We know e-cigarettes are safer than smoking, so is Australia being too cautious in not legalising them?
We know e-cigarettes are safer than smoking, so is Australia being too cautious in not legalising them?
Earlier this month, the New Zealand Government swapped fear and suspicion for faith and optimism, and began the process of legalising the sale and supply of electronic cigarettes.
In a move that delighted e-cigarette users, or vapers as they are known, the ministry of health opened consultations on legislative change that it believes will “maximise the potential benefits of e-cigarettes and minimise any risks”.
While acknowledging those benefits and risks were not yet conclusive, it recognised that “now is the time” to move forward and end its prohibition on vaping.
How different the picture is in Australia. Far from taking a more liberal stance, policy-makers are not only resisting the move to legalise e-cigarettes but tightening access and further restricting the ability to vape. Caution and suspicion remain the overwhelming sentiments this side of the Tasman.
The debate around electronic nicotine delivery systems (ENDS) – be it their use as a smoking cessation aid, the potential long-term health risks, or the fear that widespread use could normalise smoking and lead to young vapers progressing to tobacco smoking – has been long and divisive.
But it’s the voices in such debates – those of regulators and policy-makers – who are currently shaping Australia’s cautious approach.
And it’s not only nicotine-based e-cigarettes that are viewed with unease. Increasingly, those containing only a flavoured liquid, which is turned into vapour and inhaled, are facing the same restrictions as tobacco cigarettes.
In Western Australia and South Australia, the sale of all electronic vaporisers is illegal, irrespective of nicotine content, while New South Wales and the ACT have recently clamped down on their sale, usage and availability. New laws in Victoria coming into effect next year will also outlaw the open sale of equipment in specialist vape shops, legislation branded as draconian by vape retailers.
While one of the principal aims of legislation is to restrict access to children – an objective no one disagrees with – others believe the sweeping nature of new regulation is symptomatic of a risk-averse mindset that prevents smokers from using e-cigarettes to kick the smoking habit.
The counter-argument is simple. Opponents of liberalisation largely accept e-cigarettes are an improvement on tobacco smoking, but they do not believe the benefits are even close to outweighing the potential harm to public health.
At the fundamental core of Australia’s policy on e-cigarettes is its ban on liquid nicotine. Explaining its self-described “cautionary approach”, the federal Department of Health maintains there is “limited evidence” for e-cigarettes on the quality, safety and efficacy for smoking cessation or harm reduction, and stressed that nicotine for use in e-cigarettes to help people quit smoking has not been approved by the Therapeutic Goods Administration (TGA).
“The department supports the use of products for smoking cessation that have been evaluated for safety and efficacy and approved by the TGA,” a spokesperson told The Medical Republic. “If nicotine for use in an electronic cigarette was to be approved for therapeutic purposes, such as for assistance to quit smoking, it would have to be evaluated by the TGA before it could be legally supplied for this purpose. The TGA has not evaluated or approved any electronic cigarettes for this purpose.”
Illustrating that disapproval of e-cigarettes extends to the no-nicotine variety, the department said the liquid flavours – of which there are hundreds – are also a “cause for concern”.
It singled out one, Diacetyl, a buttery-flavoured chemical used in popcorn, caramel and dairy products, as having the potential to cause irreversible lung disease – known as popcorn lung – when inhaled, rather than digested.
Despite the nationwide ban on nicotine, there are loopholes. Under the TGA’s Personal Importation Scheme, nicotine can be imported into Australia if the user is in possession of a doctor’s prescription. Yet as nicotine is listed as a schedule 7 dangerous poison – the same as arsenic and strychnine – and has not been approved by the TGA, the search to find a GP prepared to write such a prescription could be a long one.
One doctor who will is Dr Attila Danko, president of the New Nicotine Alliance (NNA), a consumer advocacy group fighting to legalise the use of e-cigarettes. Dr Danko, a smoker from the age of 11 until he weaned himself off the habit with the aid of e-cigarettes four years ago, told The Medical Republic that not one of 20 doctors visited as part of a mystery patient survey were prepared to prescribe nicotine.
