Study Claiming that Vaping Causes Lung Cancer Fails to Document that a Single Case Occurred After the Person Started Vaping

An article published recently in the journal Frontiers in Oncology concluded that vaping causes lung cancer among young adults (age <50) based on the finding that lung cancer risk among dual users of cigarettes and e-cigarettes was higher than the risk among exclusive smokers. This was a case-control study of young adults in which the investigators used electronic medical records to identify patients with lung cancer and a matching set of patients without cancer and then compared the odds of having lung cancer among the dual users to the odds of having lung cancer among the smokers. 

The study found that the odds of having lung cancer among the dual users was 2.8 times higher than among the exclusive smokers. Based on this finding, the authors concluded that "vaping and smoking together accelerate lung cancer risk among young people, particularly in the development of pulmonary adenocarcinoma."

The Rest of the Story

To evaluate the study's conclusion, we need to review some basic epidemiology. In a case-control study, the odds ratio measures the odds of disease (in this case, lung cancer) among the exposed (in this case, dual users) to the odds of disease among the unexposed (in this case, smokers). Dual use is the exposure and it is being compared to exclusive smoking. 

OK, now a key thing to understand about the case-control design is that the ratio of the odds of disease among the exposed to the odds of disease among the unexposed is the same as the ratio of the odds of exposure among the diseased to the odds of exposure among the controls.  

To repeat that in terms of this study, the relevant odds ratio comparing the lung cancer risk of dual users to that of smokers is equivalent to:

The odds of dual use among smokers with lung cancer divided by the odds of dual use among smokers without lung cancer. We'll come back to this in a second.

Now, critically, in a case-control study, one has to go back in time in order to measure the exposure because if exposure and disease are measured concurrently, there is no assurance that the exposure preceded the disease, which is a key criterion for drawing a causal conclusion. If a case-control study measures exposure at the current time (concurrently) rather than retrospectively, it risks severe reverse causality, where the outcome influences the exposure rather than vice versa. This design is unsuitable for establishing causation, as it cannot confirm if the exposure occurred before the disease.

Importantly, in this study, it appears that smoking and vaping status was measured concurrently with the disease. The paper fails to state that the investigators went back in time to determine the historical trajectory of an individual's smoking and vaping status. It appears that they just drew the information from the record of the particular visit in the record database rather than searching historical records to determine smoking and vaping status in the past. For this reason, it cannot be documented that dual use preceded the lung cancer. It is very possible that dual use came after the lung cancer. And in fact, that is the most plausible explanation for the study results.

Let's go back to this point: The relevant odds ratio comparing the lung cancer risk of dual users to that of smokers is equivalent to the odds of dual use among smokers with lung cancer divided by the odds of dual use among smokers without lung cancer. The study found that the odds of dual use among lung cancer patients who smoked is 2.8 times higher than the odds of dual use among controls who smoked. So essentially, the authors are concluding that vaping causes lung cancer because when smokers are admitted to the hospital with lung cancer, they are more likely to be vaping than smokers who are admitted to the hospital but don't have any type of cancer.

Clearly, the most likely explanation for this finding is that getting lung cancer serves as a highly motivating event to trigger an attempt to quit smoking. And since e-cigarettes are a commonly used smoking cessation strategy, many of those diagnosed patients likely used e-cigarettes in an attempt to quit smoking.

Thus, it is not at all a surprise to find that the odds of dual use among smokers diagnosed with lung cancer is about 3 times higher than the odds of dual use among smokers who are not diagnosed with cancer. All that this suggests is that smokers who are diagnosed with lung cancer are more likely to be motivated to try e-cigarettes in attempt to quit than smokers who are not diagnosed with cancer.

I don't understand why the authors drew a causal conclusion from a case-control study that measured exposure concurrently with the outcome. This is a situation where reverse causation is the most plausible explanation for the study findings. 

Moreover, the authors do not even mention this possibility in the skimpy limitations section. In fact, the limitations "section" is just a single sentence: "One study limitation was that due to the nature of the electronic medical record data, we could not quantify vaping and smoking as detailed as we had planned, nor the timing of vaping relative to smoking. ... Another limitation was the lack of information on potential effect modifiers such as exposure to secondhand smoke, air pollution, and genetic predisposition to lung cancer." Well if they acknowledge that they had no idea of the timing of vaping relative to smoking then how can they possibly draw a causal conclusion?

Even worse, the paper takes the opportunity to use this single flawed conclusion to condemn harm reduction. Although they acknowledged that they had no idea of the timing of the decision of these smokers to try e-cigarettes, and although they have no idea how long the patients vaped before their lung cancer diagnosis, the authors argue that: "Our results are in marked contrast to the 'harm reduction' approach that deems vaping to be less harmful than cigarette smoking, instead showing that exposure to aerosolized e-liquid may in fact promote lung carcinogenesis, especially when combined with smoking."  

So now they go even further in their conclusion than their study would allow them even if reverse causation was not a problem. Here, they conclude that vaping is no less harmful than smoking. It certainly has the appearance that there is investigator bias involved with that bold (and false) statement. They are literally making a plea to alter the entire strategy for smoking cessation throughout the country based solely on the finding that when smokers are diagnosed with lung cancer, they then are more likely to use e-cigarettes than smokers who are not diagnosed with cancer.

Perhaps the clincher here is that the authors, in the abstract and introduction to the paper, make a false statement -- three times -- revealing a massive misunderstanding of the nature of e-liquids. They state: "the inhalation of heated aerosolized vaping oil has now replaced cigarette smoking as the major source of nicotine among young people." Then, they state: "Notably, the inhalation of heated aerosolized vaping oil is currently the major source of nicotine among young people." Shortly thereafter, they state: "While the inhalation of aerosolized nicotine-containing vaping oil is known to expose the lungs to carcinogens, only a few studies have examined the potential role of vaping as a lung cancer risk factor."

E-liquids do not contain oils. Vaping oils are used in THC vapes, not nicotine vapes (e-cigarettes). Vaping oils are not used to deliver nicotine. They are used to deliver THC, CBD, or essential oils. To be clear, the use of vaping oils can be quite dangerous. If vitamin E acetate is used to increase the viscosity of the oil, vaping it can cause severe lung damage and even death. Even without vitamin E acetate, vaping oils can cause lipoid pneumonia, which can result in permanent lung injury. The excipients in e-cigarettes are alcohols: propylene glycol and glycerin. They are not oils. 

I'm not concerned that a particular study has a flawed conclusion. However, what is very concerning is that anti-vaping groups are using this shoddy research to support their false claims that vaping is just as dangerous as smoking. This is causing real public health harm because it dissuades smokers from quitting, may cause some ex-smokers to return to smoking, and leads to public policies that result in blocking a major off-ramp for smokers looking to quit. 

Why is Dr. Glantz Calling a Letter from an Independent Public Health Practitioner an "Aggressive Lobbying Effort" by the Tobacco Industry?

Yesterday, I discussed what I believe is a mischaracterization by Dr. Stan Glantz of the scientific evidence on the relative risks of smoking vs. vaping as well as an inappropriate attack on independent scientists who happen to favor harm reduction in tobacco control. When I read the piece, I noted that Dr. Glantz accused the tobacco industry of organizing an "aggressive lobbying campaign" to "convince delegates to the 11th Conference of the Parties for The WHO Framework Convention on Tobacco Control to embrace e-cigarettes and other so-called smoke free tobacco products as part of tobacco control." I failed to click on the link because I assumed that this was a true statement. Why would Dr. Glantz call it an aggressive lobbying effort by Big Tobacco if it weren't?

After reading comments from some colleagues, I went ahead and clicked on the link to discover what this big lobbying effort of the tobacco industry consisted of. To my surprise, I found out that this "aggressive lobbying effort" by the "tobacco industry" consisted merely of a letter from one of my colleagues -- Clive Bates -- who has no affiliation with the tobacco industry, urging the delegates to the convention to embrace the idea of promoting electronic cigarettes as a safer alternative to smoking. Clive was transparent in the letter and noted that he has "no conflicts of interest regarding tobacco, nicotine, or pharmaceutical industries."

