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Premium Cigars Threatened by Pending FDA Regulations, with Negligible Public Health Benefit



Chairman Marco Rubio convened a field hearing of the Senate Committee on Small Business & Entrepreneurship on April 5 in Tampa, Florida.  The focus was on proposed FDA regulations’ likely effect on premium cigar production and marketing.  I was invited to testify on the health effects of cigar smoking.  In addition to submitting formal testimony, available here, I made the following remarks at the hearing. As an oral pathologist at a major cancer center 25 years ago, I discovered that Americans, including doctors, are grossly misinformed about the high health risks of cigarettes versus the vastly lower risks of dip and chew.  This launched my tobacco research program that has produced 70 publications in the peer-reviewed medical literature. My research established that smokeless tobacco use is 98% less hazardous than smoking, and that extends to the risk for mouth cancer.   This was confirmed by a large recent study from federal and federally-funded investigators; they found that men who dipped or chewed tobacco had no excess risk for mouth cancer. Zero.   Differences in health effects are also well documented for combustible products.  First, some basic principles.  When you burn tobacco, you release nicotine and about 7,000 other chemicals.  Twenty to 30 years of 10 deep puffs on 20 to 30 cigarettes per day builds high risks for cancers, circulatory diseases and emphysema… leading to a high death toll.  Cigars also involve burning tobacco, but patterns of use are completely different.  The FDA knows that the cigar category encompasses a wide spectrum of products.  On one end are premium cigars; the rest of the category largely consists of machine-made, mass-produced cigarillos, little cigars and filtered cigars. I will reference the latter group as “little cigars”.  In 2014 FDA staff estimated that less than one percent of Americans smoked premium cigars; most light up infrequently.  Consumers of little cigars smoke a lot more often, and they also tend to smoke cigarettes. Premium cigar smokers fit another FDA label, primary (they never smoked cigarettes), as opposed to former smokers and dual users of both products.  This is important because adding cigarettes adds risk.  In my submitted testimony I present detailed information from a published FDA analysis of 22 epidemiologic studies of the causes of death among cigar smokers, most of whom are men.    The FDA study listed many diseases associated with cigarette smoking; the biggest killers are cancers, heart diseases, strokes and emphysema.  Consumption of one or two cigars per day was not associated with significantly increased deaths from any of these.  To be clear, puffing or inhaling the smoke of burning tobacco is not a healthy activity.  But the FDA researchers misstated the facts when they concluded that “…cigar smoking carries many of the same health risks as cigarette smoking.” All tobacco consumers deserve truthful information and guidance.  The sweeping FDA indictment ignores scientific evidence and misleads cigar smokers.  The following facts are indisputable: (1) in the U.S. the prevalence of cigar use, especially premium cigars, is very low; (2) premium products are used infrequently and in small numbers; and (3) they are puffed, not inhaled.  Low prevalence, infrequent use and reduced exposure translates into minimal harm at the population level.  Conflation of cigarette smoking with dip and chew, vaping, cigar and pipe smoking falsely informs consumers that all tobacco products are equally dangerous.  When Congress gave the FDA regulation of tobacco products 10 years ago, it did not direct the agency to treat all tobacco products as equally hazardous.  Unfortunately, the FDA’s regulatory actions have done just that. The FDA’s current posture wastes government resources, undermines public health and does nothing to address the 500,000 annual deaths caused by cigarette smoking. Original author: Brad Rodu
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New Study Finds Vaping is Not Associated with Cardiovascular Disease among Never Smokers; But Tobacco Control Researcher Dismisses Findings

