Cardiology researcher Konstantinos Farsalinos is interviewed by researcher Paul Bergen on behalf of the Ashtray Blog on the motivations for his 2012 study in the latest of our series of e-cigarette interviews.
Bio: Dr, Farsalinos has been practicing medicine since 1992. After six years at the Charles University in Prague, he returned to Greece to specialize in internal medicine and then cardiology. He presently holds the post of Research Fellow in the Department of Cardiology in Onassis Cardiac Surgery Center in Athens, one of the biggest specialized cardiology and cardiac surgery centers in Greece and the only heart transplantation center in the country. His research interests are imaging in coronary artery and valve disease, myocardial function, myocardial deformation, and coronary circulation.
Awareness of Electronic Cigarettes
PB: How did you first become aware of electronic cigarettes?
KF: I knew about the existence of electronic cigarettes since 2009-2010. However, I never tried to find more information about them. In November of 2011, two friends sent me an MMS message with an attached photo of them using electronic cigarettes. I told them that they are useless (although I had no idea about them), however they kept sending me photos. That was the spark that brought up the idea to start performing research on electronic cigarettes.
PB: What is the prevailing mood in Greece regarding their use?
KF: It is estimated that more than 250,000 people use electronic cigarettes here in Greece. The mood is similar to everywhere else: users are fanatically supporting e-cigarettes, authorities (and many scientists) are against it. Unfortunately, no regulation has been implemented yet, however we are the only country (to the best of my knowledge) where more than 100 e-liquids have been tested by independent university toxicological laboratories and have been found to contain no traces of nitrosamines, heavy metals or polycyclic aromatic hydrocarbons. Worldwide, I am aware of only one European company (producer of e-liquids) that has invested money to perform even more advanced laboratory and cytotoxic tests on several e-liquids. In Greece, it was the association of Greek e-cigarette businesses that took the initiative to do these tests.
Electronic Cigarette Heart Study
PB: You seem to have designed a study which avoids the pitfalls of much of the bad research of the last few years. For instance, you are studying actual physiological effects on people who were familiar with the product rather than either using naïve subjects, a smoking machine or use-independent analysis (such as that seminal FDA analysis). Was this simply a byproduct of reasonable and logical research design or were you reacting to the sloppy protocols that seemed to be dominating the field?KF: Criticizing protocols is an easy job, but it does not offer new knowledge. Performing research is hard, but this is what we need. We have the ethical obligation towards the millions of users worldwide to inform them if these products are better than tobacco cigarettes or not. We have data from laboratory analysis; most (if not all) are favorable for e-cigarettes compared to tobacco cigarettes. Although we should continue with in vitro studies, it is time to proceed with clinical research. Studying experienced users is important because they use the product more intensively compared to novice users. Moreover, we have to see the consequences of using e-cigarettes in this group that have quit smoking. However, it is equally important to see what happens to smokers, because e-cigarettes are marketed for this population. So, both are important and we will proceed in this way. I should emphasize that the key point is the COMPARISON. Since e-cigarettes are marketed for the smoker, it is vital for research to compare their effects with the effects of regular cigarettes. No-one is suggesting that e-cigarette should be used by non-smokers. Humans are made to inhale clean air only. However, knowing the devastating consequences of smoking, and accepting that the vast majority of smokers are unable to quit with currently available methods, it is crucial to perform rigorous research on a tobacco harm reduction product that has showed the potential to help a lot of people in the future. And in this case, tobacco cigarettes are the “opponents”.
Studying E-Cigarettes in the Context of Smoking
PB: What I find refreshing about reading your abstract is that, even if you are appropriately cautious about any conclusions to be drawn from a single study (and I will return to this issue), is your point that the health effects of using electronic cigarettes need to be examined within the context of tobacco smoking.KF: I think my previous comments have already answered to your question. This is absolutely crucial, and everyone knows it. I have never seen a seller or producer in e-cigarette business saying that this is a safe product and should be used by everyone. The target is the smoker, so it is obvious that we should compare e-cigarettes with tobacco cigarettes.
Tobacco Harm Reduction
PB: Yet, that being said, if harm reduction efforts are as successful as we hope they would be, we could eventually be faced with the majority of vapers not having a previous history of smoking. If the health effects turn out to be as inconsequential in the long run as they are in the short, would that be so bad?
KF: It is very early to comment on this; however, we talk about harm reduction and not harm elimination. There might be a very small risk from electronic cigarettes, very much less than risk from smoking, but why should non-smokers face that risk? Perhaps, if electronic cigarette is proved to be that much safer, we could use it as a method to avoid smoking initiation in the future. But this is a very complicated matter and it is too early to discuss it.
PB: We already discussed this in brief communications before this interview but even if the point seems obvious it bears repeating. The research seems to have split into two types where some seems motivated by harm reduction where the effects are discussed in the larger context and the other where any effects are discussed without any reference to smoking.
