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American Association of Public Health Physicians writes on behalf of Electronic Cigarettes to the FDA

Aaron — Sun, 02 May 2010 02:40:50 +0000

For the past half century, the American Association of Public Health Physicians (AAPHP) has served as the national voice of physician directors of state and local health departments and other like-minded physicians. We have long been involved with tobacco control, with the singular goal of doing everything in our power to reduce tobacco related illness and death.

As you assume leadership of the new FDA Center for Tobacco Products, we urge you to consider the actions FDA can take, within the powers granted by this new legislation, to rapidly and substantially reduce tobacco related illness and death in current adult smokers.

Unfortunately, FDA has not gotten off to a good start. FDA condemnation of electronic cigarettes, in its July 22 press conference, and FDA insistence that electronic cigarettes should be regulated as a drug/device combination rather than as a tobacco product makes no sense from a public health perspective. It flies in the face of FDA laboratory findings on other products already approved by FDA. If one looks at electronic cigarettes as a sentinel for all tobacco products less hazardous than conventional cigarettes – the outlook for FDA action reducing tobacco-related illness and death among current adult smokers is dismal.

With this in mind, we respectfully request your consideration of the following actions:

1. We urge FDA to make public the laboratory data behind the July 22 condemnation of electronic cigarettes, along with comparable data on pharmaceutical nicotine products and conventional cigarettes. Then, on the basis of these data, either fully justify or retract the July 22 condemnation of electronic cigarettes.

2. We urge FDA to reclassify electronic cigarettes from a drug/device combination to a tobacco product. This will enable FDA to immediately regulate manufacturing and impose marketing restrictions during this initial period of FDA Tobacco Center development. This reclassification will eliminate pressure on the several hundred thousand current American users of electronic cigarettes to switch back to the much more hazardous conventional cigarettes.

This year, about 400,000 American adult cigarette smokers will die of a tobacco-related illness. Their second hand smoke will kill about 48,000 non-smokers. About 700 more will die in residential fires. Despite progress on other measures of tobacco use, per CDC estimates, this death count continues to inch up from year to year. In contrast, even though smokeless tobacco products represent about 20% of nicotine intake in the United States, the number of deaths per year from these products is too small for reliable estimates from the CDC.

Our (AAPHP) best estimate is that smokeless tobacco products currently cause about 700 cancer deaths per year in the United States. This is less than 1% of the more than 110,000 deaths that would occur each year if smokeless products carried the same mortality as conventional cigarettes.

This last week, Boffetta and Straif published a paper alleging evidence of an increased risk of fatal heart disease and stroke among smokeless tobacco users. This is a study sure to be referenced by those seeking evidence of the harmfulness of smokeless tobacco products. Unfortunately, this study suffers from major technical and ethical flaws, including failure to note in the abstract that they found no increased risk of non-fatal heart attack or stroke. Even worse, of the many studies reviewed, only two showed evidence of even a slight increase in risk of death – and these were the ones selected for the conclusion and abstract. That having been said, their allegations of a 13% increase in risk of fatal heart attack and 40% increase in risk of fatal stroke pale in comparison with the 180% to 300% increases in risk for men and women 35-64 years of age posed by smoking conventional cigarettes.

Contrary to prevailing conventional wisdom, virtually all the heart and lung disease from conventional cigarettes, and an estimated 98% of the cancer mortality, are due to direct inhalation of fresh products of combustion deep into the lung. Our best estimate (based on the work of Pankow et al and others) is that only about 2% of the cancer mortality from cigarettes is from the named carcinogens commonly found in tobacco products. Smokeless tobacco products carry little or no risk of heart disease and no risk of lung disease. They do not kill innocent bystanders and they do not burn down houses. The risk of cancer of any kind from smokeless products ranges from a high of about 5% of the risk of cancer posed by conventional cigarettes to a low well under 1% of the risk of cancer posed by conventional cigarettes. While definitive studies have not been done, we have reason to believe that tobacco products, such as electronic cigarettes, consisting of nicotine extracted from tobacco with only trace amounts of other chemical substances, should carry even less risk.

Most of the discussion to date around the new FDA/Tobacco bill has focused on reducing initiation of nicotine use by children and teens. The only discussion of current smokers has been limited to encouraging use of pharmaceutical products to aid cessation. This has been touted as doubling quit rates – but without mentioning that this doubling is from about 3% to about 5% per year. In other words, this option fails 95% of smokers willing to try it, even under study conditions with optimal counseling.

It should be possible to save the lives of 4 million or more of the 8 million adult American smokers who will otherwise die of a cigarette-related illness over the next twenty years. This could be done by making smokers aware of selected smokeless tobacco products (including but not limited to snus and electronic cigarettes) that promise to reduce the risk of tobacco-related illness by 99% or better for smokers who are unwilling or unable to quit. Rather than discouraging nicotine cessation, however, such an approach, even with no medical intervention, would be expected to triple the rate at which current smokers eventually discontinue their nicotine use.

Those writing the new FDA legislation endorsed a harm reduction component to current tobacco control programming, but in a most peculiar way. The law encourages cigarette manufacturers to develop “reduced exposure“ products and market them with no scientific proof that such reductions in exposure will reduce risk. The law then requires presumably new “scientific evidence” for smokeless products, already known to be of substantially lower risk. This makes no sense. The law encourages a harm reduction component to current tobacco control programming that might reduce tobacco-related cancer mortality by one or two percent; while actively discouraging switching to lower risk tobacco products that promise to lower total tobacco-related illness and death by 99% or better.

The secret to success, as we see it, will be to add an effective harm reduction component to current tobacco control programming while using the tools made available by this new law to prevent this new harm reduction
initiative from increasing the numbers of children and teens who initiate tobacco use.

Reconsidering the FDA stance on electronic cigarettes would be the most logical first step.

We look forward to working with FDA to use the powers granted by this new legislation to rapidly and substantially reduce tobacco-related illness and death, among both current and potential future tobacco users.

References:
The data on smoking attributable deaths on page 2 of this letter are from the Centers for Disease Control MMWR report of November 14, 2008. http://www.cdc.gov/mmwr/preview/mmwrhtml/mm5745a3.htm

The estimate that 20% of current nicotine consumption in the United States is from smokeless tobacco was generated by Mr. William Godshall, based on the formula utilized by Fagerstrom et al, when estimating 2002 nicotine consumption by type of tobacco product in multiple countries.

