About Dr Joel Nitzkin
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?
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.
" ...we have every reason to believe that the hazard posed by e-cigarettes would be much lower than one percent of the hazard posed by cigarettes. "
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.
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.
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.
What research needs to be carried out into the use of the electronic cigarette?
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.
" ...the testing guidelines that are built into the current draft of the FDA Tobacco bill would represent a defacto ban on the e-cigarettes. "
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 centre, preferably an American academic centre, to do this, and all American academic centres 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.
That wouldn't just be the e-cigarettes, would it, it would be other alternative products...?
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.
Regulation aside, would it be possible to measure the effects of the electronic cigarette on smokers who have already switched to the electronic cigarette?
That would be very difficult. The question is compared to what? If most of the people who are smoking electronic cigarettes have been smoking regular cigarettes before, who knows how much of the effects of the regular cigarettes would already be there. Now, our idea, us being the American Association of Public Health Physicians, would be that products such as e-cigarettes and the sticks and the strips and the orbs should be allowed on the marketplace based on the research that has already been done. Once on the market place there would have to be strict quality control of the manufacturing process which would allow the FDA to inspect the plants and require the testing that we talked about done by an outside laboratory. In addition to that, there would have to be post market research or post market surveillance which I think would have to be done by the federal regulatory agency using the user fee revenues. This would entail them doing studies, they would enrol regular smokers and e-cigarette smokers and then, over a period of years, while it is on the market and being sold, assess the presence or absence of any kind of adverse effects. You know, I just saw a news reports that crossed my desk today that said the Nicorette gum may pose a cancer hazard that previously wasn't suspected. I haven't read the report yet but those are the kind of things that we need to watch out for.
" I don't think there is any question, there is no possibility that e-cigarettes could be anywhere near as harmful as cigarettes. "
One way or the other I don't think there is any question, there is no possibility that e-cigarettes could be anywhere near as harmful as cigarettes. Cigarettes kill thirty percent of the people who use them. And with e-cigarettes, we are talking small fractions of one percent.
There's a body in the UK, ASH UK, that says that at least until there has been more research smokers should stick to products such as nicotine patches and gum. How do you rate the effectiveness of these products?
Well, there are two problems with the nicotine patches and gum.
Problem number one, the way they are formulated means that they don't give the nicotine hit that a smoker desires. It's a long slow release packaging of the nicotine so it doesn't offer the same satisfaction. Problem number two is that these products have only been licensed for use for short periods of time, basically up to twelve weeks as smoking cessation products. Now if somebody is going to suggest that a smoker is going to use one of these products for longer than twelve weeks, then that is what is called an off-label or illegal use of the drug, because it has not been approved for use for longer than twelve weeks.
Although that would still be better than smoking.
Oh, it would definitely be better than smoking.
They're basically running into the same problems as electronic cigarettes, then.
Yes, the research has never been done in terms of long term effects.
Now another concern, especially of non-smokers who have been raising this in comments on blogs and articles, is that the electronic cigarette still containsnicotine. Whereas my understanding is that nicotine is not that bad when compared to the use of tobacco. What is your opinion on this?
Well, nicotine is not innocuous and nicotine is very strongly addictive. Compared to foods and food additives that are acceptable on the market place nicotine would be considered a risky substance because people with underlying heart disease could suffer damage from the nicotine but compared to cigarettes ... let me try to put this in a kind of simplified perspective this is something that again - I don't know if you have downloaded our harm reduction resolution white paper, but basically at the end of the white paper it talks in terms of order of magnitude differences between tobacco and other products.
" ...the way they [nicotine patches and gum] are formulated means that they don't give the nicotine hit that a smoker desires. "
Tobacco is more than 100,000 times riskier in terms of risk of death from routine use of the product than is normally considered acceptable from a consumer point of view. So if you have a product which is three orders of magnitude less risky than a cigarette, that is less than one tenth of one percent the hazard of a cigarette, that's still 100 more times more hazardous than is generally accepted for consumer products. So, you know, you have these vast differences.
So the question is compared to what? We don't want to encourage non-smokers to take up e-cigarettes or these alternate devices but we do want to encourage smokers to switch.