“Getting a prescription is a legal avenue but very few doctors will prescribe it,” he said. “When I first began using e-cigarettes I did get a prescription from another GP who has similar views to my own. Now I can’t be bothered. It is illegal to use e-cigarettes with nicotine but there does not appear to be the appetite to prosecute.”
Regardless of whether there’s the will to prosecute individual users, vapers told a senate committee hearing into e-cigarettes earlier this year they felt they were, “labelled as criminals” because they were giving up smoking “the wrong way”.
The NNA has now taken its fight directly to the TGA by lodging a submission to have low-strength nicotine – concentrations of 3.6% or less of nicotine in e-cigarettes – removed as a schedule 7 dangerous poison. A four-week consultation period was set to end on September 1, with the TGA due to publish an interim decision in February and a final verdict in March.
“Instead of waiting for regulators to change the law, we have decided to try and change it ourselves,” Dr Danko said. “We want to differentiate between pure nicotine and low strength nicotine. Any nicotine at the moment in banned, which is a bit of a nonsense because if you ground up eggplant [which contains nicotine] and put it in an e-liquid it would be illegal. “You could make an argument that Greek restaurants should be prosecuted for selling moussaka because it will contain a degree of vaporised nicotine.”
Dr Danko admitted the submission to the TGA is likely to fail, but said the application, coupled with recent developments in New Zealand, will put pressure on the government “to push the argument forward”.
Central to his case, and that of fellow proponents of e-cigarettes, is the use of the devices in harm reduction and in smoking cessation. According to Dr Colin Mendelsohn, a tobacco treatment specialist and associate professor in the school of public health and community medicine at the University of NSW, the number of vapers in Australia is in the region of 250,000, 43% of whom use nicotine.
Users are from a cross section of socio-economic groups, he said, but skewed to a younger demographic, with more male vapers than female. But while the numbers are increasing, many more are being discouraged by what he called the “very strict regulatory environment”.
“I think we are all agreed you need some regulation,” he told The Medical Republic. “We need rules around protecting children, appropriate advertising and quality control. But e-cigarettes also need to be available for smokers to help them quit or for harm reduction. We don’t want to discourage that.”
Citing research from Greek cardiologist Konstantinos Farsalinos, Mendelsohn said studies have estimated six million people in Europe have quit smoking through the use of e-cigarettes.
“If two out of three smokers’ die from their habit, you have just saved four million lives and that is without cost to public health,” he said. “The priority here is that we improve public health and people stop smoking. That is the most important thing. And if e-cigarettes work – and the evidence is convincing – that is the end of the argument.”
Not according to Simon Chapman, emeritus professor in the School of Public Health at the University of Sydney, who said the “undoubted benefit” for those who stop smoking altogether must be seen alongside the risks for those who “dual use”.
“What you have to include in the equation is the people who might otherwise have quit smoking but who decide just to cut back, thinking they are reducing risk,” he said. “Most people hearing that argument think that surely it’s better to smoke 10 rather than 20 cigarettes a day, but cohort studies have found people who cut back did not experience reduced death rates.
“For people who quit smoking altogether and start vaping there is undoubted benefit. For those who dual use and keep on smoking but cut back, there is very poor evidence that it is harm reducing.”
Furthermore, history is littered with false dawns, or “monumental blunders”, as Professor Chapman described them, with filters and lights and mild cigarettes purporting to offer previous salvations to the high tar content of cigarettes.
“Both conferred no benefits to reducing actual risk but they convinced a lot of people they could continue to smoke in the mistaken belief their risk was being reduced,” he said. “One of my concerns with e-cigarettes is that we are seeing a mirror image of what happened then.”
As for the argument that e-cigarettes are a better option than traditional cigarettes, Professor Chapman agreed but added: “Everest is far higher than the Matterhorn but you can do yourself great injury by falling off either. E-cigarettes may be less dangerous than cigarettes. Nonetheless, if a lot of people use them in the community it produces a significant body of health problems.”
