Wednesday, January 18, 2017

Nurses Get Into the Act: Smoking is No Worse than Vaping! Don't Commend Patients for Quitting Smoking Using E-Cigarettes

Apparently, irresponsible medical advice being given to smokers about quitting is not restricted to physicians. Nurses are getting in on the act and publicly making the most reckless medical recommendations to smokers. Two egregious examples highlight the incompetent and ill-considered information being disseminated to the public in the nursing literature.

1. Smoking is No Worse than Vaping

According to an article in the current issue of the journal Nursing, two instructors at the Georgetown University School of Nursing and Health Studies claim that smoking may be no more hazardous than vaping. According to the article:

"Because e-cigarettes don't contain tobacco, they're purported to be “less toxic” than traditional tobacco products, but the lack of long-term research and the variability among available products makes this claim unsubstantiated to date."

This is complete nonsense. There is abundant evidence that vaping is much safer than smoking. Even the most ardent opponents of vaping agree that although not absolutely safe, vaping is much safer than smoking. There is abundant research which demonstrates this. But it is also common sense, as electronic cigarettes contain no tobacco and do not involve combustion. How could they be as dangerous as tobacco cigarettes, which we know kill more than 400,000 Americans each year? There is no legitimate scientific dispute over the fact that vaping is much safer than smoking.

Spreading this kind of misinformation demonstrates both incompetency and a lack of responsibility. Medical practitioners should not be disseminating false health information, especially about something so important as the severe hazards of smoking. To undermine the public's appreciation of the severity of smoking's hazards by comparing real cigarettes to fake ones is doing a huge disservice to the public and to smokers in particular. 
2. Smokers Who Quit Using E-Cigarettes Should Not be Commended

According to an article in the Journal of the American Association of Nurse Practitioners, nurses discourage patients who smoke from trying to quit using e-cigarettes and furthermore, they should not commend patients who have already quit smoking using e-cigarettes!

According to the article: "Currently, it is neither advisable for practitioners to recommend e-cigarettes for smoking cessation, nor is it recommended to commend patients for making the switch to e-cigarette use over traditional cigarette smoking."

It is certainly inappropriate medical advice to discourage smokers from using e-cigarettes in a quit attempt, especially if they are highly motivated about the idea of e-cigarettes and have not had success with traditional approaches. But it is insane to recommend that nurses not commend patients who have successfully quit smoking just because they happened to achieve success using e-cigarettes.

Have we completely lost our mind? 

I just cannot understand how a nurse could possibly be advised not to commend a patient who successfully quit smoking. It is an amazing accomplishment and the patient deserves the highest commendation for such an achievement. To withhold such a commendation simply because you don't happen to like the methods the patient used is, frankly, sick. It suggests that the health of the patient doesn't matter. What matters is that the patient quits the way this particular nurse thinks is best.

It would be one thing to suggest that nurses caution smokers that e-cigarettes are not effective for everyone. But if a smoker has tried e-cigarettes and succeeded in quitting smoking, then what is there not to like? What is the problem with that? I'd call that a public health miracle. 

It is like a spit in the face to the estimated two million Americans who have successfully quit smoking using electronic cigarettes.

Thursday, January 12, 2017

E-Cigarettes May Cause Kids to Break into Homes and Turn to a Life of Street Crime, Physician Warns

An emergency medicine physician has warned that e-cigarettes may lead to kids breaking into homes and turning to a life of street crime in order to feed their addictions to serious drugs.

In a Huffington Post column, he claims that due to e-cigarette experimentation: "teenagers — and even younger children — are getting addicted early, which could lead to smoking, and e-cigs can easily become a gateway to trying and developing an addiction to more serious drugs. Addiction correlates to crime. People need to feed their habit, they break into homes to steal things to resell, they commit robberies on the streets, all to get money to feed their addiction."

In the column, the physician also claims that vaping causes popcorn lung: "We know that when inhaled, diacetyl causes a type of bronchitis known as “popcorn lung” — a scarring of the tiny air sacs in the lungs resulting in the thickening and narrowing of the airways."

To put the icing on the cake, he claims that smoking may not be any more hazardous than vaping: "The act of “vaping” is often thought of as a safer alternative to smoking, but that’s not necessarily the case."

The Rest of the Story

Not a day has passed in 2017 that an anti-tobacco group or health professional hasn't lied to the public about the health risks of e-cigarettes. The contestants for the 2017 Lie of the Year Award are already lining up in huge numbers, and it's only early January.

Just to set the records straight, there is no current evidence that e-cigarette experimentation leads to an addiction to smoking or any other drugs. There isn't even evidence that e-cigarette use causes nonsmoking youth to become addicted to vaping itself. The overwhelming majority of nonsmoking youth who have experimented with e-cigarettes have not become regular vapers. The proportion of nonsmoking youth who report having vaped in the past 30 days is substantial, but the percentage of those who vape daily - a pattern suggesting addiction - is very small. So it's a bit of a stretch perhaps to argue that a kid who tries an e-cigarette today will tomorrow be breaking into homes to feed a serious drug addiction.

There is also no evidence that vaping causes popcorn lung. Despite of the fact that there are millions of vapers in the U.S., there has not been a single reported case of popcorn lung among this population. Moreover, smoking itself has not been associated with popcorn lung, and cigarette smoking exposes users to levels of diacetyl that are hundreds of times higher than with vaping.

Finally, there is abundant evidence that smoking is far more hazardous than vaping. This is hardly surprising, since e-cigarettes do not contain tobacco and there is no combustion or smoke.

I'm sure this physician is well-intended and is just trying to protect kids from potential risks; however, I don't think we need to lie to kids or greatly exaggerate the risks. Not only is it inappropriate to lie to and mislead youth, but this strategy has been shown many times over not to work.

The rest of the story: Just remember, the kid you see blowing vape rings today in the school courtyard at recess will soon be a street criminal who is breaking into homes to feed an insatiable addiction to heroin. It's bubble gum and cotton candy vapes today, but it's smack tomorrow.

Tuesday, January 10, 2017

Tennessee Department of Health: E-Cigarettes Create the Threat of Date Rape, Cause Popcorn Lung, and are as Addictive as Heroin

According to a new warning issued by the Tennessee Department of Health (TDOH), use of electronic cigarettes puts youth at risk of date rape. Date rape is just one of numerous devastating consequences that the Tennessee Department of Health is linking to electronic cigarette use, including “popcorn lung” (i.e., bronchiolitis obliterans) and addiction to nicotine that is just as strong as heroin addiction.

According to a “Public Health Advisory” issued by the TDOH:

ENDS can be delivery systems for incapacitating agents such as gamma butyrolactone, GBL, more commonly known as the date rape drug. According to the U.S. Drug Enforcement Association, victims of date rape drugs are frequently not aware of ingesting the drug, which is a central nervous system depressant and may cause drowsiness, dizziness, nausea, loss of inhibition, memory loss and visual disturbance. High doses will cause unconsciousness, seizures, severe respiratory distress, coma and death. Due to induced memory loss, a victim may not be aware of an attack until many hours after it occurred.”

The Tennessee Department of Health also warns that e-cigarette use may cause “popcorn lung,” stating: “The Occupational Safety and Health Administration has warned about the association of inhaling diacetyl with a debilitating condition known as bronchiolitis obliterans (also known as popcorn lung).”

The Department also warns that e-cigarette use is as addictive as heroin: “People should remember that the primary ingredient of ENDS devices is nicotine, an addictive drug that … is the most common form of chemical dependence in the United States; research suggests it is as addictive as heroin, cocaine or alcohol.”

The Rest of the Story

The Tennessee Department of Health would have us believe that experimentation with electronic cigarettes is turning our kids into a generation of nicotine-addicted junkie rapists whose lungs are rapidly obliterating and who are facing imminent death.

Of course, the TDOH is telling a tall tale. The truth – and the rest of the story – is that there is no evidence that e-cigarettes are associated with any of these outcomes.

Date rape

Despite the use of e-cigarettes by millions of youth, there are no confirmed reports of youths sneaking gamma butyrolactone into e-liquids and then using e-cigarettes to drug peers in order to rape them. There is merely one unconfirmed report that this may have occurred once. If the Tennessee Department of Health were truly interested in preventing date rape, why is it not warning that there have been many more confirmed reports of real cigarettes being used to perpetrate date rape (although even that is not a recognized public health problem)? Is the TDOH actually trying to prevent date rape, or is it merely trying to demonize electronic cigarettes? I think the answer is quite obvious.

Popcorn lung

There is no evidence that e-cigarettes cause popcorn lung. Despite millions of e-cigarette users, there has not been a single confirmed case of popcorn lung caused by e-cigarettes. Moreover, since the level of diacetyl in cigarettes is 750 times higher, on average, than in e-liquids, why isn’t the Tennessee Department of Health warning kids that smoking can cause popcorn lung? The rest of the story is that popcorn lung has not even been associated with smoking. There is absolutely no evidence that vaping causes popcorn lung. 

Nicotine addiction

There is actually no evidence at the current time that experimentation with e-cigarettes causes nicotine addiction among youth who are not already tobacco users. We do know that despite the high percentage of youth who are trying e-cigarettes, very few are progressing to regular use and most of those who do are kids who were already smoking or using other tobacco products. The jury is still out, but there is not evidence at this time to support the contention that e-cigarettes are causing nonsmoking youth to become addicted to nicotine.