The discussion on risk of heart disease and stroke from smokeless tobacco products is from Paolo Boffetta and Kurt Straif : Use of smokeless tobacco and risk of myocardial infarction and stroke: systematic review with meta-analysis. Published August 18, 2009. BMJ 2009; 339: b3060 [Abstract] [Full text]

The data on relative risk of fatal heart attack and stroke from smoking, in men and women 35-64 years of age, are data from the American Cancer Society as quoted in “Changes in cigarette-related disease risks and their implication for prevention and control.” Smoking and Tobacco Control Monograph 8. Bethesda, MD: US Department of Health and Human Services,
Public Health Service, National Institutes of Health, National Cancer Institute 1997;305-382. NIH Publication no. 97-1213.

The other references to the scientific literature that back-up the points made in this letter can be found on the Tobacco Issues page at the http://www.aaphp.org web site. There is an October 2008 “Resolution and White Paper on Tobacco Harm Reduction.” This paper, on pages 6 and 13, includes then-current CDC and AAPHP mortality projections. “The Myth of the Safe Cigarette,” is based on the paper by Pankow et al (http://cebp.aacrjournals.org/cgi/reprint/16/3/584 ) and others. It makes the case that conventional cigarettes cannot be made measurably safer. The exchange of correspondence with Zhu et al, from a paper published earlier this year, deals with the difference in quit rates, comparing conventional cigarettes to smokeless tobacco products.

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Yours,
Joel L. Nitzkin, MD, MPH, DPA
Chair, AAPHP Tobacco Control Task Force
jln@jln-md.com
504 899 7893
Kevin Sherin, MD, MPH, FACPM, FAAFP
President, American Association of Public Health Physicians
ksherin@yahoo.com

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An Interview With David Sweanor on the E-Cigarette, Tobacco harm reduction, snus and other issues

Aaron — Tue, 13 Apr 2010 06:31:02 +0000

David Sweanor has worked with numerous companies and organisations, including the International Union Against Cancer, World Health Organization, World Bank and the Pan American Health Organization, on the issue of tobacco harm reduction. He has received both international recognition and prestigious prizes for his work.

Note: Anyone can /use reproduce this interview in return for a link back to this website.

How did you get interested in the issue of Tobacco Harm Reduction?

I have been actively involved in tobacco and health policy issues since the beginning of the 1980s. During that time I have tried to apply the lessons from other successful public health campaigns. Any effort to reduce death, injury or disease entails some combination of four broad strategies:

1) Measures to prevent people from ever engaging in a risky behaviour
2) measures to get those engaging in the behaviour to cease engaging in it
3) efforts to prevent injury to third parties as a result of the behaviour
4) efforts to reduce the risks to those who will continue the behaviour.

By the early 1990s there was no doubt that the vast majority of the harm caused by smoking was from the method of nicotine delivery rather than from the nicotine itself. There would be a parallel problem if people got caffeine from smoking tea leaves rather than making an infusion of these leaves in hot water. At the same time the projections of future smoking rates was for increasing consumption despite global anti-tobacco policies, and there was increasing scientific understanding of the reasons people use nicotine. An ‘abstinence-only’ policy aimed at a nicotine-free world was simply unrealistic.

So certainly by the 1990’s, and much earlier in the case of far-sighted researchers such as Michael Russell, it was clear that there were huge gains to be made from dealing with the delivery system. Oddly, though there had by that time been much focus on issues such as where the product could be used, how it was taxed, limits on advertising, controls on places of sale, packaging requirements, etc., there was little to nothing being done about the product itself.

What progress has been made since you got involved?

Short answer: Not enough.

Longer answer: There is now a much greater awareness that there is a very pronounced continuum of risk depending upon how nicotine is delivered. We are also seeing greater (though still poor) availability of medicinal forms of nicotine and a proliferation of new nicotine products. There is also no longer any scientific doubt that combustion-based products are massively more hazardous than non-combustion products such as Swedish snus. My experience is that as soon as someone grasps the concept of the continuum of risk and recognizes that all nicotine use is not going to end anytime soon, the pieces start coming together. This comes at a time that many countries are moving toward regulating tobacco products and discussing the need for some form of comprehensive regulatory oversight of the full range of nicotine products. Clearly, any rational health-focused regulation will demand that we deal with issues of differential risks.

I know that you don’t necessarily agree with our theory that there is a conspiracy against alternative forms of smoking. Yet you have said Snus is a far safer alternative to smoking than cigarettes. How do you explain the reasons for illogical bans against alternative forms of tobacco such as in the European Union, where Snus has been banned but both cigarettes and more dangerous forms of chewing tobacco remain legal?

I think cigarettes have dominated the marketplace of most countries for so long that people have trouble even thinking of alternatives. Many of those who seek restrictions on non-combustion products, and certainly some of the companies selling them, see them as a way to perpetuate rather than replace cigarette smoking. When snus was positioned as a potential additional problem, rather than as a potential partial solution to a much bigger health problem, efforts to keep it off the market seemed logical.

We also have an issue with the tendency of our species to do something ‘because we can’ rather than to look at issues in a more comprehensive way that will better meet long term goals. It was possible to get laws banning a tobacco product that was not yet on the market, just as today it is possible to enforce existing drug laws to ban new recreational nicotine products. Had there been greater awareness of relative risks and a less risk-averse mentality snus could have been seen the way auto safety advocates saw Volvos – an agent of change for the marketplace.

What damage has been caused by the Snus ban?

I think the key thing is that we have lost a great chance to effectively show ‘proof of concept’ for the provision of less toxic alternatives to cigarettes. As soon as there is recognition that consumers can access nicotine without repetitious inhalation of tobacco smoke, and that some portion of current smokers find this to be an acceptable (even preferable) alternative to smoking, it causes a paradigm shift. If we get to the point of no longer seeing cigarettes as a ‘nicotine maintenance monopoly’ we could change the face of public health. If we recognize that the needs of smokers can be met in a way that does not necessarily result in the untimely death of roughly half of long term users maybe we can move society conceptually to the point that nicotine delivery can go through the same metamorphosis as we’ve seen with auto safety, telecommunications, sanitation, pharmaceuticals, food preparation standards, alcoholic beverages and a myriad of other goods and services. The market could be transformed (assuming an appropriate regulatory system) through a virtuous circle of increasing consumer awareness and ever-less-hazardous alternatives to cigarettes.