The Rest of the Story

In retrospect, the claim that this letter represents an aggressive lobbying effort by the tobacco industry turns out to be false. It is a letter from one person who has no affiliation with the tobacco industry. It appears that this is an attempt to malign the character and intent of Clive, who is a colleague of Dr. Glantz's in the effort to reduce morbidity and mortality associated with tobacco use. 

For six years, Clive headed up Action on Smoking and Health UK. While with ASH, Clive worked to counteract and restrict tobacco marketing, promoted tobacco product and packaging regulation, cigarette tax increases, reduction of tobacco smuggling, and smoke-free places, and he worked to increase the availability of treatment for addiction and to advance harm reduction in the tobacco control movement. He also "worked on development of the WHO's first international treaty - the Framework Convention on Tobacco Control."

There is nothing in Clive's career to even suggest that he has done anything other than to fight Big Tobacco. In fact, the tobacco industry did lobby aggressively against the Framework Convention on Tobacco Control, which Clive promoted. 

Notably, an international effort to promote e-cigarettes as a substitute for tobacco would harm the tobacco industry because it would divert people away from tobacco products and toward non-tobacco products that are much safer. The sale of tobacco would decline, not increase. So if Clive is lobbying for the tobacco industry, he's doing a really poor job!

I find this ad hominem attack disturbing because it's completely unnecessary, untrue, malicious, and arguably defamatory. There's no room for that kind of nonsense in public health. If the facts in support of Stan's position are so weak that he has to resort to character assassination in order to promote his viewpoint, then it doesn't say a lot for the strength of his arguments.

Sadly, I have been the target of defamatory attacks like this several times in my career. Ironically, the most vicious attacks against my character came not from the tobacco industry but from some of my closest colleagues in the tobacco control movement. For example, one of my colleagues - with whom I published a paper expounding the dangers of secondhand smoke - publicly accused me of being a paid hack of the e-cigarette industry. (After I questioned him about why he made this statement, he sent me an email asking whether or not I have taken e-cigarette money, to which I responded: "Shouldn't you have asked me that question before you publicly smeared me in front of an auditorium-full of people?" Incidentally, this is the same researcher who also publicly claimed that e-cigarettes cause popcorn lung.)

We are living at a time when civil discourse is under attack. While there is certainly a place for exposing corporate lobbying that is harming the public's health, making false accusations weakens our credibility. And issuing such attacks against private individuals chills much-needed civil discourse among public health practitioners about a very important scientific question that affects millions of lives.

CDC Needs to Stop Calling E-Cigarettes "Tobacco Products"

The Centers for Disease Control and Prevention's (CDC) web site on youth e-cigarette use begins: "E-cigarettes are the most commonly used tobacco product among U.S. youth."

The CDC goes beyond this and calls the use of e-cigarettes tobacco use: "Most tobacco use, including vaping, starts and is established during adolescence."

The CDC goes beyond even that and lists as one cause of youth e-cigarette use: "Tobacco advertising that targets youth." 

Finally, the CDC concludes by stating, at the bottom of the page: "Commercial tobacco use is the leading cause of preventable disease, disability, and death in the United States." This clearly implies that e-cigarettes contribute towards preventable disease, disability, and death in the United States, since it is a form of tobacco use.

The Rest of the Story

There is absolutely no reason for the CDC to be calling electronic cigarettes a "tobacco product." They are not a tobacco product, in any common sense of the term, because they do not contain any tobacco! They are a nicotine-containing, non-tobacco product. It would be like calling a non-alcoholic beer an alcohol product because it describes itself as a beer. Or like calling a potato a tobacco product because it contains nicotine.

This is problematic not only because it is wrong but because it seriously misleads the public in a harmful and damaging way. By making people think that e-cigarettes contain tobacco, the CDC is contributing towards a huge misinformation campaign that has successfully convinced the majority of the public that vaping is just as hazardous as smoking. This, in turn, has caused damage by deterring smokers from quitting via e-cigarettes and by encouraging ex-smokers who use e-cigarettes to return to cigarette smoking. It has also led to disastrous public policies that treat e-cigarettes as essentially the same thing as tobacco cigarettes. These policies have led to a demonstrable increase in smoking (or more accurately, a decrease in smoking cessation).

The only reason why e-cigarettes should ever be called a "tobacco product" is in the very specific legal use of the term in the context of FDA regulations. E-cigarettes are defined as "tobacco products" only because of a quirk in the FDA's application of the Family Smoking Prevention and Tobacco Control Act. That quirk is in the definition of a tobacco product, which includes any nicotine-containing product. However, that is merely a legal definition. It has no bearing to reality and certainly not to scientific accuracy.

Using the term "tobacco" product is a choice that CDC is intentionally making. I believe it is a choice they are making intentionally because of their strong anti-nicotine bias. They are lumping e-cigarettes in with real tobacco cigarettes because to their ideology, there actually is no difference. The idea of anyone getting pleasure out of nicotine without being punished by developing disease is anathema to them. 

Let's now go back and analyze each of the CDC's statements in this context:

1. "E-cigarettes are the most commonly used tobacco product among U.S. youth."

No they are not. Lumping them in with actual tobacco products is misleading and I think was done on purpose in order to maintain the alarm (and donations) when youth smoking decreased to extremely low levels. Rather than celebrate this victory, they artificially eliminating the gains by considering e-cigarettes to be cigarettes, thus allowing them to claim that rates of "tobacco product use" were still very high.

2. "Most tobacco use, including vaping, starts and is established during adolescence."

Tobacco use does not include vaping. Even accepting that e-cigarettes are legally classified as a tobacco product, that doesn't mean that vaping involves tobacco use. It does not because there is no tobacco in the product. This is a worse mistake than simply calling e-cigarettes a tobacco product. For that, there is at least the excuse that it meets the legal definition. But to call vaping tobacco use cannot be justified in any way, legal or otherwise.

3. "Tobacco advertising that targets youth."

Tobacco advertising cannot influence youth to use e-cigarettes because what is being advertised is, by definition, not e-cigarettes. E-cigarette advertising potentially influences youth to try vaping but tobacco advertising certainly does not.

4. "Commercial tobacco use is the leading cause of preventable disease, disability, and death in the United States."

Yes, tobacco use is still the leading cause of preventable death in the United States; however, e-cigarettes play no role in tobacco-related morbidity and mortality.

 

American Medical Association Claims that E-Cigarettes Can Cause Several Types of Cancer

The American Medical Association (AMA) yesterday claimed that electronic cigarettes cause not just one type of cancer, but multiple types. 

Here is their statement: "Overwhelming evidence demonstrates that multiple types of cancer are linked to tobacco products, including e-cigarettes, and that the longer someone uses these products the greater their health risks become."

I'm at a loss for the multiple types of cancer that are caused by electronic cigarettes. I'm thinking that the AMA may be referring to lung cancer but multiple means more than one, so what is the other cancer type to which they are referring? 

The Rest of the Story

First, to set the record straight, there is no credible evidence that electronic cigarettes cause any type of cancer, much less multiple types. Not a single study has shown that absent tobacco use, e-cigarettes increase cancer risk of any kind. The levels of carcinogenic biomarkers in people who use e-cigarettes are much lower than among people who smoke and are even lower than that seen among users of snus and smokeless tobacco. In fact, they are similar to levels observed among people who use NRT gum. I'm not aware that the AMA is warning about the cancer risk of NRT gum. So there is not strong plausibility to the idea that e-cigarettes significantly increase cancer risk.

Second, there are no epidemiological studies that have clearly demonstrated a link between electronic cigarette use and increased risk for cancer. 

Even if we just provide a gimme and allow the AMA to claim that e-cigarettes cause lung cancer without challenge, where is their evidence that e-cigarettes cause at least one other type of cancer?

The rest of the story is that the evidence for banning flavored e-cigarettes from the market is so weak that organizations have to lie and deceive the public in order to support these bans.

