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. 

 

New National Survey Shows that Youth Nicotine Product Use Has Dropped to an All-Time Low

Opponents of tobacco harm reduction (i.e., vaping) have argued for years that the dramatic declines in youth smoking we have observed in recent years have been offset by equally dramatic increases in youth vaping, such that the total use of nicotine products among youth has remained stable. A new analysis using more recent data from the National Youth Tobacco Survey has found that in contradiction with this common claim, the truth shows something quite different.

According to the article: 

"Past-30-day use of any nicotine product decreased from 24.5% (95% confidence interval = 22.5%–26.6%) to 19.6% (16.8%–22.4%) between 2014 and 2017, increased sharply, reaching 31.4% (29.0%–33.7%) in 2019 (driven by an increase in e-cigarette use), then fell to the lowest level at 12.5% (10.9%–14.1%) by 2023." 

"The proportion who reported symptoms of nicotine dependence was substantially lower, but followed a similar pattern of changes over time. For example, the proportion reporting strong cravings decreased from 7.8% (6.6%–9.0%) to 5.5% (4.3%–6.7%) between 2014 and 2017, increased to 7.9% (6.8%–9.0%) between 2017 and 2018 and remained stable up to 2020, then fell to the lowest level at 2.5% (1.9%–3.1%) by 2023." 

The paper concludes that: "The sharp rise in the prevalence of nicotine product use (in particular, e-cigarettes) among US high-school students in the late 2010s was short-lived and was not accompanied by a sustained increase in the overall population burden of nicotine dependence. By 2023, both nicotine product use and nicotine dependence had reached historic lows."

The Rest of the Story

This research dispels the myth that reductions in youth smoking have been completely offset by an increase in youth vaping. It is not the case that the total amount of nicotine product use among youth has remained steady. It has in fact declined and reached its lowest point to date in 2023, driven by dramatic declines in youth smoking over the past decade and by more recent declines in youth vaping.

It is important to point out that even if youth smoking had been completely replaced by youth vaping, it still would have been a positive public health achievement, as the long-term effects of cigarette smoking dwarf those of e-cigarette use and because lifetime use of cigarettes is very common while most youth do not appear to be retaining their vaping habits into middle adulthood. 

In light of these new findings, any health group that continues to pooh-pooh the dramatic decline in youth smoking and the unprecedented public health gains of this public health miracle is either ignoring the data, obsessed with demonizing electronic cigarettes, or heavily smoking a non-nicotine-containing product.  

 

 

American Medical Association Article Claims that Quitting Smoking by Switching to Vapes is Not Quitting

According to an article published two days ago by the American Medical Association, a person who quits smoking completely but still uses non-tobacco-containing vapes has not quit smoking. The article states: "Another major misconception is that switching to e-cigarettes or vaping is a way to quit smoking traditional cigarettes. Using any other tobacco product or any other product that contains nicotine is not actually quitting.” 

The article goes on to state: "A lot of vape companies want consumers to believe switching to other tobacco products, including vapes or e-cigarettes is a way to quit. However, it is not, and there are a lot of unproven health claims made by the e-cigarette or vape industry that is confusing people who actually want to quit smoking. This creates a lot of confusion for people who really want to quit typical cigarettes and they feel that going to e-cigarette will be a way to help, but that’s not exactly true."

The Rest of the Story

Based on this article, a person who quits smoking with the help of a nicotine patch has not actually quit smoking. I'm sure this will come as news to the hundreds of thousands of smokers who have used nicotine replacement as a way to quit. Well I hate to tell the American Medical Association this but electronic cigarettes are a form of nicotine replacement, just like nicotine patches!

However, there's one major difference between nicotine patches and e-cigarettes: 

Nicotine patches only work about 10% of the time, while e-cigarettes work at least twice that much. A number of clinical trials have demonstrated that switching to vaping is superior to using traditional nicotine replacement therapy in helping adults quit smoking. 

This shows how absurd it is that the American Medical Association accepts switching to a nicotine patch to be quitting smoking but apparently, switching to a nicotine vape is not quitting smoking. 