In addition the ban on products such as snus causes significant ethical and human rights problems. The idea of simply denying access to such a product to millions of smokers – people who are thus left using a massively more hazardous product – should be a great cause of concern. Misleading statements about the risks of products such as snus, especially those from major health organizations and government health departments, also run the risk of eroding consumer trust in public health authorities – a problem that ultimately impacts far more than issues of nicotine.

Do you see any parallels between Snus and the Electronic Cigarette, and the opposition against both of them?

Some part of the opposition to nicotine products comes from the same moral absolutism that we see in other abstinence-only efforts on issues concerning such things as alcohol and sexual activity. Actually, on a very wide range of issues there is a tension between those on a moralist/absolutist quest (usually tied to ideas on the perfectibility of mankind) and those on a pragmatic public health mission. It would wrong to characterize those on a moral quest as being public health advocates, and this is true whether looking at abstinence-only campaigns on sex, on alcohol, on illicit drugs or on nicotine. Campaigns based on making better people rather than making people better are driven by moral concerns rather than public health concerns.

You’ve stated that electronic cigarettes are not safe, but that they are a lot better than cigarettes. Just how unsafe are they?

After many tens of thousands of research papers we know what causes the illnesses associated with smoking. In short, ‘it’s the smoke, stupid’. Non-combustion products will vary in their risks, but everything we can see about the sort of product sold in the West (whether smokeless tobacco, electronic cigarettes or medicinal nicotine) tells us that cigarettes are orders of magnitude more hazardous.

As to ‘not safe’, we perhaps need elaboration. The point I try to make when faced with the ‘it’s not safe’ canard is that nothing meets the criteria of being absolutely ‘safe’. Everything has risks, so simply pointing out that something is ‘not safe’ shows a person to be either ignorant or disingenuous. The key issue in looking at safety is that it is a relative concept; we need to look at safety of any activity compared to some alternative. Rather than the unattainable standard of ‘safe’ we should be thinking in terms of ‘safer’. Despite the risks associated with soccer, I would, for instance, prefer my children play soccer rather than play with live hand grenades.

You are a supporter of the electronic cigarette? Can you tell us why?

I am a supporter of less toxic alternative for smokers. Nicotine use should not come with a death sentence.

Ideally we need a nicotine regulatory authority that can facilitate efforts to get alternative products to smokers, accurately inform them of relative risks and move them as far as possible down the continuum of risk.

The nicotine market needs to experience a shake-up and the entrepreneurs who appear to be behind the e-cigarettes might be sufficiently risk-tolerant to cause it to happen. The issue needs to get on the public and political agenda, and we will not get the needed re-thinking of the whole nicotine market until this happens.

Opponents of the electronic cigarette have said that it could stop smokers from giving up, that is untested and untried and that claims that the electronic cigarette are healthier than normal cigarettes are unproven. How would you respond to these allegations?

There is no innovation that I am aware of that did not cause detractors to list various potential negative consequences were the product to be made available – even safety bicycles in the 1890s! But when the status quo is one that will, according to the WHO, result in a billion deaths this century surely we need more than a fear ‘something bad might possibly happen’ to reject an alternative to that status quo.

The obvious solution is to have a regulatory agency that facilitates getting the least hazardous products to consumers, with post-marketing surveillance to control any unintended negative consequences. It certainly would make much more sense than the current state of affairs where government agencies are banning products like snus and e-cigarettes, greatly constraining the potential market for medicinal nicotine, and thus protecting the cigarette cartel rather than the health of citizens.

If there is anyone who believes cigarettes are no more hazardous than e-cigarettes I’d recommend a remedial course in basic sciences. For anti-nicotine campaigners who say we need to wait for more research I would point out the way they are proving Nietzsche correct – we take on the attributes of our enemies. Cigarette companies spent decades making spurious claims that we need ‘more research’ before we could move on policy measures, despite the already-existing basis for informed policy measures. They provide very poor role models.

One criticism that has been levelled at the electronic cigarette is that we don’t know the effect of heating up a nicotine vapour and inhaling it into the lungs. Is this a valid criticism?

We certainly know that inhaling a heated nicotine vapour into the lungs is one heck of a lot less hazardous than inhaling the same vapour along with the thousands of chemicals and dozens of known carcinogens that are inhaled when that vapour is delivered by smoking a cigarette. An investigation to determine if the non-smoke vapour is, say, 1/100 or 1/1,000 the risk of cigarette smoking might be a good thing. But if someone thinks cigarettes should not be challenged in the marketplace until we have such results I think they need to try thinking a little more deeply. They should also question whether they have undergone a Nietzsche-like transformation that is causing them to be sounding like a 1970s cigarette company executive.

How do you feel about the public health campaigners, via their campaign to ban electronic cigarettes, attempting to limit the choice of addicted smokers unable or unwilling to quit smoking to cigarettes and cigarettes alone?

I don’t think public health campaigners do this. I think some people on a moralistic abstinence-only agenda take this position, just as some take the position that consumers of alcohol should have no alternative to products like Jamaican Jake or that no one should have access to birth control, or that heroin addicts should not be given clean needles. But those people are not public health campaigners.

At the same time, I think there are people who are legitimate public health campaigners who oppose products like e-cigarettes. This can be because they want all such products to come within a comprehensive regulatory framework for all medicinal and recreational nicotine products; one designed to help move smokers away from cigarettes. They fear that unregulated products could proliferate and create a huge ‘snake oil’ business. But I also think it is incumbent upon such people to be advocating for such a regulatory framework rather than just inadvertently protecting the cigarette business.

The issue of electronic cigarettes is up in the air at the moment. How do you see the future – will it follow Snus into oblivion or will it become the smoking method of the future?

