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. 

Findings from the 2025 National Youth Tobacco Survey that Anti-Nicotine Groups Don't Want You to Know

Earlier this week, the FDA released the data from its 2025 National Youth Tobacco Survey. This is a public use dataset so it is freely available to all. My own analysis of these data revealed some important findings that I want to share. To the best of my knowledge, the questions I investigated in my analysis are questions that no health agency or anti-nicotine organization has ever examined. When you see the results, you will understand why.

First, I want to put forth the conceptual thinking that led me to ask these particular questions. It is based on adolescent risk-taking theory, which posits that adolescent risk-taking is not necessarily a sign of brain dysfunction, but rather a normal, necessary, and adaptive part of development. According to the UCLA Center for the Developing Adolescent: "It’s not only normal for adolescents to take risks and try new things, it’s an essential part of learning during these years. Being able and willing to take risks is a part of our natural tendency to explore new things in adolescence—in ways that help us discover who we are, expand our skills, and ultimately leave the safe nest of home." 

Moreover, independence and rebellion are the core values of adolescence. Risk-taking is a way of expressing autonomy and rebelling against adult authority. It is also a way of coping with the stresses of adolescent life. Given what is going on in the world today, it is not surprising that youth are facing unprecedented challenges to their mental health. Most are going to engage in some form of risky behavior in order to cope. The problem with authoritarian thinking in the tobacco control movement is that we have committed ourselves to the goal of eliminating all nicotine-related risk among youth rather than attempting to employ a harm reduction approach and ensure that the risks youth do take are relatively safe, at least in comparison what they could otherwise be doing.

The general theory in the tobacco control movement is that youth vape because Big Tobacco is evil and has tricked them into thinking that vapes are safer than cigarettes, has enticed them with gummy bear and cotton candy flavors, and used targeting marketing in an attempt to addict a new generation to a behavior that is a gateway to smoking and most likely, a lifetime of tobacco use. This argument is flawed for many reasons -- not the least of which is that it is untruthful -- but beyond that there is strong evidence that vaping went viral largely because of social media influencers combined with the addictive nature of nicotine. Remember that even without an addictive component, "six-seven" took off in 2025 and fidget spinners became a viral toy craze in 2017. 

The bottom line is that adolescents engage in risk-taking behavior and that youth who take one type of risk are also more likely to take other risks. For example, we know that youth who use marijuana are also more likely to smoke. So the question I posed is: Could it be that youth who use e-cigarettes are also more likely to smoke or to vape other even more risky substances, like THC, CBD, or synthetic marijuana like K2 or spice? 

The Rest of the Story

Based on my analysis of the 2025 National Youth Tobacco Survey, the prevalence of current e-cigarette use (defined as use within the past 30 days) among middle and high school students was 5.2%, drastically down from a peak of 20.0% in 2019. Among these youth current e-cigarette users, about half (51.0%) also were current smokers and/or current users of THC, CBD, or synthetic marijuana vapes. Among heavy e-cigarette users (defined as use on at least 20 of the past 30 days), a large majority (63.5%) also were current smokers and/or current users of THC, CBD, or synthetic marijuana vapes.

What this means is that for nearly two-thirds of youth heavy e-cigarette users, the biggest risk they face is not the e-cigarettes but either smoking or using black market marijuana vapes. 

The reason tobacco control groups don't want you to know this is that it exposes their culpability in the EVALI outbreak, which resulted in nearly 3,000 hospitalizations and 68 deaths. These groups were insistent upon blaming the outbreak on e-cigarettes. They promoted bans on e-cigarettes and continually insisted that the problem was e-cigarettes but failed to tell youth the truth: black market THC products tainted with vitamin E acetate are the cause and you need to stop using these product today!

The failure to warn youth about the dangers of black market THC products was very much responsible for many hospitalizations and perhaps deaths. The health groups did such a poor job of communicating this essential fact that only 11% of youth knew that EVALI was caused by marijuana vaping.

These data paint a very different picture of the youth vaping "epidemic." The large majority of youth who use e-cigarettes regularly are engaging in multiple risk taking behaviors, including ones that are far more dangerous than nicotine vaping. The use of black market THC vapes or synthetic marijuana vapes could literally be life-threatening or at least pose a significant risk of immediate health harm severe enough to require hospitalization. Even though vitamin E acetate is no longer a common component of THC vapes, the use of any black market vaping product carries the risk of tainting with synthetic cannabinoids or other drugs, a risk that is not present with the use of nicotine-containing e-cigarettes that originated in a retail store. These drugs can cause heart attacks, strokes, and seizures. Black market THC vape pens may also contain synthetic opioids whose use could be fatal. 

Based on my analysis, an alarming 15.2% of youth daily e-cigarette users are also vaping synthetic marijuana. While anti-vaping groups are trying to ban e-cigarettes, most are not even informing youth about this risk and seem to be more concerned about a youth ripping a cherry vape than having hallucinations, seizures, or being hospitalized because of black market drug use.

Yes, youth e-cigarette use is a public health problem. However, our insistence on a prohibition-based approach rather than focusing on harm reduction is putting youth at great risk, not less.

Smoke-Free Products Nearing 50% of the Nicotine Market Thanks to Tobacco and Vaping Companies But In Spite of the Actions of Most Tobacco Control Groups

A new report from the nation's leading tobacco market expert - Bonnie Herzog at Goldman Sachs - reveals that smoke-free nicotine products now account for 48% of the overall nicotine market and are projected to comprise 75% of the market within 10 years. Furthermore, the overwhelming majority of the smoke-free market is also tobacco-free, meaning that not only are combustible tobacco products on the decline but tobacco products themselves are on the decline. The major players in the smoke-free, tobacco-free nicotine market are e-cigarettes and nicotine pouches.

The Rest of the Story

Here's the sad part of the story. This transition from combustible cigarettes to smoke-free, tobacco-free electronic cigarettes and nicotine pouches is almost entirely due to innovations from tobacco and vaping companies, not because of the hard work of tobacco control and public health organizations. In fact, most tobacco control groups have tried to obstruct, rather than promote, this miraculous, live-saving transition. The rest of the story is that this public health miracle is due to innovations within the tobacco and vaping industries and it occurred in spite of, not because of the actions of tobacco control and health groups.

When Massachusetts initiated its landmark anti-smoking program in 1993, our slogan was "Let's Make Smoking History." At the time, I thought that was a goal that would never be achieved. Thirty-three years later, that dream is starting to come true. But the reason it's coming true is not because Massachusetts and other states have acted to promote a market transition away from combustible tobacco products. The sad truth is that the opposite is the case. Most tobacco control groups, health groups, and policy makers have done everything in their power to block this transition. Their attacks on e-cigarettes and now, nicotine pouches, have hindered rather than helped progress in reducing morbidity and mortality from smoking, which is still the leading preventable cause of death in the United States. 

While youth vaping is a public health problem, its negative impacts are dwarfed by the life-saving gains resulting from the decimation of the combustible tobacco market. Moreover, contrary to the actions of the mainstream tobacco control groups, we can address the problem of youth vaping without precluding adult access to the much safer, smoke-free, tobacco-free alternatives. We don't have to cut off our nose to spite our face. And in fact, current efforts to address youth vaping have harmed the public's health more than they have improved it. 

The current U.S. regulatory system for nicotine products is backwards. It prohibits or restricts the safest forms of nicotine while promoting the use of the most deadly form: cigarette smoking. And the reason for this backwards form of regulation is the advocacy done by the leading tobacco control groups, which did the cigarette companies a huge favor by trying to eliminate most or all e-cigarettes from the market while doing nothing to restrict the most harmful consumer product on the market.

