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.

Monday, September 15, 2014

“Stand Up To Cancer” Not Standing Up to Cigarette Promoters; Special Guest Commentary by Dr. Alan Blum

Tuscaloosa, AL, September 4, 2014--Several of the sponsors of this Friday’s “Stand Up To Cancer” national fundraising telethon are doing more to promote cigarette companies than to prevent or cure cancer, according to an analysis of the organization behind the event by a physician and veteran anti-cancer advocate at The University of Alabama.

“This effort to solicit money for cancer research is compromised by the inclusion of corporations and foundations closely allied with the manufacturers of cigarettes, the nation’s leading avoidable cause of cancer,” said Alan Blum, MD, professor of Family Medicine and Director of The University of Alabama Center for the Study of Tobacco and Society. “The National Cancer Institute attributes 40 percent of premature deaths from cancer to cigarette smoking,” noted Dr. Blum, “so a minimum standard for standing up to cancer ought to be not aiding and abetting the number one cause of cancer.”

SIEMENS, a multinational engineering and electronics corporation that has cultivated an image as a medical equipment and health-care company in advertisements in major magazines and newspapers (with headlines such as “More health care stories with happier endings”), is also a leading manufacturer of cigarette-making machinery and barcode tracking technology for improved efficiency of cigarette distribution. Among SIEMENS’s customers is Philip Morris USA, maker of the best-selling cigarette brand Marlboro. 

According to SIEMENS’s website, the company’s “Tobacco segment includes machines for the manufacturing and packaging of cigarettes at speeds of 4,000 to 20,000 cigarettes per minute,” and its “Simotion Motion Control System is now gaining a foothold in the cigarette manufacturing industry.” Thus, a single such SIEMENS machine could produce 1.2 million cigarettes (or 60,000 packs) during the Stand Up To Cancer telecast, Blum said. SIEMENS is listed as one of the event’s “Champions.”

The Safeway Foundation, a Hero level Partner of Stand Up To Cancer, is funded by Safeway, Inc, which was the third-largest supermarket chain in the United States until its acquisition in July by Albertsons. (The company is now the second-largest in the United States.) In contrast to Wegmans, Target, CVS and other retail chains that have ended the sale of tobacco products, Safeway continues to sell cigarettes in its more than 1,330 stores. The company’s slogan is “Ingredients for life. Creating better lives, vibrant neighborhoods, and a healthier planet.” A carton of Marlboro cigarettes sells for $70 at the company’s stores in Portland, Oregon.

Another Champion level Partner of Stand Up To Cancer is the Steve Tisch Foundation. A significant part of the Tisch family fortune was derived from the manufacture and sale of cigarettes. Between 1967 and 2008, the Tisch family-run Loews’ Corporation controlled the nation’s third leading cigarette manufacturer, Lorillard. The company, which is about to merge with the number two cigarette maker Reynolds-American, produces Newport, the nation’s top-selling menthol brand and the leading cigarette smoked by African-Americans, who experience a higher prevalence of lung cancer than the overall population, Blum said. In 1994 at a U.S. House of Representatives hearing on cigarettes, Lorillard chief executive officer Andrew Tisch (first cousin of Steve Tisch) famously testified under oath that he did not believe either that nicotine is addictive or that cigarette smoking causes lung cancer.

Four of the eight Publishing Partners of Stand Up To Cancer own mass circulation magazines that advertise cigarettes in almost every issue, long after most publications have turned down such advertisements as contrary to the health of their readers, Blum said.

The August 18, 2014, College Football Preview issue of TIME, Inc.’s Sports Illustrated includes an advertisement for Stand Up To Cancer, with this text: “When we all come together cancer doesn’t stand a chance.” Also in the issue are four color cigarette ads—three for Reynolds-American’s Camel brand (one of which reads “Passionate. Inspired. Original. Taste It All” and another that boasts “It starts with a spark, and the promise to fan the flames.”), and one for Newport promoting a “Wheel of pleasure” sweepstakes with “Hundreds of fantastic prizes waiting to be won,” including a 2015 Ford Mustang. A fifth ad is for Lorillard’s blu electronic cigarette. In its 60-year history, Sports Illustrated has rarely, if ever, published an article on the harmfulness of cigarette smoking or the athletes who have died from smoking, Blum said. A report last month in Gawker alleged that the media corporation rates its journalists for their friendliness to advertisers and included an internal TIME, Inc. document obtained by the Newspaper Guild with this ranking criterion for reporters: “Produces content that [is] beneficial to advertiser relationship." (http://gawker.com/time-inc-rates-writers-on-how-beneficial-they-are-to-1623253026.)