I think we are in the early stages of a revolution on recreational nicotine delivery. Just as with the telecommunications revolution it is likely impossible at an early stage to know how it will change. But it is a safe bet that consumer interests and entrepreneurship will combine to cause fundamental change, as we are already seeing with the rapid growth of non-combustion tobacco products in places such as Norway and the United States and the much greater use of medicinal nicotine products for purposes other than near-immediate nicotine cessation. The winning products in this market transformation will likely be of a wide variety, given differing consumer preferences and the nature of dynamic markets. I personally think that some of the most successful products will likely help consumers wean themselves off nicotine over time. But hundreds of millions of smoking-caused deaths will be averted by greater consumer choice and a proliferation of products, untold billions of dollars will be made by the owners of the successful products, and innumerable jobs will be created as this market transforms. Seldom is there an offer to become a billionaire while saving millions of lives. I think there will be takers.

Thanks to ECD for allowing us to share this important interview with the world.

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Interview with Dr Joel Nitzkin About Ecigarettes

Aaron — Tue, 13 Apr 2010 05:38:01 +0000

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.

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

ECD: Regulation aside, would it be possible to measure the effects of the electronic cigarette on smokers who have already switched to the electronic cigarette?

Dr Nitzkin: 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.

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.

ECD: 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?

Dr Nitzkin: 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 licenced 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.

ECD: Although that would still be better than smoking.

Dr Nitzkin: Oh, it would definitely be better than smoking.

ECD: They’re basically running into the same problems as electronic cigarettes, then.

Dr Nitzkin: Yes, the research has never been done in terms of long term effects..

ECD: Now another concern, especially of non-smokers who have been raising this in comments on blogs and articles, is that the electronic cigarette still contains nicotine. Whereas my understanding is that nicotine is not that bad when compared to the use of tobacco. What is your opinion on this?

Dr Nitzkin: 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 ciagrettes … 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. 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-ciagrettes or these alternate devices but we do want to encourage smokers to switch.

ECD: 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.

Dr Nitzkin: 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 people I think because 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…

ECD: But it would be difficult to carry out the research?

Dr Nitzkin: 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.

ECD: 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 people to take up smoking. Is this a concern you share?

Dr Nitzkin: 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

ECD: 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 it was 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…

Dr Nitzkin: 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.

ECD: So there is a danger of that…

Dr Nitzkin: 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.

ECD: And if you then if you take that world wide…

Dr Nitzkin: 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.

ECD: 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 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?

Dr Nitzkin: 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.

ECD: So similar to the prohibition on alcohol…

Dr Nitzkin: Yes.

ECD: And do you think it would be as unsuccessful?

Dr Nitzkin: 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.

ECD: The Tobacco bill has raised a lot off opposition from those involved in Tobacco Harm Reduction. Could you explain the concerns over the tobacco bill?

Dr Nitzkin: 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 sureveillance 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.

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 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.

ECD: 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?

Dr Nitzkin: In the early 1990′s 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 severely flawed bill but it has the votes to pass so they want to pass it. They want to claim that now there there will be federal regulation of tobacco products, even if 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.

Many thanks to ECD for letting us re-publish this interview, and allowing us to share this extremely valuable information with the world.

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An Interview with Professor Michael Siegel

Aaron — Tue, 13 Apr 2010 04:47:59 +0000

This is an interview conducted by Electronic Cigarettes Direct, a United Kingdom ecig distributor, With Doctor Michael Siegel. We thank ECD very much for allowing us to share this valuable information with the world!

Michael is a doctor, a professor, an enthusiastic supporter of tobacco harm reduction and a tireless exposer of tobacco myths that many of us e-smokers look up to in awe. We are very grateful to Michael for sparing us the time for this interview. If you would like to read more of Michael’s work please check out his Tobacco Analysis blog.

ECD: Your blog has set out to reveal examples of the lies and half truths sadly common in the anti-tobacco lobby. Can you tell us why you, a supporter of smoking bans and tobacco harm reduction, have set out to do this.

Michael: While I am decidedly a strong anti-smoking advocate who has supported smoking bans and testified in numerous lawsuits against the tobacco companies, the basis for my advocacy positions has always been the science. Increasingly it seems that the anti-smoking movement is being driven more by ideology than by science and a strong evidence base.

Part of that ideology is the belief that the ends justifies the means and that it is therefore acceptable to stretch the truth in order to achieve what we see as a noble cause. However, I believe that first and foremost, we are public health practitioners who are serving the public and we must adhere to high standards of ethical conduct and scientific integrity. One of our responsibilities is to accurately convey scientific information to the public. This is necessary not only because it is ethical, but also because our reputation – and our retention of the public’s trust – depends on it.

Perhaps the most interesting example of the dependence upon ideology rather than science and a strong evidence base is the issue of electronic cigarettes. The major national anti-smoking groups have asked the FDA to take these products off the market. This is despite evidence that electronic cigarettes are much safer than conventional cigarettes and much more effective than traditional nicotine replacement therapy products in keeping smokers off cigarettes. It really comes down to ideology vs. science.

The anti-smoking movement’s ideology – which is guided by an abstinence only type of philosophy – just doesn’t have room for a product that looks and acts like a cigarette but happens to be orders of magnitude safer. In this case, the science – the health effects – just don’t matter. The ideology is too deeply ingrained to allow the product to be given a chance of saving lives.

ECD: Could you reveal some of the worst examples of the lies you have found?

Michael Siegel: Perhaps the greatest example is the statement, being made by many anti-smoking groups, that a mere 30-minute exposure to secondhand smoke may cause atherosclerosis (hardening of the arteries). The truth is that it takes many years to develop atherosclerosis. Even among active smokers, you don’t see heart disease until a person has smoked for at least 20 years or more. So it is literally impossible for a single 30-minute exposure to secondhand smoke to cause the arteries to harden.

Another great example is the claim, on the SceneSmoking.org website, that 340 young people die each day from smoking. Smoking typically does not kill what we would consider to be “young people.” Middle-age, sure. But not many “young people” are dying every day from smoking. This is another example where the organization apparently believes that its mission is so important and noble that the facts don’t really matter.

ECD: As a result of your campaign for truth, you have suffered personal attacks on your character. Can you tell us about some of these?

Michael: Just yesterday on my blog, I was accused of having taken money from electronic cigarette manufacturers. Many other anti-smoking advocates just cannot understand that someone could take a position that opposes the orthodoxy of the movement without being on the tobacco industry dole. After questioning some of the incorrect scientific claims that I mention above, I was similarly accused of being a tobacco industry “mole.” I have been expelled from two tobacco control discussion groups because they would not tolerate my dissent from key elements of the dogma of the movement.