The rest of the story is that the mainstream tobacco control groups have largely squandered an opportunity to promote what is potentially one of the most substantial and miraculous public health advances of our time: making smoking history.

Massachusetts Association of Health Boards Wants to Ban the Use of Flavored E-Cigarettes, by ANYONE

The Massachusetts Association of Health Boards (MAHB) has disseminated a model nicotine regulation policy that it is recommending be adopted by all boards of health in Massachusetts. The policy makes it illegal for anyone in the state to possess a flavored electronic cigarette. 

Existing state law prohibits the sale of flavored tobacco products but it does not prohibit people from using these products. For example, although youth cannot be sold flavored e-cigarettes, they are not punished (i.e., fined) if they take a hit from one. Many adults use flavored e-cigarettes to keep off of real cigarettes, and although flavored products can't legally be sold in the state, an adult is not punished if they are caught vaping a non-tobacco-flavored vape.

The model policy being promoted by MAHB calls for changing the law so that not only is the sale of flavored e-cigarettes banned, but the use of these products would be prohibited as well. The law prohibits any person from "possessing, holding, or keeping" a flavored e-cigarette. This of course means that you are not allowed to use an e-cigarette because you have to hold it to use it! (You would be prohibited from using it anyway because if you're vaping, then you obviously are "possessing" it).

The specific language of the model policy reads as follows (the revised text is shown in bold): "No retailer or person, as defined herein, shall possess, hold, keep, sell or distribute or cause to be possessed, held, kept, sold or distributed any flavored tobacco product, as defined herein, or any flavored tobacco product enhancer, as defined herein, (NOTE: If the municipality permits smoking bars add this phrase [except in smoking bars for on-site consumption only])."

Technically, this also makes it illegal to even hand over a flavored e-cigarette to someone because you are then "causing it to be possessed."

The Rest of the Story

I hope that local boards of health have enough sense not to implement this recommended policy. It has long been the philosophy in tobacco control that you don't punish the users of tobacco products but focus on the sellers who violate the law. Moreover, why would you punish people who are trying to save their lives through the use of flavored vaping products?

I don't know what the MAHB is trying to do here but it certainly has the appearance of wanting to punish smokers for making the wise health decision to switch to electronic cigarettes. Passage of such an ordinance would mean that every person who uses anything other than a tobacco-flavored e-cigarette would be violating the law. Ironically, smoking a Marlboro Red would be perfectly legal. 

This proposed ordinance also recommends that nicotine pouches either be restricted to less than 6mg of nicotine or that their sale be restricted to adult-only tobacco shops. There is no scientific rationale for setting the level at 6mg and doing so could potentially make the products less effective in getting smokers to quit. Moreover, banning the sale of nicotine pouches at convenience stores but allowing deadly cigarettes to be sold makes no sense. 

What is the motivation behind wanting to make sure that it is as easy as pie for any youth or adult for that matter to obtain deadly tobacco cigarettes at your nearest gas station or convenience store but restricting much safer nicotine pouches (no tobacco, no combustion) to select stores? Requiring all nicotine products to be sold in adult-only "tobacco" shops would be consistent with public health but why do such a favor for cigarette manufacturers at the expense of people's health and lives?

End of Year Thoughts: Why are So Many Anti-Tobacco Groups Attacking a Product with Few Acute Risks, But Saying Nothing About Truly Risky Tobacco Products?

Why are so many anti-tobacco groups attacking electronic cigarettes (and to some degree nicotine pouches) but saying little about the risks of much more dangerous behaviors such as smoking? This is the $64,000 question, although I will only add my 2 cents here. But it is something that I have been thinking about for a long time (specifically, 16 years).

After a decade and a half of thought, I've gone through and discarded a slew of hypotheses and although I think there is some truth to many of them, there is only one that I find can consistently explain the shocking, irrational, unscientific, hysterical, and damaging behavior of so many anti-tobacco organizations.

First, why do I explain the behavior of so many of these groups as shocking, irrational, unscientific, hysterical, and damaging?

Shocking: It is shocking to me that an organization like the American Lung Association (with which I worked closely for several decades as both an employee and volunteer) is telling the public that quitting smoking by switching to vaping is not quitting smoking. That statement doesn't even make sense grammatically. It's false on its very face. You can't say "quitting smoking by doing X isn't quitting smoking." Unless that X is smoking! In this case, the X is not smoking, but vaping. They're not even qualifying the statement by asserting that if you don't switch completely to e-cigarettes, then you haven't quit smoking. They're actually saying - and I believe they actually mean - that if you quit smoking you have not quit smoking (if you did it in a way that they disapprove).

Irrational: It is irrational to discourage people who are addicted to smoking from switching to a much safer form of nicotine intake that has helped millions of people quit completely. Groups like the American Cancer Society are actively discouraging smokers from quitting using e-cigarettes, despite their proven effectiveness.

Unscientific: There is abundant scientific evidence that switching to vaping is the single most effective method for quitting smoking (other than cold turkey quitting for those who are highly motivated or triggered). The smoking cessation rate associated with the use of e-cigarettes is consistently about twice as high as that for nicotine replacement therapy, yet NRT is considered the "gold standard" for smoking cessation treatment.

Hysterical: By hysterical, I don't mean that the claims that many of these groups are making are funny. I mean that they are completely ungrounded in science and greatly exaggerated. In other words, that they are a form of hysteria which is helping to spread false information. For example, the claim that vaping causes popcorn lung is hysteria: there is not a shred of evidence to support that claim. Smoking itself is not associated with popcorn lung. It is, quite frankly, a hysterical claim in its lack of scientific grounding.

Damaging: As a result of all of the above, these organizations are essentially recommending against smoking cessation for smokers who desire to quit using e-cigarettes. They are actually providing medical advice to smokers indicating that they might as well continue to smoke rather than switch to e-cigarettes and some are even suggesting that switching to e-cigarettes is more dangerous than just continuing to smoke, arguing that dual use of smoking and e-cigarettes somehow greatly increases health damage despite dramatically lower tobacco smoke consumption. The campaigns of deception have resulted in demonstrable public health damage, as national surveys confirm that the majority of both youth and adults in the U.S. do not appreciate that smoking is any more hazardous than exclusive e-cigarette use. Undoubtedly, this has discouraged many smokers from quitting and has probably even led some ex-smokers to return to cigarette smoking.

The Rest of the Story

The conclusion I have come to is that the primary reason that so many of these groups are attacking these forms of nicotine use that have few acute risks is precisely because they have so few acute risks. In other words, deep down there is something about the relative lack of health dangers of these behaviors that bothers them and that they cannot accept. Ironically, these products pose such a risk to these groups because they don't pose a tremendous risk to youth and actually help adults who smoke. It finally occurred to me that the reason why these groups are attacking the very nicotine products at the lowest end of the risk continuum is because they are at the lowest end of the risk continuum. This is threatening to the idea that drug use should be harmful. 

And more specifically, it is threatening to the idea that people who use a recreational, addictive drug should be punished for that decision rather than rewarded for it. It is difficult for these groups to accept the fact that: 

(1) millions of adults are using a recreational drug involving addictive nicotine in a healthy way -- namely, in a way that actually improves their health; and

(2) hundreds of thousands of youth are using a recreational drug involving addictive nicotine without putting themselves at great risk of substantial health harm. 

