From CNN.com Today/Eissenberg study with feedback
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I wonder what the outcome would be for those of us who dearly hope to be able to continue to vape whether it's demonstrated that they do, or do not, deliver nicotine. We believe that the latter would be the case in a study using a good product and eliminating subject error in use, but... then what? We say, "See, it really DOES deliver nicotine!", and how exactly does that serve our campaign? Easy in all of this to lose sight of our deepest concerns...
Well, they (that have less vitriol) ARE professional skeptics, so you'd expect so!
And the reason there was vitriol here in the beginning, is that the resulting viewpoint (from the study of ecigs) influences decision making that is literally life or death for many people in this forum. How I feel: Smoke analog cigs, die. Vaporize ecigs, live. This was not a study that determines who likes what flavor toothpaste. Serious business for us here.
But I agree 100% about manufacture or industry related sponsors appearing biased, and at the same time REALLY like the CASAA sponsored idea, as at least it gets testing done that will reveal data not produced by test designs such as this one (no offense at all intended).
aloha
kai
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Dr E said: "Supplies aren't the issue. Supplies are a trivial expense. In my world, the Ruyan sponsored study is viewed with skepticism by many."
I don't understand this...I thought TBob and others have said it is the responsibility of the manufacturers to get the studies done...I KNOW I have seen this said. If the manufacturer's study is "viewed with skepticism", then who is supposed to do the study? Especially if studies have to be done in order to present to the FDA for approval as say a reduced harm product?
What am I missing here?
I don't understand this...I thought TBob and others have said it is the responsibility of the manufacturers to get the studies done...I KNOW I have seen this said. If the manufacturer's study is "viewed with skepticism", then who is supposed to do the study? Especially if studies have to be done in order to present to the FDA for approval as say a reduced harm product?
What am I missing here?
Ok, great. Thank you very much Dr E.
Fairly sure we have talent on board who can address that. If any are reading this thread, please PM me - I have flow path design calcs, diagrams and data available for these devices.
Kai
Here's something for consideration. Back in the fall I took my grandson to an amusement park for a Halloween event. Spread over a couple hundred acres were many dozen industrial strength fog machines, each hooked to a 5 gallon bucket of propylene glycol. The vapor filled the air, standing near one of the machines, you couldn't see your hand in front of your face, it was hard to see more than a few feet in many spots, the vapor rose to a height of a couple hundred feet and rolled across miles of countryside outside the park. A few thousand adults and children inhaled this vapor for 5 solid hours as did anybody living downwind of the park. This scene was repeated several days a week for over a month.
The FDA, medical professionals, and busybodies were nowhere to be seen and not a word was heard from any of them.
Yet if smokers take the same propylene glycol and add a few percent nicotine, and vaporize it in a similar manner (at a rate of perhaps 1 liter/year), and find that it allows them to free themselves from cigarettes with measurable health benefits, all hell breaks loose. The FDA spontaneously release their bowels and is intent on banning the practice, the medical community hems and haws, and the busybodies suffer a simultaneous stroke.
We view the FDA as a compromised organization (vis a vis electronic cigarettes) beholden to the financial interests of the tobacco and pharmaceutical industries, we view the anti-tobacco busybodies (the radicals, at least) with contempt, and we're left with the medical community, our doctors, as the group most likely to see our improved health for what it is, a blessing.
A scene at my doctor's office:
Doctor: It says here you banged up your right knee trail running?
Me: Yea, I came down bad on a root, knee turned out, feels like I tweaked my LCL..
Doctor: You told the nurse that you quit smoking?
Me: Yep, my last cigarette was in September.
Doctor: Well, your blood pressure is normal, and your chest sounds good.
Me: I don't cough anymore in the morning and I'm back to doing up to 20 miles on the trails, not fast, but I'm doing it.
Doctor: Did you use an OTC nicotine product?
Me: Naw, I use an ecigarette now.
(look of concern crosses the doctor's face)
Doctor: I can't recommend electronic cigarettes, the health effects...
Me: Well, I can start smoking again, would you prefer that?
Doctor: Now that you've quit smoking cigarettes, it would be wise to also stop using electronic cigarettes.
Me: Can't, it's one or the other. Would you prefer I take up smoking again?
Doctor: Well, no.
