It appears that the current mantra among anti-smoking researchers who are asked to comment on electronic cigarettes is to respond something like this:
"Because the FDA has not approved these products, we have no idea what chemicals are contained in electronic cigarette vapor. Thus, we cannot recommend these products. Smokers should stick with FDA-approved smoking cessation products, such as the nicotine patch and nicotine gum, which have been proven to be safe and effective."
This mantra was re-iterated by Dr. Steinberg - the president of ATTUD (Association for the Treatment of Tobacco Use Disorders) - in a recent article in the Hudson Reporter. In the article, Dr. Steinberg was quoted as stating:
"Since none of the e-cigarette products are currently regulated by the
FDA, we really have no firm information about their safety. We don’t know for sure
what other chemicals are contained in the vapor, and how much nicotine
is delivered. The perception is that since they don’t contain smoke,
they are safe."
In the same article, the medical director of a smoking cessation program repeats the exact same mantra. He is quoted as stating:
"The e-cigarette is not regulated by the FDA. Therefore you don’t really know what the
ingredients are. You may indeed be playing with fire. In the United
States, tobacco is not considered a drug. Nicotine is an ingredient in
tobacco. Therefore they don’t have any jurisdication to regulate the
e-cigarette at this time. There’s no way to ascertain what nicotine
level you are trying to achieve."
It sounds like these two anti-smoking researchers/practitioners are quoting from an identical playbook.
The Rest of the Story
The problem is that the playbook is a lie. It is simply not true that we really don't know what the ingredients in electronic cigarettes are. And it is also not true that we have no idea what chemicals are contained in electronic cigarette vapor.
In fact, we have a far more precise idea of what is in electronic cigarette vapor than we do of what is in cigarette smoke.
There have been well over 20 studies that have identified the chemicals in electronic cigarette cartridges and/or vapor. In 2011, Zachary Cahn and I reviewed the results of 15 such studies. At that time, we wrote:
"TSNAs have been detected in two studies at trace levels. The maximum level of total TSNAs reported was 8.2 ng/g. This compares with a similar level of 8.0 ng in a nicotine patch, and it is orders of magnitude lower than TSNA levels in regular cigarettes.Table 2 shows that electronic cigarettes contain only 0.07–0.2 per cent of the TSNAs present in cigarettes, a 500-fold to 1400-fold reduction in concentration. The presence of DEG in one of the 18 cartridges studied by the US Food and Drug Administration (FDA) is worrisome, yet none of the other 15 studies found any DEG. The use of a non-pharmaceutical grade of PG may explain this contamination."
"Other than TSNAs and DEG, few, if any, chemicals at levels detected in electronic cigarettes raise serious health concerns. Although the existing research does not warrant a conclusion that electronic cigarettes are safe in absolute terms and further clinical studies are needed to comprehensively assess the safety of electronic cigarettes, a preponderance of the available evidence shows them to be much safer than tobacco cigarettes and comparable in toxicity to conventional nicotine replacement products."
You can find many of the studies that have been conducted here. While there is no question that further research needs to be done to understand the exact safety profile of these products, it is also clear that the anti-smoking playbook, which instructs researchers to argue that we simply don't know what is in electronic cigarettes, is essentially instructing them to lie to the public. We do know what is in the electronic cigarette.
And what we do know is that electronic cigarette users are not "playing with fire," as the medical director of the smoking cessation clinic suggests. On the contrary, electronic cigarette users are avoiding the fire - the fire that involves the combustion of tobacco, forming tens of thousands of chemicals and more than 60 known carcinogens.
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Tuesday, February 19, 2013
Thursday, August 01, 2013
PolitiFact Rhode Island Exposes Anti-Smoking Advocates' Lies
In a PolitiFact Rhode Island expose published in the Providence Journal, the lies of many anti-smoking advocates who oppose electronic cigarettes have been exposed. Specifically, many anti-smoking advocates have argued that smokers should not quit using e-cigarettes because "we have no idea what is in them." PolitiFact's "Truth-O-Meter" scored this claim as FALSE.
According to the expose: "As PolitiFact Rhode Island listened during a July 1, 2013 discussion of legislation on electronic cigarettes, a categorical remark by a state representative caught our attention. Rep. Teresa Tanzi, D-South Kingstown, declared, "We have no idea what is contained in that vapor" when an e-cigarette is used. Is there really no information available to the public, as she seemed to suggest?"
"Our exploration of her statement took us into the world of "vaping" -- the act of using an e-cigarette. ... It didn’t take us long to discover that, despite Tanzi’s assertion, there have been numerous scientific studies about the content of e-cigarette vapors. One of the leading voices in the national tug-of-war over e-cigarettes is Dr. Michael Siegel, a professor in the Department of Community Health Sciences at the Boston University School of Health, and a Brown University graduate. He co-authored a definitive academic paper in 2010 in the peer-reviewed Journal of Public Health Policy that reviewed the available science on e-cigarettes. He cited 16 studies, most of them sponsored by the industry, but all conducted by independent laboratories." ...
"Our ruling - State Rep. Teresa Tanzi said, "We have no idea what is contained in [electronic cigarette] vapor." But we found that numerous studies have identified the primary components of the vapor. ... The judges rule her claim False."
The Rest of the Story
Hopefully this will put to bed forever the common lie being spread by many anti-smoking advocates that we have no idea what is in an electronic cigarette (either the cartridge or the vapor). This misinformation has been spread by a number of anti-smoking groups and advocates, as I have documented in The Rest of the Story over the past months.
The rest of the story is that the anti-smoking movement's electronic cigarette playbook is a lie. It is simply not true that we really don't know what the ingredients in electronic cigarettes are. And it is also not true that we have no idea what chemicals are contained in electronic cigarette vapor. In fact, we have a far more precise idea of what is in electronic cigarette vapor than we do of what is in cigarette smoke.
But it appears that these anti-smoking groups (a misnomer, as Bill Godshall astutely points out) would rather that smokers continue to take their chances with the known hazards of smoking than switch to the much safer personal vaporizers.
According to the expose: "As PolitiFact Rhode Island listened during a July 1, 2013 discussion of legislation on electronic cigarettes, a categorical remark by a state representative caught our attention. Rep. Teresa Tanzi, D-South Kingstown, declared, "We have no idea what is contained in that vapor" when an e-cigarette is used. Is there really no information available to the public, as she seemed to suggest?"
"Our exploration of her statement took us into the world of "vaping" -- the act of using an e-cigarette. ... It didn’t take us long to discover that, despite Tanzi’s assertion, there have been numerous scientific studies about the content of e-cigarette vapors. One of the leading voices in the national tug-of-war over e-cigarettes is Dr. Michael Siegel, a professor in the Department of Community Health Sciences at the Boston University School of Health, and a Brown University graduate. He co-authored a definitive academic paper in 2010 in the peer-reviewed Journal of Public Health Policy that reviewed the available science on e-cigarettes. He cited 16 studies, most of them sponsored by the industry, but all conducted by independent laboratories." ...
"Our ruling - State Rep. Teresa Tanzi said, "We have no idea what is contained in [electronic cigarette] vapor." But we found that numerous studies have identified the primary components of the vapor. ... The judges rule her claim False."
The Rest of the Story
Hopefully this will put to bed forever the common lie being spread by many anti-smoking advocates that we have no idea what is in an electronic cigarette (either the cartridge or the vapor). This misinformation has been spread by a number of anti-smoking groups and advocates, as I have documented in The Rest of the Story over the past months.
The rest of the story is that the anti-smoking movement's electronic cigarette playbook is a lie. It is simply not true that we really don't know what the ingredients in electronic cigarettes are. And it is also not true that we have no idea what chemicals are contained in electronic cigarette vapor. In fact, we have a far more precise idea of what is in electronic cigarette vapor than we do of what is in cigarette smoke.
But it appears that these anti-smoking groups (a misnomer, as Bill Godshall astutely points out) would rather that smokers continue to take their chances with the known hazards of smoking than switch to the much safer personal vaporizers.
Wednesday, June 12, 2013
A Changing World: All Three Major U.S. Tobacco Companies Have Now Entered the Electronic Cigarette Market
Reflecting massive changes in the U.S. tobacco space, all three major U.S. tobacco companies - Altria, Reynolds American, and Lorillard - have all entered the electronic cigarette market.
Lorillard had previously acquired Blu, but last week's announcement that R.J. Reynolds will introduce Vuse e-cigarettes in Colorado in July and this week's announcement that Altria will introduce MarkTen e-cigarettes in Indiana in August mean that all three companies will have entrants in the electronic cigarette market.
The Rest of the Story
There is now no question that the major cigarette companies are actively engaged in transforming the cigarette market, with a shift towards much less hazardous tobacco products. This shift has already resulted in a significant reduction in cigarette consumption, but the declines in smoking should grow as these alternative products begin to penetrate into brick-and-mortar retail stores, rather than just mall kiosks and the internet.
Ironically, the only groups which are opposing this transformation - which may result in a great reduction in cigarette-related morbidity and mortality - are the anti-smoking groups, which simply can't handle the fact that vaping looks like smoking and are not willing to actually examine the evidence that electronic cigarettes, in their seven years on the market, have not resulted in youth smoking initiation or even regular e-cigarette use among nonsmokers.
All three of the major tobacco companies are now officially in the business of harm reduction and are devoting a substantial amount of resources to promoting smoking cessation via the use of electronic cigarettes. On the other hand, anti-smoking groups are largely opposed to the use of electronic cigarettes and have called for their removal from the market. They, along with the FDA, are actively discouraging smokers from trying to quit using these products and are scaring smokers who have quit using electronic cigarettes into discontinuing the use of these devices and instead, returning to smoking.
In addition to being a strange but true ironic twist, I view this as being a major embarrassment for the anti-smoking movement.
Is it not unfortunate that we in tobacco control are the last to adopt the idea of harm reduction to help protect the health of millions of smokers who - let's face it - are not going to quit smoking? Is it not a disgrace that Big Tobacco is now promoting a form of smoking cessation that we in tobacco control are discouraging?
The entrance of the cigarette companies into the electronic cigarette market offers five distinct advantages that I believe in the long run will enhance the e-cigarette market:
1. The entrance of the tobacco companies into the electronic cigarette space now means that a substantial amount of resources - not previously available - can be devoted to marketing the product and making the public aware of electronic cigarettes, something which has previously been quite slow to develop. It is unfavorable for the e-cigarette industry that even six years after introduction of this product, consumers are still largely unaware of the very existence of the product. Even tobacco control experts remain confused about the differences between a cigarette and an electronic cigarette. Already, the entrance of the tobacco companies into the market has resulted in substantial publicity and media attention which is helping to educate the public about these products.
2. The entrance of the tobacco companies into the electronic cigarette space now means that the industry has the resources to conduct the types of studies that may be required in order to obtain FDA approval for various important marketing claims that will ultimately be pivotal for the industry. While it is unclear whether the FDA will apply section 911 to electronic cigarettes (I have urged the agency not to do so), if it does there is no chance that any of the smaller electronic cigarette companies could possibly produce the research required to meet the heavy burdens of that statute. At least there is now a chance. Even if the FDA does not apply section 911 to electronic cigarettes, the entrance of tobacco companies into the market will help facilitate the conduct of important research into the safety and effectiveness of electronic cigarettes that can help inform the development of rational public policy regarding these products.
3. The entrance of the tobacco companies into the electronic cigarette space creates a formidable force that the FDA must now deal with and which has the resources to apply pressure to the agency to promote a reasonable approach to electronic cigarette regulation.
4. The entrance of the tobacco companies into the electronic cigarette space helps the entire industry by establishing an entity that can introduce the most stringent and appropriate quality control measures and help address concerns such as:
5. Perhaps most importantly, the entrance of the tobacco companies into the electronic cigarette space may help transform the market by shifting it from an internet and mall kiosk business into a more traditional retail store operation. Already, the cigarette companies have developed arrangements with retail stores to carry their products. This could potentially lead to a more traditional market in which these products are available at brick-and-mortar stores, not just on the internet or at mall kiosks.
Lorillard had previously acquired Blu, but last week's announcement that R.J. Reynolds will introduce Vuse e-cigarettes in Colorado in July and this week's announcement that Altria will introduce MarkTen e-cigarettes in Indiana in August mean that all three companies will have entrants in the electronic cigarette market.
The Rest of the Story
There is now no question that the major cigarette companies are actively engaged in transforming the cigarette market, with a shift towards much less hazardous tobacco products. This shift has already resulted in a significant reduction in cigarette consumption, but the declines in smoking should grow as these alternative products begin to penetrate into brick-and-mortar retail stores, rather than just mall kiosks and the internet.
Ironically, the only groups which are opposing this transformation - which may result in a great reduction in cigarette-related morbidity and mortality - are the anti-smoking groups, which simply can't handle the fact that vaping looks like smoking and are not willing to actually examine the evidence that electronic cigarettes, in their seven years on the market, have not resulted in youth smoking initiation or even regular e-cigarette use among nonsmokers.
All three of the major tobacco companies are now officially in the business of harm reduction and are devoting a substantial amount of resources to promoting smoking cessation via the use of electronic cigarettes. On the other hand, anti-smoking groups are largely opposed to the use of electronic cigarettes and have called for their removal from the market. They, along with the FDA, are actively discouraging smokers from trying to quit using these products and are scaring smokers who have quit using electronic cigarettes into discontinuing the use of these devices and instead, returning to smoking.
In addition to being a strange but true ironic twist, I view this as being a major embarrassment for the anti-smoking movement.
Is it not unfortunate that we in tobacco control are the last to adopt the idea of harm reduction to help protect the health of millions of smokers who - let's face it - are not going to quit smoking? Is it not a disgrace that Big Tobacco is now promoting a form of smoking cessation that we in tobacco control are discouraging?
The entrance of the cigarette companies into the electronic cigarette market offers five distinct advantages that I believe in the long run will enhance the e-cigarette market:
1. The entrance of the tobacco companies into the electronic cigarette space now means that a substantial amount of resources - not previously available - can be devoted to marketing the product and making the public aware of electronic cigarettes, something which has previously been quite slow to develop. It is unfavorable for the e-cigarette industry that even six years after introduction of this product, consumers are still largely unaware of the very existence of the product. Even tobacco control experts remain confused about the differences between a cigarette and an electronic cigarette. Already, the entrance of the tobacco companies into the market has resulted in substantial publicity and media attention which is helping to educate the public about these products.
2. The entrance of the tobacco companies into the electronic cigarette space now means that the industry has the resources to conduct the types of studies that may be required in order to obtain FDA approval for various important marketing claims that will ultimately be pivotal for the industry. While it is unclear whether the FDA will apply section 911 to electronic cigarettes (I have urged the agency not to do so), if it does there is no chance that any of the smaller electronic cigarette companies could possibly produce the research required to meet the heavy burdens of that statute. At least there is now a chance. Even if the FDA does not apply section 911 to electronic cigarettes, the entrance of tobacco companies into the market will help facilitate the conduct of important research into the safety and effectiveness of electronic cigarettes that can help inform the development of rational public policy regarding these products.
3. The entrance of the tobacco companies into the electronic cigarette space creates a formidable force that the FDA must now deal with and which has the resources to apply pressure to the agency to promote a reasonable approach to electronic cigarette regulation.
4. The entrance of the tobacco companies into the electronic cigarette space helps the entire industry by establishing an entity that can introduce the most stringent and appropriate quality control measures and help address concerns such as:
- the presence of diethylene glycol in some cartridges;
- unpredictable delivery of nicotine;
- inaccurate nicotine levels on cartridges;
- exploding batteries;
- leaky cartridges, etc.
5. Perhaps most importantly, the entrance of the tobacco companies into the electronic cigarette space may help transform the market by shifting it from an internet and mall kiosk business into a more traditional retail store operation. Already, the cigarette companies have developed arrangements with retail stores to carry their products. This could potentially lead to a more traditional market in which these products are available at brick-and-mortar stores, not just on the internet or at mall kiosks.
Tuesday, October 15, 2013
Tobacco Control Practitioners Continue to Deceive the Public About Electronic Cigarettes
In a campaign of deception, tobacco control practitioners throughout the country continue to spread both misleading and outright false information about the health issues regarding electronic cigarettes.
Here are just a few examples from recent days:
1. A tobacco control practitioner in Indiana claimed that we don't know what is in electronic cigarette vapor. Another tobacco control practitioner, from Illinois, claimed that there's no evidence that electronic cigarettes can help people stop smoking.
According to an article in the Princeton Daily Clarion: "E-cigarette supporters claim it can help smokers on the road to becoming smoke free, but Gwen Siekman, the Coordinator for a Tobacco Free Gibson County, says that e-cigarette smokers are just trading one addiction for another." ...
"“They are totally unregulated and they are very scary,” Siekman said. Supporters of the e-cig say there’s no secondhand smoke that will affect non-smokers around them, but Siekman said, “They don’t know what that vapor has in it.”"
"Ronda Hockgeiger, Wabash County Health Department’s prevention coordinator, said that there’s no new evidence that e-cigarettes help people stop smoking." ...
"Siekman is adamant that people should not use e-cigarette to quit smoking."
2. A tobacco control practitioner in Florida was quoted as stating that "we don't know the long-term effects of inhaling that nicotine solution, all day, every day, for years. So we don't know if they're safer than tobacco. The research hasn't been done."
