Wednesday, April 02, 2025

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.


[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.

[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.

Sunday, March 09, 2025

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.

Tuesday, February 25, 2025

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.

Monday, February 24, 2025

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

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

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

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

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

The Rest of the Story

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

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

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

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

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

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

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

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

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

3. "Tobacco advertising that targets youth."

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

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

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

 

Wednesday, February 19, 2025

Iowa Health Says There's No Real Difference Between Vaping and Smoking

According to the Iowa Health web site, "Overall, there’s not much difference between smoking and vaping."

The site goes on to explain that: "Commonly, smoking was thought to be more harmful because the product is being burnt and smoke inhaled into the lungs. But we’re finding very similar damage from heating up vaping solutions and inhaling that vapor into the lungs."

Not only is there little difference between smoking and vaping when it comes to adult users, but apparently there is little difference when it comes to youth either: "Overall in the long run, the evidence shows that there’s not much difference for individuals that have never smoked. Studies have shown that when adolescents start with vaping, there is a strong likelihood that they will have future cigarette or tobacco use. Commonly, smoking is thought to be more harmful because the product is being burnt and smoke inhaled into the lungs. But we’re finding similar damage and decreased ability to fight infections from heating up vaping solutions and inhaling that vapor into the lungs. So when it comes to adolescent use (and never smokers), there isn’t much difference in harmfulness, given the concern for addiction and likely future risk for traditional tobacco use."

The same web site also makes the claim that: "Doctors are confident that within 10 years or so, they will be able to say that vaping leads to cancer."

The Rest of the Story

This web site is like a dream come true for the cigarette industry. They literally could not have paid a health organization money to produce a fact sheet that minimizes the health effects of smoking as much by equating it merely with vaping. And had they paid for such a fact sheet, it would not have been nearly as favorable to cigarette smoking as this one is.

It is one thing to make the unsupported claim that vaping causes lung cancer or heart disease but to tell the public that there's really no difference between smoking and vaping is way beyond misleading. Factually, there is no comparison between smoking and vaping. One involves the combustion of tobacco. The other contains no tobacco. One involves the burning of tobacco leaves at 1100 degrees. The other involves no burning whatsoever. One delivers more than 10,000 chemicals including at least 60 proven human carcinogens. The other delivers between 2-15 chemicals, including no or only trace levels of carcinogens. One kills more than 400,000 people each year. The other has not been shown to have killed anyone (excluding THC vaping).  

Equating smoking and vaping is like arguing that there's basically no difference between the Boston Celtics and the Washington Wizards. Or between the Philadelphia Eagles and the Tennessee Titans. Or for that matter, between the Iowa Hawkeyes and the Northern Iowa Panthers.

Thursday, February 13, 2025

New Study Demonstrates Why Anti-Vape Academics are Wrong in Concluding that E-Cigarette Use Causes Heart Attacks and COPD

Numerous researchers and health groups have claimed that e-cigarette use increases the risk of heart attacks and COPD (example 1; example 2; example 3). For example, a clinician from UnityPoint Health warned that: "Vaping is bad for your heart. The truth is people who vape are 56% more likely to have a heart attack than non-smokers and 30% more likely to suffer a stroke." The American Lung Association warned that: "E-cigarettes also contain acrolein, a herbicide primarily used to kill weeds. It can cause acute lung injury and COPD and may cause asthma and lung cancer."

These claims are based on studies showing that e-cigarette users are more likely to experience cardiovascular and respiratory disease than people who don't use e-cigarettes. The problem with these studies is that people who use e-cigarettes are more likely to also have a history of significant cigarette smoking, which is the likely cause of the diseases they experience. While studies have attempted to control for smoking, the smoking histories are often crude and cannot fully adjust for the actual exposure to smoking. 

A new study published last week in the journal Respiratory Research sheds important light on this methodological issue. The study used data from the 2020 National Health Interview Survey to conduct a cross-sectional analysis of the relationship between e-cigarette use and smoking and COPD. As in previous studies, this one too found that among former smokers, the use of e-cigarettes appeared to increase the risk of COPD. In this study, former smokers who used e-cigarettes were 2.8 times more likely to have COPD than never users of both cigarettes and e-cigarettes. However, after controlling for the number of years since the person stopped smoking, this relationship disappeared. 

Similarly, former smokers who had used e-cigarettes in the past were 1.7 times more likely than never users of nicotine to report having COPD. This relationship disappeared, however, after controlling for either the number of years since they stopped smoking or the total number of years that they smoked.   

