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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 Research & Funding Draw Ad Hominem Attack


The influential journal Sciencerecently posted on its website an article (here) on the Foundation for a Smoke-Free World, an organization funded by a pledge of almost $1 billion from Philip Morris International.  The Foundation supports tobacco harm reduction research with a stated goal of “end[ing] the production and use of combustible cigarettes and help[ing] smokers switch to less dangerous alternatives.”  Asking, should scientists take the funding, the article clearly leans toward “no”. The only affirmative comments included in the piece are from the Foundation’s director and me, with my response truncated by the author to this: “But public funding to help settle those questions is in short supply, says Brad Rodu, a harm reduction advocate at the University of Louisville in Kentucky who for years has relied on tobacco money.” As I have written, government funding, predominantly from the National Institutes of Health, keeps academic research aligned with a vision of a tobacco-free society (here).  NIH’s opposition to tobacco harm reduction dates back to the mid-1990s, as seen in the agency’s efforts to undermine my research and reputation (detailed in Jacob Sullum’s book, For Your Own Good, here). The Science writer casts me as “a harm reduction advocate…who for years has relied on tobacco money,” despite my record of 65 published professional articles (available here, with PubMed links) and 24 years of scientific endeavor, 19 of which were supported by unrestricted grants from tobacco companies to, and administered by, two universities. Elsewhere in the story, an individual with half as many published articles is respectfully described as a “tobacco control researcher” as he terms the Foundation a “scam”. I support academic freedom, including the right to use research funding from any lawful source, accompanied by total transparency and full disclosure.  Research ought to be judged on its merits, using objective standards of quality and accuracy.        The Foundation director is, regrettably, prescient in anticipating “harassment of grantees and staff” and “ad hominem attacks”.  Such behavior is, as he notes, unacceptable. Original author: Brad Rodu
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American Smokers’ Misperception of E-Cigarettes’ Relative Harm: A National Disgrace


Clive Bates recently commented on Americans’ perception of the relative harm of e-cigarettes versus cigarettes, as measured by the National Cancer Institute’s Health Information National Trends Survey (HINTS).  After looking at numbers from 2013 and 2017 (available here), he asked: “So what difference did four years of better products, academic studies, journal articles and commentaries, conferences and publicly funded risk communication make? Yes, it caused a deterioration in these already very bad numbers…those incorrectly believing e-cigs were just as harmful or worse than cigarettes had risen from 39.8% to 55.4%.” These numbers, while unfortunate, pale in comparison to growing misperception among American smokers.  These are the people whose lives will be shortened if they don’t quit.  In the chart I summarize a disheartening trend. In 2012, 38% of smokers correctly believed that vaping was safer than smoking (the green zone on the chart); the percentage increased to 57% a year later.  In contrast, about 37% and 34% of smokers thought e-cigs were equally or more harmful in those years (the red zone).  A slight decrease in accurate perceptions (green, at 55%) was seen in 2014, while those with misperceptions grew to 41% (red).  HINTS did not survey smokers again about the comparison until 2017; at that time, accuracy dropped to 38% (green), and misperception rose to 53% (red).        The sharp increase in misperceptions coincides with a sharp decline in smokers who vaped, from 6.3 million in 2014 to 4.1 million in 2016, according data from the CDC (here).       This is a national disgrace, driven by hundreds of millions of taxpayer dollars spent on anti-tobacco, anti-tobacco-harm-reduction research (here), with fawning complicity by the media and ill-advised endorsement by public health officials and major medical organizations.  Smokers are the unfortunate victims of this irresponsible crusade. Original author: Brad Rodu
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FDA Advisory Committee: Heat-Not-Burn is Lower Exposure Than Smoke