What is going on here? I'll tell you. It's called lifestyle control. The tobacco control movement has largely lost its focus on public health and instead is now focusing on lifestyle control. They promote smoking cessation, but only if you quit the way they want you to quit. They are the ones who get to define what "counts" as quitting smoking, not you. It makes no difference that you are literally saving your life by becoming an exclusive vaper. You are still using nicotine by a mechanism that they despise, so they get to tell you that you've actually not quit smoking, even though you most certainly have.

Talk about "creating confusion for people who really want to quit typical cigarettes!" It is not the vaping companies that are creating confusion. They are being quite clear about how their products can help you quit. Instead, it is the American Medical Association--through articles such as this one--which is creating massive confusion for people who want to quit smoking.

If it ended here, it would be devastating enough. However, the article goes on to make more fallacious claims. 

It states that: "they [e-cigarettes] are just as addictive and with the same or additional risk of lung injury as traditional cigarettes." So they are actually claiming that vaping is just as dangerous to the lungs, if not more dangerous, than cigarettes! This is absurd. Smoking causes about 3.2 million deaths from lung disease worldwide every year. In contrast, vaping has not even been established as a cause of COPD, and it has been shown that COPD patients who switch from cigarettes to vapes experience dramatic improvements in their lung health, both objectively and subjectively. 

The article also claims that "the nicotine within the e-cigarettes and vapes is synthetic." This also comes as news to me since there are only about six companies that manufacture synthetic nicotine and only a small number of synthetic nicotine-based vaping products on the market. The overwhelming proportion of e-cigarettes are made with nicotine that is derived from tobacco.

Unfortunately, it is apparently no longer important in the tobacco control movement to provide accurate information. When I worked for the Office on Smoking and Health at CDC, we would never have even thought about making a false statement to the public. Now, tobacco control practitioners and organizations are doing it daily and apparently without being even slightly troubled. 

New Study Finds that Youth Vaping Served as a Substitute for Smoking But Concludes the Opposite

A new study published in the journal Tobacco Control purports to show that the immense decline in youth smoking over the past decade had nothing to do with the emergence of vaping products. The study concludes: 

"Cigarette smoking has declined precipitously among both adolescents and young adults since 1997. Starting in 2017, adolescent e- cigarette vaping surged, concomitant with the popularity of flavoured, high nicotine e-cigarettes that have been shown previously to lead to dependence. Our findings do not support the previously suggested evidence that this increase in e-cigarette vaping was associated with a more rapid decline in adolescent cigarette smoking."

The Rest of the Story

Anyone who reads the conclusion of this article without reading the full article will come away with the impression that this study found evidence to dispel the notion that vaping contributed to the rapid acceleration of the rate of decline in youth smoking that occurred during the past decade. However, those who take the time to read the article will note these two major findings of the article:

1. "40% of the drop in cigarette smoking prevalence was ‘replaced’ by the increase in nicotine vaping prevalence... ."

2. "We hypothesise that the rapid increase in e-cigarette vaping between 2017 and 2020 was related to the products’ appeal to individuals with the same risk profile for cigarette smoking, but who may have been subject to strong social norms against cigarette smoking."

What these two statements suggest is that a large proportion (40%) of the observed decline in cigarette smoking prevalence occurred because smoking was "replaced" by vaping among adolescents. The authors even hypothesize that e-cigarettes served as a substitute for cigarette smoking among youths with the same profile for cigarette smoking. This finding and hypothesis are consistent with a growing body of literature demonstrating that cigarettes and e-cigarettes are essentially substitutes, both among adults and youth. 

So the rest of the story here is that for some reason, the paper concludes the exact opposite of what the research finds and what the authors hypothesize. 

I can't explain this, other than to infer that the authors set out with a predetermined conclusion that they were going to articulate regardless of what the results of the paper actually showed. There is, sadly, no question in my mind that a large number of researchers who study vaping hold a strong bias against e-cigarettes and that this skews their interpretation of study findings. Here is an example of a study whose results are consistent with a body of literature suggesting that vaping is one factor associated with the dramatic recent declines in youth smoking but which concludes that vaping is not associated with the dramatic recent declines in youth smoking. 

