From CNN.com Today/Eissenberg study with feedback

[voltaire]

I think that he satisfactorily explained why the study had to be designed the way that it was. Not having a baseline to go by, he simply had to proceed with caution while testing an unknown product on people. Otherwise, he would have had problems getting the study approved to begin with. The study "is what it is" - and unfortunately that's not what we wanted it to be. (BTW, I say this even though I think I was the first person in this thread to be critical of the study's design, rather than being critical of CNN for reporting on it.)

IMO, The only thing that I think can be reasonably criticized are some of the comments he chose to give to the media. I do find many of them hard to swallow, and some of them just seem downright misleading to me. But then again, scientists tend to speak from what they themselves can prove in the lab, which is not necessarily an accurate reflection of reality in the real-world. Knowing the limitations of his study, it would have been nice if he had spoke to the media in a way that could not be so easily misinterpreted. The way I see it though, he probably has to play the "catchy sound-bite" game to get the kind of press and reputation that will make it easier to get funding for subsequent studies. If that's true at all, it doesn't really make it right - but sadly, that's just the world we all live in these days.

But, if he was nothing but a minion of Big P. and/or Big T, as some seem to be implying, I'm sure that he (and they) could have come up with something MUCH worse than "ecigs don't deliver nicotine". Also, as others have pointed out, if that were the case, he would have nothing to gain from posting here and engaging us in discussion. He has admitted that the study had limitations and has seemed genuinely interested and willing to consider reasonable suggestions about how he might change the structure and details of future studies. The way I see it, complaining about the study or assailing his character or motivations can't possibly do anybody any good. The only productive discussion at this point, is that which addresses how to design future studies to more accurately reflect the real-world usage of ecigs. (though, that discussion may be over now)

 

[Mister]

Personally, I'd suggest we all drop the "bias" charges and let him proceed with further testing.

If he does proceed and finds, as most of us expect, that e-cigs deliver a significant amount of nicotine to the user, based on his performance so far I would not be surprised to see a CNN headline like "Electronic Cigarettes Are Toxic", with quotations from the good doctor about how they are capable of delivering nicotine in large quantities, quotations about how they deliver much more nicotine than approved products such as gum, and (especially likely) a quote that "These data scream out for the need for regulation of these devices"

I have no idea what Dr. Eissenbergs motivations are nor whether he has biases. But the data (his representation of the current study) show that he is capable of misrepresenting the facts to the media and I'm worried about that happening again.

 

[rothenbj]

We're on the same train, Kristin, riding in the same car, in fact. I agree .. but be very careful about slamming a researcher for entering a project with a preconceived bias. This man has done lots of previous testing. He knows what he's doing. He tested in a set of circumstances you find objectionable. He got what he got. And I'm not surprised, given how he tested.

Personally, I'd suggest we all drop the "bias" charges and let him proceed with further testing. He showed courage and honesty to come here and respond here. He did not back down -- and I admire him greatly for that. Some think that's a fatal flaw; I think that's a badge of courage and honor. When bullies badger, how does a person of integrity respond?

I look forward to future tests, and hope that our better suggestions are incorporated, and our ignorant utterances are forgotten.

TB, I tend to agree with you, but you make me so angry with your calm, political rightness. This is such an important social topic in such an anti anything that resembles tobacco smoking environment.

I was so, so buried in smoking before I found pv's that I was resigned to never writing. Now I'm over 2/3 rds of the way there and dedicated to the process. I'm typing this as I Vape with my first packet of Camel Snus under my lip (waiting on Swedish order thanks to you).

I kept my feelings to myself as Tom was posting, but I was very upset with his sound bits. I hope that he at least got an understanding of how important this subject is to those of us that want to get away from smoking.

It’s good for us and it‘s good for society, other than the lost tax revenue, but there is always sugar products to attack next.