The FDA Tobacco Products Scientific Advisory Committee (TPSAC) on January 25 unanimously endorsed a claim by Philip Morris International that switching completely from cigarettes to its heat-not-burn IQOS system significantly reduces smokers’ exposure to harmful and potentially harmful chemicals (here).  The committee, however, denied two other claims, that switchers “can reduce the risks of tobacco-related diseases” (8 against, 1 abstention) and that switching “presents less risk of harm” than continued smoking (5-4 against).  PMI published numerous short-term studies documenting that toxicant levels from IQOS aerosols were substantially lower than those in smoke, and demonstrating the biologic and medical impact of these differences in cells, animals and humans.  The committee’s denial of the diseases claim was understandable: risks manifest after three or four decades of steady smoke exposure, so risk reduction from switching to IQOS “can” occur over longer time periods.  However, TPSAC’s close vote rejecting the reduced harm claim is problematic.     In 2012, the FDA published a list of 93 Harmful and Potentially Harmful Constituents (HPHC) in Tobacco Products and Tobacco Smoke (hereand here).  The agency declared that the HPHCs variously posed health hazards as carcinogens, respiratory toxicants, cardiovascular toxicants, reproductive or developmental toxicants, and/or addictive agents.  The agency provided no guidance for the levels of exposure that constitute harm.  This is important, as seen in the case of formaldehyde, a weak carcinogen to which nearly everyone is exposed, but smokers significantly more so (discussed here).TPSAC rejected impressive evidence of HPHCs reduction in IQOS vapor.  I collected the following information from Appendix C of the FDA Briefing Materials (available here), which standardized toxins in IQOS aerosol and smoke according to nicotine intake.      On average, the reduction in the level of all potential and proven carcinogens (n=29) in IQOS aerosol was 90%.  For the most important carcinogens (n=9), the reduction was 96%.  Average reductions in respiratory (n=18) and cardiovascular (n=8) toxicants were 91% and 93% respectively.  The reductions for all of these individual agents are illustrated in the charts that follow.  The substantial reductions in all tested HPHCs support the claim that switching completely to IQOS “presents less risk of harm” than continuing to smoke.  There is adequate justification for the FDA to set aside TPSAC’s narrow 5-4 rejection of this claim. The two-day hearing raised no significant roadblocks to FDA market authorization for IQOS, which would allow U.S. sales.  Given the significant relative health benefits of this smoke-free product, market authorization is the appropriate action.   Original author: Brad Rodu
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Japan’s IQOS Experience Suggests Product Could Reduce U.S. Cigarette Consumption


An FDA advisory committee this week will vote whether to recommend that the FDA grants modified risk status to Philip Morris International’s IQOS heat-not-burn tobacco product (here).  A positive vote would acknowledge that the product poses a lower risk and/or lower exposure to toxins than cigarettes. The committee’s activity is garnering considerable media attention, but the larger issue is: Will the FDA permit IQOS sales in the U.S.?  In order for that to happen, the agency must approve the company’s premarket tobacco application (PMTA). IQOS is already available in 31 countries, with Japanese sales initiated in 2016.  The chart at left shows that Japanese consumption of IQOS heat sticks (green) in 2017 coincided with a 14% annual decline in cigarette consumption (red), compared with 2-3% decline in cigarette sales over the previous 5 years. The Japanese experience suggests that IQOS MRTP designation by the FDA could have a significant downward effect on American cigarette consumption. Original author: Brad Rodu
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1.7 Million High Schoolers Vaped in 2016, As Both Vaping and Smoking Declined



The Centers for Disease Control and Prevention 2016 National Youth Tobacco Survey (NYTS) shows that 1.08 million (7.2%) American high school students used e-cigarettes in the past 30 days, 580,000 (3.9%) smoked, and 660,000 (4.4%) used both products. Compared with 2015, smoking declined by about 14% and vaping by 28%.The apparent spike in e-cigarette use from 2013 to 2014 was partially due to what scientific researchers refer to as an artifact, as it stemmed from a change in the survey design.  Questions about e-cigarette use were bundled with those for other rarely used tobacco products until 2014, when they appeared in a separate section.  The NYTS also collected information on how many days e-cigarettes were used in the past month.  The chart below shows that 7 out of 10 students who vaped but did not smoke used e-cigarettes five days or fewer.  This is basically “party” or “weekend” vaping, rather than regular use.  While half of high school students who vaped and smoked used e-cigs five or fewer days, 22% used them all 30 days.Last June, the CDC published selected information from the 2016 NYTS (here), listing smoking and vaping rates separately, effectively double-counting the 660,000 high-schoolers who vaped and smoked.  The CDC only released the full NYTS data set earlier this month (here).    The federal data confirm that e-cigarette experimentation by youth since 2011 has not produced an epidemic of smoking.  In fact, the decline in youth smoking accelerated to a record low rate.Original author: Brad Rodu
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Trials and Tribulations of Reduced Risk Tobacco Products


