Tuesday, June 30, 2015

Why are So Many Anti-Tobacco Groups and Advocates Throwing Vapers Under the Bus?

There is no evidence that electronic cigarettes are a gateway to smoking, that they are attracting nonsmokers to become regular vapers, or that they are impeding smoking cessation. Nevertheless, even if all three of these were the case, one thing would remain true: smokers who succeed in quitting smoking by switching to electronic cigarettes ought to be congratulated rather than scorned. However, the anti-tobacco community has shown nothing but scorn for the vaping community.

Vapers who have quit smoking have greatly improved their health. In fact, they have taken the single most important action to improve their health. They have literally saved their lives. This is a tremendous accomplishment that should be praised. Yet many anti-tobacco groups and advocates will not publicly acknowledge that these thousands of vapers have saved their lives and have shown scorn for the vaping community rather than congratulating vapers on their accomplishment.

Even those vapers who have not quit smoking completely but have cut down substantially on their cigarette consumption have taken an action that is improving their health. In addition to helping slow the progression of respiratory disease and improving respiratory symptoms, this accomplishment has significantly reduced their level of addiction to smoking and will likely make it easier for them to quit smoking in the future. These vapers, too, deserve congratulations and encouragement. But the anti-tobacco community has shown nothing but discouragement for anyone and everyone who is using electronic cigarettes.

The Rest of the Story

Let me take this opportunity to publicly congratulate the vaping community, including all the vapers who are helping to de-normalize smoking by switching to this much safer alternative. I also congratulate all the electronic cigarette companies which are contributing to the public's health by making available this safer alternative that has the potential to reduce cigarette consumption in half in the next decade, according to tobacco financial experts, including Bonnie Herzog at Wells Fargo. For all independent electronic cigarette companies, their value proposition is to make smoking obsolete, as Craig Weiss of NJOY has clearly expressed.

While anti-tobacco groups have attacked and condemned electronic cigarette companies and vapers, I want to take this opportunity to congratulate them and praise them for what they are doing to de-normalize smoking and promote a shift from combustible tobacco products to a much safer non-tobacco-containing product.

The current smoking cessation products on the market are dismal in their effectiveness, with long-term success rates of only about 10%. Clearly, there is a need for an alternative strategy for harm reduction for the 90% of smokers who are unable to quit using nicotine replacement or other drugs. The electronic cigarette companies have provided that alternative strategy, and thanks to their continued innovation, the safety and effectiveness of this strategy are improving every day. Moreover, every smoker who has become a vaper has helped pave the way for a public health revolution.

It is time that anti-tobacco groups and advocates show some respect for the many thousands of vapers who have greatly improved their health by successfully using electronic cigarettes to quit smoking or greatly reduce their tobacco cigarette consumption.

I hope that my publicly calling out the vaping community and pulling them out from under the bus, where they have been thrown by the anti-tobacco community will help reverse the damage that anti-tobacco groups have done by discouraging quit attempts using e-cigarettes and encouraging vaping ex-smokers to return to cigarette smoking.

Monday, June 29, 2015

IN MY VIEW: Anti-Tobacco Advocates are OK With Letting Smokers Die at the Current Rate

In what to me is a shocking admission, two anti-tobacco advocates have argued that there is no need for e-cigarettes - a new and promising smoking cessation tool - because current progress in reducing smoking is sufficient and more smokers each year are trying to quit.

In other words, what they are saying is that they are content with letting smokers die at the current rate. There is no need to expand the smoking cessation alternatives available to smokers, they argue. This means that they are OK with letting smokers die at the current rate and not pursuing a wider range of alternative cessation strategies. They are apparently content with the status quo; that is, the current anti-smoking interventions and cessation treatments (and the current rate of decline in cigarette smoking).

This is shocking to me because it runs counter to not only public health, but to any concept of humanity. How can we possibly be content with letting smokers die at the current rate? How could we possibly not want to accelerate the rate of decline in smoking by making a new smoking cessation tool available to smokers? How can we possibly be content with the current slow rate of decline in smoking prevalence? How can we simply accept the more than 400,000 deaths from smoking each year, and not want to drastically reduce that by pursuing a new, alternative, and potentially much more effective tool for smoking cessation?

This argument is presented in a press release appearing on Stan Glantz's blog and is based on a new article by Kulik and Glantz which appears in the journal Tobacco Control.

According to the press release, Dr. Glantz argues as follows:

"Smokeless tobacco and, more recently, e-cigarettes have been promoted as a harm reduction strategy for smokers who are “unable or unwilling to quit.” The strategy, embraced by both industry and some public health advocates, is based on the assumption that as smoking declines overall, only those who cannot quit will remain.  A new study by researchers at UC San Francisco has found just the opposite.  

The researchers analyzed survey data spanning 18 years in the United States and six years in the European Union. They found that, contrary to the prevailing assumptions, as the fraction of the population that smoked declined, the remaining smokers actually smoked less and were more likely to quit than to stick with it. The authors said their findings challenge the need to promote new forms of nicotine delivery, such as e-cigarettes, since the smoking population continues to quit smoking as a result of proven policies and interventions."


According to Glantz:

"“The fact that the smoking population is softening has important implications for public health policy. These results suggest that current tobacco control policies have been leading to softening of the smoking population without the need to promote new recreational nicotine products like e-cigarettes.”"

Later in the press release, Dr. Kulik echoes this argument:

"We show that there is no real need to distribute e-cigarettes as part of a tobacco policy package because the smoking population is softening."

The Rest of the Story

Whether the smoking population is softening or not is irrelevant to the question of whether we should pursue new and potentially more effective alternative treatments or strategies for smoking cessation. The reason to promote the search for these more effective treatments or alternative strategies is that we are not content with watching more than 400,000 people die from smoking each year and we want to decrease the number of smoking-related deaths as much and as quickly as humanly possible. Smoking prevalence is declining, but it is declining quite slowly. The rapid rates of decline in smoking prevalence that were observed in past decades have plateaued and started to drop off. This should lead us to be open to alternative cessation strategies, not to close the door on them and be content with the current rate of progress.

The authors of this article set up a straw man by arguing that the reason for the promotion of electronic cigarettes is that the smoking population is hardening. Then, if they can show that the smoking population is actually softening, they can argue that e-cigarettes are not needed. However, this is a straw man argument because the reason why advocates like myself are promoting electronic cigarettes has nothing to do with whether the smoking population is hardening or softening.

Even if it were true that the smoking population is softening (and I'll show below that it is not), I would still be promoting electronic cigarettes because there are so many smokers (the overwhelming majority) who fail to quit with existing therapies. We cannot be content to just let these smokers die. Instead, we need to find more effective or at least equally effective alternative strategies that they can use, rather than have them give up on quitting. Electronic cigarettes are just such an alternative and they have helped thousands of smokers to quit who could not and would not have quit using existing treatments.

This reason for promoting electronic cigarettes as an alternative cessation strategy that should be made available to smokers has nothing to do with whether the smoking population is hardening or softening. Even if it were shown convincingly that there was a huge amount of softening of the smoking population, I would never use that as an argument that the status quo is acceptable and that we should be content with the current slow decline in smoking progress and smoking-related disease, disability, and death.

The Rest of the Rest of the Story

Although the potential value of electronic cigarettes is not conditioned on whether the smoking population is hardening or softening, this article misinterprets its own data to incorrectly conclude that the smoking population is softening.

The evidence presented by the article and used to argue that the smoking population is softening is that, according to the article, as smoking prevalence decreases, quit attempts and quit ratio increase. However, the data involve a panel of 50 states with annual measurements over time. Each data point represents the smoking prevalence, quit attempts, and quit ratio in a given state in a given year. So a good deal of the variation in quit attempts and quit ratios is due to differences in smoking prevalence between states, not to differences in smoking prevalence over time.

The study did attempt to make some inferences about the degree to which there were differences in the relationship between smoking prevalence and quit attempts or quit ratios over time by including two time-dependent variables. However, neither of these variables were significant in the models. Thus, there was no change in the relationship between smoking prevalence and either quit attempts or quit ratios over time. In other words, the observed relationship could be explained simply by the fact that states with a lower smoking prevalence tend to have smokers with higher quit attempts and a higher quit ratio. The analysis conducted in the paper is not answering the correct question. It is largely answering the question of whether states with higher smoking prevalence have higher smokers with more quit attempts. In fact, it could be that the reason the smoking prevalence is lower in these states is precisely because the smokers in that state are more likely to try to quit and are more likely to quit successfully.

To examine the question of hardening vs. softening, what really needs to be examined is the relationship not between smoking prevalence and quit ratios and attempts across states, but the relationship between quit attempts and quit ratios over time. What we really want to know is what percentage of quit attempts made each year are successful and how that changes over time across the United States. A state-by-state analysis is of less interest than a national analysis. But most importantly, what we need to know is what proportion of smokers made quit attempts and what proportion succeeded in quitting each year, and then how those proportions changed over time. This is what will tell us whether the percentage of successful quit attempts has been increasing or decreasing over time.

