E-Cigarette Summit, London – November 12th, 2013 – Summary
The Royal Society gives off an opulent vibe. The walls are decked with images of scientists such as Isaac Newton, golden-framed and hanging ominously overhead. Hell, there’s a picture of Watson and Crick outside the toilet.
Today the Royal Society became the site of the E-Cigarette Summit, a day dedicated to debating the safety, efficacy and regulation of e-cigarettes.
The day was split into three sessions, firstly looking at the safety and efficacy through talks with scientists and researchers such as Dr. Lynne Dawkins and Dr. Konstantinos Farsalinos, then moving on to regulation with talks from public health professors like Prof. Jean Francois Etter and important figures such as Jeremy Mean from the MHRA (Medicines and Healthcare Regulatory Authority – effectively the UK’s FDA) and finally looking at the controversies surrounding the technology with a talk from Professor of Public Health Antoine Flahault and one from Deborah Arnott of ASH UK.
Photo credit: Yahoo News
In attendance were scientists and researchers, politicians, national and international press, as well representatives from the e-cigarette industry, big pharma, tobacco companies such as British American Tobacco and Philip Morris, and a healthy collection of interested vapers. After registering, the group filled two rooms, sipping on cups of tea and coffee surrounded by a smattering of mod-puffing vapers. We’d received an email telling us that vaping was OK, so there wasn’t the usual uncertainty and discomfort you’d feel vaping without prior approval in a building so full of splendor. After a sardine-can experience on the London Underground in the midst of rush-hour, I snuck in a quick cup of tea before the proceedings begun.
Part One – Safety and Efficacy
Most vapers are current, rather than former smokers.
Research suggests e-cigs reduce cravings, but not as much as a tobacco cigarette.
They’re the most widely used quit-smoking method in Britain, and quit rates have increased since they came onto the market.
Nicotine toxicity data is extremely misleading, actual fatal dose for adult may be upwards of 500 – 1000 mg.
There are initial clinical trials, but due to the length of time trials take to arrange, the design will involve outdated e-cigs when it comes to be conducted.
Vapers are mainly young, so long-term data may be a long way away – smoking-related illnesses take a long time to develop.
E-Cigarette Summit was kicked off with an introduction from Professor Ann McNeill, Professor of Tobacco Addiction at the UK Centre for Tobacco and Alcohol Studies at King’s College London. She gave a brief introduction, thanking the E-Cigarette Forum and Smooth Events for setting up the E-Cigarette Summit. The main auditorium was filled with two blocks of chairs, all pointing to the front, where the speakers gave their talks below a large projector. Occasionally, you’d notice a stray stream of vapor emanating from a tube mod or the awesome-looking e-pipe in the mouth of one of the delegates.
Dr. Lynne Dawkins
Dr. Lynne Dawkins was the first speaker at the E-Cig Summit, Senior Lecturer at the University of East London’s School of Psychology and an e-cigarette researcher. The talk featured an introduction to the various generations of e-cigarette and the contents of e-liquid. This portion was well-conducted, and would have undoubtedly been extremely informative to anybody who thought e-cigs were all cig-a-likes. She spoke about their rise in popularity in the UK and gave some information about the characteristics of the average vaper. Research suggests that between two and eight times more current smokers use e-cigs than former smokers, and most also use “second generation” devices (like eGos), 18mg/ml nicotine and tobacco flavors. Generally speaking, e-cigarette users are younger, better educated and earn a larger income than non-users.
Dr. Dawkins then moved onto some of the initial research, showing that e-cigs can reduce cravings but not as effectively as a cigarette, and an interesting finding from a piece of her own research that showed that even 0mg (nicotine free) e-cigs reduce cravings for five minutes, although those who had nicotine experienced a further reduction after twenty minutes. Early research provides evidence that the cig-a-like “first generation” e-cigs were perhaps ineffective for their purpose, explaining the popularity of second gen models. She covered research from Michael Siegel and Riccardo Polosa, before briefly covering the results of the initial randomized controlled trials on e-cigs, one of which was the e-cig vs. patch study and another found a one year abstinence rate of 13 percent (for those on 7.2 mg nicotine liquid). There aren’t yet any clinical trials on non-cig-a-like products, a point returned to later.