When Congress gave the FDA regulatory authority over tobacco in 2009, it provided a pathway for companies to obtain approval for “modified risk tobacco products (MRTPs)…, sold or distributed for use to reduce harm or the risk of tobacco-related disease…” (here).  While decades of epidemiologic studies prove that non-combustible tobacco products are vastly safer than those involving inhaled smoke laced with thousands of toxins, the legislation required proof from manufacturers that MRTPs must “benefit the health of the population as a whole taking into account both users of tobacco products and persons who do not currently use tobacco products.” (here)  In other words, MRTPs must benefit the 60 million Americans who smoke as well as 250 million American non-smokers.Despite this challenge, tobacco manufacturers have made credible efforts to seek MRTP status.  Swedish Match in 2014 started down this pathway (here) to remedy inaccurate warning labels that are required on their smokeless tobacco products and marketing materials (here).  The FDA denied the company’s application in 2016 (here).In November of that year, Philip Morris International (PMI) requested MRTP status for its IQOS heat-not-burn tobacco (here).  IQOS is already available in 31 other countries.  However, since it is an entirely new product, the company must also pursue an FDA premarket tobacco application (PMTA) before it can be sold in the U.S. PMI seeks MRTP approval for any one of three messages: “Switching completely from cigarettes to the IQOS system can reduce the risks of tobacco-related diseases.”“Switching completely to IQOS presents less risk of harm than continuing to smoke cigarettes.” “Switching completely from cigarettes to the IQOS system significantly reduces your body’s exposure to harmful and potentially harmful chemicals.”Another manufacturer, R.J. Reynolds, filed an MRTP application in March 2017 for its Camel Snus products (here).  They, too, submitted three messages, this being the most comprehensive: “Smokers who switch completely from cigarettes to Camel Snus can significantly reduce their risk of lung cancer, oral cancer, respiratory disease, and heart disease.”Despite a wealth of evidence to support such statements, FDA took two and a half years to reject the Swedish Match MRTP application (here), as can be seen in the following table..nobr br { display: none } td { text-align: center} Key Dates for General Snus, IQOS and Camel Snus MRTP ApplicationsEventGeneral Snus (Swedish Match)IQOS (PMI)Camel Snus (R.J. Reynolds)Submission DateJune 6, 2014November 18, 2016March 31, 2017Time to next step2 months6 months9 monthsFDA AcceptanceAugust 27, 2014May 24, 2017December 18, 2017Time to next step8 months8 months---TPSAC MeetingApril 8, 2015January 24, 2018---Time to next step20 months------FDA DecisionDecember 14, 2016------ In the 30 months it took the FDA to analyze and reject the first MRTP application, 1.2 million Americans died from smoking.  The agency must move faster in its evaluation of obviously lower-risk smoke-free tobacco products and give them MRTP status. Original author: Brad Rodu
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Tobacco Gateway Report Omits Important Information


