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Precisely what risks?

As part of the implementation of the Tobacco Products Directive – 2014/40/EU – and specifically Article 20, the section that relates specifically to e-cigarettes the European Regulatory Science on Tobacco (EUREST – what can I say, the EU does alphabet soup better than the Americans) – the EU wanted a report on the “potential risks” of the product. To be fair, that is a laudable goal considering the use of the product. The problem, of course is the implementation. Not to mention the cost.

The report, edited by Constantine Vardavas and Panagiotis Behrakis (and no, I couldn’t actually pronounce those names), complete with a list of experts (I’ll leave it to you to decide how “expert” they are) – Agaku Israel, Filippidis Filippos, Girvalaki Charis, Gratziou Christina, Lundback Bosse, Maciej Goniewicz, Radu-Loghin Cornel, Tsatsakis Aristidis, Tzatzarakis Manolis (and no, I couldn’t pronounce those names either), and presented to the Directorate-General for Health and Food Safety Health Programme (I’m surprised they didn’t make an acronym out of that) cost EUR €180 450. You can find the grant award here, search the document for Chafea/2014/Health/17.

So what exactly, did this sum of Euro come up with?

Well first up is of course the disclaimer:

The European Commission and/or Chafea do not guarantee the accuracy of the data included in this report, nor do they accept responsibility for any use made by third parties thereof.

Meaning that most of what is to follow is likely to be exaggerated, snide lying or outright lying.

The objective of this report (all 102 pages of it) was to provide the Commission with an overview of potential risks to public health associated with the use of refillable electronic cigarettes and information on technical specifications for refill mechanisms.

Being the cynic that I am, when I read the line “potential risks to public health” my first thought (natch) was the numerous troughers that like to poke their noses into other peoples business, then I suspected that they might actually mean the health of the public. The latter of which withered and died as I read the rest of said report.

Being the efficient bureaucracy that it is, it could never be a simple case of going from point A to point B without first going via some random stop along the way, probably somewhere in the region of Betelgeuse. So no less than four “Work Packages” were designed:

  • Providing an overview of the EU e-cigarette market (with a particular emphasis on refillables)
  • Packages two and three focussed on identifying and assessing risks to public health (there’s that first thought again) associated with the use of refillables (predominantly package 3) and use in general (package 2)
  • Package four was to identify the technical specifications for refill mechanisms, based on the risks “discovered” in packages 2 & 3, stakeholder feedback, standards already in place (European ones natch) and in-house evaluation of purchased samples (more liquid burning then)

The handy executive summary does give a good indication of the general slant of the rest of the report:

Article 20 of the Tobacco Products Directive includes provisions aiming to harmonise the safety and quality specifications for electronic cigarettes (e-cigarettes), requiring amongst other regulatory actions to develop technical standards for the refill mechanism of e-cigarettes and prepare a report to the European Parliament and the Council on the “potential risks to public health associated with the use of refillable e-cigarettes”. The aim of the PRECISE project was, therefore, to provide input for the Commission on their work in these two areas through four interrelated work packages.

Again, laudable goals. Shame that Article 20 won’t do what they expect.

The e-cigarette market in Europe has experienced a continuous expansion since 2008 (I wonder why that is? PB). Its estimated worth in 2014 was approximately 2.16 Billion Euro(hmmm, the penny Euro drops then PB). Four European Member States (UK, Italy, Poland and France) were the largest EU markets , although there have been significant market fluctuations. According to our research in nine EU Member States, the two most popular types of e-cigarettes on the EU market were either rechargeable with disposable cartridges or refillable e-cigarettes. In all EU Member States studied (except for the UK) refillable e-cigarettes were the most prominent on the market (now that does surprise me PB). It was also noted that hundreds of brands and sub brands are available on the EU market, at different nicotine concentrations. (who’da thunk it? PB)

Continuous expansion since 2008, it wouldn’t have anything to do with the social dynamics of people using them either as an alternative to smoking, or because they want to quit smoking now would it? After all, a lot of vapers now wouldn’t necessarily be vaping if they didn’t either know someone else who was vaping, or they didn’t believe that making the switch would help them. Funny how it works isn’t it?

As regards the information provided on industry websites, almost all had a reference to the risk of accidental exposure to e-liquid via the skin and/or eyes and warnings to keep the product out of reach of minors. However, very few websites provided information on quality control and chemical testing. It is also important to note that a little under half of the industry websites had an age verification request. We concluded that continuous monitoring of both market and technological developments is needed due to the fluctuation in the market and as we anticipate that the area of product quality assurance will witness significant development.

Well, they wouldn’t exactly be responsible retailers if they didn’t have information on accidental exposure along with the eminently sensible precautionary note to keep the products out of the reach of minors – surely that’s just plain common sense? The point about quality control and testing is, frankly a moot point considering that most vendors in general would rely on the producer doing that. Not to mention that there isn’t actually a testing standard in place yet.

