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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.

Weight Wisdom: Avoid Extremes, But Being “Over” May Have Benefits


A new CDC-released study by National Center for Health Statistics’ Dr. Katherine Flegal and colleagues (here) confirms results from her groundbreaking 2005 report (here): compared with people of normal weight (BMI = 18.5 to less than 25), those who are overweight (BMI greater than 25 but less than 30) have a lower mortality rate.  Higher mortality rates are seen with obesity (BMI greater than 30) and underweight (BMI under 18.5).     Applying weight-based mortality rates to the U.S. population, Flegal estimated in 2005 that overweight resulted in 82,094 fewer deaths, and a significant number of excess deaths were associated with obesity, a (n = 111,909) and underweight, (n = 33,746).  As I noted in this blog five years ago (here), Flegal’s conclusions are consistent with those of many other scientific studies.  I have long had a professional interest in population research on weight and health. In 2004, I published the first study to show that Swedish men who quit smoking by switching to snus avoided the weight gain usually seen with smoking cessation (abstract here).  In 2015, my research group analyzed data from the National Health and Nutrition Examination Surveys to demonstrate that changes in population smoking do not contribute significantly to changes in population overweight and obesity.  (BMC Obesity article available here). The impact of weight on life expectancy is clear: Those who are underweight or severely obese are at risk of dying prematurely, while mere overweight is associated with a lower mortality rate.Original author: Brad Rodu
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Vapers: Tell the FDA You’re Not Merely An Anecdote!


A year and a half ago, I blogged about government agencies ignoring federal survey data showing that 2.5 million former smokers were current vapers (here).  When FDA tobacco center director Mitch Zeller dismissed this evidence as mere “anecdotal reports,”  I argued that such data constitutes legitimate population-level evidence. Aiming to build a fresh dataset on smokers’ success in using vapor as a quitting aid, the Vapor Technology Association (VTA) and Consumer Advocates for Smoke-Free Alternatives (CASAA) just launched a national campaign called “I Am Not An Anecdote” (here). The groups are asking vapers to submit to the FDA detailed, sworn statements to “encourage Congress and federal regulators to reject any proposal that would ban OR limit flavored e-liquid products.” The groups note that “FDA Commissioner Scott Gottlieb has said that your ‘personal stories are important to me.’  But, he also refers to your stories of quitting cigarettes with vapor products as ‘anecdotes.’” While individual cases are, in scientific terminology, anecdotal, their cumulative value is considerable.  Vapor is replacing combustion at dramatic rates worldwide.  My research team used 2013 FDA-funded survey data to produce a peer-reviewed report on U.S. e-cigarette use (hereand here).  Our analysis showed that e-cigarettes are the most popular quit-smoking aid among American smokers and that they are the only aid more likely to make them former smokers (i.e., successful quitters) than are cold-turkey attempts (here). FDA should give weight to published studies, even when they do not conform to visions of a tobacco-free society.  The agency should also recognize the scientific value of mass declarations of smoking cessation accomplished through vaping substitution. Original author: Brad Rodu
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American Cancer Society’s Combustible Tobacco Statement Contains Falsehood


The American Cancer Society’s new position statement offering a “bold new framework” for eliminating combustible tobacco use in the U.S. (here) contains a demonstrably invalid statement: “Cigarette smoking is the leading cause of cancer mortality in the United States (1), accounting for as much as 98% of all tobacco-related deaths (2) [emphasis added]. The problem with the highlighted phrase is that no estimate of “all tobacco-related deaths” in the U.S. has ever been produced by the government, academia or health organizations.  The percentage of deaths attributable to smoking, while undoubtedly large, is simply not known. In reference 2 above, ACS attributes the false assertion to a New England Journal of Medicine article by tobacco researchers Michael Fiore, Steven Schroeder and Timothy Baker (here).  That article made virtually the same statement and cited a citizen petition submitted to the FDA in 2010 by Dr. Joel Nitzkin on behalf of the Tobacco Control Task Force of the American Association of Public Health Physicians (here).  Careful review of the Nitzkin filing reveals nothing to support the ACS or NEJM claim. This falsehood can be corrected.  With some effort, the very small number of deaths from smokeless use and cigar/pipe smoking can be estimated from large federal datasets.  Government researchers and the ACS have the resources and should make this a priority, in order to provide a scientific foundation for FDA tobacco regulation. Fabrication, or repetition of false statements, particularly by trusted authorities, organizations, and public figures, can result in widespread acceptance of myth as truth. Such cavalier inattention to fact is not acceptable in scientific discourse or public health policymaking, where actual lives are at stake (here). Original author: Brad Rodu
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American Cancer Society Sees Zero Cancer Risk for Smokeless Tobacco