The current September issue of TIME features a prominent ad for Reynolds-American’s American Spirit “organic tobacco and organic menthol” cigarette brand that touts “100 percent Additive-Free Natural Tobacco” above this Food and Drug Administration-required sentence in smaller type: “Organic tobacco does NOT mean a safer cigarette.” Entertainment Weekly and People are two of TIME, Inc.’s well known magazines that run cigarette ads. Information on the revenue TIME, Inc. receives from cigarette advertising is not publicly available.

In the latest September issues of WIRED and Vanity Fair, published by Stand Up To Cancer Publishing Partner Conde Nast, the same ad for the event appears, as well as a nearly identical Camel cigarette ad (“Inspired. Passionate. Original. Taste It All.”) Other Conde Nast magazines that accept cigarette ads include Vogue, Glamour and GQ.

Mass circulation magazines with cigarette ads published by Stand Up To Cancer Publishing Partner American Media, Inc. include Playboy and The National Enquirer. The popular women’s periodical Cosmopolitan, which accepts cigarette advertising, is published by Hearst Magazines, another Stand Up To Cancer Publishing Partner.

In its three previous telethons, Stand Up To Cancer has raised more than a quarter of a billion dollars for cancer research. Dr. Blum noted that 2014 marks the 50th anniversary of the landmark U.S. Surgeon General’s Report on Smoking and Health, which confirmed the causal link between cigarette smoking and lung cancer. “It is shameful,” Blum said, “that after decades of efforts to end the leading cause of cancer, the organizers of this cause would welcome the participation of manufacturers, promoters and sellers of cigarettes.”

ABOUT DR. BLUM: As editor of the Medical Journal of Australia and the New York State Journal of Medicine in the 1980s, Dr. Blum published the first analysis of tobacco industry sponsorship of sports and the arts around the world, as well as a report revealing U.S. tobacco industry subsidiaries and suppliers in all 50 states. In the 1990s, he and the 5,000-physician member health advocacy organization he founded, DOC (Doctors Ought to Care [1977-2002]), published the results of two investigations of tobacco industry influence. “Sick Bedfellows” listed 10 major pharmaceutical and health-related companies with longstanding business ties to cigarette manufacturers. “Healthcare Hypocrites” revealed that more than 20 board members of tobacco companies were simultaneously serving on the boards of health care institutions, medical schools, or health insurance companies. In conjunction with the Interfaith Center for Corporate Responsibility, DOC helped get corporations such as Kodak, Kimberly-Clark and 3M to end their business relationships with the tobacco industry.

ABOUT THE CENTER: The Center for the Study of Tobacco and Society at The University of Alabama holds the most comprehensive collection on the tobacco industry and the antismoking movement. The Center’s most recent exhibition, to commemorate the 50th anniversary of the U.S. Surgeon General’s Report, “The Surgeon General vs. The Marlboro Man: Who Really Won?” was on view this year at the Lyndon Baines Johnson Presidential Library and the Texas Medical Center Library in Houston after debuting at the Gorgas Library of The University of Alabama. The Center’s latest film, “Blowing Smoke: The Lost Legacy of the Surgeon General’s Report” is available free online at https://docs.google.com/file/d/0B1j5VTNHmZZmcFJWLW1wbDF3Mms/

See also the following media coverage of this issue:

The Cancer Letter, Matthew Ong, September 12, 2014:
"Tobacco Interests Contribute a Portion of the $109 Million Raised by SU2C"

Knight Science Journalism Tracker, Paul Raeburn, September 12, 2014 "'Stand Up To Cancer' didn't stand up to tobacco"

al.com, Alan Blum, MD, September 9, 2014:
"'Stand Up To Cancer' Not Standing Up to Cigarette Promoters":

Thursday, September 11, 2014

Columbia Scientists Claim that E-Cigarettes May Be Gateway to Illicit Drug Use and Addiction

According to a press release issued by Columbia University Medical Center, a team of researchers from Columbia University have concluded that electronic cigarettes may serve as a gateway not only to cigarette smoking, but also to illicit drug use and addiction, such as cocaine addiction.