A new study published online ahead of print in the American Journal of Medicine reports that there is no association between vaping and cardiovascular disease among never smokers.Like previous studies of its kind, this was a cross-sectional study that examined the association between current vaping/smoking status and ever having been told that one has cardiovascular disease (including heart attack, coronary artery disease, or stroke). Previous studies used data from the National Health Interview Survey (NHIS) or the Population Assessment of Tobacco and Health (PATH) study; this paper used data from the Behavioral Risk Factor Surveillance Survey (BRFSS).The authors reported no association between current vaping and self-reported cardiovascular disease among never smokers. However, they found that among current dual users there was an increased odds of having ever been told that one has cardiovascular disease.In response to the study, one prominent tobacco control researcher concluded that dual use is causally associated with cardiovascular disease, while dismissing the negative finding that e-cigarette use was not associated with vaping among never smokers. He wrote: "The fact that the authors did not find an effect of e-cigarettes alone may be because they stratified the sample on e-cig and cigarette use, which reduces the sample size for each comparison, and so the power to detect an effect."The Rest of the StoryThis reminds me of what the tobacco industry used to do. If they saw a finding that they liked, they would emphasize that finding, but if they saw a finding that they didn't like, they would just dismiss it. This is sometimes called "cherrypicking." I've never picked cherries, but I assume that when doing so, one only picks the cherries that you like and disregards the ones that you don't.As objective scientists, we can't cherrypick. It allows one to have a pre-conceived conclusion and then to simply publicize findings that support the conclusion while dismissing those that do not. It appears that this is what is going on here.Cherrypicking is becoming more and more common among tobacco control researchers and advocacy groups. Recently I spoke at a conference on vaping, and one of the other speakers on the panel told the audience that there was no evidence vaping can help people quit smoking. The basis of that conclusion was that "there is no clinical trial that shows vaping to be effective ... we need a clinical trial." When I then pointed out that a randomized, clinical trial published last month in the prestigious New England Journal of Medicine found that vaping was twice as effective as nicotine replacement therapy for smoking cessation, they simply dismissed it, saying: "Well I still don't think it's effective." (The same person also did not think there is enough evidence to conclude that vaping is any safer than smoking.)The reality is that many tobacco control researchers and advocates will not be convinced by any amount of data. You could have two clinical trials, both finding that vaping is effective for some smokers, and they would still dismiss the findings. (In fact, we do have two clinical trials -- it's amazing to see how many tobacco control advocates continue to insist that there have not been any clinical trials on the use of vaping for smoking cessation.)Here, a positive finding is accepted and touted, while a negative finding is just dismissed. The reasoning given -- that the study didn't have the power to detect an effect -- doesn't hold water because the sample size of never smoking vapers in the study (15,863) exceeded the number of dual users (12,908).But even the conclusion that dual use is causally associated with cardiovascular disease is unsupported by the evidence presented in the paper. This is a cross-sectional study, so it is entirely possible that the onset of cardiovascular disease preceded the vaping. In fact, this is almost certainly the case for most of the study subjects because e-cigarettes have been popular for only about eight years, and it takes decades for cardiovascular disease to develop.It may actually be that the cardiovascular disease "caused" the vaping because having a heart attack or stroke is a strong stimulus for a smoker to try to quit, and many smokers try to quit by using e-cigarettes.Moreover, dual users are almost certainly a different population from exclusive vapers and one systematic difference between the groups is likely that dual users have a heavier or more intense smoking history, making it more difficult for them to get off of e-cigarettes. If this were the case, it would explain the observed finding that dual use was associated with a higher risk of reporting cardiovascular disease.  The bottom line is that we can't draw causal conclusions from a cross-sectional study like this one, especially one in which it is impossible to determine which came first: the heart attack or the vaping. So to tout the association between dual use and heart disease as a causal finding is bad enough. But cherrypicking findings that support a pre-determined conclusion, while dismissing those which do not support that conclusion, is sinking to the level of the tobacco industry which we once criticized for doing the very same thing.Original author: Michael Siegel
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What is a lie?, revisited.

by Carl V Phillips

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Some FDA Claims About Teen Vaping Confirmed, Others Evaporate




The Centers for Disease Control and Prevention just released the 2018 data for the National Youth Tobacco Survey (NYTS).  My analysis confirms the FDA claim of a substantial increase in vaping among high school students.  However, I also discovered some information that challenges the FDA commissioner’s narrative (here) that this “threatens to hook an entire generation of kids into a lifetime of addiction.” As seen in the chart at left, current (past 30 days) dual use of combustible and electronic cigarettes rose from 4.2% the year before to 5.7% in 2018.  Exclusive e-cigarette use almost doubled, from 7.6% to 15.1%.  The only good news is that exclusive cigarette use declined from 3.6% to 2.6%.  Frequency of use is seen in the table below, which displays the percentages of the estimated 14.4 million high school students in 2018 who were currently using cigarettes and/or e-cigarettes, by number of days in the past month.  For example, 76.6% of students used neither product (bold text, upper left), an 8 point decline from the year before.  Current users of e-cigarettes are in the red-bordered boxes.  In 2017, 60% of current vapers used the products 5 or fewer days (green text) – the equivalent of trying products at a party.  But in 2018, that percentage dropped to 49%.  In contrast, in 2017 only 20% of current high school vapers used the products 20-30 days (red text), i.e frequent users, which is suggestive of dependence.  That number grew to 28% in 2018.  Slightly over half of those were not currently using cigarettes (bold red text). These worrisome numbers fuel the government’s dire warning that e-cigarettes are creating a new generation of nicotine addicts.  However, these claims require context, which the newly available NYTS data provides.  For example, the FDA emphasized that 28% of high school vapers were frequent users in 2018.  However, only 25% of underage vapers were frequent users, compared with 41% of legal vapers.  Further analysis of frequent vapers according to their underage or legal status shows the following: .nobr br { display: none } td { text-align: center}Table 2. Lifetime Cigarette Consumption of Frequent High School E-Cigarette Users, NYTS 2018Lifetime Cigarette ConsumptionUnderageLegalNot Current SmokersNever smoked43.1%28.2%1 puff to 5 cigarettes35.730.3Half to 1 pack9.417.31-5 packs6.412.65+ packs5.511.6All100%100%Current SmokersNever smoked0%2.8%1 puff to 5 cigarettes16.15.6Half to 1 pack19.725.01-5 packs20.015.85+ packs44.150.8All100%100%The table shows that most frequent e-cigarette users were not virgins with respect to cigarette smoking.  In the underage nonsmoking group, 57% of frequent vapers had smoked in the past.  The percentages were even higher among legal-age and current smokers.  These percentages will likely increase if cigars, smokeless tobacco and other tobacco products are included (as I explained years ago here).  These youths had already smoked, which counters Dr. Gottlieb’s assertion that “e-cigarette use…threatens to hook an entire generation of kids into a lifetime of addiction.”  Simply put, kids who use or try stuff, use or try other stuff.I have noted previously that the FDA’s campaign to eliminate teen vaping has improperly focused on tobacco retailers (hereand here).  The following table from the 2018 NYTS confirms that the dominant sources of e-cigarettes for underage high school users are friends, family and other individuals (71%), while the primary source for legal high school vapers are retailers (64%).  Raising the legal purchase age – Tobacco 21 – remains a viable way to curb underage use. (here).nobr br { display: none } td { text-align: center} .nobr br { display: none } td { text-align: center}Table 3. Source of E-Cigarettes for High School Vapers,* NYTS 2018 UnderageLegalFriend58.0%24.9%Family6.83.2Other person6.68.0Vape shop12.946.8Gas, convenience store6.69.7Internet3.92.0Other store2.31.4Drug store1.12.7Grocery0.90.6Mall kiosk0.90.7All100%100%* Reporting a single source (81% of all)(weighted).I previously said that “The FDA’s Teen E-Cigarette-Addiction Epidemic Doesn’t Add Up” for 2017.  There is no question that e-cigarette use among high school students increased substantially in 2018.  However, analysis of NYTS data documents that the FDA claim that e-cigarettes from retailers are singlehandedly hooking an “entire generation of kids into a lifetime of addiction” is exaggerated and inaccurate.  Original author: Brad Rodu
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New statistics about vape risk misperception (and a subtle extra-bad implication)

