not going to talk about the intricacies of the parts to their average consumer.
Why not contact the corporate offices of those companies if you're truly interested? Or better yet, get in touch with the manufacturing plants and find out EXACTLY what's in the primer fluid used and how long it takes to dissipate. If the first X puffs from a new atomizer are guaranteed to contain something other than the cartridge ingredients (especially sans nicotine) then it should concern you greatly.
That is extremely interesting. It also detracts a bit from the doubts I have had regarding the study results. Thank you for sharing it.
Wonderful!
You are very right about the media. I believe that I've redirected a bit of my frustration at the media's constant spin of everything toward you, and for that I apologize.
Yes, those included instruction leaflets leave much to be desired. Just like my HP printer comes with a glossy color leaflet showing me the appropriate connections but also includes a more detailed text manual, so should these devices.
You've received a lot of good input and information, and I believe that you will use what you can in further solidifying your testing of these devices. THANK YOU!
Jan
I have to agree with the Dr on this one ... there is too great a risk of the appearance of impropriety. A researcher has to protect reputation at every turn to remain credible. Seeking out information regarding the use of the product isn't inappropriate, but seeking guidance from the manufacturer cannot be done by Dr. E.
I don't disagree that ensuring that there is nic containing fluid at the bridge and coil of the atty is necessary to ensure accurate test results, but I believe that the good Dr. will address this matter in any further testing he performs.
Jan
I believe it as well. This thread was a huge help for everyone.
Assuming those of us who decide to test our cotinine levels (who are not exposed to 2nd hand smoke, and who do not supplement vaping with smokeless tobacco, etc) find cotinine at levels generally accepted by the medical community to be indicative of regular smoking, then there is a paradox to be solved, "How is a device that is said to deliver insignicant nicotine able to yield significant cotinine?"
I intend to continue using only 15 mg/mL eliquid (mixed quantitatively and confirmed by titration) while aggressively avoiding any other form of nicotine or 2nd hand smoke. When my nicalert comes in a few days, I should have an interesting result.
(and yes, I'm tempted to run it on hi-res mass spec right now, but somehow I don't think my employer would approve of me figuratively ...... into or otherwise fooling around with a half million dollar instrument, so I won't be doing that!)
I intend to continue using only 15 mg/mL eliquid (mixed quantitatively and confirmed by titration) while aggressively avoiding any other form of nicotine or 2nd hand smoke. When my nicalert comes in a few days, I should have an interesting result.
(and yes, I'm tempted to run it on hi-res mass spec right now, but somehow I don't think my employer would approve of me figuratively ...... into or otherwise fooling around with a half million dollar instrument, so I won't be doing that!)
Following the instructions that come with the product is an effective way to test a product. Unfortunately it's a less effective way to test a delivery method. E.g. this study applies to the two PV's tested, and less so on e-cigs in general.
However, It brings up an important point, that due to the lack of regulation a person with casual interest may not ever find this site, and so they might not find the important information that we've all assimilated here. The veritable e-cigs for dummies threads that have been established here should be included in every starter kit.
This also applies to the questions we've brought up about possibility of mis-labeled, incorrectly mixed carts affecting the outcome of the study. Proper regulation would apply effective QA standards.
I don't think it should be regulated as a drug/drug delivery device because it falls more under the category of caffeinated beverages, cigarettes and alcohol. As such it'll need to have unique rules set forth, and the FDA is instead trying to put it in some pre-existing category which simply can't properly apply.
- Status
Similar threads
- Locked
