By Deborah Arnott (UK), GUEST CONTRIBUTOR, MBA FRCP (Hon), Chief Executive, Action on Smoking & Health (ASH UK) is a well-respected public health campaigner championing greater awareness about the tobacco epidemic worldwide, while pressing for evidence-based policy measures that do not attack smokers or condemn smoking. Reporting to the Royal College of Physicians, ASH provides the secretariat for the UK’s All Party Parliamentary Group on Smoking and Health.
The UK and USA are home to the leading tobacco transnationals and the birthplace of the twentieth century tobacco epidemic. Around mid-century, smoking peaked in the UK with around 80% of men and half of women smoking, slightly higher than the US40 at its height. This was an epidemic caused by manufactured cigarettes, consumption of which increased over 100 times during the century. Six million41 people a year now die globally from tobacco smoke, mostly smokers but including over half a million people killed by second-hand smoke. Unless action is taken the tally is expected to grow to eight million a year by 2030 and by then over 80% of these deaths will be in low and middle income countries. These countries are increasingly suffering from diseases caused by smoking such as cancer, diabetes, cardiovascular disorders and chronic respiratory illnesses. Tobacco caused 100 million deaths in the 20th century. If current trends continue, it may cause one billion deaths in the 21st century.
To answer the question posed by Professor Kinderlerer on the ethics of intervening in the lives of addicted people, yes of course human dignity and freedom are fundamental principles. However, to quote John Stuart Mill from On Liberty, “The principle of freedom cannot require that he should be free not to be free.” Mill was referring to slavery, but addiction, particularly to a substance as deadly and addictive as tobacco, is also a choice which limits rather than enhances freedom. In the UK two thirds of smokers want to quit42, many more wish that they had never started, yet long-term success rates in quitting are well below one in ten. It is hardly surprising that there is strong popular support for the rule of law to be used to limit smoking, support which has been growing in recent years rather than declining.
The public, certainly in the UK, understand that policy-makers, have an ethical responsibility to put in place policies designed to drive down smoking. I would add that policy-makers in the UK and the US, home of the tobacco transnationals, also have a responsibility to help prevent the global epidemic taking root in low and middle income countries. That was one of the driving forces43 behind the development and implementation of the WHO Framework Convention on Tobacco Control. The world’s first health treaty, it contains a comprehensive set of measures designed to drive down consumption of tobacco by reducing both demand and supply.
In a spare moment during the final negotiations on the WHO Framework Convention on Tobacco Control, I visited the Red Cross museum in Geneva. On the wall was an old banner setting out the rights of prisoners of war in the early part of the twentieth century. I was astonished to see that the right to tobacco was set alongside the basic human right to food and water and given equivalent weight. This illustrates how the balance between the rights, and responsibilities, of smokers and non-smokers has evolved and they are continuing to evolve.
Not much more than twenty years ago when I was heavily pregnant the rights of smokers still had priority. Smokers would light up in front of me at work without even bothering to ask if I minded. Despite the fact it made me feel sick and I knew that cigarette smoke was harmful, I had no right to request, however politely, that they stop. Subsequently I worked with the company doctor and we held a ballot of all employees on whether they wanted smoking on the premises to be prohibited or not. The trade unions in our heavily unionised workplace didn’t object to our ballot, despite almost all of their representatives being heavy smokers, because they didn’t for a minute believe we’d win the vote. But we did, and by an overwhelming majority. Non-smokers who had felt unable to speak up individually, when given the opportunity as a group, made very clear that they didn’t want to be exposed to tobacco smoke.
Years later in 2003, I was recruited by ASH (UK) to campaign for laws to require smokefree enclosed public places and by 2007, the UK had implemented comprehensive smokefree laws, following in the footsteps of Ireland, New Zealand and many parts of the US. The same year the WHO Framework Convention on Tobacco Control Conference of the Parties had adopted comprehensive guidelines very much along the same lines. In retrospect it looks easy, the laws are widely accepted and non-controversial. But it was not. We had to fight to gain acceptance for the idea that protection from second-hand smoke in enclosed public places should be made mandatory and not left to voluntary action by organisations and employers.