Huang graphs of vape risk perception

by Carl V Phillips

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

Somewhere along the line, I must have gone astray. During my master's in public health program, I was taught that one major goal of public health is to educate the public about the risks of various exposures. I was also taught that accurately communicating these risks, as well as helping the public to accurately understand the relative risks between different hazardous behaviors or products was critical.Well, based on an editorial published this morning in the Journal of the American Medical Association (JAMA) Network Open, I was misguided. For in this editorial, it states that the increasing public misunderstanding of the relative risks of smoking compared to vaping is "a good thing."The editorial responds to new research also published this morning in the same journal which documents that the majority of adults in the U.S. completely misunderstand the dangers that smoking poses compared to those posed by vaping and furthermore, that the proportion of people with this misunderstanding has been growing substantially over time. (See: Huang J, Feng B, Weaver SR, Pechacek TF, Slovic P, Eriksen MP. Changing perceptions of harm of e-cigarette vs cigarette use among adults in 2 US national surveys from 2012 to 2017. JAMA Network Open. 2019;2(3):e191047).According to the study, in 2012, only 39.4% of adults perceived e-cigarettes as less harmful than real cigarettes. This is pitiful, given the overwhelming scientific evidence that vaping is much less hazardous than smoking. But even worse, the proportion of adults who correctly perceived vaping to be safer than smoking dropped to only 33.9% in 2017. Thus, two out of every three adults in the U.S. incorrectly believes that smoking is no more hazardous than vaping.Perhaps even scarier, nearly 10% of adults in 2017 perceived vaping to be more harmful than smoking!The Rest of the StoryInstead of lamenting the fact that the public's perception of the severe hazards associated with cigarette smoking has been seriously undermined over the past decade or so, the editorial almost joyfully celebrates this massive public deception that has occurred. (See: Glantz SA. The evidence of electronic cigarette risks is catching up with public perception. JAMA Network Open. 2019;2(3):e191032).It is quite a feat of magical writing to take the dismal news that the public is increasingly downplaying the severe risks of smoking and completely misunderstands the relative risks of smoking compared to vaping and to turn that into a tremendous public health victory.The truth is, however, that this public misunderstanding is having devastating public health consequences. Convinced that vaping is no safer than smoking, many former smokers who quit using e-cigarettes are returning to smoking. After all, what's the point of staying smoke-free using e-cigarettes if vaping is just as bad as smoking? You might as well go back to your Marlboros.In addition, this misinformation is deterring many smokers who would otherwise have tried to quit using e-cigarettes to just continue smoking. After all, why quit smoking and switch to e-cigarettes if vaping is every bit as harmful. You might as well just stick with your Marlboros.Huang et al., the authors of the featured article, correctly point out that: "The need for accurate communication of the risk of e-cigarettes to the public is urgent and should clearly differentiate the absolute from the relative harm of e-cigarettes." But somehow, Professor Glantz does not believe that accurate communication is the way to go. Apparently, inaccurate communication is better.This would almost be funny, were it not for the fact that many adults are going to die because of it. As Huang et al. point out: "Perception of e-cigarette harm [compared to smoking] may deter current smokers from initiating or continuing use of e-cigarettes. This perception may also deter a complete switch from cigarettes to e-cigarettes among smokers. In light of this possibility, the observed upward trend of perceiving e-cigarettes to be more as harmful as or more harmful than cigarette smoking among US adults warrants heightened attention."In public health, the means do not justify the ends. We do not lie to people in order to persuade them to change their behavior. Telling the truth is a core ethical value of public health practice. But maybe not so much in tobacco control. For us, it is apparently acceptable to spread hysteria using false comparisons and lies simply because we can't handle the idea that there are millions of vapers who have saved their lives using a device that delivers nicotine.Original author: Michael Siegel
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Tobacco Sales to Kids Is a Problem For States, Not Retailers



