New E-Cig Online Survey - PSU - Dec 20, 2012

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jlew

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I completed the survey the end of December/beginning of January and, although the biggest
"oddity" question was about the 15 puff/10 minutes thing, I saw a few questions that could
have used a little more thought or better wording, and some that could have been either split
or added to in order to be more "individual" appropriate. I also saw a few that could be misused
or imply certain things that the "wrong sort" could use as fuel against instead of for. Along with
a few open-ended, as well as "dead-ended" questions that could use an area for comment or
elaboration.

So... I got in contact with them and had the pleasure of speaking in length over the phone
with one of the key researchers.

In our discussion, I had a few concerns and asked some fairly pertinent questions about the
motive for, and how the results were going to be used. One concern that seemed to be on
some other vaper's minds was, is the study intended as research in an Impartial position or
is it for one side or the other.

The researcher told me that it was a genuine concern and that others had voiced the same.

The originator of the research, from my understanding, is doing the research as a way to
familiarize/educate the public about e-cigarettes and on an official stand-point, to help the
e-cigarette remain as an alternative to smoking... at least that is how I am understanding it.
Do Not take that for granted though as I do not have any answers as of yet regarding
the reasons behind the study, and there is a limited amount that I can discuss.

I did make it a point to stress the fact that e-cigarettes are not a form of NRT and should
not be deemed or implied as such because, although some doctors have stated they might
be a good way to help people quit cigarettes and may have had some success in that area,
there are no medical claims of record of being a successful cessation aide or even being
manufactured for that purpose.
It sounded as though some of my own knowledge about e-cigarettes was something they had
not known and the researcher found it very enlightening.

I did note a couple of questions that inquired specifics regarding use as/during/after cigarette
use, and will people continue using these even if they quit cigarettes. So, by that alone, I am
assuming their idea is one of "Alternative with a possibility for cessation".

In all honesty, and from what I gathered by speaking with the researcher, this study is to help
rather than hinder.

It is a very "Slippery Slope" and something that has to be walked on lightly - that is certain.
So, I wanted to try and provide as much enlightening and beneficial information as I could
that presents e-cigarettes as an Alternative to cigarette use in a good way.

The researcher I spoke with said that they were very appreciative of the insight and information
I was providing about e-cigarettes because the person who started this research has never used
an e-cigarette and therefore, had limited information to base the questionnaire on.
I was told that my insight very well may be used to rephrase, add to, or adjust certain questions
and when I mentioned the theory about the "10 Minutes/15 Puffs", the researcher said that made
much more sense -- hat quantifying by amount of time or puffs is moot considering "vaping" is
dependent on the individual --- that at each use, a person might take one or two puffs while at
another time, might take 30 or 40 --- thus, a better way to make a determination would be by
amount of liquid or cartridges used as opposed to the "times used/puffs per day" idea.

In my email, I specifically asked for reasoning and motive because, as I told them - in this way, I
can let the vaping community know a bit more and that it could not only help to attract people to
the survey, it would help make them feel more secure about the reason why it is being done and
a bit more at ease in filling out the survey.

I should be hearing something back around the beginning of the week.

When I hear back from them, I will be sure to let everyone know. :)
 

blebs

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Survey completed, but not going for lab rat studies. Physically unable.

Personally, I think if one wanted too, they could use it for NRT, but I wouldn't label it for that specifically. I do know some that have gradually reduced the nicotine levels to 0, but continue to vape simply for pleasure. I also know others that have done the same and quit altogether.
 

jlew

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UPDATE

As Promised... I have received more information that I think I can now share with everyone.

Mind you that there is a limited amount I can discuss regarding this survey so I am only
going to mention that part which will help people understand the reasoning behind it and
to help alleviate any fears or misconception some may have over such surveys.

My inquiry to the survey:
On Fri, Jan 4, 2013;

I am very interested in helping as much as I can with this type of research because
it can benefit those who have smoked for years and know the affects but are reluctant
to use E-Cigarettes because the public has been consistently bombarded by false and
misinformation and scare tactics from the FDA over them.

I would like to also ask... as I did on the phone about "motives"...
Since I am a member of CASAA and the ECF forums... could you give me a little
summary of the "motives" and ideas for the study and their potential use at the outcome
that I can share with others so they will be more apt to take the survey and can be a little
more at ease as to whom the study is directed at the end and why.

Since I have more or less become an advocate for e-cigarettes, I would like to be able to
assure people that there are those in position (such as PSU) that are trying to help the
e-cig remain in the reach of the e-cig community.