According to the press release: "Like conventional cigarettes, electronic cigarettes (or e-cigarettes) may function as a “gateway drug”—a drug that lowers the threshold for addiction to other substances, such as marijuana and cocaine—according to the 120th Shattuck lecture, presented to the Massachusetts Medical Society by Columbia researchers Denise and Eric Kandel and published today in the online edition of the New England Journal of Medicine." ...

"In the lecture, the Kandels review Denise Kandel’s earlier work on the gateway hypothesis and on the role of nicotine as a gateway drug, reported in a Science paper in 1975. They also review subsequent studies in which they tested the gateway hypothesis experimentally in a mouse model. In those studies, conducted in collaboration with Amir Levine, Yan You Huang, Bettina Drisaldi, Edmund A Griffin, and others at CUMC, they found that when mice are exposed to nicotine, it alters their brain biochemically and induces activation of a reward-related gene. As a result, nicotine primes the animals’ subsequent response to cocaine, providing a molecular basis for nicotine as a gateway drug for cocaine. Dr. Denise Kandel’s further analysis of 2004 epidemiologic data from a large, longitudinal sample suggested that nicotine also primes human brains to respond to cocaine." ...

"“E-cigarettes have the same physiological effects on the brain and may pose the same risk of addiction to other drugs as regular cigarettes, especially in adolescence during a critical period of brain development. ... Nicotine clearly acts as a gateway drug on the brain, and this effect is likely to occur whether the exposure comes from smoking cigarettes, passive tobacco smoke, or e-cigarettes.” ... “The effects we saw in adult mice are probably even stronger in adolescent animals,” said Dr. Eric Kandel. “E-cigarettes may be a gateway to both combustible cigarettes and illicit drugs.”"

The Rest of the Story

There is no justification for drawing this sweeping conclusion based solely on studies of mouse brains, without a shred of clinical or epidemiologic evidence that suggests e-cigarettes serve as a gateway to smoking or illicit drug addiction. And I think it is inappropriate to engage in this kind of scaremongering.

This story further illustrates the depths to which electronic cigarette opponents are sinking. They cannot defend their opposition to e-cigarettes based on actual sound scientific research or reasoning. Thus, they have to either twist and distort the science or grossly extrapolate from studies that actually have little relevance to the clinical situation at hand.

Wednesday, September 10, 2014

Everyone Agrees: FDA Should Eliminate Pre-Market Review for Electronic Cigarettes, At Least Until Effective Date of Regulations

In three separate sets of comments submitted to the FDA regarding the proposed deeming regulations, three major players in the e-cigarette space have offered the identical piece of advice for the agency:

Do not apply pre-market review requirements for electronic cigarettes, at least until the effective date of the final regulations.

Here is what each of the three companies/associations had to say regarding this issue in their submitted comments:

1. Altria Client Services (on behalf of Nu Mark): "Nothing in the FSPTCA [Family Smoking Prevention and Tobacco Control Act] requires FDA to engage in all-or-nothing deeming for all purposes. Rather than deem an entire class of tobacco products categorically subject to the FSPTCA for all purposes, FDA has multiple options for proceeding in a reasoned, scientifically sound, and incremental manner. For example, FDA should exercise its statutory authority to deem e-vapor products commercially marketed before the Final Rule for certain purposes under the FSPTCA. Such products would be subject to age restrictions, warning labels, and disclosure requirements, without subjecting them to premarket authorization. Only those e-vapor products commercially marketed after issuance of the Final Rule would be subject to ... premarket authorization."

