With all due respect Mr Drakeford….

Dear Mr Drakeford,

We would like to thank you for taking the time to attend and listen to the debate on Welsh Government proposals for a ban on the use of e-cigarettes in enclosed public spaces, substantially enclosed public places, and places of work in Wales. In your response to the debate you raised a number of issues that cause us concern.

You stated e-cigarettes were renormalising smoking and undermining the ban on smoking in public places.

On both points you were unable to provide any evidence that e-cigarettes were either renormalising smoking or undermining the ban on smoking in public places. However, Professor Robert West, Professor of health psychology and director of tobacco studies at University College London’s department of epidemiology and public health, following his latest research concluded:“Despite claims that electronic cigarettes risk re-normalising smoking, we found no evidence to support this.”[1]

You stated e-cigarettes act as a gateway to smoking tobacco cigarettes and that this was a particular problem for children who are using e-cigarettes in growing numbers. You stated that many of these children were not currently or previous smokers of tobacco cigarettes and were attracted by flavoured e-liquid.

To justify this claim you cited a study produced by John Moores University entitled ‘Young People’s Perceptions and Experiences of Electronic Cigarettes’. You gave the impression that this report stated that as a direct result of targeted advertising by e-cigarette manufacturers, large numbers of children, who had not previously smoked tobacco cigarettes, were now using e-cigarettes and then going on to smoke tobacco cigarettes. What the report actually states is that ‘Overall seven out of eight young people had never accessed e-cigarettes’. The report goes on to say, ‘Despite widespread advertising of e-cigarette brands in print, visual and social media, the majority of participants reported that they had not seen any advertising for e-cigarettes and showed a lack of awareness of advertising and marketing strategies and approaches’.

What we do know from recent research produced by ASH is that e-cigarettes are not a gateway to smoking. Deborah Arnott, Chief Executive of ASH, said: “There is no evidence from our research that e-cigarettes are acting as a gateway into smoking.”[2] Furthermore, this same survey demonstrated that children are not using e-cigarettes. The survey found that regular use of e-cigarettes amongst children and young people is rare and is confined almost entirely to those who currently or have previously smoked[3]. Research by ASH[4] found that 96 per cent of 14 year olds had never used an e-cigarette, 90 per cent of 15 year olds had never used an e-cigarette, 90 per cent of 16 year olds had never used an e-cigarette, and 91 per cent of 17 year olds had never used an e-cigarette.

Research undertaken by Queen Mary University in London[5] found that a child trying a tobacco cigarette for the first time is 50 per cent likely to become a regular smoker. The same research found no evidence that a child trying an e-cigarette for the first time goes on to become a regular vaper.

Evidence produced by a variety of organisations including ASH and the American Cancer Society (ACS) clearly shows that flavours do not entice non-smokers to use e-cigarettes either. Researchers from the ACS[6] found that flavours did not increase the attractiveness of e-cigarettes to teenagers. Rather, “Even after controlling for other statistically significant correlates, the odds of a smoker being willing to try an e-cigarette were 10 times those of a non-smoker.” Tobacco cigarettes are the gateway to tobacco smoking, not e-cigarettes.

Finally, there is no evidence to support your claim that e-cigarettes are used in significant numbers by people who have never smoked. ASH concluded that, ‘E-cigarettes are used by both smokers and ex-smokers, but there is little evidence of use by those who have never smoked or by children.’[7] In fact, recent research showed that just 0.1 per cent of e-cigarette users had never smoked tobacco cigarettes previously[8].

You stated that nicotine is addictive and highly dangerous.

Yes nicotine is addictive but that does not mean it is dangerous. Caffeine is addictive, is that dangerous? The nicotine contained in e-cigarettes is the same pharmaceutical grade nicotine used in NRT products (some of which are inhaled). As Professor Robert West said: “E-cigarettes are about as safe as you can get. We know about the health risks of nicotine. Nicotine is not what kills you when you smoke tobacco. E-cigarettes are probably about as safe as drinking coffee.”[9]

Professor Peter Hajek, Director of the Tobacco Dependence Research Unit at Queen Mary University of London, said: “E-cigarettes are orders of magnitudes safer than cigarettes because they do not release smoke which contains toxins which are responsible for heart disease, lung disease, and cancer.”[10] The NHS has also concluded that e-cigarettes are 1,000 times safer than tobacco cigarettes[11]. You should also note that many vapers use an e-cigarette that does not contain any nicotine.

You stated e-cigarettes are no more effective than nicotine patches in helping people quit smoking.

Many vapers have tried numerous times to quit smoking using conventional nicotine replacement therapies, which have a 90 per cent failure rate, and have failed, however with e-cigarettes they have all cut down their smoking or stopped completely. Professor Robert West said: “We found that those using the e-cigarette were about 60 per cent more likely still not to be smoking than those using the licensed product or nothing at all.”[12] E-cigarettes are however not some form of more effective nicotine replacement therapy, they are totally different and need to be regulated accordingly.