A June 11th American Cancer Society policy paper (here) states that the Society will “focus on the primary goal of ending deadly combustible tobacco use… Given this imperative, ACS will provide smokers and the public with clear and accurate information available on the absolute and relative health impact of combustible tobacco products, nicotine-based medications, [electronic nicotine delivery systems] and other novel tobacco products…ACS will increase its efforts to guide smokers toward evidence-based cessation options that enable them to quit as quickly as possible and eliminate their exposure to combustible tobacco smoke.” ACS researchers have estimated the number of cancer cases and deaths attributable to potentially modifiable risk factors in the United States (available here).  They identified 17 risk factors causing 660,000 cases of cancer.  Cigarette smoking was the primary cause (responsible for nearly 300,000 cases), while herpes virus type 8 produced the fewest cases (1,040).  Smokeless tobacco was not among the 17 risk factors – a tacit acknowledgment that the risk of cancer from smokeless tobacco is de minimis.  Taking this position, ACS seems to be abandoning its 30-year crusade against tobacco harm reduction. Over the years, I have noted in this blog how ACS failed to provide smokers and the public with clear and accurate information about smokeless tobacco.  Rather, it exaggerated risks (here, hereand here); withheld risk information (here, here, hereand here); and criticized the British Royal College of Physicians’ harm reduction report (here).  ACS describes its new stance on eliminating combustible tobacco use as a “bold new framework for action.”  The policy paper indicates a shift to cautious support of e-cigarettes, conceding that “although the long-term effects of [e-cigarettes] are not known, current-generation [e-cigarettes] are markedly less harmful than combustible tobacco products.” In fact, the long-term effects of smokeless tobacco use are known to be next to nil.  I hope ACS follows with bold new action explicitly acknowledging that dip and chew products are vastly safer than cigarettes.  Original author: Brad Rodu
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FDA Aims at Wrong Target in Effort to Protect Teens


FDA Commissioner Scott Gottlieb has again mistakenly blamed e-cigarette companies for teen vaping.  Addressing the American Society of Clinical Oncology, Dr. Gottlieb issued a direct threat: “They better step up and step up soon – to address these trends along with us.  So far, I must say, I’ve mostly been disappointed by the tepid response from companies that know that a meaningful portion of their sales are being derived from kids.  The e-cig companies have a chance to do something about it.  The window is open. But it won’t be open for very long.” (here)  The commissioner also tweeted about “additional regulatory policy measures and new enforcement actions as part of our ongoing campaign.” (here)  FDA survey data show that Dr. Gottlieb’s concern is misplaced.  The charge that “a meaningful portion” of e-cigarette sales are made to children is undermined by a 2014 FDA survey: of 12.9 million adult (here) and 770,000 teen current e-cig users (here), only 9.9% of teens had bought their own e-cigs.  The 76,000 teens who purchased products from retailers accounted for only 0.5% of all users and an even smaller fraction of all sales.  The fact that over 90% of teens obtained e-cigarettes from social sources, such as friends or family, makes “policy measures and new enforcement actions” against retailers entirely misguided.  It is illogical for the FDA to hold retailers responsible for teen e-cigarette use.  The federal government has pursued the elimination of tobacco sales to children for decades.  Beginning in 1997, Washington required states to report underage sales via the Synar Program (here).  The latest Synar data shows that 9.6% of retailers were noncompliant in 2013.  The FDA also conducts compliance checks of tobacco retailers.  In 2016, the FDA reported a noncompliance rate of 11% (here).  The FDA should focus on this far more dangerous illegal cigarette sales issue, rather than obsessing over e-cigarettes.  Bad actors – that small percentage of retailers who sell e-cigarettes to children – should be punished, but their infractions should not cause the entire vaping industry to suffer undue, overly broad sanctions. Were government officials to truly prioritize teen safety issues, alcohol would be their number one target.  One-third of high school seniors drank in the past 30 days last year, and nearly 1 out of 5 were drunk (here), even though the legal age for alcohol purchase is 21.   Demonizing e-cigarettes and their marketers and retailers may generate easy headlines, but real public health gains require data-based prioritization of threats, and for teens, those are alcohol and cigarettes. Original author: Brad Rodu
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Smoking Cessation Clinical Trials…and Tribulations