CDC is Concealing and Suppressing Information on Youth Marijuana Vaping to Over-hype Harms of E-Cigarettes

The Centers for Disease Control and Prevention (CDC) is concealing and suppressing information on the number one cause of severe, vaping-related health harm to youths in order to deceive the public into thinking that e-cigarettes are at the top of the list.

In fact, the number one cause of severe, vaping-related health damage to youths is not electronic cigarettes, although you would not know that from reading the CDC's literature on youth vaping.

The Rest of the Story

The chief cause of substantial health harms to youth from vaping is actually not e-cigarettes. It is marijuana or THC vaping.

The hundreds of youth who have become severely ill with respiratory failure from the EVALI outbreak have been harmed not by e-cigarettes, but by vaping marijuana carts.

The deaths that have occurred among youths from the EVALI outbreak were caused not by e-cigarettes, but by vaping THC.

Substantial numbers of youths have been affected by psychosis due to vaping THC and in some cases, groups of youths have actually had to be taken to emergency rooms because of the vaping of THC products that may have been contaminated with synthetic marijuana or other drugs.

This is by no means to minimize the harm being caused by addiction to devices such as JUUL which deliver high concentrations of nicotine salts. However, it is to point out that what is actually causing serious acute health harm to adolescents is THC vaping, not the use of e-cigarettes.

For some reason, the CDC has been concealing this critical information from the public. For three years in a row (2016-2018), the CDC's National Youth Tobacco Survey (NTYS) showed that the overwhelming majority of youths who were heavy e-cigarette vapers (use on 20 or more days per month) were also vaping marijuana. However, in all three years, the CDC failed to report these data.

In fact, had the CDC reported these data in 2016, it is possible that steps could have been taken that would have averted much of the disease and death caused by EVALI in 2019 because the problem of youth marijuana vaping would not have fallen off the radar screen.

Even if you look at all youth vapers (anyone who has used an e-cigarette in the past 30 days), more than half of these youth are vaping marijuana, not just nicotine-containing e-cigarettes.

Here are the data which the CDC has concealed:

Percentage of CURRENT youth e-cigarette users reporting ever use of THC vapes:
2016: 39%
2017: 52%
2018: 54%

Percentage of HEAVY youth e-cigarette users reporting ever use of THC vapes:
2016: 62%
2017: 73%
2018: 71%

What percentage of youth e-cigarette users reported having also vaped THC in 2019?

The answer is ...

... we have no idea.

Why? Because the CDC did not even ask the question about marijuana/THC vaping in the 2019 National Youth Tobacco Survey!

Why would the CDC intentionally take this question off the survey, when it had included the question in the 2016, 2017, and 2018 surveys?

If you put everything together:

• the fact that the CDC concealed the information on youth THC vaping for three straight years;
• the fact that the CDC blamed the EVALI outbreak on e-cigarettes rather than on THC vaping for months before finally having to admit that e-cigarettes were not to blame; and
• the fact that the CDC intentionally removed the THC vaping question from the 2019 NYTS,

one can only get the impression that the CDC is intentionally hiding from the public the extent of the youth marijuana vaping problem because it wants the public to incorrectly believe that e-cigarettes--not THC vapes--are the greatest and most serious vaping-related health risk faced by our nation's youth.

The CDC cover-up of the role being played by THC vaping in the youth vaping epidemic has had serious consequences. Arguably, it contributed to the sudden and unexpected outbreak of respiratory disease that took the public health world by storm last year, something that could potentially have been avoided or reduced had health practitioners and agencies throughout the country been aware of the severe health risks being posed by youth THC vaping.

It could also have helped avoid misguided policies - such as the e-cigarette flavor bans that are sweeping the nation - which are going to push youth towards more THC vaping as flavored e-liquids become less available.

The CDC had better add the THC vaping question back into the 2020 survey because I am predicting that the proportion of youth vapers who report the use of marijuana/THC vapes is going to rise significantly in 2020 and beyond because of the widespread bans on flavored e-liquids.

The rest of the story is that the CDC is concealing and suppressing critical health data on youth marijuana use, apparently in an attempt to over-hype the harms of e-cigarettes. This is causing significant adverse public health consequences. Unless heath practitioners and agencies understand that the problem of youth vaping is not solely a problem of youth e-cigarette use, they will be unable to craft an effective policy to protect the health of our nation's youth.

Tobacco Researcher Claims that Smoking May Be Safer than E-Cigarettes

Imagine if a tobacco company came out today and publicly claimed that smoking might very well be safer than using an e-cigarette. It would be a completely irresponsible statement and the company would rightly be vigorously criticized and attacked for asserting that its deadly products, which kill more than 400,000 people each year, are potentially safer than e-cigarettes, which do not contain tobacco, involve no combustion, and have been documented to have much lower levels of thousands of different chemicals compared to cigarettes.

In a strange an shocking irony, that exact claim was made today, but it came not from Big Tobacco but from a tobacco researcher. According to a press release issued by Virginia Commonwealth University (VCU), one of its professors--who is a tobacco researcher and studies electronic cigarettes--claimed that smoking may actually be safer than vaping. The professor was quoted as stating:

"The fact is: we don't know whether e-cigarette use is as lethal as combustible cigarette use, less lethal than combustible cigarette use, or more lethal than combustible cigarette use."

The Rest of the Story

I agree that we cannot precisely quantify how much safer e-cigarettes are compared to smoking. However, there is overwhelming evidence that smoking is more hazardous than vaping. One of the most compelling lines of evidence is a series of studies showing that when smokers switch to e-cigarettes, they experience immediate and dramatic improvement in both their respiratory and cardiovascular health, measured both subjectively and objectively. Also compelling is evidence that e-cigarette aerosol contains much lower levels of thousands of chemicals, including scores of carcinogens, compared to tobacco smoke and that e-cigarette users have demonstrably lower levels of toxic chemical biomarkers than smokers. And this isn't even to mention the evidence from thousands of vapers who testify that their health has improved substantially since switching from smoking to vaping.

Tobacco companies can now have a field day with their cigarette advertising. They could legally and truthfully take out an advertisement stating:

"Smoke Marlboro. According to a professor at Virginia Commonwealth University, smoking may be safer than using e-cigarettes, which contain no tobacco and involve no combustion."

Or:

"Let's face it. People have been smoking for decades so we know exactly how many people are going to die each year. But we have no idea how many people are going to die from e-cigarette use. Take the more predictable and potentially safer path, according to a professor at Virginia Commonwealth University: smoke, don't vape."

With enemies like this anti-tobacco researcher, the tobacco companies no longer need friends. He has given Big Tobacco the most amazing public endorsement it could have ever asked for, and something that it could never have claimed to be true itself.

CDC and State Health Departments are Wrong to Inform the Public that Some Case Patients Used Only Nicotine E-Liquids

Because the CDC and state health departments have deliberately been conflating the respiratory disease outbreak with the general problem of youth vaping, they have not been clear in communicating the scientific evidence regarding the type of products that are most likely causing the outbreak. Because of the confusion they have created, a large number of state officials, health practitioners, and media outlets have been incorrectly reporting that a substantial proportion of the outbreak case patients used only nicotine-containing e-cigarettes.

For example, in its legal brief opposing a temporary restraining order against its emergency order banning the sale of vaping products, the state of Massachusetts claimed that "17% [of outbreak case patients] used only nicotine."

As another example, one chest physician told the public that about 15% of outbreak case patients: "used only nicotine-based products."

Another physician writing for UpToDate claimed that 15% of case patients "used products with nicotine but not THC."

Newsweek reported that about 16% of case patients "used only nicotine."
 
Yahoo also reported that a subset of the case patients "used only nicotine-containing products."

NBC News, too, reported that: "16 percent [of case patients] used only nicotine products."

The Rest of the Story

These statements are simply not true, or at least they are not backed up by solid evidence. It is not the case that 15% of case patients used only nicotine products. The evidence is actually that 15% (it's now down to 11%) of case patients did not admit to using products other than nicotine-containing e-liquids. The difference between these claims might sound minor, but it has immense public health implications.