FDA Commissioner Scott Gottlieb recently threatened that “some flavored e-cigarette products will no longer be sold at all…other flavored e-cigarette products that continue to be sold will be sold only in a manner that prevents youth access…” (here) Dr. Gottlieb blames the so-called youth vaping “epidemic” on illegal retail sales and “kid-friendly marketing.” (here)  Focusing so heavily on retailers, he ignores the fact that underage sales rates are extremely low in many states – Georgia (2.2%), Montana (2.7%), Hawaii (3.0%) and California (4.2%) for example, according to 2018 FDA inspection data – while violation rates in others is extremely high -- North Dakota, Michigan, Ohio and Nevada are close to 23% (here). In order to explore the connection between retailers’ violations and state enforcement efforts, I downloaded FDA information on 26,000 inspections conducted in 2018 at national retail chain stores – Walgreens, Walmart, Rite Aid, Shell, Family Dollar, Dollar General, Circle K and 7-Eleven.  I calculated the rate of violations for these chains’ stores in each state (excluding Nevada and North Dakota, with very low numbers of inspections).    The chart shows the combined results for these retailers.  Note that the x axis is the state rate, based on 146,000 inspections, and the y axis is the retailers’ rate, based on 26,000 inspections.  There is a strong correlation between violations in these chain stores and the state in which they were located (correlation coefficient, CC = +0.77).  The correlation is also seen with individual companies.  For example, Walgreens’ violation rate was 2.2% in Georgia (based on 46 inspections) and 17% in Ohio (with 229 inspections).  Note that nearly all of the retailers’ rates are below the green diagonal line, showing that they were lower than the state rates in all jurisdictions except DC, Connecticut, Oregon, Minnesota, Alaska and Hawaii. The FDA blames retailers for selling tobacco products to children, but it ignores the significant differences in violation rates among states.  Youths in Georgia, Montana, Hawaii and California can seldom buy tobacco products, suggesting that those states’ enforcement efforts are far more effective than the other 46 states. The simplest route to obtaining age restriction compliance seems to be FDA pressure for stronger state enforcement, rather than agency action against retailers or product categories. Original author: Brad Rodu
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San Francisco is the stupidest place in the world to think of the children

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by Carl V Phillips

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Response to Press Release Announcing Proposed Ban on Electronic Cigarettes in San Francisco