Just after the millennium half of all workplaces were smokefree in the UK, but this was biased towards larger organisations and professional and managerial workforces. The majority of low paid routine and manual workers still had to suffer smoking at work, and because rates of smoking were higher in those groups they were exposed to more smoke.
In the UK we had great difficulty persuading the English government that they should legislate. ASH (UK) was set up by the Royal College of Physicians to be an evidence-based advocacy organisation working to reduce the harm caused by tobacco. Together with all the other leading health organisations we provided extensive evidence of the harm caused by second-hand smoke, but the evidence was not sufficient. It was not that the politicians did not believe the evidence that second-hand smoke was harmful, that they accepted, but as the Health Minister’s political adviser said to me “show me the votes”.
The legislation passed because we were able to do just that. Indeed over the period May 2004 to December 2005, support for smokefree legislation, including all hospitality venues, rose from one half to two thirds of the adult population44. Support grew because the public were engaged in a debate, through a government consultation and in the media, about the rights of smokers versus the rights of everyone else. The debate hinged on John Stuart Mill’s harm principle, as elaborated in On Liberty, that, “The only purpose for which power can be rightfully exercised over any member of a civilized community, against his will, is to prevent harm to others.” The harm principle was cited widely on both sides of the argument for and against smokefree laws, because it is a widely accepted benchmark in the UK, as in many other democracies, for whether or not government action is acceptable or not. The argument was won in particular because the public accepted that the rights of workers in the hospitality industry to be protected from second-hand smoke superseded the rights of smokers to smoke wherever they wanted. It was the same case in Ireland when the first public-place smoking ban was introduced in 2004.
Positive steps made, but a battle not yet won
I was reminded recently that this argument is still to be won in many parts of the world. On a trip to Sarajevo, in Bosnia Herzegovina, it seemed as though every restaurant I visited allowed smoking, with at best a cursory and ill observed no smoking section. In one I even saw the chef behind the counter, smoking, while cooking. I came home every night smelling of tobacco smoke, an unpleasant and unusual experience. As a little British boy too young to remember what it used to be like said to his mother, “Why are these people being allowed to smoke over me?”
However, ASH is not anti-smoker, we’re anti-smoking. That is a very important distinction. While I have no desire to go back to the days when smokers’ rights were the priority I do believe there should be a balancing of rights and responsibilities, not just of smokers but of non-smokers, and not just in the home of the tobacco epidemic, but globally. Nowadays I fear that there is a danger that smokers’ rights are not sufficiently taken into account, particularly when it comes to the regulation of less harmful products than smoked tobacco such as electronic cigarettes. Country after country, from Canada to South Africa to New Zealand, with murmurs in France and Germany, are banning these products or regulating them as strictly as tobacco products as if they were as dangerous as smoking. This is not based on sound scientific evidence which is proving the contrary, but fear of the unknown and a residual desire to punish the smoker/vaper.
It is not easy determining an appropriate regulatory framework for less harmful products when the evidence base is still evolving. I have been criticised both for supporting a regulatory framework which is too stringent and one that is insufficiently strict. I have been attacked for challenging the presumption of ‘at least do no harm’ and for not adhering to the precautionary principle. But the precautionary principle is often misquoted as providing substantive prescriptive guidance on what steps regulators should take, rather than, as is generally accepted, that a lack of decisive evidence of harm should not be grounds for refusing to regulate. Regulation of electronic cigarettes should be designed to maximise the benefits while minimising the risks. Policy makers need to take into account benefits and risks of all kinds both to current users and potential users amongst smokers and ex-smokers, but also to non-users and never smokers, in particular amongst children and young people.
Those who argue in favour of more stringent regulation of electronic cigarettes have a range of concerns about unintended consequences. They are concerned that:
- e-cigarettes might be a gateway into smoking;
- that their use in places where smoking is forbidden might renormalise smoking;
- that dual use by smokers might sustain addiction rather than help quitting;
- that the long-term health effects are unknown;
- that second-hand vapour may be harmful; &
- that tobacco companies may use them to subvert controls on tobacco industry involvement in policy development & circumvent laws to prevent tobacco ads.
