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E-cigarettes may soon be sold as life-saving medicine
20 February 2013 by Andy Coghlan Magazine issue 2905. Subscribe and save For similar stories, visit the Drugs and Alcohol Topic Guide

Some countries ban them, but British regulators are considering electronic cigarettes on prescription – we take a puff on the evidence Editorial: "Tobacco giant wants to help you quit smoking" MY HEAD is starting to swim. It's a reminder of that buzz I used to get from smoking cigarettes 25 years ago, before I quit. There is a slight tickle at the back of my throat, but not the rasp of old. It looks like I'm smoking, but there is no smoke, just a vapour which I exhale Just letting off some steam (Image: Zuma/Rex over the heads of my colleagues here in the Features) New Scientist office. When I suck on the 1 more image "cigarette", a little red light appears at the end of the tube, and I draw in a vapour. It contains nicotine, the relatively harmless but addictive ingredient in tobacco that in normal cigarettes arrives in the toxic smoke of burning tar. Could devices like this (pictured) really be the best new hope against smoking, as some claim? We could have an answer soon, as UK regulators weigh up e-cigarettes as potential medicines. And a pivotal New Zealand trial is due to report later this year. CN Creative of Manchester, UK, makes Intellicig, the brand that I sampled, as a consumer product. The company is now putting forward its next-generation product, Nicadex, to the UK's Medicines and Healthcare products Regulatory Agency (MHRA) for approval as a medicine that aids quitting. If approved, says CN Creative's Nick Henderson, "it would be the world's first medically approved e-cigarette". And Nicadex has some serious industry weight behind it: British American Tobacco bought the company last December. The MHRA was looking at the issue before Nicadex came along. Pending approval from the government, expected in the next two months, the MHRA wants to regulate e-cigarettes primarily as medicines, which means they could be prescribed by doctors and sold as quitting aids in pharmacies and shops. And if Nicadex passes muster it could be the first to get approval, by the end of the year. The big attraction for smokers is that, unlike nicotine patches, e-cigarettes look and feel something like the real thing, except they do not smell, produce no toxic smoke or bother non-smokers. The global demand for them is rising, but can e-cigarettes really help or are they a gimmick that the tobacco

industry is now using to keep itself in business as smoking declines in the West? The UK outcome for Nicadex will set a regulatory precedent that could help other countries decide whether e-cigarettes should be defined as medicines, be banned – as they currently are in Canada and Australia – or simply classed as a type of tobacco product, as in the US (see "Medicine or tobacco product?"). The decision-making process in the UK could be helped by new evidence suggesting that e-cigarettes can help the most hard-core smokers quit. Certainly, the need is desperate. Despite anti-tobacco laws, smoking is the world's second biggest avoidable killer after high blood pressure, claiming 6 million lives a year and wiping 10 years from each smoker's life expectancy. And despite the availability of several medically approved quitting aids, known as nicotine replacement therapies (NRTs), which dispense nicotine through skin patches, lozenges or chewing gum, many smokers still find it difficult to quit. Robert West at University College London, an expert on quitting rates, says 7 out of every 20 smokers try to quit each year in the UK. Of these, only around 5 per cent succeed unaided, rising to 8 per cent with NRT, and 15 per cent if counselling is included. A review last year of 150 trials of NRTs concluded that on average, they increase the likelihood of quitting by about 50 to 70 per cent, so that's the "bar" e-cigarettes would have to meet (Cochrane Database of Systematic Reviews, doi.org/kjb). Quitting rates in the UK have levelled off in the last 20 years, says Gerry Stimson, founder of the London-based harm-reduction consultancy Knowledge, Action, Change. "Yet there's this thing staring us in the face that could turn things round very quickly." Until recently, the best evidence for whether e-cigarettes help people quit came from a pilot study of 40 hard-core smokers in Italy, all recruited on the basis that none intended to quit (BMC Public Health, doi.org/dhd5vr). Six months later, nine of them, or 23 per cent, had given up, though six of this nine continued using the e-cigarettes. In all, 22 of the 40 had either quit or more than halved their consumption of cigarettes. Now, the same researchers are about to publish a larger, year-long study of 300 smokers – again who had not been trying to quit. Although the full results are under peer review, the indications are encouraging. Lead author, Riccardo Polosa of the University of Catania in Italy, says that 9 per cent of the smokers quit, and a further 20 to 25 per cent cut intake of real cigarettes by at least half. This compares with an annual quit rate of just 0.2 per cent in Italian smokers, says Polosa, who is also a consultant for the Arbi Group in Milan, which manufactured and supplied "Categoria" e-cigarettes for the pilot study. In a further trial, published this month in Environmental Research and Public Health, Polosa and colleagues reported e-cigarettes helped some smokers with schizophrenia battle their habit (doi.org/kjc). Seven of the 14 volunteers more than halved their daily consumption of cigarettes, and another two quit altogether. Polosa says the trial is a good test because the volunteers were heavy smokers. The most telling results of all should emerge in September from New Zealand, where e-cigarettes and nicotine patches are being compared head-to-head with 657 smokers in a trial called Ascend. "It will allow us to draw inferences about how e-cigs perform against patches, the most widely used 'gold standard' cessation treatment," says Chris Bullen, head of the trial at the National Institute for Health Innovation in Auckland. Another crucial trial is under way in the UK on Nicadex, which CN Creative hopes will help persuade the MHRA. Henderson says that, unlike many rival products, Nicadex e-cigarettes would be made to the exacting quality and safety standards demanded of pharmaceuticals. For example, delivering exactly the same amount of nicotine with each puff. But as well as quality, e-cigarettes must demonstrate safety. "There is evidence that e-cigarettes, while less polluting than conventional cigarettes, put toxins in the air," says Stanton Glantz, a vocal critic of