The medical establishment has transformed a behavior, cigarette smoking, into a disease, and now defines how smoking should be “treated” and “cured”. The ramifications of this scheme were laid bare last week in a New England Journal of Medicine report on a smoking cessation clinical trial (here).  The article, “A Pragmatic Trial of E-Cigarettes, Incentives, and Drugs for Smoking Cessation,” demonstrated one important fact:Clinical trials are awful for assessing human behaviors and preferences like smoking.The authors, mostly from the University of Pennsylvania, enrolled 6,006 smokers employed at 54 companies and gave them “usual care”, consisting of wellness website links and information about the National Cancer Institute’s free text-messaging program, plus one of four “treatments”:1.     Free medicines, including nicotine, bupropion and varenicline, plus free e-cigarettes “if standard therapies failed;”2.     Free NJOY e-cigarettes;3.     A reward of up to $600 if smokers stayed abstinent, plus number 2 above; or,4.     A deposit account up to $600, plus number 2 above.Here are the results:.nobr br { display: none } td { text-align: center} “Treatment” Groups and Successful Quitting at 6 MonthsTreatment (number)Number (%) of Successful QuittersUsual Care (813)1 (0.1%)Free Medicines (1,588)8 (0.5%)Free E-cigarettes (1,199)12 (1.0%)$600 Reward (1,198)24 (2.0%)$600 Deposit (1,208)35 (2.9%)All (6,006)80 (1.3%)In all, only 1.3% of smokers quit, ranging from 0.1% with usual care, to 2-3% for those given financial incentives.  In the study, which lasted only six months, the best “treatment” had a 97% failure rate.  After a full year, the standard period for such trials, one could expect percentages to be even lower.  While the futility of using clinical trials to gauge smoking cessation has been demonstrated repeatedly, medical research and regulatory authorities still demand clinical trial proof – the medical treatment standard – for the benefits of switching from combustible cigarettes to smoke-free products.  Just as common sense tells us that a hammer can’t be used to fasten a screw, the medical community should acknowledge that clinical trials can’t be used to assess smoking cessation. The reason is simple: smoking is not a disease.  Most smokers don’t want treatment, cure, nagging or ostracism. They want information about the full suite of their options, including abstinence and all forms of tobacco harm reduction.  In publishing this uninformed study, The New England Journal of Medicine’s authors and editors demonstrate that the illness-treatment-cure model of smoking is erroneous and completely uninformative.  The medical/public health community needs to embrace population evidence from the FDA survey proving that smokers are quitting with e-cigarettes (here). Original author: Brad Rodu
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Kentucky Adopts a Rational Tobacco Tax Plan


Last month, the Kentucky legislature overrode Governor Matt Bevin’s veto and passed HB366 (here), a tax reform bill that increased cigarette excise taxes from $0.60 to $1.10, while leaving taxes on smokeless products unchanged and leaving e-cigarettes with no excise tax. This policy mirrors the tax plan that my research group designed (here) – one endorsed by 16 tobacco research and economic policy experts from across the nation, and by the Pegasus Institute (here).  Watch my interview with Nick Storm of Spectrum News here to learn more. Enacting this plan, legislators rejected demands from anti-tobacco crusaders to double the cigarette tax increase and make vastly safer smokeless and e-cigarettes equally expensive.  One of their spokesmen, Foundation for a Healthy Kentucky president Ben Chandler, had argued, “you’ve got to have the sticker shock…” (here) That reasoning is both insensitive and nonsensical.  Many Kentucky smokers are unable or unwilling to quit tobacco and nicotine entirely.  For them, traditional quit-smoking methods, which strive for nicotine and tobacco abstinence, don’t work.  Our tax plan encourages and incentivizes smokers to quit or switch to less expensive and vastly safer smoke-free tobacco products, including smokeless tobacco and e-cigarettes.  Decades of epidemiologic studies document that the health risks of dipping and chewing tobacco are, at most, a mere two percent of those associated with smoking.  Unlike cigarettes, smokeless tobacco does not cause lung cancer, heart and circulatory diseases or emphysema.  A recent study conducted by federal researchers and experienced epidemiologists found that men who dip or chew tobacco have no excess risk for mouth cancer (here).     Our plan also encourages smokers to switch to e-cigarettes, which already are among the most common – and most successful – quit aids in the U.S. (here).  HB366 contains another provision favoring reduced risk products.  Kentucky excise taxes will be reduced by half for products that are permitted by the FDA to be marketed as “lower risk.”  Reduced risk applications have already been filed with the FDA for three products: IQOS heat sticks, Camel Snus and Copenhagen moist snuff.  Science tells us that all of these are vastly safer than cigarettes.  The question is: When will the FDA acknowledge this indisputable fact? Original author: Brad Rodu
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Tobacco Research Is Not Immune to Scientific Scrutiny


