Back in 2013, e-cigs faced a huge threat: Medical regulation.
If medical regulation had gone ahead in Europe, vaping as we know it would have been changed for ever.
Tanks would have disappeared off the shelves, e-liquid would only be available on the black market and the only devices you could buy in shops would be out-of-date cigalikes.
Part of the reason the drive to medicalise e-cigs failed was because of the debate that took place in the first E-Cig Summit.
The exchange of opinions and sharing of research marked the start of a shift of public health attitudes - at least in the UK.
One of the most important events in the e-cig industry, this year’s e-cig summit took place yesterday, and we’ve put together some of the key points for interested vapers.As usual, the summit went at a breakneck pace which challenged my note taking skills - all errors are my own, and expect to find key points rather than everything that took place!
Ann McNeill: Welcome from the chair:Professor Anne McNeill kicked off the introduction, which included a recap of the what’s been happening in the E-Cig World. This included the positives - the Royal Society and Public Health England reports - but also the negatives.The negatives included the growing misconception by the public that e-cigs are as, or more, harmful than tobacco cigarettes. This was partly down to the press, and Anne pleaded for more responsible reporting.
Robert West: Population impact of the growth of e-cigarette use on smoking and smoking cessation in EnglandProfessor West highlighted a dramatic fall in the use of stop smoking services but argued this was not due to e-cigs. However, he did highlight a dramatic decline in the use of NRT or prescriptions as people are using e-cigs instead.
Robert estimated that e-cigs had lead to an additional 54,000 short term and 18,000 long term ex-smokers - this, he highlighted, was not everyone who had stopped smoking using e-cigarettes but people over and above those who would have been expected to quit anyway.His data can be viewed on the Smoking In England website here.
Professor Peter Hajek; Unbalanced communication of research on e-cigs - science v. agendaPeter asked us to look at e-cigs from the average smoker's perspective. The typical smoker has tried e-cigs but don't think they are as good as the real thing.
He predicted they will ask:
Is it worth the bother? Is it any better?This lead into a discussion of the point of the research that is being carried out - the point, Hajek argued, is to enable smokers to make more informed decisions.
What we know so far is that it is clear that e-cigs are better than tobacco cigarettes. But the problem is that year by year people are starting to think e-cigs are as or more dangerous. In the US this has increased from 13% to 40% of people.
Because of a serious misinformation campaign.
What's behind this? Both rational and irrational opposition.
Rational opposition, for example, aims to protect the sales of tobacco or medicines.
Irrational opposition, meanwhile, aims to eradicate the use of nicotine use (e.g. the EU or WHO's position.)
There's an overall feeling that anti-vaping equates to being anti-smoking.
Researchers believe it's virtuous to be anti-smoking, journals who are anti-vaping get wider reach, newspapers feel virtuous or are following another agenda.Hajek came up with 5 rules of misinformation:
- Ignore dose, don't compare anything to smoking. e.g. pop corn lung study (ignored fact that diacetyl was hundreds of times lower than that of cigarettes, which themselves had never caused popcorn lung.)
- Present irrelevant animal and in vitro data, for example by sharing the data of cells exposed to nicotine 500 times or more higher than smokers are exposed to.
- Present innocuous body reactions as proof of risk.
- In reviews, use the rules above and add some extra ones. Assert risk even if that contradicts the findings. Where the research clearly shows no risk, claim or invent a conflict of interest.
- Present irrelevant data as alarming gateway evidence.
Professor Etter: Gateway effect and electronic cigarettesProfessor Etter argued that the gateway theory has had enormous political influence since the 1960's. The way the gateway theory is calculated means that vaping will predict smoking even if there is no causal link. This might not
appear to make sense, but gateway theory which includes items such as strength of association, dose responsivity and plausibility. (For those interested, I’ve put the full checklist at the end of this blog post).
So vaping levels could increase and smoking levels decrease, but under the gateway theory e-cigs would still be seen as leading non-smokers into smoking.
As you can imagine, Etter then went on to destroy this theory. In fact he argued that vaping was a reverse gateway, a choice people chose because they look for alternatives to smoking which are cheaper, safer and more socially acceptable. Smoking has continued to fall as vaping has increased.
However, the gateway theory remains popular due to its simplicity.Etter argued for the use of the common liability theory instead of the gateway theory.