ECD: What is the motivation behind the mistruths and the attacks on you?

Michael: On the surface, the attacks are part of the common anti-smoking movement strategy of attacking the dissenter, rather than dealing with the substance of the dissenting argument. But deeper below the surface, I believe that these attacks are occurring because these colleagues of mine recognize that I am right and it is almost like an unconscious guilt reaction that they are displaying.

ECD: Moving on, how safe do you think the electronic cigarette is, and how sure of that safety are you?

Michael: I can’t say how safe the electronic cigarette is, but what I can say is that it is substantially safer than the conventional cigarette. Inhaling nicotine cannot be nearly as dangerous as inhaling nicotine plus thousands of other chemicals, including more than 40 carcinogens. It doesn’t take long-term studies to make that determination. As David Sweanor astutely pointed out, determining that a tobacco-free nicotine delivering product is safer than a product that delivers nicotine with thousands of tobacco smoke constituents is a fact of basic science, and anyone who challenges such a notion would probably benefit from a remedial course in basic sciences.

Whether electronic cigarettes are safer than conventional cigarettes is really a non-issue. The real questions are how effective the product is in helping smokers keep off cigarettes, how electronic cigarettes could figure into a long-term strategy for promoting smoking cessation, and what specific messages about electronic cigarettes and health would be appropriate to communicate to the public.

ECD: Is there a conspiracy against the electronic cigarette and other safe alternatives to smoking, and if so who is behind it and why?

Michael: I don’t believe there is a conspiracy against the electronic cigarette. I just think there is a lot of ideologically-driven, dogmatic thinking in the tobacco control movement, and that rigid thinking can get in the way of sound public policy. We’ve seen this happen in other areas of public health. Now, the abstinence-only approach seems to be getting in the way of sound policy in tobacco control.

You also have to remember that pharmaceutical treatment of tobacco dependence has become the bread and butter of tobacco control. The tobacco control movement has been largely sustained by funding from pharmaceutical companies. Our national and international conferences are now underwritten by Big Pharma. That financial relationship between the pharmaceutical companies and the tobacco control movement is also playing a role. I don’t think this is happening consciously, but whenever there are strong financial ties like this, it almost certainly creates an unconscious bias.

ECD: Finally, can you tell us why legislators are listening to those who are shouting loudest, the health groups, and not those at the cutting edge research of tobacco harm reduction such as yourself, Dr Joel Nitzkin, Dr Laudersson and others?

Michael: You have to remember that there is also a financial connection between federal and state legislators and conventional cigarette sales. These legislators have tied the fiscal solvency of critical government programs to the continued consumption of cigarettes. Our national system of providing health insurance for children from lower-income families is now dependent upon cigarette smoking. Many states are looking towards cigarette revenues to balance their budgets during these difficult economic times.

It is not, therefore, in the legislators’ “best interests” to support a policy that is potentially going to seriously threaten cigarette sales. Between the influence of Big Tobacco and Big Pharma, it’s going to be very difficult for electronic cigarette manufacturers to get the ear of public policy makers.

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Professor Carl Philips of the TobaccoHarmReduction

Aaron — Mon, 04 Jan 2010 00:33:42 +0000

ECD: Given what we know about the ingredients and carcinogens contained within the electronic cigarette, is there reason to believe it could be a safer alternative to regular cigarettes?

Carl Phillips: I think that’s quite an understatement. I think there’s absolutely no doubt that it is a safer alternative to regular cigarettes. Now safe, that’s a word that implies there is absolutely no health risk from something, and that doesn’t really apply to anything. But our estimate is that it is probably in the order of 99 percent less harmful than smoking, I think there’s little doubt that it’s down in the neighborhood.

ECD: Professor Michael Siegel suggested that if we banned electronic cigarettes based on the carcinogens found in the FDA study we would have to ban peanut butter. Is that something you would agree with?

Carl Phillips: At least! We’d have to ban half the foods that are available. I mean, the FDA study really didn’t find any cancer risk. That study was basically pure propaganda.

ECD: Is there any danger of passive smoking with electronic cigarettes?

Carl Phillips: Probably not. As far as we know, the vapour, the propylene glycol vapour, has no human health risks at low concentrations, so it’s possible that there’s some miniscule risk, far too small for us to have ever noticed it or measured it. The amount of nicotine that escapes out into the air is also quite trivial and nicotine itself has such a low risk profile… so again it is never proper science to say that there is absolutely no risk from something, just as it is not proper science to say simply that there is a risk from something without trying to quantify it. But I guess there is no serious risk from second hand vapour as I guess it would have to be called.

ECD: In your opinion, could the electronic cigarette aid smoking cessation or be of use as a tobacco harm reduction product?

Carl Phillips: Yes, not only could it but it clearly is already being used for exactly that. Self reports suggest that thousands, tens of thousands of smokers have quit smoking by switching to the electronic cigarette which is the perfect proof that it does work as a smoking cessation aid and a tobacco harm reduction tool.

ECD: Electronic Cigarettes have been in use for several years now, and there are a few organisations which are concerned about them. What side effects have been found so far?

Carl Phillips: As far as I know there hasn’t been any discoveries of acute side effects, which of course is good news. There is no reason to expect any but you never know quite what is going to happen with a new exposure. You can have reports that start to trickle in of a case here or there of something very strange happening. I’m not aware of any such thing.

We of course know that long term use of nicotine poses a small, a very small but non-zero risk of some cardiovascular diseases so I suppose you could call that a side effect which is predictable for the long run, but that’s a total risk which is down in the range of drinking coffee, nothing remotely similar to the risk from smoking cigarettes.

ECD: What’s your biggest concern with regards to the electronic cigarette?

Carl Phillips: Well, we don’t know too much about the manufacturing process and there’s not enough quality control, or at least there is not enough guarantee of quality control in the process.

Now, this of course varies from manufacturer to manufacturer, but with reasonably free entry that just about anybody with an appropriate factory in China can start manufacturing these and start putting them out under some brand name there is worry about contamination. I mean this is not a plastic toy or something like that, which alone generates a lot of worry about Chinese manufacturers.

This is something that is delivering chemicals into the body in a way which is definitely going to be absorbed so it doesn’t take much of a production mishap to create something that is very harmful. And I really fear that it is going to happen one of these days if we don’t get some effective regulation and it is going to give the entire product line a bad name which of course would be inappropriate but quite understandable.