A story published today out of Indiana illustrates why this distinction is so important. The article reports that a young male in Indiana developed vaping-associated respiratory illness and claimed to have only used nicotine-containing products. But it turns out that he really didn't know what was in the product because it was given to him, and he just assumed it was a nicotine-based product because "that’s what is mostly in vapes." Subsequent testing of the e-liquid in question revealed that it actually contained THC. But the patient had no idea that he was vaping THC oil.

What the CDC and many state health department officials don't seem to realize is that youth are not obtaining their vaping products by purchasing them at stores. They are mostly obtaining them from friends or school distributors, off the internet, or from street shops or dealers. For this reason, many youth vapers really have no way to know what is in their e-liquids. 

Moreover, as the Indiana story illustrates, even if a youth knows they are vaping THC oil, there is a strong incentive not to report it. The youth in question was expelled from school indefinitely and his mother is fighting the school system to have him reinstated. 

Furthermore, the CDC - until very recently - did not recommend that physicians conduct THC drug screens on patients, which ensured that it would not be possible to link all of the cases to the use of THC. To the best of my knowledge, the CDC has not confirmed a single outbreak case who tested negative for THC use. In light of this, I think it is irresponsible for physicians or other health practitioners or groups to report that a certain percentage of patients "did not use" THC vaping products.

The lack of understanding of youth vaping culture also explains why proposals to ban flavored e-cigarettes are misguided and will be ineffective and why claims that it is the flavors that are responsible for teen vaping are too simplistic. Youth are not vaping because they like flavors. They are vaping because they like vaping. Vaping is what's cool, not the particular type of e-liquid that you are vaping. 

Moreover, youth will vape whatever cartridges are being supplied by the kids who serve as the distribution channels in their schools. The majority of kids are not making autonomous decisions about what to vape. They are vaping what's available. The supply is largely determined by a small number of distributors. All the kids in a school know who those distributors are. The distributors essentially control the supply. 

This is why flavored e-cigarette bans will not necessarily get rid of the problem of youth vaping. What these bans will do, however, is: (1) facilitate a transition towards the use of THC oils; and (2) facilitate a shift towards the distribution of black market e-liquids. It is precisely these types of products that are causing the outbreak in the first place. This is why banning flavors will do nothing to curtail the outbreak but may make it much worse. And it will likely lead to more serious problems in the future.

A final possibility that needs to be considered is that some patients may actually be using nicotine-containing products, but contaminated THC oils may still be the reason for their illness. This is because there are bootleg, adulterated, and counterfeit products on the market in which a nicotine e-liquid is mixed with THC oil. In fact, lab testing of products recovered from case patients in two states has detected the presence of adulterated cartridges that contain both nicotine and THC.

We are still a long way from concluding that any cases of this outbreak have been caused by nicotine-only e-liquids and we are even further away from concluding that any cases have been caused by traditional nicotine-containing e-liquids sold by retail stores. In that light, bans on the sale of electronic cigarettes - even just flavored ones - are a terrible public policy that will do little to protect youth but will do a lot to put them at substantially higher risk of severe harm.

CDC's Failure to Demand Urine THC Testing of All Outbreak Patients is Inexcusable and is Putting the Entire Nation at Risk

The CDC has irresponsibly botched its entire investigation of vaping-associated respiratory illness (VARI) by failing to recommend or demand that clinicians perform a urine THC drug test on every case patient, and this is putting the entire nation at risk while leading to terrible public policies that are causing immediate harm to thousands of people.

The CDC continues to insist that we have no idea what is causing this "mystery illness" and that "no single product" has been identified that explains all of the cases. This statement, which violates basic principles of epidemiological outbreak investigations, is the single communication that has confused policy makers and the public and hindered the ability of state health agencies to issue appropriate recommendations to the public to actually curtail this epidemic of life-threatening respiratory failure.

Contrary to what the CDC seems to be insisting, this outbreak is not going to be solved by identifying a single product common to every patient. Like all outbreak investigations, it is going to be solved by identifying a type of product that is common to an overwhelming majority of patients. And frankly, we already have that and it's called marijuana. There is just far too high a proportion of case patients who have admitted to using THC or CBD oils for this to be merely a coincidence.

Just overnight it was announced that a second Oregon patient has died. The reported cause? Vaping of THC oils. Of course, this didn't stop the Oregon Health Authority from recommending that Oregonians stop vaping nicotine-containing e-liquids. This non sequiter is striking: "A second Oregonian has died from a lung illness after vaping cannabis products, and state health authorities Thursday urged people to immediately stop using all vaping products." This is like reporting a series of deaths from eating Romaine lettuce and advising people to immediately stop eating all lettuce and cabbage. Except it's a lot worse because no harm comes from people stopping eating cabbage. Severe harm is already resulting from ex-smokers stopping vaping and returning to smoking or to the black market.

There are simply too many cases of patients who were vaping for years without a problem and then decided to try THC vape carts and then suddenly getting sick to dismiss the central role of marijuana vaping in this outbreak.

So why aren't the CDC and in turn, state health authorities issuing very clear warnings to the public to stop vaping marijuana, especially THC vape pens or vape carts that are purchased on the street?

It's because the CDC keeps repeatedly issuing the irresponsible mantra of this botched investigation: "No single product" has been linked to all cases. While I was working at CDC, I was not aware of a single Epi-Aid in which a single exposure was linked to all cases of an outbreak. There are always going to be a small proportion of people who forgot that they did have a little potato salad at the church picnic. And in this investigation, the problem is far worse. There are no legal implications and no stigma attached to admitting that you ate some potato salad. But for a youth to admit that they were using illicit marijuana vaping carts purchased off the street from drug dealers could have substantial consequences, not only legal ones but stigma-related ones as well as affecting their relationships with their parents.

The CDC itself admits that about 80% of the outbreak patients admit to using THC oils. My count from media reports puts that figure closer to 90%. How high does that proportion have to go before the CDC issues a clear recommendation not to vape THC and stops undermining its own findings by emphasizing the failure to find a common product in every single case? Apparently, it's 100% before they will take the appropriate actions and enable health authorities to put an end to the tremendous morbidity and mortality this outbreak is causing.

The Rest of the Story

The sentinel failure of the CDC in investigating this outbreak is its failure to recommend or demand that all case patients be screened (via urine drug testing) for THC. In people who vape marijuana regularly, THC can be detected in the urine for at least 4-6 weeks following the last exposure. Even in people who don't vape marijuana regularly, THC can be detected for between 7 and 10 days after the most recent use. This is not going to be 100% sensitive in detecting all THC use but it would certainly help detect a large proportion of the cases where a patient is using THC but did not report it.

Even if a small proportion of patients were screened for THC, it would provide valuable information. 

The recommendation to test for THC does not need to be justified based on the premise that youth patients are "lying" about their drug use:

1. There are thousands of counterfeit products on the market that are packaged to look like legitimate nicotine-containing products but which may contain cheaply made THC oils. There are even counterfeit JUUL-compatible pods that appear to be JUUL but are actually bootleg products and could contain THC oils. So youth may simply have no idea that they are using THC. This alone makes it inexcusable for clinicians not to test for THC in every patient.

2. Many youth simply don't know what they are vaping in the first place. Data from the Monitoring the Future study and other national surveys reveal that youth are unable to accurately report what they are vaping. They may not actually know what is in the cartridges that they are using. Youth are most commonly obtaining their vaping liquids from other kids at their schools, not directly from a retail store. So they are not getting an ingredient list or being told exactly what is in the liquid. They truly may not be aware of exactly what they are vaping. Under these circumstances, it is bordering on public health negligence for the CDC not to recommend that patients be screened for THC use.

The CDC has been insisting that a small proportion of cases have occurred among patients who did not use THC. The truth is that they have no way of knowing that. Unless the patients have been tested for THC, it simply cannot be said that cases have occurred among patients who only used nicotine-containing e-liquids. This is why I believe it is so irresponsible that the CDC has repeatedly given the impression that it knows that a substantial proportion of cases do not involve THC. They actually have no way of verifying their contention that "no single product" ties together all the cases. It is entirely possible that a single product - marijuana and counterfeit vapes - does tie together all the cases.

