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Mountain Vapor Blog

Welcome to the blog area of our site where we hope to keep you updated on the trends of the e-cigarette industry as well as product reviews.

Tobacco Harm Reduction Is Science, Not Conspiracy


Technology newsmonger The Verge should stick to covering cell phones and earbuds.  Last week it published a fantastical tale of e-cigarette intrigue, suggesting the existence of an international tobacco and vaping industry conspiracy.  The article by Liza Gross (here), richly sourced, linked my work to this imagined scheme. I have always been entirely transparent about my research sponsors.   I have publicly reported that my research at the University of Alabama at Birmingham, from 1999 to 2005, and since at the University of Louisville, has been supported by unrestricted grants to those institutions. The funds are managed according to the institutions’ policies to assure that grantors have no influence on my research products or activities.  Since my first publication in tobacco harm reduction (THR) in 1994, I have been interested in all THR products, regardless of manufacturer.  The Verge cited an “unsolicited” email from me to claim a connection to Reynolds, the marketer of Eclipse, but I had submitted my note via a blind "Talk to RJR" email account, as I had no relationship with anyone at the company.  The purpose of my email was to challenge Reynolds for positioning Eclipse as a lower risk product for smokers.  I objected that it was not lower risk, but rather “a tobacco product which delivers only xx% of (specific toxins) when compared with currently available products because the tobacco is heated rather than burned.”  I was correcting Reynolds, suggesting they make a reduced exposure claim rather than a reduced risk claim.  Note that when Congress gave the FDA regulatory authority over tobacco nine years later, it included both reduced risk and reduced exposure as pathways for Modified Risk Tobacco Product approval by FDA for product claims by tobacco manufacturers. As a result of my email to Reynolds, the company provided a senior scientist to give a well- received public seminar at the UAB School of Public Health describing the company’s research and resulting peer-reviewed articles on Eclipse (here).  Elsewhere in its story, The Verge used half-truths to besmirch me and others with regards to contact with tobacco companies.  For 23 years I have worked with a wide range of organizations interested in tobacco harm reduction.  I generated peer-reviewed articles and other reports as a scientific advisor for the American Council for Science and Health, and as a fellow of the Heartland and R Street Institutes, all without financial remuneration.  These activities fall within my responsibilities as Professor of Medicine and Endowed Chair of Tobacco Harm Reduction Research at the University of Louisville. The dictionary defines “verge” as the edge, rim, or margin of something.  Ms. Gross’s article espouses a conspiracy theory that, in my case, is well beyond the margin of accuracy.  Had the author contacted me, I would have provided the Tobacco Truth. Original author: Brad Rodu
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Smoke But No Fire: IQOS Opponent Misrepresents 3-Month Studies to FDA


Stanton Glantz, a University of California, San Francisco professor, this week urged the FDA to “…deny [Philip Morris Intermational’s] application to market IQOS [its heat-not-burn cigarette] as a modified risk tobacco product because PMI’s own data fails to support a modified risk claim in people who are actually using the product.” Glantz’s declaration is based on his review of lab results from two groups of smokers three months after (1) continuing to smoke or (2) switching to IQOS.  The studies, from Japan and the U.S., were submitted by PMI in its application (available at the FDA website here). It is well known that individuals’ lab results do not improve instantly upon smoking cessation.  The PMI submission clearly indicated that many of the subjects’ lab values are not expected to change for 6-12 months or longer after quitting.  Beyond that, Glantz completely ignored a third PMI study group: smokers who had quit completely for three months.  In this post I present the comparison that Glantz emphasized – IQOS users versus continuing smokers – but I add an equally important comparison that Glantz ignored – IQOS users versus complete quitters.  Because the U.S. study had too few subjects in the latter group  (n=9) for stable comparisons, I will focus on the Japan study, which involved 70 IQOS users, 41 continuing smokers and 37 complete quitters.  I will also note one omission in Glantz’s comparison. The comparisons of IQOS and continued smoking in the table below were calculated by PMI and presented in its application.  PMI also calculated differences for IQOS versus quitting, but I could not find them in the material released so far by the FDA.  So those comparisons in the table are from my assessment of point estimates and confidence intervals from the submission.  All differences in the table are described positively with respect to health (e.g. IQOS significantly lower).  “NS” indicates no significant difference between groups for that test. .nobr br { display: none } td { text-align: center} Comparison of Laboratory Values After 3 Months: IQOS Users Versus Continuing Smokers and Versus Complete Quitters in JapanLab MarkerIQOS Versus SmokingIQOS Versus Complete Quitting*InflammationWhite blood cell countIQOS significantly lower**NSC-reactive proteinNSNSSoluble ICAMIQOS significantly lowerNSFibrinogenNSNSOxidative StressProstaglandin F2 alphaIQOS significantly lowerIQOS possibly lower11-DTX-B2NSQuitting possibly lowerCholesterol, TriglyceridesHigh density lipoproteinIQOS significantly higherNSLow density lipoproteinNSNSTotal cholesterolNSNSTriglyceridesNSIQOS possibly lowerBlood pressureSystolicNSNSSystolicNSNSLung functionForced expiratory vol, 1 sec.NSNSNS, No significant difference* My assessment based on point estimates and confidence intervals in submission  ** Omitted by Glantz The PMI calculations show that IQOS users had four statistically significant favorable comparisons at 3 months compared with smokers.  Other results show no differences.  My assessment of IQOS users versus complete quitters reveals no significant differences for ten lab results.  There were only two possibly significant results favoring IQOS and one favoring complete quitting.  In summary, the results at three months do not prove anything definitive, which was emphasized in PMI’s application.  These results were not used by PMI to support any positive claims about IQOS; they should not have been used by Professor Glantz to make any counter claims.  Original author: Brad Rodu
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Letter to the Foundation for a Smoke Free World about money, governance, conflicts and Philip Morris International