 

[voltaire]

Also, I think much of the furor is over the fact that he obviously believes that ecigs should be regulated. This is a sensitive topic for us all, and it really pushes a lot of buttons. Merely mentioning regulation has everyone expecting the worst. But I think that most of us realize that, like it or not, ecigs really have to be regulated sooner or later. We just want it to be done in a fair, reasonable, and intelligent way that takes into consideration how much potential good can come from ecigs being a widely available alternative to cigarettes.

Regulation is inevitable, and the nature of that regulation will be shaped by the type of study that Dr. E. just did, and the type he intends to do in the future.

 

[Bill Godshall]

Hate to say I told you this would happen, but I posted the following on 10/13/09 at:
http://www.e-cigarette-forum.com/fo...dvocating-reasonable-laws-e-cigarettes-5.html


In the next few months, there are likely to be news stories and probably published articles in peer reviewed health/healthcare journals claiming that e-cigarettes either contain or emit very little (if any) nicotine, and calling for a ban on the products (because they are mislabeled as containing nicotine).

Several reliable sources (including a prominant tobacco product researcher and the head of respected testing laboratory) have informed me that several tests and/or studies have been (or are being) conducted that have found that some (perhaps most or all) of the e-cigarette products tested in laboratories and clinics (on e-cigarette users) found little or no nicotine in the products or in the blood stream of users.

While I'm aware that some e-cigarette products contain no nicotine (and are marketed as such), it appears that some e-cigarette products (and/or some e-cigarette vendors) are marketing products as e-cigarettes containing nicotine (when they contain only trace levels or no nicotine).

While I don't understand why anyone would want to ban or condemn an e-cigarette product that contains no nicotine, e-cigarette opponents are likely to renew their calls for prohibition claiming that the products are fraudulantly labeled and marketed as containing nicotine.

I suspect that the forthcoming tests or studies finding very little or no nicotine in e-cigarette products only tested one or two products marketed by one or two vendors, but that the conclusion of the study and the subsequent news stories will claim that all e-cigarettes and/or all e-cigarette companies are phony/fraudulant (similar to what occurred when the FDA tested just 19 product samples from SE and NJoy, but claimed that all e-cigarette products are hazardous).

When this occurs, I suggest that the laboratory tests and/or published studies be quickly scritinized, and that quick remedial action be taken by e-cigarette companies who products emit nicotine.

This is also another reason why legitimate e-cigarette vendors and all e-cigarette users would benefit from reasonable and responsible regulations of e-cigarette products (e.g. by the FDA as a tobacco product), as there currently exist no enforcable manufacturing or marketing standards for the products.

Ironically, while some have advocated a ban on e-cigarettes by claiming that "they contain enough nicotine to kill a person", others will soon be advocating a ban on the products by claiming "they don't contain or deliver any nicotine".

 

[nojoyet]

It should be noted that Eissenberg designed his study in June 2009, and it was posted at Evaluating the Acute Effects of Electronic Nicotine Delivery Devices Marketed to Smokers. - Full Text View - ClinicalTrials.gov

Eissenberg is presenting his study next week at the Society for Research on Nicotine and Tobacco next week in Baltimore Society for Research on Nicotine and Tobacco

It would be helpful if some e-cigarette users attend, and asked Eissenberg (at his presentation) some of the many questions he refused to answer and his many contradictory statements that he refused to address on this forum.

But its expensive to attend, and most participants are funded by drug companies and/or NIH. Murray Laugesen The Ruyan®.(nicotine) E-Cigarette
from New Zealand (who conducted Ruyan's studies) is attending.

Do you know if Carl V. Phillips (www.tobaccoharmreduction.org) University of Alberta, will be attending?

Thanks

 

[DC2]

Also, I think much of the furor is over the fact that he obviously believes that ecigs should be regulated. This is a sensitive topic for us all, and it really pushes a lot of buttons. Merely mentioning regulation has everyone expecting the worst. But I think that most of us realize that, like it or not, ecigs really have to be regulated sooner or later. We just want it to be done in a fair, reasonable, and intelligent way that takes into consideration how much potential good can come from ecigs being a widely available alternative to cigarettes.

While all of this is true, there is something going on here that we should not lose sight of...