Ram Moorthy: Cigarettes and the challenge for doctors: what can practising doctors say to their patients about e-cigarettesRam Moorthy's talk was rather defensive, not surprising as his organisation (the British Medical Association) had recently been one of the few UK organisations to support the Welsh government's plan for an e-cig ban.
So his talk seemed to consist of quite a lot of excuses, which included:
- the BMA waiting for NICE guidance
- it's difficult to make/change policy in the BMA because they rarely meet to decide policy
- there are hundreds of devices, some bought abroad, and they didn't know which are safe
- they were worried e-cigs would make smoking more acceptable
- concerns that e-cigs are marketing their products on a lifestyle basis rather than on the a health/quit smoking basis
Ram, both now and later, was told by a member of the audience (from the Department of Environment, I believe) that his policy was incredibly damaging. Because of the BMA's policy, councils were banning e-cigs in public places and forcing vapers into public smoking shelters - which he called a gateway to smoking.
I'll jump straight to the panel discussion here as there was some criticism of the BMA.
Sara Jakes of the New Nicotine Alliance pointed out in the panel discussion that e-cig companies are not allowed to market on a health/quit smoking basis, as the BMA think they should do, so they don't have much choice but to market on a life-style basis.
Because of the negative press e-cigs get, she added, vaping is increasingly being equated to smoking, only the night before she had been thrown out of a pub for vaping.
Professor West argued that the BMA and their ilk had a massive fear of getting it wrong.
They should take a different approach, stop thinking of what they know/don't know and become good Bayesians i.e. they should ask themselves what their strength of belief is, and then adopt that strength of belief, adapting it each time new evidence comes in.
Ram agreed that e-cigs were less harmful but argued that doctors were worried about being drawn in to support ecigs, especially with the history of doctors supporting the tobacco industry in the past.
Dr Abrams from the audience compared the negative attitude to e-cigarettes to condoms. He said it's like telling your son not to use condoms to avoid HIV because he might get a rash from the latex.Prof. West argued that all people need us to do is NOT to give out rash and misleading information.
Lynne Dawkins: Nicotine delivery and e-cigarette puffing behaviourLynne talked about a small study that looked at self-titration.
If you haven't come across it before, titration refers to the fact that smokers adjust their smoking habit to deliver to themselves a consistent amount of nicotine.
It also means that attempts to deliver less nicotine are harmful. With low nicotine cigarettes smokers inhale more toxic smoke in order to get the roughly the same amount of nicotine.
For example, a 50% decrease in nicotine in one experiment leads to a 40% increase in smoke inhaled but only a 15% decrease in the amount of nicotine absorbed.
As the majority of the harm of smoking comes from the smoke rather than the nicotine, this is obviously not good!
Dawkins wanted to carry out a similar experiment with e-liquid. (I was pleased to see she chose our own Halo e-liquid - she must have good taste :))
Intriguingly, while there was compensatory puffing behaviour in the smokers given the lower nicotine strength, self-titration only proved to be partially effective, with those on the lower strength absorbing substantially less nicotine.
However, there was less difference in the subjective effects, withdrawal symptoms and the urge to vape.
The point is relevant both because many vapers choose to use lower nicotine levels, and because the TPD is outlawing higher strengths. Lower nicotine means more vaping which is both more costly and potentially more harmful as any risk in vaping is likely to come from the vapour rather than the nicotine.Professor Polosa agreed, arguing that vapers had the wrong idea about nicotine. He argued that health consultants need to stop demonising nicotine and start recommending higher strengths in order to decrease the amount of vapour inhaled.
Professor Marcus Munafo: The Spectrum of HarmMarcus Munafo's research has been an attempt to quantify the risk of vaping in the absence of decades of empirical evidence.
As the slides below show, based on scientists estimates vaping should be much safer.
(E-cigs are represented by ENDS (Electronic Nicotine Delivery Devices).)
And toxins in e-cigs are much lower than in cigarettes.
However, that still isn’t the same as empirical effect.
Munafo's answer was to model systems that will look at how it will affect people over decades.
To do so he looked at how genes react when they are exposed to cells.
He found that there was a marked increased in gene expression when they are exposed to cigarette smoke but none when they were exposed to vapour.
He concluded that there is unlikely to be the same amount of harm to cells when they are exposed to vapour. In fact, the expression from the control vehicle was the same as for other genes.
Marcus emphasised that he had only researched one factor of many, and that we need to target other mechanisms, for example by looking at the impact of vapour on DNA.He is currently looking for vapers for more studies if you are interested in volunteering!