A key reason for calling for a ban on the use of e-cigarettes in public places would be if there was a problem with passive vaping. We note that you did not raise this issue in your response. Could this be because there is no evidence that passive vaping is a problem? In fact a major scientific study undertaken by Dr Konstantinos Farsalinos and Professor Riccardo Polosa concluded that the “effects of e-cigarette use on by standers are minimal compared with conventional cigarettes.”[13]

You also failed to raise the issue of what support your proposal has amongst the public at large. A recent poll by the BBC[14] found that 75 per cent of the public would be happy if their friends or family switched from smoking tobacco cigarettes to using e-cigarettes, and 62 per cent of the public said that e-cigarettes should not be banned in public.

On the specific case of banning the use of e-cigarettes in the work place, you may like to know that a number of pubs that had previously introduced a ban have now gone on to reverse the ban as new evidence has emerged. You may also be interested to know that Cambridgeshire Police, following a review of “health fears”, will allow their officers to vape at work[15]. We are confident that as the evidence continues to mount, a growing number of businesses and organisations will reverse their current bans. Far from leading on this issue, it would seem that this Welsh Government proposal would actually be a backwards step if it were implemented.

Smoking tobacco cigarettes kills over 5,000 people in Wales every year. We know that nicotine replacement therapies with their 90 per cent failure rate do not work. We also know that e-cigarettes are a safer alternative to tobacco cigarettes and that they enjoy widespread popularity amongst the public at large. You must see that it is clearly better for some to use an e-cigarette rather than a tobacco cigarette. As Professor John Briton from the Royal College of Physicians said: “If all the smokers in Britain stopped smoking cigarettes and started using e-cigarettes we would save five million deaths in people who are alive today. It’s a massive potential public health prize.”[16]

The rise of e-cigarette sales is directly contributing to a decline in tobacco cigarettes sales. In the words of Professor Robert West: “What is the problem that requires further regulation?”[17] What public health gain does the Welsh Government hope to achieve by banning the use of e-cigarettes in public? You failed to answer this question in your response.

With a ban on the advertising and promotion of e-cigarettes soon to be introduced, following the passing of the Tobacco Products Directive, where are smokers to find out about e-cigarettes, particularly if they are banned in public places? Smokers need to see people using e-cigarettes in public, they need to be able to go up and speak to e-cigarette users so that they can find out further information and then hopefully make the switch to a safer alternative.

Quitting smoking or cutting down on smoking is one of the most difficult things an individual can do. If the Welsh Government succeeded in having e-cigarettes banned in public places they will be forcing vapers to vape alongside smokers. We are in contact with vapers on a daily basis and many have said such a ban will simply force them back to smoking, is this really what you want? Surely you would rather people used e-cigarettes rather than tobacco cigarettes? Professor Antoine Flahault, Dean of EHESP School of Public Health (Ecole des Hautes Etudes en Santé Publique), concluded: “It is better to have an addiction to a behavior that is not harmful than to have an addiction to a behavior that kills you.”[18]

Yes e-cigarettes are relatively new, but new research, including long term studies, is being produced on a regular basis. Much of the recent research has rendered the arguments behind the Tobacco Products Directive redundant and out of date, and caused some policy makers to call for a rethink.

In its approach the Welsh Government are going against the precautionary principle as it was originally intended, you are trying to mitigate for a risk that has yet to be proven and in doing so may do more harm than good. As Professor Robert West said: “We have such a massive opportunity here. It would be a shame if we let it slip away by being overly cautious.” Professor Gerry Stimson, London School of Hygiene and Tropical Medicine and the National Institute for Health and Clinical Excellence, concluded: “It would be an appalling paradox if regulators, in the name of safety, ended up tipping the balance back in favour of cigarettes.”[19]

In your comments yesterday you were unable to provide one single piece of evidence for any public health gain arising from the Welsh Government’s proposals. We know from the evidence we have laid out in this letter, the experts we have consulted, and the vapers that we are in daily contact with, that should you succeed in implementing this ban that fewer people will make the switch from tobacco cigarettes to e-cigarettes. We therefore hope that following the consultation you will conclude that for the good of harm reduction there is no need to implement a ban on the use of e-cigarettes in enclosed public spaces, substantially enclosed public places, and places of work in Wales.

Yours sincerely

Save e cigs.