The authors conclude as follows:

"Our findings raise an important question about many previous studies that have reported e-cigarette associations. These results from previous studies are summarized in a recent meta-analysis; the pooled adjusted odds ratio for COPD comparing e-cigarette use to no use was 1.46 (1.31–1.61) [36]. Our findings raise the question of how much this pooled estimate would be attenuated if the individual studies had included key variables describing smoking history in their multivariable models. Importantly, pooled estimates can be biased if the estimates from the individual studies included are biased. For example, a prospective study of PATH Study data waves 1–5 by Cook et al. 2023 [37] found that e-cigarette use was not associated with increased incidence of COPD after controlling for cigarette pack years and cigarette use status. This difference highlights the importance of adequately controlling for cigarette associated variables, which we do in our study’s models.

The Rest of the Story

These findings suggest that previous conclusions that e-cigarette use causes heart attacks and COPD (as well as lung cancer) are seriously flawed because they did not properly control for cigarette smoking history. The only foolproof way to control for smoking history is to examine the relationship between e-cigarette use and the outcome among never smokers. That way, there is no means by which smoking could confound the relationship. Every time that has been done, there has been no significant increase in disease risk among e-cigarette users (with the exception of several studies with exceedingly small sample sizes - only 1 or 2 cases of disease occurred).

Unfortunately, the cat is already out of the bag. Headlines throughout the country have informed the public that e-cigarettes cause heart disease, COPD, and lung cancer. I doubt this new study will get much publicity and even if it did, it's difficult to change people's minds once they hold a certain belief.

Ultimately, these premature conclusions and headlines harm the public's health because they deter many smokers from quitting using e-cigarettes and they may also lead e-cigarette users to go back to smoking.

Wednesday, February 12, 2025

New Study Shows that E-Cigarettes Help Young Adult Smokers to Quit

A new study published yesterday in the journal Addiction provides evidence that rather than serving as a gateway to smoking, the use of e-cigarettes helps young adult smokers to quit smoking completely.

Excerpts of the study abstract follow:

"Latent growth modeling was used to model daily cigarette smoking over time. Models using past-month ENDS use, past-month smoking/vaping cannabis, and past-month co-use of ENDS and cannabis (using ENDS and smoking/vaping cannabis within the past month) as time-varying covariates were tested.

Findings: Over time, there was a tendency towards cessation of daily combustible cigarette use among this smoking sample. Smoking/vaping cannabis was associated with a decreased rate of daily combustible cigarette cessation among the sample, whereas ENDS use was associated with an increased rate of daily smoking cessation. The predicted additive effect of using ENDS and smoking/vaping cannabis was not significant.

Conclusions: Among young adult daily cigarette smokers, smoking cannabis, on its own, poses a risk to quitting combustible cigarettes, while using ENDS may promote cigarette cessation, possibly through substitution."

The Rest of the Story

This study is important because it adds to the body of knowledge refuting the claim that vaping is a gateway to smoking among young people. While there was already incontrovertible evidence that e-cigarettes are associated with decreased, rather than increased smoking among adolescents, this study adds the same finding for young adults. This means that for young people in general, there is no evidence that e-cigarettes are a gateway to smoking. In contrast, there is strong evidence that e-cigarettes are a substitute for real cigarettes and therefore promote smoking cessation.

This study supports the findings of a 2023 study which found that e-cigarettes significantly enhance smoking cessation among adults. And they responded to the clinical trial evidence of the effectiveness of e-cigarettes by arguing that those results were only valid in the clinical trial setting but not in real life. These two studies refute that argument because they took place outside the setting of any clinical trial and the use of e-cigarettes was self-directed.

Opponents of vaping have been arguing for years that there is no evidence that e-cigarettes aid smoking cessation. There is now strong evidence from both clinical trials and observational studies not only that e-cigarettes substantially aid smoking cessation but that they are actually more effective than "FDA-approved" strategies such as nicotine patches and gum.

Will this new evidence change the positions of tobacco control groups? Of course not. Because they aren't truly concerned about the science. They are primarily concerned with promoting their agenda of abstinence. 

Tuesday, February 04, 2025

Science by Press Release: Researchers Claim that E-Cigarette Use Increases Heart Failure by 19% But Fail to Provide Data to Back It Up

In a press release issued last April by the American College of Cardiology, researchers of a new study claimed that people who use e-cigarettes are 19% more likely to develop heart disease than people who do not. 