2. Lorillard: "FDA should exercise enforcement discretion not to require premarket review of electronic cigarettes introduced into United States commerce on or before the effective date of the final deeming regulation.

3. American E-Liquid Manufacturing Standards Association: "FDA should use the effective date of the final rule for the Deeming Regulations as the new "Grandfather Date" for e-cigarettes and e-liquid products and model the substantial equivalence requirements for these products based on the Section 510(k) pathway for medical devices."

The Rest of the Story

All three of these entities have offered common sense advice with which I wholeheartedly agree. In fact, this advice may be the single most important change that I recommend in the proposed deeming regulations.

As currently proposed, the deeming regulations will require virtually every e-cigarette product on the market to submit a pre-market review application, in which the company must demonstrate that the introduction of the product into the market is beneficial for the public's health. The data required to demonstrate this is complex, as it requires a consideration of not only the benefits of the product to intended users (adult smokers), but also the consequences of the product's availability in the market to others, such as nonsmokers and youth. The complexity and burden of this requirement makes it unfeasible for most e-cigarette companies, which are small and do not have adequate resources for such an undertaking. The result would be to pull tens of thousands of products from the market and constrict the market severely. In addition, it would create an absolute bureaucratic, nightmarish mess.

Instead, as Altria Client Services, Lorillard, and AEMSA have all recommended, the FDA should scrap the requirement for pre-market review of electronic cigarettes, at least until the effective date of the final regulations. After that time, applications for new products would be required, unless they could show substantial equivalence compared to a product already on the market (as of the final regulation effective date).

Actually, I would go one step further. I don't see a need for pre-market review of new electronic cigarette products, as it is the older ones which pose the most concern and the product quality has improved with innovation and time. Moreover, such requirements would stifle innovation. Instead, if I were the FDA, I would simply establish a set of safety standards that all products must meet. These standards would address issues such as battery safety, quality of ingredients used, type of ingredients used, temperature regulation, quality and safety of metal parts, and child-safety of packaging.

Tuesday, September 09, 2014

A Policy Supporting Death: European Respiratory Society Would Rather that Smokers Die than Switch to Electronic Cigarettes

According to a published research article and a European Lung Foundation press release, the European Respiratory Society is opposed to the use of e-cigarettes in any setting in which they are unregulated (which currently includes the United States and most countries).

According to the press release: "The ERS agrees with the recent report from the World Health Organization (WHO) and is opposed to the use of unregulated e-cigarettes. While the short-term negative impact on health appears not as great as tobacco cigarettes, the long-term effects of e-cigarettes are not known. As a Society grounded in scientific principles, ERS believes that the precautionary principle should be applied when scientific evidence is inconclusive and insufficient."

The Rest of the Story

What does it mean to be "opposed" to the use of unregulated e-cigarettes? It means that the European Respiratory Society is opposed to the use of e-cigarettes in any setting in which they are unregulated, such as the current situation throughout most of the world, including in the United States.

The European Respiratory Society, then, is opposed to the use of e-cigarettes at the present time in the United States. What this means is that the ERS would rather see smokers continue to use tobacco cigarettes than quit smoking by switching to electronic cigarettes.

Importantly, the ERS did not qualify its statement. It did not state that it is opposed to the use of e-cigarettes by smokers who may be able to quit without them. It did not state that it is opposed to the use of e-cigarettes except among smokers who cannot quit without them. It simply stated its blanket opposition to any and all use of electronic cigarettes by smokers.

This is a disastrous and irresponsible public position.

What it means is that the ERS would rather that a smoker who cannot quit using other means continue smoking than switch to electronic cigarettes. The ERS clearly states that it opposes the use of electronic cigarettes, period. Thus, it implies that it opposes the use of electronic cigarettes by a smoker who is unable to quit via any other smoking cessation method. For such an individual, the ERS statement implies that it would actually prefer the smoker to continue smoking than to quit via the use of electronic cigarettes.