ECD: Following on from those concerns about the quality of production, let’s talk about the FDA. The FDA carried out tests on electronic cigarettes in which they found diethylene glycol in one “Smoking Everywhere” e-cigarette and traces of tobacco specific nitrosamines in both Smoking Everywhere and NJOY electronic cigarettes. So what are the significance of those findings?

Carl Phillips: There’s no significance of those findings whatsoever from a scientific or health standpoint. From a political standpoint the fact that they did that was quite significant.

So on the first point the fact that there are any detectable levels of any small molecules that that can be found in the tobacco plant in the e-cigarettes is not surprising at all. The nicotine comes from tobacco and our ability to detect a few stray molecules of contamination means that basically any molecule that is small enough to be a contaminant that is found in the tobacco plant will also be found in e-cigarettes. It’ll also be found in nicoderm, nicorette, any product that contains nicotine that has been extracted from a tobacco plant. So that’s completely meaningless – the quantities of the nitrosamines in the electronic cigarette were so many orders of magnitude smaller than those, say, in smokeless tobacco, which has been shown to not cause a measurable risk of cancer, so we know that that doesn’t matter.

Now, there is some more significance in finding contamination in the carrier chemicals, not that there was enough in this particular case that it was going to be harmful but because there is not supposed to be anything other than the propylene glycol and the water there, it does mean that there is a manufacturing problem – a manufacturing problem under some circumstances could be quite a bad thing. Now what really is the biggest problem is the politics that this reflects.This shows up in all sorts of harm reduction type situations and the basic rule of thumb is, if you ban something or if you’re trying to ban something, declare war on it, then you can’t regulate it, you can’t make it safer. So if you have a war on injection drug use and you simply want to forbid it and don’t want to admit it is happening in any way, you will prevent needle exchanges from happening which would save a lot of lives.

If you want to have a war on prostitution and just absolutely forbid it and pretend it doesn’t exist then it is impossible to impose rules that force prostitutes to get health exams and so forth.

Similarly if the FDA is intent on declaring war on electronic cigarettes and simply forcing them from the market then they are going to be abdicating their responsibility to make sure that the electronic cigarettes are what they are supposed to be and keep them safe and that goes back to this quality control problem. The FDA would really be the perfect entity to help impose some quality control on ecig manufacture even though they are manufactured in a different country but it looks pretty bad in terms of the possibility of them doing that.

ECD: What health benefits, if any, might smokers find if they smoked electronic cigarettes, or changed to electronic cigarettes?

Carl Phillips: The health benefits of switching are almost exactly the same as the health benefits of quitting, and this applies to electronic cigarettes, smokeless tobacco and pharmaceutical nicotine. If a smoker can manage to switch from smoking to one of those other products the benefits are approximately the same as quitting – they lower their cancer risk, they lower their cardiovascular disease risk, they get rid of acute symptoms of lung and airway problems, a risk that comes from smoking for pulmonary diseases and so forth. Switching is so close as good as quitting that from a health point of view there is no point in worrying about the difference.

Read more: http://www.ecigarettedirect.co.uk/carl.html#ixzz0bbBhvjSiSimilar Posts:

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Dr. Anthony Panarello Gives Us The Truth About Electric Cigarettes

Aaron — Sun, 20 Dec 2009 07:43:50 +0000

Dr. Anthony Panarello, a pulminary specialist, Gives Us The Truth About Electric Cigarettes, That they are 1000 times less harmful than smoking traditional tobacco cigarettes. This video only refers to the Smoke 51 Electric Cigarettes

Buy a Smoke 51 Electric Cigarette Now – Get Started For Only $29.95

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Some Smoking Statistic From the American Cancer Society

Aaron — Sun, 20 Dec 2009 06:17:18 +0000

Based on data collected from 1995 to 1999, the CDC estimated that adult male smokers lost an average of 13.2 years of life and female smokers lost 14.5 years of life because of smoking.

Tobacco use is responsible for nearly 1 in 5 deaths in the United States. Because cigarette smoking and tobacco use are acquired behaviors — activities that people choose to do — smoking is the most preventable cause of premature death in our society.

Cigarette smoking accounts for at least 30% of all cancer deaths. It is a major cause of the following cancers: lung voice box (larynx) mouth (oral cavity) throat (pharynx) bladder the swallowing tube connected to the stomach (esophagus)

Only about half of the deaths related to smoking are from cancer. Smoking is also a major cause of heart disease, aneurysms, bronchitis, emphysema, and stroke, and it makes pneumonia and asthma worse.

About half of all Americans who keep smoking will die because of the habit. Each year about 443,600 people in the United States die from illnesses related to tobacco use. Smoking cigarettes kills more Americans than alcohol, car accidents, suicide, AIDS, homicide, and illegal drugs combined.

Smoking is responsible for about 87% of lung cancer deaths. Lung cancer is the leading cause of cancer death in both men and women, and is one of the most difficult cancers to treat. Lung cancer is a disease that can often be prevented. Some religious groups that promote non-smoking as part of their religion, such as Mormons and Seventh-day Adventists, have much lower rates of lung cancer and other smoking-related cancers.

The smoke from cigarettes (called secondhand smoke or environmental tobacco smoke) has a harmful health effect on those exposed to it. Adults and children can have health problems from breathing secondhand smoke.

Electric Cigarettes can Eliminate all of the problems associated with the consumption of nicotine via smoking.

Buy an eCigarette Starter Kit now!

Tobacco Seen Killing 6 Million People Next Year (nlm.nih.gov)
Lesser-Known Effects of Smoking Can Play Havoc with Women’s Health (newswire.ca)

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FDA Lies About eCigarettes

Aaron — Sun, 20 Dec 2009 05:31:55 +0000

At a time when the government is ostensibly trying to cut health costs, why is it trying to ban something that might help people quit smoking tobacco, perhaps the most devastating health problem in the U.S.?

The Food and Drug Administration (FDA) held a press conference late last month to scare Americans about the so-called “e-cigarette” — claiming it was loaded with harmful “toxins” and “carcinogens.” The agency was implicitly saying: Stay away from these newfangled, untested cigarette substitutes — better to stick with the real ones, the ones that we are more familiar with, the ones that cause over 450,000 deaths annually in the U.S.

