Wednesday, November 19, 2014

Proof of Concept Study Shows Great Promise for Second Generation Electronic Cigarettes

Riccardo Polosa and colleagues have just published a six month pilot study, in which 50 smokers who were not interested in quitting were provided with a second generation electronic cigarette (personal vaporizer). The specific product was the EGO/CE4 model. Participants were also provided with chargers and e-liquids throughout the study period.

At six months, a sustained 50% or greater reduction in cigarette consumption was observed in 15 subjects (30%), with mean consumption dropping from 25 cigarettes per day to 6 cigarettes per day. Of these 15 subjects, 7 (14% of the total sample) experienced a sustained reduction of 80% or more in their cigarette consumption, with their mean consumption dropping to just 3 cigarettes per day.

Also at six months, smoking abstinence was reported by 18 subjects (36% of the sample).

Therefore, in total, 33 subjects, or 66%, were either able to quit smoking or cut down on the amount they smoke by at least 50%.

The Rest of the Story

This is a small pilot study and there is no control group or randomization of subjects, so it must be interpreted cautiously. Nevertheless, considering that these were smokers who expressed no interest in quitting, the finding that two-thirds either quit or cut down by more than 50% is encouraging.

This study also demonstrates some of the complexities of studying the effectiveness of electronic cigarettes. There are a wide range of products on the market with different abilities to effectively deliver nicotine and to produce a full vapor that delivers a sufficient throat hit to satisfy many smokers. It may be that the effectiveness of these products could improve over time, as inefficient products are replaced with ones that are better able to satisfy the needs of smokers.

This is why the FDA's proposed deeming regulations make no sense. They would prohibit the introduction of new products into the market, keeping the older and antiquated products going and stifling innovation. The process to get a new product approved is complex and involves showing that the product is beneficial to the public's health. I interpret this as meaning that a new product would have to conduct a clinical trial that shows the effectiveness of the particular product whose approval is being sought. This barrier is a huge one.

This would be unfortunate because the quality and effectiveness of electronic cigarettes appear to be increasing over time. Why would the FDA want to stifle innovation and essentially force the market to be stuck with the less effective products? This is not a recipe designed to maximize the number of smokers who successfully quit smoking. If anything, it is a recipe designed to protect traditional cigarette sales.

Hopefully, the FDA will reconsider this provision of the deeming regulations and will remove it from the final regulation. Innovation in this industry should be encouraged and promoted, not stifled.

Thursday, November 13, 2014

New CDC Study Reveals that Youth Smoking has Declined Despite Tripling of Electronic Cigarette Use Among High Schoolers

A new study released today by the CDC reports that although electronic cigarette use has doubled among middle-school students and tripled among high school students, there was a marked reduction in cigarette smoking in both groups from 2011/12 to 2013.

During this time period, current e-cigarette use among middle-school students increased from 0.6% to 1.1%. At the same time, current cigarette smoking declined from 4.3% to 2.9%.

Among high school students, current e-cigarette use increased from 1.5% to 4.5%. Concurrently, current cigarette smoking dropped from 15.8% to 12.7%.

The study also reported that there were very few never smokers who were currently using electronic cigarettes.

The Rest of the Story

The finding that despite a tripling of current e-cigarette use among high school students, the smoking prevalence among this group dropped substantially suggests that electronic cigarettes are not serving as a major gateway to cigarette smoking among youth.

Although the CDC has been disseminating to the public its contention that electronic cigarettes are a gateway to youth smoking, it has yet to produce a shred of evidence that this is the case. In fact, it has not identified a single youth who started with electronic cigarettes and then progressed to cigarette smoking.

Nevertheless, the CDC director stated last year that: "many kids are starting out with e-cigarettes and then going on to smoke conventional cigarettes."

Given the absence of evidence that e-cigarette use is a gateway to smoking and the lack of any documentation that kids are starting out with e-cigarettes and then progressing to cigarette smoking, it seems that the CDC should correct its earlier statement and apologize for letting it sit out there in the media for more than a year.

It is doing damage because policy makers are accepting this unsupported statement as the truth, and are using it as the basis for stringent regulations of electronic cigarettes which may end up causing more public health harm than good. The benefits of electronic cigarettes in terms of helping smokers to quit or cut down needs to be weighed against the harms in terms of potentially recruiting new smokers or e-cigarette addicts. However, so far there is no evidence that either of these phenomena are occurring.

Certainly, we need to continue to carefully monitor the situation and to conduct research to clearly identify the trajectory and time course of electronic cigarette and tobacco cigarette use among youth. But as a start, we need our public health agencies to be honest with us about the facts. Distorting the science to create more compelling stories or to fulfill predetermined conclusions is not appropriate.

Disclosure: I have not received any funding or compensation from the tobacco, electronic cigarette, or pharmaceutical industries. However, I am seeking funding from several electronic cigarette companies to conduct a behavioral study on the effects of electronic cigarettes on smoking behavior.

Tuesday, November 11, 2014

New State Study Shows Dramatic Reduction in Youth Smoking Despite Sharp Rise in E-Cigarette Use

New data out of Minnesota shows that despite a marked increase in e-cigarette use among Minnesota teenagers, there was a corresponding dramatic decline in tobacco cigarette smoking.

According to the report: "The 2014 Minnesota Youth Tobacco Survey found that the percent of high school students who smoked cigarettes in the past 30 days dropped from 18.1 percent in 2011 to 10.6 percent in 2014."

At the same time: "12.9 percent of high school students used or tried an electronic cigarette in the past 30 days. The survey found that 28 percent of high school students reported ever having tried an e-cigarette."

The Rest of the Story

These findings add further evidence that electronic cigarettes are not currently serving as any kind of major gateway to cigarette smoking. Despite massive levels of experimentation with electronic cigarettes, youth smoking rates are falling dramatically. This pretty much rules out the hypothesis that e-cigarettes are a major gateway to smoking.

Stan Glantz has reviewed additional evidence which documents rather dramatic increases in electronic cigarette use in the past few years, some of which is occurring among nonsmokers. However, these data actually add to the evidence that e-cigarettes are not a major gateway to smoking because they demonstrate that this experimentation, even among nonsmokers, is occurring at a time when smoking rates among youth have fallen to historic low levels.

Bottom line: There is no evidence at the current time that electronic cigarettes are serving as a gateway to smoking among youth.

Unfortunately, the lack of evidence did not stop the CDC director from proclaiming publicly that e-cigarettes are a gateway to youth smoking. And sadly, I am not aware that the director has made any sort of retraction, correction, or apology.

Meanwhile, the bogus conclusion that youth electronic cigarette use is a major risk for increased youth smoking continues to deceive policy makers throughout the country and risks the formation of inappropriate and unsupported state and federal policies regarding electronic cigarettes.

Despite all the attention to the hypothetical risks of electronic cigarettes, which so far have not been shown to pose any substantial risk to young people, the policy makers remain silent about menthol cigarettes, which - according to the Minnesota report - are currently smoked by 44% of youth smokers. This is not a hypothetical risk. This is not a slight chance of progression to smoking. These are kids who are already smoking and most likely already addicted to smoking. And half of these kids who continue to smoke over a lifetime will die prematurely of this addiction.

But nobody in the anti-smoking movement seems to care. It appears that we just can't stand hypothetical or unknown risks. But known epidemics of disease and death are just fine.

Disclosure: I have not received any funding or compensation from the tobacco, electronic cigarette, or pharmaceutical industries. However, I am seeking funding from several electronic cigarette companies to conduct a behavioral study on the effects of electronic cigarettes on smoking behavior.

Thursday, November 06, 2014

New Study Suggests that Menthol Cigarettes May Be Worse for Lung Health; Policy Makers Respond by Calling for Ban on Flavored Electronic Cigarettes

I'm not much kidding in making that connection. If there is any flavor in tobacco products that is contributing toward youth addiction and ultimately, disease, it is menthol. Menthol cigarettes are preferred by nearly 50% of youth smokers. And menthol is the one flavoring that was exempt from prohibition under the Family Smoking Prevention and Tobacco Control Act.

Who was responsible for that exemption? Ironically, the policy makers who are currently calling for a ban on flavorings in electronic cigarettes.

Despite the lack of evidence that electronic cigarettes are leading to any tobacco use among youth, and despite the strength of the evidence that menthol cigarettes make up about 50% of the tobacco cigarettes that youth do smoke, it makes absolutely no sense for policy makers to call for a ban on flavorings in electronic cigarettes, but not to demand a similar policy for the menthol in cigarettes.

Unfortunately, this is exactly the state of affairs among the leading politicians who supported the Family Smoking Prevention and Tobacco Control Act and who are now switching their attention over to electronic cigarettes, which they are treating like a far greater scourge on the health of our nation's children.

The new study found that menthol smokers had higher rates of hospitalization for chronic lung disease. Beware, however. There were major differences between the populations of menthol and non-menthol smokers in this study, and I do not personally feel that the study controlled adequately enough for these differences to be able to attribute the observed health differences specifically to the presence of menthol.

Similarly, I have long argued that a policy which aims to ban menthol because menthol cigarettes pose a greater health risk than non-menthol cigarettes is flawed from the start, because the scientific evidence doesn't support such a judgment.