Electronic Cigarettes: What are they and are they effective? By Dr. Lynne Dawkins:
The safety and efficacy talks maintained this generally positive vein throughout. Professor Robert West (Professor of Health Psychology and Director of Tobacco Studies at Cancer Research UK) took the floor next, looking at the trends in the use of e-cigarettes from the Smoking Toolkit Study, which is taken from monthly surveys of around 1,800 respondents per month and has covered e-cigs since 2011. E-cigs are now the most widely-used quitting method in the UK; with one in three quit attempts now involving them. Quit rates have actually increased during this period, and Professor West made sure to point out that there is no evidence that e-cigs undermine quit attempts. He also argued that because e-cigs are evolving so quickly and organizing a randomized controlled trial takes so long, research may be continually out of date.
Trends in Electronic Cigarette Use in England. By Professor Robert West:
Next, Dr. Jacques Le Houezec (a public health consultant from France) gave a talk largely concerning nicotine, the chemical which is ultimately causing all of this fuss. The most striking portion of his talk related to the flawed overdose data for nicotine. He spoke about the chain of circular referencing which ultimately leads to some research conducted over 100 years ago which appears spectacularly misleading. Far from 50 to 60 mg being a lethal dose, he shares a report of a woman who consumed 1,500 mg (1.5 g) of nicotine without dying, and over 60 cases in which children swallowed what should be well above the lethal dose for their size. He estimates the lethal dose is at least 20 times higher than is assumed, putting the amount somewhere in the region of 500 mg to 1 g, although this is still a conservative estimate. He also mentioned the reported death from e-liquid consumption in Israel, but notes that no definitive conclusion was provided by the press.
Adding some information about the rats which received monumental doses of nicotine for two years but didn’t get cancer and the fact that nicotine-consumers “self-titrate” to ensure they receive a satisfying dose, the talk left you feeling enlightened about a much-misunderstood chemical. He also covered nitrosamines, pointing out that although snus have much higher quantities of nitrosamines than e-cigarettes, data from Sweden doesn’t show that they’re more likely to get cancer. Finally, he considered the research which indicates that pure nicotine is not as addictive as tobacco, which contains a mess of chemicals thought to contribute to the problem. It’s still addictive, of course, but possibly less so in e-cig or NRT form.
Nicotine Safety in the Context of E-Cigarette Use and Tobacco Dependence. By Dr. Jacques Le Houezec:
Dr. Konstantinos Farsalinos (a researcher at the Onassis Cardiac Surgery Center in Greece) closed the safety talks by talking the big question: do e-cigs pose health risks to users? Talking at a frantic pace you’d more likely associate with a manic caricature of a caffeine junkie, Dr. Farsalinos barreled through a huge collection of slides and presented what can only be described as a thoroughly comprehensive overview of the existing data, both positive and negative. He split the safety studies into two key groups – laboratory studies (including chemical and toxicological research) and clinical research (short term and long term).
He pointed out that the data from clinical studies is indirect evidence of safety, because a food product, for example, is obviously safe to ingest but may present problems when inhaled as a vapor. Non-the-less, these are the most widely-conducted pieces of research, and still provide important information. He spoke about the Goniewicz et. al. study, for example, which found that e-cigs contain between 9 and 450 times smaller quantities of some common toxic compounds compared to a tobacco cigarette. He noted that the researchers used an unrealistic method (two-second puffs every ten seconds) which leads to overheating and thereby creates significant quantities of organic compounds like formaldehyde (the one that was only found in 9 times greater quantities in a cigarette), but still found that e-cigs are generally much, much safer than cigarettes. Other research has shown that the formaldehyde from exhaled breath has about as noticeable an effect on concentrations in enclosed spaces as an e-cigarette. Research from Dr. Farsalinos and Dr. Romagna also shows the minimal quantities of such harmful carbon compounds released into the air if you vape in an enclosed room.
The toxicology studies presented included Dr. Farsalinos’ pieces of research into the effects of e-cig vapor on cultured cells, and as he talked through the studies he pointed out the importance of testing vapor, not liquid. Different components of vapor evaporate at varying temperatures, so for example the PG/VG mix evaporates sooner than cinnamon oils (which were just over the threshold for cytotoxicity in his research), which means that testing on liquids is misleading.