This conclusion is not consistent with the data presented in the paper. The research demonstrated that there was a substantial acceleration in the rate of decline in youth smoking between 2013 and 2018. During the same period, there was an astronomical increase in youth vaping. The paper emphasizes the rapid increase in e-cigarette vaping among youth between 2017 and 2020 but ignores the fact that the rapid rise in youth vaping began not in 2017, but in 2013. From 2013 to 2019, the prevalence of youth vaping increased more than six-fold. From 2013 to 2017, the prevalence of youth vaping doubled. 

I truly do not understand the demonization of e-cigarettes that is occurring in the tobacco control movement. I have never seen public health practitioners shun the concept of harm reduction. For some reason, we rely upon a harm reduction approach for all public health issues other than nicotine use.

New Zealand Researcher Claims that Using E-Cigarettes Coats the Lungs With Oil

An electronic cigarette researcher from Auckland University's Bio Engineering Institute is telling the public that when people use e-cigarettes, their lungs become coated with oil, leading to inflammation that eventually causes lung disease.

According to an article in RNZ, the professor is quoted as stating:

"Every time you vape, some of that will stay inside your lungs, so the e-liquids that are in vapes are sort of quite an oily substance. There'll be a lining of this oil that will stay inside your lungs and actually one of the things that is designed to get rid of that is the process of inflammation. It's when you have this inflammation occurring many times a day over many years, which is what leads to disease and tissue breakdown."

The Rest of the Story

Most, if not all, electronic cigarettes contain either propylene glycol or glycerin (or both) as the excipient in their e-liquids. This researcher is claiming that propylene glycol and glycerin, when inhaled, will coat the lungs with oil, triggering an inflammatory response that eventually will lead to chronic lung disease.

The problem with this claim is that neither propylene glycol nor glycerin is or contains any oil. Both are in fact water-soluble or water-miscible substances that are water-based, so they don't coat the airways of the lung with oil. Propylene glycol is in fact an alcohol, not an oil. Glycerin is also an alcohol (technically a polyol, or "sugar" alcohol), not an oil. So to dispel the false claims out there, using e-cigarettes is not going to coat your lungs with oil. There is no oil in virtually all, if not all, e-liquids. And if anyone finds an e-liquid with essential oils in it then they should report it immediately so that it can be taken off the market.

Perhaps the researcher's confusion is that propylene glycol and glycerin can be derived from oils. But neither of them is an oil.

The only danger of having your lungs coated with oil from vaping is if you vape THC vape carts that you bought off the black market that contain vitamin E acetate, which is an oil. This is what led to the inaptly named EVALI scare in 2019. However, black market producers of THC vape carts have largely, if not completely, stopped using vitamin E acetate as a thickening agent. I would still recommend that everyone avoid purchasing THC vape carts off the black market because of the possibility that there are still some errant warehouses where vitamin E acetate may be used. But you are not going to develop "EVALI" if you stick to retail-purchased electronic cigarettes.  

For some reason, most health departments, health organizations, tobacco control organizations, and tobacco control researchers are intentionally lumping e-cigarettes in with THC vapes as a cause of EVALI when there is no evidence that any e-cigarettes played a role. Although I could perhaps understand this in the summer of 2019 when it was not entirely clear what was causing EVALI, this is inexcusable five years later when we know that EVALI was caused by vitamin E acetate in THC vape carts. It is also inexcusable since neither propylene glycol nor glycerin are oils in the first place.

Nevertheless, even reputable health organizations continue to spread this misinformation. For example, Johns Hopkins Medicine still claims on its web site that vaping causes lipoid pneumonia. The claim: "Unlike the classic pneumonia caused by infection, lipoid pneumonia develops when fatty acids (the building blocks of fat) enter the lungs. Vaping-related lipoid pneumonia is the result of inhaling oily substances found in e-liquid, which sparks an inflammatory response in the lungs. ... The single-most important thing you can do is identify what is causing it — in this case vaping — and eliminate it."