In my opinion, there is no need for the Tennessee Department of Health to lie to the public. The truth should be enough. The end result of the Department's actions are to trivialize serious problems, including date rape, actual lung disease, and smoking of real cigarettes. The Department also undermines its own credibility, risking the loss of the public's trust. Finally, even if e-cigarettes were a serious public health threat, these hysterical scare tactics have been shown not to work. 

If anything, the Tennessee Department of Health is incredibly irresponsible because publicizing that e-cigarettes can be used to perpetrate date rape will probably lead some youth to actually try it. And that will result in more cases of e-cigarette use for date rape than have actually occurred.

For this reason, I am today demanding that the Tennessee Department of Health immediately retract these claims.

Monday, January 09, 2017

Winner of the 2016 Lie of the Year Award

Today, I am pleased to announce the winner of the 2016 Lie of the Year Award. This award is given to the health agency or organization which has lied most egregiously to the public about smoking and/or vaping in 2016.

The nominees were: the American Thoracic Society, the University of Louisville, Johns Hopkins All Children's Hospital, the Arizona Department of Health Services, the Surgeon General of the United States, the Campaign for Tobacco-Free Kids, the Alaska Department of Health and Human Services, and the Centers for Disease Control and Prevention.

The 2016 Lie of the Year Award goes to ...

... the Centers for Disease Control and Prevention (CDC).

I have made a $100 donation to the American Vaping Association and Consumer Advocates for Smoke-Free Alternatives Association ($50 each) in the name of the CDC in order to help these organizations counteract the misinformation that has been provided to the public by the CDC.

Here is the award-winning entry:

Centers for Disease Control and Prevention (CDC)

Claim: There was no decline in youth tobacco use between 2011 and 2015.

The Truth: There was a substantial decline in youth tobacco use between 2011 and 2015. Vaping is not a form of tobacco use, so it should not be included in the figure reported by CDC.

Details: In April 2016, the CDC issued a press release stating that there was: 

"No decline in overall youth tobacco use since 2011." 

The Rest of the Story

This particular false claim is actually one of a continuing series of falsehoods being disseminated by CDC to the public about electronic cigarettes. By falsely categorizing electronic cigarettes as a form of "tobacco use," the CDC has obscured from the public the fact that there have been dramatic reductions in tobacco use among youth over the past decade, with unprecedented declines in the past several years.

The only way the CDC could hide the truth from the public was to decide to classify e-cigarettes as a form of tobacco use. That allowed CDC to add the actual number of youth tobacco users and the number of e-cigarette users in 2015 and compare this sum to the number of actual youth tobacco users in 2011. Doing so turns a dramatic decline in tobacco use into a straight line and a complete lack of progress in reducing youth tobacco use. But of course, that is a lie, as youth tobacco use has dropped markedly during this time period.

The CDC's lies have continued into 2017. Today on its web site, the CDC claims that: "enhanced prevention efforts for youth are important for all forms of tobacco, including e-cigarettes." Thus, CDC is still telling the public that e-cigarettes are a form of tobacco.

But e-cigarettes are no more a form of tobacco than nicotine gum, nicotine patches, nicotine inhalers, nicotine lozenges, nicotine water, potatoes, tomatoes, eggplant, or cauliflower. All contain nicotine. And the nicotine in the first five products come from tobacco. But you don't hear the CDC going around telling smokers trying to quit using nicotine gum that they are still using a form of tobacco.

A key reason why the CDC was selected for this year's award, despite fierce competition (including the claim that smoking is no more hazardous than vaping), is that the CDC is widely listened to for health information and advice so any misinformation that it spreads is going to do a lot of harm. Moreover, it was the CDC that really initiated the backlash against e-cigarettes in the entire health and medical community, and in the media, by misleading the public in its 2009 press conference, its first major public statements about e-cigarettes.

At that press conference, the CDC tricked the public into believing that e-cigarettes were a cancer risk by reporting the finding of "tobacco-specific carcinogens" in e-cigarettes, but without also mentioning the fact that they were only found in trace amounts, that the levels were comparable to those in nicotine gum and the nicotine patch, that these trace levels were merely a result of the fact that nicotine is derived from tobacco and can't be 100% pure, and that at these low levels, there was not believed to be any significant cancer risk.

The CDC was instrumental in starting the misinformed backlash against e-cigarettes, and it has continued to lie and mislead the public to keep this campaign of demonization of e-cigarettes and vaping going. For these reasons, it is truly deserving of this award.

Friday, January 06, 2017

New FDA Rule is Wrong on the Law: Smoking Cessation Claims are Not Inherently Therapeutic Claims Because Smoking is Not a Disease

On Monday, the FDA will issue a new rule whose intent is to clarify the conditions under which electronic cigarettes will be regulated as drugs instead of as tobacco products. Essentially, this amounts to a rule regarding what claims electronic cigarette companies are allowed to make (since few, if any, of these companies can afford the expenses associated with preparing a new drug application).

As the FDA explains, by statute there are two claims that would make an electronic cigarette subject to regulation as a drug under the Food, Drug, and Cosmetic Act:

1) If the manufacturer makes a therapeutic claim

This means a claim that the product is intended to prevent or treat a "disease."

2) If the manufacturer makes a structure/function claim

This means a claim that the product will affect the structure or function of the body in a way different than the way cigarettes have traditionally been marketed.

So far, so good.

Under the second prong (structure/function claims), the FDA correctly points out that if an electronic cigarette were to be marketed with the intended purpose of treating nicotine dependence, preventing nicotine withdrawal, or another purpose associated with the delivery of nicotine that is not typically used with cigarettes, it would be subject to regulation as a drug.

So far, so good.

The Rest of the Story

The problem comes under the FDA's interpretation of the first prong. The FDA argues that pretty much any smoking cessation claim is inherently a therapeutic claim. While the agency does not go as far as proclaiming that there is no exception to this rule, the agency makes it clear that at first blush, any smoking cessation claim will essentially be taken to imply a therapeutic claim.

The document reviews public comments, and the response to Comment 38 is most relevant. The FDA describes the comment as follows: "FDA proposed that a product made or derived from tobacco that is intended for use in smoking cessation be subject to regulation as a medical product. Several comments objected that smoking is not a disease, but a behavior, and that a product that claims to help individuals quit smoking should not be regulated as a medical product absent any assertions that it will prevent disease or treat nicotine dependence." This appears to be my comment or at least to follow the lines of the argument that I've made several times on this blog.

In response, here is what the FDA says: "Over the past 50 years, smoking has been causally linked to diseases of nearly all organs of the body, diminished health status, and fetal harm. Most current adult  smokers want to quit smoking completely for health reasons. Given these facts, we believe that statements related to quitting smoking generally create a strong suggestion that a product is intended for a therapeutic purpose. We recognize, however, that public perception can change and evidence maybe developed showing that, in some situations, “smoking cessation” is understood in context as referring to ending the use of traditional cigarettes and switching to a non-combustible product made or derived from tobacco. We have revised the codified language in §1100.5(a) in the final rule, to reflect that “smoking cessation” is one type of intended use related to “the cure or treatment of nicotine addiction."

The response is problematic because it doesn't actually address my argument. The basic argument is that smoking is not a disease, so in isolation, a claim that e-cigarettes are intended to help someone quit smoking is not necessarily a claim that the product is intended to treat a disease. The intention is to help alter a health-related behavior.

Some examples may help illustrate this concept.

Suppose I design a calendar and on each page there is an inspirational quotation intended to inspire people to engage in physical activity. Clearly, the intended use of the calendar is to help change a behavior that has substantial health implications. But it also seems clear that the FDA would not regulate my calendar as a medical device because there is no therapeutic claim. Moreover, there is a second purpose to the calendar: to keep track of appointments. The intention of the calendar is clearly not merely related to helping someone to get more exercise. The quotes could be removed and the calendar might still be useful.

If marketed carefully, e-cigarettes are similar. The primary intended use is to help change a behavior, not to treat a disease. Moreover, the intention of the product is not merely to deliver nicotine but also to serve as a recreational alternative to smoking that simulates the smoking experience. In fact, many e-cigarettes are marketed with zero nicotine e-liquids. This raises a critical point: the nicotine could be removed and e-cigarettes would still be useful to many people. There are a fair number of vapers who indeed use zero nicotine e-liquids.

If e-cigarettes are marketed in widespread fashion with no nicotine and no claims regarding the treatment of any disease, then how can they possibly be considered to be a drug or device based solely on a smoking cessation claim?

Nicotine replacement products are drugs because they are specifically intended to treat a disease: nicotine dependence. They work by delivering nicotine to prevent nicotine withdrawal. In addition, there is no nicotine replacement product that doesn't contain nicotine. The idea of a zero-nicotine patch is ridiculous. Clearly, it is not putting the patch on that is being marketed. What is being marketed is the delivery of nicotine. The patch is just the delivery mechanism.

Things are very different with e-cigarettes. While nicotine is sometimes delivered, the primary feature of the product is that it substitutes for cigarettes. It is a recreational alternative that looks and feels somewhat similar. And the delivery of nicotine is not critical to the product's purpose. Otherwise, there would be no zero-nicotine e-cigarettes on the market.