Here we go again.  Another federally funded study from the University of California, San Francisco, claims that “Nonsmoking adolescents who use e-cigarettes, smokeless tobacco or tobacco water pipes are more likely to start smoking conventional cigarettes within a year.” (UCSF press release here)  Researchers analyzed data on some 10,400 teens enrolled in the Population Assessment of Tobacco and Health (PATH) Survey in 2013-2014, then followed up with the subjects one year later. “We found that teens who experimented with tobacco in any form were at greater risk of future smoking,” said senior author Dr. Benjamin W. Chaffee; his study appears in JAMA Pediatrics. The researchers report that teens who had ever used e-cigarettes, hookah, other combustible products or smokeless tobacco at the baseline survey were two or three times as likely to be smoking cigarettes (in the past-30 days) one year later than those who had not tried any tobacco product.  Those who had tried two or more products were 3.8 times more likely to be smoking.The authors used a sophisticated analysis to arrive at these results, but news stories describing this as evidence of a gateway to teen smoking (examples hereand here) are inaccurate.Chaffee and his colleagues, including anti-tobacco crusader Stanton Glantz, omitted information that is critical to putting their findings in perspective.  Although teens trying other tobacco products were more likely to smoke, the majority of new smokers after one year came from the group that had not tried tobacco at baseline.  I offer the following calculations based on obscure information in the published article..nobr br { display: none } td { text-align: center} Odds Ratios (ORs) And Numbers of Teens Smoking Cigarettes After One Year, According to Ever Tobacco Status at BaselineEver Tobacco Status- Baseline (n)OR (95% Confidence Interval)Number 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)After one year, 219 teens had smoked a cigarette in the past 30 days, and 175 of those (80%) had never used any tobacco product at baseline.  Even though the odds of smoking were higher among youth who had tried other products, the number of smokers contributed by each of these groups was minuscule.  (While actual survey numbers may vary slightly, the relative contributions of the groups will not change.)The Chaffee article emphasizes odds ratios but omits or obscures important contextual information.  While teens who try one tobacco product are more likely to try another, the dominant gateway in the PATH survey was from no previous tobacco use to cigarettes.No underage tobacco initiation is acceptable; neither is misdirection by researchers.Original author: Brad Rodu
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Regulating e-liquid flavors – could the U.S. regulator do more harm than good and how would it know?

Assessing potential harms and benefits arising from flavors in nicotine products

Following the 28 July announcement of FDA’s new nicotine strategy, publication of several Advanced Notices of Proposed Rulemaking (ANPRMs) is expected within months. These will provide a more detailed articulation of the strategy This memo discusses significant issues for consideration in the drafting of the forthcoming ANPRM on the role of flavored tobacco/nicotine products in attracting youth.

Continue reading
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Tobacco Truth Top Ten


