SCHEER NECK!

Scientific Committee on Health, Environmental and Emerging Risks (SCHEER)

Preliminary Opinion on electronic cigarettes

Yep this is now published; link here; https://ec.europa.eu/health/scientific_committees/consultations/public_consultations/scheer_consultation_10_en

I’ve given it the ‘quick read’ and will comment here. This is not a full response, that will be done using the mandatory template and within the restrictive framework SCHEER allow, this is just a commentary. Keeping my thoughts in one place kind  of thing. I’ll quote the bits and comment, to save your eyesight I will do what the SCHEER did and put my conclusion right up at the start;

SCHEER have produced a report that shows;

1 The TPD is working well to protect the health of consumers.

2 There is no evidence from human studies or epidemiological data that E- Cigs present any harm apart from mild passing irritation.

3 No real world evidence exists for a gateway theory

4 No real world evidence exists that secondhand exposure is a risk to bystanders

Yet SCHEER concludes;

1 The TPD needs strengthening

2 There is moderate to strong evidence for human adverse effects

3 The gateway is real and proven

4 Secondhand exposure is a risk.

This is ‘science’ based on quantity rather than quality. It defaults to assuming harm when no evidence is available and is designed from the assumption that e-cigs are a net harm, ignores the data which does not support this, and weights the scant evidence ( and I use that term loosely) of harm heavily. It also, in the absence of any data, defaults to opinion. No justification given for this.

This report will be a huge influence on the next revision of the TPD and judging by the contents it indicates, inclusion in smoking bans, removal of flavors, and some attempt to regulate the nicotine content of the aerosol as well as the liquid. Expect some limits on battery power.

This is tobacco control, not science, this report is policy support, not science. But we have been here before, this is how bureaucracy works.

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OK Deep-dive from here on.

“The European Commission mandated the SCHEER to assess the most recent scientific and technical information on electronic cigarettes. The aim of this scientific Opinion is to feed into the Commission’s reporting obligations under Article 28 of the Tobacco Products Directive 2014/40/EU (TPD) and also help the Commission in assessing the potential need for legislative amendments under the Directive or other regulatory/enforcement measures.

The Opinion addresses the role of electronic cigarettes, focussing into potential impacts on the EU context, in relation to:

1. their use and adverse health effects (i.e.; short- and long-term effects) risks associated with their technical design and chemical composition (e.g.; number and levels of toxicants) and with the existing EU regulatory framework (e.g. nicotine concentration and limits)

2. their role as a gateway to smoking / the initiation of smoking (particularly focusing on young people)

3. Their role in cessation of traditional tobacco smoking”

That’s the brief with specific reference to the TPD

“While drawing-up the scientific opinion, the committee should take into consideration the most recent and up-to-date scientific evidence and technical developments and, as appropriate, the existing provisions concerning e-cigarettes under the TPD (in particular Article 20(3))”

This report could be described as an impartial and cold document, except for the fact they repeat all the negative bits several times while quickly moving on from positives without further expansion.  

2.1. Terms of Reference

“their use and adverse health effects (i.e.; short- and long-term effects) risks associated with their technical design and chemical composition (e.g.; number and levels of toxicants) and with the existing EU regulatory framework (e.g. nicotine concentration and limits)”

Notice the specific absence of any reference to real-world data on users or population effects. T of R are restricted to abstraction from design and ingredients.

However; ‘The SCHEER considers also human data on health impacts on users of electronic cigarettes from epidemiological studies or clinical trials’. Wondering if they are referencing the quick reporting system (Safety Gate) or data from other sources, i.e. the EVALI thing? Very poor not to include references to the data they base this on. If they are only using the data shown in the expanded discussion later in this doc, the conclusion makes no sense at all, as no evidence has been shown other than ‘possible concerns’.

‘The adverse effects of nicotine on the cardiovascular system appear particularly relevant for the SCHEER conclusions on the use of electronic cigarettes.’

Appear to be relevant if they are based on nicotine use but I suspect they mean data from smoking research in which case, irrelevant.

“The health impacts of electronic cigarette use are still difficult to establish due to the lack of long-term data from epidemiological studies or clinical trials. However, since 2016, the World Health Organization (WHO) has already noted that, while electronic cigarettes might be “less harmful” than conventional cigarettes, electronic cigarettes still “are harmful to health and are not safe”.