In fact, the reason for the flavorings ban in the Tobacco Control Act is not that flavored cigarettes are any more hazardous, but that - hypothetically - youth would be more attracted to such products. But on that basis, not only should menthol cigarettes have been banned, but all flavorings that are added to cigarettes should have been banned as well. In other words, the policy made little sense and was internally and externally inconsistent from day one.

Now is the time for the politicians to put up or shut up. Either back up your supposed concern for kids' health by sponsoring legislation to ban menthol and all flavorings in cigarettes, or cut the crap about the need to ban the flavorings from e-cigarettes in order to end the scourge that these flavors are having on our nation's children.

Tuesday, November 04, 2014

Anti-Smoking Groups and Politicians are Way Off the Mark in Accusing Altria and Reynolds American of Targeting Children with their E-Cigarettes

In recent months, a host of anti-smoking groups as well as several leading politicians in Congress and at the state level have attacked the Big Tobacco companies - including Reynolds American and Altria - for targeting their electronic cigarette products to children.

While it may sound like a great sound bite, it fits the mantra of tobacco control, and it may be consistent with historical practices of these tobacco companies in marketing cigarettes to youth, there is much more here than meets the eye. As much as the anti-smoking groups might like, things are not that simple.

Specifically, this claim by anti-smoking groups and politicians is demonstrably false. And by continuing to make this false accusation, it detracts from the anti-smoking groups' legitimate complaints against a small number of e-cigarette companies that do appear to be crossing the line.

The Rest of the Story

In their complaints, the anti-smoking groups and politicians have specified the ways in which e-cigarette companies are targeting kids. First, according to these groups, the use of candy and fruit-flavored products is a sure sign of youth targeting. Second, selling their products over the internet is an attempt to recruit youth customers, since it is much easier for underage customers to purchase over the internet than to purchase in face-to-face sales in brick-and-mortar facilities. Third, electronic cigarette companies are targeting kids by offering disposable products at cheap prices.

Let's now examine Reynolds American's e-cigarette product (Vuse) and Altria's product (Nu Mark) to see how they fare on each of these youth targeting criteria:

Candy and fruit flavors: None. Only tobacco and menthol.
Internet sales:  None. Only available in retail stores.
Disposable products: None. Only available in more expensive, rechargeable sets.

Candy and fruit flavors: None. Only tobacco and menthol.
Internet sales:  None. Only available in retail stores.
Disposable products: None. Only available in more expensive, rechargeable sets.

Not only is there a lack of evidence that Vuse and Nu Mark are not targeting youth, but there is very strong evidence that these products are not targeting youth. 

Nevertheless, I am not aware of any mainstream tobacco control group which has so much as acknowledged that Vuse and Nu Mark are indeed being responsibly marketed toward adult smokers. 

My readers know that I can certainly dish out criticism when it is warranted. But at the same time, I feel it is important to be discriminating, and to withhold criticism unless it is warranted and backed up by adequate evidence. 

Unfortunately, the anti-smoking groups and politicians seems incapable of such discrimination. Everything is black and white, and there is no need to actually examine the scientific evidence. 

Except that the rest of the story is that for Vuse and Nu Mark, it isn't black and white. It's exclusively classic tobacco and menthol.

Disclosure: I have not received any funding or compensation from the tobacco, electronic cigarette, or pharmaceutical industries. However, I am seeking funding from several electronic cigarette companies to conduct a behavioral study on the effects of electronic cigarettes on smoking behavior.

Monday, October 27, 2014

Study Suggests that Telling Smokers the Truth About Electronic Cigarettes Could Enhance Smoking Cessation

Last week, I discussed a study, just published online ahead of print in the journal Nicotine & Tobacco Research, which reports the results of a population-based survey of smokers followed up after two years to determine whether e-cigarette use was associated with higher or lower rates of smoking cessation. The study found that intensive electronic cigarettes users at baseline were six times more likely to quit smoking after a two-year follow-up period compared to intermittent or non-users.

One additional important finding of this study deserves mention.

The study found a difference in the reasons for starting e-cigarette use between triers (those who only vaped one or two times), intermittent users, and intensive users (those who vaped daily for at least one month).

Among the intensive users, the overwhelming majority (87.6%) reported that they were vaping because of health concerns: they were concerned about their own health and/or wanted to quit smoking or cut down on the amount that they smoked.

Among the intermittent users, this percentage was only 53.6%, and among the triers, it was only 55.2%. Other major reasons given among the triers and intermittent users were vaping where smoking is not allowed and avoiding exposing others to tobacco smoke.

Overall, then, the most intensive users -- who were also more likely to quit successfully -- tended to be smokers who were using electronic cigarettes specifically with a health purpose in mind (usually, quitting smoking). There were fewer "ancillary" reasons for use among these intense users.

As the authors concluded: "those who did not progress to extended daily use of e-cigarettes were using them for reasons other than the desire to quit smoking."

The Rest of the Story

This highlights one of the major problems with the proposed regulation of e-cigarettes, as well as the way many anti-smoking groups are treating these products.

First, in terms of proposed regulation, the FDA's proposed deeming regulations would prohibit companies from telling the truth about their products. Companies could not point out that electronic cigarettes produce no smoke, nor could they truthfully make the point that these products are much safer than cigarettes. Beware of making a therapeutic claim, they could not point out that the primary purpose of these products is for smoking cessation. In short, the proposed regulations would prohibit companies from marketing these products truthfully: the companies would have to pretend that improving health has nothing to do with why these products exist or why one would want to use an e-cigarette instead of a real one.

This is absurd, and it needs to be changed in the final regulations. First, companies should be explicitly allowed to point out that these products contain no tobacco smoke. Second, companies should be allowed to truthfully inform consumers that vaping is much safer than smoking. Third, companies should be allowed to make a certain set of claims regarding smoking cessation. They should not be allowed to market these products as nicotine delivery devices or with the purpose of treating nicotine dependence or addiction (since these are diseases/conditions). But instead, they should be allowed to truthfully note that the primary intention of these products is to get smokers off of cigarettes. They should also be allowed to inform consumers that many smokers have successfully quit smoking using e-cigarettes. The FDA should allow this subset of claims to be made without running afoul of the Food, Drug, and Cosmetic Act (i.e., without having to reclassify their products as drugs and therefore pull them off the market while submitting a new drug application).

Second, in terms of the statements of anti-smoking groups, they should stop criticizing electronic cigarette companies for making truthful claims, such as that these products have helped many people quit smoking or that these products are much safer than tobacco cigarettes. By discouraging these types of truthful claims, the anti-smoking groups have in fact backed the e-cigarette companies into a corner: all they can do without arousing the ire of the anti-smoking groups is to market e-cigarettes as a glamorous or sexy form of tobacco use, or as a product that can be used where smoking is not allowed. This is exactly how we don't want these products to be marketed.

The rest of the story is that it isn't as simple as condemning electronic cigarette companies for using marketing that seems to appeal to young people, or which casts vaping as being glamorous or sexy. The companies have been boxed into a corner. And the ones boxing them into that corner are us! By us, I mean public health groups and agencies.

It is time to not only allow, but to encourage the truthful marketing of electronic cigarettes. Based on the current research, such an approach would actually aid the public's health by encouraging more serious vapers who would have a higher likelihood of making the complete switch from tobacco cigarettes to the much safer electronic ones.

Disclosure: I have not received any funding or compensation from the tobacco, electronic cigarette, or pharmaceutical industries. However, I am seeking funding from several electronic cigarette companies to conduct a behavioral study on the effects of electronic cigarettes on smoking behavior. 

Thursday, October 23, 2014

Unlike Data from U.S., Data on Youth Electronic Cigarette Use in Poland is Concerning

A new set of cross-sectional surveys of e-cigarette use among Polish students ages 15-19 was just published in the Journal of Adolescent Health.

(See: Goniewicz ML, et al. Rise in electronic cigarette use among adolescents in Poland. Journal of Adolescent Health 2014; 55:713-715.)

Like its U.S. counterpart (the National Youth Tobacco Survey), the survey from Poland found a dramatic increase in experimentation with electronic cigarettes during the period 2010/11 - 2013/14. Experimentation increased from 16.8% to 62.1%.

Different from the U.S. study, however, the Poland study found very high rates of current use of electronic cigarettes, which rose from 5.5% to 29.9%.

Most alarming, and completely different from results observed in the U.S., the prevalence of cigarette smoking during the study period increased substantially, rising from 23.9% to 38.0%.

The Rest of the Story

In and of itself, the increase in electronic cigarette experimentation in Poland is to be expected. However, there are two aspects of the data which are alarming.

First, not only did experimentation rise, but the rates of current use of electronic cigarettes are substantially higher than they are in the U.S. This suggests that not only are Polish youth trying these products, but the products seem to have more of a "stick" factor than they do in the U.S.

Second, and more alarming, is the finding that the dramatic increase in electronic cigarette use is occurring in the presence of a substantial increase in cigarette smoking. This is completely unlike the situation in the U.S., where the dramatic rise in experimentation with electronic cigarettes has been associated with a decline in youth smoking to its lowest level in recent history.