Here is my point-by-point response to several of the statements made in the press release issued by City Attorney Herrera announcing the introduction of legislation to ban the sale of all electronic cigarettes in the city of San Francisco: "City Attorney Dennis Herrera and Supervisor Shamann Walton today announced joint steps to curb the epidemic of youth e-cigarette use, which has erased more than a decade’s worth of progress in reducing youth tobacco consumption."The “epidemic” of youth e-cigarette use has not “erased” progress in reducing youth tobacco consumption. The gains in reducing youth smoking prevalence are very real and will translate into millions of lives saved down the road. The problem of vaping has nothing to do with tobacco use because e-liquids do not contain any tobacco. Youth who vape are not tobacco users. They are vapers. So youth e-cigarette use has not undermined gains in reducing smoking. It is a separate problem that, while serious, is far less of a hazard to the public’s health than the epidemic of youth smoking."San Francisco has never been afraid to lead,” Herrera said, “and we’re certainly not afraid to do so when the health and lives of our children are at stake."San Francisco is apparently afraid to lead because they are willing to take the politically expedient step of requiring safety testing for e-cigarettes, but they are not willing to place the same requirement on real cigarettes. In fact, tobacco cigarettes have already had their safety testing and they failed miserably. If San Francisco wants to lead, then why isn’t it taking cigarettes off the shelves?"Banning vaping products that target young people and push them towards addiction to nicotine and tobacco is the only way to ensure the safety of our youth."  Let’s stipulate that. But if that’s true, then certainly banning tobacco products (i.e., cigarettes and smokeless tobacco) that target young people and push them towards addiction to nicotine and tobacco is also the “only” way to ensure the safety of our youth."San Francisco, along with the City of Chicago and the City of New York, sent a letter to the FDA this morning demanding that the FDA do its job and immediately conduct the required public health review of e-cigarettes that, by law, was supposed to happen before these products were on the market." The law does not require the FDA to conduct a public health review of e-cigarettes. What it requires is that manufacturers who want their products to remain on the market must submit a pre-market tobacco application to the agency for approval. This review was not supposed to happen before the products were on the market. They were already on the market in 2014 when the FDA issued its regulations. The FDA delayed the deadline for these applications because not doing so would have resulted in the elimination of vaping products, forcing millions of ex-smokers back to smoking and removing a huge competitor to cigarettes. It would have been a huge gift for cigarette companies. So it’s a good thing that the FDA did not enforce its original August 2016 deadline."In coordination with the City Attorney’s Office, Supervisor Walton is introducing groundbreaking legislation at the Board of Supervisors today that would prohibit the sale in San Francisco of any e-cigarette that has not undergone FDA review." This is not ground-breaking. What would have been ground-breaking is if the city introduced legislation to ban all tobacco products that have not been reviewed by the FDA and found to be reasonably safe. Surely, cigarettes would have been on this list."This is not an outright ban on e-cigarettes. It’s a prohibition against any e-cigarettes that haven’t been reviewed by the FDA to confirm that they are appropriate for the protection of public health."It is essentially an outright ban on e-cigarettes because the city knows full well that there isn’t a single e-cigarette that has gone through the pre-market approval process (since that deadline was extended until 2021). But the more important question is why the Board of Supervisors believe that e-cigarettes should only be sold if they are shown to be appropriate for the public health, while they are allowing cigarettes to be sold even though we know for certain that they are not “appropriate for the public’s health.”"The FDA has simply failed to do its job in unprecedented fashion,” Herrera said. “These are prudent steps to ensure that we know the health and safety implications of products being sold here. If the FDA hasn’t reviewed it, it shouldn’t be on store shelves in San Francisco." If they really mean what they say, then certainly, cigarettes should be on store shelves in San Francisco. You can’t take as a serious public health effort a proposal that e-cigarettes should be taken off of store shelves in San Francisco because we’re not certain of their health implications, yet it’s perfectly fine to let cigarettes remain on store shelves in San Francisco despite the fact that they have dismally failed their “safety review.” There is simply no public health justification for banning e-cigarettes but not real cigarettes."Tobacco use is the leading cause of preventable disease and death in the United States. Tobacco kills more than 480,000 people a year in this country. That’s more than AIDS, alcohol, car accidents, illegal drugs, murders and suicides combined." Exactly! Yet vaping products are not responsible for a single one of those 480,000 deaths. And so the city of San Francisco’s response to 480,000 deaths from cigarettes is: Let’s ban the fake cigarettes and let the real ones, which are causing 480,000 deaths a year, to stay on the shelves."These companies may hide behind the veneer of harm reduction, but let’s be clear: their product is addiction." Veneer of harm reduction? There is overwhelming evidence that vaping is much safer than smoking. It is convenient to ignore this scientific evidence because it doesn’t make for as good of a story. But public health needs to be guided by science and evidence, not by political expediency.Original author: Michael Siegel
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San Francisco Considering Banning Electronic Cigarettes, But Letting Deadly Real Cigarettes Stay on the Shelves

Yesterday, San Francisco City Attorney Dennis Herrera and Supervisor Shamann Walton announced that they are introducing an ordinance to the Board of Supervisors that would ban all electronic cigarettes until they are officially reviewed and approved by the Food and Drug Administration (FDA). Since there is not a single e-cigarette on the market that has undergone such an approval process, the ordinance does indeed ban the sale of all electronic cigarettes in the city of San Francisco.The reasoning behind the proposal is as follows: "Today we are taking action to protect our kids. By law, before a new tobacco product goes to market, the Food and Drug Administration is supposed to conduct a review to evaluate its impact on public health. Inexplicably, the FDA has failed to do its job when it comes to e-cigarettes. Until the FDA does so, San Francisco has to step up. These products should not be on our shelves until the FDA has reviewed the threat they pose to public health."The Rest of the StoryThis has to be one of the most insane public health proposals I have ever seen. This legislation basically says: "We care so much about the health of our kids that we can't allow e-cigarettes to remain on the market until they have a complete safety review. However, we are perfectly happy allowing cigarettes--which have had extensive safety reviews and been found to be killing hundreds of thousands of Americans each year--to remain on the market. Let us be honest. We care enough about our kids to take the politically expedient step of making it look like we are truly protecting their health by banning e-cigarettes, but we don't care about our kids so much that we want to actually protect them by removing from the market a product that we know is going to kill half of those kids who become addicted to it."This is truly a political maneuver under the guise of a desire to protect children's health. Let's be clear. If the Board of Supervisors were sincerely committed to protecting kids, they would immediately remove cigarettes--the most deadly consumer product--from the market. Cigarettes are addicting and eventually killing more than 400,000 Americans each year. Yet you mean to tell me that in light of that, the Board of Supervisors wants to conduct a safety review for the fake cigarettes?And what's the point of such a safety review? We already have a safety review of cigarettes and know that they are deadly. And in light of that, the San Francisco Board of Supervisors nevertheless feels perfectly comfortable allowing those products to be sold. Do they think that electronic cigarettes are actually more hazardous than cigarettes? Of course not. They know full well that e-cigarettes are far safer than the real ones.Clearly, the reason why they want to ban the fake cigarettes but not the real ones is because they don't have the political courage to take the step that would most substantially protect the public's health. This is an easy opportunity to make it look like they are totally committed to protecting kids when in fact, they are apparently perfectly content to allow the most dangerous consumer product in history to be sold on retail shelves in gas stations, convenience stores, and other places that are easily accessible to kids throughout the city.This is an easy political victory because they know the vaping industry is not organized or centralized enough to fight it successfully. But if they are justified in banning e-cigarettes, then it is certainly imperative upon them - and actually much more justified - to ban real cigarettes. However, the tobacco industry is organized, centralized, and powerful.The rest of the story is that what is really going on here is that the proponents of this ordinance simply do not have the political courage to take the real action that would protect the public's health: banning cigarettes. Removing e-cigarettes from the shelves is an easy political victory that may make it seem like they desire to protect kids, but the truth is that they are apparently perfectly content with allowing deadly cigarettes to be sold to the kids who they purport to be protecting.Ultimately, this is politics, not public health.Original author: Michael Siegel
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Purported Links Between Vaping and Heart Attacks are Based on Crappy Science