3. A Utah tobacco control practitioner claimed that smokers who use cigarettes and electronic cigarettes increase their nicotine consumption: "smoking cigarettes and e-cigarettes leads to increased nicotine consumption."
4. A Florida physician and tobacco control advocate published an op-ed piece, in which he argued that the idea of using electronic cigarettes for harm reduction is not a public health approach, but simply a marketing strategy: "My first concern is over the concept of Tobacco Harm Reduction, or THR as those promoting e-cigarettes like to call it. They frequently question why physicians would be against a product that might reduce the risks posed by traditional tobacco products. I am against THR because it is a marketing strategy, not a public health policy."
The Rest of the Story
All of these tobacco control practitioners are spreading misleading and/or false information about electronic cigarettes. And this is just from the past several days. The amount of inaccurate information being disseminated by tobacco control groups throughout the country is alarming. It is also very damaging because it misleads the public and hides the truth. The net effect is to undermine the public's appreciation of the hazards of cigarette smoking.
Let's take the lies one by one.
First, it is not true that we have no idea what is in electronic cigarette vapor. These products have been extensively studied and we have a fairly good idea what is in there. The difficulty is not that we are unaware of the vapor constituents; the problem is that it is difficult to project the long-term risks of inhalation of small levels of a chemical like formaldehyde or acrolein. But we actually have a much better idea what is in electronic cigarette vapor than what is in tobacco smoke.
Second, it is not true that we don't know whether vaping is safer than smoking. Even tobacco companies would not argue that smoking is no more dangerous than vaping. It doesn't take rocket toxicology to figure out that inhaling nicotine plus tens of thousands of chemicals including more than 60 known carcinogens is going to be more dangerous than inhaling nicotine plus low levels of a few chemicals. It doesn't take rocket epidemiology to figure out that burning tobacco is going to result in a more dangerous product than heating nicotine dissolved in propylene glycol and glycerin. tobacco companies don't argue that smoking may be no more dangerous than vaping. Why would a public health advocate advance such an argument?
Third, it is not true that dual users of electronic cigarettes and regular cigarettes increase their nicotine consumption. Actually, smokers who substitute electronic cigarettes for regular ones decrease their nicotine consumption because the electronic cigarette is nowhere close to a tobacco cigarette in its ability to deliver nicotine. The overwhelming majority of electronic cigarette users are lowering their nicotine consumption, even if they maintain dual use of both products.
Fourth, it is not true that the idea of using electronic cigarettes for harm reduction is simply a marketing strategy. Vaping is much safer than smoking, and smokers who have been able to quit using electronic cigarettes have likely saved their lives. This is a bona fide public health strategy that could literally transform the tobacco epidemic. Other examples of harm reduction strategies in public health are needle exchange programs, methadone programs, and comprehensive sex education. Are those also merely marketing strategies?
In addition to spreading lies and misinformation, these tobacco control practitioners (and hundreds like them throughout the country - these are just a few recent examples of what I am reading literally every day in newspapers nationwide) are providing damaging and inappropriate advice: telling smokers not to quit smoking using electronic cigarettes. This is terrible advice. If a smoker is able to quit, we should be congratulating that person, not attacking them or telling them that they did something wrong and are endangering their health. It's quite the opposite.
To my mind, publicly advising smokers who are or may be able to quit using electronic cigarettes not to quit using these products is tantamount to committing public health malpractice on a grand scale.
Here are just a few examples from recent days:
1. A tobacco control practitioner in Indiana claimed that we don't know what is in electronic cigarette vapor. Another tobacco control practitioner, from Illinois, claimed that there's no evidence that electronic cigarettes can help people stop smoking.
According to an article in the Princeton Daily Clarion: "E-cigarette supporters claim it can help smokers on the road to becoming smoke free, but Gwen Siekman, the Coordinator for a Tobacco Free Gibson County, says that e-cigarette smokers are just trading one addiction for another." ...
"“They are totally unregulated and they are very scary,” Siekman said. Supporters of the e-cig say there’s no secondhand smoke that will affect non-smokers around them, but Siekman said, “They don’t know what that vapor has in it.”"
"Ronda Hockgeiger, Wabash County Health Department’s prevention coordinator, said that there’s no new evidence that e-cigarettes help people stop smoking." ...
"Siekman is adamant that people should not use e-cigarette to quit smoking."
2. A tobacco control practitioner in Florida was quoted as stating that "we don't know the long-term effects of inhaling that nicotine solution, all day, every day, for years. So we don't know if they're safer than tobacco. The research hasn't been done."
3. A Utah tobacco control practitioner claimed that smokers who use cigarettes and electronic cigarettes increase their nicotine consumption: "smoking cigarettes and e-cigarettes leads to increased nicotine consumption."
4. A Florida physician and tobacco control advocate published an op-ed piece, in which he argued that the idea of using electronic cigarettes for harm reduction is not a public health approach, but simply a marketing strategy: "My first concern is over the concept of Tobacco Harm Reduction, or THR as those promoting e-cigarettes like to call it. They frequently question why physicians would be against a product that might reduce the risks posed by traditional tobacco products. I am against THR because it is a marketing strategy, not a public health policy."
The Rest of the Story
All of these tobacco control practitioners are spreading misleading and/or false information about electronic cigarettes. And this is just from the past several days. The amount of inaccurate information being disseminated by tobacco control groups throughout the country is alarming. It is also very damaging because it misleads the public and hides the truth. The net effect is to undermine the public's appreciation of the hazards of cigarette smoking.
Let's take the lies one by one.
First, it is not true that we have no idea what is in electronic cigarette vapor. These products have been extensively studied and we have a fairly good idea what is in there. The difficulty is not that we are unaware of the vapor constituents; the problem is that it is difficult to project the long-term risks of inhalation of small levels of a chemical like formaldehyde or acrolein. But we actually have a much better idea what is in electronic cigarette vapor than what is in tobacco smoke.
Second, it is not true that we don't know whether vaping is safer than smoking. Even tobacco companies would not argue that smoking is no more dangerous than vaping. It doesn't take rocket toxicology to figure out that inhaling nicotine plus tens of thousands of chemicals including more than 60 known carcinogens is going to be more dangerous than inhaling nicotine plus low levels of a few chemicals. It doesn't take rocket epidemiology to figure out that burning tobacco is going to result in a more dangerous product than heating nicotine dissolved in propylene glycol and glycerin. tobacco companies don't argue that smoking may be no more dangerous than vaping. Why would a public health advocate advance such an argument?
Third, it is not true that dual users of electronic cigarettes and regular cigarettes increase their nicotine consumption. Actually, smokers who substitute electronic cigarettes for regular ones decrease their nicotine consumption because the electronic cigarette is nowhere close to a tobacco cigarette in its ability to deliver nicotine. The overwhelming majority of electronic cigarette users are lowering their nicotine consumption, even if they maintain dual use of both products.
Fourth, it is not true that the idea of using electronic cigarettes for harm reduction is simply a marketing strategy. Vaping is much safer than smoking, and smokers who have been able to quit using electronic cigarettes have likely saved their lives. This is a bona fide public health strategy that could literally transform the tobacco epidemic. Other examples of harm reduction strategies in public health are needle exchange programs, methadone programs, and comprehensive sex education. Are those also merely marketing strategies?
In addition to spreading lies and misinformation, these tobacco control practitioners (and hundreds like them throughout the country - these are just a few recent examples of what I am reading literally every day in newspapers nationwide) are providing damaging and inappropriate advice: telling smokers not to quit smoking using electronic cigarettes. This is terrible advice. If a smoker is able to quit, we should be congratulating that person, not attacking them or telling them that they did something wrong and are endangering their health. It's quite the opposite.
To my mind, publicly advising smokers who are or may be able to quit using electronic cigarettes not to quit using these products is tantamount to committing public health malpractice on a grand scale.
Wednesday, September 05, 2012
"Experts" from University of Athens Tell the Public They Are Not Sure if Smoking is Any More Hazardous than Vaping, Despite Lack of Demonstration of Clinically Significant Effects on Airways and Improvement in Respiratory Symptoms in Many Vapers
Despite the fact that no clinically significant effect of electronic cigarettes on pulmonary function has been demonstrated while many vapers experience an improvement in respiratory symptoms, self-proclaimed "experts" from the University of Athens are telling the public they are unsure that smoking is any more hazardous than vaping.
Moreover, despite the finding that electronic cigarettes contain only traces of tobacco-specific nitrosamines and that the level of these carcinogens is two orders of magnitude lower than in Marlboros, these "experts" are telling the public that they may be just as healthy smoking Marlboros as quitting smoking completely and using electronic cigarettes instead.
In a press release issued earlier this week entitled "Experts warn that e-cigarettes can damage the lungs," a group of researchers from the University of Athens report the results of a study of the acute effects of vaping on airways resistance in smokers with and without existing lung disease. They studied 24 smokers, 11 with normal lung function and 13 with COPD or asthma. Subjects used an electronic cigarette for 10 minutes. Airway resistance was measured before and after e-cigarette use.
The main finding was that: "In smokers with normal spirometry there was a statistically significant increase from a mean average of 176% to 220%. In COPD and asthma patients the use of one e-cigarette seemed to have no immediate effect to airway resistance."
Based on these findings the researchers concluded: "We do not yet know whether unapproved nicotine delivery products, such as e-cigarettes, are safer than normal cigarettes, despite marketing claims that they are less harmful."
The results and conclusions of the study were released to the media and the public via press release, apparently prior to peer review and publication of the study. In fact, there is no actual written study available, merely the abstract as this was an abstract presented at a scientific conference: the 2012 meeting of the European Respiratory Society.
The conclusions of the study, as disseminated by the media, were more drastic than presented in the actual abstract. Many of these headlines warned that electronic cigarette use was found to "harm the lungs," "damage the lungs," or to "cause less oxygen to be absorbed by the blood."
Before going any further, let's correct the misrepresentation of the study findings by the media and then the misrepresentation of the study findings by the study authors.
The media claimed that the results indicate that electronic cigarettes cause "damage" to the lungs and/or cause "less oxygen to be absorbed by the blood." This is incorrect. The study found that use of an electronic cigarette for 10 minutes increased airway resistance in smokers without existing lung disease (although there was no effect on airway resistance in those with existing obstructive lung disease). A temporary increase in airway resistance does not equate to "lung damage."
For example, breathing hot, humid air has been found to increase airway resistance in some healthy subjects, but one would not claim that breathing humid air damages the lung. Obviously, a behavior such as smoking, with prolonged exposure to chemicals that cause airway inflammation can ultimately lead to lung damage and a condition of chronic obstructive lung disease with permanent increases in airway resistance that cause clinical symptoms. But a transient increase in airway resistance due to an exposure does not necessarily translate into a clinically meaningful effect, or to "harm" or "damage" to the lungs.
Even more fallacious is the claim that the study found that electronic cigarettes cause hypoxemia (lowered oxygen in the blood). The study did not even measure oxygen levels in the blood, and a small increase in airway resistance is not going to cause hypoxemia (otherwise, millions of people in Tampa would be walking around constantly with hypoxemia due to the constant heat and humidity). Tampa has other issues, but chronic hypoxemia among the majority of the population is not one of them.
Importantly, the misrepresentation of the study results regarding oxygen levels in the blood appears to be the fault of the media, as nowhere in the press release does it suggest anything about hypoxemia. However, that the media got the impression that this study demonstrates lung damage is directly attributable to the misrepresentation of the study by the authors, who titled their press release: "Experts warn that e-cigarettes can damage the lungs," rather than "Researchers warn that e-cigarettes increase airway resistance."
Readers should be aware of the fact that this finding is not new. A previous study - which was actually peer-reviewed and published - reported that electronic cigarette use can cause a mild increase in airway resistance. As I commented on that article: "The rest of the story is that a propylene-based electronic cigarette system has been shown to produce airways inflammation in users, resulting in subclinical evidence of increased airway resistance. Whether long-term use of electronic cigarettes would lead to clinical manifestations due to actual airway obstruction is unclear, and more research is necessary to make such a determination. What we do know, however, is that long-term continuation of cigarette smoking will almost certainly lead to clinically significant airway obstruction. The bottom line: if a smoker is choosing between active smoking and electronic cigarette use, the use of the electronic cigarette is clearly the wiser choice."
The same comment is relevant to the present study. Readers should be aware that in the previous study, the authors were careful to point out that their research only detected subclinical evidence of increased airway resistance and that it remained unclear whether electronic cigarettes cause any clinically significant manifestations: "We must state, however, that although the differences within our study are of statistical significance, the clinical changes may be too small to be of major clinical importance."
No such caveat is given by the authors of the present study. But the bottom line is the same. If a smoker is choosing between active smoking and electronic cigarette use, the use of the electronic cigarette is clearly the wiser choice. And in fact, this is the choice that most electronic users are facing. The idea that any substantial proportion of electronic cigarette users will quit smoking if they take the article's advice and stick to approved NRT or pharmacotherapy products is unsupported by the scientific evidence.
Although the claim that they found lung damage as a result of electronic cigarette smoking is a misrepresentation of the study findings by the authors, there is a far worse and more damaging misrepresentation. The authors, based on their finding of a possible small increase in airways resistance in some smokers, have concluded that cigarette smoking may be no more harmful than vaping. This is a sweeping conclusion that even the tobacco companies would not dare make. You would never hear a tobacco company claim that their products may be no more dangerous than inhaling nicotine and propylene glycol from a tube that contains no tobacco and involves no combustion process. However, anti-smoking researchers are making precisely that assertion.
The claim is ridiculous, damaging, and ignores all of the existing evidence. While electronic cigarettes have been shown to cause mild increases in airway resistance with uncertain clinical implications, we know that cigarette smoking causes chronic obstructive lung disease. So even if you look only at respiratory effects, there is strong evidence that smoking is more dangerous than vaping. Moreover, many vapers have experienced dramatic improvement in respiratory symptoms, which is not consistent with the argument that smoking may be no more hazardous than vaping in terms of respiratory effects.
There are no known effects of electronic cigarette use on heart disease. And the levels of tobacco-specific nitrosamines and formaldehyde (the only two carcinogens detected in electronic cigarettes) are much lower than in tobacco cigarettes. How these researchers could claim that the carcinogenic risk associated with vaping could be equivalent to that associated with cigarettes, which contain an additional 58 known carcinogens, is beyond me.
That this study was released using the "science by press release" method is also problematic. As I have argued before, scientific results should not be released to the media and the public unless either: (1) the study has been peer-reviewed and published; or (2) the entire study is made available publicly so that the work can be properly evaluated. In this case, there is no actual study I am aware of, merely an abstract. Thus, we have no way of evaluating the validity of the findings. But the results have already been widely disseminated. If the paper is subsequently peer-reviewed and the authors are told to tone down their conclusions (as I would if I were reviewing the paper), it is too late. The conclusion of these experts that vaping causes lung damage has already been disseminated. If the authors later come back and tell the media: "Sorry, we misspoke. Actually, the study only shows subclinical evidence of airway resistance and it is not clear whether this translates into any clinically meaningful effect," it will not matter. The word is already out there on the street.
In searching for a reason why the press release misrepresented the findings of the paper, the first thought that came to my mind is that perhaps there is a financial conflict of interest with Big Pharma. And indeed, it turns out that one of the study authors - Dr. Gratziou - was lead author of a study that was funded by, and conducted in part by Pfizer, maker of Chantix, a drug which stands to lose considerable sales if electronic cigarettes become popular.
Thus, this co-author of the study has a significant financial conflict of interest with Big Pharma that has the appearance of having biased the interpretation and presentation of the study findings. However, that conflict was not disclosed, either in the abstract or in the press release.
The failure to disclose this conflict of interest is inappropriate, because it essentially is hiding this important financial relationship from the public. Not only has the author been funded by Pfizer, but she has worked directly with Pfizer on the research. Thus, she has a substantial financial interest in a company whose products are a direct competitor of the product this study examines. This is a great example of why conflict of interest disclosure rules exist in the first place. It is breaches like this which led the Department of Health and Human Services to adopt a financial disclosure policy for all academic research.
The rest of the story is that the media has misrepresented the study findings, due in part to misrepresentation of the study findings by the authors themselves. Even worse, the press release disseminates a completely unsupported conclusion that runs contrary to all existing scientific evidence and which - if made by a tobacco company - would be considered fraudulent. Finally, all of this misrepresentation and deception occurs in the existence of a severe financial conflict of interest which was hidden from the media and the public.
(Thanks to Bill Godshall, Farrell Delman, Riccardo Polosa, and Dave Ryder for insights and information that have been incorporated into this commentary.)
Moreover, despite the finding that electronic cigarettes contain only traces of tobacco-specific nitrosamines and that the level of these carcinogens is two orders of magnitude lower than in Marlboros, these "experts" are telling the public that they may be just as healthy smoking Marlboros as quitting smoking completely and using electronic cigarettes instead.
In a press release issued earlier this week entitled "Experts warn that e-cigarettes can damage the lungs," a group of researchers from the University of Athens report the results of a study of the acute effects of vaping on airways resistance in smokers with and without existing lung disease. They studied 24 smokers, 11 with normal lung function and 13 with COPD or asthma. Subjects used an electronic cigarette for 10 minutes. Airway resistance was measured before and after e-cigarette use.
The main finding was that: "In smokers with normal spirometry there was a statistically significant increase from a mean average of 176% to 220%. In COPD and asthma patients the use of one e-cigarette seemed to have no immediate effect to airway resistance."