The email above included my suggestions for changes or additions to several (16 in all) of
the survey questions. Whether these will be used or included in the survey is not known.

The email of thanks I received:
On Sat, Jan 5, 2013;
Re: ecig survey

Thanks for the note. I appreciate your caution regarding the motives of the study. The goal of the survey is to learn more about e-cigs and e-cig use, including what sorts of individuals use the devices, what types of devices they use, and what their e-cig experiences have been like. The study also includes a laboratory component, which focuses on examining the subjective and physiological effects associated with the use of different types of e-cigs. The study is funded by a seed grant from Penn State and, speaking for myself as lead researcher on the project, my goal is to gather objective data about e-cigs (i.e., I am not motivated to support or oppose their use, but advance knowledge regarding their use). Regarding PSU's policy on e-cigs, I honestly do not know if the university has an official position on them. I know that standard (combustible) cigarettes may only be smoked in approved outdoor locations, but I do not know what (if anything) is in the rules regarding e-cig use, or what the plans may be for such rules in the future (I don't actually have any input into administrative policies at the school). Thanks again for your great feedback.

Some of this sounded a bit vague so I asked for verification and elaboration...

My Reply to the above email:
On Sat, January 5, 2013;

Hello again,

Please forgive me but... if at all possible, could you elaborate on a few points.

Quote: "The goal of the survey is to learn more about e-cigs and e-cig use..."

Could you explain the "Why/What-for" of this?

The reason I ask is because just simple wanting to know more about them merely
requires simple searches and talking with people who have either used or researched
them.

As a Medical and psychological research study, there must be some "reason" for
wanting to know these things.

Although you say you are basically an impartial (to gather objective data) researcher,
there would still be a reason for it and the results will be used "How"?
Examples for use of results may be:
1) Papers written on the results for educational/scientific explanation to the public
2) Reports to be used by an agency for a purpose

Basically, is this a study to gather results to release to the public (good or bad)?

The "examining the subjective and physiological effects associated with the use of"
I can fully appreciate and understand as there really has not been enough research or
study done and too many people have the wrong idea.

Quote: "including what sorts of individuals use the devices..."

Please explain "sorts of individuals" (it sounds like a categorization of specific
persona types). I can tell you without the research that e-cigarettes are being used
by all walks of life in general... lol

Also, I did miss a large portion of the FDA HEaring online and would like to ask...
since Dr Foulds was there and spoke.
In general, what was/is his standing on e-cigarettes and what was/is the premise of his
testimony?

Other than that, it all sounds pretty good.

As I stated before, I am simply interested in helping the e-cigarette community get
a better understanding of the reasons behind such studies regardless of where they are
coming from... I just want to make sure that people are aware that things like this
can be a great influence on whether e-cigarettes stay on the market or not and in taking
such surveys, the more people who know the study is not a means of advocating against,
the more likely they will be to take the survey.

Thank you again so much and keep in touch.

The following is in response to the above email:
On Sun, January 8, 2013;

Hi there,
Essentially, the scientific goals of the study include learning more about the characteristics of the devices that people use and learning more about characteristics of e-cig users in terms of patterns of use (how frequently, how many are using as smoking cessation tool, etc.).

break... continued.....
NOTE: I have to break here because the next sentence deals with particualars that will
be examined during the actual lab study and in order to keep that relatively unbiased, I
cannot include here what will be done during the lab portion.

continued from above.....

We do plan to present our findings through standard scientific outlets (publication in peer-reviewed journals and presentation at scientific conferences). No hidden agenda here. I cannot speak for Jonathan regarding his stance on e-cigs (you would have to ask him directly), but he has never expressed any oppositional views towards e-cigs that I'm aware of. I do know that he has a primary interest in researching methods for helping people to quit smoking and my sense is that he sees e-cigs as a potentially useful tool toward this end, but he would have to tell you more about his specific views. Hope this helps.

So there you have the general ideas and reasons for the research and survey.

I have asked that Dr Jonathan Foulds get in touch with me regarding his actual views
and stand on e-cigarettes in general and I will follow this post up with that information
as soon as it becomes available.

Hope this helps anyone who may have had concerns about the reasons for the survey
and hopefully, more people will take it and even join the Lab portion.