Neal Benowitz: Electronic Cigarettes, Nicotine and Policy ImplicationsNeal Benowitz was less enthusiastic about nicotine than the other speakers.
He agreed that nicotine was not the cause of cancer, but argued that it could have a negative impact in other areas, especially in cardiovascular disease and reproductive toxicity.
He was particularly concerned about the use of nicotine by younger people, as it's possible that it could impact the development of the brain. Specifically, for those who want to know, the prefrontal cortex, which deals with decision making, impulse control and executive function.
Unfortunately, it’s difficult to be sure about this impact, as the sort of children who tend to smoke are also those who come from backgrounds which are likely make them disposed to this sort of behaviour.
However, nicotine in ecigs was not the same as nicotine in cigarettes.
Puffing is more spread out than in tobacco cigarettes, more like smokeless tobacco. This means that there are lower peak levels of nicotine.
What’s more, cigarette smoke contains more than just nicotine, and other elements in smoke (MAOI inhibitors) increases the effect of nicotine. So e-cigarettes don’t have the same profile as nicotine from cigarettes and are probably less addictive than tobacco cigarettes.
He also pointed out that there is a lot of zero nicotine use, which is not the same as with tobacco smoking. Very few 12th graders use e-cigarettes regularly, and their use does not look like nicotine addiction. However, safety studies will need to be device specific as there may be differing risks between different sizes.Benowitz is also interested in the “end game” for tobacco cigarettes, which he thought could be achieved by reducing nicotine levels in cigarettes until they no longer satisfied and at the same time promoting the use of alternative nicotine delivery systems.
Konstantinos Farsalinos: Absolute risk from e-vapour products for users and bystandersDespite being one handed in this talk (due to a motor bike accident a few days before), Farsalinos responded to the tight time frame by increasing his usual whirlwind speed, flying through somes slides faster than you could snap them on your phone!
So here follows a few key points I managed to pick up...
Propylene Glycol (PG): Konstantinos pointed out that PG protects against flu and influenza. He pointed out that continuous exposure over 12-18 months for rats and monkeys lead to no known harmful effects, even on the lungs.
PG has only had adverse effects when used in very high concentrates. However, the EU has misinterpreted this research to classify pg as an irritant.
Also see: Is PG dangerous to inhale?
Vegetable Glycerine: VG has very little data we can use to analyse.
Nicotine: Farsalinos argued that nicotine can raise blood pressure, but this is a temporary effect and is not a risk factor for hypertension.
Passive exposure to nicotine is present but only in very low levels, the most that has been found in passive vapers is 25 ug, but you need to absorb at least 260 UG for it to have any effect.
In conclusion, Farsalinos argued that e-cigs carry far lower risk than smoking, but are probably not harmless and therefore should not be recommended for use by non-smokers.Passive exposure, on the other hand, was of no concern. The precautionary principle has been mis-used with e-cigarettes. Public bans will expose vapers to the harmful effects of smoke and and send a message to smokers that e-cigs are of a similar risk to smoking.
Professor Riccardo Polosa: E-Cigs and Harm reversal, evidence for cardiopulmonary health-effectsPolosa believes the the narrative needs to be changed, there needs to be more focus on the positive aspects of vaping rather than demonising it.
While there are still legitimate concerns there are also many positive indicators. For examples, healthy smokers are switching to vaping with no negative health effect. But what happens when unhealthy smokers switch to vaping?
Over time, Polosa has found, that smokers with high blood pressure who switch to vaping see a substantial decrease in their blood pressure, equivalent to that you would expect from taking medicine.
And with asthma "the good story continues".After smokers switch to vaping there is a significant improvement in asthma by the time of the first follow up, including improved function of the lungs and the quality of life. Even better, improvements continue in further follow ups.
Panel Discussion: Should Nicotine Use Be Accepted in SocietyIn the panel discussion, one member (I think it was Polosa) asked us to imagine that hundreds of years ago nicotine had been made into a drink and caffeine into a cigarette - the implication being that we would now be attacking caffeine and not worrying about nicotine.There was some disagreement here - Benowitz argued that nicotine was not the same, while others argued that essentially it was exactly the same as caffeine.
Tim Phillips: E-Cig Intelligence: The E-Cigarette Industry Market OverviewJust a few years ago there were massive expectations for e-cigarettes, including that they would replace cigarettes in ten years. That doesn't leave many years left, said Tim. There hasn't been a huge uptake compared with smoking, especially on a worldwide basis.
