About Dr Murray Laugesen
We have been fortunate enough to talk to the man who, outside the laboratories of the e-cigarette manufacturers themselves, probably knows most about the e-cigarette than anyone. Respected researcher, Dr Murray Laugesen of Health New Zealand, is one of the few (at the time of this interview) to have carried out an in-depth 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.
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?
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.
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?
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.
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?
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 medicinal products 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).
" ...nicotine is one of the safest of drugs, and is being sold as the alternative to the most dangerous consumer product – the tobacco cigarette"
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.
" The product is safe, efficacious, and possibly effective in stopping smoking."
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.
The WHO amongst others have raised concerns about the delivery of nicotine to the lungs via the device. Is this a concern you share?
First we now know that the nicotine dose per puff is low, and more puffs need to be taken to satisfy cravings as do tobacco cigarettes. Secondly we find that the e-cigarette nicotine is more likely absorbed in the upper airways rather than in the lungs – and so it will not be delivered very rapidly to the brain as in the case of the tobacco cigarette. The lower nicotine per puff in the e-cigarette and the slower uptake compared with tobacco cigarettes means the addiction risk is probably low. Perhaps e-cigarettes could be made more satisfying, without impairing the taste. Such e-brands may already exist, but the lack of research funds means we just do not know which they are. E-cigarette distributors wishing to move product, and public health agencies, wishing to save lives, need to pay much closer attention to nicotine deliveries, because without sufficient nicotine, e-cigarettes will not satisfy as cigarette substitutes.
" The lower nicotine per puff in the e-cigarette and the slower uptake compared with tobacco cigarettes means the addiction risk is probably low."
By using an electronic cigarette, using what we know of the ingredients, in what ways could a smoker expect their health to improve?
The main health advantage of using the electronic cigarette is if and when it replaces tobacco cigarettes, which carry a one in two risk of early death. Those who quit smoking tobacco by any other means such as cold turkey also reap that advantage as long as they do not relapse. E-cigarette users should switch completely or quit nicotine completely and avoid even one tobacco cigarette per day, as even a single cigarette daily greatly increases the risk of a heart attack.
" Propylene glycol, the main ingredient of e-cigarette mist, is known to kill airborne flu virus and bacteria, and tends to protect those exposed to it in inhaled air. "
Propylene glycol, the main ingredient of e-cigarette mist, is known to kill airborne flu virus and bacteria and tends to protect those exposed to it in inhaled air, whereas in contrast smoking tobacco doubles the risk of death in a flu epidemic. However we don't have any data as to the extent that propylene glycol inhaled intermittently from an e-cigarette might prevent inhalation of live bacteria and viruses. This merits research.
What conditions are not likely to improve after switching to the electronic cigarette?
Electronic cigarettes will not protect from diseases and damage due to past tobacco smoking, but they can help the smoker to stop making things much worse by continued inhalation of irritant and toxic tobacco smoke.
Despite your own studies in New Zealand and many supporters in the Tobacco Harm Reduction community, electronic cigarettes have been banned in Australia and in your own country, New Zealand; there seems to be a defacto ban in Canada and they look likely to be made illegal in the US under requirements which require testing which is physically impossible to carry out.
Yet such a ban on a product so much safer than cigarettes seems absurd. What is the reason for the opposition to the electronic cigarette?
Most regulators would privately agree the system is absurd. E-cigarettes are caught in a two-box regulatory trap. Nicotine products are in law usually either tobacco products or medicines. A choice between only two options is a dilemma for the regulator. E-cigarettes, seeking to be tobacco-free, no longer fit the first box. So regulators classify it in the second box, as a medicine. From a smoker's viewpoint, however, it belongs in a third box, as a lifestyle choice or cigarette alternative. It is also a question of market power. Big Tobacco controls Box no. 1, Big Pharma and the white coat health professional prescribers and dispensers control box no 2, while many smokers addicted to nicotine, the ones most likely to be sitting on death row, are powerless. They would like to buy from Box no. 3, but it is empty.
One study in Europe has suggested that making Snus illegal has cost thousands of European lives. While obviously difficult to quantify, in your opinion would a ban on the electronic cigarette in the US cost the lives of smokers?
Making snus illegal in Europe has helped ensure that the popularity of snus in Swedish men, the low cigarette smoking rates in men, and the low Swedish lung cancer rates in men have not benefited men in Europe. Compared with snus, the e-cigarette has the advantage of appealing to both women and men. Bans on electronic cigarette in countries such as the United States could frustrate efforts to know whether the e-cigarette can wrest market share from tobacco cigarettes. If I can, then a ban on their sale would crimp their potential to save lives. However, we need some statistics as to how many e-cigarettes have sold industry-wide, and how many of these customers are still smoking.
Please note that comments of the interviewee do not necessarily represent the views of E-Cigarette Direct.
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