From the various posts in this thread between Dr. Eissenberg and Mr. Godshall, it is clear they are very familiar with each other's opinions on the matter of regulating electronic cigarettes. It has been implied by Mr. Godshall in this thread that Dr. Eissenberg holds an opinion that electronic cigarettes should be regulated as a drug delivery device.

If that is true, nothing Dr. Eissenberg says or does is likely to help our cause.

 

[voltaire]

If that is true, nothing Dr. Eissenberg says or does is likely to help our cause.

If that is true, you may be right about what he says, but you're certainly not right about what he does. After all, if he were dead-set on ecigs being regulated as drug-delivery devices, then finding that ecigs don't deliver any drugs wouldn't be a very smart way to get what he supposedly wants.

That's pretty good proof right there that *if* he believes they should be regulated as drug delivery devices, he's at least not letting that belief affect the outcome of his studies.

 

[DC2]

If that is true, you may be right about what he says, but you're certainly not right about what he does. After all, if he were dead-set on ecigs being regulated as drug-delivery devices, then finding that ecigs don't deliver any drugs wouldn't be a very smart way to get what he supposedly wants.

That's pretty good proof right there that *if* he believes they should be regulated as drug delivery devices, he's at least not letting that belief affect the outcome of his studies.

I can not agree with you there, which I'm sure is obvious by my post below from a different thread.
And my post preceded the one below from Mr. Godshall...

Posted in another thread yesterday morning...

Seems to me the idea that there is no nicotine being delivered sort of paves the way for the FDA to say fine, you aren't getting any nicotine so you clearly don't need it to be in the liquid, so we will ban liquid containing nicotine and we will leave you alone and everybody will be happy.

Ironically, while some have advocated a ban on e-cigarettes by claiming that "they contain enough nicotine to kill a person", others will soon be advocating a ban on the products by claiming "they don't contain or deliver any nicotine".

 

[voltaire]

My comments were directed towards the point you made asserting that he wanted ecigs regulated as drug delivery devices. Now you're disagreeing with that based on the assertion that he wants them banned outright?

 

[Vocalek]

I think that he satisfactorily explained why the study had to be designed the way that it was. Not having a baseline to go by, he simply had to proceed with caution while testing an unknown product on people. Otherwise, he would have had problems getting the study approved to begin with. The study "is what it is" - and unfortunately that's not what we wanted it to be. (BTW, I say this even though I think I was the first person in this thread to be critical of the study's design, rather than being critical of CNN for reporting on it.) )

I disagree. Dr. Murray Laugesen presented a poster in April of 2009 on the results of his trials conducted on 40 participants where subjects were allowed to use the devices or smoke their own brand for an entire day. http://www.healthnz.co.nz/DublinEcigBenchtopHandout.pdf

A 35 mL puff from the Ruyan® V8 delivers only 10% of the nicotine obtained from a similar puff of a Marlboro regular cigarette.​

This poster is listed as one of the references in Dr. Eissenberg's article:

3.

Laugesen M. Ruyan e-cigarette bench-top tests.

Poster presented to the joint conference of the Society
for Research on Nicotine and Tobacco and Society for
Research on Nicotine and Tobacco-Europe; April 30 2009.​

​

​

​

​

​

Now it is possibile that Dr. Eissenberg did not know ahead of time that e-cigarette puffs taken by human subjects are equivalent to 1/10 of a regular cigarette puff (in the hands of users who have some practice). But he certainly knew by the time he published his results. So why the "these things are deliver no nicotine" spin on things?

At the very least, the October 2008 New Zealand Report, which was a toxicology report rather than a clinical trial, was available before Dr. Eissenberg's experiments started. In that report, we find these observations:

Each puff contains one third to one half the nicotine in a tobacco cigarette’s puff.

(Page 3)​

Table 3.1.2 Compounds measured in first 38 ml sample of e-cigarette mist.
Nicotine: Not detected

(Page 10)

It seems the user will get little benefit from a short puff. Presumably this is due to the time taken to heat the cartridge.