Recently, the authors of a research article on e-cigarettes groundlessly attacked my credentials and academic independence after I noted, in a letter to journal editors, a lack of scientific rigor in their reporting. The article falsely claimed that e-cigarette use caused experimental smokers to become regular smokers.  In response to my critical remarks, the authors made these charges in their own letter to the editors: “This recent comment is another in a long series of letters or comments from Dr. Rodu…in which he has criticized research that is inconsistent with the tobacco industry’s interests in promoting e-cigarettes and smokeless tobacco.” As an academician, I have both authored articles and scrutinized tobacco research for many years, advising journal editors on those occasions when I found factual deficiencies in published articles.  This effort has served the interests of science and the pursuit of truth. Professional medical journals position themselves as platforms for the publication of honest, transparent, reproducible research.  In an effort to identify inaccuracies and other defects, submissions are subjected to review by editors and multiple external authorities who are experts in relevant fields. Over the last 24 years, in addition to my authorship of 54 peer-reviewed articles for medical and scientific journals (here), I have had 11 letters of scientific criticism published in leading journals, linked below.                1.  Rodu B, Cole P.  Excess Mortality in Smokeless Tobacco Users Not Meaningful.  American Journal of Public Health85:118, 1995. 2. Rodu B, Cole P. Smokeless Tobacco and Periodontal Disease. Letters to the Editor. Journal of Dental Research84:1086-1088, 2005. 3. Rodu B, Cole P. A deficient study of smokeless tobacco use and cancer (letter).  International Journal of Cancer 118: 1585, 2005. 4. Rodu B. Snus and the risk of cancer of the mouth, lung, and pancreas.  Lancet 370: 1207, 2007. 5. Rodu B.  Smokeless tobacco: Society response debatable (electronic letter).  CA: A Cancer Journal for Clinicians 2008; 58.  6. Rodu B, Heavner KK.  Errors and omissions in the study of snuff use and hypertension (letter).  Journal of Internal Medicine 265: 507-8, 2009. 7. Rodu B, Heavner KK, Phillips CV.  Snuff use and stroke (letter).  Epidemiology 20: 468-9, 2009. 8. Rodu B.  Dual use (letter).  Nicotine & Tobacco Research 13: 221, 2011. 9. Rodu B, Plurphanswat N, Phillips CV.  Discrepant results for smoking and cessation among electronic cigarette users (letter).  Cancer 2015 Mar 4. doi: 10.1002/cncr.29307. [Epub ahead of print] 10. Rodu B, Phillips CV.  Regarding “Discontinuation of Smokeless Tobacco and Mortality Risk after Myocardial Infarction” (letter).  Circulation 2015 Apr 28;131(17):e422. doi: 10.1161/CIRCULATIONAHA.114.012038. 11. Rodu B.  Re: Smokeless tobacco use and the risk of head and neck cancer: pooled analysis of US studies in the INHANCE consortium.  American Journal of Epidemiology2017  DOI: 10.1093/aje/kwx211 All scientific research should be subjected to rigorous objective review. On those occasions when pre-publication editorial and peer review fail to identify deficiencies, honest criticism should be encouraged and acknowledged by offending publications. Original author: Brad Rodu
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Pediatrics Editors Claim Compliance with – But Instead Violate Publication Ethics Guidelines


In previous blog posts I described how Pediatrics editors refused to retract a fatally flawed study by University of California San Francisco authors (hereand here).  I also described how they allowed publication of unsubstantiated ad hominem attacks, then tried to cover them up by scrubbing the journal website (here).  Carl Phillips afforded the editors a chance to account for their unprofessional actions in an article at The Daily Vaper (here).  They responded by saying that their actions were consistent with the Committee on Publication Ethics (COPE) guidelines for journals.  This is demonstrably false.  The editors violated three of the guidelines (available here). The COPE guidelines say that “Editors are accountable and should take responsibility for everything they publish.”  However, instead of taking responsibility for publishing an ad hominem attack, they simply erased the attack from the Pediatrics website with no retraction or apology (here).  To make matters worse, they also deleted another comment by Bates and colleagues (here), which violated another COPE principle: “Editors should adopt editorial policies that encourage maximum transparency and complete, honest reporting.” Carl Phillips described another instance of zero transparency: “During the dispute over the comments, the editors informed Rodu that they were commissioning an independent ‘expert’ review of the dispute. Clearly there was no genuinely expert review, because that would have concluded that Rodu was right and Chaffee’s comment was nonsense. The editors did not post the review to the comments thread, as they should have, and refused a request by The Daily Vaperto see a copy of it.” Finally, as Phillips and I have documented in detail, the Pediatrics editors violated a third principle: “Editors should guard the integrity of the published record by issuing corrections and retractions when needed and pursuing suspected or alleged research and publication misconduct.” The original manuscript from Benjamin W. Chaffee, Shannon Lea Watkins, and Stanton A. Glantz was never retracted after it was clearly demonstrated to be deficient, and the Pediatricseditors – Drs. Lewis First (University of Vermont), Alex Kemper (Nationwide Children’s Hospital, Columbus Ohio) and Mark Neuman (Harvard) – are guilty of publication misconduct. Original author: Brad Rodu
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Pediatrics Journal Ignores Its Stated Editorial Standards