As the authors point, out the combination of the dramatic increase in e-cigarette experimentation, the high prevalence of current e-cigarette use, and both in the setting of a substantial increase in smoking prevalence do not appear to be consistent with the hypothesis that the use of electronic cigarettes among youth in Poland is displacing tobacco cigarettes.

Of course, this is only a cross-sectional study so it is premature to conclude that it is the electronic cigarette use that caused the observed increase in smoking. There are many other factors which could be at play. Nevertheless, these are the type of data which would cause me concern should they appear in U.S. surveys.

There are three major takeaways from this story.

First, having seen what concerning data about e-cigarette and cigarette use among youth would look like, this should be reassuring to public health advocates in the United States, where the data look very different and do not support the conclusion that e-cigarettes are serving as any sort of gateway to cigarette smoking.

Second, it may be that country-specific policies are necessary to regulate e-cigarettes, as the products being used and the use and popularity of the products may differ from country to country. A one size fits all approach may not make sense for such a complex phenomenon with an incredible diversity of types of products.

Third, comparing how different anti-smoking groups present the results of these findings along with those of the U.S. findings should be instructive in terms of identifying potential biases.

Those who report both the U.S. findings and Poland findings as demonstrating the gateway effect of youth moving from e-cigarettes to smoking (i.e., Glantz, Dutra, etc.) are clearly biased towards presenting the negative effects of e-cigarettes, rather than the truth.

Those who report both the U.S. findings and Poland findings as great news that should spare us concerns about the use of electronic cigarettes among youth are clearly biased towards electronic cigarettes and downplaying potential risks.

Those who report the U.S. findings and Poland findings differently (with the Poland findings showing reason for concern and the U.S. findings not ringing alarm bells about any significant gateway effects) are probably presenting a much more balanced and nuanced (and less biased) picture of the scientific data.

Disclosure: I have not received any funding or compensation from the tobacco, electronic cigarette, or pharmaceutical industries. However, I am seeking funding from several electronic cigarette companies to conduct a behavioral study on the effects of electronic cigarettes on smoking behavior. 

Wednesday, October 22, 2014

New Research Suggests that Banning E-Cigarette Flavors Could Have Tragic Consequences

As I noted yesterday, one of the most central tenets of medicine and public health is "to do no harm." Research out of the Center for Survey Research at the University of Massachusetts Boston suggests that policy makers and anti-smoking groups which are supporting bans on e-cigarette flavors - such as one proposed in New York City - would be violating this principle, causing tragic consequences by promoting smoking to a significant proportion of the population.

Monday, I discussed a study, just published online ahead of print in the journal Nicotine & Tobacco Research, which reports the results of a population-based survey of smokers followed up after two years to determine whether e-cigarette use was associated with higher or lower rates of smoking cessation. The study found that intensive electronic cigarettes users at baseline were six times more likely to quit smoking after a two-year follow-up period compared to intermittent or non-users.

However, the survey included a very useful question for all smokers who had tried, intermittently used, or intensively used electronic cigarettes but discontinued e-cigarette use for some reason and returned to smoking. Specifically, these smokers were asked to name the most important reasons why they returned to cigarette smoking.

The number one reason given by smokers for stopping electronic cigarette use was the taste of the product. More than one-third (35.0%) of triers reported that taste was a major factor in their discontinuation of vaping.

Very few intensive users and only a small number of intermittent users listed taste as an important consideration in discontinuing vaping. This suggests that taste is a critical aspect of the vaping experience which largely explains whether a smoker will progress to more intensive and perhaps more advanced use of these products, which are associated with a higher likelihood of smoking cessation.

The Rest of the Story

What does this mean?

It means that if electronic cigarette flavors are banned, the percentage of smokers who progress to regular e-cigarette use will plummet. Moreover, the benefits of e-cigarettes in terms of promoting smoking cessation will be largely negated. Worst of all, thousands of smokers who would otherwise have been likely to reduce their cigarette consumption or perhaps quit with e-cigarettes will instead return to cigarette smoking or never give e-cigarettes the light of day.

Simply, it would be a public health tragedy that would cost countless lives.

It would, of course, also be a huge boon for combustible cigarette profits.

Proponents of these flavoring ban proposals have failed to present a cost-benefit analysis demonstrating that these enormous costs of basically decimating the e-cigarette market would be offset by a reduction in harm to youth who are picking up e-cigarettes because of the flavor and suffering serious health consequences (presumably as a result of initiating smoking). In fact, the current evidence base does not suggest that the use of flavored e-cigarettes is causing any net harm. If anything, it appears that youth e-cigarette use might be associated with some amount of smoking reduction among youth smokers.

It is critical that before policy makers, whether in New York City or at the FDA, take the draconian step of banning electronic cigarette flavors, they demonstrate that such a measure's public health benefits would outweigh its harms. The current evidence demonstrates that the opposite is the case. There would be very little public health benefit at the expense of tragic consequences to ex-smokers, who would return to smoking in huge numbers, and to current smokers, who would continue to smoke combustible cigarettes rather than make a potentially successful quit or reduction attempt using e-cigarettes.

Disclosure: I have not received any funding or compensation from the tobacco, electronic cigarette, or pharmaceutical industries. However, I am seeking funding from several electronic cigarette companies to conduct a behavioral study on the effects of electronic cigarettes on smoking behavior. 

Tuesday, October 21, 2014

New Research Suggests that Anti-Smoking Groups' Propaganda About Electronic Cigarettes' Harms is Causing Tragic Consequences

One of the most central tenets of medicine and public health is "to do no harm." Research out of the Center for Survey Research at the University of Massachusetts Boston suggests that many anti-smoking groups are violating this principle, causing tragic consequences by promoting smoking to a significant proportion of the population.

Yesterday, I discussed a study, just published online ahead of print in the journal Nicotine & Tobacco Research, which reports the results of a population-based survey of smokers followed up after two years to determine whether e-cigarette use was associated with higher or lower rates of smoking cessation. The study found that intensive electronic cigarettes users at baseline were six times more likely to quit smoking after a two-year follow-up period compared to intermittent or non-users.

However, the survey included a very useful question for all smokers who had tried, intermittently used, or intensively used electronic cigarettes but discontinued e-cigarette use for some reason and returned to smoking. Specifically, these smokers were asked to name the most important reasons why they returned to cigarette smoking.

Sadly, the third most common reason given by smokers was concern over the health effects of electronic cigarettes. Nearly one-third (29.3%) of smokers who discontinued e-cigarette use and returned to exclusive smoking listed concern over the health effects of vaping as a very important reason for stopping e-cigarette use.

This is unfortunate because despite the propaganda being disseminated by many anti-smoking groups, vaping is much safer than smoking and there is no legitimate health concern that should lead a smoker to choose tobacco cigarettes over fake, tobacco-free ones.

I find it truly tragic that a substantial proportion of smokers who have used e-cigarettes - perhaps as many as one-third - have fallen for the propaganda of many anti-smoking groups and have discontinued their cessation or reduction attempts and returned to full-time cigarette smoking because of a concern about their health. This is completely irrational, as there is no question that switching to electronic cigarettes is much safer than continuing to smoke, and that even a major reduction in smoking has positive respiratory health consequences.

Where are these smokers getting the irrational and completely unfounded idea that a concern about their health should lead them to switch completely from vaping to smoking? The answer - and here is the sad part of the story - is that these smokers are almost certainly getting this false information from a host of supposedly "anti-smoking" groups which, as documented on The Rest of the Story over the past years, have been spreading false and misleading propaganda about the relative health effects of electronic cigarettes compared to tobacco cigarettes.

No later than yesterday did Stan Glantz again disseminate hysterical propaganda designed to scare people into thinking that the nicotine in electronic cigarettes causes heart attacks, despite the lack of any direct evidence that this is the case, and despite the fact that most scientists are unsure that the nicotine in cigarette smoke contributes to heart attacks. While Glantz provides the caveat that: "there are not yet direct evidence on the effects of e-cigarettes on the sympathetic nervous system," this is likely to be lost, given that the headline reads: "Reasons to worry about e-cig induced heart attacks."

I don't mean to single Stan out because he is joined by a host of supposedly "anti-smoking" groups. But the irony is that these groups, by disseminating propaganda that is demonstrably resulting in vapers deciding to switch completely back to smoking, are actually helping to promote cigarette smoking. Thus, it is uncomfortable to continue to refer to these organizations as "anti-smoking" groups. I do not question their intentions. However, when the effects of their actions are to promote smoking, then something is wrong.

And something needs to change. Right away.

Disclosure: I have not received any funding or compensation from the tobacco, electronic cigarette, or pharmaceutical industries. However, I am seeking funding from several electronic cigarette companies to conduct a behavioral study on the effects of electronic cigarettes on smoking behavior.

Monday, October 20, 2014

New Cohort Survey Study Shows that Intensive E-Cigarette Use Greatly Increases Chances of Quitting Smoking; Also Shows Need for a Clinical Study

A new study, just published online ahead of print in the journal Nicotine & Tobacco Research, reports the results of a population-based survey of smokers followed up after two years to determine whether e-cigarette use was associated with higher or lower rates of smoking cessation.

