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E-Cigarettes represent the best method yet to reduce the smoking-related death and disease rate, because they are a clean nicotine delivery system and reproduce the smoking experience better than any other product. Swedish Snus are the best proven safe and effective replacement for smoking [1] but are not seen as anywhere near as popular by comparison. The target market for e-cigarettes is older smokers who have failed in several quit attempts, although all smokers can successfully switch to an e-cigarette given the correct motivation and advice.

The basic principal behind electronic cigarettes is Tobacco Harm Reduction: the replacement of a dangerous delivery system by a clean nicotine delivery system. The harm is almost all caused by the smoke; remove the smoke and most of the potential for harm goes with it. For the vast majority of people, with responsible consumption, the consumption of nicotine poses no identifiable risk. There are no clinical trials or surveys that show nicotine consumption over several decades has any elevated risk, and this can be clearly seen at population level from the Snus data.

Is there any evidence this approach works?

Indeed there is. Sweden reduced their smoking death rate by 40%, due to smokers changing in large numbers to the special smokeless tobacco known locally as Snus. As a result they have the lowest smoking-related death rate in the developed world by a wide margin, understandable since they now

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have the lowest number of smokers: just 12% of the population. It’s known as ‘the Swedish Miracle’ in public health circles [2].

We fully expect the take-up of e-cigarettes to be even higher than that of Snus in Sweden. It has been estimated that the free availablity of e-cigarettes and Snus in a country such as the UK would reduce the smoking-related death rate by more than 50% [3].

Unfortunately, the smoking prevalence reduction in some developed countries has plateaued: the rapid drop in the number of smokers has ceased, and the current drop is around 0.4% annually in the US and UK. There are no measures left that will substantially reduce it further, and prevalence is stuck around 21% to 22% (the average of the figure quoted by various organizations, which tends to vary between 19% and 24%, according to who is paying).

However, smokers themselves have now found a better option, and have already taken action that outperforms all official health initiatives by several times: in the US and UK we know that 4% of smokers have already switched to an e-cigarette. These ‘vapers’ now probably have the same expectation of risk as a Snus user – and a Snus user has the same risk as a non-smoker [2]. The smokers’ own action has already outperformed official action by approximately an order of magnitude, and the difference will increase.

If e-cigarettes remain freely available and unobstructed, there is no reason why their effect should not equal and even overtake that of Snus in Sweden, which has reduced both the number of smokers and the number of smoking deaths by 40%.

Do e-cigarettes work?

As a safe replacement for smoking, for long-term use, we know that e-cigarettes work. Millions and millions of people use them for that purpose. Many people have successfully used them for several years. In the US, the annual market is worth over $100m, so we are not talking about a passing fad here.

As regards their use for ‘quitting’, if that means total quitting of cigarettes, tobacco and nicotine – we don’t know the answer because nobody cares. Comparatively few people buy an e-cigarette for that purpose, there is no need. No doubt this works for some but it is not an application for which any community or industry members either support or are much interested in –the community because their prime interest is product improvements, and the industry because losing customers in a comparatively small market is not

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good business. Such persons would be hard to track by the usual community methods such as forums in any case, as they would disappear from view.

It has been suggested that research be carried out on this aspect of their ‘efficacy’, but from the point of view of everyone involved currently, this would be the most pointless waste of money imaginable. Why quit drinking coffee?

The safety of e-cigarettes

There have been more than fifty clinical trials, clinical surveys and other research papers published on e-cigarettes. None show any evidence of potential for harm. Since the main ingredients are also used in inhalable medicines and disco fog machines, this is hardly surprising. Fog machines are licensed under employee health and safety regulations for long-term high-volume inhalation duty, and these regulations are both strict and impossible to pervert. There is 70 years of safety data on these materials in any case –we list around 40 references below [8].

Many professors of medicine and public health heads of departments have endorsed e-cigarettes. Their work is easily found by googling: profs. M Siegel, C Phillips, C Bergen, B Rodu and others [13]. Prof Siegel’s evidence was instrumental in obtaining the huge Master Settlement Agreement against the US tobacco industry.

Doctor’s associations and groups have endorsed e-cigarettes:

AAPHP, the American Association of Public Health Physicians

ACSH, the American Council on Science and Health (whose physicians have been vociferous in denouncing the propaganda published against e-cigarettes)

The most well-known anti-smoking harm activist in the USA (and probably the world), William T Godshall of Smokefree Pennsylvania, whose evidence has been instrumental in the success of many actions against the tobacco industry, fully endorses e-cigarettes. He attended a State vaper’s meet in the US where hundreds of participants deliberately attempted to inconvenience him with their exhaled vapor, and found no observed effect. He dismissed a recent report paid for by the pharmaceutical industry that claims second-hand e-cigarette vapor causes throat constriction and dizziness as absolute rubbish [5].