The journal Pediatricsin March published an article by University of California San Francisco’s Benjamin Chaffee, Shannon Lea Watkins and Stanton Glantz claiming that e-cigarettes lead to smoking. The claim was baseless; the authors ignored subjects’ past smoking activity, as I explained in an earlier blog post (here). On March 15, I submitted a comment to the journal with a re-analysis of Chaffee’s data using the omitted variable and demonstrating the invalidity of Chaffee’s claim.  On the basis of this flaw, I requested retraction of the article.  Our comment was published on the Pediatrics website March 30, along with a response from Chaffee et al. that further validated a retraction (here).  Their response included an attack on my independence, veracity and transparency.  Clive Bates, David Sweanor, David Abrams and Raymond Niaura endorsed our analysis in an April 11 comment, labeling Chaffee’s response “inadequate, disappointing and surprising.”  They pointed out that it was “disappointing because the authors, apparently with the approval of the journal, have resorted to an ad hominem attack on Rodu and without showing any improper conduct or incomplete disclosure.”  I had responded to the attack by Chaffee et al. with an email to the Pediatrics editors on April 9: “Chaffee et al. stated that my ‘financial ties to the tobacco industry are much more extensive than the posted disclosures suggest.’ This is false, defamatory and potentially libelous on two accounts, alleging that I made an inadequate disclosure, and that I have more ‘financial ties.’ My disclosure was accurate and complete. In addition, the website they cited contains no supporting evidence for their allegation, because I have no other financial ties or conflicts of interest. The journal has specific policies prohibiting both defamatory/libelous comments and weblinks. These policies also provide guidance for your immediate attention to this matter.” (here) On or about April 24, Pediatricspublished a revised response from Chaffee et al.  Their fictitious claims about “financial ties” had disappeared, but the revised text carried the same date as the authors’ original comment.  The editors failed to indicate a correction had been made, and that erroneous and disparaging remarks had been removed.  The editors had allowed the libelous statements to remain on the journal site for nearly a month; the offending remarks are still available elsewhere on the Internet (here). The editors violated the journal’s stated policy: “Once a comment has been posted on the website, you will not have the right to have it removed or edited… Be sure to follow all of the consideration criteria below; you will not be able to modify your comment after submission.” (emphasis in original) Compounding this journalistic failure, the editors encouraged Clive Bates and colleagues to edit their published comment and delete language countering Chaffee et al.’s defamatory remarks.  When Bates did not immediately comply, the editors deleted the entire Bates comment.  However, it is still available here. Journal editors Drs. Lewis First (University of Vermont), Alex Kemper (Nationwide Children’s Hospital, Columbus Ohio) and Mark Neuman (Harvard) owe Pediatrics readers full compliance with their journal’s editorial standards, including a detailed correction notice and republication of the full text of the Bates et al. comment. Original author: Brad Rodu
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Poison Control Centers' Data Puts E-Cigarette Exposure Risk in Perspective


The journal Pediatricsrecently reported that “there were more than 8,200 calls to US poison centers regarding exposures to liquid nicotine and e-cigarettes among children younger than 6 years of age from January 2012 through April 2017, averaging 129 calls each month or more than 4 a day.” (here) As I previously noted (here), annual exposures (which were 1,548 according to the Pediatrics article) should be considered in appropriate perspective.  While the journal article acknowledged that e-cigarette exposures “decreased by about 20% from 2015 to 2016,” its senior author called for additional regulation.  If children’s exposure to products should guide regulatory priorities, the following chart from the American Association of Poison Control Centers (2016 report available here) may be instructive..nobr br { display: none } td { text-align: center} Non-Pharmaceutical Exposures Reported To Poison Control Centers in the U.S., 2016Product CategoryNumber Among Children Under 6 YearsNumber Among All AgesDeaths Per 100,000 Exposures*Cosmetics, personal care products136,004180,0653Household cleaners111,445179,82813Foreign bodies65,86490,6671Pesticides33,45877,57322Plants27,56545,15024Arts, crafts, office supplies20,09627,3190Deodorizers17,39821,26614Essential oils (clove, etc.)13,26418,9970Tobacco11,35813,3190Cigarettes6,3316,699--E-Cigarettes2,0752,827--Chewing tobacco1,2201,357--Other1,7322,436--Foods, additives, spoilage10,83933,9099Alcohols9,56222,289117Chemicals9,32833,91080Gasoline, other hydrocarbons8,82127,80776Bites, venom6,70846,98915Paint, strippers6,60112,2380Batteries5,4839,65141Adhesives, glue4,6929,6220Fumes, vapors3,67331,337214Fertilizers2,7594,59080Other35,85994,02444All540,777980,55026* All AgesOf the half million exposures among children under 6 years of age recorded by poison control centers in 2016, 45.8% involved cosmetics, personal care products or household cleaners, while e-cigarettes accounted for just 0.4%.  Looking at product-related deaths per 100,000 exposures, rates were highest for fumes and vapors (which included carbon monoxide) and for alcohols, but there were no deaths recorded for tobacco exposures, including e-cigarettes.Public health generally and children’s health in particular may benefit from regulatory reform that is keyed to demonstrated risk exposure.Original author: Brad Rodu
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The urge to ban: 10 questions to ask first

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Original linkOriginal author: Clive Bates
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FDA Blocks Consumer Access to New Smokeless Products