Yes, I spoke to David Sweanor and he said much the same thing.
There is one criticism I have seen which is that we don't know the effect of heating up and inhaling nicotine and that this could potentially cause harm.
That's true, we don't know the effects of that and we can only guess at what the impact can be. My guess is that it would probably make it somewhat more toxic to people with heart disease, that's research that ought to be done. The other factor that I don't know with e-cigarettes is how much of the nicotine actually gets down to the lung. Is it absorbed from feural mucosal like cigars are, or is it absorbed from the lung by patterns of inhalation like smokers use? It's probably in the lung, like smokers do because I think people tend to use them in the same way. But that is research that needs to be done, there is an open question there but compared to what we already know the likely risk would appear to be much smaller than cigarettes...
But it would be difficult to carry out the research?
That research would not be terribly difficult to carry out. That research would require one of the companies to hire a skilled researcher to probably get somewhere between 40 and a hundred non-smokers or actually maybe even smokers could do this. Have them randomized, have half of them using e-cigarettes with no nicotine, the others using e-cigarettes with nicotine, and then you could measure cardiac status, and you could measure other blood tests to see what is going on. That would not be a difficult study to do.
Let me clarify, let me add one thing to that statement. That would be an easy subject to do it you are looking at acute short term health effects. That would not give you any ideas as to whether or not there is a long term effect like an increased risk of cancer. The increased risk of cancer study would require decades to complete. And probably it couldn't be done.
Health groups such as Cancer America are concerned that the existence of an alternative to smoking will prevent smokers from quitting, and may encourage young peopleto take up smoking. Is this a concern you share?
Yeah, this is a major concern. And this is a concern - and keep in mind with the FDA tobacco bill, it was negotiated between the Campaign for Tobacco Free Kids and the Phillip Morris company The Campaign for Tobacco Free Kids has as their only concern keeping children and teenagers from initiating tobacco use. In their minds all tobacco and tobacco related products are evil and any time you add any new product to the marketplace you increase the risk of teens initiating tobacco use. So they are therefore unalterably opposed to the addition of any new tobacco or tobacco related products to the market place because in their minds until proven otherwise the impact of that product will be to dramatically increase teen use of nicotine. I know of no research that has been done on this point. Every one of the e-cigarette companies I have talked to have claimed that they do not market their product to teenagers but neither are our cigarettes ostensibly marketed to teenagers, so there would have to be some other studies done to determine the extent to which teenagers use e-ciagrettes or any of these other products.
" In their minds all tobacco and tobacco related products are evil. "
I'm just thinking that when I was a kid there was a certain kind of child who would take up smoking. And part of the attraction was that it was bad for you and itwas forbidden. I'm just wondering if the sort of child who is going to do that is going to take up smoking whether it is cigarettes or e-cigarettes...
Well, my guess is that if somebody like that is going to take up a product they're going to take up the real thing not fake cigarettes. And what they use and whether or not they use it will be largely dependent on what their peers use, their friends and what they see their parents using in the home.
So there is a danger of that?
There is a danger. We don't know how much of a danger there is. Now let me put it yet another way. Cigarettes currently cause 400,000 deaths a year in the United States. If we get all those smokers to switch from regular cigarettes to e cigarettes or one of the other alternate nicotine delivery products we would eventually reduce that death toll from 400,000 a year to less than 4000 a year, maybe as low as 400 a year. Now, if we addicted every man, woman and child in the United States to e-cigarettes - we currently have 20% of the American population using tobacco products - and we'd multiply that by 5, so even at our worst estimates of 4000 deaths a year you'd have 20,000 deaths a year that's still a huge reduction from 400,000 a year.
" If we get all those smokers to switch from regular cigarettes ... we would eventually reduce that death toll from 400,000 a year to less than 4000 a year, maybe as low as 400 a year. "
And if you then if you take that worldwide...
