Ken Wassum, Associate Director, Clinical Development & Support
Everyone in the field of tobacco dependence treatment can agree on one thing. There is no tobacco product or nicotine delivery device more dangerous than the traditional combustible cigarette. However, that is where the common ground seems to end when the discussion turns to the electronic cigarette. And when those outside the field of tobacco dependence treatment weigh in the discussion gets even livelier! I know of no other device that has generated such strong feelings as the e-cigarette.
For those of you who may not be familiar with the e-cig it is a device that looks a lot like a cigarette. It has a cartridge with a nicotine solution, a battery, and a heating element. When the user takes a “drag” on it the battery vaporizes a small amount of the solution which the user takes into their mouth or lungs. It produces a vapor, not smoke.
A recent PubMed search using the term “electronic cigarette” yielded about 60 articles that have been published in scientific and health journals since 2007. To be very candid, I have not read all of these articles, just as I have not read every article on FDA-approved cessation medications that have been published in the past 5 years. But I have read a lot of them.
Over the past 3 years or so I have posted a number of blogs about the e-cigarette as I have been very intrigued by the device. I have worked in the field of tobacco dependence treatment for about 20 years and am committed to evidence-based treatment. I am also a former pack-a-day plus smoker who began smoking at age 16 and quit at age 41. So I know what it is to be a smoker and I have my own experience about what it took to quit. My father died of lung cancer, so like most Americans I have lost a family member to smoking. But, I also have a sound understanding of the 8700+ peer reviewed studies that provide the scientific evidence for what is proven to be effective in helping smokers quit.
Two primary things have to happen for a medication or drug delivery device (i.e. e-cigarette, nicotine patch, nicotine gum, etc.) to be an approved cessation tool. First, it has to be shown to be “effective” in helping smokers quit. To do this large studies lasting two or three years are conducted. Smokers are randomly assigned to a medication group or a “control” group who gets a placebo, but the smokers do not know which they have. For a drug to be “effective” it has to generate a statistically significant higher number of quitters using the medication than those who did not use the medication. More than one study is required to demonstrate effectiveness.
Secondly, a medication or drug delivery device has to be proven to be “safe”. A drug or device that is not safe means that it has demonstrated harmful effects that outweigh the benefits or that demonstrate a significant risk to those who use it.
So where does this leave us with the e-cigarette when it comes to effectiveness and safety? To date a few studies have suggested that the e-cigarette might be effective in helping smokers quit. Studies by Eissenberg and others have shown the e-cig to “expose users to measureable levels of nicotine….and suppress nicotine withdrawal symptoms.” Dawkins produced similar results with a small group of smokers. Caponnetto and colleagues conducted a study where 3 smokers quit and another study where 40 smokers not interested in quitting “substantially reduced cigarette consumption”. All this is great, but the numbers are just too small to conclusively demonstrate that the device is “effective”. It looks promising, but needs more study that would randomize a much larger number of smokers to e-cigs and “placebo” e-cigs.
With regard to “safety” we have no data at all. Analysis of a small number of e-cigs has turned up occasional toxins, albeit at very low levels. However no systematic safety analysis has been done. This is because the manufacturers of e-cigarettes made a conscious decision to not submit the product for approval as a cessation device, but as an alternative type of “cigarette”. For e-cigarettes to be considered a nicotine delivery cessation device (or medication), they have to go through the rigor of these trials. The risks are too great to use them as a cessation device on a large scale only to find that they cause long-term health problems. Safety has to be proved first.
At Alere Wellbeing we train our Quit Coaches not to “demonize” the e-cigarette. No one who comes to us using them is told that they must stop using the e-cigarette or that e-cigarettes are anywhere near as dangerous as a traditional cigarette. The same holds true for those who ask about using the e-cigarette to quit. Instead they are told that we don’t know whether they are truly effective in helping smokers quit and that we don’t know if they are safe. As such, the e-cigarette does not meet the criteria for an evidence-based method for helping smokers quit.
I personally think the electronic cigarette has great potential to be a useful tool to help smokers quit. But at this point it is just potential – we need more data to be sure we would not be doing harm in advising e-cigarette use. Until then we will recommend smokers use FDA-approved nicotine delivery medications.
Ken Wassum has been treating tobacco users for over 19 years. He is past President of The Association for the Treatment of Tobacco Use and Dependence and previously served on its Board of Directors. Join him as he blogs about the effects of the tobacco epidemic, the efforts of cessation advocates, and the work left for us to rid the world of nicotine addiction. Read Ken Wassum's blog posts.
Visit www.alerewellbeing.com to learn about Alere Wellbeing’s Quit For Life® Program, the only commercial tobacco cessation program in the U.S. with proof of effectiveness published in multiple peer-reviewed scientific journals over the course of 25 years.