A case for e-cigarettes

A case for e-cigarettes

Professor Gerry Stimson  takes a closer look at electronic cigarettes and asks – if e-cigarettes can save lives, why are we jeopardising this public health breakthrough?

Until recently, an end to cigarette smoking looked like a long and slow business. Year on year only small reductions have been made in reducing smoking prevalence in developed countries.

The arrival of electronic cigarettes (e-cigarettes) and other new nicotine delivery devices changes that. These new devices are a disruptive technology, just as the invention of the cigarette-making machine was in the 1880s. There are now real prospects of helping smokers shift from smoking tobacco to using nicotine by less harmful routes.

The Medicines and Healthcare Products Regulatory Agency (MHRA) and the European Commission (EC) now want to regulate e-cigarettes as medicines. Will this advance the sale of e-cigarettes, or push back the progress that has been made?

First introduced to the UK in 2006, uptake of e-cigarettes has been a relatively quiet consumer-led revolution. There has been no public health input or encouragement, and no spending of NHS resources – no taxpayers have been harmed in this process. There has been little expenditure on marketing. The growth in popularity has come about by word of mouth and internet advertising. Unlike many public health measures, there is a population ready and eager to change – most smokers want to stop smoking. Until e-cigarettes there was no viable option but to quit smoking altogether or to use nicotine replacement therapy (NRT).

The MHRA estimates that 1.3m people are using e-cigarettes in 2013. The proportion of smokers using them rose from 3 per cent in 2010 to 11 per cent in 2013. The European market is estimated at around EUR 400-500m, and sales of e-cigarettes now equal those of NRT. The market has been dominated by mainly small and medium-sized distributors, but this will change as most major tobacco companies are already selling or investing in the development of new nicotine delivery devices.

Most anti-smoking organisations aim for an end of the tobacco industry. Ironically – for many public health experts – an end to tobacco smoking may be hastened not through the end of the tobacco industry but through its transformation. In the next couple of decades, tobacco companies, under pressure from anti-tobacco legislation, will move towards becoming nicotine companies. Wells Fargo stock analysts predict that revenue from e-cigarettes will overtake ordinary cigarettes by 2021.

E-cigarettes v smoking tobacco

E-cigarettes have major advantages over smoking tobacco. More than 4,000 chemical compounds are found in tobacco smoke, and it’s the products of the burnt organic material that are so harmful to health. Around 80,000 people in England die every year from smoking-related disease. Smoking is the single most common cause of preventable illness and death. As Mike Russell noted long ago, people smoke cigarettes for the nicotine but die from the tars.

e-cig3 

E-cigarettes contain nicotine, propylene glycol (a carrier that creates the vapour when heated) and flavourings. They deliver nicotine but without the dangerous toxins found when tobacco is burnt. They are used by people who want to stop smoking but who do not want to or cannot stop using nicotine. 

A visit to e-cigarettes and vaping websites indicates extraordinary testimony of their successful use by long-term smokers. E-cigarettes contain some potentially harmful constituents but at traces very much lower than found in regular cigarettes, within the safe limits for consumer products, and indeed at similar levels to potentially harmful constituents found in NRT. And their attraction for many users is precisely that they are not medicines.

Where to with tobacco policy?

Harm reduction is central to current tobacco policy in England. This will be welcome news to those in the drugs field who feel rather beleaguered and browbeaten by the drugs recovery agenda.

The history of tobacco harm reduction is tied in with the development of NRT. In 1990 there were only three NRT products, all prescription-only. Pharmacy sales started in 1991, expanded to all products by 2000, and since 2009 all NRT products have been on general sale. Initially NRT was only indicated for abrupt quitting, and later extended for people who wanted to cut down more gradually before stopping. But in 2009/2010 the MHRA agreed it could be used for harm reduction, including temporary abstinence and a reduction in smoking with no intention to quit.

 

The Department of Health’s 2011 tobacco control plan committed to encouraging tobacco users who cannot quit to switch to safer sources of nicotine and to encourage manufacturers of safer sources of nicotine to develop new types of nicotine products. In 2012 the Cabinet Office’s behavioural insights team – the so-called ‘nudge unit’ – urged the use of e-cigarettes.

The most recent piece of the story is the work of the National Institute for Health and Clinical Excellence (NICE) which gives a strong endorsement for tobacco harm reduction for people who do not wish to quit smoking altogether, and for people who want to quit smoking but are unable or unwilling to quit using nicotine. The NICE group concluded that nicotine does not pose a significant health risk.

Enter MHRA and the European Tobacco Products Directive. The MHRA has decided to regulate all electronic cigarettes as medicinal products by 2016, and the European Tobacco Products Directive – currently going through the European legislative process – proposes that all e-cigarettes should be regulated under medicines legislation.

‘Smoking cessation’ or ‘smoking sensation’? 

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Those in favour of medical regulation argue that electronic cigarettes are currently unregulated products, that they are accessible to children, that there is no control over advertising, that they contain potentially dangerous constituents, and that the devices themselves, including the batteries, pose a threat to user safety.

Medicines regulation, they argue, will improve safety, quality and efficacy, and make them work better as a smoking cessation product.

There is another thread going through the political argument however, which is that electronic cigarettes are just another way to feed addiction to nicotine, and that they send the wrong message and undermine attempts to drive down tobacco use. Some claim that electronic cigarettes are contrary to efforts to ‘de-normalise’ smoking. There are already scaremongering stories about schoolchildren using them. Certainly they might be a short-term fad amongst some children who wish to challenge authority, but the e-cigarettes market is made up of long-term smokers and surveys by Action on Smoking and Health (ASH) show minimal use by non-smokers and by young people.

