Electronic Cigarette Interview with Dr Joel Nitzkin.
Dr Joel Nitzkin, Chair of the Tobacco Control Task Force for the American Association of Public Health Physicians, gives us his expert opinion on the electronic cigarette.
ECD: You have stated that based on available research e-cigarettes are far safer than cigarettes. How much safer are they, and how sure can we be of their relative safety?
Dr Nitzkin: There is no research per se on e cigarettes. The safety information we have is on the delivery of nicotine for nicotine cessation and also on the safest of the tobacco products which basically deliver the same nicotine.
Now the safest of the tobacco products are what they call snus. And the literature on snus, which is evaluated on our website, basically shows that in the best of the epidemiological studies available today snus do not increase any cause of death. In other words, if there is a health hazard from snus it is smaller than can be measured with these studies. With that in mind we would figure that a tobacco product that is delivered with just the nicotine and without any of the other toxic chemicals should be at least as safe.
So if we can figure that the nicotine in the e-cigarettes is basically a generic version of the same nicotine that is in prescription products, we have every reason to believe that the hazard posed by e-cigarettes would be much lower than one percent, probably lower than one tenth of one percent of the hazard posed by regular cigarettes.
ECD: I spoke to Ash UK and they said there hasn't been enough research on e-cigarettes and that they haven't been chemically tested.
Dr Nitzkin: Well, at least one manufacturer has been chemically tested. There are many different manufacturers of e-cigarettes...
One of the positive things we would hope would come out of FDA legislation would be requirements for quality assurances of manufacturing to make sure that the doses were accurate and to make that there aren't contaminants that would increase the health risk. For example, many of these products have flavourings and I don't know whether or not those flavourings might impose something of a risk. If they do I would think it would be small.
ECD: What research needs to be carried out into the use of the electronic cigarette?
Dr Nitzkin: Well, the first thing which I don't really see as research is quality controlled assessment by an independent lab on an ongoing basis batch by batch to make sure that the chemical content is not contaminated by heavy metals or cancer causing substances. They would also need to make sure that the doses are accurate as stated.
Now there is a big difference of opinion in terms of what other research needs to be done. Those who oppose e cigarettes and the entire family of alternative nicotine delivery devices express the view that to be sure they are safe there have to be tested and controlled clinical trials.
"...it would be a physical impossibility to do that research."
The problem with controlled and clinical trials is that it would be a physical impossibility to do that research. Why would it be physically impossible? Because it would involve recruiting a large number, probably several thousand, non smokers, and then getting them to agree to be randomised into one or two or more groups. One of these groups would smoke cigarettes which clearly poses a severe health hazard, and others would test various smokeless products, including e-cigarettes.
Not only that, since these products are not being marketed for short term use of smoking cessation the study would probably have to run a decade or more to show if there are long term effects. Now such a study would cost tens of millions of dollars per product and basically costs aside it would be physically impossible to do. One of the reasons it would be physically impossible to do is that I don't think you could ever recruit non-smokers to expose themselves to that sort of a risk and if you started with smokers you would have a residual risk from the smoking they had already done.
Number two, to be respectable you would probably have to hire an academic center, preferably an American academic center, to do this, and all American academic centers have what they call Institutional Review Boards that have to approve any research before it is done. And when you have research that has to be done that might pose a health risk to the research subjects but would be of no therapeutic value to the research subjects, their guidelines would prohibit them from approving such a study. That's why I have made the statement, and I have tried to repeat the statement, that the testing guidelines that are built into the current draft of the FDA Tobacco bill would represent a defacto ban on the e-cigarettes.
They'll say well, you can't sell the cigarettes until you can show you have completed these studies to the satisfaction of the food and drug administration and if the studies are impossible to conduct you simply have the products banned. Period.
ECD: That wouldn't just be the e-cigarettes, would it, it would be other alternative products...
Dr Nitzkin: E cigarettes, the sticks, the strips, the orbs, the snus, the camel, the Marlborough products and it would also relate to any other tobacco product that might be marketed as a lower risk or modified risk product.
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