In other words, the huge threats here are that an adult can use nicotine as a recreational drug in a way that improves their health and that a youth can use nicotine as a recreational drug in a way that does not put them at a particularly high risk of suffering severe health damage.

Let's play this argument out a little more. 

A devil's advocate argument might be that it can't be the lack of risk that is the cause for alarm because these same anti-tobacco groups are OK with the low risks associated with pharmaceutical nicotine products -- such as nicotine patches or gum or drugs like varenicline or buproprion. If these groups are threatened by the fact that people might be using nicotine in a healthy way, then why wouldn't they also be attacking NRT?

But it's not the use of nicotine in a healthy way that is threatening to these groups -- it is the recreational use of nicotine that bothers them. For decades, we in tobacco control have demonized nicotine. Given its demonic status, how can we possibly condone, or even support and recommend, the recreational use of this drug for any purpose, even one that improves the health of an individual? We're not offended if it's prescribed by a doctor as a medication because then it's not recreational use. It's the recreational use aspect that makes it unacceptable.

It's unfortunate because in some ways, latching on to nicotine as a central evil of cigarettes was what helped greatly reduce cigarette smoking, promote effective regulations, destroy the reputation of the cigarette companies, and achieve major legislative and litigation battles. In many ways, it was former FDA Commissioner David Kessler's pronouncement of nicotine as a drug that ultimately led to passage of the Family Smoking Prevention and Tobacco Control Act of 2009. So recognizing and emphasizing the role of nicotine in smoking addiction played a major role in fighting the tobacco industry and in greatly reducing smoking rates.

The problem is that now, what was previously an appropriate obsession with the problem of nicotine addiction is threatening to destroy a golden opportunity to literally make smoking history, as we had previously indicated was our primary goal (e.g., the slogan of the Massachusetts anti-smoking campaign for many years was "Let's Make Smoking History.")

Ironically, it is the tobacco control movement that is now the greatest threat to making smoking history as the movement's continuing demonization of nicotine--divorced from any consideration of its actual health effects--is leading to misguided public recommendations, physician misinformation, public deception, and ill-conceived regulation and legislation that has combined to achieve the effect of doing everything possible to protect combustible tobacco use from being completely displaced by much safer forms of nicotine use that do not even involve tobacco (although the mainstream tobacco control groups continue to incorrectly call e-cigarettes and nicotine pouches "tobacco products" and "forms of tobacco use"). 

While the mainstream tobacco control movement has become obsessed with trying to destroy the safest forms of nicotine available, they are at the same time protecting the most dangerous form of nicotine available (cigarette smoking). And while groups like Parents Against Vaping E-Cigarettes would apparently like to see nicotine e-cigarettes banned, they don't utter a word about much more acute and severe threats to youth health like black market THC vapes, drug-spiked cannabis products, and alcohol use. Apparently, while they think that every single flavored e-cigarette product needs to be banned, they are OK with alcohol companies recruiting kids to dangerous drinking by indoctrinating them with flavored alcoholic beverages (which, unlike e-cigarettes, are a gateway to more dangerous forms of drug use). Ultimately, it's not doing any good for our nation's youth to teach them that ripping an occasional cherry vape is the greatest risk to their health.

The rest of the story is that the demonization of nicotine--while it previously played a critical role in the fight against smoking--is now impeding progress in what would otherwise be a golden opportunity to eliminate the use of combustible tobacco. This is largely a result of the inability of the tobacco control movement to change its old paradigms as the world changes: as new scientific evidence arises, as the market changes, as the actions of the tobacco industry change. 

I understand the difficulty of changing your paradigm. Look - I have acknowledged that between 2007 and 2009 (when I first heard about e-cigarettes), my position on these products was exactly what the position of the mainstream tobacco control groups are today: I thought this was a Big Tobacco ploy to addict a new generation of kids by marketing a product as being safer when it really wasn't. But I changed my views, and my paradigms, when I learned more about what was actually happening and what the science actually indicated. I challenged my pre-existing thinking, allowing myself to be swayed by new scientific evidence. I took the time to speak with the heads of many e-cigarette companies, to visit vape shops, to talk to hundreds of vapers, and to conduct my own research. And by 2009, my opinion had changed. 

This was not a ploy by Big Tobacco because Big Tobacco was actually not involved (they didn't even enter the picture until 2011). The companies weren't lying in claiming that vapes were safer than cigarettes - they were safer. The goal of the product was not to addict a new generation of youth but to help adult smokers quit. And the product was effective. Large numbers of smokers who were not able to quit using any other method were finding vaping an effective quitting strategy.  And the safety and effectiveness of these products has only improved since 2009.

I can only hope that the new year will bring a fresh perspective and a more rational approach to the public health practice of tobacco control. 

World Health Organization Explicitly Rejects Harm Reduction in Tobacco Control, Endangering Millions of Lives Worldwide

The Conference of the Parties to the World Health Organization's (WHO) Framework Convention on Tobacco Control (FCTC) met recently to update their international strategies to (supposedly) reduce the international burden of tobacco-related morbidity and mortality. Today, the Tobacco Tactics team published an article in the journal Tobacco Control that summarizes the consensus approach to the issue of harm reduction in tobacco control.

Here is the summary:  

"COP11 included a specific agenda item on nicotine addiction in light of the tobacco industry’s narrative on ‘harm reduction’, during which Parties discussed proposed decisions. This year’s discussion demonstrated the strong interest among Parties in identifying the best approaches to protect future generations from both tobacco and nicotine addiction. In preparation for this discussion, the Convention Secretariat prepared a report,10 making it clear that there is no legitimate ‘tobacco harm reduction’ based on advancing the commercial and vested interests of the tobacco industry. In the context of the WHO FCTC, ‘harm reduction’ is ‘harm elimination, the intended outcome from the full implementation of the treaty’s existing, evidence-based measures."

The Rest of the Story

This is a shocking statement. It explicitly asserts that there is no legitimacy to the concept of harm reduction in tobacco control and it claims that tobacco harm reduction is only promoted by the tobacco industry and its sole purpose is to advance the commercial interests of the tobacco industry. It goes so far as to say that the only legitimate harm reduction regarding smokers is harm elimination, meaning that there is only benefit if a smoker becomes abstinent from nicotine, not if that smoker quits smoking using one of the most popular and effective methods in the world.

It is demonstrably false that harm reduction is only promoted by the tobacco industry. In fact, harm reduction is a central concept of public health and is promoted widely by tens of thousands of public health professionals, organizations, and agencies throughout the world. Harm reduction is a central approach in the field of drug addiction. It is also being promoted widely throughout the world by scientists and advocates who have no affiliation with Big Tobacco.

Moreover, the overwhelming majority of the companies selling e-cigarettes are not part of the tobacco industry. And the idea of e-cigarettes for harm reduction did not originate with Big Tobacco. These products came to market in 2005 and the tobacco industry did not get involved until 2011. 

It is also demonstrably false that harm reduction is solely being promoted to advance the interests of the tobacco industry. In fact, the more smokers switch to e-cigarettes, the lower the profits are for cigarette sales. While it is true that the cigarette companies that also produce e-cigarettes will obtain sales revenue from e-cigarettes, is that not a far better outcome than these companies gaining revenue from cigarette sales? 

The rejection of harm reduction by WHO endangers the lives of millions of smokers worldwide. The WHO is literally abandoning smokers and using them as sacrificial lambs in an effort to demonize safer alternatives to cigarettes because the FCTC leaders can't stand the idea that the use of a nicotine product could actually be beneficial to health (even though they have no problem with pharmaceutical companies reaping in billions of dollars based on the same concept - perhaps this is because the WHO Foundation receives millions from the pharmaceutical industry). 