For some, it would be better to waste a billion dollars

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More Vaper Insights Drawn from the FDA PATH Survey, 2013-14


Following are additional insights into smoking and vaping from my Nicotine & Tobacco Research study (abstract here), coauthored by my economist colleague Dr. Nantaporn Plurphanswat.  Earlier blog notes on this analysis of the 2013-14 FDA-funded Population Assessment of Tobacco and Health (PATH) Survey are here. Flavors and Nicotine Flavors are important to vapers, but the PATH questionnaire inquired about flavoring only by grouping them: “menthol, mint, clove, spice, candy, fruit, chocolate, alcohol (such as wine or cognac), or other sweets.”  Nevertheless, we report that flavors “were consumed by 7 out of 10 current users.  Never-smokers were significantly more likely to use them than current and former smokers (84% vs. 67% and 69%), and they were significantly less likely to use liquid containing nicotine (69% vs. 93% and 88%).  Notably, …5.2% of current smokers, 7.8% of former smokers, and 25.9% of never-smokers used e-cigarettes that contained flavor, but no nicotine.” Buying E-Cigarettes We found that “The majority of users bought e-cigarettes in person (81%).  Former smokers were significantly more likely to buy them from the internet than current and never-smokers (21% vs. 10.3% and 13.0%).  Never-smokers were the least likely to buy their own e-cigarettes.  Two-thirds of former smokers purchased their e-cigarettes in a smoke shop or vape shop, which was significantly higher than current or never-smokers (55% and 45%).” Reasons for Vaping The PATH Survey asked vapers why they used e-cigarettes.  The top five reasons among former smokers who vaped were: 1.     “less harmful to me” (94%), 2.     “less harmful to persons around me,” (88%) 3.     “help to quit smoking,” (86%) 4.     “don’t smell” (80%) 5.     “use when/where smoking not allowed” (78%). Current smokers who vaped listed the same top five reasons in slightly different order.  Understandably, #5 moved to the #2 slot.  Notably, “E-cigarette use by other people (‘important to me’ or ‘in the media or other public figures’) and appealing advertising were the least popular reasons for use among all groups.” Perceptions of Nicotine and E-Cigarette Harm Regardless of smoking status, most vapers were misinformed about nicotine: 84% of never smokers believed that nicotine causes most cancers, as did 77% of current smokers and 66% of former smokers.  There was better news with respect to relative risk of vaping versus smoking: “The majority of users thought that e-cigarettes were less harmful than cigarettes. Ninety-four percent of former smokers thought that e-cigarettes were less harmful, which was significantly higher than either current or never-smokers (78% and 77%).” This is meaningful, as a 2015 National Cancer Institute survey showed that only 26% of U.S. adults believed that e-cigarettes were less harmful than traditional cigarettes (discussed here).  The PATH results show that, despite a tsunami of misinformation from government agencies and health organizations, e-cigarette users are much better informed than the general public about differential risks of vaping and smoking.  Original author: Brad Rodu
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NY Wrongheadedly Bans Indoor Vaping