As the FDA itself points out, the approved label for nicotine replacement therapies states: "Purpose: Stop smoking aid; Use: reduces withdrawal symptoms, including nicotine craving, associated with quitting smoking." The reduction of withdrawal symptoms is critical to the product's function. In addition, it is intended to affect the structure/function of the body because it is designed to occupy nicotine receptors in order to prevent a physiological phenomenon of nicotine withdrawal.

I am not arguing that there are never situations in which a smoking cessation claim by an e-cigarette manufacturer should be treated as a therapeutic claim. But I am arguing that making a smoking cessation claim is not dispositive of demonstrating a therapeutic intent.

First Longitudinal Study to Examine Progression from Vaping to Smoking among Young People Finds No Effect of Vaping

The first longitudinal study that examines progression from vaping to smoking among young people has been published in the journal Addictive Behaviors. The study followed college freshmen at Virginia Commonwealth University for one year to examine whether vaping at baseline was associated with the progression from never smoking to ever and/or current smoking at follow-up.

(See: Spindle TR, et al. Electronic cigarette use and uptake of cigarette smoking: A longitudinal examination of U.S. college students. Addictive Behaviors 2017; 67:66-72.)

As reported by Dr. Stan Glantz, the major finding of the study was that: "controlling for a wide range of demographic and behavioral variables, ... e-cigarette users at baseline were about 3.4 times as likely to be smoking cigarettes a year later as young adults who were not using e-cigarettes."

According to Dr. Glantz, the "evidence just keeps piling up" that experimentation with e-cigarettes causes youth to become cigarette smokers.

The article itself concludes that: "Given that never-smoking participants who had tried e-cigarettes were more likely to initiate cigarette use later, limiting young adults' access to these products may be beneficial."

In other words, the paper appears to be concluding, like Dr. Glantz, that e-cigarette experimentation causes youth to become cigarette smokers.

These conclusions, if accurate, are ominous for the role of vaping as a harm reduction strategy in tobacco control because although e-cigarettes may help many smokers quit, this benefit would be largely offset if e-cigarettes also propel many youth to become smokers.

The Rest of the Story

Before you throw in the towel on the prospects for e-cigarettes as a harm reduction strategy in tobacco control, you may want to consider this:

You have only been told part of the story. There is another part to the story which is curiously omitted by Dr. Glantz and de-emphasized in the paper.

Here is the rest of the story:

The finding that "[current] e-cigarette users at baseline were about 3.4 times as likely to be smoking cigarettes a year later as young adults who were not using e-cigarettes" is just one finding in the paper. A second finding, which is actually more critical than the first and more relevant to the question of whether vaping leads youth to progress to regular cigarette smoking, is the following:

Current e-cigarette users at baseline were no more likely to progress to current smoking than young adults who were not using e-cigarettes.

Dr. Glantz doesn't even mention this key finding. While he reports the finding from the left column of Table 3 (the association between current vaping and ever use of cigarettes), he hides the finding from the right column of Table 3 (the association between current vaping and current use of cigarettes).

What this means is that all we know for sure about the young people who Dr. Glantz would have us believe have become smokers because of e-cigarettes is that they have at least once tried a cigarette, but that they have not smoked a cigarette in the past 30 days. So all these kids who Dr. Glantz would have us believe have been addicted to cancer sticks because of e-cigarettes are actually not current smokers. If the result of regular e-cigarette use is that while you may try a cigarette, one year later you end up not being a smoker, then vaping is doing no harm and e-cigarettes are not serving as a gateway to "a lifetime of addiction to smoking," as the CDC would like us to believe.

Why would someone who is reporting the results of this important study omit this critical finding, the key finding of the entire paper? Clearly, it's because that person is trying to hide that result from you. It's because, I think, the finding being hidden from you is damaging. It's damaging to a pre-determined conclusion that would be threatened if this finding were to be revealed.

Now the authors of the paper itself do not hide this finding completely, but they do de-emphasize it in three ways. First, they de-emphasize the finding by putting it in parentheses. In other words, while they highlight the "positive" finding (current e-cigarette use is associated with young adults trying a real cigarette), they mention the "negative" finding only parenthetically (current e-cigarette use is not associated with young adults becoming smokers).

The abstract reports the results as follows: "Ever use of e-cigarettes (but not current use) also increased participants' likelihood of being current smokers at time 2." The parentheses are not mine, but are in the original manuscript text.

Second, they omit the finding from the "highlights" to the paper, which reports that current e-cigarette use is associated with young people trying a cigarette, but hides the finding that it is not associated with young people actually becoming smokers. The authors also ignore this critical finding in the conclusion section of the abstract, where they conclude that limiting young adults' access to e-cigarettes may be beneficial even though they have not demonstrated any harms and in fact have produced evidence that there are no harms.

Third, the authors try to explain away this critical finding by pointing out that the estimate is unstable because there were so few kids who progressed from vaping to current smoking. In an apparent attempt to explain away the key finding of the paper, the authors emphasize that: "Indeed, only six initial nonsmokers transitioned from a time 1 current e-cigarette user into a current cigarette smoker at time 2."


And alas, that is the entire point here. Out of a sample of 3,757 college students, the investigators were only able to find six young people who transitioned from being a vaper to becoming a smoker!!!

On the other hand, there were 20 students who had used cigarettes at baseline but had ceased smoking and were using only e-cigarettes at follow-up, and there were an additional 45 students who had smoked and vaped at baseline but were only vaping at follow-up. So while e-cigarettes were associated with positive health outcomes for 65 students, they were associated with negative outcomes for just six students.

As you can see, one could easily conclude from this paper that e-cigarette use was actually beneficial to this population of college students.

I wouldn't go that far. However, I do think it is clear that the main finding of the study is that there is no evidence that vaping is causing youth to become smokers and that in fact, the paper provides strong evidence that vaping is not associated with progression to smoking. After all, only six of the 3,757 students were shown to have progressed from vaping to smoking, and those six students were no more likely to have progressed to smoking than students who were not vaping at baseline.

The rest of the story is that far from adding to the (non-existent) evidence that vaping leads youth to become smokers, this study actually provides evidence that the phenomenon of youth becoming vapers and then progressing to become smokers is actually quite rare. Thus, the study actually provides evidence that use of e-cigarettes does not lead over time to youth becoming smokers.

Thursday, January 05, 2017

Physician Says that Youth Vaping Leads to Crack Cocaine Addiction

In an article published on New Year's Eve in the Philadelphia Inquirer, a physician from the Philadelphia College of Osteopathic Medicine tackles what should have been a very simple question: "Are e-cigarettes any safer for my child than tobacco?"

The actual answer, based on the scientific evidence, is unequivocally "Yes." However, that's not her answer.

The Rest of the Story

Instead of simply acknowledging that e-cigarettes are indeed safer than smoking tobacco, the physician gives a five-paragraph answer in which she never actually answers the question. If anything, her dire warnings about the unknown risks of e-cigarettes seems to suggest that her answer is "No."

Certainly, a reader who is unfamiliar with the scientific literature might well come away from this article believing that vaping is just as harmful for their child than smoking.

Sadly, this is not only inaccurate, but it is a tremendous disservice to parents because if they give the same information to their children, it could have devastating public health consequences. If youth are widely led to believe that smoking is no more hazardous than vaping, then the public's appreciation of the severe hazards of smoking will be undermined. This will in turn undermine what has been a remarkably dramatic decline in youth smoking driven by the de-normalization of smoking in our society.

Equally disturbing is how ridiculous this physician's answer is. She argues that: "e-cigarettes are a potential “gateway drug” to other substances, including traditional cigarettes, marijuana, alcohol, and crack cocaine." I defy this physician to identify a single case in which experimentation with electronic cigarettes has led a kid to try crack cocaine. I've read the literature on this topic, and there is absolutely no evidence that vaping is a gateway to crack cocaine use.

Moreover, this claim is ridiculous on its face. Despite the skyrocketing prevalence of e-cigarette experimentation among youth in the past five years, the prevalence of all cocaine use among youth has remained extremely low, at about 0.2%. Moreover, in some sections of the country, like the Northeast, the prevalence of cocaine use among youth is virtually zero, despite extremely high levels of e-cigarette use.

It seems irresponsible of a physician to put out this blatantly false, hysterical information. She essentially blames youth use of cigarettes, marijuana, alcohol, and crack cocaine on e-cigarettes. I've boasted a good deal about the significant contributions that e-cigarettes have made, but stimulating addiction to crack cocaine is not one of them. It would be quite unfortunate if we were to look to the solution to the problem of youth smoking, marijuana, alcohol, and cocaine use by focusing on the scourge of youth blowing a few vape rings from time to time.

The article also gets its facts wrong on the basic elements of the difference between vaping and smoking. The author states that: "the current recommendation is to discourage young people from smoking anything — including e-cigarettes." But you don't smoke e-cigarettes. Vaping does not involve any combustion. In fact, that's one of the most important distinguishing characteristics between vaping and smoking (the other being that e-cigarettes do not contain tobacco).

In defense of her implication that vaping is as hazardous as smoking, the only scientific evidence that the author is able to provide is that there is: "a lack of extensive and solid research on those devices, so many questions remain about their risks."