During the holidays we celebrate this blog’s eight years of factual reporting and critical analysis of science and policy surrounding tobacco and tobacco harm reduction.  We’ve strived to satisfy the curiosity and technical interests of health professionals, while couching our message in terms that are comprehensible to the lay consumer as well.  We are proud to note that Tobacco Truth has some 450 posts, with over 2.8 million pageviews.  We sincerely hope this translates into a significant number of lives extended and improved. Based on pageviews, here are the Top Ten Tobacco Truths, with notable quotes from each.     I’m a Smokeless Tobacco User – Will I Get Mouth Cancer?  2012  “Harm reduction doesn’t allow us to enjoy risk-free lives. It does give us valuable information to manage the risks of the activities that make life enjoyable.”     Nicotine Levels in American Smokeless Tobacco Products  2012  “The broad range of free nicotine levels among these products is good news for smokers.  They should look for a smokeless substitute that satisfies them.”     The Proven Positive Effects of Nicotine and Tobacco  2010  “It’s time to be honest with the 50 million Americans, and hundreds of millions around the world, who use tobacco. The benefits they get from tobacco are very real, not imaginary or just the periodic elimination of withdrawal. It’s time to abandon the myth that tobacco is devoid of benefits, and to focus on how we can help smokers continue to derive those benefits with a safer delivery system.”     Tobacco Trick or Treat by Florida’s Surgeon General  2012  “The availability of flavored tobacco products is important for tobacco harm reduction among adults who smoke…it is important that these individuals have access to appealing, vastly safer smoke-free alternatives to cigarettes…Banning tobacco flavoring is no more logical than banning flavored beer, wine and mixed drinks on the grounds that those products appeal to youth.”     More Evidence That Smokeless Tobacco Products in the U.S. Have Low TSNA Levels  2012  “this study shows that TSNAs are present in tiny concentrations.  As discussed in a previous post (here), there is virtually no evidence that current TSNA levels are associated with any measurable cancer risks.”     Nebraska Legislature Passes Tobacco Harm Reduction Resolution  2012  “The Nebraska legislature on March 27 [2012] passed resolution LR 499 to ‘recognize the importance of tobacco harm reduction strategies as an additional choice to assist cigarette smokers in quitting.’ ”     The Health Risks of Cigar Smoking  2012  “Cigars, the data show, have few health effects when used in moderation.”  Also see this popular post in 2016.      Regulatory Purgatory: Tobacco Harm Reduction at Risk  2012  “The FDA should abandon regulatory fundamentalism that condemns safer product development to a purgatory of red tape.”      Cancer Risks From Smokeless Tobacco Use: Next To Nil  2009  “The clear implication is that the deaths each year of 103,635 male smokers in the U.S. could be avoided if public health leaders shared the truth about safer smokeless tobacco, and if tobacco manufacturers were allowed and encouraged to urge smokers to switch.”     E-Cigarettes – No Toxic Effects from Inhaled Propylene Glycol Aerosol  2011  “First, even high concentrations of PG vapor don’t have any measurable harmful effects, which is fully consistent with its designation by the FDA as “generally recognized as safe” as a food additive for all food categories up to 2% (here). Just as important, there will be no impact on bystanders from “second-hand” exposure to e-cigarette vapor, if it occurs at all.” The following posts from the past year have been very popular as well. E-Cigarette Toxic Chemical Exposure Is Same as for Nonsmokers  “The fact that vapers’ [volatile organic compound] exposures are similar to those of nonsmokers is headline-worthy.” Federal Studies: ZERO Mouth Cancer Deaths Among Men Who Dip or Chew Tobacco  “The U.S. Food & Drug Administration (FDA) on January 23, 2017 published a proposed smokeless tobacco (ST) regulation that is based on erroneous calculations of ST risks.” FDA Tobacco Director Ignores 2.5 Million “Anecdotal Reports” About E-Cigarettes  “The FDA’s refusal to acknowledge population data on e-cigarettes facilitates its effort to impose industry-killing regulations on the vapor market.  The chief federal regulator of tobacco products should acknowledge government survey data showing that e-cigarettes have helped as many as 2.5 million Americans quit smoking and/or stay smoke-free.” We approach the new year with a renewed commitment to elevate global public discourse on the science of tobacco harm reduction. Original author: Brad Rodu
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Population-Level Proof: E-Cigarettes Are Popular & Successful Quit-Smoking Aids


