E-smoke stokes controversy

ELECTRONIC cigarettes, which are also known as electronic nicotine delivery systems (ENDS) and “e-cigs”, are devices that deliver a vaporised mixture of nicotine and other chemicals to the user’s lungs.
Each device has an electronic vaporisation system and controls, rechargeable batteries, and cartridges, which contain varying amounts of liquid nicotine to be vaporised.Most ENDS also contain propylene glycol, which is an irritant when inhaled. Some ENDS have flavours that are attractive to the user, and some claim they do not contain nicotine. Although many ENDS appear like their tobacco counterparts, a match or lighter is not required for its use. All that is needed is for the user to puff on the device, and the ENDS heats up the liquid nicotine, converting it to a vapour, which is inhaled. The user appears to be smoking a cigarette or another tobacco counterpart, but there is no smell because there is no burning.

ENDS have been available in the United States since 2007. It is estimated that there are more than 250 brands available in the US, with different designs and quality, which impact upon the nature and potential danger of the vapour. As such, it is difficult to put all ENDS in the same basket. There is no information available on the number and types of ENDS available in Malaysia. According to the World Health Organization (WHO) Global Tobacco Survey 2011, the prevalence of ENDS smoking in Malaysian adults was 0.8% – an estimated 164,000 people. It is estimated that about one in five smokers in developed economies have tried the ENDS. Since the ENDS do not contain tobacco, they are not subject to laws. This means they can be purchased by anyone and can be used in public places.
Safety issues

Manufacturers claim that the nicotine vapour has advantages over traditional cigarette smoking. Some claim that ENDS is beneficial as an alternative to tobacco. However, most manufacturers of ENDS have not made specific claims about the safety of their products. Health experts and regulators worldwide are unsure about the safety or otherwise of the ENDS. Questions are being asked about the possible risks of inhaling nicotine vapour to the user and the public.

The jury is still out on the safety of ENDS. There is insufficient information from scientific studies available to make definitive conclusions about its safety. When you consider the time it took to prove the risks to health from tobacco smoking, the current state is not surprising. However, there is information already known about ENDS.

The ENDS products have been found to contain variable amounts of nicotine and other chemicals. The nicotine levels vary from what is labelled, and from batch to batch in some ENDS. The amount of nicotine delivered by an ENDS depends on the nicotine content of the cartridge in it. Some contain an amount like that of a cigarette, or a bit more. Other ENDS have nicotine levels like that of a “light” cigarette.

There are also cartridges that contain liquid, but without nicotine, for users who want to experience the sensation of smoking without the effects of nicotine. Nicotine is hazardous, whether it is inhaled, eaten or comes into direct contact with the skin. Nicotine poisoning can occur in vulnerable groups like children, pregnant women, breastfeeding mothers, young adults, senior citizens and those with heart conditions, and can lead to death in children.

Most ENDS contain a large amount of propylene glycol, which is an irritant when inhaled. It has been reported some ENDS that were tested contained other toxic chemicals as well. There is no way a user can find out about the contents of the ENDS they are using. Although ENDS do not produce environmental (second-hand) smoke, they produce second-hand vapour. There are reports that this vapour causes irritation to the eyes, nose and throat, affecting breathing and causing nausea in people with certain health conditions. Manufacturers claim that this is water vapour, and hence, harmless.

However, regulators and experts state that there is insufficient research to substantiate the manufacturers’ claims. Public health and consumer organisations have also argued that the public should not be subjected to second-hand vapour until it is proven safe for everyone, especially children, senior citizens and those with certain health conditions.

Tobacco companies
The recent involvement of tobacco companies in ENDs is pertinent.
The Wall Street Journal stated on July 31, that “giants of the tobacco industry are diving into the market”. It reported that “British American Tobacco’s first electronic cigarette, the Vype, has gone on sale. Reynolds American, the second-biggest tobacco company in the US and maker of brands like Camel and Pall Mall, recently held a flashy launch event for its Vuse e-cigarette. “Altria, the largest player and owner of Malboro maker Philip Morris, announced details of its first e-cigarette, named MarkTen, in June.” Prof Simon Chapman of the University of Sydney, Australia, wrote in the British Medical Journal that tobacco companies “want smokers to use e-cigarettes, as well as cigarettes, not instead of them. Its five goals are widespread dual use; retarding smoking cessation; re-socialising public smoking back into fashion from its forlorn exile outside buildings; conveying to young, apprehensive would-be smokers that nicotine is a benign drug; and welcoming back lapsed smokers”.