Finally, he looked at some of the limited clinical research currently available. He pointed out that since vapers were generally young, any potential harmful effects from long term use would take even longer to emerge because they’d normally present at an old age. This is one of the biggest problems with long-term data for e-cigarettes. In this portion, he discussed a study which found an increase in airway resistance after e-cig use, and how the results are likely due to mechanical irritation (something unusual is processed by the lungs, thereby causing minor transient irritation). Some researchers tried to repeat the results this year, but only found a significant effect when a cigarette was smoked. Overall, he concluded that based on current data, it’s reasonable to expect a significant health improvement in smokers switching to e-cigarettes, but called for more research using realistic methods to maximize the potential benefits.
Research on Safety of Electronic Cigarettes. By Dr. Konstantinos Farsalinos:
Before a short break, there was a brief but entertaining open questions session, in which Dr. Farsalinos debunked the FDA analysis, Dr. Dawkins gave an early warning about the dangers of over-regulation and Dr. Le Houezec spoke about the potential benefits of nicotine, as well as pointing out that since some kidsdo start smoking, minors using e-cigarettes is a positive thing, if anything.
After lunch, I had a vape with Dr. Farsalinos and spoke to him about the research so far. I asked what he thought about the fact that some flavors (such as cinnamon) appear to be worse than others. He argued that it’s only to be expected that some flavors will be slightly worse than others with such a huge variety available, and that it is still nothing in comparison to cigarettes. He was passionate about the technology, driving home the point that everything with e-cigarettes must be placed into context by comparing it to tobacco cigarettes, especially when researchers conduct studies. Talking about the plasma-nicotine levels after using e-cigarettes, he wondered why companies with such sizeable revenues didn’t conduct studies into the most effective atomizer materials, for example, to generate a cigarette-like spike in nicotine after use.
Part Two – Regulation and Public Health
With an impressively positive morning with the researchers and scientists, it was time to consider the dark cloud of regulation currently looming over the future of e-cigarettes.
UK healthcare excellence organization cannot recommend an unlicensed product.
Misinformation may play a role in discussions – research shows almost half of people in both the US and UK believe that nicotine causes most cancer.
Clive Bates equation for harm reduction: harm reduction = reduced risk × number who switch. The reduced risk is without question with or without regulation and medicines regulation will only reduce the appeal of e-cigs.
Many believe the black market would thrive in the presence of harsh regulation.
MHRA argues that the “spectrum” of medicines regulation would allow e-cigs to continue to thrive.
MHRA believe e-cigs don’t meet safety standards, and have received 12 reports about e-cigs to date (out of 1.3 million UK users), including one of lipoid pneumonia (which is impossible without oils in e-liquid).
When questioned about the cost of medical regulation to small businesses, Jeremy Mean did not provide a sufficiently detailed answer.
When questioned about virtually anything else, Jeremy Mean did not provide a sufficiently detailed answer.
Prof. Jean Francois Etter believes “light touch” regulation does not exist, and argues that neither medicines nor tobacco regulations are appropriate for e-cigs. Says regulators should make room for “recreational nicotine products.”
Liberal Democrat MEP comments to Prof. Etter that they had to think practically about what would be accepted in EU.
Prof. Linda Bauld
Professor Linda Bauld (Professor of Health Policy at the University of Stirling) gave a talk summarizing the current situation in the EU and UK. She opened with the crucial point that more smokers want to cut down than to quit entirely. However, she presented evidence from studies that have suggested that there are limited health benefits from cutting down, with the data being unclear on the topic as a whole.
She then moved on to discuss regulation, starting with an introduction to the National Institute for Health and Care Excellence (cutely abbreviated to NICE) and their guidelines for tobacco control and smoking cessation. They prioritize abstinence in their original guidelines, but also published harm reduction guidance earlier this year. However, because e-cigs are unlicensed they are currently unable to recommend them, but they state that they would otherwise. Professor Bauld commented that they are safer than smoking regardless of the licensing situation.
Along with an introduction to the situation in the EU (medicines regulation of e-cigs has been rejected and the guidelines would only be a minimum for member states – a final decision is due by March 2014), she draws attention to some barriers to implementation. Largely that people are misinformed enough to believe that nicotine causes most cancer, with a startling 44 percent of US respondents and 49 percent of UK respondents answering in the affirmative.