The CDC's failure to conduct this investigation properly (as outlined above) is not only putting the entire public at risk because we are failing to properly communicate the role of black market THC vape carts, but it is also leading to bad public policy that is already having devastating public health consequences as well as putting hundreds of vape shops out of business and creating massive job loss and financial harm for small business owners.

The final question that I want to tackle in this commentary is why the CDC is failing to recommend THC testing of every case patient. There is no legitimate public health justification for this failure. The only explanation is that the CDC does not actually want to tie all the cases together by detecting marijuana use in a large proportion of patients who reported using only nicotine-liquids because that would let legally sold, store-bought nicotine-containing e-cigarettes off the hook. The CDC's actions tell me that they actually desire to be able to tie these cases to traditional e-cigarette use. They are apparently going to hold out as long as possible before admitting clearly that THC carts are playing a major role in this epidemic.

The CDC's irresponsibility is perhaps best demonstrated by the testimony of a CDC deputy director at this week's Congressional hearing. She testified that one possible cause of the outbreak is something about the act of vaping itself. In other words, she testified that something about the process of vaping itself may be causing this outbreak, rather than the specific products that are being vaped.

Sorry - I hate to have to use this type of language but my conscience does not allow me to express it any other way:

This is complete bullshit.

People have been vaping for the past 12 years without any problems. Millions of smokers who quit smoking by switching to vaping have experienced dramatic improvement in their respiratory health, not rapid progression to respiratory failure. The act of vaping is not causing this outbreak. It is something in the e-liquid or that results from the heating of the e-liquid that is responsible.

At an August 23rd press briefing, one CDC official had this to contribute to a reporter's question about why there has been an upsurge in cases: "We do know that e-cigarettes do not emit a harmless aerosol."

Instead of that meaningless observation, the official could have instead explained that one major change we do know about is the use of a new thickening agent that had not been used previously - vitamin E acetate oil - and could have pointed out that the overwhelming majority of cases were associated with vaping black market THC cartridges. But he was apparently more concerned about creating the perception that e-cigarette companies continue to insist that their products are harmless and then attacking this straw man than actually providing a useful answer to the question.

I get the idea that the CDC really doesn't know anything about vaping. They keep talking about it as if it is some great "mystery" and we don't have any clues about what may be going on. The truth is that we have an immense amount of information, but they are just not putting it together. They keep discounting the information that they do have. The cannabis experts actually know far more about the outbreak and its potential causes than the CDC does. In fact, some cannabis experts actually predicted this outbreak before it occurred because of the changes they were observing in the production of black market THC vape carts and the counterfeiting of legitimate products that they observed.

Although I'm convinced that the CDC's failure to recommend THC testing, its failed communication on the potential causes of the outbreak, and the actions of policy makers to ban electronic cigarettes are all contributing towards making the outbreak worse by obscuring the potential role of marijuana vaping, it is not too late to prevent further deaths by initiating THC testing of case patients. I hope that the CDC will institute this recommendation immediately.

As Another Person Dies from Using Illicit THC Vape Carts, Health Authorities Still Insist that We Have No Idea What is Causing the Problem

Yesterday we learned that a seventh person has died from the growing epidemic of "vaping-associated respiratory illness" that is sweeping the country. In the six previous deaths, authorities released information about the products used in three of them, each of which involved vaping marijuana, not electronic cigarettes.

Although authorities did not release information about what caused this seventh death, family members apparently attribute it to the use of an illicit THC vape cart. It's not clear, however, whether the brand used - a Lucky Charms CUREpen - was real or whether it was a counterfeit product that was packaged in the same packaging. Cannabis insiders have been warning us since last January about the dangers of counterfeit THC vape carts that started to go into wide distribution around that time. How prescient they were!

All in all, marijuana vaping has been associated with approximately 90% of the cases. Although about 10% of cases reported using only nicotine-based e-liquids, we know that there is significant under-reporting of THC use by youth. In addition, many youth may actually not know what is in their cartridges. Moreover, we know that there are many counterfeit cartridges on the market. Finally, the CDC has not recommended that case patients be tested for THC so its use cannot be ruled out. In fact, unless THC testing was conducted, the use of THC oils cannot be ruled out in any of the cases.

Given these facts, you would think that health authorities would issue very clear warnings to youth to avoid vaping marijuana, especially illicit THC vape carts that are purchased off the street.

The Rest of the Story

Instead, here is what one physician is telling the public in an article published by The Mighty:

"The Mighty spoke to Meghan Cirulis, M.D., a physician and researcher at the University of Utah. She has led a number of studies on lung diseases and was recently involved in research for the New England Journal of Medicine identifying markers physicians could use to diagnose vaping-induced lung injury. Is there a safe way to vape? “At this stage, I would say no,” Dr. Cirulis said. “Until we figure this out, I think vaping puts people at immediate risk of health consequences that can be severe, even fatal.”

"She added that while some vape products may seem safer than others, we can’t make reliable risk assessments until these products are studied more. Cirulis said that while a “higher proportion of cases” have been linked to e-cigarettes containing CBD and THC, she “wouldn’t consider any product higher or lower risk” until more information is available. “We have definitely seen cases in patients only using nicotine products,” she noted. A lot of discussion has centered on legal versus illegal e-cigarettes, but Cirulis said that at the moment, it’s not clear commercial vapes are safer than “street” vapes. “Some of the cases have reported use of only commercial e-liquids — so I wouldn’t say any product is ‘safe’ currently,” she told us."

"This is in part because even legally sold vape products are subject to very little government oversight. “I have found it interesting that we still don’t really know exactly what is causing the issue,” said Cirulis. “I think [it] speaks to how poorly regulated the e-cigarette market really is — we have no idea what is in even the commercially sold e-liquids.”"

So the main points this physician is making are:

1. The vaping of any e-liquid, even if it is a product that has been on the market for ten years and has caused no problems, is dangerous and could be fatal.

2. No e-liquids are any safer than any others. They are all equally risky. Vaping illicit THC carts purchased off the black market is no more dangerous than vaping a nicotine-containing e-cigarette purchased from a reputable retailer and made by a reputable company.

3. It is no riskier to buy a vaping cartridge off the street where you have no idea what is in the e-liquid than to purchase an e-cigarette from a retail store made by a reputable manufacturer where you know exactly what is in the e-liquid.

This is just crazy. And irresponsible.

There is no way I would give the public advice that buying a THC vape cart from some drug dealer on the street is just as safe as buying an electronic cigarette from a reputable retailer. Or for that matter, that buying a THC vape cart from some drug dealer on the street is just as safe as buying a THC vaping liquid sold at a licensed dispensary.

As inaccurate, uninformed, and irresponsible is this advice, I don't completely blame the physician. I think that physicians are relying on the CDC to do its job and they listen to what the CDC has to say. And so far, the CDC has essentially been saying the same thing. They have lumped all vaping together and have not clearly stated that using THC vape carts is more risky than using traditional e-cigarettes.

I have never seen such a dismissal of the idea that there are gradations in risk. Apparently, I missed the memo that told us that from now on, everything is either dangerous or not. There is no middle ground and everything gets lumped together.

Unfortunately, whoever sent that memo is endangering the lives of our nation's youth.

CDC's Obfuscation of Link Between Illicit THC Carts and Lung Disease Outbreak is Worsening the Situation and Probably Leading to More Cases

Instead of simply acknowledging that a large number of cases in the recent outbreak of severe, acute respiratory failure are due to black market THC vape carts, the Centers for Disease Control and Prevention (CDC) is undermining that key information and continuing to do everything it can to pin the outbreak on the use of traditional, nicotine-containing electronic cigarettes. Today, I provide three examples to show how the CDC's fraudulent conduct is causing state officials to issue inappropriate warnings that are almost certainly worsening the situation and leading to more cases of disease.