This story is particularly alarming, because it shows that for some anti-smoking groups, it really is no longer about health. It is solely about ideology. And apparently, the European Respiratory Society will cling to its precautionary ideology while smokers go to their graves.

Monday, September 08, 2014

Fascinating Op-Ed in Richmond Times-Dispatch Reveals that Lack of Current E-Cigarette Regulation is the Fault of Anti-Smoking Groups

Revealing an all-but-forgotten piece of legislative and political history, Drs. Alan Blum and Amy Muhlberg provide the "rest of the story" regarding the FDA's failure to regulate electronic cigarettes for the past five years, leading to its inability to develop a sound, coherent, and informed approach to maximizing the benefits while minimizing the risks of these innovative products. Their insightful comments appear in an op-ed piece published in Saturday's Richmond Times-Dispatch.

Drs. Blum and Muhlberg reveal this fascinating piece of history regarding the development of the 2009 Family Smoking Prevention and Tobacco Control Act:

"By 2009, it wasn’t clear if e-cigarettes met the bill’s definition of tobacco products. There were differing opinions among e-cigarette manufacturers about how to proceed, but there was consensus that if e-cigarettes had to be regulated by the FDA, it would be better to be considered a tobacco product than a medical product."

"During the Senate committee debate on the bill, Republican members offered for consideration language that would grant the FDA authority to regulate e-cigarettes as tobacco products and restrict the agency from regulating them as medical products. But the sponsors of the bill and the FDA leadership under the new administration wanted the option to use the FDA’s medical product regulatory authority, so they were not open to including “regulate once but not twice” language. The amendment was withdrawn." ...

"If the FDA had been willing to agree in 2009 that they were tobacco products and not medical products, the agency would have had vast authority over e-cigarettes. For the past five years, the FDA could have acted against adulterated or misbranded products, required manufacturer registration and ingredient-reporting, and inspected manufacturers, among other actions. It’s impossible to know how much ground was lost because of the FDA’s overreaching position that e-cigarettes were possibly medical products."

The Rest of the Story

It is interesting to find out that the "wild, wild West" that anti-smoking groups have complained so much about (i.e., the lack of current regulation of e-cigarettes because they fall into the cracks of the FDA Tobacco Act) is actually their own fault. Had these groups pressured the sponsors of the Tobacco Act to regulate e-cigarettes as tobacco products back in 2009, these products would have been introduced to the U.S. market under a regulated framework, in which, at very least, the FDA would have been able to inform itself about the products by collecting key information, such as ingredients and basic quality control information.

Instead, we are now faced with the "deeming regulations," a disastrous proposal under which most of the existing e-cigarette market may be destroyed and the market essentially handed over to Big Tobacco, which are the only companies large enough to successfully complete the new product applications which will be required for every single e-cigarette product on the market.

This is yet another example of the anti-smoking groups bemoaning a situation for which they are actually responsible. For example, the anti-smoking groups have complained about the menthol loophole, but it was the Campaign for Tobacco-Free Kids and friends which insisted upon this loophole in the first place. The anti-smoking groups complained about the introduction of Marlboro No. 54, but again, it was the Campaign and its friends that made this introduction possible by exempting menthol as the only characterizing flavor allowed in cigarettes.

Now, thanks to Drs. Blum and Muhlberg, we find out that all the complaining by the anti-smoking groups about the "wild, wild West" of e-cigarette marketing in an unregulated environment is bogus, as these groups failed to insist on an amendment which would have regulated e-cigarettes as tobacco products. Instead, these groups - back in 2009 - were actually fighting to get e-cigarettes off the market entirely. Regulating them as tobacco products would have meant institutionalizing their entrance and penetration into the market. It would have risked having these safer products compete with much more hazardous products like regular tobacco cigarettes. And that, by the reasoning of Tobacco-Free Kids and Friends, would have been a disaster.

You see, the goal of the Tobacco Act was not to save lives, but to gain a political victory for the anti-smoking groups. The goal was to put a feather in the cap of the anti-smoking groups' national leaders, rather than to establish a rational, science-based policy designed to reduce cigarette smoking, make cigarettes safer, and promote the public's health.