Quit Victoria manager of tobacco control policy, Kylie Lindorff, said the organisation wanted to see a total ban on nicotine and non-nicotine vaporising products until they are a proven smoking cessation aid.
She echoed Professor Chapman’s fear that far from accelerating quit rates, e-cigarettes could prolong nicotine addiction and even encourage impressionable young people to take up smoking. “We have the lowest rate of youth smoking ever recorded, so what we are doing in Australia around high prices, plain packaging and mass market media campaigns, absolutely works in reducing prevalence,” she said.
“We think people will be enticed to e-cigarettes and we’ll have a new generation who have a nicotine addiction who wouldn’t have done had they not been exposed to vaping.
“The claims about how wonderful they are from the UK [which has a far more relaxed view than Australia] are failing to recognise that most people are using both e-cigarettes and tobacco so there is no harm reduction.”
Lindorff branded non-nicotine products as, “gimmicks and toys” which, with their variety of flavours, are “clearly aimed at children”. Though welcoming legislation to prevent under 18s buying such products and being exposed to advertising, she called for a complete ban.
“We want to see all those products gone, off the market until such time as they go through the TGA approval process and are shown to have a therapeutic benefit,” she said. “That is exactly our position for nicotine e-cigarettes as well.”
Lindorff pointed to research released this month by Cancer Council Victoria which found former smokers exposed to e-cigarette advertising – which states and territories are cracking down on – triggered an urge to light up.
“We make absolutely no apology for taking a cautious approach to these products particularly when there are proven nicotine replacement therapies on the market in Australia that we know are safe.” It is this question of safety, and the fear that vaping acts as a gateway to tobacco smoking, that creates particular divisions in the medical and public health community.
In the controversial field of e-cigarettes, research is produced, and then discredited, with monotonous regularity. The simmering debate sometimes borders on the personal. One of the most contentious views is that of Public Health England, a UK Government health agency, which concluded e-cigarettes are, “unlikely to exceed 5% of the harm from smoking tobacco”. Put another way, it believes e-cigarettes are 95% safer than tobacco cigarettes, a figure backed by the UK’s Royal College of Physicians.
It is regularly held up as hugely significant by proponents of vaping – and regularly slapped down as worthless by opponents. “We know what is in this vapour mostly,” Mendelsohn said. “We know most of the 7000 chemicals in cigarette smoke are absent, and those that are present contain less than 5% of what is in tobacco smoke, and in most cases it’s less than 1%.”
He also rebuked the “gateway” theory, saying e-cigarettes are almost exclusively confined to young people who already smoke. “It’s very rare for never smokers to become regular vapers,” he said, again quoting the Varsalinos study that found only 0.09% of vapers had never smoked.
Such a view is backed by Wayne Hall, inaugural professor and director of the Centre for Youth Substance Abuse Research at the University of Queensland, who argues that studies supporting the gateway argument are “still very speculative”.
“I am not quite as sold on this as being massively disrupting or a game changer, but there is potential value in these sorts of products and that is what we should be looking at,” he said. “But the policies we have adopted preclude us from exploring them. We are treating e-cigarettes in Australia the same way as heroin and cannabis.
“It’s certainly true that we don’t know the long term health risks, but what we do know is that what is in vapour, as opposed to cigarettes, is chalk and cheese in terms of the quality and number of nasties.
“Over the long haul I wouldn’t be surprised if inhaling vapour made up of various constituents, and flavouring containing nicotine, is bad for your lungs. But it’s not a question of whether it is risk free. It’s a question of what the comparator is. And if the comparator is smoking cigarettes then it’s a no-brainer that you would allow smokers to use them.
“In WA you can’t even sell something that looks like a cigarette but it’s quite ok to sell cigarettes. It just shows what an absurdity the law is.
“The crazy thing is that we are restricting a less risky product while we continue to allow the most risky to be sold at corner shops.”
Professor Chapman has derided Public Health England’s 95% safer figure, arguing that members of the committee who reached that conclusion had connections with tobacco and pharmaceutical companies. Such a “handpicked group” as he described them “were almost guaranteed to come up with a result like that”.