Based on these findings the researchers concluded: "We do not yet know whether unapproved nicotine delivery products, such as e-cigarettes, are safer than normal cigarettes, despite marketing claims that they are less harmful."
The results and conclusions of the study were released to the media and the public via press release, apparently prior to peer review and publication of the study. In fact, there is no actual written study available, merely the abstract as this was an abstract presented at a scientific conference: the 2012 meeting of the European Respiratory Society.
The conclusions of the study, as disseminated by the media, were more drastic than presented in the actual abstract. Many of these headlines warned that electronic cigarette use was found to "harm the lungs," "damage the lungs," or to "cause less oxygen to be absorbed by the blood."
The Rest of the Story
Before going any further, let's correct the misrepresentation of the study findings by the media and then the misrepresentation of the study findings by the study authors.
The media claimed that the results indicate that electronic cigarettes cause "damage" to the lungs and/or cause "less oxygen to be absorbed by the blood." This is incorrect. The study found that use of an electronic cigarette for 10 minutes increased airway resistance in smokers without existing lung disease (although there was no effect on airway resistance in those with existing obstructive lung disease). A temporary increase in airway resistance does not equate to "lung damage."
For example, breathing hot, humid air has been found to increase airway resistance in some healthy subjects, but one would not claim that breathing humid air damages the lung. Obviously, a behavior such as smoking, with prolonged exposure to chemicals that cause airway inflammation can ultimately lead to lung damage and a condition of chronic obstructive lung disease with permanent increases in airway resistance that cause clinical symptoms. But a transient increase in airway resistance due to an exposure does not necessarily translate into a clinically meaningful effect, or to "harm" or "damage" to the lungs.
Even more fallacious is the claim that the study found that electronic cigarettes cause hypoxemia (lowered oxygen in the blood). The study did not even measure oxygen levels in the blood, and a small increase in airway resistance is not going to cause hypoxemia (otherwise, millions of people in Tampa would be walking around constantly with hypoxemia due to the constant heat and humidity). Tampa has other issues, but chronic hypoxemia among the majority of the population is not one of them.
Importantly, the misrepresentation of the study results regarding oxygen levels in the blood appears to be the fault of the media, as nowhere in the press release does it suggest anything about hypoxemia. However, that the media got the impression that this study demonstrates lung damage is directly attributable to the misrepresentation of the study by the authors, who titled their press release: "Experts warn that e-cigarettes can damage the lungs," rather than "Researchers warn that e-cigarettes increase airway resistance."
Readers should be aware of the fact that this finding is not new. A previous study - which was actually peer-reviewed and published - reported that electronic cigarette use can cause a mild increase in airway resistance. As I commented on that article: "The rest of the story is that a propylene-based electronic cigarette system has been shown to produce airways inflammation in users, resulting in subclinical evidence of increased airway resistance. Whether long-term use of electronic cigarettes would lead to clinical manifestations due to actual airway obstruction is unclear, and more research is necessary to make such a determination. What we do know, however, is that long-term continuation of cigarette smoking will almost certainly lead to clinically significant airway obstruction. The bottom line: if a smoker is choosing between active smoking and electronic cigarette use, the use of the electronic cigarette is clearly the wiser choice."
The same comment is relevant to the present study. Readers should be aware that in the previous study, the authors were careful to point out that their research only detected subclinical evidence of increased airway resistance and that it remained unclear whether electronic cigarettes cause any clinically significant manifestations: "We must state, however, that although the differences within our study are of statistical significance, the clinical changes may be too small to be of major clinical importance."
No such caveat is given by the authors of the present study. But the bottom line is the same. If a smoker is choosing between active smoking and electronic cigarette use, the use of the electronic cigarette is clearly the wiser choice. And in fact, this is the choice that most electronic users are facing. The idea that any substantial proportion of electronic cigarette users will quit smoking if they take the article's advice and stick to approved NRT or pharmacotherapy products is unsupported by the scientific evidence.
Although the claim that they found lung damage as a result of electronic cigarette smoking is a misrepresentation of the study findings by the authors, there is a far worse and more damaging misrepresentation. The authors, based on their finding of a possible small increase in airways resistance in some smokers, have concluded that cigarette smoking may be no more harmful than vaping. This is a sweeping conclusion that even the tobacco companies would not dare make. You would never hear a tobacco company claim that their products may be no more dangerous than inhaling nicotine and propylene glycol from a tube that contains no tobacco and involves no combustion process. However, anti-smoking researchers are making precisely that assertion.
The claim is ridiculous, damaging, and ignores all of the existing evidence. While electronic cigarettes have been shown to cause mild increases in airway resistance with uncertain clinical implications, we know that cigarette smoking causes chronic obstructive lung disease. So even if you look only at respiratory effects, there is strong evidence that smoking is more dangerous than vaping. Moreover, many vapers have experienced dramatic improvement in respiratory symptoms, which is not consistent with the argument that smoking may be no more hazardous than vaping in terms of respiratory effects.
There are no known effects of electronic cigarette use on heart disease. And the levels of tobacco-specific nitrosamines and formaldehyde (the only two carcinogens detected in electronic cigarettes) are much lower than in tobacco cigarettes. How these researchers could claim that the carcinogenic risk associated with vaping could be equivalent to that associated with cigarettes, which contain an additional 58 known carcinogens, is beyond me.
That this study was released using the "science by press release" method is also problematic. As I have argued before, scientific results should not be released to the media and the public unless either: (1) the study has been peer-reviewed and published; or (2) the entire study is made available publicly so that the work can be properly evaluated. In this case, there is no actual study I am aware of, merely an abstract. Thus, we have no way of evaluating the validity of the findings. But the results have already been widely disseminated. If the paper is subsequently peer-reviewed and the authors are told to tone down their conclusions (as I would if I were reviewing the paper), it is too late. The conclusion of these experts that vaping causes lung damage has already been disseminated. If the authors later come back and tell the media: "Sorry, we misspoke. Actually, the study only shows subclinical evidence of airway resistance and it is not clear whether this translates into any clinically meaningful effect," it will not matter. The word is already out there on the street.
In searching for a reason why the press release misrepresented the findings of the paper, the first thought that came to my mind is that perhaps there is a financial conflict of interest with Big Pharma. And indeed, it turns out that one of the study authors - Dr. Gratziou - was lead author of a study that was funded by, and conducted in part by Pfizer, maker of Chantix, a drug which stands to lose considerable sales if electronic cigarettes become popular.
Thus, this co-author of the study has a significant financial conflict of interest with Big Pharma that has the appearance of having biased the interpretation and presentation of the study findings. However, that conflict was not disclosed, either in the abstract or in the press release.
The failure to disclose this conflict of interest is inappropriate, because it essentially is hiding this important financial relationship from the public. Not only has the author been funded by Pfizer, but she has worked directly with Pfizer on the research. Thus, she has a substantial financial interest in a company whose products are a direct competitor of the product this study examines. This is a great example of why conflict of interest disclosure rules exist in the first place. It is breaches like this which led the Department of Health and Human Services to adopt a financial disclosure policy for all academic research.
The rest of the story is that the media has misrepresented the study findings, due in part to misrepresentation of the study findings by the authors themselves. Even worse, the press release disseminates a completely unsupported conclusion that runs contrary to all existing scientific evidence and which - if made by a tobacco company - would be considered fraudulent. Finally, all of this misrepresentation and deception occurs in the existence of a severe financial conflict of interest which was hidden from the media and the public.
(Thanks to Bill Godshall, Farrell Delman, Riccardo Polosa, and Dave Ryder for insights and information that have been incorporated into this commentary.)
Monday, September 09, 2013
Electronic Cigarette Experimentation Increases Among Youth, But Use Among Nonsmokers Remains Low and Regular Use Rates are Still Unknown
The Centers for Disease Control and Prevention (CDC) reported last week that the prevalence of youth in grades 6-12 who have experimented with electronic cigarettes in the past month increased from 1.1% in 2011 to 2.1% in 2012. Among middle school students, the prevalence of past month use increased from 0.6% to 1.1%. Among high school students, past-month use increased from 1.5% to 2.8%.
Based on these results, CDC Director Dr. Thomas Frieden proclaimed: "The increased use of e-cigarettes by teens is deeply troubling....Nicotine is a highly addictive drug. Many teens who start with e-cigarettes may be condemned to struggling with a lifelong addiction to nicotine and conventional cigarettes."
In response to the CDC report, Connecticut Attorney General Richard Blumenthal stated as follows: "“Electronic cigarettes as marketed today – with flavors like bubblegum and strawberry – are targeted at young people with the very clear intent of creating a new generation of smokers. Without question, tobacco companies are using the same despicable tactics with e-cigarettes that they used in previous decades with traditional cigarettes to lure youth down a path of nicotine addiction and eventual death."
Senator Markey responded: "“These e-cigarettes are a gateway to tobacco use by children and teens and should not be marketed to youth."
The Rest of the Story
The alarm calls being made by public health officials and politicians are premature. And their conclusions are unsupported by these data.
In no way do these data support the hypothesis that electronic cigarettes are a "gateway to tobacco use" by children and teens as Senator Markey claims. And there is no evidence provided that electronic cigarettes are being "targeted at young people with the very clear intent of creating a new generation of smokers" as Attorney General Blumenthal claims.
It is not at all surprising that youth smokers might experiment with electronic cigarettes. To the extent that these youth are able to switch over to electronic cigarettes, they are most likely reducing their long-term prospects of becoming cigarette smoking addicts. The danger is if nonsmoking youth start using these products and then end up becoming addicted to nicotine, causing them to transition to cigarette smoking.
But what do the CDC data tell us about whether the kids experimenting with e-cigarettes are smokers or nonsmokers?
Among youth who experimented with electronic cigarettes in 2012, the overwhelming majority - 90.6% - were smokers.Only about one in ten of the youths who experimented with electronic cigarettes were never smokers. And among the high school students who tried electronic cigarettes, only 7.2% were never smokers. Thus, it is quite clear that the overwhelming majority of the experimentation that is occurring among youth is happening among youth who already smoke cigarettes. This is not necessarily a bad thing, on its own, if it can reduce the chances of these youths becoming lifelong cigarette addicts.
The proportion of nonsmoking youth who experimented with e-cigarettes in the past 30 days remains small:
1. The survey measured experimentation, but not regular e-cigarette use.
It is not surprising that about 2% of youth would try electronic cigarettes. But the important issue is what percentage of these youth enjoy them enough to become regular users? The CDC survey measured past month use (which is essentially experimentation), but it did not assess daily use, or anything close to regular use. So what we end up with is a measure of experimentation, but no idea of whether youth are actually taking up this behavior and becoming regular vapers.
2. The survey found no evidence that e-cigarettes are a gateway to smoking.
In contrast to the alarming statements of the politicians and the CDC director (who was talking more like a politician), the survey provided no evidence whatsoever that electronic cigarettes are serving as a gateway to cigarette use. Not a single case was documented in which a nonsmoking youth began using electronic cigarettes, became addicted to nicotine, and then went on to become a regular cigarette smoker. So we're still in the realm of unsubstantiated claims.
3. The low rates of youth nonsmoker use of e-cigarettes in light of the high rates of experimentation with e-cigarettes among youth suggest that e-cigarettes are not currently a major problem that is creating a gateway to increased cigarette addiction.
Given that the rate of experimentation with electronic cigarettes is as high as 10% among high school students, the finding that only 0.5% of high school students are nonsmoking, current electronic cigarette users is actually somewhat reassuring. It suggests that this behavior has not caught on among nonsmokers -- at least not yet.
4. Neither this study, nor other evidence, supports the assertion that electronic cigarettes are being marketed with the intention of recruiting youth and/or creating new cigarette smokers from those youth.
It is difficult to refute a statement for which there is no evidence presented in support. Attorney General Blumenthal claims that electronic cigarettes "are targeted at young people with the very clear intent of creating a new generation of smokers." However, he provides not a shred of evidence to support this outcontention. Perhaps in political circles, that flies. But in science, it does not. I cannot make a statement like that with providing at least some supporting evidence.
In fact, the existing evidence refutes Blumenthal's contention, because the clear intention of electronic cigarette marketers is to sell as many electronic cigarettes as they can, not as many cigarettes as they can. In fact, of the more than 250 companies now on the general market, only one even sells cigarettes in the first place. Blumenthal's assertion, therefore, is not only unsubstantiated, but preposterous.
Summary
The rest of the story is that both health leaders and politicians (perhaps being one in the same) are using these data to make false and exaggerated claims that have no basis in science. There is no evidence that regular electronic cigarette use is becoming a substantial problem among youth nonsmokers and there remains no evidence that electronic cigarettes have become a gateway to cigarette addiction. These is also no evidence that these products are being marketed with the intention of turning youth into new cigarette smokers.
Nevertheless, I am in no way arguing here that regulation is not needed. Just the opposite. The FDA needs to step in and do everything it reasonably can to ensure that electronic cigarettes do not become popular among youth, and especially that they do not become a gateway to nicotine addiction and cigarette use.
Based on these results, CDC Director Dr. Thomas Frieden proclaimed: "The increased use of e-cigarettes by teens is deeply troubling....Nicotine is a highly addictive drug. Many teens who start with e-cigarettes may be condemned to struggling with a lifelong addiction to nicotine and conventional cigarettes."
In response to the CDC report, Connecticut Attorney General Richard Blumenthal stated as follows: "“Electronic cigarettes as marketed today – with flavors like bubblegum and strawberry – are targeted at young people with the very clear intent of creating a new generation of smokers. Without question, tobacco companies are using the same despicable tactics with e-cigarettes that they used in previous decades with traditional cigarettes to lure youth down a path of nicotine addiction and eventual death."
Senator Markey responded: "“These e-cigarettes are a gateway to tobacco use by children and teens and should not be marketed to youth."
The Rest of the Story
The alarm calls being made by public health officials and politicians are premature. And their conclusions are unsupported by these data.
In no way do these data support the hypothesis that electronic cigarettes are a "gateway to tobacco use" by children and teens as Senator Markey claims. And there is no evidence provided that electronic cigarettes are being "targeted at young people with the very clear intent of creating a new generation of smokers" as Attorney General Blumenthal claims.
It is not at all surprising that youth smokers might experiment with electronic cigarettes. To the extent that these youth are able to switch over to electronic cigarettes, they are most likely reducing their long-term prospects of becoming cigarette smoking addicts. The danger is if nonsmoking youth start using these products and then end up becoming addicted to nicotine, causing them to transition to cigarette smoking.
But what do the CDC data tell us about whether the kids experimenting with e-cigarettes are smokers or nonsmokers?
Among youth who experimented with electronic cigarettes in 2012, the overwhelming majority - 90.6% - were smokers.Only about one in ten of the youths who experimented with electronic cigarettes were never smokers. And among the high school students who tried electronic cigarettes, only 7.2% were never smokers. Thus, it is quite clear that the overwhelming majority of the experimentation that is occurring among youth is happening among youth who already smoke cigarettes. This is not necessarily a bad thing, on its own, if it can reduce the chances of these youths becoming lifelong cigarette addicts.
The proportion of nonsmoking youth who experimented with e-cigarettes in the past 30 days remains small:
- Overall, only 0.5% of youth were nonsmokers using e-cigarettes in the past 30 days;
- Among middle school students, only 0.4% were nonsmokers using e-cigarettes in the past 30 days; and
- Among high school students, only 0.5% were nonsmokers using e-cigarettes in the past 30 days.
1. The survey measured experimentation, but not regular e-cigarette use.
It is not surprising that about 2% of youth would try electronic cigarettes. But the important issue is what percentage of these youth enjoy them enough to become regular users? The CDC survey measured past month use (which is essentially experimentation), but it did not assess daily use, or anything close to regular use. So what we end up with is a measure of experimentation, but no idea of whether youth are actually taking up this behavior and becoming regular vapers.
2. The survey found no evidence that e-cigarettes are a gateway to smoking.
In contrast to the alarming statements of the politicians and the CDC director (who was talking more like a politician), the survey provided no evidence whatsoever that electronic cigarettes are serving as a gateway to cigarette use. Not a single case was documented in which a nonsmoking youth began using electronic cigarettes, became addicted to nicotine, and then went on to become a regular cigarette smoker. So we're still in the realm of unsubstantiated claims.
3. The low rates of youth nonsmoker use of e-cigarettes in light of the high rates of experimentation with e-cigarettes among youth suggest that e-cigarettes are not currently a major problem that is creating a gateway to increased cigarette addiction.
Given that the rate of experimentation with electronic cigarettes is as high as 10% among high school students, the finding that only 0.5% of high school students are nonsmoking, current electronic cigarette users is actually somewhat reassuring. It suggests that this behavior has not caught on among nonsmokers -- at least not yet.
4. Neither this study, nor other evidence, supports the assertion that electronic cigarettes are being marketed with the intention of recruiting youth and/or creating new cigarette smokers from those youth.
It is difficult to refute a statement for which there is no evidence presented in support. Attorney General Blumenthal claims that electronic cigarettes "are targeted at young people with the very clear intent of creating a new generation of smokers." However, he provides not a shred of evidence to support this outcontention. Perhaps in political circles, that flies. But in science, it does not. I cannot make a statement like that with providing at least some supporting evidence.