According to the release: "People who use e-cigarettes are significantly more likely to develop heart failure compared with those who have never used them, according to one of the largest prospective studies to date investigating possible links between vaping and heart failure. The findings are being presented at the American College of Cardiology’s Annual Scientific Session. ... The results showed that people who used e-cigarettes at any point were 19% more likely to develop heart failure compared with people who had never used e-cigarettes."

The study was not released publicly. Instead, the researchers made available merely an abstract of the study. In fact, it appears that the study presented was merely a poster, not even an oral presentation.

The press release led to widespread headlines warning that using even a single e-cigarette could increase someone's risk of heart failure. For example, the headline of Medical News Today read: "Vaping, Even Once, May Raise the Risk of Heart Failure, Study Finds." That's pretty scary. If it is true that a single vape can increase your risk of heart failure by 19%, then e-cigarettes are one of the most dangerous substances out there. Is this scary propaganda warranted?

The Rest of the Story

Here's the problem. It is now 9 months after the press release and still there is no publicly available paper that we can examine to see whether these headlines are justified. This is a problem that I call "science by press release." It means releasing study results to the media before publishing your paper and without also providing your entire methodology and results. I find it troubling when investigators do this because there is no way for anyone to analyze the validity of the study conclusions when all you have are the conclusions and not the study!

The fact that the study will eventually published (albeit we are at nine months and there is no publication yet as far as I can tell) is no justification because the media has already spread these headlines and it's too late to take them back. Even if the study comes out and says: "Whoops - sorry we were wrong in our conference presentation," it's too late because the media are unlikely to publish a story headlined: "Abstract from 9 months ago was incorrect."

There are three exceptions to the impropriety of releasing study results before a paper is published. One is if you release the full study and not just the abstract or conclusions. Second is if you present the paper to an audience without media and do not issue a press release. Third is if the paper is of such immediate importance that it cannot wait (e.g., a study finding that a COVID-19 vaccine is effective may deserve sharing prior to publication). 

None of these exceptions applies here. The full study was not released. The abstract was shared with the media at the time of presentation. And there is certainly no emergency that warrants the early release of these findings.

Now as to the findings themselves. This was a longitudinal study of a cohort of participants from the NIH All of Use Research Program. As described by the investigators: "Data on electronic nicotine product use was obtained from participants using the Population Assessment of Tobacco and Health-styled questions. We determined the association between electronic nicotine products use and incident HF using Cox proportional hazards models adjusted for demographic and socioeconomic factors, diabetes mellitus, hypertension, hyperlipidemia, BMI and concomitant substance use (cigarette, cigar, hookah, smokeless cigarette and alcohol use)."

The major finding was that "Compared to never users, ever users of electronic nicotine products had an increased risk of incident HF [heart failure] (aHR = 1.19, 95% CI 1.06 -1.35) in our fully adjusted model." This indeed means that compared to never e-cigarette users anyone who had ever used an e-cigarette experienced a 19% increased risk of developing heart failure. The problem, however, is that most people who use e-cigarettes do so because they are trying to quit smoking. Thus, the overwhelming majority of e-cigarette users are either current or former smokers. So how do we know that it was the e-cigarettes, rather than the tobacco cigarettes, that caused their heart failure?

The answer is that we don't, unless you stratify the results by use of tobacco products. In other words, you derive the risk estimates for heart failure among e-cigarette users who have never used tobacco products and then separately for e-cigarette users who have used tobacco products. Well, if you read the abstract carefully, the authors apparently did this. They report the following: "In sensitivity analysis, we excluded participants with a history of cigarette, cigar, hookah and smokeless cigarettes (aHR = 1.04, 95% CI 0.57 - 1.89)." In other words, when the investigators restricted the analysis only to e-cigarette users and non-users who had no history of tobacco use, they found no significant relationship between e-cigarette use and heart failure. 

A 2022 paper published in the journal Circulation provides evidence that when you stratify by smoking status, you no longer find a link between e-cigarette use and cardiovascular disease. In a longitudinal analysis of the PATH study, my former colleagues at Boston University found that:

(1) Exclusive e-cigarette use was not associated with cardiovascular disease.

(2) Exclusive cigarette use was associated with a 53% increase in cardiovascular disease.

(3) Dual use did not increase the cardiovascular disease risk above that of smoking alone.

(4) Compared to smoking, use of e-cigarettes was associated with a 34% reduction in cardiovascular disease.

(5) Dual users had the same cardiovascular disease risk as exclusive smokers.

Nearly the same results were found when the outcome was heart attack, heart failure, or stroke (as opposed to any cardiovascular disease).