This article confirms that the proportion of smokers making quit attempts in the United States has increased over time. However, trends in smoking prevalence during the same time period confirm that the decline in prevalence has declined over the past decade and a half. And since the number of quit attempts has gone way up, this means that the proportion of quit attempts that are successful has dropped. In other words, smokers are finding it more difficult, not easier, to quit. This actually suggests that the smoking population is hardening.

Dick Puddlecote has provided an excellent explanation of this phenomenon and does a fine job of showing why the conclusions of this study are inconsistent with the very data that it presents. He summarizes his argument as follows:

"Glantz has ... proven that more people are embarking on quit attempts. However, since there is no steepening decline in prevalence from real life data - in fact it is the opposite - this can only mean one thing; that a smaller percentage of smokers are successful with their quit attempts than in the past and making people quit is therefore getting harder."

Interestingly, data from the UK (the Smoking Toolkit Study) quite ironically show that while the proportion of successful quit attempts was stable prior to the dramatic rise in e-cigarette use, this proportion has increased as e-cigarette use has proliferated in the UK. Moreover, the advent of e-cigarettes was associated with large increases in the number of quit attempts being made. Furthermore, the most common aid now used in quit attempts is e-cigarettes.

To be clear, whether the smoking population is hardening or softening is irrelevant to the issue of whether e-cigarettes should be promoted or not. If e-cigarettes are a bona fide smoking cessation aid for many smokers who could not or would not quit using existing therapies, then e-cigarettes should be promoted as an alternative for this sub-population of smokers (which is, in fact, the vast majority - about 90% to 97%). Even if smokers were making ever more quit attempts and becoming more successful, that is no reason to deny the large proportion of smokers who are not successful quitting using traditional drugs the opportunity to try e-cigarettes as an alternative approach.

The rest of the story is that in this new article, the study sets up an irrelevant straw man argument, misconstrues the reasons why e-cigarettes are being promoted, misinterprets the data analysis, and draws an invalid conclusion about the "irrelevant" research question which it set out to answer. But the worst part of the story is that the article, or at least the statements accompanying the article, essentially argue that we should not pursue e-cigarettes because we should be content with the status quo, as smokers are making more quit attempts each year.

But that status quo is actually the death of more than 400,000 smokers each year. That status quo is a decreasing rate of decline in smoking prevalence. How any anti-tobacco activist could be content with the status quo is not clear to me. I honestly believe that it is Dr. Glantz's extreme hatred for e-cigarettes that has led him to express this inane (and rather inhumane) argument.

Current projections suggest that the U.S. is not going to reach the Healthy People 2020 goal of reducing adult smoking prevalence to 12% in the next five years. Why Glantz and Kulik seem to be content with that failure is not clear to me. I would argue that we should not accept the slow rate of progress and we should not be content to rely on current interventions. We need to expand these interventions, not sit on them. Most importantly, we need to pursue alternative smoking cessation treatments for the vast majority of smokers who are unsuccessful using current approaches. Why are Glantz and Kulik throwing these smokers under the bus?

Thursday, June 25, 2015

New Study Finds that Problem of E-Cigarette Use Among Nonsmoking Adults is Non-Existent

Contrary to the claims of many e-cigarette opponents, who argue that nonsmokers will be attracted to take up electronic cigarette use, the results of a Minnesota study just published in Tobacco Control finds that regular e-cigarette use among nonsmoking adults is a rarity.

In this study of Minnesota adults, although 5.6% of nonsmokers had tried e-cigarettes and 1.2% had used e-cigarettes in the past month, only 0.1% of nonsmokers had used e-cigarettes more than 5 days in the past month.

The study concludes that: "These results suggest that many infrequent users are experimenters, unlikely to continue their e-cigarette use over time. If that is the case, then measuring e-cigarette current use prevalence based on any use in the past 30 days may lead to an overestimate of regular users. That conclusion is reinforced by the finding that most individuals who had ever used e-cigarettes reported no use in the past 30 days."

As I reported recently, a study by Cancer Research UK found a similar result among youth. Virtually no nonsmoking youth could be found who were regular e-cigarette users.

The Rest of the Story

Together, these studies suggest that both among youth and adults, there is currently no problem with nonsmokers being enticed into regular vaping behavior. This is yet another claim of e-cigarette opponents that has not held up when the actual evidence is examined.

The CDC has not measured and reported data on the frequency of e-cigarette use beyond use at least once in the past 30 days. These studies suggest that if the CDC refined its questions to inquire about the actual frequency of use, it would find that very few nonsmokers have become regular vapers. Regular vaping appears to be an activity that is exclusive to smokers (and ex-smokers, many or most of whom have likely quit smoking because of e-cigarettes).

In discussing the results of these studies, Jacob Sullum, senior editor at Reason magazine, notes that: "public health officials and anti-smoking activists are grasping at straws to justify their knee-jerk animosity toward e-cigarettes. Instead of harping on unfounded fears that vaping will lead to nicotine addiction and an increase in smoking, they should be investigating the lifesaving potential of e-cigarettes, a far less hazardous alternative to the conventional kind."

But anti-smoking activists don't even want to consider the possibility that e-cigarettes could be saving lives because it goes against their deeply entrenched ideology and their pre-determined conclusions based on that ideology. Anything that looks like smoking is a bad thing, all nicotine use is bad, and no one should gain pleasure from a substance that can be addictive.

House Appropriations Bill Would Protect Public Health By Allowing E-Cigarettes to Stay on the Market

Sharing my concerns that the FDA deeming regulation will decimate much of the electronic cigarette industry, Representative Robert Aderholt (R-AL) has introduced a rider to the House appropriations bill that would essentially overrule the FDA and statutorily set the "grandfather" date for electronic cigarettes as the effective date of the FDA deeming regulation.

The significance of this legislation is that it would allow all electronic cigarettes currently on the market (and all those on the market as of the effective date of FDA regulation) to remain on the market without having to submit complex and resource-intensive new product or substantial equivalence applications.

If the final FDA regulations look anything like the proposed deeming regulation, then every electronic cigarette product on the market will have to submit a new product application (because no product on the market today is "substantially equivalent" to products on the market as of February 2007). To do this successfully, a company would have to demonstrate that its product is beneficial to the public's health, taking into account not only product users but those who do not currently use e-cigarettes but who might start vaping because of the availability of the product.

This is an incredibly complex and difficult showing because a manufacturer or distributor would have to demonstrate that:

1. Every one of their products is safer than smoking.
2. Every one of their products will help smokers quit.
3. The uptake of their products by non-users (especially youth) will not offset the public health benefits that accrue to product users.

Most e-cigarette companies, distributors, and retailers are very small businesses that do not have the personnel, expertise, or resources required to prepare these applications and to deal successfully with the difficult scientific questions that arise. Even scientists and other experts in the tobacco control field have not yet determined how one can properly weigh the benefits and risks of electronic cigarettes, much less to do so with one particular product at a time.

This requirement makes no sense whatsoever for electronic cigarettes. When applied to regular cigarettes, it could at least make some sense because one could argue that there is no need to introduce new cigarettes to the market unless they are somehow safer than existing products. However, all e-cigarettes are safer than existing tobacco cigarettes. So there's absolutely no public health benefits to be gained from requiring e-cigarettes to go through this complicated process.

Moreover, such a process would create a nightmare of a bureaucracy at the FDA, wasting precious time and resources. The FDA already has all it can handle just trying to process the thousands of substantial equivalence applications it faces for regular cigarettes. Tying the agency down with tens of thousands of additional applications for e-cigarettes makes no sense.

As I have argued before, the FDA should simply promulgate rules that set minimum safety standards that all e-cigarettes must meet. These would address issues such as battery safety, overcharge protection, leak-proof cartridges, childproof packaging, basic quality control and assurance procedures, and some sort of regulation of temperature to minimize or prevent the formation of formaldehyde and other unwanted and unnecessary degradation products of propylene glycol and glycerin.

If the FDA deeming regulations do not change the grandfather date from 2007 to at least the effective date of regulation, then Representative Aderholt's bill will be absolutely necessary to protect the e-cigarette market and ensure that smokers have full access to all available options for smoking cessation. Hopefully, Congress will prevent the FDA from wiping out most of the e-cigarette industry by enacting Representative Aderholt's bill.

Wednesday, June 24, 2015

A Must-Read Treatment of the CDC's Campaign of Deception Regarding E-Cigarettes

Dr. Peter Sandman, an expert in risk communication, has written an outstanding, detailed analysis and evaluation of the CDC's public communications regarding electronic cigarettes, focusing on the agency's communications related to its recent MMWR article reporting a dramatic increase in teen e-cigarette use accompanied by a dramatic decline in teen smoking.

His commentary, entitled "A Promising Candidate for Most Dangerously Dishonest Public Health News Release of the Year," provides the most detailed analysis I have seen regarding the CDC's communications surrounding its April 2015 MMWR article. This is an issue about which I have written extensively in the past months. Dr. Sandman supports my arguments with an analysis that is guided by attention to basic risk communication and public health principles.

Dr. Sandman argues that the CDC papered over the most significant finding of the article - that youth smoking dropped dramatically to historically low levels - by considering e-cigarettes to be tobacco products and thereby being able to emphasize, instead, that overall "tobacco" use among youth remained steady.