Saying that e-cigarettes “carry long-term risks to the health of users and those around them,” New York Governor Andrew Cuomo signed into law on October 23 a bill that bans indoor vaping.   The governor got his facts wrong.  While e-cigarette usage rates have boomed over the past five years, there is no evidence that they have any significant short-, medium- or long-term health effects.  Andrew Stuttaford in the National Review (here) labeled Cuomo’s action “an unscientific war,” citing the Royal College of Physicians’ 2016 report (here)(emphasis in original).  The case for e-cigarettes can be summed up by four key recommendations from the RCP report: ·       E-cigarettes are marketed as consumer products and are proving much more popular than NRT [nicotine replacement therapy] as a substitute and competitor for tobacco cigarettes.  ·       E-cigarettes appear to be effective when used by smokers as an aid to quitting smoking. ·       … the hazard to health arising from long-term vapour inhalation from the e-cigarettes available today is unlikely to exceed 5% of the harm from smoking tobacco. ·       …in the interests of public health it is important to promote the use of e-cigarettes, NRT and other non-tobacco nicotine products as widely as possible as a substitute for smoking Ignoring clear evidence of vapor’s relative safety and widespread use in smoking cessation, politicians and public health officials in New York and elsewhere support the deadly cigarette status quo. Beyond science issues, vaping bans have little impact on consumer behavior.  E-cigarette vapor dissipates quickly, so while bans may stifle e-cigarette use in public settings, enthusiasts know that they can continue vaping indoors; if they are discreet, no one will know. The biggest flaw in vaping bans is the false implication – if not the explicit false claim – that vapor is as dangerous as smoke.  In the war on vaping by Governor Cuomo and others, such deception misleads American tobacco users and denies them use of proven harm reduction aids. That is the denial, not the promotion, of public health. Original author: Brad Rodu
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A Sensible Tobacco Tax Plan to Benefit Smokers & States

Most tobacco taxes aim to punish tobacco consumers and companies.  My University of Louisville economics colleague Dr. Nantaporn Plurphanswat and I offer a rational tobacco tax plan (here) to benefit tobacco users and state governments.  It’s supported by 16 tobacco research and economic policy experts from across the nation, and it’s co-sponsored by the Pegasus Institute.  Watch my interview with Nick Storm of Spectrum News here, or click on the image above.Original author: Brad Rodu
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FDA wants to reduce nicotine in cigarettes – what could possibly go wrong (and right)?


October 25th, 2017

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New Vaping Insights Based on FDA’s PATH Survey 2013-2014



Analyzing data from the baseline 2013-14 FDA-funded Population Assessment of Tobacco and Health (PATH) Study, my economist colleague Dr. Nantaporn Plurphanswat and I have produced a comprehensive study of e-cigarette use in the United States.  The research appears in the journal Nicotine & Tobacco Research (abstract here). The standard vaping definition has two components: participants must have regularly vapedAND now vape every day or some days.  Using this definition, we estimate that there were 5.5 million current e-cigarette users (2.4% of the U.S. population), of which 2.3 million used them daily and 3.2 million used them some days. However, there are 7.4 million participants who have NOT “regularly vaped” but report that they use e-cigs every day or some days.  It is important to count them too, and to distinguish them from current users, so we call them “e-cigarette triers,” the vast majority of whom (95%) use them some days.  The total of current users and triers is 12.9 million (or about 5.6% of the population). (In a recent blog entry (here) I estimated that there were 8.9 million U.S. vapers in 2014, based on the National Health Interview Survey [NHIS].  The fact that the NHIS does not collect data on “regular” vaping likely accounts for the difference with our new PATH-based 12.9 million estimate.) The figure above shows that the vast majority of every day current vapers were either current smokers (47%) or former smokers (46%).  In contrast, most some day vapers and all e-cigarette triers were current smokers, and the percentage of never smokers was higher in these groups (discussed below).  PATH also collected more detailed cigarette smoking information than did NHIS.  In our new article we note that we use a similar “…classification strategy…for estimates of cigarette smoking. The number of current smokers in PATH was 41.5 million, and 80% were daily smokers, which is consistent with the 2014 NHIS.  However, there were also 7.1 million cigarette triers, who are distinguished by being every day or some day smokers who had not consumed 100 cigarettes in their lifetime.  Triers do not fit the traditional definition of current smokers, so we have included them as a subset of ‘never-smokers’ for comparison with NHIS surveys, where they would have been classified as never-smokers by answering ‘no’ to the 100-cigarette question and not being asked about every or some day smoking. This is an indication that a substantial number of American smokers may have been misclassified as never-smokers in previous national surveys.”These details illuminate critical characteristics of both vapers and smokers.  For example, as shown the chart at left, the vast majority of vapers who “never smoked” according to the NHIS definition are actually current or former cigarette triers.  Only a small fraction (7-11%) have never tried cigarettes.  This finding refutes the common claim that vaping attracts never smokers. Other vaping insights gleaned from the PATH survey will be discussed in a future post. Original author: Brad Rodu
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Is Australia falling behind on tobacco policy?


Sources: Office for National Statistics (UK). Smoking habits in the UK and its constituent countries, 2016.  Australian Institute of Health and Welfare, National Drug Strategy Household Survey, 2016.

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“Deception or Evasion” by FDA CTP & National Cancer Institute Regarding Smokeless Tobacco?