 This one is a puzzler, if there’s no data then the WHO reference is nothing more than a guess and should be irrelevant to any report tasked with evaluating the evidence. Are they implying the WHO has evidence that they are keeping hidden?

“According to the literature, the level of evidence regarding the cardiovascular effects of nicotine contained in cigarettes and the related pathophysiological mechanisms is considered from moderate to strong, and it can be assumed that similar mechanisms exist regarding the exposure to nicotine from electronic cigarettes use”.

As I said, assuming here would be a mistake, Was no data on the effect of nicotine outside smoking available? Say NRT or Snus?

“Therefore, further research is needed whether children and adolescents have higher risk than adults when regularly second-hand exposed {to aersol} within their home environments”

No extrapolation from exposure to smoking and adjustment for toxicant reduction here? Hmmm, they don’t seem to want the answer.

“Based on human evidence, there is a moderate and growing evidence for harmful health effects for electronic cigarette users, especially, for cardiovascular disease.”

 Presumably, this is the Glantz reference mentioned in the sources. Pity they don’t mark each ‘claim’ with the reference it’s based on. I suspect this claim depends on a now-retracted paper. https://www.medscape.com/viewarticle/925461

“In the US a decline in past 30-day smoking prevalence between 2014-2017 was reported, which coincides with the time–frame of electronic cigarette proliferation in the US.”

This is the only reference to smoking rates !

It seems to have been ignored as ‘evidence’ because ‘Specific to youth, nicotine addiction and dependence leading to lifelong tobacco use is a major concern when considering electronic cigarette use.” ‘

Concerns trumps empirical data it seems.

Conclusion:

” Overall, the SCHEER is of the opinion that there is strong evidence that electronic cigarettes are a gateway to smoking for young people. In addition, there is strong evidence that nicotine in e-liquids is implicated in the development of addiction”

The evidence they refer to is modeling not empirical data because as they admit there has been a fall in smoking prevalence parallel to the introduction and increased use of e-cigs.

‘It is also interesting to note that a modified version of a popular pod device with a 76% US24 market share is now on the EU market, with technological adjustments. This product type compensates for the lower nicotine levels in the liquid, and the increased aerosolisation results in nicotine delivery per puff approximately equal to the American original using high nicotine levels in the liquid’

This is a reference to Juul, and the modification referred to is a new wick material. Juul seemingly modified the device to comply with EU regulations while maintaining the quality of the US version. This is to be expected, products evolve, but the way it’s worded here makes you think the EU regulations were intended to cripple devices and Juul tried to circumvent this noble goal.. As they don’t give a source for this I will; https://link.springer.com/article/10.1007/s00204-020-02716-3

‘experimentation with electronic cigarettes as a smoking cessation device in the last quit attempt differed substantially across different European Member states, ranging from 5% in Spain to 51.6% in England – highlighting the differences across the EU’.

The wording here implies it’s the people that differ not the regulatory regime they live in.

“This Opinion is restricted to the terms of references given by the European Commission. It covers electronic cigarette products complying with the TPD”

Yet data from the USA and studies on products not available in the EU are included when it suits the narrative.

They really do have a bee in their bonnet about Juul. US reefer madness being imported, despite the exclusion of non EU products from the SCHEER brief.

6.3 European Regulatory Framework

The next section admits all their concerns and worries are covered by the TPD as it stands. Apart from the bits they don’t like about e-cigs; their appeal and success as a consumer product. Let’s face it this is what irks tobacco control the most, e-cigs are attractive to users, unlike NRT and medicinal cessation aids.

“A survey conducted in 2017 and related to ~20,000 e-liquids marketed in the Netherlands, classified 19,266 e-liquids into the 16 main categories of the e-liquid flavour wheel, and among 16,300 e-liquids (85%) for which sufficient information were available, identified 245 unique flavour descriptions (Havermans et al., 2019). The categories containing the highest number of e-liquids were fruit (34%) and tobacco (16%), the latter preferred by dual users (using electronic cigarettes as well as traditional cigarettes)”

The objection seems to be not to flavors but to descriptions or ‘Branding’ as we call it. Not sure what information is gained by the last bit, perhaps that if they restrict flavors to tobacco, e-cigs will be ineffective as smoking cessation. Do they think this is a good thing to aim for?