This would be equivalent to the CDC reporting that heroin use dropped from 10% to 1%, while methadone use increased from 1% to 10%, and putting out headlines noting that there has been no change in opiate use in the population. Or to make it more extreme, suppose that every heroin user switched to methadone and the CDC headline was that opiate use has remained unchanged over time.

Dr. Sandman gives many more relevant examples of the deception in CDC's communications. He also speculates on the reasons for this deception. One hypothesis: "What might lead 12 public health experts to coauthor a report that papers over the comparative risk of vaping versus smoking? I don’t know. Something deeply ideological, I think. Something puritan and fundamentalist. All tobacco use is (equally) evil because it all enriches the tobacco industry? All tobacco use is (equally) disgusting because it all enables users to get illicit pleasure?"

Another important point that Dr. Sandman makes relates to the CDC's absolute refusal to address the relative risks of vaping compared to smoking. He writes: "Frieden’s clarification also tells us why he wanted to talk about the uptick [in overall tobacco use] in the first place. He saw it as a rationale to argue that vaping wasn’t replacing smoking but rather supplementing it. To make this case he ignored not just the small size of the uptick in the number of kids using any tobacco product, but also the absence of any uptick at all in the number of kids using more than one tobacco product, the decline in the number of kids smoking cigarettes, and the decline in the number of kids smoking anything. The real issue here isn’t Frieden’s decision to lean on a statistically insignificant increase in kids’ overall tobacco use to argue against the replacement hypothesis. The real issue is adding apples and oranges. Combining e-cig use, real cig use, and the use of seven other tobacco products into one overall number (the percentage of kids using any tobacco product) means treating the distinction between vaping and smoking as if it were unrelated to health. This is especially deceptive in the absence of any discussion of the decline in total teen smoking between 2011 and 2014."

Dr. Sandman concludes that: "The MMWR report, the CDC news release accompanying the report, and the CDC press briefing about the report are all seriously misleading about the findings of the annual National Youth Tobacco Surveys. The press briefing is the most explicitly misleading of the three, but the news release almost certainly had the most influence on coverage and thus on what the public learned. All three go out of their way to distort the study results and the underlying facts on four key points:
  • They highlight the bad news (potentially, maybe, somewhat bad news) that teenage e-cigarette use has soared.
  • They obscure the good news (definitely, wondrously good news) that teenage real cigarette use and overall smoking are continuing to decline, despite an increase in the use of hookahs.
  • They assert that e-cigarettes are dangerous, imply that e-cigarettes are as dangerous as real cigarettes, and hide that virtually all experts agree e-cigarettes are significantly safer than real cigarettes.
  • They ignore or deny the suggestive evidence (suggestive but far from conclusive) that teenage vaping might be replacing smoking, not leading to it.
I stand by the judgment in my title that the news release is a promising candidate for most dangerously dishonest public health news release of the year."

Finally, Dr. Sandman notes that the CDC's communication campaign is not just deceptive, but potentially damaging as well: "The other difference is that the CDC isn’t just exaggerating the risk of e-cigs. It is misrepresenting the comparative risk of e-cigs and real cigs. And it is denying the possibility that vaping might help woo some teenagers from smoking or keep them from starting to smoke in the first place. I frankly don’t care much if the public ends up believing that electronic cigarettes are more dangerous than they really are. But I care enormously if the public – and especially the teenage public – ends up believing that vaping is just as dangerous as smoking so they might as well smoke. Several surveys have shown that while most Americans and most American teenagers still believe that vaping is safer than smoking, the number who believe that vaping and smoking are equally dangerous has climbed substantially. Making that number continue to climb is a key goal of the public health “education” campaign against electronic cigarettes, one small recent piece of which I have discussed in this column."

The Rest of the Story

I urge all of my readers to read Dr. Sandman's excellent critique.

To me, as a former CDC employee (I worked in the Office on Smoking and Health, which is largely responsible for most of these reports and communications), the saddest part of this story is the seeming loss of perspective that has taken place at the agency. In the face of the most dramatic decline in youth smoking in history, the CDC is essentially arguing that there is no cause for celebration because lots of kids are now experimenting with e-cigarettes, which are just as bad as tobacco cigarettes. The CDC has redefined the problem from morbidity and mortality to nicotine use. It doesn't matter how many people die, as long as we minimize the use of nicotine in the population. By the CDC's logic, if every smoker in the nation switched completely to vaping, it would have no public health benefit because the overall use of "tobacco" would remain unchanged.

Tuesday, June 23, 2015

CDC Hiding from the Public the Fact that E-Cigarettes Do Not Contain Tobacco

Yesterday, I explained how the CDC is lying to the public by classifying e-cigarettes as "tobacco products," thus insinuating that e-cigarettes contain tobacco, which is not true. Today, I reveal that this lie is part of a larger campaign, in which the CDC is actively hiding from the public the fact that e-cigarettes do not contain tobacco.

Arguably, one of the most important facts that the public needs to know about e-cigarettes is that they contain no tobacco. Unlike all other "tobacco products" on the market, e-cigarettes are unique in not containing tobacco, and therefore, not really being "tobacco products." Regardless of how they are classified, it is imperative that the public understand that e-cigarettes are qualitatively different from real cigarettes in that they do not contain, nor burn tobacco. The most important distinction, of course, is the absence of tobacco in the product.

Now, one would think that the nation's leading public health agency, in putting out loads of information about e-cigarettes, would somewhere ... someplace ... inform the public that e-cigarettes do not contain tobacco.

The Rest of the Story

The rest of the story is that I can find no location, no web page, no MMWR article, no communication of any kind in which the CDC informs the public that e-cigarettes are devoid of tobacco. Moreover, in every important communication about e-cigarettes that the CDC has transmitted, especially those which gained huge amounts of media coverage, the agency hid from the public the fact that e-cigarettes do not contain tobacco.

For example, let's look at the all-important press release in which the CDC announced a tripling of e-cigarette use among youth in just a one year period. Nowhere in that press release does it explain that e-cigarettes are not tobacco-containing products. On the contrary, the release insinuates that e-cigarettes do contain tobacco by referring to these devices as tobacco products.

In the MMWR article associated with this press release, there is absolutely no mention of the fact that e-cigarettes contain no tobacco. On the contrary, the CDC explicitly states that e-cigarettes do contain tobacco, which is an outright lie. The CDC states in the article:

"Youth use of tobacco in any form, whether it be combustible, noncombustible, or electronic, is unsafe... ." 

Thus, the CDC is telling the public that electronic cigarettes are a "form" of using tobacco. This, of course, is untrue because e-cigarettes do not contain tobacco in any form.

If the CDC classified e-cigarettes as tobacco products, but readily disclosed that these devices do not actually contain tobacco, then one could argue that its classification was based merely on semantics and was not a deliberate attempt to mislead the public. However, in light of the fact that throughout all of its communications on e-cigarettes the CDC actively hides from the public the critical fact that e-cigarettes are not a form of tobacco, I do not believe that this is merely about semantics. It seems clear to me that the CDC is intentionally deceiving the public in order to demonize electronic cigarettes.

Unfortunately, as I mentioned yesterday, this campaign of lies and deception is not just dishonest, it is also damaging. It is literally costing lives because it is protecting combustible tobacco products (cigarettes) from competition from a non-tobacco, non-combusted product that is a much safer alternative (e-cigarettes).

The rest of the story is that the CDC is hiding from the public the critical fact that e-cigarettes do not contain tobacco. It is unfathomable to me that the nation's leading public health prevention agency is not only lying to the public about e-cigarettes being tobacco products, but that it is also hiding critical information from the public in an apparently deliberate attempt to confuse the public about the relative hazards of smoking compared to vaping.

Sunday, June 21, 2015

CDC Continues to Lie to the Public By Calling Electronic Cigarettes "Tobacco Products"

Despite being informed that its classification of electronic cigarettes as tobacco products is wrong because e-cigarettes do not contain any tobacco, the CDC continues to refer to electronic cigarettes as being tobacco products. This naturally implies that electronic cigarettes contain tobacco. As this is untrue, the CDC's recurrent statements that e-cigarettes are tobacco products are essentially lying to the public.

The Rest of the Story

According to the CDC's web site: "Tobacco product types include cigarettes, cigars, hookahs, snus, smokeless tobacco, pipes, bidis, dissolvable tobacco, and electronic cigarettes."

Here is a breakdown of each of these "tobacco products" and whether they contain tobacco or not:

Cigarettes - YES
Cigars - YES
Hookahs - YES
Snus - YES
Smokeless tobacco - YES
Pipes - YES
Bidis - YES
Dissolvable tobacco - YES
Electronic cigarettes - NO

You don't need to be a rocket scientist to figure out which one of these things doesn't belong.

Electronic cigarettes are not tobacco products because they do not contain tobacco. The only way in which they can be referred to as tobacco products is in a strict legal sense. Thus, from an FDA regulatory perspective, e-cigarettes do meet the definition of tobacco product under the Family Smoking Prevention and Tobacco Control Act. But beyond the use of that term by the FDA, e-cigarettes are not tobacco products and classifying them as such is certainly going to mislead the public into thinking that they contain tobacco. In turn, this will lead the public to believe that e-cigarettes are just as hazardous as tobacco cigarettes, which is blatantly false.