I would hazard a guess that the vast majority of sites do have age verification in place since in the Member States that have an implementation do indeed require it. Not exactly a deal breaking argument there. Don’t forget this report was released in May this year, though it seems to have been released quietly – or I simply missed it, one of the two.

As regards risks to public health associated with the use of e-cigarettes, and refillable ecigarettes (including refill containers) three different approaches were employed to assess the potential risks, in particular:

  • A systematic review of published peer reviewed literature (this is somewhat of a misnomer as I’ll discuss later on in this post)
  • Incidents and/or adverse events related to e-cigarettes from EU Poison Centres
  • A qualitative and quantitative chemical assessment of the products purchased (won’t somebody think of the mice?)

Think we can see where this will lead can’t we?

Through the triangulation of these three data sources we were able to conclude that ecigarettes may pose a threat to European public health. While further research is needed to determine the magnitude and gravity of each risk identified, this report provides a picture of the current status quo of the evidence. Key points of our report include:

Yep. From their “review”, an investigation into calls to poison centres and their own “assessment”, they conclude that e-cigarettes may pose a threat to public health. So what risks do they actually highlight in this report?

  • Risks of leakage due to design and production flaws – silicon O rings feature prominently in their “solutions”
  • Accidental exposure from refillable e-cigarettes leading to vomiting, dizziness and nausea – especially among children (well isn’t it the responsibility of the parent to keep this out of their reach?)
  • Risks associated with inadequate or misleading information, unwarranted claims on smoking cessation and health benefits (many juice makers were already putting a list of ingredients and other information on the bottles before the TPD came into force. As for the cessation & health benefits, the results – as in a substantial decrease in smoking prevalence – speak for themselves)
  • Risks associated with refillables due to the possibility to modify and/or blend refill liquids (well isn’t that the whole damn point of a refillable device, so you can mix your own? These folks are no fun at all)
  • E-cigarettes produce emissions that contain a number of hazardous substances (Really?)
  • Uncertainty on the long-term public health effects (so this justifies the draconian measures set out in Article 20 then. Good grief)
  • Experimentation by non-smokers (so what?)
  • Gateway risks (look, there’s going to be some that’ll try a combustible, likely not like it and return to vaping. There’s no guarantees that it’ll happen, but it is indeed a possibility, but at what point does that become an untenable risk? 1 in 1000, 10 in 1000, 100 in 1000?)
  • Another potential health risk is the use of e-cigarettes where smoking is not allowed. (as in passive vaping. Thing is, vaping isn’t smoking. Something these folks are clearly unaware of – tacitly conflating the two to make it seem like a bad thing.)

Risks of leakage and accidental exposure? Let me refer you to the excellent comparison between two chemicals posted by Tom Pruen that highlights just how disproportionate the EU are actually being in relation to nicotine containing liquids. As for the “inadequate or misleading information” – we saw, in California, a certain senator highlight some voluntary warnings that were on vendor (mostly tobacco industry) websites about nicotine. These warnings were then used as “proof” that e-liquid is dangerous. No doubt the man would have highlighted just how dangerous the industry was being by not implementing these voluntary warnings.

The “risks” with refillables and the ability to ‘mix your own’ are generally only undertaken by those that want to mix their own. Those that do that are more than aware of any potential ‘risks’, not to mention the cost savings associated with mixing your own over buying pre-made over the counter. Remind you of anything?

They just had to mention the experimentation and “gateway” claims didn’t they? Look, I get it. I really do. These folks in ‘public health’ really don’t like anyone doing anything they don’t approve of so they conjure up “risks”. Experimentation by non-smokers is going to happen, there is no way around that. They’ll either experiment with e-cigs (most likely zero nic too) or if e-cigs weren’t available there’s every possibility (despite the “susceptibility” research) that they’ll try a cigarette. Those in “power” need to understand that folks who want to try stuff, will bloody well try stuff – you don’t need to be a damned rocket scientist to figure that one out!

The final objective was to identify technical specifications for refill mechanisms, based on the aforementioned risks, stakeholder feedback, European standards already in place and the evaluation of purchased samples. Certain design features were identified that may limit the risks associated with the refilling processes and leakage during handling. Such parameters included the adoption of international standards on child resistant and tamper resistant packaging; an appropriate design and flow rate of the refill vial nozzle; use of a removable plastic seal; the existence of a silicon ring at sealing positions; a reduction in the steps needed to perform the refill and the use of warnings/leaflets to increase consumer caution during refilling.

It is important to outline that, to the best of our knowledge, there is no way to a priori eliminate the risks related to the refill process as this is inherent to the function of refillable e-cigarettes. However, design features may limit the risks associated with the refilling processes and may also address requirements that e-cigarettes do not leak and are child and tamper-proof, thereby protecting both users and non-users, especially children.