So you mean to tell me that a product which kills more than 400,000 people each year in the U.S. is no more hazardous than one about which the worst we can say is that its long-term risks have not been quantified? The same thing could be said about many dietary supplements, whose adverse effects have not been studied in clinical trials and are therefore unknown. However, you don't hear reputable scientists going around and telling people that taking dietary supplements is as dangerous as smoking.

A physician who went around telling his patients that dietary supplements may not be any safer than smoking should probably not be treating patients.

The rest of the story is that public health advocates should not be going around telling the public that e-cigarettes may not be any safer than smoking. And they certainly shouldn't be telling parents that if their child tries a vape pen, the next thing you know they will wind up as a crack cocaine addict.

Tuesday, January 03, 2017

You Can't Identify Potential Benefits of E-Cigarettes if You Only Look for the Risks: The Flaw in Current E-Cigarette Research

A new paper published online ahead of print in the journal Preventive Medicine finds that telling smokers that vaping is safer than smoking may lead them to try vaping. In the study, smokers randomized into groups that were either told that cigarettes contain many more toxic chemicals than e-cigarettes or that cigarettes and e-cigarettes contain an equal number of toxic chemicals. The smokers were then asked whether and how that might alter their interest in changing their smoking and/or vaping behavior.

The paper reports that 328 of the 1,164 smokers (28.2%) would likely be dual users of e-cigarettes and tobacco cigarettes after being told information about the relative hazards of smoking compared to vaping. Smokers who were told that e-cigarettes contain fewer harmful chemicals than vaping were much more likely to indicate an interest in dual use.

The paper concludes that: "Smokers associated higher chemical amounts in cigarettes versus e-cigarettes with greater health harms from cigarettes and thus expressed increased interest in dual use. The findings suggest that disclosing amounts of chemicals in cigarette smoke and e-cigarette aerosol could unintentionally encourage dual use."

In the discussion, the paper argues that these findings have implications for the messages that the FDA delivers to the public regarding vaping products:

"FDA is required to publicly display information about the quantities of chemicals in cigarettes and cigarette smoke in a way that is not misleading. This information, if paired with information from advertising or FDA disclosures indicating that e-cigarette aerosol contains lower amounts of those same chemicals, could have the unfortunate effect of encouraging smokers to become dual users or increase their existing dual use under the mistaken impression that they are significantly reducing their health risks."

The Rest of the Story

At first glance, this study makes it appear that telling smokers that vaping is safer than smoking will have adverse public health consequences because it will lead many smokers to become or remain dual users.

But there are four major problems with this conclusion:

1. If You Only Look at the Risks, You Can't Find the Benefits

While the paper only looks at one potential consequence of telling smokers that vaping is safer (i.e., dual use), there are actually three potential outcomes, each of which was measured in this study:
  • the smoker might express an interest in becoming or continuing as a dual user;
  • the smoker might express an interest in continuing to smoke without using e-cigarettes; or
  • the smoker might express an interest in quitting smoking using e-cigarettes.
The first outcome, the paper argues, is a bad one for public health. The second outcome might be considered neutral, since it does not change the status quo. However, the third outcome is a profoundly positive one for public health, because these smokers, who presumably have not been able to quit (they are still current smokers) intend to quit smoking by switching completely to vaping.

Importantly, this paper only reports the proportion of smokers with the first outcome (i.e., the "bad" one). The paper does not report the proportion of smokers with the second (neutral) or third (good) outcome. Nor does the paper compare the differences in the various messages in stimulating smokers to quit using e-cigarettes (a good outcome). It only examines differences in the messages in the supposedly "bad" outcome.

For example, in the group of smokers who were told that e-cigarettes contain 100 times fewer harmful chemicals than tobacco cigarettes, the paper reports that 88 of the 276 expressed an interest in dual use. But what the paper does not examine is the outcome for the other 188 smokers. Of those 188 smokers, some expressed no interest in quitting using e-cigarettes, but presumably there were some who did. It is critical to know the number of smokers who did express an interest in quitting using e-cigarettes because that would be a very positive outcome. And without knowing the potential benefits of the various health messages, you can't possibly assess the overall public health consequences.

This is particularly problematic because the intended purpose of this research is to inform the FDA and to provide guidance to the agency in deciding what health messages to encourage, use, or allow for vaping products. By only giving the FDA one side of the story, this research hides critical information necessary to weigh potential risks and benefits.

The costs are always going to outweigh the benefits if you only quantify the risks!

Frankly, the entire research and grant portfolio of the NIH and FDA's Center for Tobacco Products is designed in exactly this way. The research is focusing on quantifying the risks associated with electronic cigarettes, but little if any work is being done to quantify the benefits.

2. Dual Use is Not Necessarily a Bad Outcome

The paper makes the assumption that dual use is a bad thing, but it might actually be a very positive development. There is solid evidence that dual use can serve as a transition on the path to eventual smoking cessation. There is also solid evidence that if a smoker is able to cut down substantially on the amount smoked, it could lessen their addiction and make it easier for them to subsequently quit smoking. Moreover, there are health benefits associated with making substantial reductions in the amount smoked, especially in terms of respiratory function and decreasing the rate of progression of lung disease.

The only way in which dual use is a bad outcome is if the smoker, in the absence of e-cigarettes, would have quit smoking. However, we know that the overwhelming majority of smokers who are attracted to e-cigarettes use these products specifically because they have been unable to quit or are not interested in quitting. It is unlikely that any significant proportion of dual users are smokers who would have quit in the absence of e-cigarettes.

3. In Public Health, We Don't Lie to the Public

Even if it is true that telling smokers that vaping is safer than smoking will encourage dual use, and even if dual use had negative public health implications, we can't lie to the public. While there might be fewer vapers if we told the public that smoking is every bit as bad as vaping, lying to the public cannot be justified because honesty and transparency are core ethical principles of the public health code of conduct. The implication of this paper is that we need to avoid telling the public the truth about the relative safety of smoking compared to vaping and that we may even need to lie about the relative risks of vaping compared to smoking.

4. The Impression that Switching from Smoking to Vaping Will Lower Health Risks is Not a "Mistaken" Impression

The paper argues that telling smokers that e-cigarettes contain fewer toxic chemicals than real cigarettes may result in "the mistaken impression that they are significantly reducing their health risks." But this is not a mistaken impression at all! It is a correct impression. Telling smokers that vaping is just about the same as smoking in terms of health risks is what is creating a mistaken impression. If there is any problem with the public's understanding of the relative risks of vaping compared to smoking, it is not the perception that vaping is safer, but instead, it is the perception that vaping is not safer than smoking.

The rest of the story is that if you only quantify the risks of a health message, you can't possibly evaluate the risk-benefit ratio because you can't find benefits if you don't look for them. In this study, only risks are quantified and although the beneficial outcome was measured, it was not analyzed or reported. To properly inform the FDA so that it can formulate rational policies, the agency needs to know about both the negative and positive consequences of a potential action. This paper is only telling part of the story.

Tuesday, December 20, 2016

Switching to Vaping Improves Health of Smokers with COPD

A new study by Dr. Riccardo Polosa and colleagues, published in the journal Respiratory Research, finds that smokers with chronic obstructive pulmonary disease (COPD) who switch to electronic cigarettes experience an improvement in their symptoms and have fewer COPD exacerbations.

(See: Polosa R, et al. Evidence for harm reduction in COPD smokers who switch to electronic cigarettes. Respiratory Research. Published online on December 16, 2016. DOI: 10.1186/s12931-016-0481-x.)

An improvement in respiratory symptoms was observed both in smokers who switched completely to electronic cigarettes and in dual users, although those who switched completely experienced a more substantial improvement.

Although the sample size was small (24 patients in each group), the authors conclude that: "These findings suggest that ECs use may aid smokers with COPD reduce their cigarette consumption or remain abstinent, which results in marked improvements in annual exacerbation rate as well as subjective and objective COPD outcomes."

The Rest of the Story

This study adds to the evidence that electronic cigarettes can play a significant role in achieving harm reduction among smokers who are unable to quit using traditional methods. Why anti-tobacco groups and many health agencies are discouraging smokers from using e-cigarettes to quit smoking is baffling. Ironically, the tobacco companies are encouraging smokers to quit using e-cigarettes, but the health groups apparently don't want to see that happen. There is something very wrong in the modern practice of tobacco control.

Monday, December 19, 2016

Finalists Announced for 2016 Lie of the Year Award

Today, I am announcing the finalists for the 2016 Lie of the Year Award. This award will be given to the health agency or organization which has lied most egregiously to the public about smoking and/or vaping in 2016. Feel free to cast your ballot in the comment section. Readers' votes will be taken into consideration in making the final determination. The award consists of a $100 donation to the American Vaping Association and Consumer Advocates for Smoke-Free Alternatives Association ($50 each) made in the name of the winning organization.

The 2016 finalists are:

1. American Thoracic Society

Claim: E-cigarettes are not safer than conventional cigarettes.

The Truth: E-cigarettes are much safer than conventional cigarettes.

Details: In a press release issued in April 2016, the American Thoracic Society stated as follows:

"Frank Leone, MD, chair of the ATS Tobacco Action Committee, believes the misconception that e-cigarettes are safer than traditional cigarettes is driving the trend to increased use, which puts children and other first-time users at risk for significant health problems."
2. University of Louisville

Claim: E-cigarettes are not safer than conventional cigarettes.