“A majority of adults do not think smokeless tobacco is less harmful than cigarettes,” according to a study by the FDA Center for Tobacco Products and the Tobacco Control Research Branch of National Cancer Institute (abstract here).  Sheri P. Feirman and colleagues analyzed responses to a question in the Health Information National Trends Survey (HINTS), 2012, 2014, and 2015: “Do you believe that some smokeless tobacco products, such as chewing tobacco and snuff, are less harmful than cigarettes?”  Do You Believe that Some Smokeless Tobacco Products…Are Less Harmful Than Cigarettes?201220142015Yes9.4%12.0%10.9%No73.5%72.1%66.8%Don’t Know17.1%15.9%22.2% Simply put, only 9 to 12% of Americans correctly believe that smokeless tobacco is less harmful than cigarettes. In a PubMed Commons commentary on this study, David Sweanor and I note: “The article failed to specify that the correct answer [to the question] is:  ‘Yes, smokeless tobacco products are less harmful than cigarettes.’  The article instead focuses on the majority of participants who inaccurately answered ‘No’ or ‘Don’t Know,’ which demonstrates the misperception fostered by an effective ‘quarantine’ of truthful risk information by federal agencies (Kozlowski and Sweanor, 2016). “Decades of epidemiologic studies have documented that the health risks of smokeless tobacco use are, at most, 2% those of smoking (Rodu and Godshall, 2006; Rodu, 2011; Fisher 2017; Royal College of Physicians, 2002; Lee and Hamling, 2009).  Unlike cigarettes, smokeless tobacco does not cause lung cancer, heart and circulatory diseases or emphysema.  The Royal College of Physicians concluded in 2002: ‘As a way of using nicotine, the consumption of non-combustible [smokeless] tobacco is on the order of 10–1,000 times less hazardous than smoking, depending on the product.’” (Royal College of Physicians, 2002) ”Low risks from smokeless tobacco use extend to mouth cancer.  A 2002 review documented that men in the U.S. who use moist snuff and chewing tobacco have minimal to no risk for mouth cancer (Rodu and Cole, 2002), and a recent federal study found no excess deaths from the disease among American men who use moist snuff or chewing tobacco (Wyss, 2016). “As one of us recently wrote, ‘Deception or evasion about major differences in product risks is not supported by public health ethics, health communication or consumer practices.  Public health agencies have an obligation to correct the current dramatic level of consumer misinformation on relative risks that they have fostered.’ (Kozlowski and Sweanor, 2018).” The FDA and NCI must be more forthcoming with the American public.Original author: Brad Rodu
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Mythic Tobacco Endgames



A new $1.2 million campaign to promote tobacco prohibition on college campuses was announced on September 19 (here).  As I have noted, the federal government annually spends hundreds of millions of dollars in support of academic anti-tobacco research (here).  This time, the money is coming from pharmacy giant CVS’s Health Foundation as part of a five-year, $50 million campaign.  CVS collaborators include the misnamed Truth Initiative (see hereand here) and the American Cancer Society, whose numerous prohibitionist exploits are reported in this blog (here, here, here, here, here, here, here, here, here, here). Campaign awards to several Texas schools were reported in a Houston Chronicle article (here) that included illustrations offering and refuting four tobacco “myths”.  In this effort, the paper (or the campaign) repeated fantastical claims that are often made by prohibitionists. Myth #1: “Almost no one smokes any more [sic].”  A myth, by definition, is a widely held view, so this attempt fails from the start. The latest data from the CDC, for 2016, shows 38 million smokers in the United States – a substantial and highly visible group of people, all in need of effective quit-smoking tools and support. Myth #2: “e-Cigarettes, hookahs and cigars are safe alternatives.”  Again, few people hold this view (here).  Scientists, the industry and public health officials agree that no form of tobacco use is perfectly “safe.”  Eminent authorities like Britain’s Royal College of Physicians, however, have pronounced that vaping “is unlikely to exceed 5% of the harm from smoking tobacco.” (here)  Furthermore, FDA data shows that smoking one or two cigars a day have almost no health risks (hereand here). Myth #3: “Infrequent, social smoking is harmless.”  This is creating a myth when one doesn’t exist. Myth #4: “Smoking outside eliminates secondhand smoke dangers.”  Myths convey false information.  This statement is entirely true. Ironically, some viewers of the online Chronicle article are shown an advertisement for Nicorette gum, reproduced here.  While pharmaceutical nicotine has a known 93% quit-smoking failure rate (here), this ad touts one day of success – an extraordinarily low bar for cessation. Original author: Brad Rodu
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2016 CDC Data Shows E-Cigarette Use Declines Again