In making its distorted, incomplete and misleading statement, FDA was violating its long-cherished tradition of sticking to sound science as the basis for its policies. And in doing so, it is putting the lives and health of millions of Americans at risk.

The truthful part of the FDA statement was that e-cigarettes have not been through formal efficacy and safety tests at the FDA, and they have only been around a few years. But in the press conference, here is what the FDA did not tell you but should have:

c Traditional cigarettes are lethal not because of the trace level presence of specific “carcinogens” and “toxins,” but because by using them, smokers inhale enormous amounts of smoke — otherwise known as “products of combustion.” It is the inhaled smoke that kills in so many ways — from cancers, cardiovascular and lung disease, and more.

c The cigarette was a relatively obscure product in our society until the invention of a cigarette rolling machine, and sales rose quickly prior to World War I.

Before that, tobacco was used relatively safely — in chew, pipes, cigars — because little if any smoke was inhaled. Cigarettes changed all of that.

c The e-cigarette — a cigarette-mimicking device made up of a battery, an atomizer and a cartridge — allows smokers to inhale, getting a dose of the nicotine they crave, and then sending steam out the other end (with little or no odor) to mimic the ritual and feel of smoking normal cigarettes.

c The FDA complained that the e-cigarette was a “nicotine-delivery system.” Well, it got that much right. But again, it’s the smoke that kills, not the nicotine. Yes, nicotine is highly addictive, and it is what keeps the smoker hooked. But getting the nicotine without the smoke is an enormous health advantage for cigarette smokers (the nicotine inserts come in various strengths and the users can adjust them downward as they wish).

c The FDA has approved other nicotine-delivery systems in the form of gums and patches — and they have been abysmal failures. The smoking cessation rates using these devices is less than 15 percent after one year, condemning millions of addicted smokers to a lingering death. We desperately need other alternatives. But the FDA has now joined a long list of so-called public-health organizations — including the Campaign for Tobacco Free Kids and the American Lung Association — whose collective motto seems to be “quit or die.” Not only do they reject e-cigarettes, but they also condemn other smokeless products like snus, which have a mere fraction of the health risks associated with smoking cigarettes.

c More than 1 million smokers are now using the e-cigarette — a product that offers some, if not all, of the “social amenities” of the real thing — holding the cigarette, taking a drag, seeing a plume of “smoke.” The FDA, lacking data that e-cigarettes pose a health hazard, was so desperate, it called on consumers to phone in adverse side effects of e-cigarettes so they could begin to build a case against them and proceed with their intended ban. They neglected, however, to request smokers who successfully quit using the e-cigarette to also call in.

Cigarette smoking remains the leading cause of preventable disease and death in the United States today. Any alternative acceptable to addicted smokers should be taken seriously. Instead of condemning the e-cigarette, the FDA should be sponsoring studies to evaluate its safety and efficacy — leaving it on the market in the interim.Similar Posts:

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ABC News report about electric cigarettes

Aaron — Sun, 20 Dec 2009 03:41:40 +0000

This is a report from ABC News about the benefits of switching to ecigs rather than smoking traditional tobacco cigarettes.

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E-Cigarettes Under Fire

admin — Mon, 30 Nov 2009 08:46:53 +0000

OVERLAND PARK, Kan. — As more cities ban smoking in restaurants and bars, there is a newer product to the United States that makers claim you can still smoke indoors. It’s under fire from cities across the country, the Food and Drug Administration and a metro parent.

If you’ve been to the mall lately, you may have seen a kiosk selling electronic cigarettes. We’ve found the kiosks at Independence Center and Oak Park mall.

If you walk past the kiosk at Oak Park, a salesperson will ask if you smoke.

At Smoke51 we were shown a product that closely resembled a real cigarette. It comes with a battery and filter and even comes in flavors.

“There’s a heating element that steams water, nicotine, and flavor so you’re going to see me blow out smoke but it’s actually steam or water vapor,” the salesman said.

There are many questions about how this product is marketed.

The Electronic Cigarette Association (ECA) tells its members they can’t make health claims, cannot sell to minors, and they should not make cessation claims.

“We do not market it as a smoking cessation device or healthy alternative. We market it as an alternative to smoking tobacco that kills 500,000 people a year,” President Matt Salmon said.

Despite ECA goals, we were clearly told it’s a healthy alternative at Independence Center and Oak Park Mall kiosks by companies that are not part of the ECA membership.

At Smoke51, the owner calls it a “healthy alternative.”

His salesman says, “It’s not harmful to you.”

The salesman went on to say, “You’re getting a cigarette with all the pros and not the cons. It saves your life and it saves your health.”

In Independence Center, the flavors were pushed to a minor we sent to the kiosk.

“Most girls really like it again my wife absolutely loves the blueberry. It gives you Vitamin D and it gives you the exact same thing you get out of a regular cigarette the only difference it’s not killing you,” the salesman said at Smoking Everywhere.

Kids Think They’re Cool

E-cigarettes are available in a variety of flavors and have different levels of nicotine.

Since they don’t contain tobacco, it’s not illegal to sell them to a minor. However, most company websites and kiosks won’t sell to someone under age 18. Online, you’re not even allowed on some Web sites unless you certify you’re over 18.

It’s still a concern to parents who thought their teens were safe at the mall.

John Wickwire says his 17-year-old son came home from the mall and talked all about electronic cigarettes. John says his son was with a group of teens who were all under age 18 except for one.

“He came home all excited, and I was like, freaked, and I think he was surprised by how I reacted.

“He’s excited and saying, ‘Oh, yeah, there’s this new thing. It’s so cool. They have these flavors,’ and I’m like, ‘What is it?’

“And then he said, ‘Oh, it’s this new kind of cigarette’.

“And I’m like, ‘No, I don’t want you doing cigarettes’,” Wickwire said.

Wickwire thinks there’s a better place for this product than the mall.

“It’s nicotine. It’s addictive. It should be in a drugstore,” Wickwire said.

He says he complained to management at Independence Center. Then he called for action.

Undercover: Easy Access for Kids

We launched an investigation, sending our intern into the mall with a minor whose parents gave us permission. They were armed with a hidden camera.

At the kiosk in Independence Center, our minor wasn’t allowed to try the e-cigarrette.