I feel this is going to be a Milestone in e-cigarettes making the grade and getting the public
to better understand them and their use. I also feel this may be a very helpful tool for the
e-cigarette community against the Anti's and any future FDA/Gov Opposition. :)
 

jfjardine02

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This article, published in the journal "Addiction" as a commentary on a previous survey published by Etter & Bullen, summarizes Foulds' current views on e-cigs. I have provided the text below for those without online access to the journal. The purposes of the research project are precisely as Dr Wilson described.
Commentary on Etter & Bullen (2011): Could E-cigs become the ultimate nicotine maintenance device? - FOULDS - 2011 - Addiction - Wiley Online Library

Smoked tobacco products are the only legal products that kill half their consumers, and some of those around them, when used as intended. Over seventeen billion cigarettes are smoked worldwide every day, and that number continues to increase [1]. People smoke for the psychoactive and addictive effects of nicotine, but are killed by other toxins in the smoke [2,3].

Almost twenty years ago in this journal, the following comment was made on “the ultimate nicotine replacement device”:

“If people have difficulty overcoming both nicotine dependence and long-term habit change, then surely the solution is to help them avoid most of the health risks with only a minimal alteration in their nicotine-seeking habits. This implies a nicotine replacement device which looks like a cigarette and delivers cigarette-like boli of nicotine, but does not deliver the tar and carbon monoxide which cause the vast majority of smoking-related disease..... the development and promotion of such a product (and its eventual replacement of tobacco) could have massive beneficial public health implications lasting into the 21st century.” [4]

Might electronic cigarettes (e-cigs) be the product that could replace regular cigarettes and prevent millions of cases of premature deaths? Although e-cigs were initially perceived as something of a gimmick that was likely to be banned, their increasing popularity and resistance to regulatory efforts suggest it is more likely they are here to stay.

As e-cigs are largely sold via the internet, it is difficult to estimate total sales. Two U.S. companies reported selling 735,000 e-cigs in just over a year [5], and among recent U.K. smokers, 9% had used e-cigs and 3% were still using them [6]. In 2010, internet searches for e-cigs were several-hundred-fold greater than searches for medicinal nicotine therapy products [7]. E-cigs obviously look like a cigarette, and do not deliver tobacco tar or carbon monoxide, but questions remain about their nicotine delivery and regulatory status.

Early laboratory studies of e-cigs found meager nicotine delivery [8,9]. However, Etter and Bullen [10] concluded that e-cigs are being used as aids to smoking cessation much as people use nicotine replacement medications. Preliminary results from a study in which experienced e-cig users were allowed to use their own (customized) e-cigs reported that they achieved cigarette-like increases in blood nicotine concentration (> 10 ng/ml in 5 minutes) [11].
This and other studies [10,12,13] show that some e-cigs are capable of cigarette-like nicotine delivery and so it is important that their potential to improve public health be given due consideration. Clearly further research is necessary to clarify the best direction for e-cig regulation [14]. Electronic cigarettes are already banned in some countries (e.g. Brazil). Other countries have attempted to restrict their sale or importation (including USA). Meanwhile these same countries permit the sale of regular cigarettes, in the certainty that those real cigarettes will cause the premature death of about half of long-term users. Is banning the appropriate response to e-cigs while allowing toxic cigarettes to dominate the nicotine market?

E-cigs should be allowed to compete for the middle ground between highly toxic smoked tobacco products, and smoking cessation medicines that have been demonstrated to be safe and effective for that purpose [15]. Thus e-cigs are currently competing for the smoke-free nicotine maintenance market, primarily against other smokeless tobacco products like snuff, snus, and dissolvable tobacco products [2,16,17]. How successful they are in competing in that marketplace will depend on whether manufacturers can mass-produce and market relatively low-cost, safe, reliable and user-friendly products with adequate nicotine delivery. They should be regulated to ensure that they do not deliver toxic chemicals unnecessary to their purpose (e.g. quality control measures should ensure no contaminants are in the liquid or vapor), and are as safe as technically possible (e.g. liquid should be in a child-proof container, and instructions for use should be clear and accurate) [18].

Currently, the e-cig market is awash with numerous, sometimes low quality products, and users need to navigate a personal and on-line learning curve to find a good product [13,18]. Improved quality-control, including assessment of nicotine delivery, will be necessary for smokers to be able to comfortably and confidently switch to e-cigs in large numbers.