These are all rational hypotheses about potential harms, but the overwhelming evidence to date is actually to the contrary: that these products have provided public health benefit, certainly in the UK where we are a leading monitor engaged with smokers and vapers.
The UK: developing the evidence base
In the UK, rapid growth in e-cigarette use has been associated with increased rates in adult quitting and a continued decline in adult smoking prevalence, now below 20% for the first time since records began.45 Research by ASH over the last five years has now been supplemented by official government statistics finds that almost no-one who is not a smoker is using electronic cigarettes.46,47 The most common reasons cited by smokers for using e-cigarettes is to help them quit smoking, prevent relapse or cut down and that being able to save money by switching is a powerful motivator. Smokers are increasingly using electronic cigarettes to help in quit attempts and they are proving significantly more effective than medicinal nicotine products bought over the counter such as patches, gums and sprays.49
There is little sign of youth use except amongst pre-existing smokers.47,48 The vast majority of young people who have not smoked or vaped have no intention to do so. Youth and adult smoking prevalence has continued to decline, not something you would expect to see if e-cigarettes were a gateway into smoking.50 While a causal relationship cannot easily be proven, there is certainly no evidence that the growth in e-cigarette use is leading to an increase in smoking. The evidence from the US is very similar.51
Smoking cigarettes can never be made safe, inhalation of smoke, whether from cigarettes, household fires52, or any other source is harmful, the lungs are a fragile organ. It is too soon to say how safe e-cigarette use is longer-term and more research is needed. However, although the precise extent of harm from long-term use is not known, from the concentrations of potentially harmful inhalants in vapour, e-cigarette use from brands that have been tested so far is likely to be many magnitudes safer than smoking tobacco cigarettes in terms of long-term health risks. The vapour exhaled by e-cigarette users contains concentrations of chemicals which are below concentrations expected to cause significant harm to health of bystanders.
We at ASH are not against regulation and we would like to make sure that the risks, in particular of youth uptake, are monitored and action is taken if they materialise, as appropriate. That is why we support an age of sale for e-cigarettes of 18 with appropriate enforcement. We support regulation to prevent marketing promoting smoking and encouraging uptake by non-smokers and young people. We also want to see appropriate regulation to ensure that e-cigarettes are safe, reliable and effective and that their marketing is controlled, and aimed at smokers.
In Europe, we have an evolving twin track regulatory approach which will be in force by 2016/17 which will require novel nicotine delivery devices to be regulated under the EU Tobacco Products Directive54 or to have a medicines licence.
There are those concerned that such regulation is already too stringent and may undermine the growing market for alternative nicotine products. Our view is that since this is the regulatory framework that is due to be put in place we need to do all we can to ensure that it works to the benefit of smokers and of public health, in line with the evidence base.
ASH has supported medicines regulation and is pleased to see the UK medicines regulator the MHRA (Medicines and Healthcare Products Regulatory Agency) has given a licence to the first novel nicotine product, a nicotine inhaler and is in the process of licensing the first electronic cigarette.
But even this has its problems. The first licensed product is being marketed by a company which is a wholly owned subsidiary of British American Tobacco, which could mean that for the first time a tobacco company product will be available on prescription. This is causing concern amongst many in the public health community who find it hard to believe the tobacco industry is acting in the public interest. It is our view that products, whoever they are made by, should be prescribed on the basis of clinical need in the light of the evidence base. However, it is essential, in line with Article 5.3 of the WHO FCTC, that this does not allow BAT, or any other tobacco company for that matter, a foot in the door to unduly influence tobacco policy.
Having grown rapidly for a number of years, recently electronic cigarette use has started to flat-line in the UK. In these circumstances the mantra ‘at least do no harm’ needs to be re-examined. WHO produced a reasonably nuanced policy report in advance of the 2014 Conference of the Parties to the WHO Framework Convention on Tobacco Control, which stated that ecigrettes “represent an evolving frontier, filled with promise and threat for tobacco control.” 53 However, its tweets were much less nuanced, for example stating that the “WHO report shows: e-cigarettes & other electronic nicotine delivery devices pose threats to public health”.