The Truth: E-cigarettes are much safer than conventional cigarettes.

Details: In a July 2016 paper published in the journal Current Cardiovascular Risk Reports, Dr. Aruni Bhatnagar of the University of Louisville concluded that:

"The dose-response relationship between smoking and cardiovascular mortality is non-linear, suggesting that reduction in HPHC concentrations in e-cigarette aerosols may not result in proportional harm reduction and decreased HPHC exposure may be offset by increased use by individuals who believe that e-cigarettes are safer than conventional cigarettes. Thus, taken together, current evidence does not entirely support the notion that e-cigarettes are reduced harm products... ."

3. Johns Hopkins All Children's Hospital

Claim: Vaping is just as dangerous as smoking.

The Truth: Vaping is much safer than smoking.

Details: In an August 2016 web site article, Dr. Rachel Dawkins of the Johns Hopkins All Children's Hospital was quoted as stating:

"Most importantly, parents should talk to their children about the dangers and harmful side effects of e-cigarettes and others drugs. Parents should also consider vaping just as dangerous as smoking cigarettes when talking to their teens about the dangers of tobacco use and smoking."

4. Arizona Department of Health Services

Claim: Vaping is as dangerous as smoking.

The Truth: Vaping is much safer than smoking.

Details: On its web site in October 2016, the director of the Arizona Department of Health Services stated:

"We did research this year with several youth focus groups around the state and found there is a misconception that using a vape pen is not as dangerous as a regular cigarette. The truth is there are many of the same dangerous chemicals in a vape pen that are in a cigarette, including nicotine which is a highly addictive chemical." 

5. Surgeon General of the United States

Claim: Vaping is a form of tobacco use.

The Truth: Vaping is not a form of tobacco use. Electronic cigarettes do not contain any tobacco.

Details: In his 2016 report, the Surgeon General stated:

"These products [e-cigarettes] are now the most commonly used form of tobacco among youth in the United States, surpassing conventional tobacco products, including cigarettes, cigars, chewing tobacco, and hookahs." 

6. Campaign for Tobacco-Free Kids

Claim: Tobacco companies are marketing gummy bear and cotton candy e-cigarettes.

The Truth: None of the tobacco companies markets gummy bear or cotton candy e-cigarettes.
Details: In a solicitation for donations, the Campaign for Tobacco-Free Kids stated:

"These are just a few of the [tobacco] industry's latest tricks: ... Using slick ads, celebrity spokespeople, and sweet flavors like gummy bear and cotton candy to push e-cigarettes."

7. Alaska Department of Health and Human Services

Claim: Using e-cigarettes is riskier than smoking.

The Truth: Vaping is much safer than smoking.

Details: According to a KTUU News article in January 2016, Dr. Jay Butler - the state's chief medical officer - stated: 

"We do see more kids using e-cigarettes now than smoking, so e-cigarettes right now are the neatest, shiniest thing and they're kind of cool so in that sense they do provide a riskier alternative to cigarettes."

8. Centers for Disease Control and Prevention (CDC)

Claim: There was no decline in youth tobacco use between 2011 and 2015.

The Truth: There was a substantial decline in youth tobacco use between 2011 and 2015. Vaping is not a form of tobacco use, so it should not be included in the figure reported by CDC.

Details: In April 2016, the CDC issued a press release stating that there was: 

"No decline in overall youth tobacco use since 2011."

Thursday, December 15, 2016

D.C. District Court Should Issue an Immediate Injunction Against Enforcement of FDA Deeming Regulations

According to an ABC News story, a Connecticut man was injured when an electronic cigarette exploded in his mouth. The problem, according to the local Deputy Fire Marshal, is that "cheaply made aftermarket batteries can short circuit in milliseconds." The article reports that there have been at least 92 other documented explosions.

There seems to be a simple solution to the problem. The company that manufactured the defective e-cigarette used by this Connecticut man should find a different source of batteries, instead of using the cheap aftermarket batteries that can short circuit in milliseconds.

However, there is just one problem. The FDA deeming regulations do not allow that e-cigarette company, or any of the multiple others whose batteries have exploded, to replace the cheap aftermarket batteries with safer ones. If they did so, it would constitute a new "tobacco product," and could not be placed on the market until the company applied for and received a marketing authorization from the FDA, a process that would take years and millions of dollars. So effectively, the FDA has banned safety improvements such as replacing defective batteries.

Because of this, the FDA deeming regulations represent a clear and present danger to the health of the public. Accordingly, the D.C. District Court should issue an immediate injunction against the enforcement of the new tobacco product application provisions of the regulations, thus allowing companies to make critical safety improvements necessary to protect the health and lives of consumers.

The FDA justifies its regulations based on pure speculation about the hazards of vaping products, yet is taking no action to remedy the one documented adverse health effect of these products: the potential for exploding batteries. Not only is the FDA failing to take action about this problem, but it has made the problem much worse by prohibiting companies from fixing the problem.

In all my years in public health, I cannot think of another public health regulatory action that is so acutely threatening to the public's health.

An alternative to a federal court injunction would be an executive action by the new president directing the FDA to immediately halt enforcement of the pre-market tobacco application requirements of the deeming regulations.

The Rest of the Story

Regardless of how anti-tobacco groups feel about the use of e-cigarettes for harm reduction in tobacco control, all should agree that sensible regulations would not block critical safety improvements to these products. The deeming regulations are nonsensical, and they need to be voided and replaced. This is something I and many others will be working on in the new year.

Ironically, the approach being advocated by anti-tobacco groups to providing safeguards against potential hazards of electronic cigarettes is doing the exact opposite. In contrast, my recommended approach - trashing the new product application process and directly promulgating safety standards - would have taken care of the exploding battery problem years ago.

The rest of the story is that the desire to just get rid of these products has overshadowed the desire to actually regulate the safety of the products and to protect public health and safety. In other words, in the tobacco control movement, ideology has overtaken science.

Wednesday, December 14, 2016

Lying for Money: Campaign for Tobacco-Free Kids Solicitation is Fundamentally Dishonest

This Monday, the Campaign for Tobacco-Free Kids sent out a solicitation for donations that stated:

"The tobacco industry spends $9.1 billion a year on marketing in the U.S. alone. That's over $1 million every hour! And much of it is aimed at kids. The industry needs kids as "replacements" for the nearly half a million Americans killed by smoking each year, and for those who quit.They know that 90% of smokers start as teens or earlier. That's why their marketing is geared toward youth. But they're not just selling your dad's cigarettes or your grandpa's cigars anymore. The industry is introducing new products to lure another generation of kids into addiction. And they're going to extraordinary lengths to make these products cheap, "cool," and highly visible."

"These are just a few of the industry's latest tricks: ...
  • Using slick ads, celebrity spokespeople, and sweet flavors like gummy bear and cotton candy to push e-cigarettes."
This certainly sounds like a show stopper and an excellent reason for people to donate to the Campaign. The tobacco industry is targeting kids with gummy bear and cotton candy cigarettes. Sounds pernicious. Who wouldn't want to help the Campaign stop the tobacco industry from preying on kids like this. I mean, seriously? Gummy bear and cotton candy e-cigarettes?

The Rest of the Story

While effective, there's just one problem with the Campaign for Tobacco-Free Kids' appeal:

It's not true!

Not a single one of the tobacco companies is producing gummy bear or cotton candy e-cigarettes.

Altria's MarkTen e-cigarettes come in four flavors: classic (tobacco), menthol, fusion, and winter mint. Their MarkTen XL Bold e-cigarettes only come in two flavors: classic and menthol.

R.J. Reynolds Vapor Company's Vuse e-cigarettes come in seven flavors: original, mint, melon, nectar, berry, chai, and crema.

Imperial Brands' blu e-cigarettes come in 14 flavors: tobacco, menthol, vanilla, cherry, blueberry, peach schnapps, strawberry mint, Carolina bold, pina colada, mint chocolate, glacier mint, caramel cafe, gold leaf, and berry cobbler.

British American Tobacco's Vype e-cigarettes come in 12 basic flavor types: tobacco, apple, master blend, vanilla, mint, wild berry, green snap, scarlet kick, indigo dive, dark cherry, oriental spice, and rich aniseed.

Thus, not a single one of the tobacco companies are producing gummy bear or cotton candy e-cigarettes.

The cotton candy and gummy bear flavors of e-liquids are being produced by independent companies that have nothing to do with Big Tobacco. However, that apparently does not make a good enough story to solicit donations. So instead of just telling the truth, the Campaign for Tobacco-Free Kids decided to lie and tell people that Big Tobacco is the culprit for marketing these flavors.

When I used to work for the American Heart Association, the American Lung Association, and other anti-smoking organizations, we were always very careful to be accurate in our communications, especially when we were accusing the tobacco companies of inappropriate behavior. We carefully documented all allegations that we were making, so as to be sure that we were being truthful and avoiding making potentially defamatory accusations.

Today, it appears that not only caution, but honesty itself is thrown to the wind.