While it is bad enough that tobacco control organizations and health agencies in the United States have shunned harm reduction in tobacco control, the fact that WHO has rejected harm reduction strategies to address the worldwide burden of smoking-related disease is truly a global public health disaster. 

 

Many Tobacco Control Organizations are Asserting that Quitting Smoking is Not Quitting Smoking if You Use E-Cigarettes to Quit

The American Lung Association has long been trumpeting the falsehood that quitting smoking by switching to electronic cigarettes isn't quitting smoking, a statement that is false on its face. The American Lung Association has been telling the public that "Switching Isn't Quitting." 

Can you imagine a public health organization telling people trying to get off of heroin that "Switching (to methadone) Isn't Quitting"? 

The Rest of the Story

Unfortunately, it is not just the American Lung Association that has been spreading this nonsensical, false, and dangerous rhetoric. Here is a list of other tobacco control groups that have made the same assertion.

Tobacco Education Clearinghouse of California

El Dorado County Public Health

DePaul University Office of Student Affairs

Fresno County Department of Public Health

North Dakota Department of Health

Butte County Health Department

California Tobacco Free Colleges

Kick It California

American Lung Association of Rhode Island

Cuesta College Student Health Services

Fargo Cass Public Health

Healthy UC Davis

Southeast Asia Tobacco Control Alliance

Tobacco Free North Dakota

Shasta County Tobacco Education Coalition

Clearly, there is a major misinformation campaign going on within the tobacco control movement. Many of these groups are using false information to discourage smokers from quitting and entice ex-smokers to return to smoking.

American Lung Association Directs Youth to Complain about Seeing People Use Nicotine Pouches in Workplaces

A campaign being run by youth in Wisconsin who are part of a group called FACT is urging their fellow youth to complain to legislators about having to see people using nicotine pouches in workplaces. Youth are instructed to tell their legislators: "What tobacco products do you still see used in places covered by the smoke-free air law (workplaces like restaurants, hotels, and offices)? Vapes? Nicotine pouches? What bothers you about seeing these products in those places?"

I spent many years of my career lobbying for smoke-free workplace laws. But when I said "smoke-free" I meant "smoke-free." In other words, I was promoting the elimination of tobacco smoke in workplaces. My efforts were based on voluminous scientific evidence of the long-terms harms of tobacco smoke exposure for employees, especially those working in smoky bars and restaurants. 

I have to honestly say that I'm not crazy about banning vaping in public places because I'm not aware of solid evidence that it causes significant health effects but I can at least understand the rationale. People are being slightly exposed to chemicals in aerosol that they did not create. However, I fail to see the rationale behind banning the use of nicotine pouches in public places. The use of a nicotine pouch has absolutely no health effects for bystanders. It doesn't create any kind of smoke, vapor, aerosol, or any other exposure for people who are not actually using the product. So why would youth want to ban the use of this product? It just doesn't make any sense. 

Something else bothers me about the appeal being made by this FACT organization. The appeal does not give youth the option of not being bothered by the use of nicotine pouches in public places. It asks "what bothers you" about seeing nicotine pouches in these places, essentially implying to youth that there is no option other than to be bothered by the use of nicotine pouches.

This sends a bad message to youth. It sends the message that we should be banning individual behavior that has no harmful effect on anyone else. And that we should ban a behavior that actually may be life-saving for people, since many - if not most - adults who use nicotine pouches are doing so in an effort to quit smoking.

This is tantamount to telling kids that they should be bothered by seeing methadone clinics, naloxone distribution programs, or needle exchange programs. It asks youth to oppose life-saving harm reduction policies in the name of regulating people's lifestyle choices that affect nobody else except themselves.

It struck me that there has to be something else behind this organization because youth on their own would not promote such an idea that is totally contrary to public health and also contrary to the way most youth think.

The Rest of the Story

Well, the truth is that these youth are not acting independently. The organization is actually an initiative of the American Lung Association and is funded by the state health department!

According to the web site: "FACT is ably managed by the American Lung Association, funded by Wisconsin’s Commercial Tobacco Prevention & Treatment Program, and organized with the help of local health alliances." 

The American Lung Association is basically using youth to do their bidding. They are taking advantage of youth in order to try to push their own agenda of banning nicotine pouches. 

This is not the first time I have exposed tobacco control organizations using kids as a pawn in their efforts to support their own agenda in a way that is far from transparent. While anti-nicotine groups have the right to try to ban life-saving harm reduction products, they should not be manipulating youth into promoting these misguided policies for them. This is why I find what the American Lung Association is doing in Wisconsin so disturbing.

Misinformation from Anti-Vaping Groups is Causing Increasing False Beliefs among Policy Makers

The role of the tobacco control movement should be to increase the public's and policy makers' understanding of the health effects of smoking and tobacco use. Instead, data from a new survey by ECigIntelligence reveal that among members of the European Parliament (MEPs), an increasing percentage of policy makers fail to understand that smoking is more hazardous than vaping.

In 2000, a similar survey showed that 68% of MEPs correctly understood that smoking is more hazardous than vaping. However, in 2025, that percentage is down to 60%. The percentage of MEPs who believe that smoking is less harmful than vaping remains at about 8-9%; however, the percentage who believe that smoking and vaping are equally harmful doubled from 12% to 24%.

The Rest of the Story

These surprising and unfortunate results are no accident. They are the direct result of a concerted misinformation campaign by anti-vaping organizations to mislead the public and policy makers into falsely believing that vaping is essentially just another form of smoking and offers no health advantages.

Ironically, it is the tobacco industry that is actually accurately conveying the relative health risks of vaping compared to smoking.

All I can say is that I never thought this day would come. For decades we have been condemning Big Tobacco for its long-standing campaign of deception and misinformation. Now, it is the mainstream of the tobacco control movement which is waging a campaign of deception while the tobacco companies are the ones being honest in their communications regarding the relative risks of smoking compared to vaping.

New Data from New York State Show that Youth Smoking is at Its Lowest Level in Recorded History; Anti-Nicotine Groups Continue to Claim that Vaping is a Gateway to Smoking

New data from the New York State Department of Health show that youth cigarette smoking is at its lowest level in recorded history (meaning ever since youth smoking prevalence began to measured in surveys). Only 2.4% of high school students in New York State reported smoking cigarettes in 2024. E-cigarette use among high school students continued its sharp decline, dropping from 27.4% in 2018 to 18.7% in 2022 to 13.1% in 2024. Overall "tobacco use" (which is actually a measure of tobacco use plus non-tobacco e-cigarette use) dropped from 30.6% in 2018 to 17.0% in 2024.

Meanwhile, many nicotine researchers and anti-nicotine organizations continue to tell the public that youth vaping is a gateway to the initiation of cigarette smoking and that youth vaping is leading to a new epidemic of smoking that is undermining the progress we have made over the past two decades. 

For example, if you go to the Johns Hopkins Medicine website, you'll find an article entitled "Will Vaping Lead Teens to Smoking Cigarettes?" The article answers the question affirmatively. In the article, a professor of medicine at Hopkins states that: "I think perhaps the #1 concern about vaping right now is the so-called gateway effect." And he claims that: "We might be causing the next smoking epidemic through young people getting addicted to electronic cigarettes early in life." 