Consumers do not want medical regulation. There has been extensive comment on the proposals on social media sites, Twitter, and letters to members of the European Parliament – current users insist that these are consumer products, a safe way of enjoying nicotine, rather than a therapy. These products are popular precisely because they are not medicines. As one user put it – these are not ‘smoking cessation products’, they are ‘smoking sensation products’.

Getting the balance right

The problem is the trade-off between making the product safe enough, but also sufficiently attractive to achieve widespread uptake. On balance more weight should be given to attractiveness, given their relatively low risks and the huge consequences of continued smoking.

The argument that these products are currently unregulated is false. The Electronic Cigarette Industry Trade Association has shown that they are covered by the General Product Safety Directive and various other EC directives covering electrical safety, chemical safety, weights and measures, packaging and labelling, commercial selling practice and data protection.

Applications to MHRA are costly, including the licence fee and the required studies, analyses, documentation. There are fears that few companies will be able to afford this, that the process will favour big players and drive many products off the market. There are further problems with medical regulation in that e-cigarettes include a big range of products and product combinations. Not all of them are simple pre-packaged cigarette lookalikes, but many are customisable, where the user can vary the delivery device and the nicotine strength and flavourings. It is likely that medical regulation will prematurely limit the range of products and stifle innovation.

Even the announcement of future medical regulation has created uncertainty among retailers, current and potential e-cigarettes users.Picture 5

How this will play out is uncertain. Given that MHRA has put the deadline as 2016, by then there will be a much larger market and it will be harder to limit and control products. Already there have been four successful legal challenges against classing these products as medical products (two in Germany, and one each in Estonia and the Netherlands).

At the end of the day the potential public health gains from e-cigarettes will be determined by the decisions about how to regulate these devices. There is right thinking about tobacco harm reduction, but a risk of making significant mistakes in the way this is played out in regulatory frameworks.

The danger is a classic regulatory trap: making safer products harder to obtain than their unsafe counterparts. The regulatory proposals are tougher on e-cigarettes than on tobacco cigarettes. The framing of electronic cigarettes within a regulatory context misses the point that the public health drive must be to promote, endorse and facilitate their use. 

Prof Gerry Stimson is visiting professor, London School of Hygiene and Tropical Medicine and director of Knowledge-Action-Change.

 

8 COMMENTS

  1. Happy that it has cases too. Most e-cigarettes contain a battery, an atomiser and a replaceable cartridge. The cartridge contains nicotine in a solution of either propylene glycol or glycerine and water, and sometimes also flavourings.When you suck on the device, a sensor detects the air flow and starts a process to heat the liquid inside the cartridge, so it evaporates to form water vapour. Inhaling this vapour delivers a hit of nicotine straight to your lungs.

  2. The fees involved in licensing proposed by the MHRA, are really quite astronomical. These proposed regulations are simply going to close down the majority of vendors businesses. Very few could afford the huge fees involved in licensing that the MHRA charge on a yearly basis. At the very least the costs of ecigs would rise dramatically. So the whole situation is very counter productive considering that the focus is supposed to be harm reduction.

    The MHRA chose advisors from companies that produce Nicorette and Champix. So unfortunately the advice that the government has received has been very bias.

  3. Probably one of the best, simply but factually written articles on the subject I’ve read.

    As a vaper, I wasn’t looking to give up smoking but tried a look-a-like style ecig and found I wasn’t interested in smoking tobacco any longer. I’ve progressed to a ‘mod’ which is a large ‘pro’ version of a ecig that looks more like a light saber handle.

    Vaping has become more of a hobby now. I love trying the different juice flavours and shopping for gadgets. I’ve even become part of a vaping community (ukvapers.org) who chat online and meet up and swap tips and fun.

    I haven’t given up cigs, I’ve moved on, evolved you could say. I really hope they don’t take this away from me and the millions of others who love ecigs. Medical regulation would be as good as a ban for us and the only people who will benefit will be big pharma who make the money on NRT that is proven not to be effective.

    We’re intelligent adults for the most part – I ask the regulators to please allow us the trust that we know what we’re doing and let us be happy and healthier than when we smoked tobacco.

  4. I entered the Vaping world three months ago after smoking 30 cigarettes a day. I have tried for years to kick the filthy, unhealthy and expensive habit of tobacco smoking with great difficulty.
    Vaping is wonderful, cheap and safe, and I’m now a free, happy person. More and more people appear to be following the trend.
    It can only grow!!!!

  5. They certainly worked for me, have not smoked for nearly a year since getting a decent ecig. I tried to quit a few times with NRT with no success. I think it was because I was concerned for my health (and my wallet) that I tried but didn’t really want to quit something I enjoyed.
    P.S The disposable ones in supermarkets and pharmacies are really not very good, the sooner there is a proper vapour shop in every town the better.

  6. Thanks for a level headed article. I’ve been off cigarettes for over 2 years now, by use of an ecig. I tried other methods (patch, gum, Wellbutrin, and cold turkey) repeatedly, and an ecig is the only thing that has ever worked to get me off cigarettes. I hope that the knee jerk opposition to these can eventually be moderated by thoughtful and pragmatic people who see the positive side of this new technology similar to the way you do.

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