When Congress gave the FDA regulatory authority over tobacco in 2009, it specified that manufacturers wanting to sell a new product must get a “substantial equivalence” (SE) order demonstrating to the FDA that the product has the “same characteristics as a predicate tobacco product [i.e. on the market before February 15, 2007]; or has different characteristics than the predicate tobacco product but…does not raise different questions of public health.” (here) Copenhagen brand moist snuff has been available in the U.S. since 1822.  The U.S. Tobacco Company (UST) had 17 different styles of the brand, including 5 pouches and 4 with wintergreen flavoring on the market in 2007. It's worth examining UST's SE application submitted on November 13, 2015 for a variant to be called Copenhagen Bold Wintergreen Pouches.  According to the Troutman Sanders law firm blog (here): “The Copenhagen Bold [WG Pouches] SE submission compared the new product, a portioned smokeless tobacco in pouches with a grandfathered product in the same format (pouched smokeless tobacco) but containing different tobacco.  UST had considered using a different grandfathered product – a loose tobacco product with the exact same blend and formula as Copenhagen Bold – but the FDA discouraged UST from doing so because the grandfathered product was in a different format.  At the FDA’s suggestion, UST designated the grandfathered loose tobacco product with the exact same tobacco blend and formula as Copenhagen Bold as a ‘surrogate’ product.” Despite the company’s acquiescence in using its loose wintergreen snuff as the predicate product, the FDA denied the SE on July 13, 2017.  UST’s appeal of that decision was denied by the agency on January 2, 2018. The company sued the FDA on February 2, seeking to overturn the agency’s action. The filing is available here. This lengthy, so far futile attempt to gain marketing approval for a simple variation of a moist snuff product that is associated with nearly zero health risks underscores the broken state of the FDA review process. To be clear, my criticism of FDA is not intended to further the interests of any company, but rather to advance the health interests of American smokers who should be encouraged to switch to safer smoke-free cigarette substitutes. Limiting the market entry of potentially attractive cigarette alternatives reduces the chance that smokers will give up their dangerous habit. Original author: Brad Rodu
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FDA Is Targeting E-Cigarette Retailers, But They’re Not Teens’ Primary E-Cigarette Source


FDA Commissioner Scott Gottlieb reportedlytestified at a House Appropriations subcommittee April 17 about “excessive use of e-cigarettes among youths…Gottlieb said the FDA will crack down on youths' use of e-cigarettes in the coming weeks.  ‘We are going to take some vigorous enforcement steps to try to perceive what we see is inappropriate use by youth,’ Gottlieb said, refusing to elaborate on when the action will happen.  The agency has several avenues for targeting retailers that are selling to minors.  Those include a warning letter, massive fines, or banning the retailer from selling any tobacco or e-cigarettes.”A common theme among e-cigarette prohibitionists is that the protection of children justifies all forms of regulation.  Beyond that, the commissioner’s remarks are undercut by the fact that only a small percentage of children have tried e-cigarettes, and only a tiny fraction of those youths bought c-cigarettes from retailers.  Support for this is seen in the FDA’s Population Assessment of Tobacco and Health (PATH) survey.  The PATH youth survey collected detailed information about tobacco use from 13,628 participants age 12-17 years in 2013-2014.  Based on the survey’s sophisticated weighting formula, the figures below are estimates for 25 million teens across the U.S.The data reveal that about 2.6 million teens had ever used an e-cigarette in 2013-14.  Of these, about 771,000 had used e-cigarettes in the past 30 days – the widely accepted definition of “current” use among youth and consistent with another federal survey of teen tobacco use (discussed here).  This means that there were far fewer current e-cig users in PATH than currently used alcohol (1.83 million) or marijuana (1.24 million), which is also consistent with other federal surveys (discussed here).Current e-cig users were asked: “In the past 30 days, how did you usually get your own e-cigarettes/cartridges and e-liquid?”  Here are the results:.nobr br { display: none } td { text-align: center} PATH Survey: How Did You Get Your E-Cigarettes?HowNumber of teensPercentageSomeone offered me one353,70046%Gave someone else money to buy them126,50016%Bought them myself75,7009.9%Asked someone to give me one73,7009.7%Got them some other way52,5006.9%Took them from a store or another person31,6004.1%Bought them from another person24,7003.2%Don’t know, refused to answer32,4004.2%All770,800100%The table shows that only 10% of current teen users, about 76,000, bought e-cigarettes for themselves.  In other words, while the FDA and other government agencies pursue vaping manufacturers and retailers, the vast majority of teens get e-cigarettes from unregulated sources.  Of course, even more teens use alcohol, which is only sold to adults age 21+ years, and marijuana, the sale of which is legal to adults only in limited states.Original author: Brad Rodu
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Another UC San Francisco E-Cigarette Gateway Claim, Based on Tiny Numbers