In fact, the existing evidence refutes Blumenthal's contention, because the clear intention of electronic cigarette marketers is to sell as many electronic cigarettes as they can, not as many cigarettes as they can. In fact, of the more than 250 companies now on the general market, only one even sells cigarettes in the first place. Blumenthal's assertion, therefore, is not only unsubstantiated, but preposterous.
Summary
The rest of the story is that both health leaders and politicians (perhaps being one in the same) are using these data to make false and exaggerated claims that have no basis in science. There is no evidence that regular electronic cigarette use is becoming a substantial problem among youth nonsmokers and there remains no evidence that electronic cigarettes have become a gateway to cigarette addiction. These is also no evidence that these products are being marketed with the intention of turning youth into new cigarette smokers.
Nevertheless, I am in no way arguing here that regulation is not needed. Just the opposite. The FDA needs to step in and do everything it reasonably can to ensure that electronic cigarettes do not become popular among youth, and especially that they do not become a gateway to nicotine addiction and cigarette use.
Friday, June 28, 2013
Electronic Cigarette Opponent Grasps at Straws to Discredit New E-Cigarette Clinical Trial
As I correctly predicted yesterday based on his one-line email inquiry, electronic cigarette opponent (and my mentor, hero, and colleague) Stan Glantz was nonplussed with the clinical trial showing that electronic cigarettes achieved an almost miraculous 13% one-year quit rate among Italian smokers who had no interest in quitting. As I also correctly predicted, he quickly scrambled to try to discredit the study in order to support what I believe is a predetermined conclusion in his mind that electronic cigarettes are useless.
Today, he posted on his blog a critique of the study.
In his critique, Stan makes two main arguments:
1. "There is not a control group of people who were not using e-cigarettes that would allow assessment of spontaneous quit rates. By not having a true control group that would account for spontaneous quitting without using e-cigarettes one cannot say anything about whether e-cigarettes affected quitting."
2. "The [second] problem is that the authors failed to include the required Yates correction in their calculation of the chi-square test statistic and associated p value. Recalculating the test properly yields p = 0.07, which is no longer statistically significant. Thus, the correct conclusion is that there is no statistically significant difference between the nicotine and non-nicotine e-cigarettes."
The Rest of the Story
Let's take each of these arguments in turn.
First, it is true that the study did not include any control group. However, that doesn't necessarily mean that we have no idea what the quit rate would have been for smokers with no interest in quitting in the absence of electronic cigarettes. We can simply examine the ample scientific evidence reporting one-year quit rates among smokers in the absence of intervention.
However, as I noted yesterday, what we really want is the one-year quit rate among smokers with no interest in quitting. To be conservative, we can use the one-year quit rate among smokers who do want to quit (and try to quit), which is about 3%.
Clearly, the quit rate observed in the high-nicotine electronic cigarette group (13%) is considerably larger than the 3% observed for the population of smokers who want to quit and make quit attempts. The natural quit rate among smokers with no desire to quit would be substantially lower than 3%.
In fact, the paper provides population-based data showing that in Italy, the spontaneous quit rate during the study period was a dismal 0.02%.
So this first argument does not invalidate the study's conclusion that electronic cigarettes did help achieve smoking cessation for some smokers. There is no scenario under which you would observe 13% of non-motivated smokers quitting within one year without any intervention.
It is also important to point out that the comparison group Stan requests is not possible. One could not ethically conduct a clinical trial of smoking cessation in which one group is assigned to receive no intervention.
What is really needed is a head-to-head comparison of electronic cigarettes compared to nicotine replacement therapy (NRT).
Stan's second argument is that the study conclusions are invalid because of failure to apply the Yates correction. This argument is invalid because it is a sort of sleight-of-hand. It is kind of like magic, where the magician can succeed in a trick by diverting the audience's attention away from the central event taking place.
Why is this argument a diversion? It is a diversion because there is no placebo in this trial. Had this study compared electronic cigarettes with a placebo, then the appropriate analysis would indeed be to statistically compare the cessation rates in the e-cigarette vs. placebo groups. But there was no placebo. The group receiving electronic cigarettes without nicotine was in fact an intervention arm. Even without nicotine, electronic cigarettes have been shown to reduce the craving to smoke. And in fact, in this trial, the most remarkable finding was that in the zero nicotine e-cigarette group, 14% either quit or cut down by more than half. This is remarkable for a group of smokers who had no intention to quit and who received no non-tobacco cigarette nicotine for an entire year.
The paper actually acknowledges the lack of statistical significance in quit rates between the three study arms at one year. But this doesn't mean the treatment wasn't effective. It reflects the small sample size of the study along with the fact that there was some effect among the 0 nicotine e-cigarette group.
Stan is absolutely right that the correct comparison to make to evaluate the results of the study is how the observed quit rate (about 9% for all three groups combined) compares to the spontaneous one-year quit rate among the population of smokers, except that one would have to restrict that to the population of smokers who have no interest in quitting.
If anyone can show me data demonstrating that more than 2% of smokers with no interest in quitting achieve smoking cessation over a one-year period, then I will retract my conclusion about this study. But short of that, it cannot be denied that the results achieved in this study are better than what one would have obtained with no intervention.
Today, he posted on his blog a critique of the study.
In his critique, Stan makes two main arguments:
1. "There is not a control group of people who were not using e-cigarettes that would allow assessment of spontaneous quit rates. By not having a true control group that would account for spontaneous quitting without using e-cigarettes one cannot say anything about whether e-cigarettes affected quitting."
2. "The [second] problem is that the authors failed to include the required Yates correction in their calculation of the chi-square test statistic and associated p value. Recalculating the test properly yields p = 0.07, which is no longer statistically significant. Thus, the correct conclusion is that there is no statistically significant difference between the nicotine and non-nicotine e-cigarettes."
The Rest of the Story
Let's take each of these arguments in turn.
First, it is true that the study did not include any control group. However, that doesn't necessarily mean that we have no idea what the quit rate would have been for smokers with no interest in quitting in the absence of electronic cigarettes. We can simply examine the ample scientific evidence reporting one-year quit rates among smokers in the absence of intervention.
However, as I noted yesterday, what we really want is the one-year quit rate among smokers with no interest in quitting. To be conservative, we can use the one-year quit rate among smokers who do want to quit (and try to quit), which is about 3%.
Clearly, the quit rate observed in the high-nicotine electronic cigarette group (13%) is considerably larger than the 3% observed for the population of smokers who want to quit and make quit attempts. The natural quit rate among smokers with no desire to quit would be substantially lower than 3%.
In fact, the paper provides population-based data showing that in Italy, the spontaneous quit rate during the study period was a dismal 0.02%.
So this first argument does not invalidate the study's conclusion that electronic cigarettes did help achieve smoking cessation for some smokers. There is no scenario under which you would observe 13% of non-motivated smokers quitting within one year without any intervention.
It is also important to point out that the comparison group Stan requests is not possible. One could not ethically conduct a clinical trial of smoking cessation in which one group is assigned to receive no intervention.
What is really needed is a head-to-head comparison of electronic cigarettes compared to nicotine replacement therapy (NRT).
Stan's second argument is that the study conclusions are invalid because of failure to apply the Yates correction. This argument is invalid because it is a sort of sleight-of-hand. It is kind of like magic, where the magician can succeed in a trick by diverting the audience's attention away from the central event taking place.
Why is this argument a diversion? It is a diversion because there is no placebo in this trial. Had this study compared electronic cigarettes with a placebo, then the appropriate analysis would indeed be to statistically compare the cessation rates in the e-cigarette vs. placebo groups. But there was no placebo. The group receiving electronic cigarettes without nicotine was in fact an intervention arm. Even without nicotine, electronic cigarettes have been shown to reduce the craving to smoke. And in fact, in this trial, the most remarkable finding was that in the zero nicotine e-cigarette group, 14% either quit or cut down by more than half. This is remarkable for a group of smokers who had no intention to quit and who received no non-tobacco cigarette nicotine for an entire year.
The paper actually acknowledges the lack of statistical significance in quit rates between the three study arms at one year. But this doesn't mean the treatment wasn't effective. It reflects the small sample size of the study along with the fact that there was some effect among the 0 nicotine e-cigarette group.
Stan is absolutely right that the correct comparison to make to evaluate the results of the study is how the observed quit rate (about 9% for all three groups combined) compares to the spontaneous one-year quit rate among the population of smokers, except that one would have to restrict that to the population of smokers who have no interest in quitting.
If anyone can show me data demonstrating that more than 2% of smokers with no interest in quitting achieve smoking cessation over a one-year period, then I will retract my conclusion about this study. But short of that, it cannot be denied that the results achieved in this study are better than what one would have obtained with no intervention.
Friday, August 07, 2009
Experiences of Electronic Cigarette Users Suggest that These Could Be Life-Saving Devices and that They are Effective for Smoking Cessation
While I agree that there is a need for research into the relative safety and effectiveness of electronic cigarettes, there is also a need for anti-smoking groups and the FDA to study the experience of electronic cigarette users with this product. The passionate testimonials of hundreds of electronic cigarette users suggest that these devices are effective in helping smokers to quit and stay off cigarettes.
I challenge the anti-smoking groups and the FDA to read all of these comments and then to reiterate their position that electronic cigarettes must be taken off the market.
These are all the comments from electronic cigarette users in response to Dr. Whelan's Washington Times op-ed piece. They are taken from the Washington Times site as well as the Digg site for this article. I have not omitted any comments from electronic cigarette users, which is remarkable because there is not a single comment from a user who has not found these devices to be effective in smoking cessation.
The Rest of the Story
"I smoked traditional cigarettes for 27 years.... 2+ packs a day. On June 11th, my first e-cigarette starter kit arrived in the mail. I opened it up and started using it. I have not had a traditional cigarette since that day!! Even if there are some risks associated with these products, it can NEVER be as dangerous as traditional cigarettes so WHY would the FDA (or anyone else) want to stop me and other smokers from using them??? THANK YOU Dr. Whelan for putting this in proper perspective!!"
"Do not allow this product to be taken off the market. It saved my life (my smoker's morning cough disappeared in 3 days after switching to an e-cig) and many thousands more. The FDA is being unbelievably hypocritical in this matter and it shows how politics and money, rather then genuine concern for public health, is behind everything they do. And this is coing from a registered Pharmacist."
"E-cigarettes (also known as Personal Vaporizers) got me off smoking after 20 + years. They're a miracle IMO. The deeply flawed FDA study is being used as a propaganda tool to mislead people about these devices. Their implication that e-cigarettes are just as dangerous as traditional smoking is absolutely incorrect. E-cigarettes save lives."
"E-Cigarette got me off 2 pack a day habit."
"I was a 30+ yr. smoker. None of the other stop smoking aids ever helped me. My blood pressure was out of control. After 8 days of use I was able to stop smoking entirely and my blood pressure has come down substantially. I've been smoke free for 3 months now. I think it would be a travesty to take these away from thousands of people and tell them to go back to smoking."
"I still have a pack of Marlboro cigarettes unsmoked since I took a first puff of these 2 weeks ago. To take them off the market would be a horrible idea and drive many smokers back. Of course tobacco companies and governments stand to lose billions in revenues if these catch on... and they will... so expect to see everything thrown at these new e-cigarette startups to stop this trend."
"I have smoked for nearly 20 years and NEVER went a day without smoking at least a full pack of smokes. Ever since I got my E-cig (3 weeks ago), I never had another reg cig since... I feel better, breathe better, sleep better and thats just to name a few. These are choices we made, please don't take these life changing choices from us!"
"I haven't smoked a tobacco cigarette in over 20 days thanks to the e-cigarette. Nothing else worked before. If this device becomes illegal, it will cause me to go back to using tobacco products or get a prescription to aid in my addiction which has more harmful side effects. Spread the word, this device is helping people lead healthier lives."
"Many of us, e_smokers, would have to go back to smoking regular cigarettes and harm not only yourself but non-smokers too with second hand smoke, increase health insurance cost and so on..."
"I use electronic cigarettes and have cut my consumption of tobacco cigs from a pack a day for 40 years to 1-5 cigarettes a day. I actually now prefer electronic cigarettes, and in the process have gone from thousands of chemicals in smoked tobacco to about 4 in e cigs. Do the math."
"I was smoking the traditional cigarettes for 20 years until I heard about the electronic cigarette. I have not touched a traditional CANCER stick in over 4 months, and I have slowly reduced my nicotine down to the lowest strength. I believe the FDA is working hard on this situation, my main question is, who are they working for. It makes no sense to stop an obvious safer alternative, for the ones they are trying to push us back on that kills over 450,000 people a year."
"I too smoked cigs for 25 years. I bought myself a kit, started "vaping" and haven't looked back."
"Almost 45 years a smoker at better than two packs a day. In less than two days I got rid of the wheezing, coughing and my tobacco cigarette intake dropped to less than five a day and falling. Someone in the FDA needs to see that there is a difference between trace elements of a carcinogen found in the e liquid (the vaporized liquid wasn't even tested by them) and the 60 some know heavy dosages of carcinogens found in cigarettes."
"I was a smoker for 10 years, tried to quit dozens of times. This product is the only thing that has made it possible for me to quit. Please don't ban e-cigs."
"I don't use e-cigs as a smoking cessation device. They are not for smoking cessation, although, many have quit smoking because they have this alternative. It is a much safer alternative, than inhaling 4000 chemicals the tobacco companies only recently admitted to. This is an alternative. I quit smoking over 3 months ago, prior to using an e-cig. I found that I missed the ritual, much like I'd miss having a cup of coffee in the morning. If for some reason I couldn't drink coffee anymore, I might have a cup of tea, or perhaps some other warm drink in my cup. Why on Earth couldn't I have an alternative to a deadly cigarette? Now I have come to know, after talking and listening to many people who have been using e-cigs, that they are very concerned over the safety of what is being inhaled, so much so, that they'd rather use this, than buy what they know is infinitely more harmful, tobacco cigarettes. Many are also not "vaping" nicotine at all!
When I smoked about 2 pack of cigarettes a day, I was wheezing, out of breath, and feeling horrible. The one room I smoked in was covered with tar, and smelled terrible. Since using the e-cig, there is no smell, I have no wheezing, I don't feel sick. There is no second hand smoke to keep from my family."
"I smoked for 25 years, and tried to quit (and failed) at least 5 times. My e-cig made it so easy. It took between 1 and 2 weeks, but the desire for a regular cigarette just melted away. You have to actually want to quit--but if you do, these things make it SO EASY!!! I haven't had a real one in 8 months and I don't miss them at all."
"I started smoking at age 19. From there, I smoked for 9 years until I was 28. I considered myself a casual / light smoker. A pack of lights or ultra-lights would last me about a week/week and a half. It was easy to switch over to e-cigs. Haven't touched a cigarette since. I love my e-cig."
"Massive Harm Reduction! 30 years of smoking cigarettes and now an alternative that works."
"I'll throw my 2 cents in to say e-cigs enabled me to quit after many many years of smoking. I thought I'd never be able to quit. These things are fantastic as a cigarette replacement. Still addicted to nicotine but nothing like the addiction I had when the delivery system was a cigarette."
"Great to read something positive about E-Cigarettes. I've been using this product for about 6 months and I have completely quit smoking cigarettes. I didn't even purchase this product for that- I was just curious. I found that the urge to smoke disappeared completely within a week of using this product. It makes me sick to think that the FDA could be so negative about a product that could potentially save millions of Americans from death."
"My wife and (Me 30yr smoker her 6yr smoker) have tried everything patches gums pills cold turkey and nothing has worked until now. We plan to quit within 3 months not long term."
"We are no longer smoking ANY tobacco cigarettes and feel great. We have already dropped from 24mg to 18mg and plan to keep going until finished with nicotine. we then may choose to use 0mg for as long as it takes to loose the psychological addiction. That is the real tough nut. I quit for a year once and went back. If I had the e-cig I would have used them and not gone back to the real cigarettes resulting in an additional 10 years of smoking."
"Thank you Dr Whelan. As corny as it sounds I almost cried when I read this. We as a people have been bombarded with the false claims of the FDA on this device, however, I truly feel it can save my life. I have tried every cessation method out there with no success until the ecig. I am a former two pack a day smoker and have not even looked back."
"I’ve been a life long cigarette smoker (35 years) whom has unsuccessfully attempted to quit many times. After the failure of the patch, nicotine gum, prescription drugs and cold turkey attempts; I have the e-cigarette to thank for my success."
"I have smoked for 20 years and have been 5 months now tobacco free because of e cigarettes. I have not touched a real cigarette since the day I received my electronic cigarette. Before that, NOTHING could get me off the tobacco cigarettes. I am taking in very low doses of nicotine and have reduced my nicotine immensely. The e cigarette has changed my life and I will never go back to smoking again. This is a crime to try and take this away from me. Without a doubt I know that what I am doing is WAY safer than smoking real cigarettes. SHAME on the FDA for what they are trying to do to us while they sit there and allow real tobacco known and proven cancer causing cancer sticks."
"These devices are a miracle. I tried everything to quit. Nothing worked. I quit cigarettes on the first day with ecigs. I am an adult. This is my choice and no one elses. Why would you force someone to go back to cigarettes?"
"After using an e-cigarette for 4months and 5 days, the only side effect I can report is I have been tobacco free all that time. I didn't buy it to quit smoking; I bought it to cut back my usage a little. NEVER would I have expected this to take the place of my tabacco cigarettes! And yes; I've used the patch, gum, drugs, candy sticks - all those APPROVED methods. I've 'suffered' with smoking for over 25 years. Is this the same as smoking? Well, when I asked my Dr, he said "*ell no! Congrats! you are now a NON SMOKER!""