Me: Then it's settled, thanks Doc.
Doctor: Let's have a look at that knee.
That's the basic gist of the exchange, not word for word, but as well as I can recall. I respect my doctor too much to tell him, "You have to recommend one or the other", because that puts him in a situation he doesn't want to be in, and anyway, he won't play that game, and will insist on neither.
[edit: To his credit, the word "Chantix" was never uttered.]
The FDA, medical professionals, and busybodies were nowhere to be seen and not a word was heard from any of them.
Yet if smokers take the same propylene glycol and add a few percent nicotine, and vaporize it in a similar manner (at a rate of perhaps 1 liter/year), and find that it allows them to free themselves from cigarettes with measurable health benefits, all hell breaks loose. The FDA spontaneously release their bowels and is intent on banning the practice, the medical community hems and haws, and the busybodies suffer a simultaneous stroke.
We view the FDA as a compromised organization (vis a vis electronic cigarettes) beholden to the financial interests of the tobacco and pharmaceutical industries, we view the anti-tobacco busybodies (the radicals, at least) with contempt, and we're left with the medical community, our doctors, as the group most likely to see our improved health for what it is, a blessing.
A scene at my doctor's office:
Doctor: It says here you banged up your right knee trail running?
Me: Yea, I came down bad on a root, knee turned out, feels like I tweaked my LCL..
Doctor: You told the nurse that you quit smoking?
Me: Yep, my last cigarette was in September.
Doctor: Well, your blood pressure is normal, and your chest sounds good.
Me: I don't cough anymore in the morning and I'm back to doing up to 20 miles on the trails, not fast, but I'm doing it.
Doctor: Did you use an OTC nicotine product?
Me: Naw, I use an ecigarette now.
(look of concern crosses the doctor's face)
Doctor: I can't recommend electronic cigarettes, the health effects...
Me: Well, I can start smoking again, would you prefer that?
Doctor: Now that you've quit smoking cigarettes, it would be wise to also stop using electronic cigarettes.
Me: Can't, it's one or the other. Would you prefer I take up smoking again?
Doctor: Well, no.
Me: Then it's settled, thanks Doc.
Doctor: Let's have a look at that knee.
That's the basic gist of the exchange, not word for word, but as well as I can recall. I respect my doctor too much to tell him, "You have to recommend one or the other", because that puts him in a situation he doesn't want to be in, and anyway, he won't play that game, and will insist on neither.
[edit: To his credit, the word "Chantix" was never uttered.]
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We haven't come up with a specific device recommendation on this thread in reply to Dr. Eissenberg's question.
I have a specific recommendation I would like to make but before doing so would like to know whether there is general support for it or criticism of it. If you have an opinion on the recommendation to make please read my proposal and comment on it on this thread: http://www.e-cigarette-forum.com/fo...recommendation-dr-eissenberg.html#post1050207
I have a specific recommendation I would like to make but before doing so would like to know whether there is general support for it or criticism of it. If you have an opinion on the recommendation to make please read my proposal and comment on it on this thread: http://www.e-cigarette-forum.com/fo...recommendation-dr-eissenberg.html#post1050207
their are so many powerful competing interests and laws (and new recent tobacco regulation), that one cannot know which power will gain more control by a given test result. power over ecigs will be interpreted by the court, after appeals are exhausted. further broader testing must and will occur - with or without us, in any case - too much money and political clout at risk.
my biggest concern: having the freedom to vaporize without paying Pharma or Tobacco execs' bonuses. i can brew beer legally and drink it, after all...
kai
Regarding funding:
At the risk of being pilloried all over again, the difference between e-cig industry funding a study now and big pharma funding a study now is that e-cig industry is not subject to regulation and big pharma is.