As another example, Baystate Health states: "Much of the concern about vaping revolves around vape juice. Hart explains, “Vitamin E is frequently used as the base for vape juice. People hear ‘vitamin’ and assume it’s safe. And while Vitamin E is safe when taken as an oral supplement or even in lotions, it’s not really meant to be heated and inhaled and has been found in the lungs of people with severe, vaping-related damage." While the last two sentences are accurate, the first two are very misleading. Vitamin E is never used as the base for vape juice. In 2019, it served as an "additive" specifically for many black market THC vape carts, but it has never been used in e-liquids for nicotine-based e-cigarettes. 

Houston Methodist makes a similar claim to that of Johns Hopkins: "Unlike classic pneumonia, which is caused by infection, lipoid pneumonia develops when fatty acids enter the lungs. The liquids used in vaping products contain oily substances, which, when inhaled, can spark an inflammatory response in the lungs."

The problem with all three of these statements, as well as the hundreds of similar ones being made by many health and tobacco control groups, is that they lump e-cigarettes in with THC vapes. They are all talking about potential harms of "vaping." This is not very helpful if you're really committed to keeping young people alive and free of severe acute respiratory distress. Most youth are not going to stop vaping completely. However, if you can direct them away from the truly hazardous products, then you are giving them a feasible path to safety. We should have been specifically warning youth about the dangers of vaping black market THC carts, not condemning all vaping (even e-cigarettes) as potentially leading to fatal respiratory disease.

Is the American Cancer Society Really Interested in Preventing Cancer or Just Punishing Smokers Who Don't Use Cessation Products Made by ACS Donors?

Product A is a flavored product that appeals to youth and has rapidly gained in popularity among youth.

Product B is a flavored product that appeals to youth and has rapidly gained in popularity among youth.

Product A is largely manufactured by companies that have a history of marketing to youth.

Product B is largely manufactured by companies that have a history of marketing to youth.

Product A is potentially addictive.

Product B is potentially addictive.

Product A is thought to entice youth to use the product because of its appealing flavor varieties.

Product B is thought to entice youth to use the product because of its appealing flavor varieties.

Product A is not known to have caused any deaths among youths nor has it been linked to chronic disease.

Product B causes thousands of youth deaths each year and is known to cause chronic disease, including cancer.

Product A is being used by millions of adults to immediately improve their health and essentially save their lives.

Product B causes cancer even at low doses and does not have any overall health benefits.

The Rest of the Story

The American Cancer Society is lobbying aggressively for a complete ban on Product A.

The American Cancer Society seems perfectly content to let Product B stay on the market, essentially unregulated. It is not promoting a ban on Product B or even strict regulation of marketing for Product B, even though it is a leading cause of cancer in the United States.

If you haven't guessed yet, Product A is flavored electronic cigarettes.

Product B is flavored alcoholic beverages.

The American Cancer Society is calling for a ban on flavored e-cigarettes based on the premise that if a potentially harmful product uses flavors that appeal to youth, it should be taken off the market. However, they are not calling for a similar ban on flavored alcoholic beverages even though these products use flavors that appeal to youth and are far more harmful than nicotine vapes.

While its website is chock full of advocacy efforts to eliminate flavored e-cigarettes, I am unable to find a single mention of any similar effort to prohibit or even just to regulate flavored alcoholic beverages.

This inconsistency raises the question of why? Why should alcohol companies be allowed to market flavored alcoholic beverages to underage youth and why should these products remain on the market essentially unregulated while flavored vapes are completely banned?

Presumably, the American Cancer Society is not pushing for a ban on flavored alcoholic beverages because it understand the need for these products to remain on the market because they are also used by many adults. Then why is it pushing for a ban on flavored e-cigarettes even though they, too, are used by many adults? If anything, it would make more sense to ban flavored alcoholic beverages because they do not have any health benefits for adults but cause thousands of deaths every year.