Another crappy study has come along, this one again using cross-sectional data from the National Health Interview Survey to claim that e-cigarette use is associated with a higher risk of having a heart attack, developing coronary artery disease, and having depression.This study, being presented tomorrow (Monday) morning at the annual meeting of the American College of Cardiology in New Orleans, reports that "adults who report puffing e-cigarettes, or vaping, are significantly more likely to have a heart attack, coronary artery disease and depression compared with those who don’t use them or any tobacco products."These conclusions were based on a cross-sectional analysis of data from the 2014, 2016, and 2017 National Health Interview Surveys. Respondents were asked to report whether they had ever been diagnosed with having had a heart attack, coronary artery disease, or depression. The analysis found that people who reported vaping were more likely to have ever had a heart attack, to have ever been told they have coronary artery disease, or to have ever been diagnosed with depression. The analysis did control for smoking by including smoking status as a variable in the regression model.The Rest of the StoryThis is yet another example of the junk science that is rapidly being spewed out by anti-tobacco researchers who are apparently more interested in demonizing vaping than in using rigorous scientific reasoning.The problem with the study's conclusion is that this is a cross-sectional analysis and the researchers have no idea which came first: the vaping or the heart attack, heart disease, or depression.Let's consider heart attacks. It is entirely possible (and actually quite likely) that most - if not all - of the respondents who reported that they are vapers had started vaping after, not before their heart attacks. In fact, a likely explanation for the findings is that smokers who experience a heart attack are much more likely to try to quit smoking, and since switching to vaping is a common method of attempting to quit smoking, they are more likely to respond that they are vapers.The investigators claim that they have controlled for smoking. But here's the problem: smoking is not only a confounder in the analysis; it is also an effect modifier. This means that the association between vaping and having had a heart attack is different for nonsmokers and smokers. For nonsmokers, there is no association. The association only holds for former smokers and current smokers. In the presence of effect modification, treating smoking purely as a confounder will yield inaccurate results. In order to model the relationship correctly, you need to stratify the analysis on smoking status: that is, you need to report the relationship separately for nonsmokers, former smokers, and current smokers.None of the papers that have claimed vaping causes heart attacks, heart disease, stroke, or COPD have done that. They treat smoking as a confounder, but do not test for effect modification.It is unfortunate that this crappy science is being reported at scientific conferences and in scientific journals. But what makes this a real tragedy is that this junk science is being used to justify policies to regulate vaping more harshly than smoking, by: (1) heavily taxing these products; (2) banning e-cigarette flavors; and/or (3) completely banning the sale of e-cigarettes in convenience stores.The rest of the story is that rather than demonstrating that vaping causes heart attacks, heart disease, COPD, and depression, what these studies show is that when smokers get very sick, they are highly motivated to quit in order to save their lives, and many of them do so by switching to vaping.This is about 11 million lives, not 11 million lies.Original author: Michael Siegel
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Sunday Science Lesson: phenomena and measurement

by Carl V Phillips

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11 Million Lies: The Tobacco Control Movement is Committing Public Health Malpractice by Misrepresenting the Health Effects of Vaping