"After 25 yrs of smoking, I have finally found something to get me off of the tobacco, tar, carcinogens and fire."
"I was an analog cigarette addict for 40 years. Forty Years. for Forty years, I was degraded and looked down upon by co-workers, even fired from one job by a boss who swore I 'smelled like cigarettes'. I've been subjected to restriction to designated smoking areas which are unsafe, poorly maintained, inconvenient and invariably exposed to the elements. I've been penalized by health insurance companies with higher premiums, even tho I've never been sick. I've been taxed exorbitantly by a government who capitalizes on my addiction. I've been lied to by Big Tobacco about what's in their product. I've been ripped off by Big Pharm with their snake-oil cessation products with alarming side-effects that invariably do more harm than good. And then I found the e-cigarette. And ended my days of paying up to $3/day/pack in taxes. For Forty Years. Ended my days of being analog cigarette dependent. My self-esteem is back. I haven't picked up a Big Tobacco cigarette in a month. for the first time in Fourty years. I may still die from 40 years of smoking, but at least I won't be surrounded by cigarette butts and ashtrays and I will have finally kicked my addiction. e-cigarettes save lives."
"I smoked for 25 years. Last year April I found out about the e-cigarette, started using them and I had my last real cigarette July 20th. of last year. So thankfully I am a nonsmoker now for over a year. I will never go back to smoking, will stick around for vaping. I feel better, I don't have a smokers cough anymore, I have more energy. Most people who quit smoking will gain weight. I have not even gained one pound. Also I have been saving a lot of money by not having to spend $ 4.00 on a pack of cigarettes. All in all it's a winner."
"I use a device called the electronic cigarette as a part of a personal harm reduction strategy, and it has helped me to break my 30+ year addiction to tobacco cigarettes. This device contains absolutely no tobacco and creates no smoke, yet provides some of the chemical, physical and psychological aspects of smoking without the deadly effects of a tobacco cigarette. I wish I had never made the foolish decision to smoke as a youngster. My wife of twenty years has never seen me without a cigarette in my hand. I can find very few family photographs that do not show me with a cigarette in my hand. I was completely addicted to tobacco. Two days after I chose to begin using an electronic cigarette with a fluid containing propylene glycol, water, flavorings and nicotine (optional component), I stopped smoking tobacco. I breathe easier, my sense of taste and smell has greatly improved and I no longer reek like an ashtray! Am I now addicted to another device, perhaps; but I am damn comfortable with my decision to inhale nicotine (think nicotine inhalers from drug companies) and propylene glycol (think theater fog). I can control my nicotine intake, I have the option to gradually reduce my nicotine intake and will trust my body to tell me if I am doing something wrong or harmful. My other recourse was to continue to burn thousands of chemicals in tobacco while I wheezed and coughed my way to death. I chose to make a change and the electronic cigarette has improved my life."
"I smoked for 45 years, tried to quit several times only to fail again. I discovered ecigs and within 14 days I quit, I have not touched a cigarette now for six months. I have no desire to smoke tobacco, in fact find it utterly repulsive now. This option could improve the lives of a lot of people not to mention health related cost savings."
"I have been perfectly content since stopping all analogs from day one after my e-cig arrived. A little on the jittery side for the first couple months, and after I switched away from PG to VG, I am now really content, no more jitters, if fact, so content that almost 3 weeks ago now I dropped the nicotine density of my juice from 24mg/ml down to 18mg/ml, with no side effects whatsoever! I find that fascinating, how can that happen when it never happened that way with analogs...if I cut down, I was a physical and mental MESS!!! So what is the secret? It's just a bad system? Tell that to the Doc that just published that article in the Wash Times! She seems to think it's a great idea. AND, that is why these tests have been valuable to me. I wanted to know the truth about what I was actually pulling into my body. And oh yes I was pulling nicotine into my body, and true to the testing done by Ruyan group, it is exponentially lower than when compared to a tobacco cigarette! That was the whole idea! And, if it quenches the god-awful withdrawal side effects of conventional and FDA approved NRT's (nicotine replacement therapy) PLUS gives the person using the options each individual needs to be able to stop smoking cigarettes, Lo and Behold, it has proven itself to be the very BEST kind of NRT. We're happy, this bunch, for some it may be just something new to do, but for me it was for quality of Life and removal of toxins and poisons that I knew and have known for a long time would eventually cause my death! That's pretty powerful, to me. I am now feeling more alive than I have at any time during my 44 years of smoking tobacco cigarettes."
"I have been using the e-cigarette for two months now with no side-effects and with almost no nicotine. I was almost a pack a day smoker and have no desire to go back to cancer sticks. Actually I take that back - I have had side effects, like being able to run without getting winded, more energy, and a better sense of taste/smell. I find the FDA's objections to the e-cigarette to be highly questionable."
"I smoked for 45 years one and half packs a day. Tried to quit numerous times and failed. I discovered ecigs and within 14 days I quit completely and have not had a desire to go back. This could improve the lives of many not to mention health related cost savings."
"I was a 1 1/2 to 2 pack a day smoker for over 40 years. When I first tried e-cigs it was to try to slow down on my tobacco cigarette smoking. My smokers cough was out of control. I coughed and hacked all the time, night and day. After about a week on e-cigs the cough was GONE!! I didn't start out to stop smoking, but it happened. I feel so much better! I can breath again. My sense of smell and taste have returned an I don't smell like cigarettes anymore. I don't need a lighter on me all the time and I don't need ashtrays either."
"I have been a smoker for 25 years and with the e-cigs I have been able to quit smoking real cigarettes. I am so grateful for this story I could really tear up."
"In this decade it's been nearly impossible to find honesty coming from a news source. Now that I can finally breath again since switching to e-cigs 5 months ago, I can truly appreciate a breath of fresh air."
"After 25 years of smoking, and at least 5 failed attempts to quit, I finally did it with my electric cigarette. And it was so incredibly easy, I didn't realize I was doing it--the urge to smoke real cigarettes just fell away over the first week or two I had it. Patches, gum, willpower, and Alan Carr all failed me, but this actually worked."
"I, too, smoked those "nasty stinkies" (tobacco cigarettes) for 40 years, tried all of the "smoking cessation" rip-offs, to no avail, until 9 months ago, when I bought my first E-Cig...2 1/2 weeks later, I had smoked my last tobacco cigarette! Now, 9 months later, I never would have imagined I would feel this good & healthy at the age of 60. I thank God for the invention of the electronic cigarette. Please, God, don't let them take THIS away from us. We want to live."
"I have not had a cigarette for 7 months. I detest the smell of them. I can't believe I smoked for so long. I started out with medium strength, then went to low, and I am now at extra low. I have not coughed in months. I no longer hear myself wheezing in bed. If the ecig has done all this for me, how can it be bad?"
"I have used e-cigarettes for over a year and have experienced health benefit from using them personally. I have had major health problems and the NRT's currently available, did not help and caused side effects. I hope more Doctors, join in this fight for harm reduction in using e-cigarettes."
"After 37 yrs of cigarette addiction, and many unsuccessful attempts to quit; it was only e-cigs that actually enabled me to give up smoking. This product has saved my life. It gets even better. Within a few weeks of using this product, I was down to level ZERO with the nicotine. There were no side effects. That suggests to me that my addiction was more in the mechanics of smoking."
"I smoked for 25 years, and tried to quit (and failed) at least 5 times. My e-cig made it so easy. It took between 1 and 2 weeks, but the desire for a regular cigarette just melted away. You have to actually want to quit--but if you do, these things make it SO EASY!!! I haven't had a real one in 8 months and I don't miss them at all."
"I smoked for 32 years and have been using the E-Cig for 2 months. I really needed to quit because I have Diabetes and other health problems. The Doctor said I was "a ticking time bomb" for stroke or heart attack. NOW? My blood pressure is back to where it was 32 YEARS AGO!! And my lungs were described by my Doc as "wonderful" I feel so much better. Thanks to a PV I have not polluted the air around me for almost 3 months. I did not buy this devise with the intention of quitting tobacco cigarettes, I was tired of being forced outdoors in all weather to feed my addiction. Within 2 weeks I was tobacco free by accident."
"I bought my first ecig last Friday. One week without a cigarette! I breathe better, I smell better, and I am excited and hopeful for a better future!"
"I quit smoking real cigarettes from the very first day after being a pack a day smoker. I can breathe again. I can smell again, I'm not as tired either."
I challenge the anti-smoking groups and the FDA to read all of these comments and then to reiterate their position that electronic cigarettes must be taken off the market.
These are all the comments from electronic cigarette users in response to Dr. Whelan's Washington Times op-ed piece. They are taken from the Washington Times site as well as the Digg site for this article. I have not omitted any comments from electronic cigarette users, which is remarkable because there is not a single comment from a user who has not found these devices to be effective in smoking cessation.
The Rest of the Story
"I smoked traditional cigarettes for 27 years.... 2+ packs a day. On June 11th, my first e-cigarette starter kit arrived in the mail. I opened it up and started using it. I have not had a traditional cigarette since that day!! Even if there are some risks associated with these products, it can NEVER be as dangerous as traditional cigarettes so WHY would the FDA (or anyone else) want to stop me and other smokers from using them??? THANK YOU Dr. Whelan for putting this in proper perspective!!"
"Do not allow this product to be taken off the market. It saved my life (my smoker's morning cough disappeared in 3 days after switching to an e-cig) and many thousands more. The FDA is being unbelievably hypocritical in this matter and it shows how politics and money, rather then genuine concern for public health, is behind everything they do. And this is coing from a registered Pharmacist."
"E-cigarettes (also known as Personal Vaporizers) got me off smoking after 20 + years. They're a miracle IMO. The deeply flawed FDA study is being used as a propaganda tool to mislead people about these devices. Their implication that e-cigarettes are just as dangerous as traditional smoking is absolutely incorrect. E-cigarettes save lives."
"E-Cigarette got me off 2 pack a day habit."
"I was a 30+ yr. smoker. None of the other stop smoking aids ever helped me. My blood pressure was out of control. After 8 days of use I was able to stop smoking entirely and my blood pressure has come down substantially. I've been smoke free for 3 months now. I think it would be a travesty to take these away from thousands of people and tell them to go back to smoking."
"I still have a pack of Marlboro cigarettes unsmoked since I took a first puff of these 2 weeks ago. To take them off the market would be a horrible idea and drive many smokers back. Of course tobacco companies and governments stand to lose billions in revenues if these catch on... and they will... so expect to see everything thrown at these new e-cigarette startups to stop this trend."
"I have smoked for nearly 20 years and NEVER went a day without smoking at least a full pack of smokes. Ever since I got my E-cig (3 weeks ago), I never had another reg cig since... I feel better, breathe better, sleep better and thats just to name a few. These are choices we made, please don't take these life changing choices from us!"
"I haven't smoked a tobacco cigarette in over 20 days thanks to the e-cigarette. Nothing else worked before. If this device becomes illegal, it will cause me to go back to using tobacco products or get a prescription to aid in my addiction which has more harmful side effects. Spread the word, this device is helping people lead healthier lives."
"Many of us, e_smokers, would have to go back to smoking regular cigarettes and harm not only yourself but non-smokers too with second hand smoke, increase health insurance cost and so on..."
"I use electronic cigarettes and have cut my consumption of tobacco cigs from a pack a day for 40 years to 1-5 cigarettes a day. I actually now prefer electronic cigarettes, and in the process have gone from thousands of chemicals in smoked tobacco to about 4 in e cigs. Do the math."
"I was smoking the traditional cigarettes for 20 years until I heard about the electronic cigarette. I have not touched a traditional CANCER stick in over 4 months, and I have slowly reduced my nicotine down to the lowest strength. I believe the FDA is working hard on this situation, my main question is, who are they working for. It makes no sense to stop an obvious safer alternative, for the ones they are trying to push us back on that kills over 450,000 people a year."
"I too smoked cigs for 25 years. I bought myself a kit, started "vaping" and haven't looked back."
"Almost 45 years a smoker at better than two packs a day. In less than two days I got rid of the wheezing, coughing and my tobacco cigarette intake dropped to less than five a day and falling. Someone in the FDA needs to see that there is a difference between trace elements of a carcinogen found in the e liquid (the vaporized liquid wasn't even tested by them) and the 60 some know heavy dosages of carcinogens found in cigarettes."
"I was a smoker for 10 years, tried to quit dozens of times. This product is the only thing that has made it possible for me to quit. Please don't ban e-cigs."
"I don't use e-cigs as a smoking cessation device. They are not for smoking cessation, although, many have quit smoking because they have this alternative. It is a much safer alternative, than inhaling 4000 chemicals the tobacco companies only recently admitted to. This is an alternative. I quit smoking over 3 months ago, prior to using an e-cig. I found that I missed the ritual, much like I'd miss having a cup of coffee in the morning. If for some reason I couldn't drink coffee anymore, I might have a cup of tea, or perhaps some other warm drink in my cup. Why on Earth couldn't I have an alternative to a deadly cigarette? Now I have come to know, after talking and listening to many people who have been using e-cigs, that they are very concerned over the safety of what is being inhaled, so much so, that they'd rather use this, than buy what they know is infinitely more harmful, tobacco cigarettes. Many are also not "vaping" nicotine at all!
When I smoked about 2 pack of cigarettes a day, I was wheezing, out of breath, and feeling horrible. The one room I smoked in was covered with tar, and smelled terrible. Since using the e-cig, there is no smell, I have no wheezing, I don't feel sick. There is no second hand smoke to keep from my family."
"I smoked for 25 years, and tried to quit (and failed) at least 5 times. My e-cig made it so easy. It took between 1 and 2 weeks, but the desire for a regular cigarette just melted away. You have to actually want to quit--but if you do, these things make it SO EASY!!! I haven't had a real one in 8 months and I don't miss them at all."
"I started smoking at age 19. From there, I smoked for 9 years until I was 28. I considered myself a casual / light smoker. A pack of lights or ultra-lights would last me about a week/week and a half. It was easy to switch over to e-cigs. Haven't touched a cigarette since. I love my e-cig."
"Massive Harm Reduction! 30 years of smoking cigarettes and now an alternative that works."
"I'll throw my 2 cents in to say e-cigs enabled me to quit after many many years of smoking. I thought I'd never be able to quit. These things are fantastic as a cigarette replacement. Still addicted to nicotine but nothing like the addiction I had when the delivery system was a cigarette."
"Great to read something positive about E-Cigarettes. I've been using this product for about 6 months and I have completely quit smoking cigarettes. I didn't even purchase this product for that- I was just curious. I found that the urge to smoke disappeared completely within a week of using this product. It makes me sick to think that the FDA could be so negative about a product that could potentially save millions of Americans from death."
"My wife and (Me 30yr smoker her 6yr smoker) have tried everything patches gums pills cold turkey and nothing has worked until now. We plan to quit within 3 months not long term."
"We are no longer smoking ANY tobacco cigarettes and feel great. We have already dropped from 24mg to 18mg and plan to keep going until finished with nicotine. we then may choose to use 0mg for as long as it takes to loose the psychological addiction. That is the real tough nut. I quit for a year once and went back. If I had the e-cig I would have used them and not gone back to the real cigarettes resulting in an additional 10 years of smoking."
"Thank you Dr Whelan. As corny as it sounds I almost cried when I read this. We as a people have been bombarded with the false claims of the FDA on this device, however, I truly feel it can save my life. I have tried every cessation method out there with no success until the ecig. I am a former two pack a day smoker and have not even looked back."
"I’ve been a life long cigarette smoker (35 years) whom has unsuccessfully attempted to quit many times. After the failure of the patch, nicotine gum, prescription drugs and cold turkey attempts; I have the e-cigarette to thank for my success."
"I have smoked for 20 years and have been 5 months now tobacco free because of e cigarettes. I have not touched a real cigarette since the day I received my electronic cigarette. Before that, NOTHING could get me off the tobacco cigarettes. I am taking in very low doses of nicotine and have reduced my nicotine immensely. The e cigarette has changed my life and I will never go back to smoking again. This is a crime to try and take this away from me. Without a doubt I know that what I am doing is WAY safer than smoking real cigarettes. SHAME on the FDA for what they are trying to do to us while they sit there and allow real tobacco known and proven cancer causing cancer sticks."
"These devices are a miracle. I tried everything to quit. Nothing worked. I quit cigarettes on the first day with ecigs. I am an adult. This is my choice and no one elses. Why would you force someone to go back to cigarettes?"
"After using an e-cigarette for 4months and 5 days, the only side effect I can report is I have been tobacco free all that time. I didn't buy it to quit smoking; I bought it to cut back my usage a little. NEVER would I have expected this to take the place of my tabacco cigarettes! And yes; I've used the patch, gum, drugs, candy sticks - all those APPROVED methods. I've 'suffered' with smoking for over 25 years. Is this the same as smoking? Well, when I asked my Dr, he said "*ell no! Congrats! you are now a NON SMOKER!""
"After 25 yrs of smoking, I have finally found something to get me off of the tobacco, tar, carcinogens and fire."