When pharma commissions a study -- say an abuse liability study like we discussed earlier -- they provide support to ensure that it is conducted under exceedingly stringent review procedures because they know FDA is going to scrutinize (or at least has the option of scrutinizing) every element of that study, from the first screening form to the final analysis. I've conducted pharma-sponsored studies in my lab (not related to nicotine) and I can tell you that the level of paperwork and data review is quadruple any of my NIH-funded studies. We must use complicated hand-entered "case report forms" for any measure taken (sometimes signed or initialed by the study participant), we have independently contracted study monitors in the lab daily or weekly to check all study procedures/records for completeness, and any missing form or value becomes a "protocol violation" that requires additional paperwork to document what happened and why. Once the data are collected, there is a comprehensive review to ensure that the case report forms match the computer-entered data, then the computer entered data are shipped somewhere for independent data entry and "database lock". Etc. etc. etc. All of these steps are taken at *great cost* by the pharma sponsor in part because they know that the entire study is looked at as potentially biased. So they have all these safeguards to minimize any chance of bias. There is an entire industry (the contract research organizations, or CROs) that thrives on running these type of studies.
I'm not saying bias doesn't happen, of course. I will say that bias is very difficult to introduce into the screening, data collection, and data analysis phases of a pharma study (interpretation of the analysis results is a different issue and requires other controls). I will also say that, without regulation of industry X, industry X is not going to pay the substantial additional costs of running a study under these extraordinary conditions that are used to minimize bias in screening, data collection, and data analysis (i.e., a 250,000 dollar study becomes a 1 million dollar study). Thus, when industry X sponsors a study on their own products, all of us have an obligation to be skeptical (and I have no objection to a healthy skepticism of big pharma either).
I hope this response helps a little....
At the risk of being pilloried all over again, the difference between e-cig industry funding a study now and big pharma funding a study now is that e-cig industry is not subject to regulation and big pharma is.
When pharma commissions a study -- say an abuse liability study like we discussed earlier -- they provide support to ensure that it is conducted under exceedingly stringent review procedures because they know FDA is going to scrutinize (or at least has the option of scrutinizing) every element of that study, from the first screening form to the final analysis. I've conducted pharma-sponsored studies in my lab (not related to nicotine) and I can tell you that the level of paperwork and data review is quadruple any of my NIH-funded studies. We must use complicated hand-entered "case report forms" for any measure taken (sometimes signed or initialed by the study participant), we have independently contracted study monitors in the lab daily or weekly to check all study procedures/records for completeness, and any missing form or value becomes a "protocol violation" that requires additional paperwork to document what happened and why. Once the data are collected, there is a comprehensive review to ensure that the case report forms match the computer-entered data, then the computer entered data are shipped somewhere for independent data entry and "database lock". Etc. etc. etc. All of these steps are taken at *great cost* by the pharma sponsor in part because they know that the entire study is looked at as potentially biased. So they have all these safeguards to minimize any chance of bias. There is an entire industry (the contract research organizations, or CROs) that thrives on running these type of studies.
I'm not saying bias doesn't happen, of course. I will say that bias is very difficult to introduce into the screening, data collection, and data analysis phases of a pharma study (interpretation of the analysis results is a different issue and requires other controls). I will also say that, without regulation of industry X, industry X is not going to pay the substantial additional costs of running a study under these extraordinary conditions that are used to minimize bias in screening, data collection, and data analysis (i.e., a 250,000 dollar study becomes a 1 million dollar study). Thus, when industry X sponsors a study on their own products, all of us have an obligation to be skeptical (and I have no objection to a healthy skepticism of big pharma either).
I hope this response helps a little....
thanks -
are you saying the procedures outlined for a moderate scope study for a pharma/fda acceptable study costs 1 million?
are you saying the procedures outlined for a moderate scope study for a pharma/fda acceptable study costs 1 million?
To me this illuminates many things, thank you!
I intuitively understood that quality research implied many costly overheads. Yet I didn't appreciate the scope of the overheads which exist when a study is supplier funded. Your explanation of them makes a lot of sense. I'm mulling over the "common sense" consequences of this, which seem unfortunate (to say the least) for ethical researchers. Still your explanation makes it clear that in a situation where funding can only come from a supplier (and whether our society might avoid that is a separate and very complex subject), overheads of this kind are unavoidable if impartiality is to be demonstrably preserved.
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In academia (whether NIH, or pharma funded) there is review of the study design, protocols and consent forms by an institutional review board prior to beginning to recruit subjects. The point of all the paperwork identified by teissenb is to protect study subjects and eliminate/minimize bias. it does add to the costs- and these days doesn't always seem to provide much protection...but there are cost/benefit analysis that happen at every level of testing. Skepticism is always healthy when reading results - and the associated news releases ;-)
CES I agree with you.