My colleagues and I in the tobacco control movement have based our entire careers on the principle that it is wrong to lie to the public. The bulk of our campaign against Big Tobacco was based on the contention that the cigarette companies lied to the public about the health risks of smoking. Numerous lawsuits were filed against Big Tobacco, seeking damages based on the claim that the companies are responsible because they misrepresented the health effects of their products, thus preventing smokers from making an informed choice. The name of the major youth anti-tobacco campaign is called "Truth." Clearly, honesty is the central value that has been at the core of the tobacco control movement for decades.In the last few years, however, I believe that our movement has largely abandoned truth as a central value in our campaigns against vaping. Driven by an almost puritanical inability to accept the fact that a person could obtain pleasure from nicotine without it killing them, we have made the demonization of vaping the solitary goal of the movement, at the direct expense of what I always believed was our primary goal: to make smoking history.Why is vaping so threatening to the tobacco control movement? Is it threatening because it is extremely dangerous -- basically as harmful as smoking -- and therefore is is harming the health of the nation's 11 million adult vapers?No - it's precisely the opposite. It is threatening to us because it is not as harmful as smoking. We simply cannot tolerate the fact that there are millions of adults who are deriving pleasure from, and improving their health because of, the use of a much safer form of nicotine delivery. The problem with vaping is that it is not killing anyone, so there is no punishment for the vice of being addicted to nicotine. And that's something that the tobacco control movement can simply not tolerate.I believe that it is precisely because the truth is so threatening that many anti-tobacco groups, public health agencies, physicians, and researchers have resorted to lying to the public about the health effects of vaping.The Rest of the StoryWhile the tobacco control movement is spewing numerous lies about vaping, perhaps the most damaging to the public's health is the false claim that vaping is not any safer than smoking. This is a direct affront to each one of the 11 million adult vapers in the United States who are trying to improve their health by switching from combustible tobacco use (i.e., smoking) to the use of non-tobacco-containing, non-combusted vaping products. And it is particularly offensive to the more than 2.5 million adult vapers who quit smoking completely because of these products and who are now relying on vaping to keep them from returning to smoking. For these 2.5 million ex-smokers, vaping has literally saved their lives.So it is shameful that we are now trying to take that away from them based on a complete lie: that switching to vaping is doing nothing to protect their health.Today, I highlight just a few of the individuals and organizations that are spreading the lie that vaping is no safer than smoking. Keep in mind that by definition, what these groups are saying is that smoking is no more dangerous than vaping. That's quite a claim, given the fact that smoking kills more than 400,000 people a year, contains more than 10,000 chemicals, and contains more than 60 known human carcinogens, while vaping aerosol, at worst, contains a few chemicals of concern and has not, after 12 years of use by millions of people, resulted in a single death (excepting one person who was killed due to an exploding battery, but not to the health effects of vaping itself).So here is today's top 10 examples of the individuals, groups, and researchers who are helping to spread the false assertion that cigarette smoking is no more hazardous than vaping.#1) National Center for Health Research"The body’s reaction to many of the chemicals in traditional cigarette smoke causes long-lasting inflammation, which in turn leads to chronic diseases like bronchitis, emphysema, and heart disease. Since e-cigarettes also contain many of the same toxic chemicals, there is no reason to believe that they will significantly reduce the risks for these diseases. ... Because they are smokeless, many incorrectly assume that e-cigarettes are safer for non-smokers and the environment than traditional cigarettes. ... There are no long-term studies to back up claims that the vapor from e-cigarettes is less harmful than conventional smoke."#2) Loyola University Medical Center"E-cigarettes are not safer than cigarettes. .. They have not been scientifically proven as healthier or safer, and the U.S. surgeon general has not approved them for use in smoking cessation." #3) South Dakota Department of Health"Vape is not safer than cigarettes."#4) Tennessee Medical Association"Despite being marketed as a safe alternative to smoking, e-cigarettes are not safer and they never have been. They have simply been marketed that way. As a result, many people believe trading a traditional combustible cigarette for vaping is going to make them healthier, and that the vaping or e-cigarette use is far less damaging health-wise."#5) Harford County Health Department"E-cigarettes are not safer than smoking tobacco."#6) Jane Goodall Institute"E-cigarettes are the biggest problem, and for the third year in a row they are the first choice among youth smokers. But contrary to popular belief, they are not safer than other tobacco products, they are actually more addictive due to the menthol component that makes them so easy to consume."#7) Des Moines Children's Hospital"It is absolutely not safer than smoking, that is a fallacy that adolescents believe because it tastes good."#8) Texas Tech University School of Pharmacy"These data suggest, from a cerebrovascular perspective, that e-Cig vaping is not safer than tobacco smoking, and may pose a similar, if not higher risk for stroke severity."#9) University of Rochester Medical Center"Studies by his group and others, Rahman says, suggest that vaping is not safer than smoking: 'It’s equally bad.'"#10) East Rockaway Prevention Task Force"Too many teens, officials said, believe vaping is safer than smoking, when it’s not."Original author: Michael Siegel
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My first Patreon science lesson tutorial

Posted on 16 March 2019 by Carl V Phillips | Leave a comment

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FDA’s Campaign Against Tobacco Retailers Doesn’t Hold Up to Inspection