(See: Biener L, Hargraves JL. A longitudinal study of electronic cigarette use in a population-based sample of adult smokers: association with smoking cessation and motivation to quit. Nicotine & Tobacco Research, 2014; doi:10.1093/ntr/ntru200.)

A baseline survey conducted in the Dallas and Indianapolis metropolitan areas in 2011/2012 identified 1,374 smokers who agreed to be re-contacted. Of these, 695 were successfully re-contacted in 2014. At the baseline interview, all respondents were current smokers and their use of electronic cigarettes was assessed. At the follow-up interview, smoking cessation was defined as abstinence from cigarettes for at least one month.

Smoking cessation rates were compared between intensive e-cigarettes users at baseline (daily use for at least one month), intermittent users (use more than once or twice but not daily for a month or more); and non-users (use no more than once or twice).

The chief finding was as follows: "Logistic regression controlling for demographics and tobacco dependence indicated that intensive users of e-cigarettes were 6 times as likely as non-users/triers to report that they quit smoking (O.R. 6.07, 95% C.I. 1.11, 33.2). No such relationship was seen for intermittent users."

The Rest of the Story

This is very important research, because it demonstrates that the intensive use of electronic cigarettes is associated with greatly increased rates of smoking cessation, even among a sample of dual users (i.e., all users were smokers at baseline).

However, the study also shows that for a number of reasons, many smokers do not become intensive e-cigarette users, and these individuals do not appear to gain any benefit from e-cigarettes in terms of smoking cessation. Trying to identify the factors that impede progression to more intensive electronic cigarette use could help to discover ways to make e-cigarettes more appealing and more likely to lead to more regular and sustained use. This would in turn increase the value of these products for smoking cessation.

One difficulty in interpreting the results of the study is that different levels of use may correspond with different levels of motivation to quit. For example, it may be that intensive users are more likely to be using e-cigarettes as part of an explicit quit attempt, while intermittent users are more or less experimenting with the products or using them for some other reason. This means that the results of any survey study must be interpreted strictly with respect to the nature of the use of the product in that specific sample.

This problem explains why two previous survey studies have found that e-cigarette users had lower chances of quitting. In those studies, many of the users were likely those who were not highly motivated to quit and who were not even making a quit attempt.

This is one major reason why a clinical study of the effects of e-cigarettes on smoking behavior is so critical. There is simply no other way to equalize the levels of motivation to quit and reasons for wanting to use an alternative product.

Interestingly, this study did not find a consistent relationship between electronic cigarette use and motivation to quit. Thus, even when one measures motivation to quit explicitly, it is not clear that controlling for this variable is adequate to account for differences between groups.

What does this all mean? It means that while survey research continues to be valuable, especially when it carefully defines and compares different subsets of e-cigarette users and attempts to focus on users who are explicitly making quit attempts, there are still major limitations with this methodology that cannot be overcome. We no doubt need many more survey studies to help elucidate the complex behavioral effects of  electronic cigarettes on smoking behavior. However, we also need a clinical study in which smokers at exactly the same level of motivation to quit are compared - that is, we need a randomized study in which the behavioral effects on smoking with e-cigarettes are identified and compared with another product such as NRT.

Disclosure: I have not received any funding or compensation from the tobacco, electronic cigarette, or pharmaceutical industries. However, I am seeking funding from several electronic cigarette companies to conduct a behavioral study on the effects of electronic cigarettes on smoking behavior.

Wednesday, October 15, 2014

Why a Randomized Behavioral Study is Essential to Understanding the Potential Benefits of Electronic Cigarettes

Some of the researchers and advocates who opposed our crowdfunding campaign to raise money for a randomized behavioral study of the effects of electronic cigarettes on smoking behavior argued that randomized clinical trials (RCTs) are simply not appropriate to study e-cigarettes because they cannot simulate the real-life situation, where smokers have many choices of different types of products, can engage with social networks, and can experiment over time, change products, advance from one type of product to another, etc.

Instead, these advocates argued that surveys are the best way to study the potential benefits of e-cigarettes. Surveys measure the real-life situation of how e-cigarettes and vapor products are actually used.

According to the argument, surveys produce valid results, while RCTs produce invalid results.

The Rest of the Story

Unfortunately, it's just not that simple.

The above argument is convenient for advocates who want to suppress "negative" or "unfavorable" findings by discouraging RCTs - which they believe will "underestimate" the effectiveness of e-cigarettes for smoking cessation and encouraging survey studies - which they believe will show the effects of vapor products in all their possible glory. However, the argument carries with it a lack of scientific validity.

The truth is that there are major advantages and disadvantages of both surveys and clinical trials to examine the potential benefits of electronic cigarettes. Both types of study designs have inherent biases which can produce results that are more "favorable" or "unfavorable." This is why the methodology of published research needs to be examined so carefully. It is not so simple as to dismiss RCT evidence and accept survey evidence. One needs to consider the strengths and limitations inherent in both approaches. And at the end of the day, the only defensible approach, I believe, is that both types of studies are necessary, and we must carefully interpret and synthesize the findings from studies of multiple designs, using the totality of the evidence to make final judgments about the benefits of electronic cigarettes.

This is why I find it so troubling that some major voices in the e-cigarette community are arguing that RCTs should not be conducted and only survey studies are of value.

The randomized study provides a number of important benefits that can never be realized in a survey study. Most importantly, the RCT can equalize between study groups the known and unknown confounding variables that may lead to invalid study results.

For example, one of the major problems in some of the previous survey studies of electronic cigarettes (the ones cited by Stan Glantz, for example) is that they fail to control for a major confounder: the level of a smoker's addiction to smoking and motivation to quit. Some of the studies that Glantz has cited to show that e-cigarettes are ineffective for smoking cessation compare users of e-cigarettes and non-users of e-cigarettes. In two of these studies, those who did not use e-cigarettes had higher quit rates.

The problem is that the smokers who used e-cigarettes were likely more heavily addicted and more resistant to quitting. The reason they tried e-cigarettes was probably related to their failure to quit smoking using other types of therapy, such as NRT or other drugs. E-cigarettes, after all, are not generally the first smoking cessation approach that a smoker will try.

The impact of this confounding is that it will bias the results towards finding that e-cigarettes are much less effective than other approaches. In fact, this is exactly what happened and it is the reason why the evidence that Glantz and others are citing to support their contention that e-cigarettes hinder smoking cessation is invalid.

The beauty of a randomized study is that it can equalize the levels of smoking addiction, reasons for wanting to quit, and motivation to quit across groups. In addition, it equalizes other confounders, including unknown confounders which could affect the study results. There is no way for a survey study to accomplish this.  Thus, to simply throw out the RCT is quite unscientific, in my opinion. It throws out one of the most valid pieces of evidence that is necessary to make an informed judgment about the effect of these products: the differences in effectiveness of the products under conditions in which confounding cannot throw off the results.

A second major advantage of a clinical trial is that it can examine the potential effectiveness of interventions in which the use of a product is promoted for use among smokers who are interested in quitting. A survey cannot do this, because it can only examine the use of products under current conditions. It provides no information on what would happen if the product was actively promoted to a group of smokers, as it is in a clinical trial.

A third major advantage of a clinical trial is that conditions are controlled as carefully as possible, minimizing potential biases. Both sampling and measurement bias are greatly reduced, if not eliminated. In contrast, survey studies are generally subject to significant sampling and measurement bias.

There are some specific problems with survey studies that could lead to an overestimation of the benefits of electronic cigarettes. One major problem is that a survey study of the use of advanced vapor products would result in a severe bias towards finding a high level of effectiveness of these products. The reason? By the time smokers advance to use products like open-ended systems, they have already experienced success, fulfillment, and enjoyment with vaping. In other words, limiting the sample to users of advanced vapor products filters out the majority of e-cigarette users, who do not experience great success and therefore don't go on to the more advanced products.

Although the survey approach described above would lead to "invalid" results, I would never argue that survey studies should be thrown out and that we should only be conducting RCTs. My point is that there are strengths and limitations of various study designs, and causal inference is enhanced by having research evidence from multiple study designs. On balance, the strengths and weaknesses balance each other out, leading to a much greater ability to draw valid conclusions.

Neither the survey approach or the RCT approach is perfect. Both have major strengths and significant limitations. The best way to proceed is to conduct both types of studies and to synthesize the results across study designs, keeping in mind the methodological strengths and limitations of each individual study. Only by looking at this totality of the evidence can we draw valid scientific conclusions.

And this is why when some responded to our proposal for a randomized behavioral study by arguing that such an approach was invalid and that we should do a survey instead, I viewed those responses as being unscientific and unsound. Instead, I believe what is truly behind these draconian opinions (draconian because they would throw out an entire line of potential evidence) is a bias towards electronic cigarettes. I'm not arguing that it is a conscious bias. It may be subconscious. But I don't believe that any objective scientist would argue for completely throwing out a randomized clinical study design and relying solely on survey evidence to draw conclusions about the effectiveness of a product such as electronic cigarettes.