The Rest of the Story

The claims of many nicotine researchers and anti-nicotine groups, including the conclusion expressed by this Johns Hopkins physician, are not consistent with the actual data. If it were true that youth vaping was a gateway to smoking, then the large increase in youth vaping that peaked in 2018 would certainly have resulted in an increase in smoking in subsequent years and would have been very apparent in surveys conducted over the past six years. Instead, just the opposite is happening. Youth are smoking in lower and lower numbers than ever before.  

If anything, the data show that as electronic cigarette use among youth took off, the rate of decline in smoking accelerated. These data refute the contention of so many anti-nicotine groups and researchers that vaping is problematic because it leads to kids turning to cigarettes. The evidence demonstrates that vapes are largely a substitute for cigarettes, not a gateway to cigarette smoking.

The question is: When will these researchers and groups stop making these claims that have now been definitively disproved? When more data comes out showing that youth smoking is on its way out? Probably not. The fact that even with the scientific evidence we have now they are still making these unsupported claims suggests that no amount of scientific evidence will change their public statements. 

This is so disappointing to me because public health is an evidence-based field and we are supposed to change our opinions and positions if the evidence changes. 

John Maynard Keynes is quoted as having said: "When the facts change, I change my mind - what do you do, sir?" With regard to most of the anti-nicotine groups--the mainstream of the tobacco control movement--I think we have our answer.

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.

Prominent Anti-Vaping Advocate is Misrepresenting Scientific Evidence and Being Unnecessarily Divisive, Polarizing, and Disrespectful

On his blog, Professor Stan Glantz, a highly respected researcher in the anti-tobacco field (and a former mentor, role model, and hero of mine), has posted a set of slides with the title "E-cigarettes Increase Harm to Smokers, So Should Not Be Promoted as a Harm Reduction Strategy." 

In the presentation, Dr. Glantz claims that: "There is now a large scientific literature that, in fact, e-cigarettes increase rather than reduce harm, which moots industry arguments that they should be promoted as a part of modern tobacco control."

He goes on to argue that: "The tobacco industry and its allies continue to use claims of reduced harm to argue against applying strong tobacco control policies to e-cigarettes and other noncombusted tobacco products.  For example, there is an aggressive lobbying effort 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."

The Rest of the Story

There are three disturbing things about Dr. Glantz's presentation. 

First, it misrepresents the scientific evidence. There is a large body of scientific and clinical evidence that switching from smoking to vaping substantially improves health. Clinical studies have demonstrated that there is an almost immediate improvement in respiratory symptoms and in objective lung function, measured by spirometry. Any vaper who has switched from smoking to vaping can tell you this. It has been experienced by literally millions of people. To suggest that e-cigarettes increase harm is not only false but I think irresponsible. There is abundant evidence that quitting smoking brings substantial health benefits - both in the short-term and long-term - and despite the statements of anti-tobacco organizations, switching from smoking to vaping is quitting.

While it is true that smokers who only partially substitute e-cigarettes for real cigarettes do not reap the health benefits of those who are able to quit smoking, there is no convincing evidence that dual use increases the harms from smoking. The idea that any benefits from people quitting by switching to e-cigarettes is more than offset by increased harms of dual use is not grounded in rigorous science. 

Moreover, the presentation denies that even if one only considers smokers who completely switch to vaping, there is an improvement in health. It does, however, provide a well-grounded, evidence-based and scientifically confirmed explanation for why quitting smoking by using e-cigarettes does substantially improve health: "They [e-cigarettes] generate the nicotine aerosol that users inhale by heating a liquid rather than burning tobacco, so users are not exposed to many toxic combustion products so people who switch completely from cigarettes to e-cigarettes would be better off." Yes, exactly.

Second, the presentation is disturbing because by arguing that vaping increases harms for smokers, it discourages smokers from quitting and is likely to have the effect of actually advising smokers not to quit. After all, if vaping is more harmful than smoking, as Dr Glantz claims, then a smoker is better off continuing to smoke than quitting and switching to e-cigarettes. Whether intended or not, this presentation is essentially providing medical advice to smokers that they are better off continuing to smoke if they are unsuccessful using NRT or other pharmaceutical methods and should not quit by switching to vapes even if they are interested in doing so.

Third, and perhaps most disturbing, is that the presentation portrays anyone who argues that smoking is more hazardous than vaping as "the tobacco industry and its allies." In other words, you can't possibly be an independent scientist who happens to believe the evidence showing that smoking is more hazardous than vaping. If that's what you believe, then you are either part of the tobacco industry or an ally of the tobacco industry.

This is exactly the kind of attitude that is leading to the polarization that we see in America today. You're either in the in-group or the out-group and your policy attitudes automatically put you in one group or the other. There's no nuance. There's no middle ground. 

I can state unequivocally that I am neither part of the tobacco industry nor am I a tobacco industry ally. Yet I believe, as a scientist with 40 years of experience in studying smoking, that cigarette smoking is more dangerous than using a vape that contains no tobacco and involves no combustion and has only a few chemicals as opposed to the more than 10,000 present in tobacco smoke. Because of that belief, I am apparently now an ally of the tobacco industry - an industry against which I testified in numerous lawsuits that resulted in punitive damage awards of more than $150 billion!

Not only is this attack on scientists who support harm reduction divisive and polarizing (and untrue) but it is also disrespectful. It is an insult to the many researchers and distinguished professors throughout the country and the world who have concluded, based on a multitude of evidence, that cigarette smoking is more hazardous than vaping. It is dangerous to define someone's identity and industry affiliation based solely on their scientific opinions. There's no need for this divisiveness, polarization, and disrespect. One can offer their opinion without disparaging an entire group of academics who are dedicating their careers to trying to save people's lives and who have no affiliation whatsoever with the tobacco industry.  

Campaign for Tobacco-Free Kids Decries Supposed Fast-Tracking of Safer Alternatives to Cigarettes But Says Nothing About FDA's Inaction on Real Cigarettes

The FDA is planning to fast-track applications for the marketing of nicotine pouches, according to Reuters. Nicotine pouches are much safer alternatives to real tobacco cigarettes. They contain no tobacco, involve no combustion, and do not even involve inhalation. The FDA has already approved Zyn nicotine pouches after concluding that they are appropriate for the protection of the public's health because they are much safer than cigarettes and may help smokers quit. The FDA wrote:

"Among several key considerations, the agency’s evaluation showed that, due to substantially lower amounts of harmful constituents than cigarettes and most smokeless tobacco products, such as moist snuff and snus, the authorized products pose lower risk of cancer and other serious health conditions than such products. The applicant also provided evidence from a study showing that a substantial proportion of adults who use cigarette and/or smokeless tobacco products completely switched to the newly authorized nicotine pouch products."  

In response to the revelation that the FDA is going to speed up review of these potentially life-saving products, the Campaign for Tobacco-Free Kids complained and accused the FDA of taking "shortcuts." The Campaign is quoted as stating: "There should be no shortcuts when it comes to our kids’ health."

The Rest of the Story

Let's examine how much of a "shortcut" the FDA is taking in reviewing nicotine pouches. According to statute, the FDA has 180 days to review any application to introduce a new nicotine product into the market. However, the typical application is currently taking years, rather than months, to review and thousands of products have not even received a decision yet. Zyn took five years to be reviewed. So to call a quicker review a "shortcut" is disingenuous. Improving the review time so that it doesn't take years for a potentially much safer cigarette alternative to be approved is not a shortcut to harm kids' health, but an appropriate (and legally required) step to more quickly move products onto the market that can help smokers quit.