"I was an analog cigarette addict for 40 years. Forty Years. for Forty years, I was degraded and looked down upon by co-workers, even fired from one job by a boss who swore I 'smelled like cigarettes'. I've been subjected to restriction to designated smoking areas which are unsafe, poorly maintained, inconvenient and invariably exposed to the elements. I've been penalized by health insurance companies with higher premiums, even tho I've never been sick. I've been taxed exorbitantly by a government who capitalizes on my addiction. I've been lied to by Big Tobacco about what's in their product. I've been ripped off by Big Pharm with their snake-oil cessation products with alarming side-effects that invariably do more harm than good. And then I found the e-cigarette. And ended my days of paying up to $3/day/pack in taxes. For Forty Years. Ended my days of being analog cigarette dependent. My self-esteem is back. I haven't picked up a Big Tobacco cigarette in a month. for the first time in Fourty years. I may still die from 40 years of smoking, but at least I won't be surrounded by cigarette butts and ashtrays and I will have finally kicked my addiction. e-cigarettes save lives."
"I smoked for 25 years. Last year April I found out about the e-cigarette, started using them and I had my last real cigarette July 20th. of last year. So thankfully I am a nonsmoker now for over a year. I will never go back to smoking, will stick around for vaping. I feel better, I don't have a smokers cough anymore, I have more energy. Most people who quit smoking will gain weight. I have not even gained one pound. Also I have been saving a lot of money by not having to spend $ 4.00 on a pack of cigarettes. All in all it's a winner."
"I use a device called the electronic cigarette as a part of a personal harm reduction strategy, and it has helped me to break my 30+ year addiction to tobacco cigarettes. This device contains absolutely no tobacco and creates no smoke, yet provides some of the chemical, physical and psychological aspects of smoking without the deadly effects of a tobacco cigarette. I wish I had never made the foolish decision to smoke as a youngster. My wife of twenty years has never seen me without a cigarette in my hand. I can find very few family photographs that do not show me with a cigarette in my hand. I was completely addicted to tobacco. Two days after I chose to begin using an electronic cigarette with a fluid containing propylene glycol, water, flavorings and nicotine (optional component), I stopped smoking tobacco. I breathe easier, my sense of taste and smell has greatly improved and I no longer reek like an ashtray! Am I now addicted to another device, perhaps; but I am damn comfortable with my decision to inhale nicotine (think nicotine inhalers from drug companies) and propylene glycol (think theater fog). I can control my nicotine intake, I have the option to gradually reduce my nicotine intake and will trust my body to tell me if I am doing something wrong or harmful. My other recourse was to continue to burn thousands of chemicals in tobacco while I wheezed and coughed my way to death. I chose to make a change and the electronic cigarette has improved my life."
"I smoked for 45 years, tried to quit several times only to fail again. I discovered ecigs and within 14 days I quit, I have not touched a cigarette now for six months. I have no desire to smoke tobacco, in fact find it utterly repulsive now. This option could improve the lives of a lot of people not to mention health related cost savings."
"I have been perfectly content since stopping all analogs from day one after my e-cig arrived. A little on the jittery side for the first couple months, and after I switched away from PG to VG, I am now really content, no more jitters, if fact, so content that almost 3 weeks ago now I dropped the nicotine density of my juice from 24mg/ml down to 18mg/ml, with no side effects whatsoever! I find that fascinating, how can that happen when it never happened that way with analogs...if I cut down, I was a physical and mental MESS!!! So what is the secret? It's just a bad system? Tell that to the Doc that just published that article in the Wash Times! She seems to think it's a great idea. AND, that is why these tests have been valuable to me. I wanted to know the truth about what I was actually pulling into my body. And oh yes I was pulling nicotine into my body, and true to the testing done by Ruyan group, it is exponentially lower than when compared to a tobacco cigarette! That was the whole idea! And, if it quenches the god-awful withdrawal side effects of conventional and FDA approved NRT's (nicotine replacement therapy) PLUS gives the person using the options each individual needs to be able to stop smoking cigarettes, Lo and Behold, it has proven itself to be the very BEST kind of NRT. We're happy, this bunch, for some it may be just something new to do, but for me it was for quality of Life and removal of toxins and poisons that I knew and have known for a long time would eventually cause my death! That's pretty powerful, to me. I am now feeling more alive than I have at any time during my 44 years of smoking tobacco cigarettes."
"I have been using the e-cigarette for two months now with no side-effects and with almost no nicotine. I was almost a pack a day smoker and have no desire to go back to cancer sticks. Actually I take that back - I have had side effects, like being able to run without getting winded, more energy, and a better sense of taste/smell. I find the FDA's objections to the e-cigarette to be highly questionable."
"I smoked for 45 years one and half packs a day. Tried to quit numerous times and failed. I discovered ecigs and within 14 days I quit completely and have not had a desire to go back. This could improve the lives of many not to mention health related cost savings."
"I was a 1 1/2 to 2 pack a day smoker for over 40 years. When I first tried e-cigs it was to try to slow down on my tobacco cigarette smoking. My smokers cough was out of control. I coughed and hacked all the time, night and day. After about a week on e-cigs the cough was GONE!! I didn't start out to stop smoking, but it happened. I feel so much better! I can breath again. My sense of smell and taste have returned an I don't smell like cigarettes anymore. I don't need a lighter on me all the time and I don't need ashtrays either."
"I have been a smoker for 25 years and with the e-cigs I have been able to quit smoking real cigarettes. I am so grateful for this story I could really tear up."
"In this decade it's been nearly impossible to find honesty coming from a news source. Now that I can finally breath again since switching to e-cigs 5 months ago, I can truly appreciate a breath of fresh air."
"After 25 years of smoking, and at least 5 failed attempts to quit, I finally did it with my electric cigarette. And it was so incredibly easy, I didn't realize I was doing it--the urge to smoke real cigarettes just fell away over the first week or two I had it. Patches, gum, willpower, and Alan Carr all failed me, but this actually worked."
"I, too, smoked those "nasty stinkies" (tobacco cigarettes) for 40 years, tried all of the "smoking cessation" rip-offs, to no avail, until 9 months ago, when I bought my first E-Cig...2 1/2 weeks later, I had smoked my last tobacco cigarette! Now, 9 months later, I never would have imagined I would feel this good & healthy at the age of 60. I thank God for the invention of the electronic cigarette. Please, God, don't let them take THIS away from us. We want to live."
"I have not had a cigarette for 7 months. I detest the smell of them. I can't believe I smoked for so long. I started out with medium strength, then went to low, and I am now at extra low. I have not coughed in months. I no longer hear myself wheezing in bed. If the ecig has done all this for me, how can it be bad?"
"I have used e-cigarettes for over a year and have experienced health benefit from using them personally. I have had major health problems and the NRT's currently available, did not help and caused side effects. I hope more Doctors, join in this fight for harm reduction in using e-cigarettes."
"After 37 yrs of cigarette addiction, and many unsuccessful attempts to quit; it was only e-cigs that actually enabled me to give up smoking. This product has saved my life. It gets even better. Within a few weeks of using this product, I was down to level ZERO with the nicotine. There were no side effects. That suggests to me that my addiction was more in the mechanics of smoking."
"I smoked for 25 years, and tried to quit (and failed) at least 5 times. My e-cig made it so easy. It took between 1 and 2 weeks, but the desire for a regular cigarette just melted away. You have to actually want to quit--but if you do, these things make it SO EASY!!! I haven't had a real one in 8 months and I don't miss them at all."
"I smoked for 32 years and have been using the E-Cig for 2 months. I really needed to quit because I have Diabetes and other health problems. The Doctor said I was "a ticking time bomb" for stroke or heart attack. NOW? My blood pressure is back to where it was 32 YEARS AGO!! And my lungs were described by my Doc as "wonderful" I feel so much better. Thanks to a PV I have not polluted the air around me for almost 3 months. I did not buy this devise with the intention of quitting tobacco cigarettes, I was tired of being forced outdoors in all weather to feed my addiction. Within 2 weeks I was tobacco free by accident."
"I bought my first ecig last Friday. One week without a cigarette! I breathe better, I smell better, and I am excited and hopeful for a better future!"
"I quit smoking real cigarettes from the very first day after being a pack a day smoker. I can breathe again. I can smell again, I'm not as tired either."
Tuesday, January 10, 2012
New Study Shows that in Contrast to Tobacco Cigarettes, Electronic Cigarettes Do Not Impair Acute Lung Function
A new study published online ahead of print in the journal Chest demonstrated that in contrast to both tobacco cigarette smoking and secondhand smoke exposure, which have been shown to cause acute impairment of lung function, electronic cigarettes have no acute effect on pulmonary function as measured by spirometry testing.
See: Constantine I. Vardavas, Nektarios Anagnostopoulos, Marios Kougias, Vassiliki Evangelopoulou, Gregory N. Connolly, Panagiotis K. Behrakis. Acute pulmonary effects of using an e-cigarette: impact on respiratory flow resistance, impedance and exhaled nitric oxide. Chest 2011. Published online before print December 22, 2011, doi: 10.1378/chest.11-2443.
Active smoking is known to impair lung function, as measured by pulmonary function testing of lung air flow rates (also called spirometry). For example, short-term active smoke exposure has been shown to reduce forced expiratory flow rates.
Secondhand smoke exposure has also been shown to impair lung function, as evidenced by decreased FEV1 and FEV1/FVC ratios in tobacco smoke-exposed nonsmokers.
In this study, 30 smokers used an electronic cigarette for for 5 minutes, with lung function tested before and after use. A control group of smokers used an electronic cigarette with the cartridge removed.
The study found "no differences between basic pulmonary measurements" between the two groups, demonstrating that acute exposure to electronic cigarette vapor did not affect FEV1, FVC, PEF or MEF50 and MEF75.
However, the study did find that acute electronic cigarette vapor exposure decreased exhaled nitric oxide and increased peripheral airway resistance.
The study concludes: "E-cigarettes assessed in the context of this study were found to have immediate adverse physiologic effects after short term use that are similar to some of the effects seen with tobacco smoking, however the long term health effects of e-cigarette use are unknown but potentially adverse and worthy of further investigation."
The Rest of the Story
It is first interesting to note that although the study's declared purpose was to "assess whether using an e-cigarette for five minutes has an impact on pulmonary function tests and exhaled nitric oxide," the study's abstract only reported the observed reduction in exhaled nitric oxide, not the lack of any effect on pulmonary function tests.
Moreover, the study failed to compare the acute respiratory effects of electronic cigarette exposure with those of active smoking, which is the most important comparison that needs to be made.
In contrast to what some are reporting, the study found no effect of e-cigarettes on lung function, as measured by spirometry. This is in contrast to tobacco smoking, which does have effects on lung function that can be measured using spirometric testing.
While previous research indicates that active smoking and even secondhand smoke exposure can affect acute lung function as measured by spirometry, the study demonstrated that electronic cigarette use led to no impairment of lung function detectable via spirometric testing.
What the study did show was subclinical evidence of impaired lung function, meaning that the observed (measurable) lung function was unchanged, but that there was evidence of physiologic effects consistent with some bronchial inflammation. What is not known is whether this acute bronchial inflammation has any significance in the long-term. The presence of bronchial inflammation may be a result of propylene glycol having a respiratory irritant effect. But this does not necessarily mean that long-term exposure would lead to any adverse effect on lung function. More research is necessary to clarify that point.
The authors acknowledge this: "We must state though that while the differences within our study are of statistical significance, the clinical changes may be too small to be of major clinical importance."
While this is only conjecture, I suspect that the study is detecting a respiratory irritant effect of propylene glycol. It will be interesting to see if the same effect is present or not with glycerin-based products.
The study does not change my overall assessment, which is that e-cigarettes are much safer than smoking. But it does suggest that e-cigarettes are not “safe” in any absolute sense (which we knew already because they contain nicotine). The real question is whether there are effects of long-term exposure to propylene glycol. Whether there are or not, I don’t think it will change the conclusion that e-cigarettes are much safer than smoking. However, it may have implications for the composition of e-cigarette liquid, as it may be that glycerin-based juice is safer than propylene glycol-based juice. It may be, for example, that a glycerin-based liquid fails to produce the airways inflammation that is being observed with a propylene-glycol based electronic cigarette.
In news coverage of the study, one of the authors was quoted as recommending: "If you're trying to quit, stick to the methods that are known to work." (i.e., nicotine replacement therapy and pharmacotherapy like Chantix and Buproprion).
I find this to be irresponsible advice, because these methods that are "known to work" actually are quite ineffective, with dismal results in terms of long-term cessation. Advising smokers to stick with the FDA-approved medications is tantamount to advising the overwhelming majority of smokers to continue smoking.
More importantly, since thousands of ex-smokers are remaining smoke-free with the help of electronic cigarettes, the study author's advice is essentially telling these ex-smokers that they are better off returning to active smoking than continuing to vape. Clearly, if these vapers switch to NRT or Chantix, they are very unlikely to be successful and will most likely return to cigarette smoking.
The American Council on Science and Health made the same point in its Facts and Fears column yesterday, writing: "The study’s lead researcher recommends that, instead of trying e-cigarettes as a reduced-risk method to quit smoking, smokers should “stick to the methods that are known to work.” But Dr. Ross criticizes this recommendation. 'He would have more accurately said, ‘stick to the methods that are known to not work,’ since those currently approved have a ‘success’ rate of only 5 to 10 percent. It’s the old ‘quit or die,’ abstinence-only agenda.'".
The rest of the story is that a propylene-based electronic cigarette system has been shown to produce airways inflammation in users, resulting in subclinical evidence of increased airway resistance. Whether long-term use of electronic cigarettes would lead to clinical manifestations due to actual airway obstruction is unclear, and more research is necessary to make such a determination. What we do know, however, is that long-term continuation of cigarette smoking will almost certainly lead to clinically significant airway obstruction.
The bottom line: if a smoker is choosing between active smoking and electronic cigarette use, the use of the electronic cigarette is clearly the wiser choice. And in fact, this is the choice that most electronic users are facing. The idea that any substantial proportion of electronic cigarette users will quit smoking if they take the article's advice and stick to approved NRT or pharmacotherapy products is unsupported by the scientific evidence.
See: Constantine I. Vardavas, Nektarios Anagnostopoulos, Marios Kougias, Vassiliki Evangelopoulou, Gregory N. Connolly, Panagiotis K. Behrakis. Acute pulmonary effects of using an e-cigarette: impact on respiratory flow resistance, impedance and exhaled nitric oxide. Chest 2011. Published online before print December 22, 2011, doi: 10.1378/chest.11-2443.
Active smoking is known to impair lung function, as measured by pulmonary function testing of lung air flow rates (also called spirometry). For example, short-term active smoke exposure has been shown to reduce forced expiratory flow rates.
Secondhand smoke exposure has also been shown to impair lung function, as evidenced by decreased FEV1 and FEV1/FVC ratios in tobacco smoke-exposed nonsmokers.
In this study, 30 smokers used an electronic cigarette for for 5 minutes, with lung function tested before and after use. A control group of smokers used an electronic cigarette with the cartridge removed.
The study found "no differences between basic pulmonary measurements" between the two groups, demonstrating that acute exposure to electronic cigarette vapor did not affect FEV1, FVC, PEF or MEF50 and MEF75.
However, the study did find that acute electronic cigarette vapor exposure decreased exhaled nitric oxide and increased peripheral airway resistance.
The study concludes: "E-cigarettes assessed in the context of this study were found to have immediate adverse physiologic effects after short term use that are similar to some of the effects seen with tobacco smoking, however the long term health effects of e-cigarette use are unknown but potentially adverse and worthy of further investigation."
The Rest of the Story
It is first interesting to note that although the study's declared purpose was to "assess whether using an e-cigarette for five minutes has an impact on pulmonary function tests and exhaled nitric oxide," the study's abstract only reported the observed reduction in exhaled nitric oxide, not the lack of any effect on pulmonary function tests.
Moreover, the study failed to compare the acute respiratory effects of electronic cigarette exposure with those of active smoking, which is the most important comparison that needs to be made.
In contrast to what some are reporting, the study found no effect of e-cigarettes on lung function, as measured by spirometry. This is in contrast to tobacco smoking, which does have effects on lung function that can be measured using spirometric testing.
While previous research indicates that active smoking and even secondhand smoke exposure can affect acute lung function as measured by spirometry, the study demonstrated that electronic cigarette use led to no impairment of lung function detectable via spirometric testing.
What the study did show was subclinical evidence of impaired lung function, meaning that the observed (measurable) lung function was unchanged, but that there was evidence of physiologic effects consistent with some bronchial inflammation. What is not known is whether this acute bronchial inflammation has any significance in the long-term. The presence of bronchial inflammation may be a result of propylene glycol having a respiratory irritant effect. But this does not necessarily mean that long-term exposure would lead to any adverse effect on lung function. More research is necessary to clarify that point.
The authors acknowledge this: "We must state though that while the differences within our study are of statistical significance, the clinical changes may be too small to be of major clinical importance."
While this is only conjecture, I suspect that the study is detecting a respiratory irritant effect of propylene glycol. It will be interesting to see if the same effect is present or not with glycerin-based products.
The study does not change my overall assessment, which is that e-cigarettes are much safer than smoking. But it does suggest that e-cigarettes are not “safe” in any absolute sense (which we knew already because they contain nicotine). The real question is whether there are effects of long-term exposure to propylene glycol. Whether there are or not, I don’t think it will change the conclusion that e-cigarettes are much safer than smoking. However, it may have implications for the composition of e-cigarette liquid, as it may be that glycerin-based juice is safer than propylene glycol-based juice. It may be, for example, that a glycerin-based liquid fails to produce the airways inflammation that is being observed with a propylene-glycol based electronic cigarette.