“I would let you, I don’t have a problem with it, but they would get mad at us. I’m a new employee and got four kids I have to try to support,” the salesman at Smoking Everywhere told our minor.

Wickwire is pleased our minor wasn’t offered a smoke, and hopes his complaining helped bring about that change.

Independence Center would not comment on our story. We also called the corporate Smoking Everywhere office, and have not heard back from the company.

Wickwire was also concerned that the e-cigarettes kiosk at Independence Center was located near teen stores like a skate shop, but he says it has since been moved.

At Oak Park Mall, Smoke51 has also been moved. It was on the lower level of the mall to start. The owner says it was near a carousel where moms and their children would play, so it’s been moved to the food court.

Rafael Orlan owns the Smoke51 kiosk, and says he doesn’t even want kids hanging around his kiosk.

“We have signs must be 18 to buy or try it,” says Orlan.

However, when our minor and intern went to his kiosk, they were offered an e-cigarette with no nicotine.

Our intern asked, “So what’s the point of that?”

The salesman answered, “An oral fixation. It just feels like a cigarette if you want to try the zero one I’ll let you try it.”

A few seconds later, our minor was puffing away on a product that looked like a cigarette but supposedly has no nicotine.

We showed the video to Orlan.

“He made a mistake. A horrible mistake. He did give her zero nicotine which, I guess he made a judgment call, but it was the wrong call for me,” Orlan said.

Orlan says he trains he employees to ask for ID.

“Of course they’ll take notice of this because he will get fired,” Orlan said.

While what happened is not illegal, Orlan says he doesn’t want his product marketed to people who don’t smoke and the $180 price point is one way he tries to make it unattractive to children.

The Food and Drug Administration (FDA) is also concerned about the product being targeted to teens.

It currently bans flavored cigarettes fearing they target children, but flavored e-cigarettes are allowed.

In July, the FDA did put out a warning about e-cigarettes.

“These products are marketed and sold to young people and are readily available online and in shopping malls. In addition, these products do not contain any health warnings comparable to FDA-approved nicotine replacement products or conventional cigarettes. They are also available in different flavors, such as chocolate and mint, which may appeal to young people,” the FDA says.

The FDA’s Division of Pharmaceutical Analysis analyzed a sample of cartridges from Njoy and Smoking Everywhere.

The FDA says one sample detected diethylene glycol, which the FDA says is a chemical used in antifreeze, and is toxic to humans.

The FDA says other samples revealed carcinogens.

While it did the testing, the FDA calls it a preliminary analysis and adds that you should not draw conclusions about what is or is not in these products because it can vary.

The FDA says it tested some cartridges that were labeled as having no nicotine, yet the FDA says it found low levels of nicotine in all except one cartridge. The FDA says it also found that the nicotine levels vary.

FDA Blocks Some E-Cigarette Imports

Shipments of e-cigarettes have even been detained at the border.

The FDA is concerned because these devices have not been submitted for approval or evaluation by the FDA, and they have only limited testing to determine product safety.

The FDA believes e-cigarettes meet the definition of a drug-device under the Federal Food, Drug, and Cosmetic Act. There is even a federal case pending over the FDA’s jurisdiction over this product.

For the FDA to approve the product, the company would need to submit data showing that the product is safe and effective.

Florida-based Smoking Everywhere, Inc. is asking for a preliminary injunction against the FDA so the company can import electronic cigarettes and its accessories. One-hundred percent of its e-cigarette supply is imported, and the FDA has refused some e-cigarette shipments, and added the product to an “Import Alert” list.

The company believes it was not notified correctly of this alert, and questions the FDA’s ability to regulate electronic cigarettes.

The lawsuit from Smoking Everywhere, Inc., says, “By including electronic cigarettes on the FDA’s import alert, several shipments of SE’s products have been wrongfully refused entry into the United States.”

Effective Alternative to Tobacco Smoking

The Electronic Cigarette Association questions the timing of the FDA’s testing.

“If they truly believe that the public is out there being harmed, isn’t one day too long to sit on a study like that? Whey did they not release it for three months? That’s their own factual information,” Salmon said.

Salmon doesn’t smoke, but believes you have the right to smoke and believes there should be an alternative available. He’s seen the devastating effects of smoking on family members.

As an Arizona congressman, Salmon pushed through one of the first public smoking bans. He wants the industry to sell a safe product, and applauds increased regulation as long as it’s within reason.

Since the ECA tells its members to not make health claims, he doesn’t believe FDA testing is necessary to continue sales.

“It would probably take three to eight years to accomplish that, and up to $1.5-billion to do that kind of testing. This is a small industry. We are not big pharmaceutical companies. We are tyring to offer an alternative,” Salmon said.

As for the concerns raised by Wickwire, Salmon shares his belief that e-cigarettes should be pulled from malls.

“I don’t think there’s enough safeguards in kiosks in malls to keep them out of the hands of children,” Salmon said.

He even agrees with banning the flavors if that will protect more children.

Some States have Banned or Restricted E-Cigarettes

John Wickwire is surprised safety discussions didn’t happen before the product was put in malls. He’d like to see e-cigarettes moved to drugstores.

“I thought we had a lot more safeguards,” Wickwire said.

We called the Jackson and Johnson County health departments, and they weren’t aware of the kiosks.

In Oregon, the attorney general filed a lawsuit against Smoking Everywhere, alleging the company made false claims about it’s electronic cigarette.

“It’s my duty to protect the public from products that are falsely advertised as safe,” Attorney General John Kroger said in August.

Oregon sued the company for rejecting a settlement similar to one it reached with other retailers and distributors. The deal keeps them from selling the battery-operated device until they meet state and federal standards.

In California, Governor Arnold Schwarzenegger vetoed a bill to ban e-cigarettes.

“While I support restricting access of electronic cigarettes to children under the age of 18, I cannot sign a measure that also declares them a federally regulated drug when the matter is currently being decided through pending litigation,” Schwarzenegger wrote to the California Senate.

In August, Suffolk County New York passed a bill that means e-cigarettes will face the same restrictions as traditional cigarettes. You can’t sell cigarettes to anyone under age 19 and you can’t use them in public places where traditional smoking is banned. “We here in Suffolk County can be proud that we didn’t sit on our hands and wait for Washington to act,” said Majority Leader John Cooper in August.

The e-cigarettes are also banned in some countries across the world.

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