So not only is the CDC lying about whether e-cigarettes contain tobacco, but this recurrent lie is having the damaging effect of undermining the public's appreciation of the hazards of smoking and deterring smokers who might otherwise quit using e-cigarettes from doing so. This lie is also sure to convince many former smokers, who quit using e-cigarettes, to return to cigarette smoking. So these are not just innocent lies. They are lies which are literally causing an increase in disease and death due to combustible tobacco use.

This CDC lie is also leading to further misinformation from the agency. For example, on the same web page, the CDC claims that: "Youth who use multiple tobacco products are at higher risk for developing nicotine dependence and might be more likely to continue using tobacco into adulthood." 

Naturally, the reader is going to assume this statement means that youth who use e-cigarettes are at higher risk for continuing using tobacco into adulthood. However, this statement is true only for actual tobacco products (i.e., products that contain tobacco). There is no evidence that e-cigarettes increase the risk of youth using tobacco into adulthood. However, the CDC's claim, in the context of it having defined e-cigarettes as tobacco products, is going to lead the public to believe that e-cigarette experimentation leads to a lifetime of tobacco use. Keep in mind that recent data from the UK failed to find a single youth who started as a nonsmoker and then became addicted to e-cigarettes, much less who transitioned to a lifetime of addiction to real tobacco cigarettes. 

The CDC also claims that: "Tobacco use is started and established primarily during adolescence." With respect to actual tobacco products, this is true. But with respect to electronic cigarettes, it is false. So this statement, too, becomes highly misleading in the context of the CDC calling e-cigarettes tobacco products.

The rest of the story is that by repeatedly referring to electronic cigarettes as tobacco products, the CDC is lying to the public and deceiving the public into believing that e-cigarettes contain tobacco, which is untrue. More importantly, this deception is causing tangible health damage: it is undermining the public's appreciation of the hazards of smoking, deterring many smokers from quitting, and encouraging many former smokers to return to tobacco cigarette smoking. These are not just lies. These are lies that are costing lives.

Friday, June 19, 2015

New UK Research Refutes E-Cigarette Gateway Claims

New research out of the UK completely refutes the e-cigarette gateway claim by demonstrating that nonsmoking youth who experiment with e-cigarettes are not becoming addicted to vaping and are not even becoming regular e-cigarette users.

According to Cancer Research UK, which funded the study: "Of the 1,205 children aged 11-16 who took part in the new UK-wide survey, 12 per cent reported that they had tried an e-cigarette. Figures for regular use were lower with two per cent reporting e-cigarette use more than monthly and one per cent more than weekly. Regular e-cigarette use was found only in children who also smoked tobacco. Experimental e-cigarette use among non-smoking children was low at three per cent." ...

"Professor Linda Bauld, Cancer Research UK scientist at the University of Stirling, said: 'There’s a common perception that the rise we’ve seen in the use of electronic cigarettes will lead to a new generation of adults who have never smoked but are dependent on nicotine. This fear is based on the expectation that due to the appeal of the products, children who have never used tobacco will be attracted to e-cigarettes and start to use them regularly. Our survey is in line with others in the different parts of the UK that show this is not happening. Young people are certainly experimenting with e-cigarettes, some of which do contain nicotine. However, our data show that at the moment this experimentation is not translating into regular use.'"

"Alison Cox, director of cancer prevention at Cancer Research UK, said: 'These data on electronic cigarette use in youth suggests that e-cigarettes are not serving as a gateway to tobacco. It’s reassuring that rates of smoking in young people are continuing to fall at a time when e-cigarette use has been rising.'"

The Rest of the Story

This study demonstrates that at least in the UK, electronic cigarettes are not serving as a gateway to smoking. Moreover, e-cigarette experimentation is not leading to a significant amount of regular e-cigarette use and certainly not to a significant amount of addiction to vaping.

In the U.S., while the CDC has claimed that e-cigarettes are a gateway to addiction and smoking, it has not produced a shred of evidence to support this claim. Furthermore, the CDC has deliberately avoided seeking evidence that might refute the claim by refusing to even ask the question of how often nonsmokers who experiment with e-cigarettes are using these products. The CDC's surveys, at least through 2013, did not inquire about the frequency of e-cigarette use, other than to ask if the youth vaped at least once in the past 30 days. And the CDC has never reported data on frequency of e-cigarette use. Thus, it is possible that most or all of the nonsmokers who the agency claims are addicted to e-cigarettes have only used these products once or a few times in the past month.

While these new data do not prove that e-cigarettes are not a gateway to smoking in the U.S., they do demonstrate that such a phenomenon is not occurring in the UK, and they cast serious doubt on the claims of the CDC and a number of anti-smoking groups and advocates that e-cigarettes are, as the CDC stated, condemning many teens "to struggling with a lifelong addiction to nicotine and conventional cigarettes."

Thursday, June 18, 2015

In 2015, FDA Still Maintains that Smoking May Be No More Hazardous than Vaping

Which of the following are willing to publicly admit that smoking is definitely more hazardous than vaping?

A. Philip Morris/Altria
B. Reynolds American
C. Imperial Tobacco
D. The Food and Drug Administration (FDA)
E. All but D

Shockingly, the correct answer is E.

While the cigarette companies have all acknowledged that their combusted tobacco products are definitely more hazardous than e-cigarettes (which contain absolutely no tobacco and involve absolutely no combustion), the FDA - as of today - continues to tell the public that it is not sure that vaping has any benefits over smoking; i.e., that vaping is safer than smoking.

According to the FDA's web site today (June 18, 2015):

"E-cigarettes have not been fully studied, so consumers currently don’t know ... whether there are any benefits associated with using these products."

This means that it is not clear to the FDA that if a smoker quits smoking and switches to e-cigarettes, he or she will experience any health benefits.

If you think about it, that's quite an astounding statement for the FDA to make, especially in June 2015. It might have been an acceptable statement to make during the first few months when e-cigarettes came onto the market and we really didn't know anything about them. But given the amount of research that has been conducted in the past 8 years on the relative safety of e-cigarettes, it is simply unfathomable that the FDA would be telling the public that there may be no health benefits to switching from smoking to vaping.

This is precisely the same as the FDA stating that cigarette smoking may be no more hazardous than vaping.

This is hard for me to believe. The federal agency that has been entrusted with regulating tobacco products and which will soon be regulating e-cigarettes is not sure that smoking is any more hazardous than vaping!

The Rest of the Story

Not only is the FDA continuing to make this irresponsible and unscientific, even fraudulent, statement, but the media are relying on it and thus communicating serious misinformation to the public. That the FDA is not sure there are any benefits of vaping over smoking is plastered on literally hundreds of health-related web sites.

This has led to massive public confusion over what is actually a very simple scientific issue. Electronic cigarette use is undoubtedly safer than cigarette smoking. Not only is the FDA's obfuscation of this basic science irresponsible and damaging, but it also undermines the public's appreciation of the serious hazards of smoking.

What confidence can we have that the FDA will take a science-based approach to the regulation of cigarettes and e-cigarettes when it can't even get the most simple science correct?

Tuesday, June 16, 2015

E-Cigarette Opponents Continue to Use Inappropriate Research Designs to Conclude that E-Cigarettes Impede Smoking Cessation

A new study published in the American Journal of Public Health is being used by e-cigarette opponents to conclude that the use of e-cigarettes actually impedes the smoking cessation process.

(See: Sutfin EL, et al. The impact of trying electronic cigarettes on cigarette smoking by college students: a prospective analysis. American Journal of Public Health; June 11, 2015. doi: 10.2105/AJPH.2015.302707.)

The study followed 271 college smokers who, at baseline, had never used an e-cigarette for a three-year period. The probability of remaining a smoker at the final interview was compared between smokers who tried electronic cigarettes in the interim an those who did not. The study reported that the odds of continued smoking at wave 6 (the final study wave) were 2.5 times higher for smokers who had tried e-cigarettes. The study concludes that: "Trying e-cigarettes during college did not deter cigarete smoking and may have contributed to continued smoking."

Stan Glantz touted this study as showing that e-cigarette use impedes smoking cessation. He wrote that the study result: "adds to the evidence that e-cigarette use is depressing quitting smoking cigarettes."

The Rest of the Story

There are several reasons why this study (and similar ones) cannot be used to conclude that e-cigarettes make it more difficult to quit smoking.

The most important reason is that there is a severe problem of confounding. In this case, the confounder is lack of confidence in one's ability to quit smoking and/or nicotine use completely. We know that e-cigarette users are much more likely than other smokers to feel unable to quit smoking or quit nicotine use. In fact, the primary reason why many smokers are attracted to e-cigarettes is that they have tried to quit and failed using traditional methods and e-cigarettes provide an alternative that does not necessarily require them to quit nicotine use altogether. And it doesn't necessarily require them to quit smoking completely either.

But we also know that lack of self-efficacy (lack of confidence in one's ability to quit smoking) is a strong predictor of not being able to quit. Therefore, in an observational study such as this one, smokers who try e-cigarettes are, by definition, going to have lower rates of smoking cessation simply because they have lower levels of self-efficacy to quit.