In news coverage of the study, one of the authors was quoted as recommending: "If you're trying to quit, stick to the methods that are known to work." (i.e., nicotine replacement therapy and pharmacotherapy like Chantix and Buproprion).
I find this to be irresponsible advice, because these methods that are "known to work" actually are quite ineffective, with dismal results in terms of long-term cessation. Advising smokers to stick with the FDA-approved medications is tantamount to advising the overwhelming majority of smokers to continue smoking.
More importantly, since thousands of ex-smokers are remaining smoke-free with the help of electronic cigarettes, the study author's advice is essentially telling these ex-smokers that they are better off returning to active smoking than continuing to vape. Clearly, if these vapers switch to NRT or Chantix, they are very unlikely to be successful and will most likely return to cigarette smoking.
The American Council on Science and Health made the same point in its Facts and Fears column yesterday, writing: "The study’s lead researcher recommends that, instead of trying e-cigarettes as a reduced-risk method to quit smoking, smokers should “stick to the methods that are known to work.” But Dr. Ross criticizes this recommendation. 'He would have more accurately said, ‘stick to the methods that are known to not work,’ since those currently approved have a ‘success’ rate of only 5 to 10 percent. It’s the old ‘quit or die,’ abstinence-only agenda.'".
The rest of the story is that a propylene-based electronic cigarette system has been shown to produce airways inflammation in users, resulting in subclinical evidence of increased airway resistance. Whether long-term use of electronic cigarettes would lead to clinical manifestations due to actual airway obstruction is unclear, and more research is necessary to make such a determination. What we do know, however, is that long-term continuation of cigarette smoking will almost certainly lead to clinically significant airway obstruction.
The bottom line: if a smoker is choosing between active smoking and electronic cigarette use, the use of the electronic cigarette is clearly the wiser choice. And in fact, this is the choice that most electronic users are facing. The idea that any substantial proportion of electronic cigarette users will quit smoking if they take the article's advice and stick to approved NRT or pharmacotherapy products is unsupported by the scientific evidence.
Wednesday, October 07, 2015
Bias in Anti-Tobacco Movement is Laid Bare: If You Don't Quit the Way We Want You to Quit, Then Don't Bother
After last week's publication of a new study which found that smokers switching to very low-nicotine cigarettes did not compensate by smoking more, anti-tobacco groups jumped on the bandwagon, telling the public that these products helped smokers cut down and quit and should therefore be an integral part of a national smoking cessation strategy.
For example, as I revealed on Monday, three anti-tobacco groups - the Campaign for Tobacco-Free Kids, the American Legacy Foundation, and the Center for Tobacco Control Research & Education - have embraced low-nicotine cigarettes as an effective smoking cessation tool.
At the same time, each of these groups (as well as most anti-tobacco groups) has rejected electronic cigarettes as a legitimate smoking cessation strategy.
But let's look at the actual evidence regarding the effect of switching to either low-nicotine cigarettes or electronic cigarettes among smokers who have no desire to quit smoking. The Donny et al. study, published last week in the New England Journal of Medicine, provides data on changes in cigarette consumption among smokers with no desire to quit who were assigned to smoke very low-nicotine cigarettes. Similarly, an earlier study by Caponnetto et al. provides data on changes in cigarette consumption among smokers with no desire to quit who were assigned to use electronic cigarettes.
In the low-nicotine cigarette study, smokers provided with low-nicotine cigarettes failed to reduce their cigarette consumption significantly over a six-week period, and their quit rate was not significantly different than the control group of usual brand smokers.
In the electronic cigarette study, 13% of smokers assigned to a high nicotine e-cigarette quit smoking at one year, and an additional 10% of smokers reduced their cigarette consumption by more than 50%.
These results are not exactly comparable because the low-nicotine cigarette study only followed subjects for six weeks. At six weeks, 9% of the electronic cigarette users had quit smoking, and an additional 24% had reduced their cigarette consumption by at least 50%.
The Rest of the Story
Despite the findings that low-nicotine cigarettes failed to result in a significant increase in quitting or in any reduction in cigarette consumption, while the electronic cigarettes resulted in a substantial proportion of smokers who quit or greatly reduced their cigarette consumption, anti-tobacco groups have concluded that low-nicotine cigarettes help smokers quit and cut down, while electronic cigarettes do not. The conclusion of the anti-tobacco groups is exactly the opposite of what the data show.
This reveals a huge bias in the anti-tobacco movement. But it is a strange bias because it actually favors deadly tobacco cigarettes over much safer electronic ones. Why is it that anti-tobacco groups are completely misrepresenting the scientific evidence, lying to the public, and embracing a strategy in which combustible tobacco products remain the mainstay of nicotine use instead of one in which combustible tobacco products could become obsolete?
I believe the explanation is that "we" thought of the idea of nicotine reduction, but not the idea of electronic cigarettes. Thus, we don't really want to see e-cigarettes work, while we'd love to see low-nicotine cigarettes work. The end goal, you see, is not to save lives by getting smokers to quit. Instead, the end goal is to be able to claim victory by getting smokers to quit in the way we want them to quit. And if such a strategy results in far few smokers quitting, it doesn't matter. The movement is now concerned more with money and prestige than with reducing morbidity and mortality. (See my earlier commentary for a more detailed synthesis of this point.)
As I wrote earlier: "I firmly believe that if the idea of an electronic cigarette was conceived by individuals, researchers, or groups within the tobacco control movement, our reaction to these products would be completely different. It would not represent a threat to our status and prestige because we could claim credit for the "victory," for the accomplishment, for the transformation of the tobacco industry, for the unprecedented magnitude of the saving of lives."
But e-cigarettes are not our baby. Instead, we're casting our lot with a strategy for which there is no evidence. But it doesn't matter because it's our strategy. And it doesn't matter if the strategy is not as effective as e-cigarettes because it's not the saving of lives that matters most. It's retaining our ideology and our prestige.
For example, as I revealed on Monday, three anti-tobacco groups - the Campaign for Tobacco-Free Kids, the American Legacy Foundation, and the Center for Tobacco Control Research & Education - have embraced low-nicotine cigarettes as an effective smoking cessation tool.
At the same time, each of these groups (as well as most anti-tobacco groups) has rejected electronic cigarettes as a legitimate smoking cessation strategy.
But let's look at the actual evidence regarding the effect of switching to either low-nicotine cigarettes or electronic cigarettes among smokers who have no desire to quit smoking. The Donny et al. study, published last week in the New England Journal of Medicine, provides data on changes in cigarette consumption among smokers with no desire to quit who were assigned to smoke very low-nicotine cigarettes. Similarly, an earlier study by Caponnetto et al. provides data on changes in cigarette consumption among smokers with no desire to quit who were assigned to use electronic cigarettes.
In the low-nicotine cigarette study, smokers provided with low-nicotine cigarettes failed to reduce their cigarette consumption significantly over a six-week period, and their quit rate was not significantly different than the control group of usual brand smokers.
In the electronic cigarette study, 13% of smokers assigned to a high nicotine e-cigarette quit smoking at one year, and an additional 10% of smokers reduced their cigarette consumption by more than 50%.
These results are not exactly comparable because the low-nicotine cigarette study only followed subjects for six weeks. At six weeks, 9% of the electronic cigarette users had quit smoking, and an additional 24% had reduced their cigarette consumption by at least 50%.
The Rest of the Story
Despite the findings that low-nicotine cigarettes failed to result in a significant increase in quitting or in any reduction in cigarette consumption, while the electronic cigarettes resulted in a substantial proportion of smokers who quit or greatly reduced their cigarette consumption, anti-tobacco groups have concluded that low-nicotine cigarettes help smokers quit and cut down, while electronic cigarettes do not. The conclusion of the anti-tobacco groups is exactly the opposite of what the data show.
This reveals a huge bias in the anti-tobacco movement. But it is a strange bias because it actually favors deadly tobacco cigarettes over much safer electronic ones. Why is it that anti-tobacco groups are completely misrepresenting the scientific evidence, lying to the public, and embracing a strategy in which combustible tobacco products remain the mainstay of nicotine use instead of one in which combustible tobacco products could become obsolete?
I believe the explanation is that "we" thought of the idea of nicotine reduction, but not the idea of electronic cigarettes. Thus, we don't really want to see e-cigarettes work, while we'd love to see low-nicotine cigarettes work. The end goal, you see, is not to save lives by getting smokers to quit. Instead, the end goal is to be able to claim victory by getting smokers to quit in the way we want them to quit. And if such a strategy results in far few smokers quitting, it doesn't matter. The movement is now concerned more with money and prestige than with reducing morbidity and mortality. (See my earlier commentary for a more detailed synthesis of this point.)
As I wrote earlier: "I firmly believe that if the idea of an electronic cigarette was conceived by individuals, researchers, or groups within the tobacco control movement, our reaction to these products would be completely different. It would not represent a threat to our status and prestige because we could claim credit for the "victory," for the accomplishment, for the transformation of the tobacco industry, for the unprecedented magnitude of the saving of lives."
But e-cigarettes are not our baby. Instead, we're casting our lot with a strategy for which there is no evidence. But it doesn't matter because it's our strategy. And it doesn't matter if the strategy is not as effective as e-cigarettes because it's not the saving of lives that matters most. It's retaining our ideology and our prestige.
Tuesday, August 18, 2009
Initial Characterization of E-Cigarette Liquid and Vapor Reveals that It Contains...
...Nicotine, Glycerin, and Propylene Glycol
A laboratory analysis of the chemical composition of the electronic cigarette liquid and vapor produced by one brand of electronic cigarette (Johnson Creek Enterprises) has revealed that the ingredients in this product are: nicotine, propylene glycol, and glycerin.
In contrast to the claims of anti-smoking groups, who are telling the public that "we have no idea what is in this product," laboratory analysis has made it very clear that we do know what is in the product: nicotine, glycerin, and propylene glycol. The results of this testing are in line with those of several other laboratory analyses of other e-cigarette brands, which have also confirmed that these are the main ingredients in the product. In previous studies, only trace levels of tobacco by-products (tobacco-specific nitrosamines) were detected. While the present analysis probably does not rule out the presence of trace levels of carcinogens, it certainly suggests that there is no major contamination of these products with carcinogens, indicating that these products are much safer than conventional cigarettes.
Since glycerin and propylene glycol are generally believed to be safe, the only real remaining issue in terms of the safety of the product ingredients is the diethylene glycol which was detected by the FDA in one brand of electronic cigarette. This is most likely a result of the use of non-pharmaceutical-grade diethylene glycol so it can most likely be easily corrected.
The Rest of the Story
The rest of the story is that there simply is nothing behind the unwarranted claims of anti-smoking groups that "we have no idea what is in this product." In fact, we know a lot more about what is in electronic cigarettes than we do about what is in conventional cigarettes. While we know the main ingredients of electronic cigarettes are nicotine and propylene glycol, and that with the exception of one brand of e-cigarette, there are only trace levels of other chemicals present, we do not know the overwhelming majority of the chemicals present in tobacco smoke.
So the next time an anti-smoking group tells you that we need to ban e-cigarettes because we don't know what is in them, you tell them: "Sorry. Good try, but we do know what is in them, and it's a heck of a lot safer than what's in conventional cigarettes. Plus, if you really want to talk about a product for which we have no idea what the ingredients are, try conventional cigarettes. Which reminds me, why did you just lobby to have the FDA approve these products? And what's the logic behind asking the FDA to approve the conventional cigarettes but ban the non-tobacco ones, which contain, we happen to know, nicotine, glycerin, and propylene glycol?"
While further testing of electronic cigarettes is certainly warranted, and while restrictions on the sales of these products to minors and the types of marketing claims that can be made are reasonable, it would be criminal to take these products off the market. Smokers who have found these products to be a life-saver, allowing them to stay off regular cigarettes, should be permitted to have the choice of continuing to use the product while more definitive studies are conducted.
Anti-smoking groups which want electronic cigarettes yanked off the market are going to have to do a much better job of providing a rationale for why they think these products pose serious harm to users, especially in light of the fact that the users of the product are doing so to stay off of conventional cigarettes. If the major ingredients of the product are nicotine, glycerin, and propylene glycol, then how exactly do anti-smoking groups hypothesize that these products cause serious harm to users, and what exactly is the evidence to support those claims? And most importantly, why is it better for the public's health to have these hundreds of thousands of ex-smokers return to cigarette smoking rather than to remain quit through the use of a product that delivers the nicotine without the 10,000+ other chemicals and which has been shown to have carcinogen levels that are up to 1400 times lower?
Tuesday, December 04, 2012
New Study Suggests that Electronic Cigarettes May Encourage Maintenance of Tobacco Use
A new study, published online ahead of print in the journal Tobacco Control, concludes that electronic cigarettes may encourage the maintenance of tobacco use.
(See: Cheah NP, et al. Electronic nicotine delivery systems: Regulatory and safety challenges: Singapore perspective. Tobacco Control 2012; doi: 10.1136/tobaccocontrol-2012-050483.)
The study examined 20 brands of electronic cigarettes, and analyzed the contents of their cartridges for nicotine, propylene glycol, glycerin, polycyclic aromatic hydrocarbons, and tobacco-specific nitrosamines.
The results were reported in the study abstract as follows: "Varying nicotine amounts were found in ENDS cartridges which were labelled with the same concentration. Chemicals such as PPG and glycerol were found to be present in the nicotine-containing liquid of the cartridges. ENDS varied in their contents and packaging information. Limited information was available on the contents of nicotine and other chemicals present in a variety of ENDS sampled."
The paper concludes as follows:
"While the current attention on traditional tobacco products is important, it is also necessary to focus on novelty products like ENDS, which may encourage maintenance of tobacco usage behaviour and slow down the impact of national smoking control programmes. Tobacco control policy makers and professionals are seriously urged to find ways to address the gap in the scientific understanding and the legal framework of such products, as this gap may impede efforts at curbing tobacco use."
The Rest of the Story
If you read the introduction, methods, and results of this study, and then proceed to the discussion, you will be shocked and you might think you are reading the discussion to a different study. This is because the discussion has very little relevance to the actual findings in the paper.
First, while the discussion section focuses on what the authors claim are serious health effects associated with electronic cigarettes, the paper's results actually found that there were no detectable polycyclic aromatic hydrocarbons or tobacco-specific nitrosamines in any of the 20 brands of electronic cigarettes tested, providing powerful evidence that these products are much safer than tobacco cigarettes. Curiously, this latter finding is not reported or addressed in the paper's abstract or discussion section. It is almost as if the authors are intent upon only reporting the risks of electronic cigarette use, but not the potential benefits.
Second, while the discussion section warns users about the finding of high levels of propylene glycol and glycerin in the cartridges, it fails to inform readers that propylene glycol and glycerin are the excipients used to vaporize the nicotine. They are indeed the ingredients of the cartridges, so their presence in high levels in the cartridges is not of concern.
Third, while the paper's abstract implies that the mislabeling of nicotine content is a safety concern, the truth is that this is solely an efficacy concern. In fact, the lack of consistency in nicotine delivery likely makes electronic cigarettes less addictive than regular ones.
But most importantly, the paper's conclusion - that electronic cigarette use promotes the maintenance of tobacco use - literally comes out of nowhere. There is nothing in the results or findings of this paper which provides evidence that electronic cigarette use promotes the maintenance of tobacco use. Nor does the paper cite any evidence whatsoever that electronic cigarette use promotes the maintenance of tobacco use.
It appears that the authors have simply made up this conclusion, making it appear out of thin air. This again suggests that the point of this paper was not simply to report the scientific findings, but to make a pre-ordained statement against electronic cigarette use.
In fact, it is counter-intuitive to conclude that electronic cigarette use would promote tobacco use. By definition, the use of electronic cigarettes is an alternative or substitute to cigarettes. Thus, the more electronic cigarettes are used, the less tobacco cigarettes are smoked. The majority of smoker who use electronic cigarettes are doing so because they want to reduce or eliminate their cigarette smoking. Far from promoting tobacco use, electronic cigarettes are devices designed to reduce cigarette use. Furthermore, there is abundant evidence that electronic cigarette use has accomplished exactly that: reducing tobacco use among smokers.
The only two ways in which electronic cigarette use could promote tobacco use would be: (1) if they encouraged youth (nonsmokers) to use nicotine and then to become smokers; or (2) if they caused users to smoke more.
The second hypothesis is absurd and there is abundant evidence that contradicts that notion. As far as the first hypothesis goes, there is no evidence to support it.
The rest of the story is that this is apparently another electronic cigarette smear job by anti-smoking researchers who cannot tolerate the idea that something which looks like a cigarette could possibly be helpful in reducing cigarette use.
Perhaps the most telling statement in the paper is this one: "Due to its odourless and smokeless delivery system, the e-cigarette can be used in non-smoking areas, as suggested by some ENDS product inserts. This has the potential to allow people to satisfy the smoking urge despite being in areas where smoking is prohibited."
To an objective observer, this would be seen as a tremendous benefit of electronic cigarettes. By satisfying the smoking urge in the face of increasing smoking bans, these products can help smokers refrain from smoking. Without the products, addicted smokers would be forced to go outside and light up a cigarette to satisfy their cravings. But with the advent of electronic cigarettes, they can satisfy that urge without the use of tobacco.