Proposed Changes to How E-Cigarettes are Regulated: UK and EU context. By Professor Linda Bauld:
The extremely likeable Clive Bates (public health commentator at the Counterfactual and once ASH CEO) took the stage afterwards, presenting the room with an equation for harm reduction. He said that harm reduction equals reduced risk multiplied by the number who switch – and used this basic but acceptable proposition to investigate the impact of regulation. For the reduced risk element, he hit the nail on the head. Showing a scale of “harm” with unregulated e-cigs at one end and regulated e-cigs much closer to the “lowest risk” point, the benefits initially appear obvious. However, when it’s placed into context with tobacco cigarettes – courtesy of a larger scale – the reality sinks in. With the talks from researchers generally concluding that e-cigs are around 99 percent safer than cigarettes, the impact of regulation would only be to move down the risk scale by an imperceptibly small amount – from 1 percent of the risk of cigarettes to 0.1 percent. The only thing regulation really accomplishes would be virtually irrelevant.
For the other factor in the equation, he argues that regulation reduces appeal. Through increased cost, reduced variety, an overtly slow “innovation” process (gums and patches have hardly changed since the 70s), dull marketing, a lack of competition, small and medium enterprises crushed under financial pressure and thriving black markets, e-cigs would become unappealing and fewer people would switch. Bates proposes that harsh regulation would benefit big tobacco, and that the best solution is to purpose-build something to account for e-cigs. They aren’t medicines or tobacco, so why treat them the same? An excellent talk overall, with a gem of a quote nestled within, “Being tough on harm reduction is being easy on harm.”
Jeremy Mean (the unfortunately-named group manager for the Access and Information for Medicines and Standards at the MHRA) was up next, and soon became the villain of the day. He was tasked with justifying the UK’s decision to regulate e-cigs as medicines to the assembled, largely pro e-cig group. His pitch was that medicines regulation is flexible and won’t impact unnecessarily on businesses – displaying images of different medicines (like athlete’s foot and antiseptic creams) available over the counter and repeating many of the claims the MHRA originally used to justify their position. E-cigarettes don’t have consistent nicotine levels, they fail to meet (unstated) safety standards and there is limited evidence for their effectiveness.
He claimed that general product safety regulations are not fit for regulating e-cigs, and that they’ve already received several “yellow card” reports (yellow cards are a warning on the soccer pitch), one of which was regarding a case of lipoid pneumonia. This is a literal impossibility, with no lipoids present in e-cigs. He then went to the CDC study (won’t somebody please think of the children!) but thankfully admitted the “gateway” evidence is effectively absent. He said they’re ready to regulate, and have already received around 30 enquiries regarding licensing. Overall, his conclusion was that the “spectrum” of medicines regulation enables the MHRA to support “true innovation,” and moreover, made out as if the UK was going to set an example others in Europe will follow.
Katherine Devlin asked him about the cost analysis she sent to him, which basically shows how the proposed regulation would bankrupt many businesses. His response was simply that he couldn’t provide information about cost because the legislation is evolving, apparently to add provisions for specific flavors.
The Regulation of Nicotine-Containing Products (NCPs). By Jeremy Mean:
Professor Jean Francois Etter (Professor of Public Health at the University of Geneva) spoke about what e-cig regulation should look like, considering the two main options before making his own proposal. He states the aims of regulation – in an idealistic sense – should be to decrease harm and protect freedom, but acknowledges that this will differ by country. He provided an introduction to the situation in the US, and then set about addressing some of the issues with regulation in general.
“Light touch” regulation is a myth, according to Etter, it does not exist. He says lobbying works, and regulation will always favor those who are most proficient in it. As an example, he points to the fact that smokeless tobacco (snus) is banned in many European countries, a decision he calls a failure of public health.
Considering the options, he questions the “tobacco product” approach for obvious reasons. It’s why we started using e-cigs in the first place: no tobacco, drastically reduced harm and no evidence of harm to bystanders. As for the entire “appeal to youths” issue, he says the “gateway” hypothesis is unsupported, and also mentions that since minors can buy patches and gums, it would arguably be better to let them use e-cigs. As for medicines regulation, he points out that in other European countries, medicines are only available in pharmacies, so the UK’s approach won’t work in most places. In addition, there is no therapeutic claim, they would be treated more harshly than tobacco, prices would rise and the huge administrative barriers (citing the MHRA’s 10,000 page application form for licensing) would destroy small businesses.