Thus, rather than demonstrating that e-cigarettes impede smoking cessation, what this study actually shows is that smokers who choose to try e-cigarettes have much less confidence in their ability to quit (which explains their subsequent lower rates of smoking cessation).

Another major problem with this study is that it only measured one-time use of e-cigarettes in the past six months. Thus, anyone who merely tried an e-cigarette once in the past six months was included as having tried to make a quit attempt using e-cigarettes. The smoker may not have had the slightest interest in quitting. He may have simply been curious about what vaping feels like. Yet that smoker's failure to quit would be counted as a failure of e-cigarettes.

Furthermore, the study was not restricted to smokers who used e-cigarettes with any intention of quitting. How can e-cigarettes impair a quit attempt if the smoker is not even making a quit attempt. In fact, we have no information whatsoever on the reason that the e-cigarette users in this study were trying these products, how often they were using them, and whether they were indeed trying to quit by using these products.

You can easily see from these points that the results of the present study cannot be used to conclude that e-cigarettes "depress" smoking cessation.

I, however, am depressed because it is sad to see the rigor of the science in tobacco control degraded to such a degree. I believe that our desire to demonstrate a pre-determined and desired conclusion is overriding our care and rigor in interpreting scientific data.

The only way to truly answer this research question is to conduct a randomized trial. By randomizing smokers to receive either e-cigarettes or a traditional therapy (such as the nicotine patch), one ensures that the levels of self-efficacy to quit smoking and to quit nicotine use are equivalent among both groups. Then, and only then, can one make a valid comparison of the differences in quit rates between the two groups.

Unfortunately, only one randomized trial has been conducted. In that study, by Bullen et al., electronic cigarettes were found to be just as effective as the nicotine patch for smoking cessation. This is absolutely not consistent with the conclusion that e-cigarettes impede smoking cessation.

Clearly, there is an urgent need for more randomized trials to test the efficacy of e-cigarettes in smoking cessation and to compare them to traditional therapies, like nicotine replacement therapy.

But until that time, e-cigarette opponents must stop using the results of these observational studies, which are not even designed to compare smoking cesation rates betweeen groups, as evidence that e-cigarettes depress smoking cessation.

Monday, June 15, 2015

Is It Just Me, or Have Anti-Tobacco Activists Completely Lost Sight of the Goal?

According to an article in The Times of India, public health officials in Maharashtra are thrilled because electronic cigarettes are soon to be banned.

According to the article:

"On World No-Tobacco Day, the state Food and Drug Administration (FDA) gave anti-tobacco activists a gift by making sales of e-cigarettes illegal in Maharashtra. The move may not have been made primarily for public health, but activists are happy nonetheless. Last week, state FDA issued show cause notice to importers and sellers of e-cigarettes on the grounds that the product was being sold without proper permissions from the Drug Controller General of India (DCGI). The absence of permissions means that selling e-cigarettes becomes illegal as it violates Drugs and Cosmetics Act. Calling e-cigarette the evil twin of cigarettes, dean of city's Government Dental College Dr Vinay Hazarey said, "Banning e-cigarettes at this stage is like nipping an evil in the bud as the product has only recently started catching the fancy of youngsters. E-cigarettes and hookah are among products that introduce many young people to tobacco consumption." He is worried, however, that kids could still order these products online."

The article notes that: "Electronic cigarettes or electronic nicotine delivery system (ENDS) is exactly like a cigarette, containing nicotine, liquids and flavouring agents. The only difference is that it is battery operated."

The Rest of the Story

Are we hearing this straight? Anti-tobacco activists in Maharashtra are happy because the sale of e-cigarettes will become illegal in the state, while the sale of cigarettes and all other actual tobacco products will not be touched.

The article should have stated:

"On World No-Tobacco Day, the state FDA gave cigarette companies a gift by making sales of e-cigarettes illegal in Maharashtra. The move was contrary to public health, and activists are angry.

Since e-cigarettes contain No Tobacco and help many smokers quit or substantially reduce their tobacco consumption, shouldn't the availability of e-cigarettes be something to celebrate on World No-Tobacco Day? And shouldn't a law which bans these non-tobacco-containing products be shunned, as it gives a huge competitive advantage to tobacco products, and shields them from any competition from alternative non-tobacco products?

It is not exactly reassuring to hear that getting it exactly backwards about e-cigarettes is not unique to anti-tobacco groups in the U.S., but appears to be common throughout the world. And there is a strong parallel. In the U.S., misleading and often false propaganda from leading groups and agencies such as the FDA, CDC, California Department of Public Health, the Mayo Clinic, and the University of Kentucky have influenced state and local public health groups in their taking a backwards position. Similarly, misleading information disseminated by the World Health Organization has influenced public health bodies in a number of countries to take the same backwards position.

At the end of the day, these public health groups have lost sight of the actual goal, which is supposed to be improving health, saving lives, and decreasing morbidity and mortality from smoking and other forms of tobacco use. Financial analysts have predicted that e-cigarettes could eventually cut a dent in cigarette sales, on the order of a 50% reduction in cigarette consumption over the next decade. If the ultimate goal is to save lives, especially from smoking, then electronic cigarettes are a critical strategy to help accomplish this goal. Banning electronic cigarettes while keeping tobacco cigarettes on the market, unchecked, makes absolutely no sense if saving lives is our goal.

Thursday, June 11, 2015

CDC Lying About Financial Conflicts of Interest and Failing to Disclose Big Pharma Funding When It Releases Statements About E-Cigarettes

The Centers for Disease Control and Prevention (CDC) makes a multitude of recommendations regarding the prevention and treatment of a variety of diseases and adverse health conditions. Many of these recommendations involve the promotion of specific pharmaceutical products, such as antibiotics, vaccines, or smoking cessation drugs.

For this reason, it would seem important that the CDC remain independent of any corporate influence and that the agency not accept funding from corporations, especially from Big Pharma.

In fact, the CDC claims to have no financial interests or other relationships with any manufacturers of commercial products that are involved in its recommendations. The CDC claims that it does not accept any commercial support.

For example, on the web page for a smoking cessation tutorial funded by CDC, the following disclaimer is provided:

"CDC, our planners, and our content experts wish to disclose they have no financial interests or other relationships with the manufacturers of commercial products, suppliers of commercial services, or commercial supporters with the exception of: Dr. Neal Benowitz. He wishes to disclose that he was a member of the Pfizer Inc. advisory board and a paid consultant for GlaxoSmithKline. Dr. Nancy Rigotti. She wishes to disclose that she was a member of the Pfizer Inc. scientific advisory board, receives royalties for chapter on smoking cessation from UpToDate, Inc., and a research grant was awarded to Massachusetts General Hospital (not to Dr. Rigotti) from Nabi Biopharmaceuticals."

Thus, CDC is claiming that the agency receives no funding from any companies.

This disclaimer appears widely in virtually all of the course content provided by the agency.

For example, in its course on the tetanus/diphtheria/pertussis vaccine, the CDC states:

"CDC, our planners, and our content experts wish to disclose they have no financial interests or other relationships with the manufacturers of commercial products, suppliers of commercial services, or commercial supporters. ... CDC does not accept commercial support."

As I have revealed on this blog, the CDC has made numerous (false) public statements about electronic cigarettes, including the claim that they are a gateway to youth smoking and a source of lifetime addiction for kids who experiment with them. In none of these statements has the CDC disclosed any financial conflicts of interest. This would certainly lead the public to believe that CDC has no financial relationship with Big Pharma, as this would represent a conflict of interest. The pharmaceutical companies' profits are seriously threatened by electronic cigarettes, as these products represent an alternative to smoking cessation drugs, including the nicotine patch, nicotine gum, nicotine inhaler, Chantix, Zyban, and others.

The Rest of the Story

The rest of the story, quite simply and sadly, is that the CDC is lying. Not only about electronic cigarettes being a gateway to smoking and a source of lifetime addiction for kids, but also about its having no financial interests or other relationships with the manufacturers of commercial products.

The truth is that CDC has multiple partnerships with corporations and that it receives a great deal of funding from multiple companies. And these companies include Big Pharma.

According to its fiscal year 2014 report, the CDC Foundation, which provides financial support for CDC programs, received funding from multiple pharmaceutical companies, including:
  • Bristol-Myers Squibb;
  • Jansenn Therapeutics;
  • Johnson & Johnson;
  • Kadman Pharmaceuticals;
  • Lupin Pharmaceuticals;
  • Merck;
  • Novo Nordisk;
  • Onyx Pharmaceuticals;
  • Pfizer;
  • Sanofi-Aventis; and
  • Vertex Pharmaceuticals.
The CDC Foundation readily admits that its purpose is to forge relationships between CDC and private companies and to raise money to support CDC's work. The CDC partners with at least one funding partner (i.e., company) to implement public health programs. In the CDC Foundation's own words:

"Established by Congress as an independent, nonprofit organization, the CDC Foundation connects the Centers for Disease Control and Prevention (CDC) with private-sector organizations and individuals to build public health programs that make our world healthier and safer. Since 1995, the CDC Foundation has provided $450 million to support CDC's work, launched more than 750 programs around the world and built a network of individuals and organizations committed to supporting CDC and public health. Each CDC Foundation program involves a talented team of experts at CDC and at least one outside funding partner. Sometimes, a program begins with a CDC scientist who has a great idea and wants to collaborate with an outside partner to make it happen. At other times, organizations in the private sector recognize that they can better accomplish their own public health goals by working with CDC through the CDC Foundation."