Yeah... so there are unanswered questions, and a lot would have to do with how the products are marketed, how they are regulated and so on but every time you introduce a new product to the marketplace you do add a risk that there will be some teenagers that will be attracted to that product that otherwise would not be attracted to cigarettes. Let me point out one factor in particular. Women tend to be very concerned about their weight. People smoke or take up smoking and one of the major reasons for women to smoke is that it resets their body weight limit and generally they can expect to lose anywhere from 5 to 7 or 8 pounds and maintain that weight loss. That for many women is a lot of weight and the reason they keep smoking. If women think that there is a product out there that doesn't carry the risks of smoking or the yellow stained fingers of smoking, that will enable them to lose this weight, such a product could be very attractive to a large number of young women.
One question I didn't send you before our interview but is something that worries me is that if the electronic cigarette is as safe as experts like you to think, isn't it ethically wrong to remove the choice from people of having a safer smoking alternative? I mean the information is out there, the debate is out there, the product assessment is out there - shouldn't smokers be allowed to make their own choice?
Well, we think so but that is not the prevailing opinion here in the United States. The problem is, dating back to the 1960's and the original surgeon general's reports on tobacco and tobacco related illness they did not differentiate between deaths due to cigarettes and deaths due to other tobacco products. And they set as the national goal a tobacco-free society. Once you subscribe to the concept of a tobacco-free society you then consider all tobacco and tobacco-related products as equally harmful no matter what the science says. I mean you feel that it would be in the best interest of American society to stop any new tobacco products from entering the marketplace. Their goal quite frankly is prohibition.
So similar to the prohibition on alcohol...
And do you think it would be as unsuccessful?
Well, I think if they moved in that direction what you would see is a lot of illegal sales and a lot of smuggling. But not only that, even with that smuggling you would not get anywhere near the health benefits that you could if the products were legal and their was honest communication about the relative health risk.
The Tobacco bill has raised a lot of opposition from those involved in Tobacco Harm Reduction. Could you explain the concerns over the tobacco bill?
There was a document we posted on our website just a couple of days ago. That listed our proposed amendments to the tobacco bill and the amendments to deal with the issues we think should be changed, number one is a friendly and positive attitude towards harm reduction, to invite the products into the market place but then through manufacturing and quality control and post market surveillance assure the safety and do the research needed to adjust our estimates. Number two remove other limitations from the regulatory agency having to do largely with marketing concerns and issues.
" Their goal quite frankly is prohibition. "
The third one, I am speaking off the top of my head without looking at the document, has to do with the cigarette warnings as a specific issue because the warnings for any smokeless product says: "Warning - this product is not a safe alternative to cigarettes". And that wording has convinced 87% of American smokers that all tobacco products are equally hazardous.
Then the fourth change is we question the choice of the Food and Drug Administration as the regulatory agency because by doing it creates a situation whereby the food and drug administration is certifying the safety of current cigarettes as they are currently formulated.
Finally we feel that the bill has to give the federal agency independent authorisation to do health education post market surveillance and research not by the individual tobacco companies but by the federal agency that paid for through the tobacco company user fees. But you know another way of looking at our concern is the fact that this piece of legislation has been sold to health organisations to endorse and to congressmen here in the United States to sponsor using a summary in the description of the bill which is extremely inaccurate and which does not reflect the actual impact the bill will have if passed.
Given the concerns raised by doctors and tobacco harm reduction activists like yourself, what, in your opinion, is the main motivation for pushing the bill through?
In the early 1990s when Richard Kessler, who was then the Secretary of the Food and Drug Administration Agency, tried to regulate cigarettes. The Supreme Court said he couldn't do so without Congressional authorisation. Since then, key legislators in both houses of Congress have been trying to develop and pass a bill that would give the federal government authority to regulate tobacco products. After all those years of working on this issue, they seem to have reached a point where they don't care what the bill says they just want to pass a bill to get their foot in the door. They have this bill which is a severely flawed bill but it has the votes to pass so they want to pass it. They want to claim that now there will be federal regulation of tobacco products, even it is totally dysfunctional. This is one of the reasons why they are trying to push it as is, with no amendments. They succeeded in doing that in the House of Representatives. It looks like they are going to try and do the same thing in the Senate.
Please note that comments of the interviewee do not necessarily represent the views of E-Cigarette Direct.