Tellingly, while decrying these supposed "shortcuts" with the review of much safer nicotine products, the Campaign for Tobacco-Free Kids has said nothing about the FDA's de facto approval of deadly tobacco cigarettes. The Campaign for Tobacco-Free Kids did not call for the removal of deadly cigarettes from the market, nor did it even call for safety standards that could make these products less hazardous.

For some reason, the Campaign for Tobacco-Free Kids is obsessed with getting safer alternatives to cigarettes off the market so that real deadly cigarettes have no competition in the marketplace, which will obviously drive up cigarette consumption. 

I never thought I would see this. A supposed anti-smoking organization pushing to protect the cigarette market by keeping safer alternative products off the market!

Why is Philip Morris International, But Not Anti-Tobacco Groups, Urging Smokers to Quit by Switching to Much Safer Products

Taylor Millard has written a very nice piece at Inside Sources which reports the results of a new survey showing that a tragically low percentage of physicians are providing smokers with the facts about less harmful alternatives to smoking. This he attributes to the failure of the FDA as well as anti-tobacco organizations to endorse harm reduction, but instead to take a prohibition approach. As Millard notes: "Advocates for moving smokers to pouches and other products are getting pushback from activist groups that support a total-prohibition approach to tobacco and nicotine. The Campaign for Tobacco-Free Kids, a prohibitionist organization, denounced the FDA’s decision to authorize the marketing of Zyn nicotine pouch products in January." I'll let the piece speak for itself, but merely note the irony that Philip Morris, but not the Campaign for Tobacco-Free Kids or other anti-tobacco groups, is encouraging smoking cessation by switching to much safer alternatives. The health groups seem perfectly content to have the 28 million current smokers in the United States continue smoking if they are unable to quit using drugs.

Response from Investigators of Clinical Trial of Very Low Nicotine Cigarettes

For the purposes of fairness and completeness, I am sharing the response from study authors to my criticism of the recently published clinical trial of very low nicotine cigarettes. The text below is the response. At the bottom, after "The Rest of the Story" title, I offer just a few comments.

It has come to our attention that Dr. Michael Siegel has twice raised concerns in posts to his blog about a peer-reviewed publication of ours published in Preventive Medicine (https://pubmed.ncbi.nlm.nih.gov/40623557/). The report details results from a federally-supported pilot trial that we conducted examining the use of very low nicotine content cigarettes during pregnancy. In our opinion, Dr. Siegel has drawn the wrong conclusions in asserting that the trial was unethical and suggesting that the paper should be retracted. There are four aspects of Dr. Siegel’s concerns on which we wish to comment.

1. There is no question that smoking cessation is the ideal during pregnancy. Indeed, we have worked for the past 25 years to develop a highly effective perinatal smoking-cessation intervention and together have published more than 40 peer-reviewed papers in this area. However, not all pregnant women are able to quit, even with the best interventions currently available, and we need to consider other ways to reduce the adverse impacts of smoking during pregnancy. The U.S. Food and Drug Administration (FDA) is considering implementing a national nicotine reduction policy that would lower the nicotine content in cigarettes to minimally addictive levels to decrease the likelihood that youth who experiment with smoking get addicted and to increase the likelihood that people who are already chronic smokers will quit. Of course, any such national policy regarding nicotine levels in cigarettes would inevitably reach pregnant women who are continuing to smoke. From the time such a policy was proposed, there were concerns that reducing the nicotine content of commercial cigarettes might lead to sustained compensatory smoking (that is, smoking more cigarettes per day to try to reach usual nicotine level, leading to more smoke exposure and the adverse consequences that engenders) which could potentially outweigh the expected public health benefits of the policy. Fortunately, this has not proven to be the case in multiple studies and trials with not-pregnant people who continue to smoke. Given that there is a sizeable proportion of women who continue to smoke after learning they are pregnant, it is inevitable that pregnant women will be impacted by this policy. As such, it is important to the FDA to know how they respond to very low nicotine content cigarettes so that can be taken into consideration in weighing the potential population health benefits and costs of implementing such a policy. For that reason, we received a competitive research grant funded collaboratively by the National Institute on Drug Abuse and FDA to investigate how a national policy reducing the nicotine content in commercial cigarettes to minimally addictive levels might impact vulnerable populations including pregnant women.

2. The trials we designed including this one with pregnant women who smoke underwent many layers of peer review for scientific merit and research ethics before being funded or implemented. These trials including this one with pregnant women also adhered to all ethical guidelines for federally supported research. It is important to note that for safety purposes this particular trial was preceded by two laboratory studies, the first in not-pregnant women and the second in pregnant women, where participants smoked very low nicotine content cigarettes in a highly controlled laboratory setting to look for any evidence of compensatory smoking or other potential adverse effects during acute exposure to these reduced nicotine content cigarettes. Observing no substantive issues, we then proceeded to trials where the duration of exposure was extended. Paralleling the acute exposure studies, the protocol for the present extended-exposure study with pregnant women was based on that of an earlier trial we conducted with not-pregnant women. The trial with not-pregnant participants showed that providing them with very low nicotine content cigarettes reduced overall cigarette consumption and biomarkers of smoke and tobacco exposure without engendering sustained compensatory smoking. Only then did we move on to the study of extended exposure with pregnant women. Again, we want to emphasize that this extended-exposure trial with pregnant women underwent competitive peer review before being selected for joint funding by the National Institute on Drug Abuse and the FDA. It underwent additional review by FDA staff and was reviewed and approved by the Institutional Review Boards (IRBs) at all trial sites prior to initiation. Following approval, the study was monitored by an independent Data and Safety Monitoring Board made up of professional experts in tobacco research and research ethics. A small number of participants completed each protocol prior to initiation of the full study to ensure there were no glaring safety issues. The trial was also registered on ClinicalTrials.gov prior to initiation. Following practices used in our prior studies, all of the primary outcomes were published in a peer-reviewed journal. Any issues, ethical or otherwise, raised by reviewers or oversight committees at any stage in this process were addressed to their satisfaction or they would not have permitted the research to proceed.

3. Important to emphasize is this trial on which Dr. Siegel commented was NOT a smoking-cessation trial. Instead, it was a study designed to investigate how a national nicotine reduction policy might impact women who continue to smoke after learning they are pregnant. While this trial was not on smoking cessation, all potential participants were advised to quit. Indeed, the third sentence of the trial consent form stated, “It is known that smoking is harmful and all smokers are encouraged to quit smoking.” A subsequent section detailed the risks of smoking generally (“All cigarettes are harmful to a person's health and can lead to cardiovascular (heart) disease, respiratory (lung) disease, cancer and other health problems.”) and of smoking during pregnancy (“Smoking during pregnancy can lead to miscarriage, preterm delivery, stillbirth, low birth weight, problems with the placenta, birth defects such as cleft palate, sudden infant death syndrome (SIDS), and early childhood behavioral problems.”). In reiterating that the trial did not offer smoking cessation treatment, potential participants were also told that if they were seeking treatment, trial staff would help them find a treatment program. The consent form also assured potential participants that if they enrolled in the trial but later wanted to quit smoking, they could still continue in the study and receive all scheduled monetary compensation for doing so.
Women who reported that they planned to quit smoking in the next 30 days and those who had made a quit attempt in the past 30 days that resulted in 3 or more days of smoking abstinence were excluded from participating in the trial. Enrolled participants were subsequently asked at each of the 12 weekly study visits whether they were currently abstaining from smoking. If so, they were offered the National Cancer Institute’s smoking cessation booklet, Clearing the Air, and a referral to the state quitline. Those who were still smoking were asked if they were planning to quit before the next weekly study visit. If so, they were also offered the booklet and quitline referral and were asked what day they planned to quit. Finally, all trial completers were offered the booklet and quitline referral at the end of the intervention period.