According to an article in The BMJ, the CDC Foundation received $12 million from corporations in 2014 and the CDC itself received $16 million from sources including individuals, philanthropic organizations, and corporations. Moreover, the CDC receives some funding directly from the CDC Foundation.

According to the article:

"Despite the agency’s disclaimer, the CDC does receive millions of dollars in industry gifts and funding, both directly and indirectly, and several recent CDC actions and recommendations have raised questions about the science it cites, the clinical guidelines it promotes, and the money it is taking. Marcia Angell, former editor in chief of the New England Journal of Medicine, told The BMJ, “The CDC has enormous credibility among physicians, in no small part because the agency is generally thought to be free of industry bias. Financial dealings with biopharmaceutical companies threaten that reputation.”"

According to the article, CDC director Dr. Thomas Frieden "did not respond to a question about the disclaimer." However, he apparently did acknowledge that the agency's funding from corporations does present conflicts of interest, stating: "When possible conflicts of interest arise, we take a hard, close look to ensure that proper policies and guideline are followed before accepting outside donations."

In other words, Dr. Frieden has essentially admitted that the CDC is lying in its disclaimer.

If the CDC is lying so readily about its funding from and partnerships with private corporations then perhaps it is not surprising that the CDC is also lying about electronic cigarettes being a gateway to smoking and condemning millions of kids to a lifetime of addiction. The agency's funding from pharmaceutical companies that stand to lose severely if electronic cigarettes are promoted creates a clear conflict of interest that CDC has failed to disclose.

This story is particularly troubling because CDC is the nation's leading public health agency and the public relies on its credibility to make decisions and formulate policies that literally affect life and death. That the CDC's recommendations may be tainted by corporate conflicts of interest is inexcusable. That the CDC is hiding these conflicts is reprehensible. And that the CDC is lying about having these financial relationships in the first place is a tragedy because it threatens the basic credibility of the agency, which in turn, threatens the agency's ability to protect and promote the public's health.

Wednesday, June 10, 2015

Anti-Smoking Movement Has It Backward: It's Not E-Cigarettes that's the Problem But Smoking

I've borrowed, and slightly adapted, the title of an excellent commentary by Oscar Cabrera and Lawrence Gostin of the O'Neill Institute at Georgetown University. In that commentary, they argue that Indonesia, which recently announced that it will ban e-cigarettes, is doing exactly the opposite of what it should be doing to protect kids and improve the public's health. Oscar Cabrera is a Visiting Professor and Lawrence Gostin is University Professor at the Georgetown University Law Center. Both are experts in global health and both have conducted research and provided advice regarding tobacco control issues.

Instead of banning e-cigarettes, Cabrera and Gostin argue, Indonesia should embrace these innovative products as a harm reduction strategy. They write:

" If Indonesia really wanted to protect kids and improve the public health, it would keep e-cigarettes legal and use them effectively as a less-harmful alternative to smoking. Indonesia could strictly regulate e-cigarettes, such as making them safer, banning e-cigarette advertising that reaches children and banning their use (along with smoking) in public places. But banning e-cigarettes will make reducing smoking more difficult."

"If there were no cigarettes or smoking, banning e-cigarettes would make good sense. But the main tobacco/nicotine public health problem facing the world today is smoking, and Indonesia has one of the world’s highest rates of cigarette smoking. E-cigarettes should not divert policymakers attention away from implementing strong new measures to sharply reduce smoking and all the unnecessary death, disease, disability and economic costs caused by smoking."

"Better yet, policy makers should recognize that e-cigarettes offer a useful tool for reducing smoking. Indeed, from a public health perspective, the only reason to allow e-cigarettes to be legally marketed and sold is to serve as an alternative source of nicotine for addicted smokers. Moreover, the availability of e-cigarettes as a smoking alternative opens the door to much more aggressive anti-smoking measures."

The article concludes:

"By banning e-cigarettes, Indonesia has got it backwards and curtailed its ability to minimize smoking in the future. Banning any category of tobacco products is a commendable display of active tobacco control policy making. But Indonesia is directing its tobacco control policies at the wrong target."

The Rest of the Story

Unfortunately, what Professors Cabrera and Gostin say about Indonesia having it backwards applies equally well to the mainstream tobacco control movement in the United States. The anti-smoking movement in this country has become almost obsessed with e-cigarettes and has re-defined the problem of tobacco-related disease and death as being one of e-cigarette use, rather than smoking, even though e-cigarettes contain no tobacco! In fact, the CDC and other national health groups have downplayed recent surveys showing that youth smoking has declined to historically low levels, arguing that these gains are being offset by the rise in youth experimentation with electronic cigarettes.

The CDC is deceptively classifying e-cigarettes as a tobacco product, and has told the public that youth tobacco use has remained unchanged, even though youth smoking rates have dropped precipitously in recent years. The FDA is spending nearly all of its time on e-cigarette regulation, and has not taken a single step to require changes in cigarettes to make them safer or less addictive. Instead, it is using all of its regulatory authority to create hurdles for e-cigarettes, which are already much less harmful and much less addictive than cigarettes.

Many anti-smoking groups are pushing for legislative protections for real cigarettes that would shield them from competition from the fake, and much safer ones. Misguided policies such as levying heavy taxes on e-cigarettes will result in a switch from e-cigarettes to real cigarettes for many existing vapers and will dissuade many smokers from quitting via e-cigarettes. Moreover, many anti-smoking groups are demanding that e-cigarettes be regulated in an identical manner to real cigarettes, which again provides a protective shield for the cigarette industry by decreasing the threat posed by an alternative nicotine-containing product that might otherwise eat heavily into cigarette sales.

Professors Cabrera and Gostin are absolutely right in pointing out that the continued spread of e-cigarettes among adult smokers is going to make possible much stricter regulations on cigarettes than would otherwise be possible. For example, greatly reducing the nicotine levels in cigarettes might not be feasible if there is no alternative to cigarettes, but with the availability of e-cigarettes as an alternative, such a measure could potentially be a workable option. Anti-smoking groups are going to end up destroying this possibility by their continuing to demonize e-cigarettes.

The end result of the current position of the mainstream anti-smoking movement on e-cigarettes is the worsening of the public's health by reducing or eliminating the transition from smoking to vaping and ultimately to complete nicotine cessation for many vapers. The policies being promoted by many anti-smoking groups, as well as the misleading information they are disseminating, will result in increased cigarette consumption compared to what would have happened had these groups chosen to embrace e-cigarettes rather than the real ones.

We are already witnessing the damage being done by the anti-smoking movement. The public's appreciation of the hazards of cigarette smoking has declined, as evidenced by an increasing proportion of the population believing that e-cigarettes are just as hazardous or even more hazardous than smoking. While these groups don't recognize it, in their zeal to demonize vaping they are actually helping to re-normalize smoking.

Tuesday, June 09, 2015

University of Kentucky Center for Smoke-Free Policy Lying to Public About Effects of Smoking

It used to be that we could turn to the tobacco industry if we wanted to see examples of lies being told to the public that minimized the hazards of smoking. But ironically, it is the University of Kentucky Center for Smoke-Free Policy, a public health group, that is lying to the public about the hazards of smoking.

According to a "fact sheet" produced by the Kentucky Center for Smoke-Free Policy, the acute effects of smoking on the lungs are similar to the effects of vaping. Since vaping has no clinically meaningful effects on the lung and has been shown not to affect lung function as measured by spirometry, the Center is essentially telling the public that smoking has very little acute effect on lung function. This is of course not true because smoking does cause an acute decrement in lung function as measured by spirometry.

The Kentucky Center for Smoke-Free Policy states as follows:

"Using electronic cigarettes for even a span of five minutes has been found to cause lung effects similar to smoking."

The clear insinuation of this statement is that the acute effects of vaping and smoking on lung function are about the same. This is not true. While smoking has been documented to acutely affect lung function, electronic cigarettes have been shown not to cause any clinically meaningful decrement in lung function. What has been shown is that e-cigarettes can cause mild respiratory irritation which can result in sub-clinical signs of increased respiratory resistance. However, this irritation does not cause a measurable change in lung function as measured by spirometry. In contrast, cigarette smoking does cause such a change.

Specifically, Flouris et al. reported that: "Neither a brief session of active e-cigarette smoking (indicative: 3% reduction in FEV1/FVC) nor a 1 h passive e-cigarette smoking (indicative: 2.3% reduction in FEV1/FVC) significantly affected the lung function. In contrast, active (indicative: 7.2% reduction in FEV1/FVC) but not passive (indicative: 3.4% reduction in FEV1/FVC) tobacco cigarette smoking undermined lung function." The authors concluded that: "The assessment of lung function demonstrated that neither a brief session of active e-cigarette smoking nor a 1 h passive e-cigarette smoking session significantly interfered with normal lung function. On the other hand, acute active and passive tobacco cigarette smoking undermined lung function, as repeatedly shown in previous studies... ."
 