1. Montana: Today, health officials in Montana issued a warning to state residents concerning the disease outbreak. This warning was reported by the state's Public News Service. Instead of informing the public that oil-laden THC vape carts are associated with most of the cases and should absolutely be avoided, the state health department's medical director told the public that we have no idea what is causing the outbreak and that everyone should simply stop vaping. According to the article, the state medical director stated: "We have something that has serious consequences and we don't know what's exactly going on. Protect yourself and stay away from these products at this time, until we have a better understanding. And hopefully, this would be a good time to stop using the products completely."

This is not only blatantly inaccurate information but it is highly irresponsible. However, I don't completely blame the Montana health department because they are simply relaying information that originates from the top: from the CDC.

Inexplicably and inexcusably, the warning does not even mention the words marijuana or THC. Hiding the fact that oil-laden THC vape carts are right now extremely dangerous to use is going to result in the continued use of these products by young people and result in further cases of the disease that could be prevented by simply telling the public the truth. Again, this stems from the CDC's obfuscation of the observed link between marijuana vaping and most of the cases. By hiding the truth, the CDC is essentially lying to the public. It is a lie of omission. And it is endangering the health of our nation's young people.

2. Ohio: Mirroring a line that it obtained directly from the CDC, a Cincinnati public radio story informed the public that: "no specific e-cigarette device or substance has been linked to the illnesses. While some patients used marijuana-based products, others used marijuana and nicotine products, and a smaller group reported using nicotine products only." This statement deliberately obscures the role of marijuana-based products with high oil content in inducing the majority of the observed cases, many of which have been confirmed to have been caused by lipoid pneumonia due to oil inhalation. Again, the media are simply mimicking what they are hearing from CDC, so I'm not blaming them. It is the CDC that is to blame for this inaccurate and irresponsible information.

3. Tennessee: A story run by the NBC News Knoxville affiliate reports that six cases of the disease have been reported in the state. The story reports only that these cases are associated with the use of e-cigarettes. Nothing more specific than that. However, if you dig in more closely, you'll find that (in small print in a different article) a Knox County teenager who was hospitalized for a "vape-related" illness actually reported that what he was using was an illicit THC vape cart. As the teen explained: "You buy these from people off the streets. Anywhere. You can find these anywhere. People make these. They put, what I've heard, butane, lighter fluid, other chemicals and stuff inside of these."

It is a shame that this teen appears to know more about the outbreak than the Centers for Disease Control and Prevention and that the warning he is giving is far more accurate and effective than the CDC's.

I'm sure we could go down the list of all 50 states and demonstrate that they are all putting out inaccurate and irresponsible warnings. But this all stems from the top - from the CDC. That is why it is absolutely inexcusable that the agency continues to try to blame the outbreak on traditional, legal e-cigarettes, even in the face of overwhelming and compelling evidence that the primary (if only) culprit is illegal, black market marijuana vaping products being made by an illicit drug cartel that is making millions of dollars spreading this poison to our nation's youth through an elaborate distribution of network of drug dealers.

Public Misunderstanding of Health Risks is "a Good Thing" According to Some in the Tobacco Control Movement

Somewhere along the line, I must have gone astray. During my master's in public health program, I was taught that one major goal of public health is to educate the public about the risks of various exposures. I was also taught that accurately communicating these risks, as well as helping the public to accurately understand the relative risks between different hazardous behaviors or products was critical.

Well, based on an editorial published this morning in the Journal of the American Medical Association (JAMA) Network Open, I was misguided. For in this editorial, it states that the increasing public misunderstanding of the relative risks of smoking compared to vaping is "a good thing."

The editorial responds to new research also published this morning in the same journal which documents that the majority of adults in the U.S. completely misunderstand the dangers that smoking poses compared to those posed by vaping and furthermore, that the proportion of people with this misunderstanding has been growing substantially over time. (See: Huang J, Feng B, Weaver SR, Pechacek TF, Slovic P, Eriksen MP. Changing perceptions of harm of e-cigarette vs cigarette use among adults in 2 US national surveys from 2012 to 2017. JAMA Network Open. 2019;2(3):e191047).

According to the study, in 2012, only 39.4% of adults perceived e-cigarettes as less harmful than real cigarettes. This is pitiful, given the overwhelming scientific evidence that vaping is much less hazardous than smoking. But even worse, the proportion of adults who correctly perceived vaping to be safer than smoking dropped to only 33.9% in 2017. Thus, two out of every three adults in the U.S. incorrectly believes that smoking is no more hazardous than vaping.

Perhaps even scarier, nearly 10% of adults in 2017 perceived vaping to be more harmful than smoking!

The Rest of the Story

Instead of lamenting the fact that the public's perception of the severe hazards associated with cigarette smoking has been seriously undermined over the past decade or so, the editorial almost joyfully celebrates this massive public deception that has occurred. (See: Glantz SA. The evidence of electronic cigarette risks is catching up with public perception. JAMA Network Open. 2019;2(3):e191032).

It is quite a feat of magical writing to take the dismal news that the public is increasingly downplaying the severe risks of smoking and completely misunderstands the relative risks of smoking compared to vaping and to turn that into a tremendous public health victory.

The truth is, however, that this public misunderstanding is having devastating public health consequences. Convinced that vaping is no safer than smoking, many former smokers who quit using e-cigarettes are returning to smoking. After all, what's the point of staying smoke-free using e-cigarettes if vaping is just as bad as smoking? You might as well go back to your Marlboros.

In addition, this misinformation is deterring many smokers who would otherwise have tried to quit using e-cigarettes to just continue smoking. After all, why quit smoking and switch to e-cigarettes if vaping is every bit as harmful. You might as well just stick with your Marlboros.

Huang et al., the authors of the featured article, correctly point out that: "The need for accurate communication of the risk of e-cigarettes to the public is urgent and should clearly differentiate the absolute from the relative harm of e-cigarettes." But somehow, Professor Glantz does not believe that accurate communication is the way to go. Apparently, inaccurate communication is better.

This would almost be funny, were it not for the fact that many adults are going to die because of it. As Huang et al. point out: "Perception of e-cigarette harm [compared to smoking] may deter current smokers from initiating or continuing use of e-cigarettes. This perception may also deter a complete switch from cigarettes to e-cigarettes among smokers. In light of this possibility, the observed upward trend of perceiving e-cigarettes to be more as harmful as or more harmful than cigarette smoking among US adults warrants heightened attention."

In public health, the means do not justify the ends. We do not lie to people in order to persuade them to change their behavior. Telling the truth is a core ethical value of public health practice. But maybe not so much in tobacco control. For us, it is apparently acceptable to spread hysteria using false comparisons and lies simply because we can't handle the idea that there are millions of vapers who have saved their lives using a device that delivers nicotine.

Researchers Tell Public that Vaping Causes COPD as Scientific Rigor in Tobacco Control Drops to an All-Time Low

Based on the results of a cross-sectional study showing an association between using e-cigarettes and reporting that one has ever been told they have COPD (chronic obstructive lung disease), a number of researchers have essentially concluded that vaping causes COPD, and one researcher is telling the public that use of e-cigarettes increases one's risk of COPD just like cigarettes.

The paper, published in Drug and Alcohol Dependence, reports the results of a cross-sectional study based on the 2016 Behavioral Risk Factor Surveillance System (BRFSS) survey in Hawaii. The outcome variable was reporting ever having been told that one has COPD. The main predictor variable was ever having used an e-cigarette. The key finding of the study was that: "there was a significant association of e-cigarette use with COPD among nonsmokers (AOR = 2.98, CI 1.51–5.88, p <  .01), but the association was not significant among smokers (AOR = 1.29, CI 0.94–1.77, ns.)."

The paper concludes that: "The fact that findings for respiratory symptoms occurred primarily for nonsmokers argues against several alternative interpretations of the results." In other words, the paper is essentially arguing that this is most likely a causal effect (i.e., vaping causes COPD).

The Rest of the Story

There is absolutely no way one can conclude, or even speculate, based on the results of this cross-sectional study, that vaping is a cause of chronic obstructive lung disease. Remember, we are talking here about emphysema and chronic bronchitis (that's what is meant by COPD).