Some 7.8 million American adults used e-cigarettes in 2016, according to data from the 2016 National Health Interview Survey, the source for CDC national smoking estimates.  That is about half a million fewer than a year earlier, and 1.1 million fewer than in 2014, the first year NHIS surveyed for vaping.  As the CDC reported a month ago (here), the 2016 data indicates 3.2% adult prevalence – 3.9% (about 4.5 million) for men, and 2.6%, (about 3.3 million) for women.   The 2.62 million former smokers who are current vapers comprised an increasing percentage of all vapers, from 22% in 2014, to almost 34% in 2016.  This is more evidence that smokers are using e-cigarettes to quit their habit.  As the following chart shows, 87% of former smokers currently using e-cigarettes quit in the last 5 years, suggesting that e-cigarettes played a significant role.  Meanwhile, 13% of former-smoker current-vapers quit over 6 years ago.  The CDC admits that relapse among former smokers is common (here), so health advocates should applaud these former-smokers’ choice of e-cigarettes over far more dangerous cigarettes. As noted previously (here), the 2.6 million former smokers represent more than mere anecdotal evidence; their documented experience ought to carry substantial weight with government policymakers.  In view of the important positive health implications of switching to smoke-free products, the number of former smokers ought to be growing faster.  Unfortunately, the sustained war on all smoke-free products is likely suppressing broader transition away from cigarettes.Original author: Brad Rodu
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Guest post: BAT executive on disruption of the tobacco industry

On June 12th, I published a blog, Pariahs, predators or players? The tobacco industry and the end of smoking, in which I tried to guess how tobacco companies are thinking about the future from my vantage point on the sidelines.  But I also asked if any industry figures would like to offer an informed insider’s view and offered a right of reply. Well, to my surprise one executive did reply.  David O’Reilly is BAT’s Group Scientific and R&D Director, and here is his perspective.

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Advertising code at fault over e-cigarette public health ad ban


This year’s Stoptober campaign encourages smokers to try vaping – bravo!

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Antidote to NEJM Formaldehype Arrives at Last


In January 2015, R. Paul Jensen and colleagues created global headlines with a defective e-cigarette experiment (here).  They claimed in the New England Journal of Medicine that vapor contains “hidden” formaldehyde at far higher levels than cigarettes (here).  Their measurements required overheating or “dry-puffing” e-cigarette liquid, a process that produces such harsh (not hidden) oral sensations that the vapor is intolerable to normal consumers.  As Churchill said, “A lie gets halfway around the world before the truth has a chance to get its pants on.”  The Jensen mischaracterization caused considerable damage, as it encouraged smokers to believe that vaping is more dangerous than smoking.  Last week, the formaldehyde fallacy was laid bare.  Dr. Konstantinos Farsalinos and colleagues reproduced the Jensen experiment and found that “The high levels of formaldehyde emissions that were reported in [the Jensen] study were caused by unrealistic use conditions that create the unpleasant taste of dry puffs to e-cigarette users and are thus avoided.” Their work appears in Food and Chemical Toxicology (abstract here).  Farsalinos’ group painstakingly reproduced the earlier experiment, using the same now-outdated vaping equipment that was prone to dry puffs.  First, they had experienced vapers identify at what settings the “burning” taste of a dry puff was detected: 4.2 volts, 8.0 watts.  They then used Jensen’s methods to measure formaldehyde at various voltage-power settings, seen in the chart (above) adapted from their publication. Vapers detected dry puffs when the formaldehyde level was 100 micrograms (per 10 puffs).  Given that a microgram is one-millionth of a gram, Jensen’s formaldehyde level wasn’t hidden at all; at 380 micrograms, it was much higher than vapers could tolerate.  At lower, normal vaping power, formaldehyde was only 20 micrograms, or two-thirds that of cigarettes. Farsalinos cautions the scientific community: “blindly testing e-cigarettes in the laboratory setting without evaluating realistic use is a serious omission that can result in misleading conclusions about the risk to consumers compared to smoking;” and such conclusions can wrongly imply “that there is little to be gained by switching to e-cigarettes.” In response to the Jensen article in 2015, Clive Bates and Konstantinos Farsalinos published a letter in Addiction calling for its retraction (here); the demand was ignored.  The current publication is a much-needed antidote to Jensen’s seriously flawed and misleading findings. Original author: Brad Rodu
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Do Smokers Quit After Hospital Cessation Trials? Don’t Count on It, or Them