In fact, it has been documented that asthmatic smokers who switch to electronic cigarettes experience immediate improvement in their lung function, both subjectively and objectively. Thus, the evidence is extremely strong that the acute lung effects of electronic cigarettes are strikingly different than those of real cigarettes.

If the tobacco industry made such a claim, anti-smoking advocates would nail them to the wall. We would immediately attack the companies, accuse them of undermining the public's appreciation of the severe health hazards of smoking, and condemn them for claiming that the respiratory effects of smoking are only as bad as those of vaping (which we know are minimal).

If the public actually believes what the Kentucky Center for Smoke-Free Policy is saying, they will think that smoking is only a mild respiratory irritant, nothing more. Even the tobacco companies of old didn't make such a claim.

Elsewhere, the Kentucky Center for Smoke-Free Policy repeats this bogus claim that smoking and vaping have essentially the same effect on the lungs. In another "fact sheet," the Center writes that vaping "hurts your lungs like smoking."

Once again, the clear insinuation is that the respiratory effects of smoking and vaping are similar.

Sadly, this brochure actively discourages smokers from quitting via e-cigarettes, asking: "Why spend your money on some new way to get hooked?" While I have criticized some physicians and anti-smoking advocates for not embracing electronic cigarettes, this is much worse. It is actively discouraging smokers who might otherwise quit successfully (as thousands have done) from making a quit attempt using e-cigarettes. This is irresponsible and damaging medical advice.

I have already pointed out that the Center manufactured a claim that e-cigarettes cause cancer, without any supporting evidence. Interestingly, while the Center believes that we need more information before we can conclude that e-cigarettes are safer than smoking, it apparently doesn't need any clinical evidence to conclude that vaping causes cancer. The basis of the Center's claim was the finding of trace levels of nitrosamines in e-cigarette aerosol. What the Center fails to inform the public is that the levels of nitrosamines in e-cigarette aerosol are about the same as those present in nicotine patches and nicotine gum. However, the Center does not claim that nicotine gum causes cancer. Apparently, tobacco-specific nitrosamines only cause cancer when they are present in e-cigarettes, not in other nicotine-containing products, even if the levels of nitrosamines are the same.

The Rest of the Story

Let me first make it very clear that I fully support the mission of the Kentucky Center for Smoke-Free Policy. As my readers know, I have lobbied extensively throughout the country for smoke-free workplace, bar, restaurant, and casino policies.

However, I don't see why there is a need for us to lie in order to advocate public health policies. Why do we need to completely undermine the public's appreciation of the severe hazards of smoking by equating the effects of smoking on lung function with those of electronic cigarettes? Why do we have to try to convince the public that vaping for just 5 minutes is just as bad as smoking? Why do we have to manufacture evidence that doesn't exist, such as telling the public that e-cigarettes cause cancer, when there is not a shred of clinical evidence that this is true?

Even though I disagree with the Kentucky Center for Smoke-Free Policy regarding their position on the role of e-cigarettes in smoking cessation, I would fully respect their right to oppose the use of e-cigarettes as a harm reduction strategy in tobacco control if they would only tell the truth. I cannot respect lying to the public in order to demonize e-cigarettes.

At the end of the day, when we lie to the public we are acting no more ethically than the tobacco companies of old, from which we would always separate ourselves on the basis of us being honest and them being liars. Sadly, we cannot do that any more. And what is gained by our lying?

Nothing. We can promote the public's health by simply telling the truth. It is enough and always has been.

Sunday, June 07, 2015

Tobacco Control Advocate Argues that to Reduce Smoking, We Should Ban Fake Cigarettes But Keep the Real Ones

In a twist of logic that completely defies me, an Australian professor and tobacco control advocate is calling for a complete ban on e-cigarette sales, but wants real cigarettes to continue being sold. And such a policy, he argues, is designed to reduce smoking.

In an article in the Sydney Morning Herald, this professor argues that e-cigarettes should be completely banned because of concerns about their safety and efficacy and because of what he claims are outrageous claims and irresponsible promotion.

According to the article: "Professor of Health Policy at Curtin University Mike Daube said Australia was leading the world on reducing smoking, and the last thing we needed was the distraction of e-cigarettes. 'It is worrying that although there are serious concerns about both safety and efficacy, these products are being sold and promoted,' he said. 'Some of the products on the market are simply outrageous, with utterly irresponsible promotion. The priority now is to get on with all the action we know can reduce smoking, and not be distracted by the siren songs of Big Tobacco and fly-by-night companies.'"

However, despite even worse concerns about the "safety and efficacy" of real cigarettes and a history of "outrageous claims" and "irresponsible promotion," the same professor wants smokers to be able to continuing buying these deadly products. In fact, he has publicly argued against banning real cigarettes.

With respect to cigarettes, Professor Daube argues that: "It is one thing to protect non-smokers from the harms of passive smoking, but banning someone from engaging in an activity in private falls into a different category."

But apparently, banning someone from engaging in an activity in private doesn't fall into a different category if that activity happens to be vaping.

A second reason Professor Daube gives for keeping cigarettes on the market is that: "We have to recognise that some smokers find it hard to quit, and a complete ban on smoking is a measure that could lead to legitimate counter-arguments. Proposals for a total ban on smoking would provide justification for hitherto unsubstantiated claims from tobacco companies and their fellow-travelers that tobacco control advocates are penalising and persecuting smokers, when the reality is that our activities are aimed at helping them... ."

But apparently, a complete ban on vaping does not lead to any counter-arguments. Furthermore, Daube argues that while smoking shouldn't be banned because some will argue that it is an attempt to punish and persecute smokers, he apparently doesn't see any way the same argument could be made about banning vaping, even though such a ban would deprive smokers of a bona fide method of quitting smoking that is in huge demand throughout the world.

Professor Daube argues that: "We should look for new approaches to curbing cigarette sales and discouraging smoking."

But apparently, those new approaches do not include promoting a switch from deadly smoking to a much safer product which contains no tobacco and involves no combustion, and which has been used by thousands of smokers to quit smoking when all traditional approaches failed.

Tobacco industry experts have predicted that cigarette consumption could be cut in half within a decade if e-cigarettes are allowed to be promoted and sold. Professor Daube, however, prefers to prevent this from happening by banning e-cigarettes, all the while fighting against a ban on the real ones: tobacco cigarettes which are actually killing people. 

The Rest of the Story

It makes no sense to me to ban e-cigarettes while allowing the real ones to remain on the market. If anything, we should be moving in the opposite direction: shifting the use of nicotine from extremely hazardous cigarette smoking to much lower risk non-tobacco, non-combusted products.

I just don't understand how the logic in the tobacco control movement has become so seriously warped. We are now arguing that to reduce smoking, we should protect Big Tobacco's cigarettes from competition from much safer products that do not contain any tobacco.

Why do we want to do this huge favor for the cigarette industry? Why do we want to ban a product that is seriously eating away at cigarette sales and is projected to take a huge chunk out of cigarette sales in the near future? Why do we want to ban people from engaging in an activity in private, and at that, an activity which is likely greatly reducing their risk of disease and death? Why do want to interfere with the autonomy of smokers to make a decision that just might save their lives? Why do we want to ban a bona fide method for smoking cessation that has been successful for thousands of smokers, especially when the success rates for treatments currently on the market are a dismal 10-12%?

The logic of the modern-day anti-smoking movement defies me. Does anyone care to explain?

Thursday, June 04, 2015

IN MY VIEW: American Lung Association Would Rather Have Smokers Die than Switch to Electronic Cigarettes

In one of the most absurd and irresponsible positions I have ever seen taken by a public health organization, the American Lung Association recently updated a public statement that urges smokers not to use e-cigarettes to quit smoking.

The two major reasons given for this advice are:

1. That the American Lung Association is "concerned about the potential health consequences of electronic cigarettes."

2. That the American Lung Association is concerned about "the unproven claims that they [e-cigarettes] can be used to help smokers quit."

The American Lung Association's advice to smokers is as follows:

"The American Lung Association is troubled about unproven claims that e-cigarettes can be used to help smokers quit. The FDA's Center for Drug Evaluation and Research has not approved any e-cigarette as a safe and effective method to help smokers quit. When smokers are ready to quit, they should call 1-800-QUIT-NOW or talk with their doctors about using one of the seven FDA-approved medications proven to be safe and effective in helping smokers quit."

The Rest of the Story

The rest of the story is that what the American Lung Association is essentially saying is that they would rather have smokers die than quit smoking using electronic cigarettes.

The American Lung Association's recommendation for all smokers is that they not use e-cigarettes to quit smoking. In 2015, this is a completely irresponsible position. What it means is that the ALA is recommending to smokers who have tried and failed to quit previously with FDA-approved medication and who know that they will not be able to quit successfully using those drugs that they continue to make futile attempts to quit smoking, rather than try a new approach that has worked for thousands of smokers, many of whom testify they they could not have quit in any other way.

The ALA fails to recognize that the FDA-approved medications have a dismal record of effectiveness. They work in only about 10% of cases. For the other 90% of smokers, the ALA would apparently rather they keep smoking than that they give e-cigarettes a try.