Finally, while it is true that the typical RCT is limited because it does not simulate the real-life situation where smokers can choose between different products, change products over time, and engage in social networks to support their vaping, the study we had proposed would have allowed for all of these things. We would have given smokers a wide range of products to choose from and allowed them to experiment with different products and make changes if they desired, and we would have referred them to a number of vaping web sites and support groups. In fact, we had decided to include a training and information session with an actual vaper as part of the study. This would still not have simulated the real-life situation exactly, but it would have significantly helped to make the study more meaningful by making it more similar to what happens in "real life."

I believe that such a modified, randomized clinical study is essential to add another line of evidence with which to evaluate the potential benefits of electronic cigarettes. Yes, there are limitations to RCTs, but it makes no sense to throw out the baby with the bath water.

Disclosure: I have not received any funding or compensation from the tobacco, electronic cigarette, or pharmaceutical industries. However, I am seeking funding from several electronic cigarette companies to conduct a behavioral study on the effects of electronic cigarettes on smoking behavior.

Tuesday, October 14, 2014

New Study Finds No Benefits to Use of Over-the-Counter NRT for Smoking Cessation

A new study published in this month's issue of Mayo Clinic Proceedings casts doubt on the effectiveness of over-the-counter NRT for smoking cessation.

(See: Kotz D, Brown J, West R. Prospective cohort study of the effectiveness of smoking cessation treatments used in the "real world." Mayo Clinic Proceedings 2014; 89:1360-1367.)

The study - a prospective cohort study of 1560 adult smokers who were surveyed at baseline and 6 month follow-up and made at least one quit attempt between the two interviews - compared the quit rates for the use of prescription medication with specialist behavioral support, prescription medication with brief advice from their physician, over-the-counter NRT, and none of these (no use of medication).

The main outcome measure was sustained abstinence from the last quit attempt to the time of the survey. The analysis controlled for demographic variables as well as baseline level of cigarette dependence.

The results were as follows: "Compared with smokers using none of the cessation aids, the adjusted odds of remaining abstinent up to the time of the 6-month follow-up survey were 2.58 (95% CI, 1.48-4.52) times higher in users of prescription medication in combination with specialist behavioral support and 1.55 (95% CI, 1.11-2.16) times higher in users of prescription medication with brief advice. The use of NRT bought over the counter was associated with a lower odds of abstinence (odds ratio, 0.68; 95% CI, 0.49-0.94)."

Regarding the use of over-the-counter NRT, the study concludes: "The most frequently used form of treatment, NRT bought over the counter, appears to be associated with reduced success rates."

The Rest of the Story

This study adds to the growing evidence that while NRT is more effective than placebo in clinical trials, the real-life use of NRT is not necessarily associated with improved cessation outcomes. In this study, the researchers found that the use of over-the-counter NRT was actually associated with lower smoking cessation rates than quit attempts that did not involve the use of any medication.

The authors suggest that the reason for the failure of over-the-counter NRT in real life, but its effectiveness in clinical trials, is most likely the fact that in the clinical trials, there is intensive intervention outside of the drug, including instructions on how to use the medication, multiple study visits to help maintain adherence with medication use and the quit attempt, and consistent, long-term monitoring. As the authors argue: "This is a different situation from the real-world setting of our study in which smokers use the medication in an uncontrolled yet more realistic fashion."

The authors note that these findings are consistent with their earlier study, in which "NRT bought over the counter was equally associated with the success of quitting than not using treatment ... (adjusted odds ratio, 0.96; 95% CI, 0.81-1.13)."

Another possible reason why NRT is effective in clinical trials but may not be nearly as effective in real-life settings is that the clinical trials are not truly blinded. Many subjects receiving placebo are immediately aware that they are not receiving nicotine replacement and have a higher tendency to quickly give up on their quit attempt in frustration that they were assigned to the placebo arm of the study.

While the study did find a benefit of prescribed smoking cessation medication, especially in combination with specialist behavioral intervention, the reality remains that the most common form of NRT usage is over-the-counter purchase outside the setting of intensive behavioral intervention or physician advice and guidance. Thus, the "real world" effectiveness of NRT is brought into serious question by the results of this study.

In the context of their previous study showing that "real life" use of electronic cigarettes is associated with enhanced smoking cessation rates compared to the use of NRT, it appears that the existing evidence from survey studies suggests that electronic cigarettes may actually be more effective than NRT in real-life circumstances (i.e., outside the context of clinical trials).

I believe that what is needed urgently are randomized behavioral studies that directly compare electronic cigarettes head-to-head against over-the-counter NRT.

Disclosure: I have not received any funding or compensation from the tobacco, electronic cigarette, or pharmaceutical industries. However, I am seeking funding from several electronic cigarette companies to conduct a behavioral study on the effects of electronic cigarettes on smoking behavior.

Thursday, October 09, 2014

New UK Advertising Rules for E-Cigarettes Prohibit Companies from Telling the Truth About Their Products

The UK's Committee of Advertising Practice (CAP) has announced new rules, effective on November 10, which restrict electronic cigarette advertising.

According to CAP:

"In summary, the rules state:
  • Ads must not be likely to appeal particularly to people under 18, especially by reflecting or being associated with youth culture
  • People shown using e-cigarettes or playing a significant role must neither be, nor seem to be, under 25
  • Ads must not be directed at people under 18 through the selection of media or the context in which they appear
  • Ads must not encourage non-smokers or non-nicotine users to use e-cigarettes
  • Ads must make clear that the product is an e-cigarette and not a tobacco product
Ads on TV and radio will be subject to scheduling restrictions to reduce the chance of e-cigarette advertisements being seen or heard by children. Furthermore, unless manufacturers obtain an authorisation for their product from the Medicines and Healthcare products Regulatory Agency, ads for e-cigarettes cannot convey health benefits or claim that they are ‘safer’ or ‘healthier’ than smoking tobacco."

The Rest of the Story

While many of these restrictions are reasonable, the final restriction mentioned - the prohibition on electronic cigarette companies claiming that these products are safer than tobacco cigarettes - is both inappropriate and devastating to the public health interest.

The restriction is inappropriate because it prohibits companies from simply telling consumers the truth about the relative safety of their products. Arguably, this is the single most important piece of information that every consumer needs to know. Keeping consumers in the dark about the relative safety of electronic cigarettes vs. tobacco cigarettes does not serve any public health interest. In fact, it does just the opposite.

By blocking e-cigarette companies from telling the truth to consumers, CAP has completely undermined the very purpose of electronic cigarette marketing. The only reason these products are on the market and being used extensively in the first place is that they are much safer than regular cigarettes. If they weren't safer than cigarettes, there would be no justification for these products to even remain on the market. Moreover, they would not have become so popular among smokers because no one is going to switch to a product that delivers less nicotine unless it has health benefits.

The relative safety of e-cigarettes over tobacco cigarettes is their primary selling point.

Destroying this selling point helps no one except for the UK's cigarette companies, which stand to enjoy a bigger run of profits due to CAP's stupidity.

The major purpose of regulating advertising in the first place is to prohibit companies from deceiving consumers. But by precluding companies from telling consumers the truth, the CAP's regulations actually ensure that consumers are deceived. There is no legal nor public health justification for this campaign of deception. It protects cigarette profits at the expense of the lives and health of UK citizens.

Disclosure: I have not received any funding or compensation from the tobacco, electronic cigarette, or pharmaceutical industries. However, I am seeking funding from several electronic cigarette companies to conduct a behavioral study on the effects of electronic cigarettes on smoking behavior. 

Wednesday, October 08, 2014

New York City Council Considering Ban on Flavored Electronic Cigarettes

According to an article in the New York Daily News, New York City councilman Costa Constantinides (D-Queens) yesterday introduced legislation that would ban the sale of all flavored electronic cigarettes.

According to the article: "Councilman Costa Constantinides (D-Queens) will introduce legislation Tuesday to ban the fruity flavors, saying they entice kids to start puffing on the devices. “These flavors are direct marketing to children,” Constantinides said. “They appeal to children, and we’re taking them out of that market.” ... “These guys are not in the quitting business. They’re in the addiction business,” Constantinides said."

The Rest of the Story

Actually, these "guys" are in the quitting business, not the addiction business. The overwhelming majority of electronic cigarette users are people who are already addicted to cigarette smoking. And the reason they are using these products is because they want to overcome their addiction to smoking. They want a safer product that can help them get off cigarettes, or at least to greatly reduce their cigarette consumption in order to protect their health. Very few never smokers are regular electronic cigarette users, and there is at present no evidence that the use of electronic cigarettes leads to nicotine or smoking addiction in anyone who was not already a tobacco user.

Banning the sale of flavored electronic cigarettes would be tantamount to a ban on virtually all electronic cigarettes. In reality, virtually every electronic cigarette product is flavored. Even the "tobacco" type of electronic cigarette is actually a flavored product, since flavorings are generally used to create that "tobacco" taste. Otherwise, the only ingredients in electronic cigarettes are nicotine, propylene glycol, and glycerin.

Councilman Constantinides' desire to take flavored electronic cigarettes off the market may be motivated by a legitimate desire to protect kids from addiction, but the reality is that his proposal would greatly increase smoking addiction in New York City by removing from the market a product that is helping thousands of New Yorkers to eliminate their smoking addiction or at least to greatly reduce the level of that addiction.