I would like to make clear that the level of oversight I am describing regarding pharma-funded studies goes far beyond the IRB review that all studies with human participants undergo. Besides being an NIH-funded Principal Investigator, I am a member of VCU's IRB and a former chair of the American Psychological Association's Presidential Task Force on IRBs and Psychological Science, so I deal with that sort of review daily.
A potentially relevant document for this discussion is this paper:
The time for tobacco industry sponsored PREP evaluation has arrived.
Tob Control. 2006 Feb;15(1):1-2.
Eissenberg T.
PREP = Potential reduced exposure products
Contact me if you want a PDF.
I would like to make clear that the level of oversight I am describing regarding pharma-funded studies goes far beyond the IRB review that all studies with human participants undergo. Besides being an NIH-funded Principal Investigator, I am a member of VCU's IRB and a former chair of the American Psychological Association's Presidential Task Force on IRBs and Psychological Science, so I deal with that sort of review daily.
A potentially relevant document for this discussion is this paper:
The time for tobacco industry sponsored PREP evaluation has arrived.
Tob Control. 2006 Feb;15(1):1-2.
Eissenberg T.
PREP = Potential reduced exposure products
Contact me if you want a PDF.
KK: No, I guess I was saying that doing an pharma-sponsored study can increase costs by at least 4x. At least.
My greatest dilemma in all this is that smoking a cigarette and the vaping technique are two completely different things. (examples would be drinking and eating).
Ecigs often need primer puffs to get them going.
Analog smokers smoke differently, inhale times are different, the way they inhale and exhale is different.
I would understand this study better if it were comparing two different cigarette brands, to see which type of analog delivered most.
On the other hand, two different e cig brands could be tested.
All the smokers that i have helped use ecigs took at least one hour to get accustomed to the way we puff on ecigs.
Most smokers cough their lungs out when they try ecigs for the first time.
In my mind it's simply not possible to test one against the other unless a multitude of different protocols are adhered to.
Ecigs often need primer puffs to get them going.
Analog smokers smoke differently, inhale times are different, the way they inhale and exhale is different.
I would understand this study better if it were comparing two different cigarette brands, to see which type of analog delivered most.
On the other hand, two different e cig brands could be tested.
All the smokers that i have helped use ecigs took at least one hour to get accustomed to the way we puff on ecigs.
Most smokers cough their lungs out when they try ecigs for the first time.
In my mind it's simply not possible to test one against the other unless a multitude of different protocols are adhered to.
Hi,
Just registered at this message board but been reading for a few weeks.
I've got an e cigarette starter kit sitting on my kitchen counter unopened. I plan to play around with it when the kids go back to school on Tues.
So I want to know have a purchased something that does not in fact deliver nicotine? I need to know. If it doesn't deliver nicotine then I want my money back.
Would any of you 'vapors' consider taking a home nicotine test to confirm whether nictotine is being delivered to you or not. That should pretty much settle the CNN's claim as to whether nicotine is being delivered to the bloodstream - right?
Here's one I found: (had to edit cos It would appear I'm not allowed to post links yet)
Cotinine Urine Test Kit is only $9.95
There are other nictotine test kits on the market that all seem to be targetted at parents trying to see if their kids are smoking.
Also are there any E cig suppliers that can prove to me that the products they are selling really do deliver nictotine?
I want hard proof or my money back.
Thanks.
Just registered at this message board but been reading for a few weeks.
I've got an e cigarette starter kit sitting on my kitchen counter unopened. I plan to play around with it when the kids go back to school on Tues.
So I want to know have a purchased something that does not in fact deliver nicotine? I need to know. If it doesn't deliver nicotine then I want my money back.
Would any of you 'vapors' consider taking a home nicotine test to confirm whether nictotine is being delivered to you or not. That should pretty much settle the CNN's claim as to whether nicotine is being delivered to the bloodstream - right?
Here's one I found: (had to edit cos It would appear I'm not allowed to post links yet)
Cotinine Urine Test Kit is only $9.95
There are other nictotine test kits on the market that all seem to be targetted at parents trying to see if their kids are smoking.
Also are there any E cig suppliers that can prove to me that the products they are selling really do deliver nictotine?
I want hard proof or my money back.
Thanks.
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