So if the Campaign for Tobacco-Free Kids is going to lie to the public, then why not make the solicitation even more appealing? If the truth doesn't matter, then why not just accuse the tobacco companies of lacing e-cigarettes with cyanide? That would make a great appeal. But if you think the reason the Campaign is not making such a claim is that it is inaccurate, you would be wrong. We've already established that making truthful claims is apparently not part of the criteria for the Campaign's public statements.

The rest of the story is that the Campaign for Tobacco-Free Kids is lying for money. They are dishonestly claiming that tobacco companies are marketing gummy bear and cotton candy e-cigarettes in order to create a more shocking appeal for donations.

I do not understand why there seems to be such a need for health agencies and anti-tobacco groups to lie about electronic cigarettes. And we are not just talking about mild degrees of deception. We are talking here about factual misrepresentations of the truth. I don’t understand why telling the truth is not good enough. Honesty is part of the public health code of conduct. Moreover, since we have spent years attacking the tobacco companies for their history of lies and deceit, it seems that we should be beyond reproach in the honesty of our own public communications. I understand the need to solicit donations, but it seems to me that an honest appeal would have been equally effective.

I have certainly issued my fair share of attacks on the tobacco industry, as much as the next guy. I testified against the tobacco companies at least 11 times, including 5 times in the Engle case alone. But I was always careful to provide documentation of my assertions about the industry’s misconduct. I don’t think the fact that the industry has acted irresponsibly in the past gives us carte blanche to say anything we want about them now.

I think the Campaign for Tobacco-Free Kids needs to produce the documentation that supports its accusation that the tobacco industry is marketing gummy bear and cotton candy e-cigarettes, or else issue a retraction and an apology to their constituents.

Tuesday, December 13, 2016

Claims that Youth E-Cigarette Use Leads to Smoking are Destroyed; 2016 Monitoring the Future Survey Shows Steep Decline in Smoking

The claims of anti-tobacco groups and health agencies -- including the Surgeon General's Office -- that youth e-cigarette experimentation leads to smoking have been essentially destroyed after this morning's release of results from the 2016 Monitoring the Future Survey.

The 2016 survey finds that from 2015 to 2016, current cigarette smoking among 8th and 10th grade students dropped by the greatest amount in history. For 8th graders, current smoking dropped from 3.6% to 2.6%. Among 10th graders, smoking dropped from 6.3% to 4.9%.

Smoking among 12th graders also declined, although not as sharply as from 2013 to 2014, dropping from 11.4% to 10.5%.

From 2013 to 2016, a period during which e-cigarette use among youth skyrocketed, current smoking among 12th graders dropped from 16.3% to 10.5%. Among 10th graders, current smoking during this period dropped from 9.1% to 4.9%.

The survey also found that rates of past 30-day vaping itself among 10th and 12th graders dropped for the second consecutive year, falling from 16.2% to 12.5% among 12th graders and from 14.0% to 11.0% among 10th graders.

The Rest of the Story

At this point, it is clear that whatever the risks of youth vaping may be, one of them is not the risk of progressing to smoking. If this hypothesis were true, we would simply not be seeing the historic declines in youth smoking that are occurring. Quite clearly, smoking continues to be de-normalized, not re-normalized as anti-tobacco groups and many health agencies have claimed. It appears that a culture of vaping is largely replacing a culture of smoking.

If anything, it appears that the advent of e-cigarettes has accelerated the de-normalization of smoking by largely replacing it. Increases in vaping are mirrored by corresponding declines in youth smoking. Vaping appears not to be making smoking more cool, as claimed by the Surgeon General, the CDC, and anti-tobacco groups, but to be making smoking less cool.

It also appears that there has been a plateau and now a decline in the rising fad of youth vaping, which should help ease the concerns of anti-tobacco groups that an entire generation of kids is going to be addicted to nicotine.

These data are cause for celebration. They show that smoking continues to be less cool among teenagers and suggest that the new vaping culture has contributed further to the de-normalization of smoking. Given the high potential of smoking during adolescence to lead to a lifetime of cigarette addiction and its resulting disease and premature death, it appears that the phenomenon of youth e-cigarette experimentation has been a net positive for the public's health, or at very least neutral. This does not mean that youth vaping should be promoted, but it does mean that the claims of health agencies, including the Surgeon General's office, are simply not standing up to scientific scrutiny.

If the science matters in tobacco control - which apparently it doesn't - this should put an end to the Surgeon General, the CDC, and others claiming that youth experimentation with e-cigarettes will lead to a progression to smoking and to a re-normalization of smoking among youth. What we need is not a further campaign of lies and deception about how tobacco use "in any form," including e-cigarettes, is horrific, but a truthful campaign that acknowledges different levels of risk of nicotine-containing products, informs youth that e-cigarettes do not contain tobacco and are therefore not a form of tobacco use, and explains that most e-cigarettes do contain nicotine and may also expose them to other chemicals which could be harmful with long-term use.

It is interesting that the Surgeon General released his report just prior to the release of these new data. Perhaps he realized that once these data came out, his "story" about the scourge of e-cigarettes would be destroyed, so he wanted to get it in so it could have the maximum media impact. Even if it is purely a coincidence, it is going to be difficult to undo the damage caused by the Surgeon General's report.

Arizona Health Department: Vaping is as Dangerous as Smoking; When Will the Lies Stop?

According to the Arizona Department of Health Services, vaping is just as dangerous as smoking. The state health department has initiated a campaign entitled "Vape is a Lie" to teach kids about the dangers of vaping and nicotine use. The director of the state agency describes the primary purpose of the campaign as follows:

"We did research this year with several youth focus groups around the state and found there is a misconception that using a vape pen is not as dangerous as a regular cigarette. The truth is there are many of the same dangerous chemicals in a vape pen that are in a cigarette, including nicotine which is a highly addictive chemical."

According to the Department: "Our goal with this new campaign is to give youth the truth about the potential dangers of using e-cigarettes."

The Rest of the Story

Ironically, the rest of the story is that it is the Arizona Department of Health Services which is telling the greatest lie about vaping. It is simply not true that using a vape pen is as dangerous as smoking a real cigarette. In fact, vaping is much safer than smoking. There is abundant research which demonstrates this. But it is also common sense, as electronic cigarettes contain no tobacco and do not involve combustion. How could they be as dangerous as tobacco cigarettes, which we know kill more than 400,000 Americans each year? There is no legitimate scientific dispute over the fact that vaping is much safer than smoking.

If the goal of the new campaign is "to give youth the truth," then it is failing miserably. Rather than providing youth with the truth, the campaign is blatantly lying to kids. Not only is it giving them false information about the relative risks of vaping vs. smoking, but it is undermining decades of public education about the severe hazards of smoking.

Why is there a need for the Arizona Department of Health Services to lie? Why isn't the truth enough? Not only does this campaign run afoul of the public health code of conduct, of which honesty is a key principle, but the campaign also insults the intelligence of youth. It assumes that kids are so stupid that you have to lie to them. What kind of message does this send, especially to parents? Apparently, the Arizona Department of Health Services thinks that parents should lie to their kids about the hazards of vaping. This runs counter to the basic principles of public health and to the principles of risk communication.

Tim Mechling of Mt Baker Vapor breaks down the dishonesty of the Vape is a Lie campaign in a post aptly entitled "'Vape is a Lie' is a Lie."

Sunday, December 11, 2016

Youth Vaping Plummets in Wake of Surgeon General's Report

A survey conducted by the Pew Foundation this past weekend found that self-reported rates of youth vaping have dropped sharply following Thursday's release of the Surgeon General's report on e-cigarette use, which, after a 263-page review of the scientific evidence, warned that vaping is "not harmless" and that e-cigarette aerosol is not "just water vapor."

Foundation president Robert J. Pew said that although the survey results are subject to a margin of error, "the decline is so sharp that even with the maximum amount of error, the drop in vaping is significant." While Pew acknowledged that the decline cannot "definitively be attributed to the report," the timing of the findings is uncanny and "it is difficult to believe that anything else could explain such a sharp decline."

Pew also noted that it is plausible that the report would have immediately affected so many youth, because "we know how sensitive kids are to finding out that a behavior is not harmless. They immediately stop doing it. We saw exactly the same thing after the Surgeon General released his 2015 report on alcohol, in which he concluded that alcoholic beverages are not just "pure water." Youth drinking rates plummeted within weeks of that report's release.

The Surgeon General's office also defended the plausibility of the quick decline in vaping, reminding reporters of the immediate and dramatic increase in calls to the smoking quitline following the release of the landmark 1964 Surgeon General's report on smoking, which concluded that contrary to public opinion, smoking is "not harmless" and inhaling tobacco smoke is not the same as "breathing in clean air."

Health advocates across the nation have demanded that federal, state, and local governments take drastic action to protect youth from what the American Lung Association has called "a scourge of devastating impacts from exposure to non-harmless chemicals." The American Heart Association similarly warned of what it called "an impending epidemic of non-harmless recreational behavior among our nation's youth."

An American Lung Association spokesperson explained that: "Youth should not inhale anything other than pure, clean air. And they should only engage in behaviors which have been determined by the federal government to be harmless."