This is a considerable statement when it comes from Bill Godshall, recognized as the most committed anti-smoke campaigner in the USA .

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Nicotine

There is no research that shows responsible consumption of nicotine has any more health risk than drinking coffee. Nicotine does not cause the cancer and cardiovascular diseases caused by smoking.

However there are some individuals who would be wise to strictly limit their nicotine consumption – pregnant women and those with pre-existing heart disease for example.

It should be recognised that nicotine is a normal part of the diet and everyone tests positive for it in the bloodstream. This is why nicotine or cotinine tests for smokers have to have a minimum value delineated above which the person qualifies, since everyone tests positive at low levels (unless they eat no vegetables). The CDC in the US tested 800 people, all of whom tested positive, in order to validate the results of an earlier study in which 136 subjects all tested positive. It is possible however that if an individual avoids all vegetables, tea, ketchup and so on that they will be able to avoid nicotine, although this does not seem wise, since apart from other nutritional reasons, it is probable that nicotinic acid (vitamin B3 or niacin) would also be missing from the diet. This nutrient is co-located in vegetables and nutritional plants with nicotine, and is also a nicotine metabolyte.

It therefore seems to be the case that ‘nicotine consumption’ as we refer to it in relation to tobacco use, in fact refers to ingestion of additional, larger amounts of a normal dietary constituent. Nicotine cannot be referred to in any way as an alien, toxic chemical or dangerous drug, it is part of the diet in small quantities. Like many such materials it is toxic in high doses since the one of the main differences between a nutrient or medicine and a poison is simply the dose (cf vitamin D).

The propaganda

All sorts of hysterical press releases, junk science and propaganda have been paid for by the pharmaceutical industry in their attempts to destroy a commercial rival. All these pseudo-scientific and quasi-medical efforts have been dismissed as junk science by professors of medicine who have actually carried out research into and investigations of e-cigarettes. In fact the authors of such propaganda have been dismissed as “crooks and liars” by one professor of medicine and public health expert.

There is not one shred of evidence that e-cigarettes can cause harm or pose any substantial risk to health. If there were, the FDA and MHRA would have

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found it. They have looked very hard for such evidence and millions of dollars has probably been spent on such searches. Nothing was found, which is why the FDA lost in their court action in the USA against e-cigarettes, the judge clearly stating they had provided no evidence to show any potential for harm, never mind any recorded incident. The fact they have been used globally by millions of people for many years without incident was found relevant. This can be easily be compared with the safety record of a certain quit-smoking drug introduced at the same time, which is widely reported to have ruined thousands of lives.

Lung issues

Realistically, the only prospect e-cigarettes have for causing harm is in the area of minor lung issues. There will always be individuals who prove intolerant to one or other of the flavorings used. The other ingredients in an e-cigarette are used in asthma inhalers and the nebulisers used by lung transplant patients [10], so hardly pose a threat (glycerine and propylene glycol as the principal excipients).

There is some question about the inclusion of contaminants in e-liquids. In general it is not in the interests of a business to poison its customers, so responsible vendors buy good-quality materials and carry out testing. In the UK, all materials are tested by the Trading Standards agencies and no contamination has been found. The UK trade association, ECITA, own a GC-MS machine and have a professional chemist available for testing. It is in everyone’s interest if rogue traders are identified and shut down.

Some contaminants have occasionally been found in some samples elsewhere but these have all been shown to be insignificant or not relevant. For example one sample of liquid from 18 tested by the FDA showed very low level DEG contamination, but this was not detected in the vapor so is not of concern. Carcinogens are frequently detected but at the same level or lower than those in NRTs, which are assumed to be safe. If e-cigarettes are unsafe due to the carcinogens then all NRTs would presumably need to be withdrawn from the market immediately. Of course this argument is ridiculous, since the long-term Snus data shows no elevated risk for any kind of cancer, despite the levels in Snus being considerably higher. In fact a professor of medicine commented on the issue of carcinogens in e-cigarette refills, describing the hysterical press releases on this subject as laughable since the levels,”…are millions of times lower than conceivably harmful to health”.

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The drawbacks of e-cigarettes

1. It is impossible that all ingredients in all brands of e-liquid will be well-tolerated by all individuals. The most likely problems that may be encountered are minor lung irritation issues that can be resolved by changing to a brand with a different ingredient profile. Some individuals may tolerate glycerine as the excipient better than propylene glycol, and some vice-versa. Some individuals may not tolerate some flavourings.