CC

All members of the Welsh Assembly

All Welsh members of the House of Commons

 

[1] http://metro.co.uk/2014/04/27/e-cigs-cleared-of-being-route-into-smoking-4710734/

[2] http://metro.co.uk/2014/04/27/e-cigs-cleared-of-being-route-into-smoking-4710734/

[3] http://www.ash.org.uk/files/documents/ASH_891.pdf

[4] http://www.ash.org.uk/files/documents/ASH_891.pdf

[5] Research undertaken by Professor Peter Hajek, Director of the Tobacco Dependence Research Unit at Queen Mary University of London

[6] http://www.jahonline.org/article/S1054-139X(12)00409-0/fulltext

[7] http://ash.org.uk/files/documents/ASH_715.pdf

[8] http://www.theguardian.com/society/2014/apr/28/e-cigarette-users-triple-ash-survey

[9] The Guardian Newspaper, 05 June 2013

[10] http://www.bbc.co.uk/news/health-27161965

[11] http://www.spectator.co.uk/features/9197731/vape-alarm/

[12] Study carried out on 5,000 smokers, by Professor Robert West looking at the success rate of different methods to stop smoking: nicotine gum, nicotine patches, nothing, or e-cigarettes. Reported on BBC Breakfast 28 April 2014

[13] Safety evaluation and risk assessment of electronic cigarettes as tobacco cigarette substitutes: a systematic review:

Konstantinos E. Farsalinos and Riccardo Polosa

published online 13 February 2014 Therapeutic Advances in Drug Safety

[14] http://www.bbc.co.uk/news/health-24909648

[15] http://www.cambridge-news.co.uk/Cambridge/Police-in-Cambridgeshire-can-smoke-e-cigarettes-after-health-review-but-they-are-banned-on-our-trains-20130821131920.htm

[16] The Independent Newspaper, 29 March 2013

[17] Professor Robert West speaking at the E-cigarette Summit, The Royal Society, London on the 12th of November 2013.

[18] http://www.youtube.com/watch?v=wTHGsTPklY4&list=UUAy2QbmqgmTUJ–CoK5J3xA

[19] Open letter to ENVI Committee members form Professor Gerry Stimson 22 April 2013

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3,000mg of nicotine allowed for tobacco products, yet only 200mg for e-cigs? Has tobacco labelling confused MEPs?

When e-cigs first came onto the market in 2008, vendors told customers that one pre-filled e-cig cartridge equalled 20 tobacco cigarettes.

This myth was soon exposed and done away with.

Today, responsible vendors will do their best to give customers an indication of equivalency, but this has never been an exact science as people vape and absorb nicotine at different rates.  We also have to be aware that when we take the stated mg of nicotine from a tobacco cigarette and compare it to the stated mgs in e liquid, we are actually comparing apples to oranges.  Why?

Tobacco cigarettes – the nicotine content stated on a packet of cigarettes is produced on a scale of nicotine being delivered in the body.  This is known as yield.

The yield means that if you smoke a cigarette that has stated 1mg nicotine content, your body will pretty much receive that 1mg of nicotine. This figure though bears no resemblance to the amount of nicotine in dry weight that is in the actual cigarette.  Put simply, manufacturers account for two factors in being able to state significantly lower ‘yield’ figures than the true contained nicotine content: an agreed average percentage of the maximum amount of smoke that can be produced by a fully burned cigarette which is inhaled, and the percentage of this inhaled nicotine that is actually absorbed by the body.

If you took a King Size cigarette for example, and worked out the dry weight nicotine content of said King Size cigarette, the dry weight nicotine of the complete packet of 20 King Size cigarettes, and then the dry weight nicotine content of 200 King Size cigarettes, what would you find?

The weight of the tobacco in the cigarette is in the region of a gram, and with the dry weight of nicotine being at 0.6 – 3.0 per cent of tobacco, each cigarette in the packet would contain between 6 and 30 mg of nicotine.  After some modest research and with a median of 1.5 per cent dry weight of nicotine in cigarette tobacco, an average cigarette will contain 15 mg of nicotine, with a packet of 20 containing 300 mg of nicotine.  As cigarettes are routinely sold in cartons of 10 packets, the sale of 3,000 mg of nicotine in a single carton is allowed.

Again, the nicotine stated on the side of a packet of cigarettes only refers to the amount of nicotine that will be delivered to the median user’s body – the yield, but the actual dry weight nicotine content will be far higher, in this example 15 mg per King Size cigarette.

Electronic cigarettes – 20 mg/ml of e liquid will tell you how much nicotine is in the liquid (much like the dry weight of nicotine in tobacco cigarettes), but it will not tell you how much nicotine is delivered to an individual’s system – the yield.

Looking at the nicotine absorption rates for smoking compared with vaping: smoking tobacco cigarettes is the fastest and most efficient way for an individual to get nicotine into their system.  With vaping however, it takes longer, and, like smoking, you are not absorbing all the nicotine you inhale, as is shown in the chart below taken from Matt Gluggles blog.

nicotine delivery rates

nicotine delivery rates

The tmax above states the time taken for the nicotine to enter the blood stream, the Cmax is the concentration of nicotine delivered to an individual’s blood stream.  Comparing that Cmax of a cigarette to that of an e-cig (ENDD) you see that the individual is absorbing 10 times less nicotine from vaping than smoking.