Do smokers lie about quitting?  A new study analyzes smokers’ self-reports of their smoking habits six months after their participation in quit-smoking clinical trials. Several years ago, researchers recruited sick smokers at a group of hospitals – the Consortium of Hospitals Advancing Research on Tobacco, or CHART – and conducted federally-supported smoking cessation trials.  Now Taneisha Scheuermann et al. in the journal Addiction (abstract here) examine the post-trial results, focusing on levels of cotinine, a nicotine breakdown product, in trial participants’ saliva. Hospitals in six cities provided 5,827 smoking patients with a variety of quit-smoking interventions.  Six months later, 4,206 of those subjects completed a survey, with 1,708 reporting that they had not smoked in the past seven days.  Nearly 10% of them reported using pharmaceutical nicotine, e-cigarettes or other tobacco harm reduction products in the past seven days; those subjects were among the 530 excluded from the Scheuermann analysis.  Self-described non-smokers were offered $50 to $100 in exchange for saliva samples, but only 923 participants responded; of those, 822 supplied usable samples. Scheuermann used a standard saliva cotinine cutoff of 10 nanograms per milliliter: participants below this level were considered to be not smoking, while those at or above were still smoking. Of the 822 participants who reported 7-day abstinence, 347 (42.2%) were dissembling, as their saliva cotinine levels indicated they were smoking.  That so many individuals failed to quit evidences a fact that tobacco prohibitionists often ignore: The vast majority of smokers are unable or unwilling to quit.  The 475 verified quitters constituted roughly 8% of the 5,827 patients who started the trials – a percentage that is consistent with the quit rate among the general population.  Also note that these smokers were recruited during a hospitalization, when their focus on health issues might have increased their motivation to quit. Treating smokers as social outcasts may influence their decision to lie about the results of their quit attempts. The CHART study was supported from 2009 to 2014 by five NIH grants costing taxpayers $15.5 million.      Original author: Brad Rodu
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Teen Smoking Unconnected to Cinematic Smoking


In a July report (here), the CDC Office on Smoking and Health asserted the following about tobacco use in movies: “The Surgeon General has concluded that there is a causal relationship between depictions of smoking in the movies and the initiation of smoking among young persons.” “…the decline in the total number of tobacco incidents [in top-grossing movies] has not progressed since 2010.” “Reducing tobacco incidents that appear in youth-related movies would prevent the initiation of tobacco use among young persons.” “An R rating for movies with tobacco use could potentially reduce the number of teen smokers by 18%...” Responding, Guy Bentley published an excellent commentary noting that any connection between smoking in movies and among teens is illusory (here).  I provide statistical evidence of this by analyzing the CDC report’s numbers together with smoking prevalence rates among high school seniors for the same years.  The resulting chart fails to support any of the above claims.  The number of tobacco incidents per year in top-grossing movies varied from 1,600 to 3,300 over 25 years, 1991-2016, except for a couple years around 2005.  Smoking among high school seniors plummeted continuously after 1996.  There appears to be no connection between the two data sets. The report clearly lacks objectivity.  It was authored by CDC staffer Michael Tynan; Jonathan Polansky, founder of the advocacy firm Onbeyond and creator of the Smokefree Movies campaign (here); Kori Titus and Renata Atayeva from Breathe California Sacramento Region (here), an organization that “…has been fighting for…tobacco-free communities [otherwise known as prohibition] since 1917…”; and Stanton Glantz, faculty member of the University of California, San Francisco, and long-time tobacco opponent.  Polansky, Titus and Glantz acknowledge grant support from the Truth Initiative as their only conflict of interest. Note that the tobacco incident numbers were collected by “Youth volunteers between the ages of 14-22… trained to analyze tobacco content in films…Their data is posted weekly on our sister website SceneSmoking.org and is used by university-level researchers and public health professionals across the globe….”  This underlying data does not appear to be publicly available.  The link to SceneSmoking was not functional and redirected to Breathe California Sacramento.   Original author: Brad Rodu
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Negligible Evidence of Radical Nicotine Reduction Benefit