The Lung Association spokesperson cited several recent federal actions, such as the elimination of high school football in 2013 after studies showing that repeatedly getting hit in the head with a hard helmet worn by a 215-pound lineman is not harmless and the ban on resistance training programs in high school gym classes because it has been shown to cause an acute increase in the number of epithelial progenitor cells, which Dr. Stan Glantz has said "are markers of damage to the lining of arteries (called the vascular endothelium)." Glantz added that: "Damage to the endothelium is linked to immediate increases of the risk of a heart attack in people at risk of heart attacks and also contributes to the long-term development of atherosclerosis (buildup of blockages of arteries in the heart) and peripheral vascular disease (blockage of other arteries)."

A review of interventions to prevent risk-taking youth behavior published in Annual Reviews of Public Health in 2014 reported that educational campaigns which inform kids that there are possibly some risks associated with health behaviors are "highly effective" in preventing those risk-taking behaviors. The article cited the steep decline in youth marijuana use following the Surgeon General's 2015 conclusion that "the inhalation of smoke from burning leaves containing a psychoactive substance may not be risk-free."

When asked why the report could say nothing worse about vaping than that it is merely "not harmless," the Surgeon General's office explained that: "there actually have been no studies that have documented any actual harms to youth from vaping. It would be pure conjecture to conclude from the present evidence that vaping carries significant harms, and that is not something a Surgeon General's report would ever do."

Despite popular misconceptions, the tobacco companies did not try to impede the Surgeon General's report on smoking in 1964. Joseph F. Cullman III, Philip Morris president at the time, is widely reported to have joked in internal memos: "Johnny is alive and well. If all the Surgeon General can say about smoking is that it is 'not harmless,' we are in a position to thrive. Until something safer comes along - like a non-tobacco cigarette that delivers nicotine without combustion - the market for combustible tobacco products will remain strong and active."

Several high school youth interviewed over the weekend by CNN confirmed that as soon as their classmates learned that vaping was not harmless, they immediately stopped. "Instead of blowing vape rings at parties, the cool thing now is to drink pure mountain spring water," said 16-year-old Heather Walters of Oak Spring, Illinois.

The National Association for the Preservation of Puritan Practices (NAPPP) released a statement praising the Surgeon General's report on vaping: "It's great to see that the Surgeon General of the United States is so deeply committed to preventing even the most minor of risks among youth and that he is willing to hysterically cast as a dire threat any behavior that might convey any risk. It's also great to see that he understands the importance of not differentiating between the levels of different risks. To be pure, moral, and safe, you have to disavow all risky practices, not just the most strikingly dangerous ones. And if you think that switching from an extremely hazardous behavior to one that is just 'not harmless' will save you from eternal damnation, you've got something coming to you."

The Department of Health and Human Services' campaign to condemn e-cigarettes follows a long public health tradition of banning or seeking to prevent any behavior that merely reduces harm. According to a deputy secretary, the demonization of e-cigarettes is consistent with the Department's long-standing opposition to sex education, methadone maintenance programs, needle exchange programs, distribution of naloxone to emergency responders and law enforcement officers, and promotion of "low-calorie" rather than "no-calorie" diets.

ADDENDUM: This is a parody. It was written to highlight the absurdity of the Surgeon General's report and the approach it takes to tobacco control. I thought it was obvious but a number of people have been asking to see the survey results. Stay tuned, however, as there should be some actual survey results out later this week.

Friday, December 09, 2016

Tobacco Industry Unveils New Ad Campaign: "Any Form of Tobacco Use is Harmful, So You Might as Well Smoke"

A major tobacco company today announced a new, national advertising campaign that is based on the primary message that since the Surgeon General has declared that any form of tobacco use is harmful, people might as well smoke since it provides the best "nicotine hit" of any tobacco product currently on the market. The campaign will roll out over the next six months, with print media ads first appearing in February 2017.

Unlike previous tobacco company ad campaigns, which have relied upon the industry's own claims, this campaign is based entirely on the statements of the Surgeon General, the FDA, the CDC, and other public health groups. The company's president and chief executive officer stated in a press release announcing the campaign: "We realize that in 2016, we don't enjoy a great deal of public trust. So we're saying 'don't take our word for it, listen to what public health authorities like the Surgeon General have to say.'"

While the actual ad executions to be used in the campaign have yet to be developed, several mock-ups of sample ads showed that the industry's main message is that people should not be deceived into thinking that by switching from smoking to another form of tobacco use they will eliminate their disease risk. One mock-up emphasizes that even if smokers switch to tobacco-free e-cigarettes, they are still at risk of tobacco-related disease. An excerpt from the text of that ad reads:

"Don't believe us. Here is what the Surgeon General has concluded:

Besides nicotine, e-cigarettes can contain harmful and potentially harmful ingredients, including:

  • ultrafine particles that can be inhaled deep into the lungs
  • flavorants such as diacetyl, a chemical linked to serious lung disease
  • volatile organic compounds
  • heavy metals, such as nickel, tin, and lead."
The second mock-up also quoted from the Surgeon General's report:

"While these products are novel, we know they contain harmful ingredients that are dangerous. Tobacco use among youth and young adults in any form, including e-cigarettes, is not safe."

The tobacco company's director of communications emphasized that: "We agree that all smokers should try to quit. All we are saying is that if someone is unable to quit and makes an informed decision to use a tobacco product, they should understand that all forms of tobacco are unsafe. So whether they are using smokeless tobacco, snus, cigars, e-cigarettes, or the nicotine patch, all tobacco and nicotine products are dangerous."

The same tobacco company also announced that it will initiate a $15 million national campaign to educate youth about the hazards of all nicotine and tobacco use. "Youth need to understand that vaping is not safe. We want all youth to be aware that it doesn't matter whether you smoke, vape, light a cigar, or use a nicotine inhaler. It's all the same. They're all dangerous."

Research has shown that although nicotine is present in cigarettes, cigars, smokeless tobacco, and many e-cigarettes, none of these products delivers nicotine as efficiently as the cigarette, which has been perfected over decades to deliver nicotine quickly into the bloodstream and to the brain in a manner which creates a nicotine "hit" that the user experiences to a much greater degree than with other forms of tobacco. The tobacco company's public relations director stated that: "We are absolutely not encouraging anyone to smoke. We just want them to be aware of the facts as laid out clearly by the Surgeon General. All existing alternatives to the cigarette are hazardous. Don't fool yourself by thinking that if you switch from smoking to say, vaping, you are safe. Just be aware that if you make a decision to use nicotine, smoking is clearly the only activity where you will feel the nicotine hit strongly."

In response to this morning's announcement, several anti-tobacco groups were angry and accused the industry of perpetrating a hoax. The newly-named "Campaign for Nicotine-Free Kids" stated in a press release that: "We don't buy the argument that the industry is just trying to educate youth about the dangers of all tobacco products. We think that by emphasizing that all tobacco use is harmful, by lumping in e-cigarettes with real tobacco cigarettes, the industry wants youth to think that smoking does not carry particularly severe health risks. Putting cigarettes in the same category as vaping products and nicotine patches is deceptive and dishonest. The tobacco companies say they have changed, but this demonstrates that the industry is still living in the 20th century."

The Surgeon General's office, responding this morning to criticism of its characterization of electronic cigarettes as a "form of tobacco use," explained its reasoning:

"Whether e-cigarettes contain tobacco or not isn't the issue. The key point is that most e-cigarettes contain nicotine, a chemical that is a central component of tobacco. Any consumed product that contains nicotine represents a form of tobacco use. Given the known effects of nicotine on adolescent brain development, youth should not be using any tobacco product."

The Associated Press compiled a list of products that meet the Surgeon General's definition of a form of tobacco use. They include:
  • cigarettes;
  • smokeless tobacco;
  • snus;
  • cigarillos;
  • cigars;
  • bidis;
  • hookah;
  • electronic cigarettes;
  • other vaping products;
  • nicotine patch;
  • nicotine gum;
  • nicotine inhaler;
  • nicotine lozenges;
  • potatoes;
  • tomatoes;
  • eggplant;
  • cauliflower;
  • peppers;
  • green tea; and
  • black tea.
While the Surgeon General claimed yesterday that electronic cigarettes are now the predominant form of tobacco use among youth, the Associated Press conducted a fact-checking analysis which revealed that the Surgeon General's statement is not accurate. According to statistics compiled by the AP, tomatoes are actually the predominant form of tobacco use among youth.

The North Carolina Tomato Growers Association reacted angrily to the Associated Press article. A spokesperson for the NCTGA said: "This is really disingenuous. I mean, calling us a form of tobacco use simply because we contain nicotine is ludicrous. Look, the bottom line is we don't contain any tobacco. North Carolina tomatoes are not even grown in the same areas of the state as tobacco. Lumping our products in with cigarettes, which kill hundreds of thousands of Americans each year, is an injustice."

Although a spokesperson for the Long Island Cauliflower Association did not immediately respond, the Association posted on its web site the following statement: "We challenge anyone who declares that cauliflower impairs adolescent brain development to show us the evidence. Yes, cauliflower contains nicotine. We admit that. But it doesn't make us a form of tobacco use. We will take any steps necessary, including legal action, to have our products taken off the Associated Press list."

Thursday, December 08, 2016

Surgeon General’s Report on E-Cigarettes is Scientifically Dishonest

Today, the Surgeon General released a new report on electronic cigarettes, purporting to provide a scientific summary of the evidence regarding e-cigarettes and vaping products. However, the report is scientifically dishonest and it essentially lies about the single most important fact that the public needs to understand about e-cigarettes and vaping products: that they do not contain tobacco and therefore, vaping is not a form of tobacco use.