With the 16 mg ENDD you can see that from the 16 mg/ml nicotine content, (equivalent to the dry weight) only 1.3 ng/ml of nicotine concentration in the blood is produced, about 10 per cent of the nicotine concentration produced by a tobacco cigarette.

There is no easy way of directly comparing nicotine content of e-liquid with the yield of tobacco cigarettes, but during the above research it’s clear that a 16 mg/ml e-liquid gave the users just one tenth of the peak nicotine concentration provided by a “1.0 mg” tobacco cigarette.  Perhaps it would therefore be fairer to label 16 mg/ml e-liquid as “0.1 mg cigarette equivalent”.

This raises an interesting question…

The revised TPD will continue to allow tobacco cigarettes to be sold in cartons containing 3,000 mg of dry weight of nicotine, with a yield of 200 mg of nicotine, yet the highest nicotine content proposed in the TPD for e-cigs is 20 mg/ml, in a bottle no larger than 10 mls, meaning 200 mg nicotine content at its highest.  That is 3,000 mg versus 200 mg for a product that is several orders of magnitude less harmful.

We have to ask where is the level playing field, where is the rationality?

The more we look at the TPD, the more evident it is that it is about protecting the tobacco and pharmaceutical industries and nothing to do with public health.  How else can this 3,000 mg of nicotine limit versus 200 mg be justified?

Finally, what about the policy makers in all of this?  Whilst they have focussed all their attentions on the size and colour of a tobacco cigarette packet, they have paid no real attention to the labelling on the packet and what it means.  We suspect that this is because they have no real understanding of nicotine and how it is absorbed into the system.  That they did not have the courage to recognise this and seek expert advice is a shocking dereliction of duty and yet another example of the truly appalling way our elected representatives and their officials have gone about revising the TPD.

Although not relevant in this document, it is worth considering a smoking survey completed in 2001 that concludes the nicotine yield displayed on cigarette packs are misleading.

http://www.ncbi.nlm.nih.gov/pubmed/11208883

The survey concludes: “Current approaches to characterising tar and nicotine yields of cigarettes provide a simplistic guide to smokers’ exposure that is misleading to consumers and regulators alike and should be abandoned”

 

 

 

 

 

 

 

 

 

Lets face the truth, decisions in the area of tobacco products are always and exclusively made for financial and not health reasons.

dr-riccardo-polosa-italie+

Guest post by Dr Riccardo Polosa.

I was positively surprised when Members of European Parliament voted  against the pharmaceutical regulation of e-cigs proposed by the European Commission, during the first reading of Tobacco Products Directive (TPD), on 8th October 2013. It seemed as if they finally figured out the risks of over-regulating a product designed to reduce the health damage caused by tobacco smoking. Or so I thought.

 

Hurriedly, behind closed doors, and with restricted consultation, the EU legislators managed to introduced substantial modifications in the revised TPD, producing a profoundly mutated document that takes a completely different approach for e-cigs. The newly approved document is riddled with many arbitrary and disproportionate measures. And it could have been much worse thanks to the determination of a handful of brave MEPs who have fought hard to limit the damage.

 

In essence, this new document makes e-cigs much less attractive for those tobacco smokers contemplating to switch to a much reduced risk product. In particular, introduces the arbitrary limit of 20 mg/ml on the max strength of nicotine allowed in e-liquids, advertising bans as stringent as those currently in place for conventional cigarettes, plus several (yet, poorly defined) lab testing, reporting and compliance requirements.

 

Unfortunately, no consideration was given to setting up useful agreed purity standards for e-liquids or operating standards for devices. A simple regulatory framework that ensures consumer protection and product quality and that may work for these products already exists.

For example, e-liquids may be marketed as dietary supplements or cosmetics, whereas marketing and safety of e-cigarettes’ electronics, batteries, and spare parts are already regulated by the existing directives about electronic products design.

 

The minor or implausible health concerns that have constituted the main obsessive focus of EU legislators in the e-cig debate may sound like stupid excuses, when in fact they are not stupid at all. To tell the truth, they are clever excuses. So clever that they succeeded in their purpose of dictating rules in line with the precautionary principle. Hence, the fact that the new document makes e-cigs much less appealing for new smokers is deliberate…

 

Lets face the truth, decisions in the area of tobacco products are always and exclusively made for financial and not health  reasons. After weeks and weeks of fierce debate with the EU “legislators” I came to the conclusion that this has very little to do with a medical issue or science, it is a political and financial one. I briefly addressed this point in the concluding paragraph of my opinion letter

in the Lancet:

http://www.thelancet.com/journals/lanres/article/PIIS2213-2600(13)70175-9/fu

lltext

 

Similar conclusion can be drawn from the current situation in Italy.