This suggests that somehow, the American Cancer Society values adults who are potentially harming their health by drinking more than it values adults who are undoubtedly improving their health by switching from smoking to vaping. To promote a ban on flavored e-cigarettes, you really have to be OK with punishing smokers who use e-cigarettes as a cessation tool. If you are really trying to prevent cancer, it should be more important to address the enormous problem of the use of flavored alcohol products among underage drinkers--a product that has been demonstrated to be a starter drink that leads to heavier alcohol consumption, a cause of thousands of cancer deaths each year--than to ban flavored vapes that have been demonstrated to lead to decreases in youth smoking rates and for which there is no evidence that it causes cancer.

On the other hand, the American Cancer Society is perfectly OK with smokers quitting by using medications (like varenicline) that are manufactured by pharmaceutical companies which have donated huge amounts of money to them.

Campaign for Tobacco-Free Kids Falsely Claims that Vaping is "Tobacco Use"

In its Take Down Tobacco program, the Campaign for Tobacco-Free Kids is lamenting the fact that through its sale of flavored vapes, the tobacco industry is addicting youth and reversing progress in reducing tobacco use. 

The Campaign for Tobacco-Free Kids states that: "Flavored vapes have fueled the youth e-cigarette epidemic, which is addicting a generation of kids and threatening to reverse decades of progress to reduce youth tobacco use in the U.S." 

They also claim that: "Eliminating the sale of flavored e-cigarettes is a critical step toward ending the tobacco industry’s modern day pipeline of youth addiction."

The Rest of the Story

The Campaign for Tobacco-Free Kids is being disingenuous in claiming that youth who vape are using tobacco. They are doing nothing of the sort. They may be inhaling nicotine, but they are not using tobacco. Perhaps the Campaign is not aware of this, but vapes do not contain any tobacco. Thus, it is inaccurate and irresponsibly misleading to publicly state that vaping is a form of tobacco use.

I don't believe for a moment that the Campaign for Tobacco-Free Kids is not aware that vapes do not contain tobacco. I believe, instead, that they are deliberately making false statements in order to advance their goal of eliminating these products from the market. While youth vaping should be discouraged, it is completely disingenuous to tell kids who are vaping that they are using tobacco. I support campaigns to try to prevent youth e-cigarette use, but I do not support lying to kids in order to achieve this goal.

I also have to question the validity of the claim that tobacco companies are currently marketing flavored vapes (other than tobacco and menthol-flavored products). The FDA has only authorized tobacco or menthol vapes produced by tobacco companies. I'm not aware that they are defying the law by selling other non-authorized flavors as the Campaign for Tobacco-Free Kids seems to be claiming.

For decades, we attacked the tobacco companies for lying to the American people about tobacco use. Ironically, we are now the ones who are lying about tobacco use. And we're getting away with it because the tobacco companies are no longer challenging anything we say. 

As I've stated before, I don't believe that the ends justify the means. In public health, transparency and honesty are core values. We are not justified in pursuing the end of preventing youth vaping by using the means of lying to youth and to the general public. This dishonesty has got to end. 

My Testimony Before the Rhode Island Senate Finance Committee on S543 - A Bill to Allow the Sale of Electronic Cigarettes at Adult-only Vape Shops

I had the pleasure yesterday of testifying before the Rhode Island Senate Finance Committee on bill S543, introduced by Senator DiPalma, which would create an exemption in the state's current an on the sale of flavored e-cigarettes to allow the sale of these products at adult-only (21+) vape shops. Here is my written testimony:

Written Testimony of Michael Siegel, MD, MPH on Bill S543

Allowing Vape Shops to Sell Flavored E-Cigarettes

Professor, Tufts University School of Medicine

March 30, 2025

Dear Members of the Senate Finance Committee:

I am a physician and a professor in the Department of Public Health and Community Medicine at the Tufts University School of Medicine. For the past 35 years, I have been a tobacco control researcher and anti-tobacco advocate. I played a major role in lobbying across the United States for 100% smoke-free bar and restaurant regulations. In fact, as a student at Brown University, I wrote and lobbied for the first smoke-free workplace law in Rhode Island, which the legislature enacted in 1986. I have also testified as an expert witness for plaintiffs in eight different lawsuits against the tobacco industry, including the infamous Engle case which resulted in an unprecedented $145 billion verdict against the cigarette companies. I have published nearly 100 peer-reviewed journal articles relating to smoking and tobacco use. In short, I am a long-time, committed anti-tobacco researcher and advocate.