‘The SCHEER is of the opinion, that mainly chemicals present in the aerosol are responsible for possible health effects for users of electronic cigarettes’

This is terrible English, either something is responsible or it’s not, it can’t be responsible for possibly being something. And also, no shit Sherlock, did they think it was chemicals not in the aerosol that might be responsible?

“The frequency of use of electronic cigarettes is increasingly rising particularly in the USA and Europe,” 

 Presumably, they mean prevalence of use. Though ‘regular and/or current use among adults ranging between 0.9% and 1.8%,’, is a low bar to describe as ‘increasingly rising’ over a 10 year period.

SCHEER then goes on to cite figures for ever-use without providing evidence that this is anything more than experimentation, the figures for prevalence would indicate that this is what it is.

They make no mention of smoking rates or any correlation between smoking and ‘use of e-cigarettes’. Again half a picture, not the full picture.

Having made a big deal of refusing to refer to vaping as vaping but instead as ‘use of e-cigerettes’

“The consumption of an electronic cigarette is often described as “vaping”. The SCHEER does not use this term, as it may imply, that the consumption of electronic cigarettes are a “healthy” alternative to cigarette smoking and consumers may misperceive risks associated with the use of electronic cigarettes. The SCHEER prefers to use the neutral “use (users) of electronic cigarette”.

They now refer to “electronic cigarette smoking behaviour” I guess the rationale for refusing to use vaping (it implied a reduced risk) doesn’t apply to the use of smoking which implies equal risk.

“As explained above, the EU TPD upper limit of 20 mg/ml does not mean that users will be exposed to lower levels of nicotine, as they can puff more intensely and adapt their device settings.”

This was not the purpose of the 20mg limit. The limit was based on the toxicity of nicotine and reducing the risk of possible poisoning by ingestion. Hence the 10 ml restriction on containers. You wonder if they understand the TPD at all.

Secondhand exposure is being judged on exposure, not the toxicity of what the exposure is to. Remember they assumed it was ‘established’ from smoking studies for nicotine.

“To determine if metal nanoparticles (100 nm) were present in aerosol, samples were examined by transmission electron microscopy (TEM) and Energy Dispersive X-Ray Spectroscopy (EDS). Tin, chromium and nickel, silicate beads, and nanoparticles were found in cartomizer aerosol, in some cases probably greater than a conventional cigarette (Williams et al., 2013)”

Is this the study on a now obsolete product no longer available on the market? Oh yes, it is! https://journals.plos.org/plosone/article?id=10.1371/journal.pone.0057987

“these chemicals may confer a characterising flavour to the e-liquid meaning a clearly noticeable smell or taste as for maltol, menthol or vanillin, thus contributing to attractiveness of electronic cigarettes.”

They say this as though it were a bad thing.

Health effects for younger populations seems to be activeness. Also a bad thing in itself according to SCHEER. Oh, and perception of being less harmful.

“6.5.4 Human evidence for health impacts of electronic cigarettes.”

“ The health impacts of electronic cigarette’s use are still difficult to be established due to the lack of long-term data from epidemiological studies or clinical trials. However, since 2016, the World Health Organization (WHO) has already noted that, while electronic cigarettes might be “less harmful” than conventional cigarettes, electronic cigarettes still “are harmful to health and are not safe”. Therefore, WHO suggested to “deter electronic cigarette promotion to non-smokers and young people; prohibit unproven health claims about electronic cigarettes; prevent/Bar/Ban involvement of the tobacco industry in the marketing and promoting of e- cigarettes”.

Again when faced with a lack of data fall back to opinion. I could use the old Dude meme here.

“Palamidas et al. studied short term use of nicotine electronic cigarettes in healthy volunteers, asthmatics and COPD patients.”

No mention of the studies showing health improvements in COPD patients. https://www.ncbi.nlm.nih.gov/pmc/articles/PMC6113943/

Oversight or evidence of ‘cherry picking’ ?