He echoed Clive Bates’ concerns in many ways, but added some important points. Firstly, he argues that the existing regulations on e-cigs should be enforced properly before more are applied, and suggests that a small tax could be applied to fund research and education regarding e-cigs. He strongly asserts that the main danger to public health is excessive regulation, and thinks they should make room for “recreational nicotine products.”
Liberal Democrat MEP (Member of European Parliament) Rebecca Taylor stood up in the brief question-and-answer session following the talk, commenting that they had to think practically and do something that would be accepted. Etter’s argument was strong, and it was easy to detect a touch of regret in her comment, as if she was justifying her part in the EU decision to the room.
How E-Cigarettes Should be Regulated. By Professor Jean-François ETTER:
The speakers gathered on the open floor after this round of talks, and Jeremy Mean proceeded to have virtually every question thrown his way, to the point where questions which he was obviously in the best position to answer (or more accurately, avoid answering) were put to other panelists out of what must have been pity. Overall, he squirmed and avoided questions with the transparent non-answers of a politician, with well-considered and valid issues being flung at him throughout.
Among the standout comments which received no real response from Mean was Fraser Cropper from Totally Wicked E-Liquid, questioning why the government is looking to intervene when there is no evidence of risk, and asking him to explain his position with that in mind. A Green Smoke representative enquired regarding details of what type of “approved” facility they would need access to, and someone else questioned the future of the industry in the UK, given that with 20 to 30 enquires, only two applications have been submitted. There were still no real answers.
Part Three – Controversy and Opinions
The final portion of the E-Cigarette Summit tied everything together, with opinions re-stated and some more lively panel discussions. Jeremy Mean’s opposition to the majority opinion stimulated some debate amongst the delegates, and the final panels looked set to be interesting ones.
Professor Flahault argues that the precautionary principle favors the use of e-cigs to curb the suffering from tobacco.
Sweden, after embracing snus, has the lowest lung cancer and oral cancer rate in Europe.
Jeremy Mean continued to push the core points of his talk but left criticisms poorly addressed.
Deborah Arnott claims that tobacco companies are driven by profit, like all companies except with a dangerous product, and fears their entry into the e-cig market.
Arnott shows pictures of e-cig advertisements and questions whether they’re trying to make smoking sexy, and repeats claims of potential marketing to children.
ASH favors regulation to ensure product standards, monitor health impact over the long-term and manage the “threat” of e-cigs being a “gateway” to smoking.
Clive Bates says those who oppose e-cigs are “clutching at evidential straws.”
Prof. Antoine Flahault
Professor Antoine Flahault (Professor of Public Health at the Descartes School of Medicine in France) gave the room an introduction to the precautionary principle, and why we need to follow the example set by Sweden. There, 13 percent of men are smokers, and 19 percent use snus. As a result, they have the lowest rate of both oral and lung cancer in Europe. To the “gateway” argument, he points out that according to the World Health Organization Sweden has one of the smallest smoking populations in the world.
The precautionary principle was created for environmental issues, but the key point, “Where there are threats of serious or irreversible damage, lack of full scientific certainty shall not be used as a reason for postponing cost-effective measures to prevent environmental degradation,” is clearly applicable to e-cigs. He argues that the threats of serious or irreversible damage come from tobacco, and that the lack of certainty behind their efficacy should not be used as a reason for postponing recommending e-cigs. He likens it to condoms: there is a small chance that if you’re allergic to latex you could have a bad time, but the reduction in AIDS transmission is well worth it.
E-Cigarettes a Disruptive Public Health Phenomenon: Ethics, risk and the precautionary principle. By Professor Antoine Flahault:
Next up was a 50 minute panel on whether medical regulation of e-cigs will result in better quality and safer products. The panelists (Prof. Rob West, Clive Bates, Deborah Arnott, Prof. Jean Francois Etter, Dr. Jacques Le Houezec and Jeremy Mean) re-stated their positions, with Arnott (of ASH UK) coming down in favor of the idea that regulation will work. It didn’t take long for this to become much like the previous open floor, consisting of numerous questions flung at Jeremy Mean, with him spouting politically-avoidant responses, partially supported by Arnott, and with the remainder of the panel occasionally interjecting to add some common sense and context to the entire debate.