From 1st January 2014 e-cigs will be regulated as tobacco products. Measures will include: excise taxes, lengthy bureaucratic process to obtain marketing permission from the national tobacco authority, vaping bans in public places, and advertising bans. No scientific debate was allowed, no input from vapers and their families was taken into consideration, the political agenda being “destroy e-cigs as soon as possible”. These draconian measures are already driving the prosperous and active national e-cig industry outside Italian borders, thousands of vape shops are closing, and current vapers will either have to turn into black market to stay off tobacco smoking or return to their own tobacco brand. Italy is well known for its lengthy legislative processes. For the e-cigs this was completed in less than 6 months ! A word to the wise is enough….

 

Clearly, the rapidly expanding popularity of e-cigs represents a threat to the interests of many, including national governments – because of the fat revenues generated by tobacco excise taxes. Only if these obstacles can be overcome, a truly sensible and rational regulation of e-cigs will be agreed upon, and millions of lives saved.

 

 

Musings from a vaping Scottish MSP

 

Guest post from Mike Mackenzie, MSP.

I like smokers. They are honest. They aren’t hypocritical. They aren’t afraid to admit they have faults. They don’t pretend to be perfect. Having at least this one very public fault, they are often understanding and tolerant of the faults of others.

I used to be one. Not a part time smoker, not an occasional smoker, but a hard bitten, life long, full blown smoker. I smoked roll ups. I didn’t use filters. I smoked an ounce of tobacco every day for over thirty years. I enjoyed every lungful.

Tobacco was my best friend. It was with me in the best of times and the worst of times. I never had a cup of coffee without a cigarette. I never had a glass of whisky without one. In triumph or disaster a cigarette was called for or came to the rescue, reassuring and consoling. Every problem had a solution when a cigarette was at hand.

Smokers often have this reflective quality. They don’t panic or lose the plot in the face of problems. They light up. They inhale. They think. They are philosophical in the face of all the ups and downs of life and all of its uncertainties.

My addiction as you may have gathered was by no means only physical. I started smoking at 12 years old; just an occasional secret fag shared with friends. Until I left school I was a weekend smoker only, but I got going in earnest when I went to University. I rolled cigarettes without conscious thought or effort. I could roll them in the dark or riding a bike. I could roll them with one hand if a party trick was called for.

Newly elected in 2011, perhaps because of the stresses of a new job, perhaps because of the amount of driving I was now doing, I found I was smoking more and getting less exercise. I began to think about cutting down my smoking. As a lifelong fitness fanatic friends were often confounded at the apparent anachronism I presented. I would breakfast on two cups of coffee and four cigarettes and then head off to the gym or go for a run. I kidded myself that somehow being fit would protect me against the worst effects of tobacco.

Perhaps it did but when I turned fifty I began to notice these effects. I couldn’t run as fast or as far. I couldn’t yet feel his hot breath on my neck but I began to sense the grim reaper gaining ground on me. Still I didn’t want to stop smoking. I didn’t want to abandon my lifelong friend. It was merely as an aid to cutting down that I thought I would give e-cigarettes a try.

Within two days and without really wanting to I had stopped smoking altogether. Eighteen months on I feel ten years younger. I get less exercise than I used to but I feel fitter. I have more energy, I sleep less and my powers of concentration have increased. Friends say I look younger.

Nicotine, as drugs go, is benign. It may even have some beneficial properties. How else do you explain our five hundred year habit of smoking? It was always the delivery system that was at fault, but even wrapped up in the cancerous cocktail of tobacco, for many people the pros still outweighed the cons. They chose to smoke knowing the risks. Life, after all, is not merely a competition to see who can live the longest.

Still the health costs of smoking tobacco are high, far too high and the technological solution, the e-cigarette, is one of those triumphs of the ingenuity of humanity. It gives me hope that we will solve many of our other problems.

The debate surrounding the regulation of e-cigarettes, is perhaps inevitable, but it has some unfortunate undertones. Those with little understanding seek to ban them or regulate them out of existence. Often these are the same people who have campaigned so avidly against tobacco. The logical inconsistency of holding these two antipathies seems lost on them. There is risk that the baby will be thrown out with the bathwater.

Proponents of e-cigarettes should see regulation as an opportunity. Proportionate and reasonable regulation will put many of the fears to bed. For responsible manufacturers it will provide a quality hallmark and for consumers, confidence that their health is not put before profit. It is not regulation itself which is bad but bad regulation and care should be taken on both sides of this argument that such regulation that emerges is as good as it can be.

European Union regulating e-cigarettes based on ideology and theories, but not science

Guest post by Dr Farsalinos

It is unfortunate for a scientist to see how politics work and how decisions are made. For public health issues, especially for the very sensitive issue of smoking, one would expect that common sense and scientific facts would prevail. Instead, we are seeing decisions made on the basis of theoretical concerns, fear-mongering tactics and intimidation.