2. Smoking dependence is a complex habit with multiple factors contributing to the dependence profile, which varies between individuals. As far as the active tobacco alkaloids are concerned, nicotine is the most likely to cause dependence but others are certainly involved for some individuals. If a smoker still experiences cravings even when consuming a high strength of nicotine when using an e-cigarette, with all factors therefore seemingly well-replicated, and a blood plasma nicotine test shows a sufficient level of nicotine, then clearly we are missing something. This occurs in a percentage of smokers during conversion. This missing component has been shown to be the other WTAs in tobacco, the whole tobacco alkaloids nornicotine, anabasine, anatabine, and myosmine. Adding Snus to the equation removes such cravings as Snus is a whole tobacco product. Another method is to use a liquid refill that contains such WTAs, of which there are two brands currently, and many more will become available.

Some smokers can convert immediately with no cravings, some take a week or two to get over the craving for the other WTAs, and some must employ Snus or WTA liquid refills, perhaps in the long term, in order to succeed. Opinions vary on the percentages of each group and there is no current agreement. One reason an e-cigarette may fail a particular individual is the lack of these WTAs, so it is something that can be resolved with a little application.

3. Many smokers who attempt to convert to an e-cigarette will start with a ‘mini’ e-cigarette that resembles a regular cigarette: a small 1st-generation model, with a refill liquid that may not suit them, of a nicotine strength that may be too low to prevent cravings. It has been shown recently that higher levels of nicotine than are normally supplied with regular e-cigarette refills may be required in order to raise plasma nicotine levels sufficiently, for some individuals. Within the e-cigarette community we have clearly demonstrated a difference in individual tolerance to nicotine of a factor of 10, so this needs to be taken into account. We have demonstrated that what suits one person may be ten times too low or too high for another.

Mentoring is therefore quite important as the initial experience may not be optimal. There are hundreds of different equipment options and thousands of

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different refills, and the initial choice is not usually successful as a long-term solution – the equipment and refills must fit the individual, not the other way around [11]. We know that 92% of long-term users have changed their equipment choices, and it can be assumed that virtually all will have changed their refill choice. We cannot underestimate the value of mentoring, even if via remote methods such as effective forum support.

It can be admitted that although e-cigarettes are provably highly effective, they are not a simple ‘buy-and-go’ option; their principal drawback may well be that they need to be tuned to the individual. In many cases the subject will find the optimal solution by trial and error; in others, they may fail due to lack of support.

E-Cigarette medical license for NRT use

In Q3 2012 it is expected that the first pharmaceutical license for e-cigarette use as an NRT will be issued. The expected cost to the firm concerned is around £2.2m, which explains why there are few takers for this option. Subsequently, we expect there to be a considerable reduction in the propaganda about e-cigarettes since the offenders may face legal action.

And, of course, the people who fund the propaganda will be wanting to get in on the action; hardly surprising, as whatever purpose might be claimed for e-cigarettes, they work orders of magnitude better than any current NRT [12].

UK-specific information

At Q4 2011 the number of UK smokers who had switched to an e-cigarette was 4%, and by 2013 the proportion will be 6%. Already the action of smokers themselves has been several times more effective than NHS efforts in reducing the future death rate [9].

Given the immense cost of the NHS Stop Smoking Services to the taxpayer, not to mention the fact that virtually all patients will return to smoking [4], many people feel that consumer Harm Reduction offers a far better deal. It would also help if elements within the Department of Health did not appear to be acting with the pharmaceutical industry to remove their commercial rivals; especially since the rivals in question will indisputably save a vast number more lives.

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Notes

[1] Snus is a special Swedish form of smokeless, oral tobacco that is usually sold in tins of very small packets that resemble tiny, flat teabags. It can be referred to as ‘spitless’ or ‘non-chewing’ tobacco because it is invisible in use, and no extra saliva is produced. A packet is inserted behind the upper lip (not lower), and disposed of after 10 minutes.

This THR alternative to smoking is very popular in Sweden, where they reduced the number of smokers by 40% by promoting its availability as a consumer Harm Reduction product. The smoking-related death rate also fell exactly in parallel, with the result that Sweden has the lowest smoking-related mortality rate of any developed country by a wide margin.

The tobacco is specially processed by steam in a method sometimes referred to as ‘pasteurising’. This steam-processing removes most of the carcinogens. Although some are left (c. 1,000 – 2,000ng/gm) the amounts remaining are not cancer-forming because the very large amount of clinical research data available shows this not to be the case. In addition, Swedish oral cancer rates have dropped sharply while Snus use has increased markedly. It is said that the most cancer-forming of all chewing tobaccos is still 4 times less likely to cause oral cancer than smoking, but Snus has no identifiable risk of oral cancer.

[2] When pharmaceutical NRTs were licensed for long-term use in the UK recently, the only source of safety data that could be referenced was the Snus research from Sweden. Because this huge amount of data (>150 trials over >25 years) proves that long-term nicotine use poses no significant risk, NRTs were successfully licensed as long-term treatments.