Tobacco regulation in the United States appears to be slowly moving towards the “reduced nicotine” model [19]. This model would require cigarette manufacturers to reduce the nicotine content to the point where cigarettes are no longer addictive (current U.S. legislation does not allow nicotine to be completely banned, but does allow any other chemical to be eliminated). E-cigs demonstrate the feasibility for a “reduced toxin” model, allowing nicotine to remain, but requiring manufacturers to eliminate delivery of the other toxic chemicals that harm health [3]. Whichever model prevails, it is unlikely to be successful if it does not provide smokers with an acceptable alternative nicotine product to switch to. E-cigs have the potential to become such a product.

References
1. Shafey O, Eriksen M, Ross H, Mackay J. The Tobacco Atlas. Third ed. Atlanta: American Cancer Society; 2009.
2. Royal College of Physicians. Harm reduction in nicotine addiction: helping people who can't quit. A report by the Tobacco Advisory Group of the Royal College of Physicians. London: RCP, 2007.
3. Foulds J, Ghodse AH. The role of nicotine in tobacco smoking: implications for tobacco control policy. J R Soc Health 1995 Aug;115(4):225-230.
4. Foulds J. Nicotine replacement therapy does work: time to stop sitting on the fence. A reply. Addiction 1994 April 1994;89(4):438-439.
5. United States District Court for the District of Columbia. Smoking Everywhere, Inc., and Sottera, Inc. v. U.S. Food and Drug Administration, et al. 2010 January 14, 2010;09-771.
6. "It sounds like the replacement I need to help me stop smoking": use and acceptability of "e-cigarettes" among UK smokers. 2010; 12th annual meeting of the Society for Research on Nicotine and Tobacco Europe. Bath, UK.
7. Ayers JW, Ribisl KM, Brownstein JS. Tracking the rise in popularity of electronic nicotine delivery systems (electronic cigarettes) using search query surveillance. Am J Prev Med 2011 Apr;40(4):448-453.
8. Bullen C, McRobbie H, Thornley S, Glover M, Lin R, Laugesen M. Effect of an electronic nicotine delivery device (e cigarette) on desire to smoke and withdrawal, user preferences and nicotine delivery: randomised cross-over trial. Tob Control 2010 Apr;19(2):98-103.
9. Vansickel AR, Cobb CO, Weaver MF, Eissenberg TE. A clinical laboratory model for evaluating the acute effects of electronic "cigarettes": nicotine delivery profile and cardiovascular and subjective effects. Cancer Epidemiology, Biomarkers & Prevention 2010 Aug;19(8):1945-1953.
10. Etter JF, Bullen C. Electronic cigarettes: users profile, utilization, satisfaction and perceived efficacy. Addiction 2011 (In press this issue).
11. Clinical Laboratory model for evaluating the effects of electronic "cigarettes". ; February 2011; 17th annual meeting of the Society for Research on Nicotine and Tobacco. Toronto, Canada; 2011.
12. Foulds J, Veldheer S, Berg A. Electronic cigarettes: Views of aficianados and public health/clinical perspectives. Int J Clin Pract (Submitted).
13. McQueen A, Tower S, Sumner W. Interviews With "Vapers": Implications for Future Research With Electronic Cigarettes. Nicotine Tob Res 2011 May 12.
14. Etter JF, Bullen C, Flouris AD, Laugesen M, Eissenberg T. Electronic nicotine delivery systems: a research agenda. Tob Control 2011 May;20(3):243-248.
15. Foulds J, Steinberg MB, Williams JM, Ziedonis DM. Developments in pharmacotherapy for tobacco dependence: past, present and future. Drug Alcohol Rev 2006 Jan;25(1):59-71.
16. Foulds J, Kozlowski L. Snus--what should the public-health response be? Lancet 2007 Jun 16;369(9578):1976-1978.
17. Ramstrom LM, Foulds J. Role of snus in initiation and cessation of tobacco smoking in Sweden. Tob Control 2006 Jun;15(3):210-214.
18. Trtchounian A, Talbot P. Electronic nicotine delivery systems: is there a need for regulation? Tob Control 2011;20:47-52.
19. Hatsukami DK, Perkins KA, Lesage MG, Ashley DL, Henningfield JE, Benowitz NL, et al. Nicotine reduction revisited: science and future directions. Tob Control 2010 Oct;19(5):e1-10.
 