Last week I called for retraction of a flawed study by University of California San Francisco’s Benjamin W. Chaffee, Shannon Lea Watkins and Stanton A. Glantz that appeared in the journal Pediatrics (hereand here).  Once again using the FDA Population Assessment of Tobacco and Health (PATH) survey, the same authors exaggerated the gateway effect of e-cigarettes, hookah and smokeless tobacco in a January JAMA Pediatrics article (here).  I criticized at that time the omission of information that would have provided context for their findings (here).  The exaggerations were amplified in the media.In an interview with National Public Radio (here), Dr. Watkins failed to note the minuscule numbers used in her study to support the gateway claim.  I have inserted those numbers in bold in her quote, here:“We found that kids who tried e-cigarettes [n=11] or hookah [n=8] or smokeless tobacco [n=3]or cigars [n=7] – any noncigarette tobacco product – were all twice as likely to try cigarettes a year later compared to kids who hadn’t used any of those other tobacco products [n=175].  Kids who were using two or more noncigarette products [n=15] were four times as likely to report using cigarettes a year later.” (I have confirmed these numbers in the FDA data; they are in the table below)Dr. Watkins added the extraordinary claim that trying one tobacco product changes one’s perception of cigarettes: “Using these products might change a kid’s perception of the harm of cigarettes, and so they are perceived as less dangerous and they get used to using tobacco and so using conventional cigarettes is not so scary or ‘bad’.”In her view, trying a tobacco product causes one to change friends: “It will expose them to different kinds of kids, maybe kids that are already using conventional cigarettes, and then they might go on to try them.”Instead of sharing her conjecture on how e-cigarettes led 11 children to begin smoking, Dr. Watkins should have focused on the fact that 80% of the 219 new smokers [n=175] in her study had not previously used any tobacco product..nobr br { display: none } td { text-align: center} Odds Ratios And Numbers of Teens Smoking Cigarettes After One Year, According to Ever Tobacco Status at BaselineEver Tobacco Status- Baseline (n)Odds RatioNumber Smoking At One Year (%)Never tobacco use (9,058)Referent175 (79.9)E-cigarettes (255)2.1211 (5.0)Hookah (189)2.158 (3.7)Other combustible (114)3.087 (3.2)Smokeless tobacco (93)1.533 (1.4)Two or more products (200)3.8115 (6.8)All (9,909)219 (100)Original author: Brad Rodu
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The US media is losing its mind over vaping and Juul – the questions a credible journalist should ask


April 9th, 2018

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Ten perverse intellectual contortions: a guide to the sophistry of anti-vaping activists







This puts it nicely:

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UC San Francisco Authors Inadvertently Validate Our Call for Retraction



In the previous post I described fatal flaws in a study by University of California San Francisco’s Benjamin W. Chaffee, Shannon Lea Watkins and Stanton A. Glantz in the journal Pediatrics(here).  Their published response (here) validates my criticism. Chaffee et al. correctly observed that I have frequently challenged flawed research, and they kindly provided three examples of my published letters to editors of scientific and medical journals.  My professional blog is replete with fact checks of published claims by federal officials (here, here, here, here, here, here) and government-funded researchers (here, here, here, here, here, herehere, here) that e-cigarettes are a gateway to teen smoking.  My criticism has extended to research published by UCSF faculty (here, here, and here) The recent Pediatricsanalysis by Chaffee et al. showed that teen e-cigarette users in the Wave 1 FDA Population Assessment of Tobacco and Health (PATH) survey had higher odds of consuming 100+ cigarettes or past 30-day smoking one year later at follow-up.  I noted that the authors ignored important information about lifetime cigarette consumption (LCC), from as little as “1 puff but never a whole cigarette” all the way to having smoked 99 cigarettes.  When my research team applied LCC data to Dr. Chaffee’s analysis, his positive results for an e-cigarette “gateway” essentially disappeared.  In response, Chaffee et al. called our addition of the LCC information a “statistical trick.”  By using that term, it appears that they believe, incorrectly, that the LCC variable is an outcome rather than a confounding factor.  Inexplicably, they described our analysis as “akin to suggesting that a study of hypertension should adjust for confounding by systolic blood pressure.”  In this, Chaffee et al. prove our case.  Let’s say we are studying the effect of dietary salt consumption on development of hypertension (systolic blood pressure, bp >140 mm) after one year of follow-up among participants who were not hypertensive at baseline (that is, they had a systolic bp = 90 to 139 mm).  If someone has a baseline bp of 139 mm, it is much more likely that they will have a bp of >140 mm after one year, compared to a person who had a baseline bp of 90.  It would be negligent to blame salt for causing hypertension while completely ignoring baseline systolic bp values in this example.  The same principle applies to Dr. Chaffee’s e-cigarette study.  The chart below clearly illustrates the large differences in LCC that Chaffee et al. ignored between never e-cigarette users and past 30 day users or triers. It is negligent to ignore cigarette consumption at baseline while placing all the blame for smoking one year later on e-cigarette use.  The Chafee article must be retracted.  Original author: Brad Rodu
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Retract the UC San Francisco E-Cigarette “Gateway” Study


