Thanks Bill.
Briefly, this trial confirms my previous statement that:
If a new ecigarette user, with a new ecigarette, is deliberately isolated from expert advice as to how to specify the correct materials, how to set up the product correctly, and how to use it correctly, then they will get little or no nicotine in the bloodstream as a result of using it.
This is my conclusion from the results of three clinical trials which all agree on this result (Bullen / Laugesen, Siegel, Eissenberg).
Difference from tobacco cigarettes
The most important fact that an experienced user would be aware of is that there is no comparison with a tobacco cigarette whatsoever in either the purchase procedure for e-cigarette hardware or refills [1], the product preparation [2], or the use of the product [3]. The single common factor is that both are placed in the mouth. Apart from that, there are no similarities between a tobacco cigarette and an e-cigarette.
[1] The strongest retail e-liquid available is needed for a new user - 36mg. It is proven (by these three trials) that medium or low-strength liquid does not work. This high-strength liquid needs to be ordered specifically as it will not be included in standard retail packs. In contrast, a cigarette buyer just buys their preferred brand over the counter and it will deliver exactly the result they need.
[2] A new unit needs the zero-nic transport liquid removed, and some high-strength refill liquid dripped onto the atomizer. This sort of procedure is unknown to a cigarette smoker, who simply extracts the product from a pack and lights it up.
[3] Inhalation technique is of a completely different type from that used with a tobacco cigarette. For example an experienced user, given one of these low-power units loaded with medium or low-strength liquid, would inhale lightly, direct to the lungs, for between 6 and 10 seconds. Of course, this cannot be achieved by a first-time user without expert instruction. In addition, a standard e-cigarette must be used for between three and four times as long as a tobacco cigarette in order to acquire sufficient nicotine input (ie around fifteen minutes). In contrast a cigarette smoker automatically inhales strongly, for a brief period of around one second, and the cigarette is finished in about five minutes. Thus there is no similarity in the way the two products are used. An e-cigarette is bought, prepared and used as differently from a tobacco cigarette as a power drill is. There are no similarities at all.
E-cigs don't work
Therefore, three carefully conducted and valid clinical trials have effectively proved that e-cigarettes don't work.
This is an interesting conclusion because:
a) It creates a very strong legal definition. Ecigarettes are proven not to deliver nicotine to the user, or in such insignificant amounts that they cannot constitute in any way a drug delivery system. Both the amounts observed, or lack of them, plus the carefully observed metabolic effects (none), prove this.
b) In order to challenge this result, more trials would need to be conducted that strongly contradicted these results.
c) If e-cigarettes are to be regulated on the basis they actually do something, as against being claimed to do something, then this third trial which again confirms the results of previous trials destroys any possibility that such an attempt at regulation could succeed at law. In effect, e-cigarettes are proven not to do anything, and this could not now be challenged in court (without further trials that produced directly contradictory results).
The fact that we know different is neither here nor there - it certainly has no legal significance.
It should be noted here that the results of Intellicig's recent trial appear to conflict. However, the full trial results have not been published, and they appear unwilling to publish the precise levels of serum nicotine, which may also be insignificant, although one would doubt this as they should at least know how to use an e-cigarette.
Notes on the PDF content
The phrase 'own brand' is initially confusing as it is not explained. It means the subject's preferred cigarette brand.
The trial was conducted in accordance with:
'.....package instructions [that] state that electronic cigarettes should be used similarly to a tobacco cigarette, .....'
Any experienced user would know that any such instruction is incorrect and will lead to sub-optimal results.
Repeated here:
'Consistent with product instructions, participants were instructed to puff from the electronic cigarette devices as they would a normal cigarette.....'
As stated, this instruction is incorrect.
'...unlike puffing from a tobacco cigarette, two 10-puff bouts with the two electronic cigarettes described here expose users to no measurable nicotine or CO...'
So, e-cigarettes don't work. In addition they don't poison the user with carbon monoxide, which is useful to know.
And repeated:
' Despite the failure to deliver nicotine, .....'
And again:
'In spite of delivering no measurable nicotine, .....'
So we can be quite sure that electronic cigarettes don't work.
With regard to CO intake:
'Importantly, neither of the electronic cigarettes tested in this study was associated with any measurable CO exposure. Long-term CO exposure has been linked to cardio vascular disease caused by tobacco cigarette smoking.....'
Apparently, they are unlikely to cause heart disease either - again, useful to know.
An interesting statement:
' Clinical laboratory methods have an important role to play in this empirical examination, ...... These methods will likely be extremely important to any future regulation of electronic cigarettes either as tobacco products or drug delivery devices in the United States (i.e., by the Food and Drug Administration) and elsewhere.'
Although it's not possible to know exactly what the author had in mind, one reading of this statement is: "If e-cigarettes are to be regulated on their efficacy or otherwise as drug delivery devices, then as such they are proven not to deliver". This statement therefore appears sympathetic to us.
On the topic of using beginners instead of experienced users:
'...and inclusion of electronic cigarette-naïve participants who may be representative of cigarette smokers sampling an electronic cigarette for the first time, but not of a more experienced electronic cigarette user population.'
The author admits that beginners may not be the best subjects, experienced users might produce a different result.
He notes that the results of other trials concur:
'It is noted that the nicotine delivery results are similar to another clinical trial (the Bullen/Laugesen Ruyan trial).'
And sums up by stating:
'In sum, this study revealed that two electronic cigarette brands do not expose electronic cigarette-naïve users to nicotine or carbon monoxide under the acute testing procedures described here, .....'
Conclusion
So there we have it: ecigs don't work - and if they are to be regulated on the basis that they deliver a drug or have some form of effect on the human body, we now have three trials that say there is no such delivery and no such effect.
This creates a firm legal position that would be impossible to challenge without further, conflicting trials. If such trials were conducted by or funded by an organisation with a vested interest in producing conflicting results (such as the FDA), such results would not have the necessary stature to provide any proof.
And my viewpoint...
As an ecigarette user, I know these trials are, shall we say, 'flawed', but am very pleased indeed by the results.
We all know that an experienced user, by correct specification / preparation / user technique, can derive so much nicotine that O/D is possible*. But that doesn't matter: legally, e-cigarettes are now proven not to work and that's a great result
* This statement is simply an opinion; compared to the identical results of three independent trials it has no importance whatsoever.
You should remember that we are venturing into lala land when we enter the world of government regulation and legal dispute. Truth, fact, morals, ethics, human life or any other considerations important to the individual or even the population at large have no significance here. We now have incontrovertible proof that ecigarettes don't work and we should be very glad of it indeed.