Alarmist statements about the risks of vaping by health professionals who should know better are leading to newspaper headlines like “I thought my e-cigarette was a miracle. Turns out, I was smoking the equivalent of 40-a-day”.55 And ASH research shows that although the majority of the public still realise that vaping is less harmful than smoking, the proportion thinking it’s just as or more harmful doubled between 2013 and 2014 from 7% to 15%. The public have a right to accurate information and nicotine addicts have a right to access to safer nicotine products than smoked tobacco.
Why is this of concern? Because over fifty years after Richard Doll’s seminal research providing convincing evidence that smoking caused lung cancer was first published in the British Medical Journal, smoking is still an epidemic. Nearly one in five adults in the UK smoke and 100,000 die prematurely each year from doing so. Amongst the most disadvantaged in society, those with mental health problems, living in poverty, or lacking education, smoking rates are much higher. Smoking rates are declining but at a pace which means that for decades to come smoking will remain the major preventable cause of premature death. That is in a country which has had a comprehensive strategy in line with the recommendations set out in the WHO FCTC for many years. In many other countries without such strategies in place rates of decline are smaller or non-existent. We should be worried. That is not to say that we should stop doing what we are doing, traditional tobacco control policies are effective, but they are not sufficient.
Over-regulation could be counter productive
Electronic cigarettes have not so far been the solution for all smokers, but they are already, early on in the product life cycle, having a significant impact. Our research shows that only one in three smokers who take up electronic cigarettes switch completely, the remainder continue to smoke as well. If the products are improved so that more smokers who find it impossible to quit are encouraged to switch completely to electronic cigarettes, the potential health benefits would be much greater.
In such circumstances over-regulation itself may be the very harm that we need to avoid. It could lead to smokers continuing to smoke who otherwise would switch to safer products. Banning or heavily regulating electronic cigarettes in the same way as tobacco products, or even just discouraging their use does not equate to “do no harm”. Policy makers need to take note of Sir Richard Peto, who concluded that “helping large numbers of young people not to become smokers could avoid hundreds of millions of tobacco-related deaths in the middle and second half of the twenty-first century, but not before. In contrast, widely practicable ways of helping large numbers of adult smokers to quit… might avoid one or two hundred million tobacco-related deaths in the first half of this century.”
We must not forget that electronic cigarettes are potentially one of those widely practicable methods of helping adults to quit. When it comes to tackling our greatest preventable killer, we must insist on nothing less than ‘evidence-based policy’ trumping ‘policy-biased evidence’.
OTHER REFERENCES IN THIS ARTICLE
40) http://profiles.nlm.nih.gov/ps/access/NNBCPH.pdf
41) http://www.cancer.org/aboutus/globalhealth/globaltobaccocontrol/the-global-tobacco-epidemic
42) General Lifestyle Survey, 2010 Office for National Statistics, 2012
43) http://whqlibdoc.who.int/publications/2009/9789241563925_eng.pdf?ua=1
44) Royal College of Physicians. Passive smoking and children. A report of the Tobacco Advisory Group of the Royal College of Physicians. London, RCP, 2010.
46) Opinions & Lifestyle Survey 2013. ONS.
47) Use of electronic cigarettes in Great Britain. ASH. April 2014.
48) Health Survey for England, 2013.http://www.hscic.gov.uk/catalogue/PUB16076
49) Brown J, Beard E, Kotz D, Michie S & West R. Real-world effectiveness of e-cigarettes when used to aid smoking cessation: a cross-sectional population study. Addiction. August 2014
50) Smoking drinking and drug use among young people in England in 2013. The Information Centre for Health and Social Care, 2014.
51) CDC. National Youth Tobacco Survey. Atlanta, GA: US Department of Health and Human Services, CDC; 2013.
52) http://www.who.int/mediacentre/factsheets/fs292/en/
53) Report by WHO. Electronic Nicotine Delivery Devices. FCTC/COP/6/10 Rev.1. 1 September 2014.
54) http://ec.europa.eu/health/tobacco/products/index_en.htm
55) http://tinyurl.com/ma8ajmf