Smoking cessation and ENDS
Manufacturers and some advocates of ENDS have argued the usefulness of ENDS as an aid in smoking cessation. The WHO’s view is that “The efficacy of ENDS for helping people to quit smoking has not been scientifically demonstrated. “ENDS are often touted as tobacco replacements, smoking alternatives or smoking cessation aids. But we know that for smoking cessation products to be most effectively and safely used, they need to be used according to instructions developed for each product through scientific testing. “There are no scientifically proven instructions for using ENDS as replacements or to quit smoking. The implied health benefits associated with these claims are unsubstantiated, or may be based on inaccurate or misleading information.
“When ENDS are used as cessations aids, they are intended to deliver nicotine directly to the lungs. None of the approved, regulated cessation aids, such as nicotine patches and chewing gum, delivers nicotine to the lungs. “Therefore, the biological mechanism by which smoking cessation might be achieved by delivery of nicotine to the lungs and its effects are unknown. Delivery to the lungs might be dangerous. Therefore, independently of the effects of nicotine, it is of global importance to study lung delivery scientifically. “The dose of delivered nicotine is also unknown. It is suspected that the delivered dose varies notably by products, which contain nicotine in various quantities and concentrations.”

Consumer product or medicine
Consumer products can pose health risks and safety hazards. As such, it is the duty of regulators to protect the public by researching, assessing and collaborating in the management of the issues of health risks and safety hazards of consumer products used in daily life, including ENDS.

The regulations for medicines are considerably more stringent than consumer products. However, many consumer products are unregulated and are scrutinised by regulators when health risks and/or safety hazards are reported. Those who advocate that ENDS should be treated as a consumer product argue that there is no evidence that ENDS promote smoking. Those who advocate treating ENDS as a medicine recall the disastrous mistakes made in regulating tobacco and the time it took to do so. They point out that the dose of nicotine in the smoking cessation aids, which are regulated as medicines, is small. The pharmaceutical companies, who are aware of the health hazards of nicotine, have not produced such products in doses that would compete with the amount of nicotine in cigarettes. The question then arises as to why ENDS, where users can create their own dose of nicotine, should not be subjected to the same regulation as the smoking cessation aids produced by pharmaceutical companies. In short, the debate is about the place of nicotine in society and in the law. Regulators in some countries have already made their decisions. ENDS are banned in countries like Australia, Canada and Mexico.

It is banned from public places and subject to the same tight controls as tobacco in France. The Medicines and Health Care Products Regulatory Agency (MHRA) of the UK has announced that ENDS will be licensed as a medicine from 2016 to ensure that “standards of quality, safety and efficacy are met; monitoring safety in use, including over the long term, is provided for; and advertising is controlled through medicines provisions and any emerging risks, e.g. acting as a gateway to smoking tobacco, can be effectively managed”. Other countries consider electronic cigarettes legal, but are in the process of considering where and how people can use them.

What will be our Health Ministry’s decision?

Health message
The WHO has warned that ENDS “pose significant public health issues and raise questions for tobacco control policy and regulation”. Its health message is clear, i.e. “Until such a time as ENDS is deemed safe and effective and of acceptable quality by a competent national regulatory body, consumers should be strongly advised not to use any of these products, including electronic cigarettes.”

Dr Milton Lum is a member of the board of Medical Defence Malaysia. This article is not intended to replace, dictate or define evaluation by a qualified doctor. The views expressed do not represent that of any organisation the writer is associated with.

Disclaimer: Nothing on this blog should be considered or used as a substitute for medical advice, diagnosis or treatment. Blog visitors with personal health or medical questions should consult their health care provider.