Today, I want to call your attention to one particular age group of Rhode Island residents who are using flavored e-cigarettes in record numbers. In fact, the use of flavored e-cigarettes and vaping products is running rampant among this age group throughout the country. A recent survey of this age group revealed that 71% of those who vape prefer flavored e-cigarettes, including 61% who use fruit, candy, sweets, chocolate, clove, spice, herb, or alcohol flavors.[1] I estimate that approximately 50,000 Rhode Island residents in this age group were using flavored e-cigarettes prior to the ban which went into effect on January 1 of this year.[2]

If you think we’re talking about teenagers, think again. The study in question was a survey of adult vapers in the United States; specifically, adult ex-smokers who had quit successfully using e-cigarettes and who are currently relying upon these products to keep them from returning to cigarette smoking.

National estimates suggest that there are at least 5 million adult vapers who rely upon e-cigarettes to keep themselves off highly addictive and deadly tobacco-burning cigarettes.[3] And most of these former smokers are reliant upon flavored e-liquids, because the whole point of vaping for adult smokers is to get away from the taste of, and dependence on tobacco.

It is true, of course, that a worrisome proportion of youths are vaping, and most of them — like their adult counterparts — enjoy flavored, as opposed to tobacco-tasting, e-liquids.

But even more worrisome is that in an effort to address the problem of youth vaping, the state legislature has thrown the state’s former smokers who rely upon e-cigarettes to keep them off real cigarettes under the bus by banning the sale of practically all e-cigarettes while allowing the real cigarettes to remain on store shelves.

Here’s the problem: While youth vaping, and especially the use of flavored products, is a serious problem, the reality is that youth are not the only ones who use these products. E-cigarettes are responsible for at least 5 million former smokers having quit smoking completely. If these products remain off the shelves in Rhode Island much longer, it will likely cause a large number of them to return to smoking because it is now much easier for them to just pick up a pack of Marlboros in Rhode Island than to continue purchasing the e-cigarettes that were keeping them from returning to smoking.

A study published in the New England Journal of Medicine found that e-cigarettes are twice as effective as the nicotine patch in helping smokers quit completely.[4] These products are truly a life-saver for literally millions of former smokers. And most of these former smokers prefer flavored products. Research has demonstrated that flavored e-cigarettes are much more effective than unflavored (i.e., tobacco-flavored) e-cigarettes in helping smokers to quit.[5]

The law that went into effect on January 1 eliminated the sale of more than 95% of e-cigarettes. However, it allowed the sale of 100% of real cigarettes to continue unabated. This means that it has now become much easier for both youth and adults in Rhode Island to get access to a Marlboro than to a cherry vape. What possible justification is there for eliminating the sale of fake cigarettes, but allowing the real ones to continue to be sold?

Not only will this likely result in many former smokers going back to smoking but it may also lead to many youth figuring out that it is much easier for them to smoke than to try to track down an e-cigarette. In fact, several recent studies have demonstrated that in states that banned flavored e-cigarettes, youth smoking rates have actually increased compared to states that still allow flavored e-cigarettes to be sold.[6]

The last thing in the world that we should be doing is to give tobacco cigarettes, which kill more than 400,000 Americans each year, a competitive advantage over fake (electronic) cigarettes, which contain no tobacco, involve no combustion, are much safer than combustible cigarettes, and whose use has not been implicated in a single death despite 15 years on the market.

My message to you today is that there is simply no public health justification for banning electronic cigarettes but allowing combustible tobacco cigarettes to remain. The law that went into effect on January 1 is inconsistent with the protection of the public’s health and has no public health justification. What possible justification can you give for removing e-cigarettes from stores, but allowing those very same stores to sell Marlboros and Camels, two of the most dangerous consumer products in history?