“The reason people are saying e-cigarettes are less dangerous, myself included, is that there is no combusted material so you are not inhaling particles from burned carbon and that has got to be far less bad,” he said. “But you are still inhaling nicotine and propylene glycol and a lot of flavouring chemicals, none of which are approved for inhalation.”
He added that literature is emerging demonstrating that vaping creates inflammation of the airways, respiratory tissue and cardiovascular problems. The devastating impacts of tobacco smoking surfaced only 20 or 30 years after smoking became a social norm, he said.
Research published in Pediatrics, “added to the case that e-cigarettes are extending and expanding the tobacco epidemic”.
Quit Victoria’s Kylie Lindorff also rejected the PHE report, describing it as “simply not robust”. “It has been widely critiqued yet it keeps cropping up,” she said. “We absolutely do not agree that is an accurate figure. “Yes, e-cigarettes are less harmful but nowhere near as less harmful as the claims coming out of the UK.”
Mendelsohn described the doubts raised over PHE as “absolute rubbish”, claiming the 95% figure was derived from a study of several pieces of research. He says some opponents are stuck in a blinkered mindset and can’t comprehend that a nicotine replacement therapy has emerged from a consumer movement rather than from public health bodies.
Hall said it was understandable public health bodies have reacted in such a way, having been “enormously successful” in driving down smoking rates.
“It’s a fabulous success story and those who are opposed to e-cigarettes have played a major role,” he said. “There have also been failed attempts at harm reduction with filters and low nicotine cigarettes and that has tended to make them think we have to be careful.
“But while it’s all understandable, I do think the policy they are advocating is hard to defend.
“I think a more moderate policy would allow limited sale of these products to smokers that avoid the sort of risks they are concerned about. But people who support current the policy have closed their minds and it’s hard to imagine what evidence would change that.”
The role of tobacco firms is further muddying the waters, with public health bodies wary of inadvertently playing into the hands of an industry they have spent so many years fighting. Although the e-cigarette was the brainchild of a Chinese pharmacist, himself a smoker whose father died from lung cancer, big tobacco has moved into the space either by acquiring small manufacturers – of which there are many – or launching their own e-cigarette operations.
“The tobacco industry is pushing hard to get a range of products and they are operating through names that make it look as though they are not tobacco products, so it’s not BAT (British American Tobacco), it’s Nicoventures (the division launched by BAT in 2011),” said Mike Daube, professor of health policy at Curtin University. “Certainly there is concern tobacco firms are using this to promote their standard products. Their primary interest is still in promoting cigarettes and it may well be this is helping them to do that.”
On the general debate about e-cigarettes, Professor Daube added: “I’m not keen on this Manichean view that everything is black or white. I take a cautionary view because we still don’t know very much about these products. The evidence that they are a cessation miracle is not compelling and there are concerns about future harm.
“We are as good as anywhere in the world for reducing smoking rates in adults and kids so I also think we need to be cautious that we don’t do anything that detracts us from the measures that we know work: price, good public education, tough warnings and so on.”
Dr Danko described the conversation around tobacco firms as a “great argument” for those intent on resisting the emergence of e-cigarettes as a smoking deterrent.
“It becomes an argument of ‘oh, there’s the devil and we have to fight the devil’,” he said. “Once you bring big tobacco into it, it becomes good versus evil, people protecting poor victims from this rapacious industry.
“Tobacco firms are placing an each-way bet and they probably don’t mind which way it goes. If there is liberalisation they will have some products in the market. But they are certainly not dominant, and not one e-cigarette sold in Australia comes from a tobacco company.” –
Hall on the other hand, said with tobacco companies acquiring smaller manufacturers it “reinforces understandable anxieties” that it was just another attempt of the tobacco industry to “undermine tobacco control policy”.
With research to back both sides of the debate, people are “cherry picking” pieces of research to justify their arguments, Hall said.
Positions appear entrenched, so reaching any sort of consensus seems a long way off.
Image credit: Vaping360
