26th May 2009
We have been fortunate enough to talk to the man who, outside the labatories of the electronic cigarette manufacturers themselves, probably knows most about the electronic cigarette. Respected reseacher, Dr Murray Laugesen of Health New Zealand, is one of the few to have carried out an indepth analysis of the contents of the electronic cigarette, and has presented on his findings at international conferences. In this interview we talk to him about concerns over the electronic cigarette.
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ECD In previous interviews we have conducted scientists have estimated that, based on the evidence available, the risk to health from electronic cigarettes is between 1% and 1/10th of 1% of real cigarettes. You have actually done a product assessment of Ruyan electronic cigarette. What's your assessment of the risks?
ML We would rate the Ruyan electronic cigarette two to three orders of magnitude safer (100 to 1000 times safer) than a tobacco cigarette. We say this because our testing of the Ruyan e-cigarette for nearly 60 major toxicants has not found any cigarette smoke toxicants in any but trace quantity so far. This is not surprising, as the operating temperature of the atomiser of an e-cigarette is 5 to 10% that of a burning tobacco cigarette, so the volatile cigarette smoke toxicants are not created.
Provided each e-cigarette maker has certified good manufacturing practices, plants and uses pure ingredients their emissions should be harmless also. The problem is that most manufacturers do not comply in this respect. Ruyan has taken a risk in publicly testing their product. They come out squeaky clean.
ECD: When we first requested an interview with you several months ago, you suggested we wait, as you might well have some more information regarding the products. There has also been more research conducted in New Zealand since that time. What are the latest developments?
ML: New Zealand researchers at the Dublin conference of the international Society for Research on Nicotine and Tobacco in late April 2009 presented research showing the Ruyan e cigarette is free of cigarette smoke toxicants, is able to increase nicotine in the bloodstream of users, and relieve cravings.
ECD: The position taken by most public health groups in the US is that these devices should not be used until they have undergone further extensive testing. Is this a position you agree with?
ML: With prescription drugs, we would agree. But nicotine is one of the safest of drugs, and is being sold as the alternative to the most dangerous consumer product – the tobacco cigarette. Low risk compared to cigarettes is the real world risk that smokers face. The risk that distributors face is of being sued for defective product – an insurable risk and not huge for sellers of e-cigarettes.
Further “extensive testing” to prove near zero absolute safety in the USA means testing to FDA protocols. In the USA this costs millions of dollars, and several years delay, and implies large price markups on medicinals under near monopoly conditions. There needs to be either a simpler or provisional slate of tests required, short of medicinal registration, or, as in the UK, these devices and refills need clearance to be sold as non-medicines (with the option of some brands later qualifying as medicines).
So my hope would be that the FDA and other regulators will review their stance on e-cigarettes with the aim of how to save the most smokers' lives most effectively, balance this public health imperative against their brief to protect consumer safety, and possibly fashion a new regulatory approach for faster acting nicotine products.
The product is safe, efficacious, and possibly effective in stopping smoking. E-cigarettes have been on sale in the UK since 2007 (classed as non-medicines), and in the USA for over one year without any harm reported in the media or medical journals, or by doctors reporting adverse reactions. It is a product that potentially just might assist smokers to quit and therefore cut the 1 in 2 cumulative death rate in smokers. Further research is needed.
So far the only response from almost every government regulator has been to say that the nicotine in e-cigarettes means they classify as medicines, requiring millions of dollars and years of delay and thousands of pages of paper work to follow the regulatory processes to bring this product to market. This cost is repeated as each new product is patented and tested, for approval. Patents are in dispute, and further patents and improvements in design are in the pipeline.
There is a clash also between the absolute safety of a cigarette substitute (in fact, no drug is 100% safe) and the relative safety of e-cigarettes compared with tobacco smoking. Regulators decree what is good for populations, and this can clash with fundamental rights of citizens to be able to buy any reasonably safe product that will diminish their risks of dying early from continuing use of smoking tobacco.
Government tobacco control agencies could assist by sitting down with medicine regulators, to balance these considerations, and produce relaxed safety regulations for fast acting nicotine products as proposed by the tobacco group of the Royal College of Physicians London recently.
The tobacco control community could assist by working with government health and research agencies, to fast track this product's research and development as the first of a new generation of possible substitutes to replace tobacco smoking. But one thing is clear - smokers need a whole generation of better products to provide their needs for safe nicotine, and the sooner these can be coaxed to market, the better.
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