Today Dr. Scott Gottlieb announced a draft compliance policy predicting that ““some flavored e-cigarette products will no longer be sold at all…other flavored e-cigarette products that continue to be sold will be sold only in a manner that prevents youth access…” (here)Gottlieb has blamed a so-called youth vaping “epidemic” on illegal retail sales and “kid-friendly marketing.” (here)  Last week he spotlighted Walgreens, saying that 22% of its stores had illegal sales of tobacco products to minors “since the inception of the FDA’s retailer compliance check inspection program in 2010.”  He also listed 14 other national retail chains that had violation rates of 15% to 44%.  These shocking numbers are, in fact, inflated through the use of cumulative math covering a nine-year period. I reported on public FDA inspection data just after the program started (here) and again in 2016 (here).  In response to current FDA news, I have now analyzed the data from 2018 (available here), the year Dr. Gottlieb said youth vaping skyrocketed, based on still unpublished data from the National Youth Tobacco survey.  My findings on the 2018 FDA inspection data are illuminating.FDA contractors conducted over 146,000 retailer inspections in 2018, resulting in a national average violation rate of 12%, just one percent higher than in 2015-16 (here).  The following table contrasts the cumulative violation rate (range) reported by Dr. Gottlieb with the actual rate in 2018..nobr br { display: none } td { text-align: center} National Retailers’ Tobacco Sales Violations: “Cumulative” Versus 2018 RatesRetailerGottlieb “Cumulative” Rate (%)Actual 2018 Rate (%)Walmart15-246Walgreens15-249Family Dollar15-2411Circle K15-2412Kroger15-2413Casey’s General Stores25-34117-Eleven25-3414Shell25-3419Chevron25-3419Marathon35-4426Citgo35-4419Exxon35-4420Mobil35-4420Sunoco35-4421BP35-4424Dr. Gottlieb did not need to use inflated cumulative numbers to demonstrate that national retail chains, especially those with gas stations, are still selling tobacco products to underage youth.  Additionally, his focus on Walgreens, with a 2018 violation rate of 9%, three points lower than the national average, seems inappropriate.  Other key data points were omitted from Dr. Gottlieb’s remarks.  First, there is a large variation in state violation rates, from Georgia (2.2%), Montana (2.7%), Hawaii (3.0%) and California (4.2%) all the way to North Dakota and Michigan at 22.5%; Ohio and Nevada at 22.9%.  Retailers’ state rates were similarly diverse. For example, Walgreens and Walmarts in Georgia had much lower rates than those in Ohio.  This doesn’t absolve retailers of responsibility.  Rather, it indicates that state policies and attitudes may be contributing as significantly to underage sales as retailers.While Dr. Gottlieb’s regulatory effort is aimed ostensibly at combatting youth access to e-cigarettes, only 19% of the cited 17,500 violations in 2018 involved those products.  Cigars were the most frequent culprit (44%), followed by cigarettes (33%), with smokeless tobacco at a mere 4%.There is no excuse for a national tobacco sales violation rate of 12%; retailers everywhere must stop selling to underage youth.  Still, the federal government’s own survey data shows that more than 90% of teens who use tobacco products obtain them from social sources, such as friends or family.  Only 10% of current teen vapers buy their own e-cigs (here).  Given these facts, the FDA can’t hold retailers entirely responsible for teen e-cigarette use.Original author: Brad Rodu
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Even Norwegians do not understand how low-risk snus is

by Carl V Phillips

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Smoking is not addictive

by Carl V Phillips

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Federally Funded Authors Promote Misperceptions of Smoke-Free Tobacco Products



In their recent journal article, “U.S. adult perceptions of the harmfulness of tobacco products” (abstract here), a group of researchers from the FDA, other federal agencies, Canadian and American universities suppress important information about safer tobacco products.  G.T. Fong and 11 co-authors used federal funds to analyze the FDA Population Assessment of Tobacco and Health (PATH) Survey with respect to perceptions of eight non-cigarette tobacco products’ relative harms.  While their roughly 5,000-word treatise included three large tables, one figure, two supplemental tables, and 40 references, they included not a word about how these perceptions match up with reality.  The only time they used the word “misperception” was to suggest that Americans who view non-cigarette products as less harmful should be educated with “new information”. The authors found that “40.7% of adults believed that electronic cigarettes were less harmful than cigarettes.” In their view, “These results point to the potential value of enhancing knowledge, within the U.S. population, of the harm of tobacco products to prevent tobacco use and to encourage tobacco users to quit, through providing new information about the harms that may not be widely known and/or through countering misperceptions that may exist.” Readers of this blog know that numerous published studies document that smokeless tobacco use is vastly safer than smoking, and that the British Royal College of Physicians affirms that vaping is at least 95% less hazardous than smoking.  It is appalling that 12 government-funded researchers have published a lengthy screed without acknowledging that smoke-free products are less harmful.  Original author: Brad Rodu
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Tobacco control ratf**king

by Carl V Phillips

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Vaping research priorities – my top ten


Following up on the guest post by Louise Ross: What are the vaping research priorities? Have your say… I have now had my say and wanted to share my top 10 priorities.

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