The pending regulation for electronic cigarettes seems to be a characteristic example of applying theory on top of real evidence. There has been an astonishing effort to mis-present science, misinform regulators and the society by distorting the results of scientific studies and eventually kill a product which will probably revolutionize tobacco harm reduction. Recently, we are overwhelmed by stories demonizing nicotine. Suddenly, after so many years of research and hard evidence coming from population studies, we are seeing the news media discussing about nicotine causing cancer and heart disease. We are seeing journalists trying to interpret cell studies, while in reality I doubt if they understand a single word of what they read. Obviously, they should not be the only ones blamed; it is scientists who give the information to the news media and they push for publicity. The result is a complete distortion of truth. It is shocking to see someone support that a cell study is good enough to discard all hard evidence from population studies showing that nicotine does not cause heart disease or cancer.

However, there are other questions raised by such tactics. First of all, why is every study on nicotine targeting e-cigarettes? Don’t NRTs also have nicotine? Why don’t we hear anyone discussing about nicotine in NRTs? Well, probably because e-cigarettes are a hot topic. However, few years ago, studies showing nicotine to be harmful were strongly opposed by scientific groups (such as Cancer Research UK), stating that: “The interpretation is highly speculative and contradicted by evidence that many millions of people have been using nicotine replacement therapy with no increased risk of oral or any other cancer. If reports like this stop people using what for many would be a life-saving medication it would be very unfortunate.” They are absolutely correct, but the same statement should be done today for e-cigarettes.

All this intimidating publicity has only one result: it harms the health of smokers by discouraging them from using a less harmful alternative like e-cigarettes and it harms the health of vapers some of whom have relapsed to smoking after hearing all this misinformation.

Coming back to regulatory decisions, it is unprecedented that a product is regulated based on theoretical concerns, especially when such concerns are completely contrary to any available evidence. It is a big “victory” of the antismoking advocates (who in fact have become anti-smokers) that the agenda is not evidence but theories; theories about normalization, theories about use by youngsters, theories about health effects. Every scientific study shows the exact opposite from what they support, but none cares. Theory is more important that evidence. We have come up to a point when a professor is supporting that “We are witnessing the beginning of a new phase of the nicotine epidemic and a new route to nicotine addiction for kids” while at the same time his own study mentions that “Students who had smoked every day in the past 30 days had the highest rate of current e-cigarette use (50.8%), compared with .6% among those who not currently smoking cigarettes (p < .001).” (emphasis added).

How should this be called? Science? It is really sad that scientists are so disrespectful of smokers and their need to find a getaway from smoking. They believe they should be punished for initiating smoking and for medicine’s inability to develop an effective smoking-cessation medication. It is a dangerous path that should be condemned.

Regulators should stay away from propaganda tactics. They should be properly informed and base their decisions on facts, not on theories. Regulating based on anything besides evidence is like opening the floodgates; it will have severe consequences and will definitely harm public health.

 

Making sense of the proposed new e-cigarette regulations

Making sense of the proposed new e-cigarette regulations
Guest post by Clive Bates.

Half full or half empty?
Half full or half empty?
 