An August 17 commentary in the New England Journal of Medicine (here) by FDA Commissioner Scott Gottlieb and Center for Tobacco Products Director Mitchell Zeller raises some concern about the agency’s new tobacco regulation strategy. The piece touches on “less harmful tobacco products,” which Commissioner Gottlieb wrote favorably about earlier (here), but it includes descriptors – “potential” (four times) and “conceivable” (once) – that suggest the authors are not convinced that e-cigarettes are truly lower-risk. Smokeless tobacco, already demonstrated to be vastly safer than cigarettes, isn’t mentioned. In their commentary, the FDA officials advocate for radical nicotine reduction (RNR) in cigarettes.  RNR is a variation on a failed concept: supply-side elimination of popular products.  Full-on cigarette prohibition was adopted, then jettisoned, in 12 states from 1899 to 1909 (here). During Prohibition a decade later, brewers tried to market an alcohol-free product called near beer (here).  That bombed just as badly as Vector Group’s RNR cigarettes in 2003 (here).  Any new RNR products will likely be rejected as well, causing smokers to seek out higher-nicotine-level products, licit or otherwise. Despite a significant expenditure of taxpayer dollars on RNR research, this approach has not been demonstrated to reduce adult smoking. For example, a $29 million clinical trial by Dr. Neal Benowitz, reported in 2015, produced dismal results (my review here). The FDA commissioner and his co-author remain optimistic: “A recent 6-week study by Donny et al. showed that cigarettes with lower nicotine content reduced nicotine exposure and dependence, as well as the number of cigarettes smoked, as compared with cigarettes with standard nicotine levels.”  They are referring to another 2015 report (here), but that study’s results were unimpressive as well. Dr. Eric Donny recruited 840 smokers uninterested in quitting, and randomly provided them with one of seven types of cigarettes to use for 6 weeks: their usual brand, a full-nicotine study cigarette and five others with varying low nicotine levels (2% to 33% of the full-nicotine cigarette).  Subjects were paid up to $835 for 10 clinic visits, which probably contributed to a 92% completion rate. While it was not surprising that smokers using reduced nicotine cigarettes had lower nicotine levels in their urine, most of the low-nicotine smokers (73-81%) admitted that they smoked three or four “wildcat” cigarettes (products not distributed as part of the study) on 24-35% of days in the trial. There was little consistency regarding changes in dependence.  On the Wisconsin scale, smokers in all groups had lower scores after six weeks than at baseline, with only one of the reduced nicotine groups significantly lower than the full-nicotine group.  On the Fagerström scale, three low-nicotine groups were significantly lower than the full-nicotine group, but the changes from baseline were not impressive.  In other words, it is not clear if the low-nicotine cigarettes reduced dependence. The number of cigarettes smoked in the Donny study is interesting.  At baseline, every group was smoking about 15 cigarettes per day.  Although Commissioner Gottlieb and Mr. Zeller imply that low-nicotine groups smoked fewer cigarettes at the end of the study, they actually averaged 15-16 cigarettes per day.  Smokers of usual-brand and full-nicotine cigarettes smoked 21-22 per day after six weeks, an increase of 6-7.  Perhaps Donny contributed to this increased consumption by providing full nicotine cigarettes for free. Like the Benowitz study, the Donny study does not prove that reduced-nicotine cigarettes produce meaningful benefits for smokers. It should be noted that the Donny study was supported by $93.3 million in grants from the National Institute on Drug Abuse and the FDA. Original author: Brad Rodu
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Government-Funded Researchers Continue to Misrepresent Smokeless Tobacco Cancer Risks


The American Journal of Epidemiology in October 2016 published a report by Annah Wyss of the National Institute of Environment Health Science and 20 government-funded coauthors.  It revealed that American men had ZERO mouth cancers associated with dipping or chewing tobacco (Odds Ratio, OR = 0.9), while women, who mainly use powdered dry snuff, had a 9-fold elevated risk (here).  After trying for several months to correspond with the authors, I wrote to the journal editor.  My letter was accepted, and the authors were invited to reply.  The journal published both items on August 4 (here). Here is my letter.  Because the references are important, I provide links to the sources. “In the article… Wyss et al. omit key information that would likely yield critical insights about their most important result. “Wyss et al. reported that ever use of snuff among never cigarette smokers was associated with head and neck cancer (OR = 1.71, [95% Confidence Interval] CI: 1.08, 2.70), based on 44 exposed cases and 62 exposed controls.  The OR among women ever snuff users (8.89, CI: 3.59, 22.0, based on 20 exposed cases and 12 controls) was an order of magnitude higher than that in men (0.86, CI: 0.49, 1.51, based on 24 exposed cases and 50 controls).  “The striking difference between women and men reflects completely different snuff exposures.  It is widely known that in the southern U.S. women primarily use powdered dry snuff, whereas men throughout the U.S. use moist snuff.  Powdered dry snuff use is associated with excess oral cancer risk in four previous studies (Reference 2), all of which were cited by Wyss (3, 4, 5, 6).  In contrast, moist snuff is associated with minimal to no risk in eight previous studies (2). “Wyss and colleagues are knowledgeable about the use of powdered dry snuff by women and its cancer risk; one was first author of a 1981 study reporting that “[t]he relative risk [for oral and pharyngeal cancer] associated with snuff dipping among white [women] nonsmokers [in North Carolina] was 4.2 (95 per cent confidence limits, 2.6 to 6.7).” (4)  Subjects in that study had exclusively used powdered dry snuff.   “Wyss et al. used pooled data from 11 US case-control studies located throughout the U.S.  They have information to confirm that the 20 female [powdered dry] snuff users with cancer were from study sites in the Southern U.S., whereas the 24 male [moist] snuff users were from more diverse locations.  This information is not available from the 12 publications cited by Wyss et al. as data sources.  Six publications had insufficient information about exposed and unexposed cases and controls (i.e. no specificity with respect to smokeless tobacco type, gender, and/or smoking), three reported no results related to any smokeless tobacco product and three did not mention smokeless tobacco at all. “Wyss et al. should provide in tabular form the number of exposed and unexposed cases and controls separately for never smoking men and women from each of the 11 source studies.  This information is routinely provided in publications of pooled analyses, and it is available in the existing data and results files.” In their response, Dr. Wyss and her coauthors provided additional results, per my request.  While they confirmed no risks among men who dip, their conclusion about women was grossly inaccurate: “Snuff use was strongly associated with elevated [head and neck cancer] risk in both Southern women…and non-Southern women.” In Southern women, the risk was quite high (OR = 11.25) and statistically significant, but with a wide 95% confidence interval (2.14 – 59.07), owing to the fact that the OR was based on only 26 cases.  In non-Southern women, the OR was even higher, at 15.91, but this was based on a mere 6 cases.  While statistically significant from a technical perspective (CI = 1.20 – 211.43), the CI is so large and unstable that the estimate is virtually meaningless. Dr. Deborah Winn of the National Cancer Institute knows that powdered dry snuff is the only smokeless product with mouth cancer risk (evidence here, here, hereand here); she published a study in 1981 that falsely implicated dip and chew.  Even though Dr. Winn co-authored the new report, the authors’ only comment on powdered dry snuff was, “we cannot comment on whether snuff users – female or male, Southern or non-Southern – in our analysis used dry or moist snuff.” To be clear, numerous studies since 1981 have demonstrated that the huge difference in mouth cancer risk between women and men is attributable to powdered dry and moist snuff.  Yet federally funded researchers continue to misrepresent these established facts in order to sustain the fiction that all smokeless products are hazardous.   Original author: Brad Rodu
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E-Cigarettes: The Case for Regulatory Restraint