KF: For some reason, several scientists do not accept harm reduction as a useful strategy. I have to respect but at the same time disagree with their opinion. Harm reduction would be useless if we could provide smokers with highly successful means of smoking cessation. However, we know that more than 4 out of 5 smokers are unable to quit with currently available medical products. What shall we do with them? We know the effects of smokeless tobacco in harm reduction; Sweden has the lowest rate of lung cancer in males, mostly due to the use of snus instead of regular cigarettes by that population. Now we see a new product in tobacco harm reduction, the only one that does not contain tobacco and the only one that deals with both the behavioral and chemical addiction to cigarettes. We have to study it.
PB: This is not so much to do with your study but with your opinion on the use of harm reduction in general so do not feel bound to answer it if you do not wish to. You say “harm reduction would be useless if we could provide smokers with highly successful means of smoking cessation”. It is no secret that there are many people who function better when they have access to nicotine (either they feel much better or feel less pain, or their brains simply work better); for these people cessation is not a reasonable option. In these cases cessation is a worse option than a harm reduced product. I would argue that as with any drug or behavior that many people find attractive, harm reduction and cessation methods are complementary rather than competing strategies. Thoughts?
KF: Everyone is aware of the benefits of smoking cessation. People who need nicotine for their everyday activities will be unable to quit with current methods even if they try everything available. And no-one can force them to quit. For these people, harm reduction should be offered as an option. Yes, harm reduction and cessation methods are complementary, but only because we cannot find successful ways to treat addiction in all smokers.
PB: In terms of the science itself the context should not matter, results will be results, however when it comes to public health, the research context influences the discussion which could have real effects on public health.
KF: Indeed, I think that all clinical studies that are and will be performed have a big impact on public health. You know, most authorities want to regulate the e-cigarette market. And this is absolutely necessary! Today, anyone can open a shop or an e-shop, make their own liquids or find a producer somewhere, and start selling these products. No standards have been implemented. This is very dangerous, and it should stop. Proper research will provide the information on the way health authorities should regulate e-cigarettes. Since the product is addressed to smokers as an alternative to cigarettes, a direct comparison is the only way to properly guide the scientific community and the public health authorities on the true impact e-cigarette use will have in the future.
PB: If cigarette smoking did not exist but vaping did, would you have considered this study worth conducting?
KF: It would be better if none of them ever existed. But we must be realistic and face the truth. Smoking is a curse, and it is very hard for everyone to get free from it. The best thing would be for someone to never smoke, or to quit smoking by himself as soon as possible. These studies are about smokers who cannot quit with available methods. Unfortunately they are the vast majority.
Vapers Have Smoked More!
PB: I notice too that in the abstract your description of the vapers is that they actually had a greater lifetime exposure to smoking than your smokers. Did I read that correctly and if so, was this intentional? It would seem to make your results even more optimistic than they otherwise would have been.KF: Exactly, vapers had a higher lifetime smoking exposure. From a preliminary survey we performed, we knew that e-cigarette users were mostly heavy smokers in the past, and that is why our study also included heavy current smokers. However, we did not manage to match the lifetime exposure of vapers. Even in the final study sample (30 vapers and 28 smokers), lifetime exposure remained significantly elevated in vapers. This was of course a disadvantage for vapers, but results did not show any adverse effects from that.
The Need for Caution
PB: You are cautious in your conclusions. Is this partly because no one study should be taken too seriously unless replicated in some fashion or do you have other misgivings?
KF: It is not just for replication. Smoking-induced disease involves several pathophysiological mechanisms. We have to study all these parameters in order to see the effects of electronic cigarettes. Don’t forget that we still study the mechanisms by which smoking causes harm. But this question is a good opportunity to address another issue. Everyone asks for long-term studies to be performed. I totally agree with them, but this simply cannot be done now. Awareness and use of e-cigarettes has increased since 2009-2010, so most people use them for less than 3 years. Moreover, users are most commonly in their 30s and 40s. At this age, incidence of cardiac and respiratory disease is very low, so we need hundreds of thousands of users and many more years of use in order to see any long-term effects of e-cigarette on health. Short term studies are the only way to go now. And a final note: many argue that since long-term studies have not been performed, they should be banned. But how can we perform such studies if none uses the product? And who can name a product that was ever released to the market only after long-term studies were performed? Currently available data indicate that e-cigarette is less harmful than tobacco in the short term. This is enough justification to allow the use of these products, but we should closely monitor their use in the long term.
PB: I have not noticed any real arguments being made against your study after it was made public. Are you aware of any? And how was the reception following your presentation at the ESC Congress?
KF: Besides discussions about the short-term nature and the small sample of the study, I have not seen any specific argument against it yet. I accept criticism about the small sample (even for our final sample of 58 subjects), however, it still remains the biggest clinical study ever performed on e-cigarettes.
PB: Are you expecting to conduct more research in this area?
KF: We will have more to discuss in the future.