Jacob Sullum provides an excellent review of the literature on this topic, pointing out that there is very strong data to demonstrate that the flavors are what attract many smokers to try to quit using electronic cigarettes. You have to read his whole column, but to summarize:

"Whether or not they appeal to minors, the flavors that offend him appeal to adults who switch from smoking to vaping. In a survey conducted by E-Cigarette Forum last summer, three-quarters of adult vapers favored flavor categories other than tobacco, including fruit (31 percent), bakery/dessert (19 percent), and savory/spice (5 percent). Sales data from Palm Beach Vapors, a chain of 14 stores that sell vaping equipment and liquids to adults only, confirm that supposedly juvenile flavors are popular with adults. Last fiscal year, only two of the chain's top 19 sellers were tobacco flavors. They finished 18th and 19th, far below flavors such as strawberry, watermelon, and cinnamon."

Sullum concludes: "Critics like Constantinides and Sen. Jay Rockefeller (D-Va.), guided by little more than their own idiosyncratic tastes, want to decree which flavors adult vapers may consume, even at the cost of deterring smokers from quitting. "Studies show that e-cigarettes, particularly flavored kinds, are effective at helping smokers move away from combustible cigarettes," says Gregory Conley, president of the American Vaping Association. "The AVA supports common-sense regulation of its products, such as New York City's existing ban on [sales] to minors. But adults are free to make their own choices." For now."

Hopefully, the New York City Council will vote down this proposal. If policy makers are interested in protecting kids from electronic cigarettes, they should focus on regulating the sale and marketing of these products - just as we do with the real cigarettes. It makes no sense to ban the entire product category, especially when we know these products are helping many smokers quit or cut down and when there is no evidence that the use of these products is causing youth to become addicted to smoking, or even to e-cigarette use itself.

The saddest part of the story is that while Councilman Constantinides is so concerned about youth "addiction" that he is willing to ban electronic cigarettes, he expressed no similar desire to ban the real ones. That's not public health leadership. It's political cowardice, and hypocrisy.

Disclosure: I have not received any funding or compensation from the tobacco, electronic cigarette, or pharmaceutical industries. However, I am seeking funding from several electronic cigarette companies to conduct a behavioral study on the effects of electronic cigarettes on smoking behavior.

Thursday, October 02, 2014

Harm Reduction Debate Bringing Out the Venom on Both Sides

For several years, I have repeatedly written about how the debate over harm reduction, especially electronic cigarettes, has brought out personal attacks, distortion of the science, and even lies among a number of opponents of this novel approach to smoking cessation. Over the past several days, I have learned that there is venom on both sides of the debate, and I had a chance to experience that venom from supporters of harm reduction.

If you read the comments to yesterday's post, in which I opine that it is time for Major League Baseball to ban the use of smokeless tobacco by its players during games, you'll see that I was battered by a number of harm reduction advocates. This battering also took place on Twitter and Facebook, where further pot shots were taken.

The interesting thing is that these attacks were in response to two very simple contentions:

1. That there is a causal link between traditional smokeless tobacco use and oral cancer; and

2. That Major League Baseball should follow the lead of the minor leagues and ban the use of smokeless tobacco, such as not to set a bad example for the millions of youth who idolize these athletes and are viewing on television or at the ballpark.

The Rest of the Story

This demonstrates just how contentious harm reduction debates are, especially in tobacco control. Both sides are acting on zealous idealism, with science playing very little role.

The ironic thing is that no one actually disagreed with me on the science. Most of the advocates of smokeless tobacco acknowledged that there is a small, but real, causal relationship between traditional smokeless tobacco use and oral cancer (this relationship does not appear to hold for snus). However, simply because I made the statement that this causal link exists, I was blasted. Apparently, the simple statement that smokeless tobacco causes oral cancer is too much for many harm reduction advocates to tolerate.

As I found out when I simply proposed the rather benign, but crucial to science, idea of conducting a clinical trial to examine the effects of electronic cigarettes on smoking behavior (in comparison to the nicotine patch, a well-accepted standard), there is very little room for balanced, objective thinking in the current tobacco control/harm reduction environment. The simple proposal to conduct such a crucial study brought out personal attacks and profound criticism. This despite the fact that every single electronic cigarette company representative I talked to about the proposal felt that the study was critical and needs to be conducted. There was no opposition to conducting sound science among the electronic cigarette companies. All the opposition came from the harm reduction "community."

The impression I am left with is that the entire harm reduction debate is a toxic one, with venom on both sides, which is leading to irrational thinking, blind adherence to ideology, a focus on ad hominem attacks rather than rational scientific discourse, and a biased perspective on the scientific evidence.

This polarization is a disappointment to me, but I guess in an era where ideological-driven debates are raging over climate change, gun control, and immunization, I should not have expected this one to be any different.

I can only hope that science will be restored to its rightful place in tobacco control and public health. But right now, I am not at all optimistic.

Wednesday, October 01, 2014

Curt Schilling Announces He is a Victim of Oral Cancer from Smokeless Tobacco: Time for MLB to Ban the Stuff

This summer, former Boston Red Sox pitcher Curt Schilling announced that he had undergone treatment for oral cancer, which he clearly attributes to this 30-year history of smokeless tobacco use (he was not a smoker).

According to an article at MLB News:

"Curt Schilling said Wednesday that he believes his use of smokeless tobacco led to oral cancer that required radiation and chemotherapy. Schilling revealed the type of cancer he had while speaking on WEEI Radio during the Boston station's annual fund-raising broadcast for the Jimmy Fund. "I do believe without a doubt, unquestionably, that chewing is what gave me cancer," he said. During the broadcast, Schilling issued a warning to smokeless tobacco users. "It's like being given a death sentence without committing a crime," Schilling said. ... Schilling, who pitched in the Majors for 20 years, said that he used smokeless tobacco for 30 years and that he had been unable to kick the habit despite pain associated with it. "It's a dangerously addictive habit that I wish I had never done," Schilling said."

According to the American Cancer Society:

"Oral tobacco products (snuff or chewing tobacco) are linked with cancers of the cheek, gums, and inner surface of the lips. Using oral tobacco products for a long time poses an especially high risk. These products also cause gum disease, destruction of the bone sockets around teeth, and tooth loss. It is also important for people who have been treated for oral cavity or oropharyngeal cancer to give up any oral tobacco products."

According to the National Cancer Institute: 

"Smokeless tobacco causes oral cancer, esophageal cancer, and pancreatic cancer."

 The Rest of the Story

I think it is high time that Major League Baseball declare a ban on the use of smokeless tobacco products during all formal MLB activities (including games and practices/warmups at which the public is present). Like smoking, the use of smokeless tobacco by major league baseball players sets a bad example for the thousands of youth watching in the stadium as well as the millions who may be watching on television. Smoking is not allowed during games. Neither should smokeless tobacco use.

The use of smokeless tobacco has already been banned in minor league baseball (in 1993). Now is the time for Commissioner Bud Selig to take the next step, the right step, and ban smokeless tobacco use as well.

Saturday, September 27, 2014

Discontinuation of Crowdfunding Campaign for BSCiTS Study

It is with great regret that we announce that we are discontinuing the Behavioral Study of Cigarette and Tobacco Substitution (BSCiTS) fundraising campaign, and canceling the proposed study. For those of you who have donated to the campaign, your donations will be returned to you.

Although we officially launched the BSCiTS campaign just a week ago, our team at Boston University has invested substantial intellectual, logistical, and spiritual effort into this project for more than a year. We truly believed this campaign would be a success, and we want to extend our sincere gratitude to those from the vaping community and electronic cigarette industry who supported the development and launch of the campaign, as well as the administrative and development offices of Boston University School of Public Health.

We would like to explain our reasons for discontinuing BSCiTS.

1. Divisiveness within the e-cigarette community. The passion of the engaged, vocal members of the vaping community and e-cigarette industry is what inspired us to develop the BSCiTS project in the first place. Unfortunately, however, we discovered that there is great divisiveness within the e-cigarette community regarding the role of research—including what type of research should be done, who should do it, and who should pay for it. We welcomed feedback and suggestions about creating an optimal study design for BSCiTS, and we sought to be responsive to concerns about study methodology. However, the tone of feedback directed at our team quickly became hostile. Our integrity as researchers was questioned, and criticism quickly shifted from concerns about study methods to personal attacks.

2. BSCiTS was sparking further divisiveness. Our campaign was only public for a week, but in that short period of time it became evident it was exacerbating other, deeper fissures and ideological differences within the e-cigarette community. We were disturbed to find one organization in particular actively undermining our campaign efforts. It became apparent there is disagreement in the e-cigarette community about the need for rigorous research of the caliber that the FDA will require.

3. Initial reception from e-cigarette industry was not positive enough. Though we received much encouragement to develop and launch the BSCiTS campaign, the response from industry to our funding appeal was lukewarm. We are not confident that BSCiTS could receive enough financial support from independent e-cigarette companies to fund a rigorous study design.