If you really want to protect the public’s health and are sincere in wanting to reduce tobacco-related disease and nicotine addiction, then there is an option that is readily available: continue to restrict the sale of all flavored nicotine-containing products at most stores but allow adults over the age of 21 to purchase flavored e-cigarettes at adult-only vape shops, which have a strong track record of preventing youth access. This would allow vaping products to compete with cigarettes on a level playing field, avoid the incentivization of former smokers to return to smoking, and protect youth from easy access to vaping products, all at the same time.

This is exactly what S543 would accomplish. I urge you to set an example for states across the nation by allowing the sale of flavored e-cigarettes to adults in 21-and over vape shops so that Rhode Island smokers will continue to have access to a life-saving product that is helping tens of thousands of Ocean Staters to remain off deadly tobacco cigarettes.

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[1] Leventhal AM, Dai H. Prevalence of flavored e-cigarette use among subpopulations of adults in the United States. Journal of the National Cancer Institute 2020;113(4):418-424. https://doi.org/10.1093/jnci/djaa118.

[2] Based on data from Truth Initiative, April 5, 2024. https://truthinitiative.org/research-resources/smoking-region/tobacco-use-rhode-island-2023.

[3] My calculations based on data from the National Health Interview Survey, 2023.

[4] Hajek P, et al. A randomized trial of e-cigarettes versus nicotine-replacement therapy. New England Journal of Medicine 2019; 380:629-637. https://www.nejm.org/doi/full/10.1056/NEJMoa1808779.

[5] Li L, Borland R, Cummings KM, et al. How does the use of flavored nicotine vaping products relate to progression toward quitting smoking? Findings from the 2016 and 2018 ITC 4CV surveys. Nicotine & Tobacco Research 2021;23(9):1490-1497. https://doi.org/10.1093/ntr/ntab033.

[6] Friedman AS, Pesko MF, Whitacre TR. Flavored e-cigarette sales restrictions and young adult tobacco use. JAMA Health Forum 2024;5(12):e244594. https://doi.org/10.1001/jamahealthforum.2024.4594.

CDC Tells Public that Saving Millions of Lives is Offset by Youth Ripping Some Tobacco-Free, Smokeless Vapes

The CDC's Office on Smoking and Health (where I worked for two years as an EIS Officer in the Commissioned Corps of the U.S. Public Health Service) has just published an article that summarizes changes in smoking, tobacco use, and e-cigarette use over the past seven years (2017 to 2023). The astounding finding of the article was that cigarette smoking has reached its lowest point in 60 years and that from 2017 to 2023, the number of smokers (not counting dual users) decreased by 6.8 million people!

Since smoking is estimated to kill approximately half of all long-term users, this decline in cigarette smoking can be expected to save well over 3 million lives.

However, shockingly, rather than celebrating this enormous public health victory and acknowledging the immense prevention of disease, suffering, and death that these unprecedented reductions in smoking will bring, the CDC's headline was that there has been no change in overall tobacco product usage and that any gains from reductions in smoking have been offset by increases in youth vaping.

Here is the CDC's summary of the implications of these trends:

"While current cigarette smoking has decreased to the lowest level in 60 years, current tobacco product use among adults has not changed since 2017."    

And here is CDC's primary conclusion:

"The decrease in number of adults who currently exclusively smoke cigarettes by approximately 6.8 million persons was offset by the increase in the number who currently use e-cigarettes exclusively (approximately 7.2 million)."

The Rest of the Story

You've got to be kidding me. What the CDC is actually saying is that the saving of more than 3 million lives is offset because an increasing number of youth are ripping vapes.

The Cambridge English Dictionary defines offset as meaning "to balance one effect against an opposing effect, so that there is no great difference as a result."

Thus, the CDC is telling the public that there is no net public health gain from the fact that cigarette smoking is at its lowest level in 60 years because many youth are now dragging cherry-flavored vapes instead of smoking Marlboros, Camels, and Newports. 

Another way to say this is that the CDC would consider it to be a public health victory if there were an additional 6.8 million smokers in the U.S. but only a couple million youth were hitting vapes. The CDC doesn't see any advantage in switching people in massive amounts from combustible tobacco cigarettes to much less hazardous, tobacco-free, smokeless e-cigarettes. They would rather that people smoke real cigarettes than fake ones!