In summary, all potential participants were encouraged to quit and were offered assistance to do so at every stage of the trial, starting at the screening assessment and continuing at weekly intervals throughout the study period. Moreover, if they wanted to quit, they were assured that they could do so and still continue in the study with full monetary compensation so that the loss of potential earnings from being enrolled in the study was not a barrier to quitting.

4. Regarding the free cigarettes provided by the trial, as noted previously, one of the main concerns about very low nicotine content cigarettes is that people who smoke them might engage in compensatory smoking. To ensure that any evidence of compensatory smoking would be picked up if it were present, it is convention in trials assessing the risks and benefits of cigarettes with different nicotine levels to provide research cigarettes to all participants free, including those in the control conditions. The protocols for these trials also include provisions for withdrawing participants who show evidence of compensatory smoking to prevent additional harm. Prior trials that have given very low nicotine content cigarettes to not-pregnant people have not found any evidence of sustained compensatory smoking in the vast majority of participants, as was the case in the present trial with pregnant women. Three participants, one in the usual brand condition and two in the very low nicotine content cigarette condition, were withdrawn when their breath carbon monoxide levels exceeded 50 ppm, a cutoff set by the FDA for this trial. Among the remaining participants, as shown in the top panel of Figure 2 in the published report, there was no change in the total number of cigarettes smoked per day in either condition; that is, participants did not smoke more even though they were given free cigarettes. Indeed, smoke exposure, as measured by breath carbon monoxide levels, decreased significantly over time among participants in both conditions, as shown in Table 2. Thus, there is no evidence that participating in this trial worsened smoking outcomes among the majority of the participants; on the contrary, there is some evidence of a small benefit for many.

In closing, we recognize that cigarette smoking is one of the greatest public health problems we have faced as a country. As noted above, we have devoted several decades of our careers developing and testing more effective smoking-cessation interventions for perinatal women and mothers of young children. Unfortunately, smoking cessation interventions are not enough to reduce the terrible adverse effects of smoking on population health, including women who are pregnant. Hence, the FDA’s consideration of implementing a national nicotine reduction policy is a tobacco regulatory effort to protect people from the addiction caused by current nicotine levels in commercial cigarettes. The results of the trial to which Dr. Siegel responded, along with our other work on the effects of very low nicotine content cigarettes in vulnerable populations, provide FDA with critical information that they will weigh in evaluating the potential benefits and harms to U.S. population health of implementing such a policy. Again, we have conducted this research in an ethical manner and have adhered to all research ethical guidelines and requirements of which we are aware.

Sarah H. Heil, PhD
Professor, Departments of Psychiatry and Psychological Science
Associate Director, University of Vermont Tobacco Center of Regulatory Science
Associate Director, Center on Rural Addiction

Stephen T. Higgins, PhD
Professor, Departments of Psychiatry and Psychological Science
Director, University of Vermont Tobacco Center of Regulatory Science
Director, Vermont Center on Behavior and Health
Virginia H. Donaldson Professor of Translational Science
University Distinguished Professor 

The Rest of the Story

Just a few comments:

1. First, I do not question the integrity of the authors, all of whom have made substantial contributions to the field of smoking cessation and reduction of tobacco-related morbidity and mortality. I also do not question that there were multiple rounds of review by institutional review boards and that the study was deemed to meet all regulatory ethical standards. I think what I am actually questioning is the decision of the institutional review boards and how they concluded that the study "minimized exposure to unnecessary risk."

2. I agree that very low nicotine cigarettes could be a successful policy. Bringing all cigarettes to below non-addictive levels could be a game changer in that it separates the toxic nature of cigarette smoking from the chemical addiction element of smoking. In fact, I have been critical of the FDA for the last 16 years for not requiring cigarettes to bring nicotine levels down to the non-addictive range, something they could have done back in 2009 and have failed to do every year since then.

3. I agree that understanding whether compensatory smoking occurs with very low nicotine products is important. I agree that there is preliminary data to suggest that the use of these cigarettes could reduce harms to people who are unable to quit smoking. So I don't question the value of the research.

4. I am convinced by the response that there are enough potential benefits to the use of very low nicotine cigarettes that the intervention arm of the study is not problematic. It is the control arm that concerns me.

5. My specific concern about the control arm is whether the study "minimized exposure to unnecessary risk." This is a critical condition for all studies, even if they offer potential benefits to participants and even if the benefits outweigh the risks. Studies must do what is reasonably possible to minimize exposure to possible harm, especially when those risks are unnecessary. I am just having trouble understanding how a protocol that instructs pregnant smokers to continue smoking is minimizing exposure to unnecessary risks. In no way is it necessary for them to continue smoking. The appropriate way to minimize unnecessary risks in this study would have been to provide - at a minimum - usual care, which consists of a physician advising a patient to quit and providing behavioral interventions. Simply offering information or a quitline number is not sufficient, in my view, to constitute usual care.

6. Finally, I commend the authors for taking the time to respond to my concerns, especially in the absence of my writing a formal letter to the editor. This response is very much appreciated.  

More Reasons Why the Clinical Trial of Low Nicotine Cigarettes for Pregnant Smokers Was Unethical

Last week, I explained that a recent clinical trial of very low nicotine cigarettes for pregnant smokers was unethical because neither the intervention nor control groups were offered usual care: being instructed by a physician to quit smoking and being offered behavioral interventions, as specified by the U.S. Preventive Services Task Force. However, in addition to this ethical breach, there are several other aspects of the research which contribute to its impropriety.

The Rest of the Story

1. Unethical medical care: Physicians do not give up on our patients. We do not assume that a patient is incapable of complying with our medical advice. No physician should assume that a patient is permanently unable to quit smoking. Most ex-smokers tried to quit multiple times before finally succeeding. The presence of failed quit attempts does not mean that the next attempt will also fail. We are supposed to serve as coaches or supporters of our patients. Our role is to help them achieve healthier behavior, not to help them maintain unhealthy behavior. 

Because the physicians of these patients did not give them clear and unequivocal advice to quit smoking, they were unable to treat these patients in an ethical manner. The fact that the patients had indicated that they did not plan to quit in the next month is no excuse to assume that there is no desire to quit or that physician advice to quit might influence the patient. 

It is important to note that according to the article, the exclusion criterion was not that the patient stated that they didn't want to quit; it was they didn't plan to quit. The two relevant exclusion criteria were: (1) currently trying to quit smoking or planning to quit in the next month; and (2) past-month cessation attempt resulting in >3 days of abstinence. So someone who really wanted to quit but had not tried to do so and did not plan to do so in the next month was essentially abandoned. Instead of being helped to quit smoking, they were just thrown into a group with instructions to continue smoking as usual.

It is also important to recognize that although quitting smoking is exceedingly difficult and only about 3% of all smokers quit successfully each year, CDC data indicate that "56.1% of women who smoked before pregnancy quit smoking while pregnant." Thus, the chances are actually better than not that a pregnant women who smokes entering pregnancy will end up quitting before giving birth. 