Keithhe

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These types of surveys always worry me. Without knowledge of who commisioned it, you have no way to know how the results "might" be skewed. Universities don't do these for fun, typically, they are funded by someone or some entity. I took it, but I think through each question and the overall questions to try to see who might be the funder. They will never tell us, but could be big tobacco, E-cig related entities, advertisers (although unlikely as questions related to this were not present), some health organization. Who knows??
 

rolygate

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The only way to estimate how a clinical study will be presented is to look at the history of its managers. We would not be amenable to providing ECF facilities for researchers unless we were happy that they had either a history of neutrality or a favourable attitude toward e-cigarettes. In Dr Foulds' case we think he is neutral observer who follows the medical profession's middle ground on ecigs. We cannot know what the outcome will be - either in terms of the study's results, or its media presentation - but are happy to proceed with hope for a fair outcome.

It also needs to be recognised that medical research into electronic cigarettes is in its infancy and no one knows how to proceed at this stage. In contrast with tobacco cigarettes, there are no protocols for consumption or testing; no norms of use that can be referred to; and no established methodologies that can be followed. There is nothing of use in the literature that can be followed to give some sort of guide to how to proceed, since no one has established any sort of equivalency for the nicotine consumption, for the usage protocols, for testing of the vapour, or for aligning results with previous studies. As a result, researchers are feeling their way in the dark at present, and we cannot blame them for a little stumbling.

As examples:
- We don't even know for certain how much nicotine is in the vapour, so that the most basic comparisons cannot be made at this time. This is probably the most glaring omission in our knowledge. On top of that, every method that has ever been used to test for such a basic piece of information has produced widely differing results (such as condensate measurement, cryogenic condensation measurement, and 5kV electrostatic deposition), so that even when someone comes up with a figure, there is no reason to suppose that it will be (a) accurate or (b) widely accepted. Currently the best estimate is that about 50% of the nicotine in the refill liquid makes it into the vapour; and that e-cigarette vapour contains between 10% and 50% of the nicotine in tobacco smoke. These are not facts, they are points of debate, since every test shows different results.

- As a rough estimate we think that an ecig delivers about half the nicotine that smoke from a cigarette does, when used optimally (and it also needs to be kept in mind that usage within research, currently, has hardly proved 'optimal' since no one involved seems to know how to specify, set up, or use an ecig optimally). As a result, we estimate that an ecig 'session' needs to be about double the length of time it takes to consume a cigarette. As a cigarette is consumed in around 5 minutes, with about 10 or 12 puffs, that infers that an ecig will need 20 or 24 puffs over 10 minutes or so. However this assumes that vapers get the same nicotine delivery result, and continue to use their ecig exactly like a tobacco cigarette, that is to say for a session with a finite beginning and end. Neither of these statements will be true for all consumers.

- There are major differences in the way a tobacco cigarette and an e-cigarette are used. For example, tobacco smoke may be inhaled direct to the lungs, but no (well-advised) ecig user would do this as it doesn't work and also has negatives; the inhalation style is completely different (for optimum effect, and to avoid such issues as lung irritation); an ecig must be used for at least twice as long as a cigarette lasts; an ecig can be used on an ad hoc basis whereas this is extremely unlikely with a cigarette (i.e. by taking the occasional puff; or by taking well-spaced puffs on a continual basis); by variation of nicotine strength according to time of day; by variation of flavour according to changing taste throughout the day; and so on, almost ad infinitum. None of this is recorded in the medical literature and there is no knowledge of either the significant differences between ecig and tobacco use, nor the new protocols that need to be established before repeatable results can be achieved by researchers. Each researcher seems to start with a blank sheet: no knowledge of optimum ways to proceed, and no knowledge of the pitfalls that await.

Researchers need to establish some sort of ground rules before significant and repeatable results can be obtained. At present this process is in its infancy, partly because many refused to be guided by the experts in this field (three and four-year ecig users), and because they assume that is is acceptable to test e-cigarette use in the same way as tobacco cigarettes. Nothing illustrates this fact better than the major differences in inhalation technique needed. With an ecig, it is necessary to inhale with the mouth only, very slowly and gently, for a period of double or treble the length of time that a tobacco cigarette is drawn on - or it simply doesn't work. This would probably be news to most medical researchers working on e-cigarette clinical trials, as is clearly evidenced by the results they get: zero measurable nicotine and irritated lungs. Before any real progress can be made, researchers first need to establish protocols or the results will equal the methods used: worthless.

This is why we need to be a little generous with them at this stage, especially if they appear to want to make progress.


On a separate note, there are several points in Dr Foulds' explanation above that I have significant issues with because I believe they are erroneously founded; but this is not the place to argue about the detail.
 
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