“Table 8 summarizes the major cardiovascular effects of nicotine contained in cigarettes and pathophysiological mechanisms (Benowitz et al., 2016). According to the literature, the level of evidence regarding the underlined mechanisms is considered from moderate to strong. It could be assumed that similar mechanisms exist regarding electronic cigarettes use” 

 “Never ASSUME, because when you ASSUME, you make an ASS of U and ME.”. No reference to nicotine in NRT or snus for comparison.

“Evidence arising from both experimental and observational studies, support that electronic cigarette use may induce pulmonary toxicity, which is anticipated to emerge as a major public health concern” 

 Again ‘may’ and no reference to whether this effect is acute or chronic.

“the carcinogenic potential of electronic cigarettes and the occurrence of head and neck cancers was revealed, albeit with a low level of evidence.”

So enough time to demonstrate a long-term effect, cancer, but not enough time for any conclusion as to anything else. Funny that.

“Few studies have reviewed actual use of electronic cigarettes in pregnant women No health effects were reported.” No mention of the Irish study showing vaping expectant mothers had no adverse outcomes to their pregnancy. Again oversight or ??? https://www.rcsi.com/dublin/news-and-events/news/news-article/2020/02/new-study-investigates-outcomes-of-ecigarette-use-in-pregnancy

“In case of NRT, it was concluded that NRT during pregnancy cannot be considered as a safe alternative to conventional tobacco smoking.”

This is the dumbest thing I have ever read and I hold no torch for NRT.

“Health effects related to second-hand exposure to aerosol from electronic cigarettes  Particularly in relation to cardiovascular and other health effects of passive smoking secondary to electronic cigarettes use, it has been documented that the complete blood  counts of otherwise naïve passive smokers are not affected by such exposures “

Which should be the end of that, but no.

“Although the database on the long-term consequences of second-hand exposure to electronic cigarettes on human health is not reached, it is well established that passive smoking detrimentally impacts cardiovascular health, with recent meta-analyses revealing that such exposure increases CVD risk by 23% (Lv et al., 2015), including ischemic and coronary heart disease risk by 25-30% (He et al., 1999, Dunbar et al., 2013, Law et al., 49 1997).“

 Oh look! A reference to smoking! Intended to flatter vaping? Hell no.

“However, it is noteworthy that to date data on the long-term consequences of passive smoking of electronic cigarettes on human health are lacking.”

‘Are lacking’ here refers to the fact no adverse effects have ever been recorded.

They actually admit living in hope of someone getting sick!!

“Indoor electronic cigarette use can lead to deposition of aerosol components on surfaces. In 6 a recent review Díez-Izquierdo et al (2018) analysed the reported concentration of nicotine, 7 nitrosamines and/or cotinine as components of third-hand smoke (THS) in indoor dust.”

Dear God third hand exposure!! This is getting silly now.

“Safety Gate notification for electronic cigarette and related products from 2012 to 2020 By searching for the key-work ‘electronic cigarette’ on the Rapid Alert System for dangerous non-food products (now called Safety Gate, once known as RAPEX), which is the EU rapid alert system notifying Member states about risks to the health and safety of consumers (excluding pharmaceutical and medical devices), 54 entries were found. They come from 14 different MS, indicating that the potential risk is spread all over Europe. Considering the country of origin of the notified products, excluding a few ’unknown’, almost 50% was from China, 1 form the United States and the rest from EU MS.”

“The products did not comply with the requirements of the Low Voltage Directive and the 6 relevant European standard EN 60335 EN 60960 and EN 62133-2 and their withdrawal from the market was established, in some cases paralleled by a recall of the products from end users”

So the Safety Gate system works and this is actually about illegal products.

Assessment for second-hand exposure

 “Visser et al. (2016 and 2019) evaluated two specific second-hand exposure scenarios. The first scenario concerns a daily car trip of one hour in a small unventilated car of 2 m3 with two electronic cigarette users (puffing frequency 0.5 per minute, 1 hour of use). The exposed person is a child, sitting in the same car. This exposure scenario approximates the highest levels of exposure that may be expected in everyday situations. The second scenario concerns a daily exposure of four hours in an office-sized space (30 m3 ) with one electronic cigarette user (puffing frequency 2 per minute, 4 h of use).