2. Giving pregnant women free cigarettes to smoke: In this study, the control group subjects were not simply instructed to continue smoking as usual. They were actually provided with a supply of free cigarettes of their usual brand. Moreover, rather than provide them with fewer cigarettes than they normally smoke as an encouragement to cut down, they were actually given more than they needed in order to accommodate possible increases in smoking. Furthermore, subjects were provided with a fresh supply of free cigarettes every week: "At each weekly visit, they returned unused cigarettes and were resupplied." 

The primary ethical principle of medicine is "to do no harm." Here, physicians were doing harm by providing deadly cigarettes to pregnant women, knowing that these cigarettes would invariably cause harm to the fetus. Some of the effects that smoking has on the fetus are: inhibiting growth, damaging the lungs and brain, raising the risk for birth defects, raising the risks for stillbirth and SIDS, and increasing the risk of low birth weight. Some of the effects that smoking has on the pregnant women are: doubling the risk of abnormal bleeding during both pregnancy itself and during delivery and increasing the risk of premature rupture of membranes, placenta previa, and placental abruption.

It is one thing for these harms to occur if a woman makes an informed choice to smoke during pregnancy and goes out and purchases cigarettes. It is another thing for physicians to facilitate this damage by actually supplying those cigarettes for free throughout 12 weeks of the pregnancy. Cost is known to be a stimulator for smoking cessation. Here, the healthcare team was taking away that potential barrier to continued smoking and essentially playing the role of an enabler. 

It is also worth pointing out that because this was a federally funded study, it was actually taxpayer funding that went to purchase cigarettes for these pregnant women for 3 months.

Has Ethics in Medical Research Completely Disappeared? Study Assigns Half of Pregnant Women Subjects to Continue Smoking

A clinical trial published last week in the journal Preventive Medicine randomized pregnant women who smoked to either continue smoking their usual brand or to switch to a very low nicotine content cigarette brand. The study did inquire whether the subjects wanted or intended to quit smoking and excluded those who did. Nevertheless, after this initial indication of their present intentions, the subjects randomized to the "control" group were instructed to continue smoking their usual brand of cigarettes. The subjects in the "intervention" group were also instructed to continue smoking, but to do so using the very low nicotine cigarette brand.

The Rest of the Story

This trial raises the question of whether it is ethical to have a control group that is instructed to continue smoking, which is knowingly going to cause fetal harm to these pregnant women. 

The answer is a resounding "No." This is unethical research.

The key criterion in determining whether instructing a control group to continue doing a behavior known to be harmful to them is whether or not they are being offered "usual care." In other words, if usual care for pregnant women smokers being treated by obstetricians was to do nothing to change their smoking behavior if they did not express an initial desire to quit or did not think they were going to quit, then this trial would have been ethical. 

However, usual care for pregnant smokers who did not express an initial desire to quit is not to do nothing. And it is certainly not to instruct them to continue smoking!

According to the guidelines set forth by the U.S. Preventive Services Task Force, usual care for pregnant smokers is: "advise them to stop using tobacco, and provide behavioral interventions."

In order to meet basic ethical standards in medical research, the control arm of the study would had to have consisted of advising the patients to quit smoking and providing behavioral interventions to help them quit smoking. Instructing the patients to continue smoking as usual is not consistent with this usual care guideline.

The intervention protocol for this clinical trial was also unethical because it offered a treatment that is worse than standard care. These pregnant women, too, were instructed to continue smoking, rather than being advised to quit smoking and provided with behavioral interventions to help them quit smoking.

The only ethical way to conduct this study would have been to offer both groups the minimum standard care, meaning that both groups of patients should have received clear instructions to quit smoking and immediately provided with effective behavioral interventions that have been shown to increase smoking cessation. On top of that standard care, it would have been acceptable to provide one group with very low nicotine cigarettes to use if they were unable to comply with the physician's recommendation to quit smoking.

Absent a physician's clear recommendation to quit smoking and absent being provided with a behavioral intervention to enhance the chances of smoking cessation, this clinical trial failed to provide even a minimum standard of medical care and is therefore unethical human subjects research.

There are two potential counterarguments to this position but both fail.

First, one could argue that since these women did not plan to quit smoking, no harm was being done by assigning them to a group with instructions to continue smoking. However, this argument fails because these women were knowingly harmed by instructing them to continue a behavior known to harm the fetus and failing to provide the minimum standard of care typically offered to pregnant smokers outside of the research setting.

Second, one could argue that the women were not prevented from quitting smoking if they chose to. However, this lands fall short of the ethical standard. It is not enough to allow nature to take its course if standard practice calls for medical intervention -- namely, the U.S. Preventive Services Task Force's recommendation to advise quitting and provide behavioral modification therapies. 

Since the trial appears to have been completed, I cannot call for a discontinuation of the study. However, I am calling for the retraction of the study for violation of research ethics and some sort of compensation for the study participants.  

Anti-Vaping Physician Claims that a Single Vape Can Cause Severe and Irreversible Lung Disease

In an article posted late last month on Medscape, a physician claimed that using even a single vape can cause severe and irreversible lung damage.

Here is what she writes:

"Vaping has become a global health epidemic affecting everyone from high schoolers all the way to adults. This has gained popularity in recent years, but what people don't know is that vaping has now been shown to be linked to irreversible lung damage. It has been linked to conditions such as bronchiolitis obliterans, which is narrowing and scarring of the small airways due to diacetyl, which is found in nicotine liquid in vapes. Also, vaping has been linked to lung collapse,which can then cause hospitalizations and require patients to have chest tubes, or EVALI, which is a significant, life-threatening disease that can leave patients on a ventilator. 

It's important for us to counsel our patients and to advise our patients that these risk factors do exist when using their vapes every day or even socially on occasion. It only takes one time to try it to end up with any of these irreversible lung conditions."

 

The Rest of the Story

 

The rest of the story is that this physician is, unfortunately, lying. It is simply not true that it takes only one time to try vaping to end up with irreversible lung disease. The claim is ridiculous on its face. Even if you smoke an actual tobacco cigarette you cannot end up with irreversible lung disease. It takes years and years (if not decades) of smoking before you develop irreversible lung damage. So clearly, you're not going to develop irreversible lung disease from a single vape. It's not even clear at this point whether years of vaping will lead to chronic lung disease. There is no evidence that vaping causes bronchiolitis obliterans. Furthermore, the EVALI scare was caused not by e-cigarettes, but by black market THC vape carts that had been laced with vitamin E acetate. 

 

The question is: why does this physician feel a need to completely over-exaggerate the risks of vaping in order to try to dissuade youth from vaping? What this tells me is that subconsciously, she realizes that what she is trying to convince people of is a load of crap and so the only way she can try to make it credible is to actually make it so unbelievable that people's fear overtakes their rational thought processes.

 

Years ago, we tried the same thing with secondhand smoke. We scared people into believing that only 20 minutes of exposure to secondhand smoke could cause you to drop dead from a heart attack. In fact, it was that claim that led me to start this blog in the first place. 

 

Sometimes it is easier for people to believe a huge lie than a smaller one. So the more exaggerated the claim, the more people are likely to believe it. This is because the exaggerated claim generates an emotional response, leading to the person interpreting the response based on their limbic system (the emotional part of the brain) rather than their brain cortex (the rational part of the brain). 

 

Were this physician to advise smokers trying to quit not to use e-cigarettes because of its pulmonary effects, that would essentially be malpractice. Were she to list methods proven effective to quit smoking, but omit e-cigarettes (the single most effect approach to smoking cessation short of quitting cold turkey), that would be tantamount to malpractice. 

 

Whoops.