The Rest of the Story

Essentially, the entire premise of the report is a lie. The report repeatedly informs the public that vaping is a “form of tobacco use” and that electronic cigarettes are a “form of tobacco.” This repeated statement could not be further from the truth. Vaping is not a form of tobacco use. Electronic cigarettes are not a form of tobacco. The truth is that electronic cigarettes do not contain tobacco. A person who vapes (but does not smoke) is not a user of tobacco. Such a person is not using any form of tobacco. A nonsmoking vaper is in fact “smoke-free” and “tobacco-free.”

The Surgeon General’s repeated statements are an insult to the intelligence of the public. They apparently assume that the public is so stupid that we need to be lied to in order to appreciate the fact that vaping may be associated with some health risks. Rather than tell the truth and inform us that while e-cigarettes do not contain or burn tobacco, the constituents in the e-liquids can still degrade into chemicals that potentially could carry some risks with long-term use, the report dishonestly informs us that e-cigarettes apparently contain tobacco and represent a form of tobacco use.

If anyone actually believes the report, it is going to do a lot of public health damage. Vapers reading the report will be encouraged to return to smoking. After all, if e-cigarettes are just another form of tobacco use and if tobacco use in any form is dangerous, then why bother to remain off cigarettes? You might as well return to smoking tobacco cigarettes. Fortunately, most vapers are far more educated than the Surgeon General apparently is about the basic facts regarding vaping and the differences between vaping and smoking.

You don’t have to get very far in the report before you are lied to. In the preface itself, the report states: “These products [e-cigarettes] are now the most commonly used form of tobacco among youth in the United States, surpassing conventional tobacco products, including cigarettes, cigars, chewing tobacco, and hookahs.” What the report does not tell the public is that while cigarettes, cigars, chewing tobacco, and hookahs are a form of tobacco use because they contain tobacco, e-cigarettes are distinct from all these others because they do not contain tobacco. Perhaps the Surgeon General’s office needs a reminder lesson of “Which one of these things is not like the other?”

Also in the preface, the report recommends strategies to “discourage tobacco use in any form, including e-cigarettes” and emphasizes the need to prevent “tobacco use in any form.” Again, this is massively deceptive, as vaping is not a form of tobacco use.

In fact, not only does the report imply that e-cigarettes contain tobacco, but it never informs the public that e-cigarettes do not contain tobacco. Even in the chapter purporting to provide a detailed “background” to the issue of e-cigarettes, the Surgeon General does not inform readers that unlike cigarettes, e-cigarettes do not contain tobacco. And even in the section which goes into detail on what an e-cigarette is, there is no mention of the fact that e-cigarettes do not contain tobacco, and thus are distinct from every other "tobacco product" on the market.

Let's be clear. If the Surgeon General is going to state that vaping is a form of tobacco use, then so is using nicotine replacement therapy. And if the Surgeon General is serious in stating that "any form of tobacco use" is dangerous, then why isn't he warning people who are using nicotine gum and nicotine patches?

Obviously, it would be terribly misleading and deceptive to tell the public that the nicotine patch is a form of tobacco use. It would be lying to tell the public that people who use the nicotine patch are tobacco users. But the nicotine in a nicotine patch is derived from the same tobacco as is the nicotine in e-cigarettes. The Surgeon General would not make such a statement because it would deceive smokers into thinking that NRT is just another form of tobacco use. The Surgeon General would then have to acknowledge that ex-smokers who are still using NRT are not "tobacco-free." They are still tobacco users, and tobacco use in any form is dangerous.

How is it any less of a lie, then, to tell the public that vaping is a form of tobacco use?

What is so disturbing about the report is that while it spends an inordinate amount of time attacking the tobacco industry for historically misleading the public about the relative risks of different types of tobacco products (e.g., "light cigarettes"), the report itself then goes on to deceive the public about the relative risks of different forms of nicotine-containing products: namely, tobacco-free products and products that actually do contain tobacco.

If the Surgeon General does not recognize the substantial difference between a product that is killing more than 400,000 people a year and a product that is simply "not harmless," then we have a huge problem in our federal public health approach.

And if we are not able to communicate the vastly different risks associated with a product that is killing more than 400,000 people a year and a product that is simply "not harmless," then we have a huge problem in our risk communication ability.

Monday, December 05, 2016

Paper Concludes that São Paulo Smoking Ban Reduced Heart Attack Deaths Despite Striking Increase in Heart Attack Deaths Following Ban

One of the things I always teach my public health students about research is that when you conduct any type of longitudinal or time-series data analysis, you should always start by graphing the outcome variable over time and visually inspecting the data. A perfect demonstration of what might happen if you fail to do this was published last week in the journal Tobacco Control.

Briefly, as I reported last week: A new study published online ahead of print in the journal Tobacco Control purported to demonstrate that a smoke-free bar and restaurant law implemented in São Paulo, Brazil in August 2009 resulted in a 11.9% decline in the heart attack death rate for the first 17 months after the law was in effect (through December 2010). The paper used a time-series analysis to compare the monthly rate of heart attack deaths prior to the smoking ban to the rate after the ban was implemented. The baseline period was January 2005 through July 2009. The implementation period was August 2009 through December 2010. Thus, the researchers had data for approximately 5 1/2 years before the ban and for 17 months after the ban. The paper concluded: "In this study, a monthly decrease of almost 12% was observed in mortality rate for myocardial infarction in the first 17 months after the enactment of the comprehensive smoking ban law in São Paulo city."

The problem is that if you take the time to look at the actual data, you find that there was actually a striking increase in heart attack deaths in the year following the smoking ban:

Christopher Snowdon over at Velvet Glove, Iron Fist has graphed out the monthly data, and the picture looks the same:

From: Christopher Snowdon. Velvet Glove, Iron Fist. "Brazilian Smoking Ban Miracle," December 1, 2016.

You can see that there was a seasonal decline in heart attack deaths late in 2009, but a striking increase in heart attack deaths in 2010 that was sustained throughout the year. In fact, the number of heart attack deaths for each month in 2010 was higher than the number of heart attack deaths during the same month in any of the previous years in the study period!

As Snowdon explains the actual data: "Before the ban, the number of deaths hardly ever exceeded 600 per month and was often below 500. Within a few months of the ban, there were never fewer than 700 deaths per month."

In my post last week, I struggled to understand how an error like this could have escaped the attention of the investigators, the reviewers, and the journal and speculated that: "It appears that either nobody looked at the actual data or that they looked but ignored it. Either way, this demonstrates a severe bias on the part of the investigators, reviewers, and editorial team. Had the study found no effect of a smoking ban, you can rest assured that everyone would have scoured over the paper for hours, trying to find some explanation for why the results came out "wrong." But here, since the results were "right" (that is, favorable), it appears that there was no desire to sincerely "review" the paper."

However, in the back of my mind, I wondered whether this was all just a mistake. Perhaps there was just a typographical error and the data presented in Table 2 were mistaken. Perhaps the 2010 data presented were an anomaly and were not transcribed correctly from the original manuscript to the typeset paper. I was actually "hoping" that this would be the case and that I would have to write a retraction and correction.

The Rest of the Story

It was not to be so. The lead author of the paper confirmed that the data in Table 2 are correct. In other words, the statistical analysis miraculously turned a clear and rather striking increase in heart attack deaths into an 11.7% decline: a true miracle. Instead of blindly reporting these results, this inconsistency should have instead led the investigators to figure out what went wrong, and it should have led the reviewers and journal editors to question the analysis and interpretation of the data.

This might seem like a rather obvious epidemiological point to make but you cannot have a decline in the heart attack death rate if the heart attack death rate goes up.

Before anyone suggests as a possible explanation that perhaps the population rose drastically in 2010, thus making the high number of deaths in 2010 translate into lower death rates, let me emphasize that explanation is impossible. The paper did not use the actual annual populations but simply used a geometric progression to interpolate the populations based on censuses conducted in 2000 and 2010. Thus, the rate of population growth throughout the study period was constant, by definition.

It also needs to be remembered that even if the paper had found an actual decline in heart attack deaths in 2010, this would not justify the conclusion that the smoking ban caused a decrease in heart attacks. Another critical and fatal methodological flaw of this paper is that there is no comparison group. It is very possible that heart attack death rates were declining during the study period anyway, even in the absence of smoking bans. We actually know this to be the case from abundant international data. To conclude that the smoking ban had an effect on heart attacks, one would need to first control for secular trends in heart attack mortality that were occurring anyway, independent of the smoking ban. The paper could easily have done this by including some comparison group -- such as a nearby city, the county, the state, or the country. But there needs to be some control for secular trends.

The rest of the story is that we have here another example of the severe bias in modern-day tobacco control research. The zealotry has reached such a level that you can report frivolous findings that are not even consistent with visual observation of the data and still publish your paper without questioning from peer reviewers or journal editors, as long as the findings you are reporting are "favorable" to the cause. You can rest assured that had the paper found "unfavorable" findings, they would have received critical scrutiny.

For a similar take on this study, see Christopher Snowdon's commentary.