As the final negotiation over e-cigarettes in the tobacco products directive drew to a close. a nameless ‘senior diplomat involved in the negotiations’ was quoted in The Guardian. They were talking about e-cigarettes: It’s inhaled. It’s direct inhalation of nicotine into the lungs. That creates an addiction very fast… It encourages a switch to real cigarettes.” 
This is wrong in every respect – and not one scintilla of evidence justifies it, but plenty confounds it. So how come someone so ignorant is meddling in legislation to regulate products that are in fact amazingly positive alternatives to smoking? Why did the Guardian feel obliged to conceal the identity of this person?  So that a public official could remain unaccountable for their rogue opinions or propaganda statements?  People look at that sort of thing and rightly ask: “what do they know? And why are they in the room deciding on something important to me, when I’m shut out and no-one is listening to me and my experience?”.  I agree completely with this view – the e-cigarettes parts of the directive have been negotiated in secret, in insular meetings, where any old nonsense is treated as fact, and where evidence is brought in to support political decisions, not to inform policy.  Above all, they do not seem aware of the astonishing arrogance of agreeing something like this without consulting the millions of users and thousands of businesses affected or the dozens specialists who do the science and know the evidence?  For me, poor policy-making process is the reason why we end up with poor policy.  I’ve argued on my own blog that ‘embarrassingly poor policy-making‘ is the primary problem – poor legislation is the result of that. The right thing to do would have been to take out the e-cig proposals and do the job properly. But politicians and civil servants see themselves as heroic actors and don’t easily recognise the shortcomings of the processes in which they are playing a central role.
So what have they some up with?   
The e-cigs text, like the rest of the directive is a sprawling mess, with many arbitrary and disproportionate measures fiddling around with product design and commercial freedoms.  As a public health measure it is poor.  As a consumer protection measure it is poor.  As an EU internal market measure it is poor.  The main defence for the text as it stands is that it could have been much worse – and this is true.  We do owe thanks to MEPs like Chris Davies, Rebecca Taylor and Martin Callanan who have fought the good fight for vapers…  I only wish they’d succeeded in pulling it out and getting a new directive.
The main problem in general has been the obsessive focus on minor or implausible risks at the expense of the potential huge gains to smokers if the e-cigarettes can be made attractive enough to encourage switching.  Instead they have tried to make e-cigs deliberately unattractive, supposedly to protect non-smokers – but this is a serious public health miscalculation, given the minimal risks to the latter and huge benefits to the former. The public health establishment has done much to encourage that and has shown it has not learnt any lessons from its 21 year lethal error in supporting a ban on snus.
Compared to the darkest days of the worst proposals, the final text is not all bad and some of the most ridiculous ideas have been seen off in the negotiations.  In the end it has came down to frantic late night negotiation over rather weird things:
  • Maximum nicotine density for e-liquids now at 20mg/ml.  Completely counterproductive – limiting e-cig appeal to heavier smokers, preventing more compact energy efficient devices, and blocking future innovations.  And cuts through the ranges of the major manufacturers.  But significantly lower thresholds were under discussion at one point – the Germans wanted 5mg/ml!
  • Maximum nicotine quantity per single use cartridge – at one point an unfeasible 10mg – now specified as 2ml (therefore up to 40mg if the liquid is 20mg/ml) in a single use cartridge. There was no need to limit this quantity at all as safety concerns are addressed through packaging standards.
  • Maximum refillable container size of 10ml has been agreed.  Stupid and pointless, but not fatal as I think quite a common refill size.  We would normally control risks from hazardous liquids by packaging and labelling – not by reducing the size. Imagine if we took that approach to bleach or drain cleaner.
  • No EU ban on refillable (2nd and 3rd generation) devices.  This was in prospect but has been successfully thwarted – though with some strings. The Commission will have powers to ban them if three members states do and they can justify it on proportionality grounds – though this is more likely to apply to a specific dodgy product than the entire refillable category.
  • No EU flavour bans. Regulations are to be left to the members states. At one point they wanted to allow only flavours approved for use in NRT, which would have been absurdly limiting.  But now we will probably end up with lots of arbitrary rules based on the wrong assumption that adolescents want to use flavours that are childish.  I reckon if there was anthrax flavour it would be more popular with them than strawberry sherbet or. whatever…
  • Many forms of advertising, sponsorship, promotion, product placement – TV, radio, cross-border – are banned.  This is ridiculous and disproportionate – and will cause all sorts of damage (eg. to sponsored forums).  The products are much less dangerous than alcohol and could be regulated with a code – as the UK is planning to do.
  • Cross border distance sales – these can be banned by member states, but are not automatically banned.
  • Lots of testing, reporting and compliance requirements – but no pre-market authorisation regime, which would have created major political and administrative barriers
  • Age limits. Not included as these are a matter for member states.
  • Medicines regulation – they seem to want the flexibility to regulate e-cigs as medicines at national level.  Heads in the sand on this, given they keep losing in court. 
  • Timing.  Looks like intent is to bring in the measures 24 months after entry into force (likely May 2016) with possible additional 12 months for non-compliant products already on the market – this is one area that is unclear in the drafting.
  • A number a strange statements are made in the recitals to justify the measures,  for example about a gateway effect – something there is no evidence for at all.
Missing things
They don’t seem to have set up a proper basis for setting agreed purity standards or operating standards for devices.   That might have been useful. 
They don’t seem to have given any thought to unintended consequences – black or grey market, DIY, non-nicotine products, internet trade etc
 
An end to free speech?
Many people have picked out what sounds like a draconian curtailment of free speech in paragraph 5 of Article 18  “any form of public or private contribution to [media] with the aim or direct or indirect effect of promoting electronic cigarettes is prohibited“.  It isn’t actually – the key word is ‘contribution’, which means ‘paid for’ with the aim of promoting a product.  Brussels speak for advertising, sponsorship and promotion – as already used in the directives that ban tobacco advertising.
Legal challenges?
i mention the EU internal market above, because that is the legal base for this measure – it is supposed to support the free movement of goods around the EU, albeit with a high level of health protection.  But departures from free movement principle on health grounds do need to be based on evidence and be proportionate and non-discriminatory – and many of these are not.  It remains to be seen if anyone has both the intent and muscle to challenge any of it in court.
What happens next? 
It’s not law until both the full European Parliament and European Council (member states) agree the text.  The EP is likely to vote on it at its January or February plenaries (w/c 13 Jan, 4 Feb, or 24 Feb) but a date is not yet set. If EP agrees it goes back to the European Council for final rubber stamping – then becomes law. If the EP amends or votes it down, then it goes to a second reading or the Council can accept the EP amendment.  The UK government will also have to go into the Westminster parliament and defend its approach before it can sign up to the text at the European Council.
E-cig industry
Industry attention will turn to what many of the more vaguely expressed measures actually mean in practice….
– What will the definition of “consistent dosing” be? Will there be a standard deviation? What will this be and do current product lines respect it?
– How will manufacturers be asked to report nicotine uptake? Does this require a PK study? Are there other ways it can be done?
– How will the technical standards of the refill mechanism foreseen for bottles be drawn up?
– What kind of toxicity data will be required?
– What kind of emissions data will be required?
 