The thing with refilling your tank is, it’s all about common bloody sense. Spill some juice on your fingers? That’s just fine, once you’ve finished filling just rinse your hands. You’re not likely to suffer any symptoms from a few drops of e-liquid on your skin. Most tank manufacturers include the basic steps, and a general warning on refilling. That’s more than adequate. Anything more is interference. Can you imagine a tank manual that comes in 28 different languages with detailed steps for filling? The damn thing would be bigger than the box the tank comes in!

Systematic Review

This is the part that I wanted to look at more closely.

Within WP2/WP3, the third and most comprehensive task was a systematic review of publications relevant to electronic cigarettes and their potential risks through three separate databases: PubMed (Medline), Scopus and Web of Science. The search strategy was intentionally broad in scope, so as to ensure that all relevant studies were captured. No language, publication year or other limits were imposed. Opinion pieces, reviews, editorials and letters were not included within the review but evaluated for their references.

So issue a search for a variety of terms for the broadest possible dataset. There’s nothing wrong with that. After all, that’s pretty much what Public Health England and the Royal College of Physicians did prior to release their reports.

The systematic review was performed three times during the duration of this report, once in April 2015, once in October 2015 and a third time in January 2016, the results of which are included within the context of this report.

So three major searches of PubMed, Scopus and Web of Science at set intervals. The total number of papers found:

  • PubMed – 1395
  • Scopus – 3222
  • Web of Science – 6288

Almost 11,000 studies, opinion pieces, editorials and reviews. That’s a substantial amount of data to look through. But wait.

3351 duplicate records removed

Oh. That still leaves 7,554 right?

Well no.

ecigsearches

Let’s backtrack for a moment.

The aim of this section was to perform an evaluation of the potential risks attributable to e-cigarettes, and refillable e-cigarettes in particular, as identified through the published peer reviewed literature, within three databases.

Ah. Now it makes sense doesn’t it? They were looking for specific papers on ‘potential risks’ so naturally papers that either ignored or glossed over said risks were excluded.

Two researchers independently assessed the titles and excluded publications that were clearly ineligible. In the following stage, the two researchers independently read the abstracts of the remaining publications and excluded those that did not contain original data or did not fulfil the inclusion criteria.

Thing is, the inclusion criteria is, shall we say, vague?

inclusioncriteria

The inclusion of cell studies, which we know are of limited worth in this debate, is rather telling. Through this, rather loose, inclusion criteria the report only reviews 319 publications. Out of almost 11,000.

Remember they state, quite categorically that Opinion pieces, reviews, editorials and letters were not included?

Other than the fact that US research and Poison Control data is highly prevalent, there’s a paper on shisha-pens – specifically nicotine free ones. Well, this one is a letter, although it is a research letter – the type sent by authors to get work published during a conference. As is this one. Then there’s this one.

You will of course recognise the author of the last one. One Jessica L. Barrington-Trimis. I’ve had cause to write about her before. Twice in fact. Although she has published more than two papers on vaping. The one cited in this instance is neither a research letter, nor an actual study. It is in fact an opinion piece. As clearly indicated in the journal itself.

viewpoint

Yes, they also included the letter to the editor that sparked the whole Formaldehydegate debacle – although that did turn out to be an actual study. The list of publications included is an entirely depressing read on its own. Apparently a news item in the BMJ met the “inclusion criteria” too. Amusingly, everyone’s favourite anti-smoker & anti-vaper zealot, one Stanton Glantz only gets two mentions. One thing I do take away from this report is that US ‘research’, no matter how ridiculous that research is, has far more weight than research conducted by those in the EU. That kind of speaks volumes on its own does it not?

The conclusion of the authors?

While further research is needed, e-cigarettes, as evaluated through the triangulation of a peer review of the international literature, chemical analyses and poison centre cases may pose a threat to European public health. It is noteworthy that the available evidence that was published during the time of writing of the current report more than doubled indicating the interest of both the public and the scientific community.

The amount of data being generated, both negative and positive is a good sign that the research community is actually doing something. If only those actively looking for “potential risks” could lend their talents (snork) to actually improving the products rather than seek to have them banned.

euconclusions

Therein lies enough “evidence” for the EU to apply further draconian measures on a fledgling industry. One that, despite the best efforts from various sources, has driven down smoking rates far faster than any other “intervention” devised by those in tobacco control.

While further research is needed to determine the magnitude and gravity of each risk identified, this report provides a picture of the current status quo of the evidence.

Thing is, with the US hellbent on proving that there are “risks”, there’s always going to be reports such as these. Trouble is, with such a wild west approach to the industry as a whole, the industry isn’t really helping either. Certain activities need to stop, a new culture within the industry needs to happen. It needed to happen years ago. Now it may never happen thanks to reports such as these.

The Commission now has enough “evidence” to make vapers lives a living hell (smokers lives are already a living hell thanks to the various tobacco control ‘interventions’) for the foreseeable future, no matter how ‘liberal’ towards e-cigarettes a government wants to be.

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