e-cigarettes at the University of California, San Francisco. The World Health Organization warned in 2008 that the safety of e-cigarettes had yet to be established. So how safe are they? In e-cigarettes, liquid nicotine is vaporised for inhalation by a battery-operated heating coil. Mixed with water and carriers such as propylene glycol, it does generate toxins, but at minuscule levels compared with those in tobacco smoke. A 2010 study in the Journal of Public Health Policy found that levels of carcinogens were typically 1000 times higher in smoke from standard cigarettes compared with the vapour from e-cigarettes (doi.org/fqxjp3). The UK anti-smoking charity Action on Smoking and Health backs the qualified use of e-cigarettes as a "harm reduction" approach. And its recent surveys suggest interest among smokers in e-cigarettes is rising, with about one million users in the UK. For me, a puff on an e-cigarette was a nostalgic pleasure. But it prompted no desire to pop down to the corner shop and buy a packet of ciggies. Nicotine? I don't need it. This article appeared in print under the headline "E-ciggies to stub out your habit?"

Medicine or tobacco product?
Countries everywhere are in a fix over how to regulate e-cigarettes. Are they medicines that need to be rigorously tested, or simply another form of cigarette to be allowed on general sale? The biggest dilemma is whether to ban them until their safety and quality as consumer products can be proven. Australia and Canada have gone this way. They also do not want to dilute anti-smoking messages. Their citizens can buy e-cigarettes online, importing them for their own use, but they will not be seeing them on shop shelves soon. In the US, the Food and Drug Administration has been forced by a court ruling to classify e-cigarettes as tobacco products rather than medicines, meaning that they can legally be sold as consumer products. But the FDA has warned citizens it cannot vouch for the safety of e-cigarettes. It has also accused some vendors of violations, such as claiming that e-cigarettes can help people quit without scientific proof. Within the next few months, UK regulators could provide a model for which way to go. After a lengthy public consultation, the Medicines and Healthcare products Regulatory Agency (MHRA) has proposed regulating them as medicines to the UK government, and some companies like CN Creative are preparing to submit dossiers for possible approval. But the MHRA is also keen on compromises that would also allow continued retail sale of existing e-cigarettes, so that smokers who have switched to them do not return to smoking. Anti-smoking UK charity, Action on Smoking and Health agrees this "light touch" regulation is the best way forward.

From issue 2905 of New Scientist magazine, page 6-7. As a subscriber, you have unlimited access to our online archive. Why not browse past issues of New Scientist magazine?

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