The Snus data has been collected over 25 years, includes more than 150 clinical trials and surveys, and has cohorts of tens of thousands of subjects. It provides data that can be accessed at the individual level and at population level. It proves beyond doubt that Snus use is not only safer than smoking but it is safe in absolute terms. The meta-analyses of 85 and 150 trials carried out by PN Lee of London showed that a Snus user has no elevated risk for any type of cancer or heart disease. The difference between a Snus user and a non-smoker is not statistically significant for any type of disease (r=1.1). A Snus user has virtually the same risk as a non-smoker (that is, a smoker who has totally quit). There are individual trials with contrary results (example: for cancer of the pancreas), but these must be weighed against 150 trials showing no identifiable risk.

[3] Snus is assumed to have been banned in the EU [6][7] because of the

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impact a safe form of tobacco use has on the income of the pharmaceutical industry, since there are provably no health implications. Pharma loses in two ways:

• Sales of NRTs and other quit-smoking drugs are hit very hard indeed; sales in Sweden are the lowest of any comparable country. This is a billion-dollar market globally and one that pharma will fight hard to protect.

• Sales of chemotherapy drugs, COPD drugs, heart disease drugs and other therapies for sick and dying smokers are believed to value at least ten times the NRT market. Obviously, if the smoking death rate falls by 50%, the sales of these drugs are likely to fall drastically.

This is the most serious threat to pharmaceutical industry income that has ever been seen, and they have fought very hard to oppose e-cigarettes, even obtaining bans in some countries despite there not being a shred of evidence that e-cigarettes pose any risk.

[4] http://www.eccauk.org/index.php/nhs-quit-smoking-fail.html

[5] http://www.ecigarettedirect.co.uk/campaign/bill-godshall-report-on-e-cigarette.html

http://www.pasenategop.com/committees/finance/2009/021109/Godshall.pdf

6] http://www.eccauk.org/index.php/uk-sitrep-2.html

[7] http://www.eccauk.org/index.php/ecca-library/21-why-is-snus-important.html

8] PG research stretches back to the 1940s, and no person has ever died from its use. It is the main excipient in some nebulisers given to lung transplant patients, and is regarded as inert. Note that it is also used as the diluent in injectable medicines that are immiscible, such as diazepam, and is therefore approved for direct injection into the bloodstream. Here are around 40 references:

http://www.e-cigarette-forum.com/forum/health-safety-e-smoking/959-propylene-glycol-inhaling-17.html#post948636

http://www.e-cigarette-forum.com/forum/pdf/novartis-pg.pdf

http://tsp.plasa.org/tsp/working_groups/FS/docs/cohen.pdf

The identifiable characteristics of PG are:

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1. It is generally regarded as inert or nearly inert for all forms of consumption including injection, inhalation and ingestion.

2. It has a powerful bactericidal and virucidal action when dispersed as an aerosol.

3. It has no implications for health except for rare intolerance by individuals.

4. The only likely effect of exposure to aerosols is the drying action on mucosa due to its humectant effect.

5. There are no recorded instances of death or severe harm.

[9] ref #2 @ http://www.eccauk.org/index.php/nhs-quit-smoking-fail.html

[10] Check British Pharmacopeia for full lists of ingredients including excipients and diluents, these are not usually included in MIMS. Search: propylene glycol BP and glycerine BP. Also see:

http://www.dow.com/safechem/optim/optim-advantage/applications.htm

[11] http://onlinelibrary.wiley.com/doi/10.1111/j.1742-1241.2011.02751.x/abstract

http://live.psu.edu/youtube/Ejcnzho95FA?mid=5295763

http://onlinelibrary.wiley.com/doi/10.1111/j.1360-0443.2011.03532.x/full

Vansickel A. R., Blank M., Cobb C., Kilgalen B., Austin J., Weaver M. et al. Clinical laboratory model for evaluating the effects of electronic ‘cigarettes’. February 2011; 17th Annual Meeting of the Society for Research on Nicotine and Tobacco. Toronto, Canada, 2011.

http://onlinelibrary.wiley.com/doi/10.1111/j.1360-0443.2011.03532.x/pdf

[12] http://onlinelibrary.wiley.com/doi/10.1111/j.1360-0443.2011.03505.x/abstract

http://www.ncbi.nlm.nih.gov/pubmed?term=The%20emerging%20phenomenon%20of%20electronic%20cigarettes

[13] Siegel: http://tobaccoanalysis.blogspot.com

Rodu: http://rodutobaccotruth.blogspot.com

Phillips: http://www.tobaccoharmreduction.org

Bergen: http://smokles.wordpress.com

Laugesen: http://www.healthnz.co.nz

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Nitzkin: http://www.tobaccotoday.info/2009/05/05/electronic-cigarette-interview-with-dr-joel-nitzkin/

http://www.aaphp.org/Resources/Documents/20100402AAPHPEcigLegisStatemnt.pdf

http://www.tobaccoharmreduction.org/thr2010authors.htm

http://www.tobaccoharmreduction.org/interviews.htm

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