4. Pressure to compromise study objectivity. Finally, and most importantly, we received pressure from a major e-cigarette advocacy group to alter our proposed study design in order to produce a more positive outcome. Attempting to exert influence on independent researchers to produce more favorable results is deeply unethical and extremely problematic. Moreover, this is hypocritical given the e-cigarette community’s rejection of biased research studies produced by tobacco companies and public health professionals alike. We are unwilling to compromise our scientific integrity in order to conduct a study on behalf of the e-cigarette community. We came to realize that the current climate within the e-cigarette community is not conducive to conducting objective behavioral research at the level of rigor upon which we insist. Ultimately, we have to place our own scientific integrity ahead of the desire to successfully secure research funding. 

It is a sad day for us. We want to reiterate how much we appreciate those in the e-cigarette community—from individual vapers to entire companies—who believed in BSCiTS. Your encouragement and support has been incredibly meaningful. 

Yours sincerely, 
Michael Siegel, MD MPH and Sarah Roberts, MPH

Thursday, September 25, 2014

CDC Rejoices that Fewer Smokers are Trying to Quit

According to new data published by the CDC in the journal Nicotine & Tobacco Research, the trend of increasing use of electronic cigarettes among adult smokers halted in 2013.

According to an article by the AP's Mike Stobbe, "The proportion of adults who have ever used e-cigarettes rose from about 3 percent to 8 percent from 2010 to 2012. But there was no significant change last year, according to the Centers for Disease Control and Prevention study."

These data are consistent with financial analyst reports showing that there has been a decline in the sales of traditional cig-a-like type electronic cigarettes in retail stores.

According to multiple news articles, the CDC responded to this news by "rejoicing": that is, the agency expressed happiness that the use of electronic cigarettes by smokers is declining or leveling off.

According to the AP article: "[CDC lead author Brian King] called the leveling off in adults who have ever tried e-cigarettes "a positive note."

The Rest of the Story

A positive note? Are you serious?

The CDC is actually stating that the finding that fewer smokers are trying to quit smoking by switching to e-cigarettes is a good thing.

In other words, the CDC is happy that the combustible tobacco market is regaining strength compared to the non-combustible market. The CDC is happy that cigarette sales are facing less and less competition from the fake, but much safer cigarettes that greatly reduce a smoker's health risks, even if the person does not quit smoking completely, but greatly reduces his or her cigarette consumption.

That financial analysts had predicted that e-cigarette use might overtake smoking in the next decade would have been great news. In fact, it would have been a public health miracle - one of the greatest public health victories of our lifetime. The fact that this is apparently not going to occur is not good news, it is a tragedy.

That the CDC is rejoicing in the protection of the combustible tobacco market from competition from much safer electronic cigarettes is also tragic. Because it shows that the nation's lead prevention agency has completely lost sight of its public health mission. Instead, the CDC seems committed to an ideological mission of demonizing electronic cigarettes because they "look like" tobacco cigarettes and apparently, cannot condone the use of a product which looks like a cigarette, even if it may be saving the life of the individual using the product.

This is particularly sad for me to see, because I used to work at the Office on Smoking on Health at CDC, and at the time I worked there, we worked endlessly to promote and encourage smoking cessation attempts. To rejoice because fewer smokers are trying to quit smoking using e-cigarettes is a tragic turn of events.

Monday, September 22, 2014

New Study Claims to Have Found that E-Cigarettes are Unhelpful in Smoking Cessation among Cancer Patients

A new study published online ahead of print in the journal Cancer reports that e-cigarettes are not helpful for smoking cessation among patients with cancer.

(See: Borderud SP, Li Y, Burkhalter JE, Sheffer CE, Ostroff JS. Electronic cigarette use among cancer patients: Characteristics of e-cigarette users and their smoking cessation outcomes. Cancer. Published online ahead of print on September 22, 2014. doi: 10.1002/cncr.28810.)

The study enrolled 1,074 patients with cancer who were smokers and were therefore referred to a tobacco treatment program at a comprehensive cancer center during the years 2012 and 2013. Smoking status, nicotine dependence, and e-cigarette use was assessed at baseline and the patients were followed for six-month. The primary outcome was smoking cessation, measured as seven-day abstinence at follow-up.

The researchers reported that patients who used e-cigarettes were no more likely to have quit smoking at follow-up than patients who did not use e-cigarettes.

The study concludes that e-cigarettes are not helpful for smoking cessation among cancer patients.

The press release announcing the study results is titled "E-Cigarettes Unhelpful in Smoking Cessation among Cancer Patients."

These results were widely publicized in the media, with negative headlines such as: "E-Cigarettes Don't Help Cancer Patients Quit Smoking."

The Rest of the Story

It is easy to see why this methodology is inappropriate to assess smoking cessation rates among smokers who use e-cigarettes in an attempt to quit smoking.

Suppose that there are 1000 e-cigarette users who enter the cancer center with a diagnosis of cancer. Of these, an amazing 900 were able to quit smoking. However, 100 were very resistant smokers and could not quit smoking, even with e-cigarettes. Note that it would be these 100 resistant smokers who would be enrolled in the study. The 900 ex-smokers who quit using e-cigarettes would not be eligible for the study, because they no longer smoke.

Now, if those 100 resistant smokers were then followed for six months, we would expect that very few of them would quit smoking because all of them had already tried e-cigarettes and failed.

In other words, the blatant flaw in this study is that it enrolled smokers who had already made quit attempts using e-cigarettes in the past. By definition, this resulted in a sample of smokers who were more resistant to quitting. One would expect to find lower quitting rates among this population of e-cigarette users.

To be valid, the study needs to examine e-cigarette smokers who have not tried these products before and are trying them for the first time in an attempt to quit smoking. Otherwise, the study cannot truly claim to draw conclusions about how helpful e-cigarettes are for smoking cessation among cancer patients.

These flaws are also noted by Dr. Robert West, director of tobacco research at University College London, who pointed out that: "the study was not able to assess whether or not for cancer patients who smoke using an e-cigarette to try and quit is beneficial "because the sample could consist of e-cigarette users who had already failed in a quit attempt, so all those who would have succeeded already would be ruled out"."

Peter Hajek, director of the Tobacco Dependence Research Unit at Queen Mary, University of London, also noted this critical flaw in the study: ""The authors followed up smokers who tried e-cigarettes but did not stop smoking, and excluded smokers who tried e-cigarettes and stopped smoking," he said. "Like smokers who fail with any method, these were highly dependent smokers who found quitting difficult. The authors concluded that e-cigarette (use) was not helpful, but that would be true for any treatment however effective if only treatment failures were evaluated."

Once again, shoddy research by opponents of electronic cigarettes has led to a situation where false conclusions are being disseminated widely to the media and the public. Most unfortunately, damage is being done to the public's health because news headlines like this are likely to dissuade many smokers from trying to quit using e-cigarettes. Of course, this means they will continue smoking the toxic real ones.

It's not clear to me why researchers who oppose electronic cigarettes are so anxious to condemn these products that they are willing to use inappropriate research designs to fulfill such an aim.

Sunday, September 21, 2014

Rest of the Story Announces Fund-Raising Campaign for Research on Effectiveness of Electronic Cigarettes

As we've discussed here for the past several months, there’s a great debate about electronic cigarettes right now, involving consumers, public health officials, scientists, and doctors. The basic question is this—Do e-cigarettes help people fight their addiction to cigarettes, or do they actually make it more difficult for smokers to cut back or quit?

For the past 25 years, I have conducted nearly 100 published studies about smoking, and as both a researcher and a physician, I have struggled to find effective ways to help smokers fight this powerful addiction. Along comes a product that—for the first time—might be able to help smokers overcome their biological addiction to nicotine, but also address their psychological addiction to the act of smoking.

How has the public health community reacted to e-cigarettes? As you would expect, opinions differ. Some public health officials have gone so far as to call for a complete ban on these products, but other experts believe that e-cigarettes should be embraced as a method to help smokers cut back or quit. Unfortunately, as it stands now, we don’t have the data we need to determine the changes in smoking behavior that result from the use of electronic cigarettes.

The FDA has proposed “deeming regulations” which would require virtually every electronic cigarette on the market to file an application demonstrating that product’s benefit to the public health. To be clear, with these regulations in place, every one of these applications will require data that demonstrates the effects of e-cigarettes on smoking behavior. Many independent e-cigarette companies cannot afford to conduct this research on their own—but we are confident that, if the e-cigarette community will join forces, we can raise enough money to conduct a rigorous study that will provide the data that the FDA needs

That's why today, I am announcing the start of a fund-raising campaign to help us conduct what we hope will be the most rigorous research conducted to date on the effect of e-cigarettes on smoking behavior. The research is called BSCiTS (The Behavioral Study of Cigarette and Tobacco Substitution).

In BSCiTS, we hope to conduct a six-month, randomized study that looks at changes in smoking behavior over time when smokers who wish to quit or cut down are offered a free, ten-week supply of either nicotine patches or electronic cigarettes.

While two trials have been conducted in other countries, none have yet been reported in the U.S. However, we believe that the FDA will require research from the U.S. in the new product applications.

Three things make this study different from prior research conducted in other countries. First, we will be working with smokers who actually want to cut back or quit. Second, we will be testing the most up-to-date e-cigarette products on the market. Third, our study - if funded a the desired level - will involve the largest sample of smokers to date, making it the most rigorous and scientifically important study yet conducted.