Half the global market is in the USA with the rest centred around the EU (and that particularly concentrated in a few countries including the UK, France, Germany and Poland). There's also been a recent slowdown in uptake, and a huge number of countries with very low uptake.
Tim saw three challenges: products need to improve, a lack of trust, and regulation.
However, he remained optimistic for the future. He predicted consolidation is inevitable. There's a 68% untapped market of smokers who have never tried an e-cigarette. The big opportunity is global but there are still huge opportunities in local markets.
Vape shops will continue to exist but the primary distribution marketing would be through mainstream retail channels.Regulation, he believed, will increase consumer confidence and lead to more investment.
Anette Addison: The UK’s Implementation of the European Tobacco Products DirectiveAnnette covered the UK implementation of the TPD, and there wasn’t much that was new.
Annette did cover concerns that the UK has enforced a 2ml cap on e-liquid limits whereas France and Germany has not.
She has clarified the position with the EU, requested something called a non-paper to set out how the commission interprets the legislation, contacted the governments in questions and encouraged trade organisations to complain to the EU about other countries allowing larger tanks as it is unfair on us.
I can see our government being rather unpopular with French and German vapers!
She also covered age verification, and recent test visits had found a lot of failures in checking age, especially in specialist vape shops. She put this down partly to vape shops being less used to complying with the verification.Finally, she pointed out that despite Brexit the EU, the TPD can't change for at least two years.
Rob Morrison: Advertising regulations after TPD implementationRob Morrison from CAP (Committee of Advertising Practice) recently held a consultation on advertising regulations but can't say what the results are yet - analysis is not likely to be completed for another couple of months or so.So there wasn’t much new here! One positive aspect, though, is that CAP are reconsidering their restrictions on e-cig companies making health claims. Fingers crossed!
Beryl Keeley: The Competent Authority for e-cigarette regulation - Progress ReportBeryl gave an overview of the TPD, so nothing new there. She did reassure vendors that she knows about the problems with the submission portal they were communicating with the EU and said they will offering advice to companies.
Unfortunately, due to the EU's abysmal IT system (my words, not hers, obviously) the MHRA are unable to download any data in a meaningful way and are therefore currently unable to publish (or presumably analyse) any of the information.
The MHRA won't be doing a huge amount of checking the data and is instead encouraging companies to focus on safety in use and to add yellow cards to their leaflets so people know how to report adverse events.Medical licensing has continued to be a complete disaster (again, not Bery’s exact words!) with only 1 product approved and even that has not been marketed. (I understand from other sources that by the time the device was finally approved the technology was two years out of date.)
Fraser Cropper; The Independent Industry’s Role in Delivering Vaping’s Full PotentialCropper discussed why our trade organisation is independent and does not allow tobacco companies to join. The difference, he argued, was not an ethical one but because of essential differences in how we work.
Big Tobacco typically distributes its products via b2b to supermarkets and their ilk where purchases are transactional. Vape shops, on the other hand, need to offer choice, the ability to test different products and to build relationships with their customers to distinguish themselves from supermarkets. This is also essential for many vapers who need this support in the first few months of vaping if they are to successfully switch from tobacco to ecigs.
He also attacked the bad name of vaping businesses, citing a personal story in which a teacher asked Cropper’s daughter if her dad was still selling ecigs and killing people.
In fact vaping businesses deserved applause. Many business people in the industry had started as smokers, and after switching to vaping wanted to share it with people. Many put vapers first, and were not purely motivated by money.Of course there are bad businesses, but the good ones can and need to be trusted, can be aligned with smoking cessation and should be applauded for investing throughout 6 years of uncertainty.
Konstantinos: High powered devicesAn interjection later by Konstantinons (I've skipped a lengthy presentation on whether researchers should work with the tobacco industry) arguing that it is a misconception that high powered devices are more harmful.He cited experiments where an increase in watts had lead to a decrease in puff reduction, and that an increase in voltage had not lead to an increase in emissions.
Martin Dockrell: E-Cigarette and Tobacco Harm Reduction: A Public Health PerspectiveMartin Dockrell decried the post truth approach that is applied in public health, arguing:
- we tend to retreat into our tribe and listen to our own echo chamber
- we seek out people and studies who confirm our biases
- any challenge, however reasonable, is dismissed as biased
- we appeal to emotions and treat the facts as secondary
Linda Bauld: Priorities for Vaping Research: Pregnancy, Mental Health and Cancer PatientsLinda Bauld focussed on providing e-cigarettes to groups which have currently been unable to access them.