What can vapers do…? 
1. At every opportunity write to MPs, MEPs and ministers and keep making the case relentlessly. Watch forums for tactical advice on when and who to contact and on what theme.
2. Consider political strategy for the directive  – come out fighting or move with the punch…?
Come out fighting? Should we try to get this rejected at the European Parliament plenary? One approach would be a simple ‘delete’ amendment, replace with “The Commission shall consult and publish a review the risks, benefits and regulatory arrangements for e-cigarettes within 12 months and bring forward legislative proposals as appropriate”.  The value of this depends on the prospect of securing a majority in the European Parliament – that is still hard to gauge at present.  It would be necessary to show some fairly blatant unintended consequences or harms to convince MEPs to go out on a limb for this.
Move with the punch? Focus on making the implementation work and pressing for flexibility where there are obviously errors. Working out what it means in practice and focussing on implementing regulations.   We would need some key flash points to tackle with this,
3. Recognise that product regulation is one battle of many.  There is still huge work to be done on many fronts: vaping in public places: the attitude of NHS, Directors of Public Health and local authorities; keeping the MHRA in its box; and generally winning a propaganda war in which supposedly respectable organisations are playing dirty and elements of the media are taking every opportunity to have a go.
Clive Bates

Twitter: Clive_Bates

Legislation in ignorance portends unintended consequences

David Dorn examines all the reasons the EU parliamentary circus needs to completely re-think its approach to the Revisions to the TPD with regard to Electronic Cigarettes.

First, my declarations of interest. I am a vaper, of nearly five years standing. In that time I have not smoked a tobacco cigarette, yet I do not consider myself to be a quitter. I have continued using Nicotine, my recreational drug of choice, but have reduced the risks associated with its use – the very risks Big Public Health has bombarded me with for over thirty years.

You’d think, therefore, that Big Public Health would be not only massively chuffed for me, but would welcome my new habit as a substitute for the old one – the one they keep telling has a 50/50 chance of killing me – and support me spreading the word.

You’d think the likes of Cancer Research UK, ASH UK and the BMA would be pinning pictures of e-cigs to their walls, telling everyone how marvellous they are, and talking to their cronies in both Westminster and the EU Parliamentary circus to get them to make sure they’re more available than tobacco cigarettes, more sexy, advertised more widely and generally surrounded by the kind of buzz that has people saying “I want one of those”.

You’d think that Tonio Borg, the EU Commissioner responsible for the Revisions to the Tobacco Products Directive, would be sitting with a smile on his face typing into the text of the RTPD “we need to get these things on every shop shelf in Europe, in more places than you can buy tobacco cigarettes, and make them so appealing that everyone will want one.

You’d think…

But no. Despite some of the less extreme members of Big Public Health acknowledging that Nicotine and Caffeine are as alike as those two Irish Pop Stars – you know the ones – their colleagues continue to paint Nicotine as “highly addictive” “poisonous” “dangerous” and, in some particularly bizarre cases “carcinogenic”.

They are being ignorant – either wittingly or unwittingly.

And yet further no. Some of the members of Big Public Health preach the mantra of “re-normalisation of smoking behaviours” (that last word has recently been tacked on to their little phrase, because they KNOW e-cigs don’t re-normalise smoking). They just don’t get that, if Nicotine and Caffeine are like two peas in a pod in almost all respects, there is no problem with any amount of people enjoying either or both in whatever form. As “addictions” go, we’re probably talking a “habit” rather than all-out heebie-jeebies brought on by withdrawal and relapse.
One wonders what THEIR drug of choice is? A nice fruity red? A sharp white? A blue WKD?

And even more no. Even in the EU Parliament, there are MEPs who should know better who are, even as I type, being misled by Big Public Health and, in this case, Big Tobacco, who are trying to get them to knuckle under to a particularly insidious plan allegedly hatched by the Lithuanian Presidency and the Commission which would see every e-cig device that actually works and satisfies taken off the market, and only utterly crapulous looky-likey disposables left to be sold in, well, God only knows where, because they won’t be advertised, can’t be talked about, can’t have forums and, well, just won’t exist as far as non-voters are aware.

They need to wake up. They need to realise that they are being blackmailed by the notion that the TPD will not get through in this parliament unless they give in on the completely stupid, crass and unworkable proposals the Presidency and Commission has tabled.

Here’s an idea. Keep the rest of the TPD. It’s a mess, but obviously makes somebody happy. But take Article 18 out, and resolve to build a proper, bespoke regulatory framework for e-cigs and other nicotine containing products.

If they buckle, if they cave, if they wimp out, they will be jointly responsible for the biggest Public Health dividend ever imagined disappearing in a puff of (Big Tobacco) smoke.

They can’t want that, can they?