Jury out over ‘healthier alternative’

Despite a growing number of people choosing to consume e-cigarettes, there is not much scientific research to back up claims that e-cigarettes are “healthier” than traditional tobacco cigarettes.

“It’s complicated,” says Konstantinos Farsalinos, from the Onassis Cardiac Surgery Centre in Athens. “Because e-cigarettes are still fairly new, it is too early to gather any data on the epidemiological long-term effects.”

Dr Sarah Brewer, a medical adviser to electronic cigarette manufacturer Zebra, says e-cigs are about risk reduction. “I would much prefer someone use an e-cigarette than a normal cigarette,” she says.

The key ingredients to e-cigarettes are traditionally nicotine, water and propylene glycol or glycerine, plus flavourings. When the e-cigarette is activated, the propylene glycol-based solution is vapourised to create a mist similar to the smoke of a cigarette.

This is what makes e-cigarettes different to other nicotine replacement therapy products, says Dr Farsalinos. “E-cigarettes are unique in that they deal with both the chemical addiction of administering nicotine and the behavioral component of the addiction – holding something in your hand, inhaling and exhaling smoke. It isn’t just about the nicotine,” he says.

A problem with testing the health effects of e-cigarettes is that most users are either smokers or former smokers

But Armando Peruga, programme manager for the World Health Organization’s Tobacco-Free Initiative, says that until there is more evidence about the effects of e-cigarettes, the WHO will not recommend their usage.

“There simply has not been enough research – good or bad – on e-cigarettes, so authorities should be compelled to apply a precautionary approach to the products,” he says. “It’s better to be safe than sorry. There needs to be research on them to really allow the product to be in the market, otherwise we’re doing the general public a disservice.”

The medical industry itself is divided on whether e-cigarettes should be considered “healthier” than tobacco cigarettes.

“There is a lot of confusion with many medical colleagues happily jumping to conclusions about the potential benefits of electronic cigarettes without any proof,” says Dr Peruga. “If the product is to be sold as being ‘healthier’ than cigarettes, there needs to be proof that they are both safe and efficacious.”

Some e-cigarette companies accept this and are therefore taking a medical approach to how the products are made.

Nicocig says it is submitting its products to the Medicines and Healthcare products Regulatory Agency (MHRA) for approval. “We are submitting plans for a clinical trial to prove that our product will actually help people come off smoking and also proving that the ingredients in our products conform to European Pharmacopoeia standards,” says Nicocig managing director Nikhil Nathwani.

The company recently conducted a theoretical toxicology risk assessment on the ingredients which determined that, in current doses, they do not pose a risk to health.

“But, of course, to determine the long-term effects of these products, long-term studies are needed,” Mr Nathwani acknowledges.

CN Creative, a UK e-cigarette manufacturer, also says it will submit selected products to the MHRA in 2013 for clinical trials.

“These products need to be produced to stringent standards to conform to medical device directives. Otherwise there will continue to be too many issues around quality of production,” says CN Creative’s joint managing director David Newns.

The company’s own brand, Intellicig, is manufactured and tested in Manchester, and its nicotine preparation, ECOpure, is one of a number of products on the market that is manufactured to MHRA standards, containing measured doses of nicotine, water and glycerol.

A problem with testing the health effects of e-cigarettes is that most users are either smokers or former smokers in their 30s and 40s, and therefore already have a degree of coronary heart disease or lung disease.

“We would need several hundreds of thousands of people, studying them over ten to fifteen years, which is impossible right now,” says Dr Farsalinos. “So all we can do is observe the short-term effects on human health, and conduct in vitro chemical and psychotoxic studies.”

In one experiment with 76 subjects, which remains to be published in a peer-reviewed study, Dr Farsalinos and his colleagues compared the effects of e-cigarettes on the heart’s myocardial function – the heart’s muscle tissue.

“With tobacco cigarettes, the heart suffers a myocardial dysfunction within minutes of smoking. So we compared this with e-cigarette users,” he says. “We found that, at the baseline, smokers had a significant decrease in myocardial function, whereas e-cigarette users had no change.”

But this does not mean that e-cigarettes should get the green light from health authorities, warns Dr Farsalinos. “We don’t know what effect they have on the pulmonary function. There may still be significant adverse effects of using e-cigarettes. But the key question is whether these effects are worse than those caused by tobacco cigarettes. And right now, no doctor can answer that question for certain.”