It was concluded (by Visser et al., 2016 and 2019) that: The risk for local effects on the respiratory tract of propylene glycol cannot be excluded for scenario 1 (MoEs 17-18) and is low for scenario 2 (MoE 74-81). There is no risk for systemic effects (MoEs 535-1475).

Glycerol was not detected in exhaled air and therefore the risk for second-hand exposed persons is considered low.·

Local effects from nicotine exposure are not expected (MoEs 170-750. The MoE for systemic cardiovascular effects is 2.1 for scenario 1: adverse systemic effects are expected.

For scenario 2 systemic cardiovascular effects cannot be excluded either (MoE 6).· Aldehydes are not detected in exhaled air allowing the conclusion that there is no risk for adverse effects for second-hand exposed persons.  ·

 For TSNAs MoEs are 521 and 2297 for scenario 1 and 2, respectively.

A carcinogenic risk cannot be excluded for scenario 1 and is uncertain for scenario 2.”

So no evidence for risk but we won’t rule it out based on our sincere hope someone dies so we can ban them.

Conclusions

“In cohort studies, mouth and throat irritation, dissipating over time, was the most frequently reported adverse effect in electronic cigarette users. The overall reported incidence was low.

Resort to WHO statements again, I guess when you have nothing else.

In its report on “Electronic Nicotine Delivery Systems and Electronic Non-Nicotine Delivery Systems (ENDS/ENNDS)” published in August 2016 the WHO (WHO, 2016) stated: “Based mostly on the levels and number of toxicants produced during the typical use of unadulterated ENDS/ENNDS made with pharmaceutical-grade ingredients, it is very likely that ENDS/ENNDS are less toxic than cigarette smoke. However, ENDS/ENNDS are unlikely to be harmless, and long-term use is expected to increase the risk of chronic obstructive pulmonary disease, lung cancer, and possibly cardiovascular disease as well as some other diseases also associated with smoking. The magnitude of these risks is likely to be smaller than from tobacco smoke although there is not enough research to quantify the relative risk of ENDS/ENNDS over combustible products”.

Of course.

On risks for second-hand exposure

“The overall weight of evidence is moderate for risk of local irritative damage to the respiratory tract. The lines of evidence are the following:  This irritation is mainly due to exposure to glycols. Glycols are identified as irritants. The model studies revealed low MoEs for irritative effects from propylene glycol.  MoEs for nicotine do not point at a risk for respiratory irritation. Exposure of bystanders to glycerol or aldehydes is negligible or orders of magnitude lower than for electronic cigarette users.  – The overall weight of evidence for risk of systemic cardiovascular effects in second-hand exposed persons due to exposure to nicotine is weak to moderate. The lines of evidence are the following: Heart rate and blood pressure effects were identified as hazards for nicotine. In the model calculations, the MoEs for cardiovascular effects are low. There exists a complete paucity of human evidence regarding the acute and long-term effects on cardiovascular and other health outcomes in children and adolescents.  – The overall weight of evidence for a carcinogenic risk due to cumulative exposure to TSNAs is weak to moderate. The lines of evidence are the following: Nitrosamines have been identified as genotoxic and carcinogenic. The MoEs calculated for the carcinogenic risk from TSNAs are low. Human evidence is lacking.“

The key bit here is ‘human evidence is lacking’, in other words, there is no evidence from humans, it’s all speculation and modeling and mouse studies. No evidence, but we say there is a risk anyway, albeit it is mostly local transient irritation. I suspect the irritation is ‘seeing someone vaping’.

6.6 Role in the initiation of smoking (particularly focusing on young people) 

This section is quite good, it shows clearly that the main attractions of vaping are; flavors preferable to tobacco, seen as safer than smoking, and as a replacement for smoking. They admit the predominance of youth use is by current smokers. The big failing is not mentioning the smoking rate as a point of reference against e-cig use.