These findings suggest that neither e-cigarette use nor dual use of e-cigarettes with tobacco cigarettes was associated with an increase in cardiovascular disease [dual use was of course related to disease but not any more than smoking alone]. The study also suggested that switching from cigarettes to e-cigarettes substantially reduces one's risk of cardiovascular disease. This is not a surprise since the name for switching from cigarettes to e-cigarettes is quitting smoking, and quitting smoking is well known to produce rapid declines in cardiovascular disease risk.

The rest of the story is that practicing science by press release is troubling because it risks widely disseminating false information to the public before there is any opportunity to scrutinize the research, and by the time the paper is actually published it is far too late to correct misconceptions that have already been spread through the media. It appears that exactly this may have occurred regarding the cardiovascular disease risks associated with e-cigarette use.

Thursday, January 30, 2025

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

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

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

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

The Rest of the Story

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

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

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

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

Wednesday, January 22, 2025

Concerned About Dual Users? Then You May Want to Take NRT Products Off the Market

One of the major arguments that the major national health organizations make against the use of e-cigarettes for smoking cessation is that many smokers become "dual users" (i.e., people who use both e-cigarettes and real cigarettes). For example, the American Heart Association makes the following argument: "E-cigarette promoters claim the devices can help people quit smoking. But much more evidence is needed to determine if they are an effective way to quit. Research suggests that users are more likely to continue smoking along with vaping, which is referred to as “dual use.

According to this argument, if a nicotine-containing smoking cessation product results in more smokers using both products than switching exclusively to the less harmful product, then that product is not "an effective way to quit."

The Rest of the Story

Recent data out of England reveal that 56.4% of smokers who use NRT products continue to smoke. In other words, 56.4% of NRT users in England are "dual users." By the American Heart Association's logic, it should be concluded that NRT is not "an effective way to quit" because smokers who try NRT are more likely to become dual users than to switch completely to NRT. However, we don't see the American Heart Association calling for bans or severe restrictions on NRT, not even flavored NRT.

The same report (called the Smoking Toolkit Study) revealed that in contrast to NRT, smokers who try e-cigarettes are more likely than not able to become sole users of e-cigarettes. In contrast to the 56% of smokers trying NRT who become dual users, only 36% of smokers who try e-cigarettes become dual users. By the American Heart Association's logic, they should conclude that e-cigarettes are an effective way to quit. However, we don't see the American Heart Association demanding that e-cigarettes remain on the market to help smokers quit.

So what explains the American Heart Association's stance on e-cigarettes vs. NRT as smoking cessation methods?

The first thing I always check when trying to explain logical discrepancies like this is money. An examination of funding received by the American Heart Association in 2020-2021 reveals that they received $40.7 million from pharmaceutical and biotech companies. Specifically, they received the following amount of money from individual companies within Big Pharma:

Alexion Pharmaceuticals: $1.3 million
Alnylam Pharmaceuticals: $0.75 million
Astra Zeneca: $6.3 million
Bayer Healthcare: $1.8 million
Boehringer Ingelheim Pharmaceuticals: $4.8 million (with a pledge of $4.8 million to be paid in future)
Janssen: $0.4 million
Jazz Pharmaceuticals: $0.25 million
Johnson & Johnson: $0.14 million
Kaneka Pharma America, LLC: $0.15 million
Merck: $0.15 million
Novartis: $1.7 million (with a pledge of $18.1 million to be paid in future years)
NovoNordisk: $1.6 million
Pfizer: $0.8 million
Sanofi: $1.7 million

This totals $21.8 million, with an additional pledge of $22.9 million, for a total of $44.7 million.

I'll be quite honest. If I or my company were receiving $44.7 million a year from Big Pharma, I, too, would not recommend that any of their products be taken off the market.


Monday, January 20, 2025

Why Isn't the American Lung Association Calling for the Removal of Flavored NRT Nicotine Gum from the Market?

In its statement responding to the FDA's approval of Zyn nicotine pouches for marketing in the United States, the American Lung Association blasted the FDA and called for the removal of all flavored nicotine products from the market. This includes flavored nicotine gum but not flavored NRT nicotine gum.  

The ALA argued that flavored nicotine products appeal to youth and could cause addiction, and therefore should be removed from the market. However, the ALA was only referring to products the FDA classifies as "tobacco products," which does not include NRT nicotine gum. 

What justification is there for the American Lung Association to want flavored non-NRT nicotine gum to be removed from the market but not flavored NRT nicotine gum? Why the distinction?