To see how ridiculous such a conclusion, or even such speculation is, one needs only to look at the sample size of never smokers in the 2016 Hawaii BRFSS who were current e-cigarette users and reported having COPD. It's 13 (based on the CDC's BRFSS online analysis tool). According to the article itself, the total sample of never smokers who were current vapers was only 45. A simple bivariate online analysis of the relationship between ever use of e-cigarettes and ever diagnosis of COPD among the never smokers in the 2016 Hawaii BRFSS reveals no significant association.

If you do the same analysis using the entire 2016 BRFSS (including all states), the proportion of never smokers who report having been diagnosed with COPD is actually higher among non-vapers (2.9%) than ever vapers (2.4%).

It's not just that there are dangers with drawing causal conclusions like this from a cross-sectional study. In this case, the sample size upon which the conclusion is being drawn is so low that the analysis is not at all reliable to begin with.

The paper ignores (and does not cite a single article from) a body of literature showing that smokers with COPD who switch to electronic cigarettes experience an improvement in their symptoms.

However, the worst problem with these conclusions (and even with the speculation) is that it is biologically implausible that vaping for a few years can cause emphysema or chronic bronchitis. Since vaping did not become widely popular until about 2011, the average number of years that the vapers in the 2016 Hawaii BRFSS used e-cigarettes could not be more than about five years.

There is simply no way that you can develop COPD from vaping for five years. Even among heavy chain smokers, it takes several decades before they develop COPD. I'm not aware of more than a handful of smokers who were diagnosed with COPD (caused by smoking) before they reached the age of 40. Population-level data show that the observed increase in COPD incidence among smokers does not begin until about age 45.

Even assuming that someone did not start smoking until they reached 20, it still takes a minimum of two decades of smoking to do enough damage to the lungs that a person develops and is diagnosed with COPD. So how can you get COPD from vaping (which is even less frequent than smoking) for just a few years?

People are just not thinking. The idea that there are a substantial number of never smokers in Hawaii who have developed COPD after just a few years of vaping is absurd on its face.

This leads me to believe that there is a strong, subconscious bias among many researchers who are so determined to find an association between vaping and chronic disease that they are forgetting basic pathology.

Moreover, there have not even been anecdotal reports of nonsmokers developing COPD after a few years of vaping. And clinical studies have failed to detect any decline in lung function, as measured by spirometry, among vapers.

Furthermore, if vaping was causing COPD, we would expect to see an increase in the prevalence of COPD over the past few years, especially since vaping rates started to increase exponentially starting in about 2011. Instead, we see little if any change in COPD prevalence since 2011.

The reason this is all so disturbing to me is not simply that it shows how scientific rigor in tobacco control literature has deteriorated. It is disturbing because disseminating these scientifically unsupported claims is going to discourage many smokers from trying to quit using e-cigarettes and may even cause many former smokers to return to smoking. After all, if you can get COPD from vaping, then why not go back to the real thing?

The unsupported, sweeping, hysterical conclusions being drawn from these studies are not just scientifically poor, they are causing harm to the public's health as well.

Tobacco Control Researcher Calls for Boycott of Journal, Apparently Because the Editor Supports E-Cigarettes for Harm Reduction

In a comment posted on Dr. Stan Glantz's blog yesterday, Dr. Thomas Eissenberg--a researcher studying electronic cigarettes at Virginia Commonwealth University--called for a boycott of the journal Addiction because of his claim that the editor of the journal exhibited bias in fast-tracking an article that reported low levels of aldehydes in e-cigarette aerosol.

Specifically, Dr. Eissenberg called for researchers to boycott the journal by not submitting articles to it and not reviewing for it "until it has published the means by which it will manage the apparent conflicts of conscience among its editorial staff...". Presumably, Dr. Eissenberg is referring to what he views as a significant conflict of interest of the journal's editor--Dr. Robert West--who he claims violated the peer review process in fast-tracking a 2015 article that defended e-cigarettes against the claim that they expose users to high levels of formaldehyde.

The situation is a bit complex, so let me try to summarize the background as best as I understand it:

In May 2015, Dr. Konstantinos Farsalinos and colleagues published an article in Addiction which reported the results of an experiment showing that e-cigarettes only produce aldehydes (such as formaldehyde, a carcinogen) under dry puff conditions. A dry puff occurs when a vaping device overheats the e-liquid, resulting in an unpleasant taste. Most vapers will discontinue vaping when they experience a dry puff. Therefore, if aldehydes are present only under dry puff conditions, then they do not present a major health concern for vapers.

In September 2015, Dr. Eissenberg--along with Dr. Alan Shihadeh and Soha Talih--published a letter to the editor of Addiction in which they accused him of having a "conflict of conscience" that led to a lack of rigorous peer review and inappropriate fast-tracking of the Farsalinos et al. article. The authors' complaint was two-fold: (1) that the review period was only 11 days, which is uniquely brief for this journal; and (2) that the editor--Dr. West--has a significant conflict of interest because he was once quoted in a newspaper article as (according to Eissenberg et al.) stating that: "E-cigarettes are about as safe as you can get… E-cigarettes are probably about as safe as drinking coffee."

Eissenberg et al. went on to accuse Dr. West of exhibiting bias in handling what they call a "flawed" manuscript: "These statements suggest a potential conflict of conscience in the handling of a flawed report that reinforces Dr West's professed faith in e-cigarette safety...".

Addiction published the extremely long letter by Eissenberg et al. (which itself is unusual), along with a response from Dr. West stating that the accusation is false because he didn't even handle the paper: he designated the review to a different editor. Moreover, the paper went through the same peer review process as any other paper (although it was fast-tracked because of particular urgency of this topic). In fact, the authors went through not one, but two rounds of revisions before the manuscript was accepted for publication.

That is where the story stood until yesterday, when Dr. Eissenberg called for the boycott of the journal, apparently sticking to his accusation against Dr. West despite West's response.

The Rest of the Story

Ironically, while Dr. Eissenberg is accusing Addiction of unscientific and biased actions that threaten scientific integrity, it is actually Dr. Eissenberg's actions here that are inappropriate, biased, and a threat to scientific integrity.

First, Dr. Eissenberg makes a serious accusation against the editor of Addiction without sufficient evidence to justify the claim. He (and his co-authors) provide no substantial evidence that the peer review process was botched, that the Farsalinos et al. article was seriously flawed, or that a severe bias on the part of the editor led to a botched review and acceptance of an article that should not have been published.

As it turns out, Dr. West apparently had no role in the review of the manuscript, so Dr. Eissenberg's accusation was incorrect. Moreover, the paper did go through the normal review process, although in expedited fashion. It is perfectly legitimate for journals to fast-track articles of particular interest, and many journals do that all the time. The article was peer reviewed and the authors were required to respond to reviewer comments twice. Thus, there was nothing qualitatively different about this peer review process from the review of any other paper submitted to the journal. No evidence is provided to support the accusation that the review process was flawed in any way.

Dr. West ended his response by stating: "I hope that this will give them (Eissenberg et al.) pause for thought before making serious accusations about colleagues." I agree. The allegations against the editor and the journal were serious but no evidence was provided to support them. Making an unjustified accusation and then calling for a boycott of the journal based on that unsupported allegation is the threat to scientific integrity in this story.

Second, Eissenberg et al.'s claim that Dr. West has a "conflict of conscience" because he believes e-cigarettes are relatively safe is a perversion of the concept of conflict of interest. In fact, it would be impossible for any journal editor not to have a "conflict of conscience" according to the definition that Dr. Eissenberg and colleagues are asking us to accept. Everyone involved in tobacco control has some personal view on the relative safety of e-cigarettes. The idea that researchers should boycott the journal because the editor has expressed his personal views on the relative safety of e-cigarettes is ludicrous.