There are two important disclaimers. First, our research team reserves the right to alter the scope of the proposed research project to keep it in line with the funds raised. This might mean reducing how many smokers can be enrolled in the study, or how long we can follow them over time. Alternatively, if the funds we raise are insufficient, we might choose to conduct a survey study to answer these questions. Whatever the case, the purpose of our research will remain the same: to examine changes in smoking behavior associated with the use of electronic cigarettes, in comparison to the nicotine patch.

Second, we are unable to accept donations from tobacco companies or electronic cigarettes companies that are owned or affiliated with tobacco companies.

We need your help to accomplish this. By donating to this study, you will have a direct impact on one of the most critical public health questions of our time.  Let’s put an end to the debate about e-cigarettes and find out, once and for all, exactly how they impact the behavior of smokers.

To donate to this research, please see our BSCiTS web site

All donations are considered gifts to Boston University and are tax-deductible.

Thursday, September 18, 2014

New Data from the UK Show that Despite Dramatic E-Cigarette Experimentation among Youth, There are Few Regular Users and Very Few Nonsmoking Regular Users

Data released yesterday by Action on Smoking and Health (UK) show that although electronic cigarette use is widespread and increasing among youth, it has not resulted in regular use among a substantial proportion of youth and among nonsmokers, there are very few regular users.

Specifically, the survey of 2,000 11-18 year-olds in 2014 found that:

"Only 1.8% of children are regular users; 90% of regular or occasional users are young people who are already smokers or ex-smokers; 91% of young people have not tried an electronic cigarette even once; and this is despite the fact that over 80% of young people are now aware of e-cigarettes (up from under 70% in 2013)."

Overall, ASH reported that "98% of children who have never smoked have never even tried an electronic cigarette."

The Rest of the Story

This study confirms that in the UK, despite substantial experimentation with e-cigarettes by youth, this experimentation does not appear to be leading to regular e-cigarette use by a large proportion of youth, and those who are regular users are overwhelmingly youth who are already smokers or who smoked in the past.

In other words, there appears to be strong evidence that in the UK, electronic cigarette use is not serving as a gateway by which nonsmokers are becoming addicted to nicotine and then progressing to real cigarette smoking.

These data cast further doubt on the statements made by CDC officials and a number of tobacco control researchers, who have publicly concluded that e-cigarettes are a gateway to smoking.

Unquestionably, there is still the need to regulate the sale and marketing of electronic cigarettes to minors. Sadly, and ironically, the only ones who seem to oppose laws to ban the sale of e-cigarettes to minors are the supposedly "anti-smoking" groups.

Similar data from the U.S. would be very helpful. But unlike prior reports, these ones should quantify not only experimentation, but also regular use, stratified by prior status as smokers versus nonsmokers.

Wednesday, September 17, 2014

Anti-Smoking Groups Reveal Real Reason they Opposed Ban on E-Cig Sales to Minors: Money and Protection of Cigarette Sales

Last week, the Missouri legislature overturned a veto by Governor Jay Nixon of a bill to ban the sale of electronic cigarettes to minors. Ironically, the bill was vigorously opposed by anti-smoking groups, including Tobacco-Free Missouri and the American Cancer Society and American Heart Association.

The bill is quite simple. It classifies electronic cigarettes as a non-tobacco product and bans the sale of these products to minors.

The health groups opposed this legislation because it classified electronic cigarettes separately from real cigarettes and they wanted the two products classified exactly the same.

Today, I reveal the true reasons behind the anti-smoking groups' ironic position on this legislation. After all, why would they oppose a law to ban the sale of e-cigarettes to minors?

The Rest of the Story

The rest of the story was revealed in an article at the KCUR web site:

"“It was operating under the guise of protecting youth, but really it just created a special carve-out for a special interest,” says Traci Kennedy, executive director of Tobacco-Free Missouri. Tobacco-Free Missouri opposed the law, along with the American Cancer Society, the American Heart Association and other health groups. While the law doesn’t plainly forbid regulation of e-cigarettes, these groups point out that, by defining e-cigarettes as not tobacco, it keeps them from being subject to the same taxes and health-requirements as traditional cigarettes."

In other words, there are two reasons why the anti-smoking groups opposed this law:

1. Money

The anti-smoking groups opposed the law because they want to see electronic cigarettes taxed, just as tobacco products are taxed. Anti-smoking groups receive a considerable amount of money from tobacco tax revenue so it is not surprising that these groups would want to see heavy taxes imposed on electronic cigarettes. This is a ludicrous position from a public health perspective, however. Why would we want to give cigarettes even more of a competitive advantage in the marketplace by reducing the cost advantage to the fake cigarettes? The only one protected by such a move is Big Tobacco and their cigarette profits. Which leads us to the second reason for the anti-smoking groups' opposition to the bill.

2. Protecting Cigarette Sales

Ironically, what the anti-smoking groups are promoting is the protection of cigarette sales from competition from electronic cigarettes. They are concerned about e-cigarettes escaping from the "health requirements" to which traditional cigarettes are subject. But what health requirements are there for traditional cigarettes? Maybe I need to be educated by Tobacco-Free Missouri, but the most recent data I've seen show that those tobacco cigarettes are killing more than 400,000 people each year in the United States. And I'm not aware of any meaningful health requirements for these products. 

What Tobacco-Free Missouri and its allies are saying is that they do not want electronic cigarettes to enjoy any competitive advantage in the marketplace. Essentially, these anti-smoking groups are acting in a way to protect cigarette sales from competition. God forbid that there remain a cost incentive for smokers to switch to electronic cigarettes and quit smoking. God forbid that there is a public perception that e-cigarettes are much safer than real cigarettes and that smokers therefore quit smoking and switch to vaping.

The only one I would expect to take the position of the Missouri anti-smoking groups is Big Tobacco itself, because the cigarette companies have a financial incentive to protect their cigarette profits. But ironically, even Big Tobacco supports this ban on the sale of e-cigarettes to minors. Even Big Tobacco is not trying to protect its own cigarettes from competition from e-cigarettes.

It is shameful that anti-smoking groups in Missouri are willing to sacrifice the health of Missouri children because they want to stifle competition against cigarettes.

Tuesday, September 16, 2014

UK Professor and Government Health Adviser - An E-Cigarette Opponent - Steps Down After Crude Verbal Attacks on Vapers

Up until two days ago, Professor John Ashton was president of the Faculty of Public Health, an independent health advisory body which provides public health recommendations to health ministers and other UK government officials.

The Faculty of Public Health has been a strong opponent of e-cigarettes in the UK. In its policy statement, it recommends a complete ban on e-cigarette advertising. It also asserts that the tobacco industry is using e-cigarettes to promote cigarette smoking, that electronic cigarettes may be a gateway to smoking among youth, and that there is no solid evidence that e-cigarettes can help smokers quit. This despite its acknowledgment that there is no evidence for a gateway effect and that there is evidence that e-cigarettes are as effective as NRT for smoking cessation.

But today, I report that opponents of electronic cigarettes are using more backhanded tactics than simply drawing unsupported scientific conclusions or distorting the science to support its preconceived position.

The Rest of the Story

Apparently, some opponents of electronic cigarettes are so guided by a strong ideology against anyone who does anything that looks like smoking that their real attitudes surface in a seeming hatred of vapers. This was the case with the president of the Faculty of Public Health.

Recently, Professor Ashton went on what the Daily Mail called "a venomous spat" on Twitter. He made a number of rude and offensive comments about individual vapers, which cannot be repeated here. For details, see the Daily Mail article or this summary of the story.

I believe that this story reveals the venom that many e-cigarette opponents have for the act of smoking and anything that looks like it. And that ideological venom is what is keeping them from forming opinions based on the actual scientific evidence. Professor Ashton's apparent hatred for vapers can only be rooted in an ideology that despises the physical act of smoking, regardless of whether what is being "smoked" contains tobacco or not or whether the behavior is killing the person or perhaps saving his life. In other words, this is a great example to demonstrate the way in which ideology, not science or public health, guides the opinions and statements of many electronic cigarette opponents.

One might argue that this is just one errant professor. However, as it acknowledges on its web site:

"The Faculty of Public Health is the standard setting body for specialists in public health in the United Kingdom. The Faculty of Public Health is a joint faculty of the three Royal Colleges of Physicians of the United Kingdom (London, Edinburgh and Glasgow) and also a member of the World Federation of Public Health Associations. The Faculty of Public Health is an independently constituted body with its own membership and governance structure. The Faculty of Public Health is the professional home for more than 3,300 professionals working in public health. Our members come from a diverse range of professional backgrounds (including clinical, academic, policy) and are employed in a variety of settings, usually working at a strategic or specialist level. The Faculty of Public Health is a strategic organisation and, as such, works collaboratively, drawing on the specialist skills, knowledge and experience of our members as well as building relationships with a wide range of external organisations."

Thus, this is not just some fringe professor. This is the (former) head of a prestigious public health body that gave advice to the ministers on the electronic cigarette issue and whose advice was seriously considered in formulating e-cigarette policy in the UK.