“In the EU, according to the “Special Eurobarometer ” (May 2017), the most frequently mentioned reason (61%) for taking up electronic cigarettes was to stop or reduce tobacco consumption. Other reasons included electronic cigarettes being perceived as less harmful, (31%), and lower cost (25%). Regarding the two most often-mentioned reasons, reducing tobacco consumption and being less harmful, more than three quarters of those aged 40 or over (76-78%) cite one of these as a reason, vs. 59% of those aged 15-24. Regarding product type, especially pod devices have become a more socially acceptable alternative to combustible cigarettes among adolescents and young adults, and have become popular among this age group as a result of (1) sleek designs, (2) user-friendly functions, (3) less aversive smoking experiences, (4) desirable flavours, and (5) the ability to be used discreetly in places where smoking is forbidden“

That’s pretty much the product doing exactly what it was designed to do. Replace smoking.

 It all goes wrong in the conclusion.

“Role as a gateway product or renormalisation of traditional tobacco smoking. One of the four core purposes of this scientific opinion is to assist the Commission in assessing the most recent scientific and technical information on electronic cigarettes with regards to their role as a gateway to smoking and with respect to the initiation of smoking particularly focusing on young people. Within this context there are two hypotheses that need to be tested, the gateway hypothesis (in which the use of electronic cigarettes lead never tobacco users to begin using other tobacco products) (Bunnell et al., 2014; Kandel and Kandel 2014) and the renormalisation hypothesis (in which the public acceptance of electronic cigarette use may lead to a renomalisation of tobacco use. (Fairchild et al., 2014)). Indeed, with adult and adolescent smoking rates decreasing due to tobacco control efforts, there remains concern if the expansion of electronic cigarettes may hinder tobacco control efforts and impact smoking rates as adolescents and young adults who were likely to never use any form of nicotine products start experimenting with electronic cigarettes and other forms of nicotine delivery.”

Once the ridiculous Kendal gateway hypothesis is mentioned this loses all credibility. This is a  theory that cannot be demonstrated in studies, therefore isn’t a scientific theory and in this case, is flatly contradicted by the previously presented evidence. Still, it’s part of their core purposes and they seem to have interpreted that as ‘something they should find to be true.’

“Overall, the SCHEER is of the opinion that there is strong evidence that electronic cigarettes are a gateway to smoking/for young people. There is also strong evidence that nicotine in e-liquids is implicated in the development of addiction and that flavours have a relevant contribution for attractiveness of use of electronic cigarette and initiation.”

So where are all the new smokers? Even SCHEER admits the fall in youth smoking is worth remarking, OK, they only mention it as an aside, but when you’re examining a ‘gateway’ maybe the lack of new smokers is something you should consider in the conclusion?

6.7 Role of electronic cigarettes in the cessation of traditional tobacco smoking and dual-use.

This section is a joke. Mentioning two RCT (Cochran themselves used 15) that show doubling of success using e-cigs over other methods SCHEER conclude

 “ Regarding the role of electronic cigarettes in cessation of traditional tobacco smoking, the SCHEER concludes that there is weak evidence for the support of electronic cigarettes’ effectiveness in helping smokers to quit while the evidence on smoking reduction is assessed as weak to moderate.”

Evidence they base this contrary conclusion on?

“the most recent 2020 Surgeon general’s report on Smoking Cessation (Surgeon General 2020) concluded that “The evidence is inadequate to infer that e cigarettes, in general, increase smoking cessation”. Moreover the report also concluded that “the evidence is suggestive but not sufficient to infer that the use of e-cigarettes containing nicotine is associated with increased smoking cessation compared with the use of e cigarettes not containing nicotine, and the evidence is suggestive but not sufficient to infer that more frequent use of e-cigarettes is associated with increased smoking cessation compared with less frequent use of e-cigarettes.” In addition, the European Heart Network reported that there is not sufficient evidence until now that electronic cigarettes’ use is an effective mean for smoking cessation.”

Again when you have no evidence to support the premise resort to opinion. Also note the wording, ‘is not sufficient evidence until now‘ Basic grammar would say “was not sufficient evidence until now” or “is not sufficient evidence, full stop.” I’m left wondering if that should be ‘was not sufficient evidence until now but now there is’ or…what?

7. MINORITY OPINIONS
None.

Yep, not one member of the esteemed committee thought to ask “Where are the new smokers? Where are the patients suffering from illness due to switching to vaping? Why is smoking prevalence declining in markets where e-cigs are available if e-cigs renormalise smoking?

I guess there are some questions not included in the brief or wanted at the meetings.