Debate over FDA regulation of e-cigarettes often degenerates into bitter argument and ad hominem attack.  In contrast, a point/counterpoint presentation in the Journal of Policy Analysis and Managementis calm, thoughtful and enlightening. The case for stringent FDA regulation (citations here and here) is presented by Kurt Ribisl, a professor at the University of North Carolina, along with graduate students Andrew Seidenberg and Elizabeth Orlan (hereafter RSO).  Cornell University Professor Donald Kenkel makes the case for light regulation (here and here). Describing the problem – “Smoking is estimated to result in 480,000 deaths per year in the United States” – Kenkel underscores a death toll that has not changed in 20 years, despite increasingly harsh anti-smoking policies.  Tobacco prohibitionists frequently cite this horrid data, but they rarely support vastly safer alternative products like e-cigarettes, referred to by Kenkel as “perhaps the most revolutionary product innovation in the market…” Kenkel puts the risk differences in striking contrast.  He notes that if Britain’s health authorities are correct that vaping is no more than 5% as hazardous as smoking, then a world in which all smokers vape would suffer only 24,000 deaths attributable to e-cigarettes, compared to 480,000 actual deaths due to smoking.  This projection is similar to that in my 1994 publication (here), where I estimated 6,000 deaths among an imagined 46 million smokeless tobacco users – a mere 2% of the 419,000 actual deaths from smoking. RSO acknowledge that vaping is less risky than smoking, but they reject the 5% estimate, arguing that it “lacks empirical basis, as it came from a multicriteria decision analysis model developed from one meeting of 12 people. This type of expert opinion is at the bottom rung of the evidence hierarchy…”  That is true, but the North Carolinians offer no counter-estimate.  Kenkel suggests that even if the e-cigarette risk was as high as 10% as that of smoking – which is highly implausible, the result “would still be a revolutionary public health gain.” RSO “supports regulating e-cigarettes less stringently than combustible tobacco products,” however that position is not fully reflected in their policy recommendations.  As Kenkel notes, they still call for “restrictions on flavors, advertising and marketing restrictions, taxes, bans on indoor vaping, and mandatory product warnings.”  Using “the conceptual framework of economics,” Kenkel brings a refreshing perspective to e-cigarette use: “the key question is whether vaping and smoking are substitutes or complements… if they are complements, a policy that encourages vaping will increase smoking… If they are substitutes, a policy that encourages vaping will cause consumers to substitute vaping products for combustible cigarettes and thus reduce smoking.” Kenkel finds that “Accumulating evidence suggests that vaping is a substitute for smoking,” and he concludes: “Policies to encourage vaping could facilitate such a revolutionary change in the U.S. market for tobacco products.” Government and insurance incentives are worth considering, says Kenkel: “the benefits of reducing smoking could also justify a more activist policy approach. Taxing cigarettes and subsidizing a substitute good are alternative approaches to correct market and individual failures in the cigarette market. Many private and public health insurance plans provide generous coverage for one class of substitute goods—nicotine replacement products approved as smoking cessation aids. The same rationale might support subsidies for vaping products.” Observing that vaping is “an existential threat to the market for combustible cigarettes, unless their spread is restricted by government regulation,” Kenkel seems to be in sync with new FDA Commissioner Scott Gottlieb, who has signaled a lighter approach toward e-cigarette regulation. Original author: Brad Rodu
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