(Page 11)

Regarding safety concerns we find this comparison between the vaporized nicotine and cigarette smoke:

As nicotine has a low vapor pressure, the piezoelectric ceramic element in the e-cigarette is needed to cause vaporization of the nicotine-propylene
glycol solution. Cigarette smoke is produced by combustion at temperatures of up to 1000 degrees Centigrade, which is highly destructive, breaking up tobacco into free radicals and many small harmful gas molecules such as carbon monoxide, butadiene, benzene etc.​

(Page 20)​

Maybe it was too late for Dr. Eissenberg to go back to his IRB and say, "Hey, I have new inforamtion that tells me that the 10 puffs I planned to have subjects take is equivalent to just one puff on a regular cigarette, so let's change the design to allow me to obtain more accurate measures." But knowing this 1:10 ratio after the study design was approved but before the results were reported, it is shocking that the entire article, starting with the title itself, comes across as an indictment of e-cigarettes as ineffective.​

​

 

[teissenb]

Vocalek: I have here an e-mail proving that my study was submitted to the VCU IRB on September 3, 2008. Well before Dr. Laugesen studies were reported at SRNT in Spring 2009 and I believe also before any of his reports were released.

More information:

IRB approval received 12/22/2008 (documented and verified).
16th participant completed mid-June, 2009.

Hope that helps people understand the time line.

 

[deewal]

Vocalek strikes again. Leave it voltaire. You'll lose, and you Eissenberg.

 

[palermo45]

Many people who try these out for the first time are not aware that the atomizers have a "break in" period. It is possible that the person doing this study simply had an atomizer that wasn't working, or Mr. Brilliant used an empty cartridge, or he didn't charge the device. Under any of these scenarios, it would feel like nothing was coming out of the unit.

Study: 'Electronic cigarettes' don't deliver - CNN.com

Study: 'Electronic cigarettes' don't deliver

By Paul Courson, CNN
STORY HIGHLIGHTS
Nicotine delivery system same "as puffing on an unlit cigarette," researcher says
Virginia Commonwealth University studies "no-smoke tobacco" devices
FDA has halted imports of the devices as it studies their effect on health
RELATED TOPICS
Smoking and Tobacco Use
Food and Drug Administration
Virginia Commonwealth University
Washington (CNN) -- "Electronic cigarettes" that vaporize nicotine juice to inhale instead of smoke from burning tobacco do not deliver as promised, according to research at Virginia Commonwealth University.

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

His study, funded by the federal National Cancer Institute, is the first by American doctors to check the function of so-called "no-smoke tobacco" devices, which are unregulated in the United States for sale or use.............

Read the rest:
Study: 'Electronic cigarettes' don't deliver - CNN.com

 

[voltaire]

Vocalek strikes again. Leave it voltaire. You'll lose, and you Eissenberg.

(edit) Leave what, exactly?

Yes, although Vocalek began her response to me with "I disagree.", she actually answered all her own concerns, the main thrust of which was confirmed by Dr. Eissenberg himself.

So you see, I lost nothing, except for the time it took to respond to your worthless post.

 

[DC2]

My comments were directed towards the point you made asserting that he wanted ecigs regulated as drug delivery devices. Now you're disagreeing with that based on the assertion that he wants them banned outright?

Huh?

I am responding to your assertion that if he wanted them banned as a drug delivery device he would have no motivation to publicly claim in as loud a voice as he can muster that they deliever no drugs.

He most certainly does have a motivation, as does the FDA in my opinion.
And it was apparently predicted by Mr. Godshall, who clearly is at odds with Dr. Eissenberg.

 

[voltaire]

Huh?
I am responding to your assertion that if he wanted them banned as a drug delivery device he would have no motivation to publicly claim in as loud a voice as he can muster that they deliever no drugs.

Huh indeed. Now you're mixing up your own (mutually exclusive) assertions. It wasn't "banned as a drug delivery device" it was "regulated as a drug delivery device". And I made no assertions based on what he "publicly claims" but only based my assertion on the honesty of his research and it's conclusions.