The ALA is rightly concerned about potential health consequences of e-cigarettes; however, the current evidence documents that these products are much safer than regular cigarettes. In condemning the use of e-cigarettes because of concerns over their "health consequences," the ALA is actually demonstrating a complete lack of concern over the health consequences of smoking. What the ALA is basically saying is that they are complacent with people dying from a product with known risks, but cannot tolerate the unknown risks of what has been proven to be a much safer alternative.

If a physician were to give this same advice to a patient, I would go so far as to suggest that the advice would represent malpractice. If a smoker does not believe he or she can quit using drugs, but is very excited about the prospect of using e-cigarettes to quit smoking, then no physician should discourage the patient from making such a quit attempt.

Sadly, this is exactly what the American Lung Association is doing. Their statement literally discourages smokers who believe that they can only quit with e-cigarettes from proceeding with that quit attempt. This is tantamount to advising those smokers to continue smoking rather than make the quit attempt using e-cigarettes.

The American Lung Association is also being scientifically irresponsible. First, while it is true that the long-term consequences of e-cigarette use are not precisely known, it is quite clear that there are no major acute consequences of using e-cigarettes and further, the best available evidence makes it clear that any unknown long-term consequences of e-cigarette use are dwarfed by the known consequences of continued cigarette smoking.

Second, the ALA is simply wrong in arguing that e-cigarettes have not been shown to help smokers quit. Not only have scientific studies confirmed that e-cigarettes have helped thousands of smokers quit, but the most rigorous study - a randomized clinical trial - demonstrated that e-cigarettes are at least as effective as the nicotine patch, a medication that the ALA does recommend.

In my view, the only thing that can explain this absurd position is an underlying (subconscious) hatred of smokers. Imagine if you had a loved one who was a long-term smoker and had tried unsuccessfully to quit using the nicotine patch, Chantix, Zyban, and several other FDA-approved drugs. Now they come to you and ask your advice. They have heard from many friends that e-cigarettes were effective in helping them quit. They are excited about the prospect of trying to quit using e-cigarettes. What should they do?

I contend that if you love that person, you would encourage them, with all your heart, to make that quit attempt. In my opinion, only an underlying hatred of smokers could justify recommending that they not make such a quit attempt. But this is exactly what the ALA is doing.

Sadly, while I write about the American Lung Association, my comments hold equally for the American Cancer Society, which makes the same recommendation:

"Because the American Cancer Society doesn’t yet know whether e-cigarettes are safe and effective, we cannot recommend them to help people quit smoking. There are proven methods available to help people quit, including pure forms of inhalable nicotine as well as nasal sprays, gums, and patches. Until electronic cigarettes are scientifically proven to be safe and effective, ACS will support the regulation of e-cigarettes and laws that treat them like all other tobacco products."

The only one of the three voluntary health organizations that takes a somewhat responsible position is the American Heart Association, which at least recommends that e-cigarettes be used as a second-line therapy in patients who fail using the FDA-approved medications. The American Heart Association states:

"Some studies suggest that the use of e-cigarettes to help smokers quit may be equal or be slightly better than nicotine patches. The association will continue to encourage clinicians to use proven smoking-cessation strategies as the first line of treatment for any patient. But it reiterates in the statement that when repeated efforts with conventional treatment fails, is intolerant, or rejected by a patient who wants to utilize e-cigarettes to help them quit, clinicians should not discourage their use by the patient."

That the American Lung Association and American Cancer Society do discourage the use of e-cigarettes when repeated efforts with conventional treatment fails, is intolerant, or rejected by a patient who wants to ustilize e-cigarette to help them quit is, frankly, despicable. It shows a loss of these organization's understanding of their underlying mission, which is to save lives, not to eliminate any and all unknown health risks, no matter how small. And finally, it suggests a lack of true concern for the health and lives of smokers.

Tuesday, June 02, 2015

Rest of the Story Posts Retraction and Apology

In a post published earlier today, I argued that the Kentucky Center for Smoke-Free Policy was lying in telling the public that "formaldehyde (embalming fluid) is just one of the toxic chemicals in the liquid and the aerosol."

It turns out that formaldehyde has been detected in a number of e-liquids. At the time, I was not aware of the fact that formaldehyde was present in many e-liquids. I was only aware that it was a by-product of overheating of propylene glycol and that it therefore appeared in the aerosol of some brands of e-cigarettes.

I therefore stand corrected. In the Varlet et al. study published earlier this year, formaldehyde was present in the e-liquids tested at a concentration ranging from 0.06 ug/g to 9.00 ug/g.

While it is still untrue to claim that embalming fluid is a toxic chemical present in e-liquids (since embalming fluid itself is not added to e-liquid), it is true that formaldehyde is present in many e-liquids as well as in e-cigarette aerosol of some products.

Therefore, I apologize to the Kentucky Center for Smoke-Free Policy and retract my claim that they are lying to the public in telling us that there is formaldehyde present in e-liquids.

The Rest of the Story

The presence of formaldehyde in many e-liquids is troubling for several reasons.

First, it suggests that the presence of formaldehyde in many e-cigarette brands is not exclusively due to the formation of formaldehyde upon overheating of the e-liquid. It is possible that in some cases the formaldehyde is a contaminant already present in the e-liquid and that it enters the aerosol directly from the liquid without requiring overheating and a degradation process.

Second, this suggests that the standards used in e-liquid production are not nearly as good as I thought they were. The presence of formaldehyde in the e-liquids suggests that low quality raw materials are being used in the production process. It is also possible that formaldehyde is present in some of the flavorings used

Third, this has implications for e-cigarette regulation because it suggests that the regulation of coil temperature may not be sufficient to protect against the presence of formaldehyde in the aerosol. Instead, it may be that the FDA needs to simply set standards for the maximum allowable concentration of formaldehyde in the e-vapor (i.e., aerosol) and require each company to test and confirm that the aldehydes in the aerosol of their products do not exceed specified levels (acetaldehyde is also of concern).

The rest of the story is that given this new information, I believe that setting specific quality standards for electronic cigarettes is now an absolute necessity. The FDA must abandon its preliminarily indicated approach of requiring tens of thousands of pre-market applications that will take years to process and instead must simply promulgate minimum quality standards that all companies must follow. Anything short of this will fail to protect the public's health and will potentially put vapers at unnecessary excess risk for a matter of years. The quality standards must include maximum allowable levels of e-liquid and aerosol contaminants, especially diethylene glycol, ethylene glycol, formaldehyde, acetaldehyde, and acrolein.

Wednesday, May 27, 2015

Center for Tobacco Products Research Priorities Do Not Include Studying Potential Benefits of E-Cigarettes for Smoking Cessation

While the FDA's Center for Tobacco Products (CTP) has repeatedly claimed that it is intending to regulate e-cigarettes based on the results of scientific research, a close examination of the CTP's research portfolio reveals that the agency is heavily funding research on the potential risks of e-cigarettes but does not have a single long-term clinical trial to evaluate the potential benefits of e-cigarettes for smoking cessation.

It is great to claim to be evidence-based, but if the only evidence you produce is about the risks and none about the benefits, you can't help but conclude that the identified risks outweigh the benefits. And this appears to be exactly how the CTP has stacked the deck.

This bias is apparent even in the CTP's description of its e-cigarette research. In terms of research priorities regarding e-cigarettes, this is how CTP describes them:

"E-cigarette initiation, use (including transitions to other tobacco products and multiple use), perceptions, dependence, and toxicity."

There's a lot here about potential risks, including youth initiation, dual use, gateway to tobacco product usage, dependence, and toxicity. However, there's nothing here about the potential benefits, such as effectiveness in getting people off cigarettes!

Then, if you examine the current research on e-cigarettes that CTP is funding, you will find plenty of studies on the potential risks of e-cigarettes, but not a single clinical trial that examines the effectiveness of e-cigarettes for smoking cessation or reduction over more than a three-week period.

Thus, the deck is stacked against e-cigarettes. The research will reveal many risks but it cannot possibly identify the most important potential benefit: long-term usefulness in smoking cessation, potentially at a level that exceeds that for current FDA-approved therapies. There's simply no way to find out without conducting such a clinical trial, yet none is being funded by CTP.

Given this heavily biased research agenda, there is no way that the CTP will be able to come up with any conclusion other than that e-cigarette risks outweigh their benefits.

Unfortunately, this is not an objective research plan. Although each individual study, taken separately, may be valid research, the plan as a whole is heavily biased. This story shows how one can bias research results not necessarily by altering the results of a single study, but by crafting a research agenda that stacks the deck toward the desired finding.

The Rest of the Story

Unfortunately, if we want to see research that evaluates the potential benefits of e-cigarettes, we're apparently not going to get it from the agency that is regulating these products. The only hope of obtaining such research is if the e-cigarette industry itself conducts the research. But this is a catch-22 because if the industry conducts the research, anti-smoking advocates will immediately discredit it on those grounds alone.

For good reason, I am therefore not optimistic about the prospects for an evidence-based approach to e-cigarette policy and/or for an evidence-based approach to e-cigarette regulation.

This is tragic, because the end result is to put a protective shield around tobacco cigarette sales and help to ensure that tens of millions of smokers remain addicted to the most toxic consumer product on the market, without the opportunity to transition to a much safer alternative that could save their lives.