It certainly seems that the anti-smoking movement is out to get electronic cigarettes - a product they cannot tolerate because it simulates smoking. But their simulation of smoking is precisely why electronic cigarettes are such a promising strategy for the wide-scale promotion of smoking cessation.
(See: Cheah NP, et al. Electronic nicotine delivery systems: Regulatory and safety challenges: Singapore perspective. Tobacco Control 2012; doi: 10.1136/tobaccocontrol-2012-050483.)
The study examined 20 brands of electronic cigarettes, and analyzed the contents of their cartridges for nicotine, propylene glycol, glycerin, polycyclic aromatic hydrocarbons, and tobacco-specific nitrosamines.
The results were reported in the study abstract as follows: "Varying nicotine amounts were found in ENDS cartridges which were labelled with the same concentration. Chemicals such as PPG and glycerol were found to be present in the nicotine-containing liquid of the cartridges. ENDS varied in their contents and packaging information. Limited information was available on the contents of nicotine and other chemicals present in a variety of ENDS sampled."
The paper concludes as follows:
"While the current attention on traditional tobacco products is important, it is also necessary to focus on novelty products like ENDS, which may encourage maintenance of tobacco usage behaviour and slow down the impact of national smoking control programmes. Tobacco control policy makers and professionals are seriously urged to find ways to address the gap in the scientific understanding and the legal framework of such products, as this gap may impede efforts at curbing tobacco use."
The Rest of the Story
If you read the introduction, methods, and results of this study, and then proceed to the discussion, you will be shocked and you might think you are reading the discussion to a different study. This is because the discussion has very little relevance to the actual findings in the paper.
First, while the discussion section focuses on what the authors claim are serious health effects associated with electronic cigarettes, the paper's results actually found that there were no detectable polycyclic aromatic hydrocarbons or tobacco-specific nitrosamines in any of the 20 brands of electronic cigarettes tested, providing powerful evidence that these products are much safer than tobacco cigarettes. Curiously, this latter finding is not reported or addressed in the paper's abstract or discussion section. It is almost as if the authors are intent upon only reporting the risks of electronic cigarette use, but not the potential benefits.
Second, while the discussion section warns users about the finding of high levels of propylene glycol and glycerin in the cartridges, it fails to inform readers that propylene glycol and glycerin are the excipients used to vaporize the nicotine. They are indeed the ingredients of the cartridges, so their presence in high levels in the cartridges is not of concern.
Third, while the paper's abstract implies that the mislabeling of nicotine content is a safety concern, the truth is that this is solely an efficacy concern. In fact, the lack of consistency in nicotine delivery likely makes electronic cigarettes less addictive than regular ones.
But most importantly, the paper's conclusion - that electronic cigarette use promotes the maintenance of tobacco use - literally comes out of nowhere. There is nothing in the results or findings of this paper which provides evidence that electronic cigarette use promotes the maintenance of tobacco use. Nor does the paper cite any evidence whatsoever that electronic cigarette use promotes the maintenance of tobacco use.
It appears that the authors have simply made up this conclusion, making it appear out of thin air. This again suggests that the point of this paper was not simply to report the scientific findings, but to make a pre-ordained statement against electronic cigarette use.
In fact, it is counter-intuitive to conclude that electronic cigarette use would promote tobacco use. By definition, the use of electronic cigarettes is an alternative or substitute to cigarettes. Thus, the more electronic cigarettes are used, the less tobacco cigarettes are smoked. The majority of smoker who use electronic cigarettes are doing so because they want to reduce or eliminate their cigarette smoking. Far from promoting tobacco use, electronic cigarettes are devices designed to reduce cigarette use. Furthermore, there is abundant evidence that electronic cigarette use has accomplished exactly that: reducing tobacco use among smokers.
The only two ways in which electronic cigarette use could promote tobacco use would be: (1) if they encouraged youth (nonsmokers) to use nicotine and then to become smokers; or (2) if they caused users to smoke more.
The second hypothesis is absurd and there is abundant evidence that contradicts that notion. As far as the first hypothesis goes, there is no evidence to support it.
The rest of the story is that this is apparently another electronic cigarette smear job by anti-smoking researchers who cannot tolerate the idea that something which looks like a cigarette could possibly be helpful in reducing cigarette use.
Perhaps the most telling statement in the paper is this one: "Due to its odourless and smokeless delivery system, the e-cigarette can be used in non-smoking areas, as suggested by some ENDS product inserts. This has the potential to allow people to satisfy the smoking urge despite being in areas where smoking is prohibited."
To an objective observer, this would be seen as a tremendous benefit of electronic cigarettes. By satisfying the smoking urge in the face of increasing smoking bans, these products can help smokers refrain from smoking. Without the products, addicted smokers would be forced to go outside and light up a cigarette to satisfy their cravings. But with the advent of electronic cigarettes, they can satisfy that urge without the use of tobacco.
It certainly seems that the anti-smoking movement is out to get electronic cigarettes - a product they cannot tolerate because it simulates smoking. But their simulation of smoking is precisely why electronic cigarettes are such a promising strategy for the wide-scale promotion of smoking cessation.
Monday, October 03, 2011
Boston Public Health Commission Considering Regulation to Ban Electronic Cigarette Use in the Workplace
The Boston Public Health Commission is considering a new regulation which would ban the use of electronic cigarettes in the workplace. The regulation would also restrict the sale of electronic cigarettes to minors and require a permit for selling these products.
The proposed regulation cites as a justification for the ban on electronic cigarette use (vaping) in the workplace: "the U.S. Food and Drug Administration has conducted laboratory tests that found e-cigarettes contain toxic chemicals and carcinogens; and the health effects of involuntary exposure to e-cigarette vapors containing these chemicals and carcinogens is unknown."
The Rest of the Story
The FDA scared the public and implied that electronic cigarettes present a substantial risk of cancer to users by reporting its laboratory finding that electronic cigarettes are dangerous because they contain carcinogens. The FDA failed to inform the public about the level of carcinogens they detected and how it compares to the level of tobacco-specific nitrosamines in regular cigarettes and in nicotine replacement products. The truth is that the FDA found only trace levels of carcinogens, comparable to those found in nicotine patches and nicotine gum, and orders of magnitude below the levels of these same carcinogens in regular cigarettes.
The rest of the story is that:
The public needs to understand that there is presently no more scientific justification for banning electronic cigarette use in the workplace than there is for banning the use of the nicotine inhaler, which many smokers are using in an attempt to quit smoking. Both contain similar levels of tobacco-specific nitrosamines, and there is no evidence that the use of these inhaled products results in any significant carcinogenic exposure among bystanders.
Moreover, the statement that we don't know what vapers are inhaling is a myth. Electronic cigarette emissions have been tested in numerous laboratory studies. Cahn and I reviewed these studies in our review article published in the Journal of Public Health Policy.
We concluded as follows:
"As ~5300 of the estimated 10 000–100 000 chemicals in cigarette smoke have ever been identified,[4] we already have more comprehensive knowledge of the chemical constituents of electronic cigarettes than tobacco ones. We were able to identify 16 studies[5–17] that have characterized, quite extensively, the components contained in electronic cigarette liquid and vapor using gas chromatography mass spectrometry (GC-MS) (Table 1). These studies demonstrate that the primary components of electronic cigarette cartridges are propylene glycol (PG), glycerin, and nicotine. Of the other chemicals identified, the FDA has focused on potential health hazards associated with two: tobacco-specific nitrosamines (TSNAs) and diethylene glycol (DEG).[5]
TSNAs have been detected in two studies at trace levels.[5,6] The maximum level of total TSNAs reported was 8.2 ng/g.[6] This compares with a similar level of 8.0 ng in a nicotine patch, and it is orders of magnitude lower than TSNA levels in regular cigarettes.[18] Table 2 shows that electronic cigarettes contain only 0.07–0.2 per cent of the TSNAs present in cigarettes, a 500-fold to 1400-fold reduction in concentration. The presence of DEG in one of the 18 cartridges studied by the US Food and Drug Administration (FDA) is worrisome, yet none of the other 15 studies found any DEG. The use of a non-pharmaceutical grade of PG may explain this
contamination.
Other than TSNAs and DEG, few, if any, chemicals at levels detected in electronic cigarettes raise serious health concerns. Although the existing research does not warrant a conclusion that electronic cigarettes are safe in absolute terms and further clinical studies are needed to comprehensively assess the safety of electronic cigarettes, a preponderance of the available evidence shows them to be much safer than tobacco cigarettes and comparable in toxicity to conventional nicotine replacement products."
In summary then, there is presently no evidence that electronic cigarettes pose any known health threat to bystanders. In other words, there is no evidence that secondhand vaping poses any health hazards.
Perhaps it would be helpful here for me to present my philosophy regarding the criterion that justifies government action to ban a personal behavior in order to protect the health of bystanders. The criterion I have always adhered to is that the burden of proof is on the government to demonstrate that the behavior in question endangers the health of others. There must be substantial evidence, in other words, that a health hazard exists. The mere possibility of a health hazard is not, in my opinion, sufficient to justify banning a widespread public behavior.
For example, when I have lobbied for laws and regulations to ban smoking in the workplace, my testimony has always been based on substantial evidence of the health hazards associated with secondhand smoke exposure. I never asked any city council or state legislative body to ban smoking in workplaces simply because of the "possibility" that secondhand smoke exposure might be harmful. I, and other anti-smoking advocates, did not demand government intervention until sufficient scientific evidence had accumulated to support the contention that secondhand smoke exposure in the workplace was a cause of health harm among exposed nonsmoking workers.
There are many exposures, which, from time to time, the media or the public associate with potential harm to the public. If government agencies banned these exposures every time there was mere speculation that the exposure might be harmful, it would prove to be an undue and overly burdensome level of intervention in the workplace.
For example, Action on Smoking and Health has argued that the breathe of smokers is itself toxic and has promoted the idea of banning smokers from the workplace simply because of speculation that exhaled toxins could threaten the health of nonsmokers. Would we not all agree that for the government to take such an intrusive action without actual evidence of harms to nonsmokers caused by exhaled chemicals from smoking employees would be inappropriate?
I have two other concerns about setting a precedent of the government banning behaviors in the absence of scientific evidence that those behaviors are causing health harm. First, might it undermine efforts to protect the public in situations where we really do have evidence of harm? In this case, I fear that basing a non-vaping regulation on no scientific evidence of harm could undermine efforts in other states - which do not yet have workplace smoking laws - to protect the public from the hazards of secondhand smoke in the workplace.
Second, banning electronic cigarette use in the workplace could place an undue burden on smokers who are trying to quit smoking using electronic cigarettes or ex-smokers who have successfully quit using e-cigarettes and who are trying to stay smoke-free.
Finally, I want to make it clear that I do not oppose the aspect of the proposed regulation regarding the sale of electronic cigarettes to minors. Certainly it is reasonable to make sure that electronic cigarettes cannot be easily purchased by minors. My comments relate solely to the portion of the proposed regulation that bans vaping in the workplace.
The proposed regulation cites as a justification for the ban on electronic cigarette use (vaping) in the workplace: "the U.S. Food and Drug Administration has conducted laboratory tests that found e-cigarettes contain toxic chemicals and carcinogens; and the health effects of involuntary exposure to e-cigarette vapors containing these chemicals and carcinogens is unknown."
The Rest of the Story
The FDA scared the public and implied that electronic cigarettes present a substantial risk of cancer to users by reporting its laboratory finding that electronic cigarettes are dangerous because they contain carcinogens. The FDA failed to inform the public about the level of carcinogens they detected and how it compares to the level of tobacco-specific nitrosamines in regular cigarettes and in nicotine replacement products. The truth is that the FDA found only trace levels of carcinogens, comparable to those found in nicotine patches and nicotine gum, and orders of magnitude below the levels of these same carcinogens in regular cigarettes.
The rest of the story is that:
- The FDA found only trace levels of tobacco-specific nitrosamines in electronic cigarettes, comparable to those found in FDA-approved nicotine replacement products like nicotine patches and nicotine gum.
- The levels of carcinogens that have been detected in electronic cigarettes are orders of magnitude lower than in regular cigarettes, indicating that electronic cigarettes are likely much safer than regular cigarettes in terms of cancer risk.
- The minute levels of tobacco-specific nitrosamines in electronic cigarettes are a necessary result of the extraction of nicotine from tobacco. Overall, these devices deliver nicotine with only a few other chemicals, compared to the delivery of nicotine plus tens of thousands of chemicals and more than 60 proven carcinogens in regular cigarettes.
- There is no evidence, and little reason to believe, that there would be any significant exposure to carcinogens among bystanders in the proximity of electronic cigarette users.
The public needs to understand that there is presently no more scientific justification for banning electronic cigarette use in the workplace than there is for banning the use of the nicotine inhaler, which many smokers are using in an attempt to quit smoking. Both contain similar levels of tobacco-specific nitrosamines, and there is no evidence that the use of these inhaled products results in any significant carcinogenic exposure among bystanders.
Moreover, the statement that we don't know what vapers are inhaling is a myth. Electronic cigarette emissions have been tested in numerous laboratory studies. Cahn and I reviewed these studies in our review article published in the Journal of Public Health Policy.
We concluded as follows:
"As ~5300 of the estimated 10 000–100 000 chemicals in cigarette smoke have ever been identified,[4] we already have more comprehensive knowledge of the chemical constituents of electronic cigarettes than tobacco ones. We were able to identify 16 studies[5–17] that have characterized, quite extensively, the components contained in electronic cigarette liquid and vapor using gas chromatography mass spectrometry (GC-MS) (Table 1). These studies demonstrate that the primary components of electronic cigarette cartridges are propylene glycol (PG), glycerin, and nicotine. Of the other chemicals identified, the FDA has focused on potential health hazards associated with two: tobacco-specific nitrosamines (TSNAs) and diethylene glycol (DEG).[5]
TSNAs have been detected in two studies at trace levels.[5,6] The maximum level of total TSNAs reported was 8.2 ng/g.[6] This compares with a similar level of 8.0 ng in a nicotine patch, and it is orders of magnitude lower than TSNA levels in regular cigarettes.[18] Table 2 shows that electronic cigarettes contain only 0.07–0.2 per cent of the TSNAs present in cigarettes, a 500-fold to 1400-fold reduction in concentration. The presence of DEG in one of the 18 cartridges studied by the US Food and Drug Administration (FDA) is worrisome, yet none of the other 15 studies found any DEG. The use of a non-pharmaceutical grade of PG may explain this
contamination.
Other than TSNAs and DEG, few, if any, chemicals at levels detected in electronic cigarettes raise serious health concerns. Although the existing research does not warrant a conclusion that electronic cigarettes are safe in absolute terms and further clinical studies are needed to comprehensively assess the safety of electronic cigarettes, a preponderance of the available evidence shows them to be much safer than tobacco cigarettes and comparable in toxicity to conventional nicotine replacement products."
In summary then, there is presently no evidence that electronic cigarettes pose any known health threat to bystanders. In other words, there is no evidence that secondhand vaping poses any health hazards.
Perhaps it would be helpful here for me to present my philosophy regarding the criterion that justifies government action to ban a personal behavior in order to protect the health of bystanders. The criterion I have always adhered to is that the burden of proof is on the government to demonstrate that the behavior in question endangers the health of others. There must be substantial evidence, in other words, that a health hazard exists. The mere possibility of a health hazard is not, in my opinion, sufficient to justify banning a widespread public behavior.
For example, when I have lobbied for laws and regulations to ban smoking in the workplace, my testimony has always been based on substantial evidence of the health hazards associated with secondhand smoke exposure. I never asked any city council or state legislative body to ban smoking in workplaces simply because of the "possibility" that secondhand smoke exposure might be harmful. I, and other anti-smoking advocates, did not demand government intervention until sufficient scientific evidence had accumulated to support the contention that secondhand smoke exposure in the workplace was a cause of health harm among exposed nonsmoking workers.
There are many exposures, which, from time to time, the media or the public associate with potential harm to the public. If government agencies banned these exposures every time there was mere speculation that the exposure might be harmful, it would prove to be an undue and overly burdensome level of intervention in the workplace.
For example, Action on Smoking and Health has argued that the breathe of smokers is itself toxic and has promoted the idea of banning smokers from the workplace simply because of speculation that exhaled toxins could threaten the health of nonsmokers. Would we not all agree that for the government to take such an intrusive action without actual evidence of harms to nonsmokers caused by exhaled chemicals from smoking employees would be inappropriate?
I have two other concerns about setting a precedent of the government banning behaviors in the absence of scientific evidence that those behaviors are causing health harm. First, might it undermine efforts to protect the public in situations where we really do have evidence of harm? In this case, I fear that basing a non-vaping regulation on no scientific evidence of harm could undermine efforts in other states - which do not yet have workplace smoking laws - to protect the public from the hazards of secondhand smoke in the workplace.
Second, banning electronic cigarette use in the workplace could place an undue burden on smokers who are trying to quit smoking using electronic cigarettes or ex-smokers who have successfully quit using e-cigarettes and who are trying to stay smoke-free.
Finally, I want to make it clear that I do not oppose the aspect of the proposed regulation regarding the sale of electronic cigarettes to minors. Certainly it is reasonable to make sure that electronic cigarettes cannot be easily purchased by minors. My comments relate solely to the portion of the proposed regulation that bans vaping in the workplace.
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