 

[Brewster 59]

On posting 585 of this thread, Tom Eissenberg wrote:
"And, I hope it goes without saying, the products should be demonstrably safe and effective when used as intended."

"Safe and effective" is clearly a term that refers to FDA regulating e-cigarettes as "drug devices", not as tobacco products (as no tobacco products are considered "safe", while "effective" clearly references nicotine gums, lozenges and skin patches that FDA has approved as smoking cessation aids).

Meanwhile, clinical trials on NRT products (that have been approved and are regulated by the FDA as "safe and effective" smoking cessation drug devices) have consistently found a 93% failure rate after six months.

Virtually all of the individuals and organizations that have been urging the FDA to ban e-cigarettes also have insisted that e-cigarettes be proven (to the FDA drug office's satisfaction) "safe and effective" smoking cessation drug devices.

And of course, the FDA continues to maintain that e-cigarettes are "unapproved" smoking cessation drug devices, which is why the agency has seized and blocked e-cigarette shipments.

So it appears that Tom Eissenberg is actually urging the FDA to continue down its already chosen policy of e-cigarette prohibition.

Tom Eissenberg wrote:
"This thread has been very instructive and informative to me. I do not want
it to degrade into an argument between Bill and I, as there is no value to
anyone in that outcome. Please do not take my silence in response to Bill's
comments as agreement. Instead, please understand that the safe bet is that
Bill and I are unlikely to convince each other when we differ in this
manner, and so I prefer not to tire myself and others by trying."

Unless/until Tom answers and addresses my questions and comments, nobody but Tom will know what he and I may agree or disagree upon. In the past week, Tom has contradicted himself so many times that only he knows what he truly believes and what are his true motives and goals.

At least my views on e-cigarettes have been consistent and unambiguous for more than two years: e-cigarettes should be reasonably and responsibly regulate by the FDA as a new category of tobacco products to ensure that products are correctly labelled, remain affordable and legally accessible, don't emit harmful levels of chemicals, and aren't marketed to youth.

And for the past decade, I've consistently urged government health agencies, private health organizations, researchers and others to truthfully inform smokers (and the public) of the comparable health risks/benefits of different tobacco/nicotine products (because it is their ethical duty to do so and because smokers have a human right to truthful health information).

Bill this is an excellent post, as far as Im concerned all the approved nrts and their numbers of success rates are terrible and chantix which has been fda approved has shown that it success rate is dismal while having very determental effects on some people.

I do have to say that while standards would be a great thing regulation is worrisome because I believe that if the govt regulates these they will be regulated to the point that they are ineffective like the other approved methods.

All approved nrts require self regulation, If nic gum delivers 4mg of nic and I decide to chew 10 at a time, or if I decide to use 10 patches what is to stop me. So the argument that we are modifying our pvs doesnt seem to hold water as I can do the same thing with approved nrts.

You guys can take it any way you want but I think DR E is an anti, and is going to use info you give him against ENI. While he can get all the info he wants from these forums I dont think it is wise to make it easy for him or to give him direct quotes from users. He himself says he is looking for funding and just who do think is going to fund him?

 

[DC2]

Huh indeed. Now you're mixing up your own (mutually exclusive) assertions. It wasn't "banned as a drug delivery device" it was "regulated as a drug delivery device".

Regulated... banned... sorry for the misrepresentation of your quote.
Same difference in my opinion, and my comments still stand.

Regulated as a drug delivery device = banned

And I made no assertions based on what he "publicly claims" but only based my assertion on the honesty of his research and it's conclusions.

And my assertions to what he publicly claims are my own observations.
Although I would think the tone of those comments is obvious to more than just myself.

 

[voltaire]

Regulated as a drug delivery device = banned

Although I obviously don't support regulation as a drug delivery device, and think that would be silly, that is NOT the same thing as banned.

And my assertions to what he publicly claims are my own observations.
Although I would think the tone of those comments is obvious to more than just myself.

As are my similar opinions and observations on those same comments, which should be clear from my previous posts.