Pregnant women is one group, and there is both a qualitative study being lead and midwives are being provided with fact sheets showing that e-cigs are much safer than smoking.There is also a pilot study being carried out with cancer patients, and working with mental health patient and prisons to assess the impact of vaping.
Louise Ross: Vaping and inequalities, turning lives aroundLouise Ross was concerned smokers who are heavy smokers and can't afford to go out because the majority of their disposable income is spent on tobacco.
Many don't have access to computers except in library, in fact 1/3rd of her clients do not have access to the internet. This makes info on e-cigs harder to find.
Here’s where stop smoking services can help: by providing information and assistance to disadvantaged groups. She gave the example of a homeless person who had been given an e-cig but had nowhere to charge - they enlisted an e-cig business who provided him with charging stations and low cost vaping supplies.Louise said many disadvantaged smokers were distressed about having to stop smoking, and were astonished to find out they could “keep the pleasure and lose the harm”.
Deborah Arnott: Tobacco Control and Harm ReductionDeborah Arnott has been under some flack recently.
She has been seen as part of the status quo at the WHO which recently refused to let the public and journalists into its discussions on tobacco and e-cigs, and then recommended that e-cigs are either banned or regulated.
Arnott argued that the ban on journalists was due to fears of tobacco industry infiltration.She also pointed that the EU and representatives from the UK argued that the WHO needed to take some time to research ecigs, and shouldn't take a position on ecigs for now and that the result was better than just calling for a ban.
David Abrams: Key Note IntroductionAbrams had a beautiful model on screen which is easier shown than explained!
The essence, though, is that we should be trying to move people through the model to the least harmful alternative possible - so if they're non-smoking we want to keep them non-smoking, but if they smoke we want to move them along the continuum as far as possible - which means to vaping and if possible beyond to non-usage. The problem is that we are not collecting the right data.For example, we are collecting evidence of experimental use by kids and portraying it as regular use which is not helpful. There are many policies and hypotheses that are blurring the big picture, but we need to remember there are one billion lives at stake.
Tom Miller: Protecting consumers from inaccurate informationTom Miller is the attorney general from Iowa.
He pointed out that there are 40 million smokers in the USA, ecigs offer opportunity to save 10-15 million of them, and so he is appalled at what is being said by the public health community and journalists. He gave some examples of how these would violate consumer law if they were businesses:
Law: Can't omit a material fact in customer transactions Infraction: Many kids smoke every day. However, most kids who use e-cigs have only used them in the last 30 days. However, when reported this frequency is left out, leaving to the claim that 16% of youth are regular e-cig users.
Law: Can't convey a net impression that is untrue. Infraction: One advertisement showed a sick dying women who said ecigs were responsible for her health. The truth was she had been paid money to make the claim, which was untrue.
Law: Can't imply something that's untrue Infraction: It’s claimed that e-cigs can cause cancer through formaldehyde (in fact formaldehyde levels from e-cigs are close to that of normal breath except for when coils were burnt out).
Tom had almost invariably found that e-cig claims weren't true. Once you remove combustion from the equation, there is no way that nicotine will deliver the same amount of harm. In fact, denying e-cigs are helpful is equivalent to denying climate change.
The big problem is that there has been a tremendous amount of misinformation. Only 15-20% of people know that e-cigs are a lot less harmful than smoking. The pro-vaping movement should take the high ground, as we are the ones that are being true to the facts.Tom concluded by saying that America needs England. England gave the warnings about smoking in the 60’s, and now England is leading the way on e-cigarettes. Now they need us to come to the USA, give information updates, share experience and help the US save lives.
ConclusionIn the UK at least a consensus is building that e-cigs are safer than smoking, and studies are continuing to build the evidence in favour of vaping.
However, now the imminent threat of further regulation is behind us pro-vaping scientists are cautioning that we still don’t know everything about e-cigs, and it will take time for us to know the exact risk level involved.Finally, thank you to Amanda Strange from Smooth Events and to E-Cigarette Forum for putting on another fantastic summit!
Gateway theory: 9 point checklist
- Strength of the association
- Consistency (across trials, investigators, persons)
- Specificity (can other things cause it?)
- Temporal precedence (do we know if cause precedes effect)
- Dose responsivity
- Plausibility (biological and psychological)
- Coherence (consistent with other lines of evidence)
- Analogy (do similar agents act similarly?)