Interestingly, in making their accusation that Dr. West has some sort of unusual "conflict of conscience" that would make it inappropriate for the journal to consider papers on e-cigarettes, Eissenberg et al. only quoted a small portion of Dr. West's comments in the newspaper article. I could just have easily accused Dr. West of having a strong personal bias against e-cigarettes by selectively quoting him from the newspaper article as stating:

"This is a danger. Regulators should monitor this."

In fact, Dr. West's views as expressed in the newspaper article appear to me to be balanced and evidence-based. His full comment to the paper explains the scientific reasoning behind his view, which I find quite reasonable:

"We have such a massive opportunity here. It would be a shame to let it slip away by being overly cautious. E-cigarettes are about as safe as you can get. We know about the health risks of nicotine from studies in Sweden into the use of "Snus", a smokeless tobacco. Nicotine is not what kills you when you smoke tobacco. E-cigarettes are probably about as safe as drinking coffee. All they contain is water vapour, nicotine and propylene glycol [which is used to help vaporise the liquid nicotine]."

But more to the point, the entire concept of suggesting that researchers boycott a journal based on the scientific views of the journal editor is a dangerous one. It is basically setting up a system where the only journals that survive would be ones whose editors express opinions that are in line with the mainstream scientific opinion. In fact, the very idea that researchers should boycott journals based on the opinions of the journal editor is nonsensical. Should we boycott the journal Tobacco Control because the editor does not personally believe that e-cigarettes are orders of magnitude safer than real cigarettes? Once we start going down that path, we end up challenging the existence of scientific integrity in research reporting.

This is the reason why journals screen for financial conflicts of interest, rather than conduct a McCarthy-like witch hunt to determine whether a researcher may be biased because of opinions they have expressed. Believe me, we don't want to go down that path.

There may be unusual situations in which an editor may have such a personal connection to an issue that it may be appropriate to recuse themselves from review and ask a deputy or assistant editor to handle the review, but that's certainly not true in this case. Here, the review was apparently handed off to a different editor anyway, even though I don't see any reason whatsoever why that would have been necessary.

What is perhaps most ironic about the letter to the editor by Eissenberg et al. is that although they accuse the editor and the journal of a serious conflict of interest, the letter itself fails to disclose an apparent financial conflict of interest of one of its authors. The letter fails to disclose any conflicts of interest among its authors (this link is to the PDF version of the letter which I checked to make sure a disclosure statement wasn't just missing in the online version). Thus, one would assume that none of the authors has any connection to the tobacco industry, such as -- for example -- having received funding from an organization chaired by a tobacco industry executive.

But it appears that Dr. Shihadeh -- the lead author of the letter to the editor -- has failed to disclose that he has, in the past, received funding from an organization chaired by a tobacco industry executive. Dr. Shihadeh is the co-author of several papers that acknowledge funding from the International Development Research Centre, which -- at the time -- was chaired by Barbara McDougall, who was on the Board of Directors of the Imperial Tobacco Company.

In addition, Dr. Eissenberg -- the senior author of the letter to the editor -- also acknowledged having received funding from the same organization, which was at the time chaired by a tobacco company executive.

I find it ironic that the only real conflict of interest in this story is the fact that two of the authors of the letter to the editor have, in the past, received funding from an organization that was chaired by a tobacco industry executive. And that conflict of interest is not disclosed by the authors.

Now, to be very clear, I am not accusing Dr. Shihadeh or Dr. Eissenberg of voluntarily accepting tobacco industry-related funding. They stated that they were unaware, at the time of the funding, that the chair of the organization was a tobacco industry executive. So I'm not blaming them for accepting that funding. However, they were certainly aware in 2015 - when they wrote the letter to the editor - that they had been funded by an organization chaired by a tobacco industry executive. It seems to me that is a fact that should have been disclosed. That lack of disclosure, by the way, stands in contrast to Dr. West's full disclosure of his industry-related funding from pharmaceutical companies and his clear statement that he has never been funded by the tobacco or e-cigarette industries.

The rest of the story is that in my view, Dr. Eissenberg is falsely accusing the journal Addiction of having violated scientific principles of peer review because of a personal bias on the part of the editor. Worse still, he has now called for a boycott of the journal based on these unsupported allegations.

It would truly be a shame if researchers followed this misguided recommendation.

It's Official: Anti-Tobacco Groups Willing to Throw Away the Lives of Smokers to Promote Radical Ideology

For months, I have been arguing that the major anti-tobacco groups in the United States have been waging a war against electronic cigarettes that is motivated not by a pure concern for the public's health, but by an ideological opposition to the idea that anyone could get pleasure from nicotine in whatever form -- even if they are improving their health and saving their life.

Today, the American Thoracic Society (ATS) made it official.

In a letter to the editor published in the Washington Post, the American Thoracic Society confirmed what I have been suggesting for months.

The vice chair of the American Thoracic Society’s Tobacco Action Committee essentially confirmed that the ATS is willing to throw away the lives of smokers in order to promote the radical ideology that no one should derive pleasure from nicotine in any form, even if it is a life-saving switch from deadly cigarettes to very low-risk e-cigarettes.

In the letter, Dr. Enid Neptune writes: "As a physician who treats patients devastated by tobacco-caused lung disease, I was concerned by the Aug. 5 editorial “Breaking nicotine’s grip,” which embraced Food and Drug Administration Commissioner Scott Gottlieb’s plan for regulating tobacco products. The commissioner seems unconcerned about switching one form of nicotine addiction with another. Nicotine in any form is bad for your health, adversely affecting neurological and cardiovascular systems and reproductive health. Evidence shows that nicotine can be a gateway drug. ... The FDA’s job is to protect youths from all types of tobacco and nicotine addiction, not to negotiate which types of nicotine addiction it will allow."

The title of the letter is: "The FDA’s new plans could just switch one form of nicotine addiction with another."

The Rest of the Story

The writer makes a great point. We should never promote the idea of people switching from one addiction to another. And it is not the concern of public health what health risks are associated with any form of addiction. All addiction is bad and our job in public health is to make sure that no one, anywhere, at any time, is addicted to any substance.

For example, when heroin addicts are treated with methadone or bupenorphine, the physician is just substituting one addiction for another. These physicians seem unconcerned about switching one form of nicotine addiction with another. Opiates in any form are bad for your health, adversely affecting neurological and cardiovascular systems and reproductive health. Evidence shows that opiates can be a gateway drug and there is a great risk of overdose with any opiate. The job of physicians is to protect people from all types of opiate addiction, not to negotiate which types of opiate addiction they will allow.

OK - I was being facetious. But this demonstrates the insanity of the argument that the e-cigarette industry should be decimated through burdensome regulations because vaping is just another form of nicotine addiction and all nicotine addiction is equally evil.

I, and fortunately the new FDA Commissioner, strongly reject this radical ideology. Risk does matter. Addiction is a public health problem not because the concept of someone being addicted to a substance is severely damaging, but because the addictive substance carries severe health risks. Switching from a high-risk addictive substance to a low-risk addictive substance is not a zero-sum game. It is a critical and life-saving intervention. Just as methadone maintenance programs have saved thousands of lives from heroin-associated morbidity and mortality, electronic cigarettes are saving thousands of lives from smoking-associated disease and death.

While this writer speaks only for the American Thoracic Society, it is clear to me that this is indeed the underlying philosophy of all the major anti-tobacco groups, and even of many health departments and agencies, including the Centers for Disease Control and Prevention and the state health departments in California, Vermont, and Washington (to name a few).

Fortunately, Commissioner Gottlieb has rejected this philosophy, strongly and definitively. Public health is about saving lives, not fighting for some ideological principle of no addiction to any substance, regardless of how low-risk the product might be or how the product might be saving a life by switching someone to a much safer form of drug delivery.

Of course we need to restrict the sale and marketing of vaping products to youth and educate them about the health risks of all types of nicotine products, including real cigarettes and fake ones. But discouraging youth from using e-cigarettes should not come at the expense of wiping out 99% of the e-cigarette market, depriving millions of former smokers of the product they are using successfully to stay off tobacco cigarettes, and risking tens of thousands of these former smokers returning to cigarette smoking because their vaping products are taken off the market.

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.

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.