There are 4 possible justifications:

First, if non-NRT nicotine gum came in flavors that could attract youth while NRT nicotine did not.

Second, if non-NRT nicotine gum were more hazardous than NRT nicotine gum. The main concern here is the potential presence of carcinogens, specifically tobacco-specific nitrosamines.

Third, if non-NRT nicotine gum was used by a substantially greater proportion of youths compared to NRT nicotine gum.

Fourth, if non-NRT nicotine gum contained much higher levels of nicotine than NRT nicotine gum and was therefore more addictive.

Let's examine each of these.

1. Flavors

This is not a distinguishing factor between non-NRT nicotine gum and NRT nicotine gum because NRT nicotine gum comes in at least the following flavors:

Cinnamon

Fruit

Fruit Freeze and Mint Freeze

Fruit Chill

Ice Mint

Mint, Spearmint, and White Ice Mint

2. Tobacco-Specific Nitrosamines

There is little evidence that non-NRT nicotine gum contains substantially higher levels of tobacco-specific nitrosamines than NRT nicotine gum. Existing studies show that both contain either non-detectable or trace levels and so nicotine gum should not pose any significant carcinogenic risk.

3. Prevalence of Youth Use

According to 2024 data from the FDA, the prevalence of use of all oral nicotine products not including nicotine pouches (lozenges, sticks, and gums) was 1.2%. Thus, the prevalence of non-NRT nicotine gum use among adolescents appears to be around 1%.

Unfortunately, data on use of NRT nicotine gum among adolescents is difficult to find. The only estimate I could find was that every day use of NRT nicotine gum in one sample of students was approximately 1%.

It does not appear that there is a substantial difference here, and I have not seen any data to support the contention that there is a substantial difference.

4. Amount of Nicotine

NRT nicotine gum typically contains either 2mg or 4mg of nicotine. Most non-nicotine NRT gum appears to contain either 2mg or 4mg of nicotine, although I was able to find one brand that contained 8mg of nicotine. 

The Rest of the Story

If the American Lung Association truly believes that any flavored nicotine product that may appeal to youths and pose a risk of addiction should be removed from the market, then why are they not calling for all flavored nicotine gum to be removed from the market?

One logical reason could be that the American Lung Association doesn't want to remove from the market a product that is helping many smokers to quit. However, if that is the case, then it is a strong argument for keeping other nicotine gum products on the market as well, since there are many smokers who are using these products in an attempt to quit. 

It's not clear to me that the primary motivation here is to help smokers. If that were the case, then the ALA would certainly want to balance the benefit of flavored nicotine products in helping adult smokers quit with the potential harms to youth. This is exactly what the FDA did in its consideration of Zyn, and its finding was that the balance is clearly in favor of its benefits. It appears that the ALA and many other tobacco control organizations are not even considering the potential benefits of non-tobacco nicotine products in helping millions of smokers to quit. Instead, they have a sole focus on the use of any flavored nicotine product by youth. Well, any flavored nicotine product that is not manufactured by a pharmaceutical company. 

I have been struggling to understand why the ALA wants to selectively ban all flavored nicotine gum except for those made by Big Pharma. The only answer that I have come up with is this:

I believe that the American Lung Association and many other tobacco control groups simply cannot tolerate the fact that someone might be using nicotine and getting pleasure from it without suffering severe health effects and thus not being punished for their bad decision. After all, these groups are not calling on states to ban the sale of real cigarettes. Apparently, it is OK for adults to use cigarettes recreationally because they are going to be punished for their poor decision. But as soon as someone is using a relatively safe nicotine product, it must immediately be removed from the market.

From a broader perspective, why are so many health groups calling for a ban on any flavored nicotine product that may appeal to youths, but not calling for a ban on the sale of flavored alcohol? To be sure, flavored alcohol products are causing much more harm to the lives of adolescents than electronic cigarettes or nicotine pouches. And unlike these much safer products, flavored alcohol use has been shown to be a gateway to problem drinking behaviors. 

I'm afraid that the tobacco control movement's nearly sole focus on what is probably the safest form of youth substance use is diverting attention from much more hazardous forms of youth substance use like alcohol. When is the last time you heard the American Cancer Society call for a ban on flavored alcohol products, which are used by many more youths than nicotine pouches and which actually do cause cancer?

I'm not calling for a ban on flavored alcohol but if it's not reasonable to ban flavored alcohol then it's much less reasonable to ban flavored reduced risk nicotine products.