I find this disturbing not only because it completely distorts the science and misleads the public into thinking that smoking and vaping are equivalent in terms of health risks, but because it demonstrates a complete lack of compassion for adult smokers who are suffering debilitating disease and death due to their use of actual tobacco that is actually combusted. It also shows a profound disrespect for the millions of people who have overcome one of the strongest addictions (smoking) by switching to a much less hazardous product that likely saved their lives. 

Finally, it is disingenuous to classify e-cigarettes as tobacco products simply to make it look like there has been no progress. That's an artificial decision that is not accurate or necessary. Vapes are not "tobacco products" because they do not contain tobacco. Yes, from a strictly legal standpoint they are defined as "tobacco products" but that is purely in the context of FDA regulation. There is no necessity to use that terminology outside of the FDA regulatory context. That is a decision that CDC is making. It is a choice. And they are making that choice for a reason: they truly want to paint a picture of no progress in tackling the problem of tobacco use. It provides an excuse for them to continue to be needed and to argue for continued funding. The same motivation, I believe, is driving groups like ALA, AHA, and ACS to make the same decision to treat a non-tobacco product as a tobacco product.

Researchers of Severely Flawed Study Conclude that Vaping is Just as Harmful as Smoking and Causes Heart Disease and Dementia

According to an article published yesterday in the Daily Mail, researchers from Manchester Metropolitan University have conducted a study demonstrating that vaping is just as harmful as smoking, causes severely impaired respiratory function, and can cause dementia. 

One of the researchers was quoted as saying: "What we have found is the dangers for someone who keeps vaping are no different from smokers. ... At the beginning (of the study) I also believed that vaping was more beneficial than smoking. You see a lot more people vaping these days because they don’t think it’s too bad. Many will be horrified to know the truth.”

The study was not published or publicly released but was apparently shared with the tabloids. They are apparently the only ones who have seen the actual study. After some investigation, I found that this research appears to be the same or similar to work that was presented at last year's European Respiratory Congress annual meeting. In that study, the researchers compared treadmill respiratory performance among 20 vapers, 20 smokers, and 20 non-vaper, non-smokers. All were in their 20s and healthy.

The study found that exercise capacity and respiratory function were lower in the smokers and vapers than in the never smokers and never vapers. The degree of reduction in exercise capacity was similar among the vapers and smokers.

Based on these findings, the researchers concluded that "The smokers and the vapers had measurably excess breathing while using the exercise bikes. They found it harder to breath, their muscles became more fatigued, and they were less fit overall. In this regard, our research indicated that vaping is no better than smoking." 

The Rest of the Story

This is a fatally flawed study and shows how far certain researchers are willing to distort scientific rigor in order to condemn vaping. Do you see the fatal flaw in the study?

The fatal flaw is that the researchers apparently failed to confirm that the vapers were not ex-smokers. Because the overwhelming majority of vapers are using e-cigarettes in an attempt to quit smoking, it is highly likely that the vapers in this study were ex-smokers. Because of their young age, they likely quit smoking quite recently, perhaps 2-3 years earlier.

Thus, this study did not show that vaping is no better than smoking. Instead, what it showed was that the respiratory function and exercise capacity of ex-smokers takes a while to return to normal. It does not go back to normal within just a couple of years. This is not surprising. The lung damage done by smoking is so severe that it takes the lungs a long time to fully recover, even after someone starts smoking.

The correct way to conduct this study would have been to compare never smokers who vaped with never smokers who never vaped with smokers. It certainly appears that this was not done since I would expect that if it were, the researchers would have been eager to point that out. 

Instead, they drew a wild and unscientific conclusion without pointing out the flaw in their study, shared the results prior to publication, and generated hysteria in the news that is going to be far more damaging than vaping itself, as this is going to certainly cause many vapers to return to smoking and many smokers to cancel their plans to quit smoking via switching to vaping. 

If this study is eventually published -- and no reputable journal would do so -- it will be too late to reverse these headlines. Therefore, I believe this behavior is irresponsible and should be retracted immediately. Even that will not reverse the damage, but it would be better than nothing.