Some published articles are so flawed that they deserve retraction.   A case in point is the Pediatrics article by University of California San Francisco's Benjamin W. Chaffee, Shannon Lea Watkins, and Stanton A. Glantz (here) that features a totally baseless claim: “Among adolescent cigarette experimenters, using e-cigarettes was positively and independently associated with progression to current established smoking.”  Using Wave 1 of the FDA Population Assessment of Tobacco and Health (PATH) survey, Chaffee et al. define teen experimental smokers as having smoked “in your entire life” anywhere from “1 or more puffs but never a whole cigarette” up to 99 cigarettes.  They divide experimental smokers into three groups according to e-cigarette use: never users, past 30-day users and ever triers.  In their analysis, controlling for numerous variables, e-cigarette users at Wave 1 had higher odds of having consumed 100+ cigarettes or having smoked in the past 30 days at follow-up one year later. The findings and the claim are false. In their analysis, the authors ignore the fact that their study group consisted entirely of experimental smokers with widely varied experience – one or more puffs but never a whole cigarette, one cigarette, 2-10, 11-20, 21-50 and 51-99 cigarettes.  Using the PATH data, my research team reproduced Chaffee’s analysis and Pediatrics published our results online (here).  The table we submitted to the journal was published in an unreadable fashion, so we offer it here..nobr br { display: none } td { text-align: center}Odds Ratios (95% Confidence Interval) for Smoking Outcomes in the Wave 2 PATH Survey, According to E-Cigarette Use at Wave 1MetalChaffee’s ResultsBR-NPBR-NP + Wave 1 LCCOutcome: Smoked 100+ CigarettesNever E-CigReferentReferentReferentE-Cig Past 30 Days2.56 (1.58 – 4.14)2.60 (1.61 – 4.19)1.21 (0.69 – 2.13)E-Cig Trier2.13 (1.43 – 3.18)2.16 (1.46 – 3.22)1.45 (0.88 – 2.38)Outcome: Smoked Past 30 DaysNever E-CigReferentReferentReferentE-Cig Past 30 Days2.29 (1.64 – 3.19)2.12 (1.52 – 2.96)1.41 (0.998 – 2.00)E-Cig Trier1.56 (1.15 – 2.12)1.43 (1.05 – 1.95)1.09 (0.78 – 1.52)Outcome: Smoked 100+ Cigarettes and Smoked Past 30 DaysNever E-CigReferentReferentReferentE-Cig Past 30 Days2.56 (1.52 – 4.32)2.55 (1.51 – 4.31)1.32 (0.75 – 2.30)E-Cig Trier2.41 (1.46 – 3.97)2.45 (1.49 – 4.03)1.70 (0.96 – 3.01)BR-NP, Rodu-Plurphanswat reproduction of Chaffee et al. odds ratios  When we added lifetime cigarette consumption (LCC), the positive results for e-cigarettes essentially disappeared, negating Chaffee’s core claim.  It is well established that past smoking (in this case, LCC at Wave 1) predicts future smoking (one year later).  Chaffee, Watkins and Glantz ignored this information in order to claim that e-cigarettes are a gateway to smoking.  Their study should be retracted.   I will review in my next post Chafee’s published response to our comment. Original author: Brad Rodu
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Instead of Greenlighting IQOS Sales, FDA Continues to Slow-Walk Safer Cigarette Substitutes


The introduction of heat-not-burn cigarette substitutes in Japan has led to a precipitous reduction in cigarette consumption.   Tobacco industry analyst Michael Livery of Piper Jaffray recently issued a report on the Japanese market, citing 2017 sales data. The chart at left suggests that Philip Morris International’s IQOS heat sticks (green) and BAT’s Glo products (blue) caused a 13% decline in cigarette consumption for the year.  Livery deliberately underestimated the number of heat sticks sold because of evidence that up “to 20% (4th Quarter 2017) of iQOS HeatStick volumes…is getting re-sold in China, Thailand, and Hong Kong, and likely other parts of Asia.” I suggested (here) that a similar result could be possible in the U.S., if the FDA grants marketing approval for such products. The agency, however, appears to be in no rush to make a decision. Philip Morris submitted a premarket tobacco application (PMTA) to the FDA on March 31, 2017; it has been pending ever since. According to the FDA (here), if a PMTA is accepted and found to be complete, the agency will file it and begin substantive review.  “After completing its review, FDA intends to issue an order within 180 days after receipt of the Premarket Tobacco Application that the new product may or may not be introduced or delivered for introduction to consumers.” (emphasis added) The FDA took eight months to grant Swedish Match a PMTA for eight snus products in 2015 (here).  This week marks the twelfth month of FDA consideration of the IQOS PMTA submitted March 31, 2017. It is often said that regulation is a slow, deliberate process.  But in this instance the FDA is in apparent violation of its own procedural guidelines.  The FDA simply slow walks any decision on safer options for smokers: it took 2.5 years (here) and 4 years (here) to reject requests to correct inaccurate smokeless tobacco warnings.  All of these are examples of regulatory purgatory that I warned about six years ago (here).  Our country’s smokers and their loved ones deserve better.Original author: Brad Rodu
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