The vapers in attendance were united, and many of the questions focused on what vaping in Britain would look like post regulation. Most people agreed with Clive Bates, who asked “what’s not to like?” and pointed out that the burden of proof is with those alleging that something dangerous is going on here, and with Professors West and Etter when they argued that the black market would thrive, but the same responses repeated over and over from Jeremy Mean didn’t allay any fears. Deborah Arnott quoted statistics claiming that most e-cig users don’t quit smoking, which means they’re ineffective (the only real new argument against e-cigs proposed by the panel) but Bates quickly pointed out that something doesn’t need to work for everybody to be effective.
The stand-out moment came from Dave Dorn (of Vapourtrails.tv), who called attention to the variety of e-cigs by calling on the vapers in attendance to hold up their devices. E-cigs of every shape and size (although primarily mods) were raised aloft, held proud in the air in a strange show of solidarity, with his comment “there should be nothing about us, without us” ringing in the air. He asked that if everything here isn’t effective, what would be left? Mean’s response was that they’ve tried to engage with vapers, offering up the fact that they haven’t banned e-cigs like it’s something we should be happy about. There were more empty claims that there would still be variety, and it’s hard to imagine that anybody believed him.
Overall, it was much like the previous open question session; general unification against Jeremy Mean’s approach, but some uncertainty about best how to proceed.
ASH UK’s Deborah Arnott gave a pretty awful talk on the need for caution when it comes to e-cigs. It was a patchwork collection of stupid arguments pulled right from the headlines of tabloid newspapers, including the “think of the children” rallying call, the “re-normalization” of smoking, pictures of e-cig adverts she accuses of attempting to “make smoking sexy again” and claims about the lack of long-term safety evidence. She says, “the problem with e-cigs is that the damage won’t materialize for several years.”
Much of her presentation was taken up with horrendous quotes from tobacco companies in the era of overt marketing and widespread lies. Tobacco companies did bad things in the past, and some are now buying e-cig companies, and this is justification enough for Arnott to proceed to assume e-cigs are doing all the same things. ASH wants regulation that ensures products meet safety standards, monitoring health impact over the long term, advertising only to smokers and managing of the “gateway” risk.
She received a couple of questions after her talk, and her answers speak volumes. Justifying her claim of potential harm, she didn’t provide any evidence, merely saying there are carcinogens (paying no attention whatsoever to quantity). When asked if medicines regulation would crush small business, she replied that the large companies would prevail in the end anyway.
Harm Reduction, the Profit Motive and Tobacco Industry Tactics. Why caution is necessary. By Deborah Arnott:
The second panel closed the day, and in the absence of Jeremy Mean (who left early) it was a re-statement of positions more than anything else. In the place of Mean and Prof Le Houezec were Prof. Linda Bauld and Lorien Jollye (a vaper and ECCA member). Aside from Deborah Arnott, it seemed like the panel and the majority of those in attendance had reached reasonable conclusions. Medical regulation may kill off the industry and reduce the products’ appeal, and tobacco regulation is excessive given the huge disparity in terms of potential for harm. Clive Bates pointed out that the anti-e-cig arguments are weak, saying that those opposed are “clutching at evidential straws.”
Soon afterwards, a woman from the audience stood up and said she’s never been around so many e-cig users before, and feels like she has a headache as a result. Lorien Jollye rightfully identified this as unrelated, arguing that since our society is so widely anti-smoking, it may elicit negative responses, but they aren’t physical. In other words: get a grip, you’re probably just dehydrated. This absurd episode summarizes the debate in many ways; on one side, you have hysterical, unproven fear, and on the other you have reasonable analysis, evidence and insight.
Anybody leaving that day of enlightening lectures and stimulating debate believing e-cigs to be a danger to public health or anything to be feared would be effectively impossible to convince otherwise. There is no serious debate about their relative safety, nor much of one about the notion that e-cigs are about as safe as NRT products, and in terms of efficacy, Jean Francois Etter summed it up perfectly by saying that the only issue is that they’re “not addictive enough.” As for regulation, the take away message is simple: let them thrive for the sake of public health, and if you must regulate, don’t treat them like something they aren’t.