Tobacco harm reduction opponents have belittled reported use of e-cigarettes as smoking cessation aids, dismissing case studies as mere “anecdotes” (here) and claiming a lack of population evidence to support a quit-smoking claim.  Now that evidence exists.In a just published study, my colleague Nantaporn Plurphanswat and I use federal government data to demonstrate that e-cigarettes were one of the most commonly used quit aids by American smokers in 2013-2014, and that they were the only aid more likely to make one a former smoker (i.e., a successful quitter) than quitting cold-turkey.  Our study, appearing in the International Journal of Environmental Research and Public Health(open access, available here), analyzed data in the Population Assessment of Tobacco and Health (PATH) Survey, a combined project of the U.S. Food and Drug Administration and the National Institutes of Health.  The PATH survey asked current smokers which aids they used when they tried to quit, and former smokers which aids they used to quit, in the past 12 months.  Participants could pick from the following: (1) no aid, (2) support from friends and family, (3) other aids (counseling, quit line, books, pamphlets, videos, clinic, class, web program), (4) e-cigarettes, (5) other combustible tobacco (cigars, cigarillos, filtered cigars, pipe tobacco, hookah), (6) smokeless tobacco (dip, chew, or snuff, and dissolvable tobacco), (7) pharmaceutical nicotine (NRT: patch, gum, inhaler, nasal spray, lozenge or pill), and (8) prescription drugs (Chantix, varenicline, Wellbutrin, Zyban, or bupropion).Here is a summary of the results for smokers using a single quit aid:.nobr br { display: none } td { text-align: center} Single Quit Aids Used By American Smokers, 2013-2014AidCurrent Smokers*Former Smokers*All*% FormerOdds Ratio** (95% Confidence IntervalNo aid5,546,0001,429,0006,975,00020.5ReferentSupport, friends family1,992,000446,0002,438,00018.30.98 (0.75-1.28)Other aids139,00037,000176,00021.00.89 (0.36-2.17)E-cigarettes1,652,000540,0002,192,00024.61.43 (1.12-1.83)Other combustible91,00024,000115,00020.91.43 (0.78-2.63)***Smokeless tobacco92,00032,000124,00025.81.43 (0.78-2.63)***NRT1,190,000284,0001,474,00019.30.89 (0.61-1.28)Prescription drug347,00070,000417,00016.80.97 (0.55-1.71)All aids11,049,0002,862,00013,911,00020.6*estimated from PATH survey weighting.  Some numbers do not appear in the peer-reviewed publication.**Odds ratio of being a former smoker, adjusted for number of quit attempts, age, sex, race/ethnicity, education, income and region***categories combined to produce a single OR Overall, nearly 14 million smokers tried to or did quit using a single quit aid in 2013-2014.  As we note, “E-cigarettes were used…by 2.2 million smokers…, NRT by 1.47 million, prescription drugs by 418,000 and smokeless tobacco by 124,000.”  While NRT and prescription drugs, combined, helped some 354,000 smokers quit, it was e-cigarettes, which are routinely condemned by many public health institutions, that produced the greater success, helping 540,000 smokers quit.  Given the government’s own evidence, it’s time to acknowledge the scientific legitimacy, value and benefit of e-cigarettes with respect to the health of the population. Original author: Brad Rodu
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FDA Releases More Positive Results for IQOS; British Medical Association Supports E-Cigs


I earlier reported (here) that Stanton Glantz, a University of California, San Francisco professor, urged the FDA to deny Philip Morris International’s application to market its IQOS heat-not-burn cigarette as a modified risk tobacco product, based on his comparison of lab results for IQOS users versus continuing smokers.  I noted that Glantz ignored data for IQOS users versus complete quitters, although that statistical comparison was not in the documents released by the FDA.Additional data released by the FDA yesterday shows that PMI had submitted considerably more information from its Japanese study.  PMI reported data on exposure to carcinogens, carbon monoxide and nicotine, and, importantly, analyses for all of these results, including IQOS versus smoking, and IQOS versus quitting.The following table shows all results after three months.  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.  The primary carcinogens are listed, with lengthy chemical metabolites abbreviated in parentheses.   IQOS users were not significantly different than quitters with respect to inflammation, oxidative stress, blood pressure, lung function and carbon monoxide levels.  Compared with continuing smokers, IQOS users had significantly lower levels of 15 out of 16 carcinogen markers after 90 days of use.  There were no differences between IQOS and quitting for 13 of 16 markers.My previous blog post was based on partial results released by FDA.  The agency’s latest release provides further evidence that toxin levels three months after switching to IQOS look more like complete quitting.No one is claiming that IQOS is perfectly safe.  However, exposure to toxic agents among IQOS users is substantially lower than exposure among smokers, and very close to that associated with complete quitting. In breaking news, the British Medical Association Board of Science has just issued a positive report on e-cigarettes (here).  Their findings, which likely apply to IQOS, appear below verbatim.Is it safe to use an e-cigarette in the long-term?In the absence of long-term studies it is not possible to be certain about the long-term health risks, but there is growing consensus that use of e-cigarettes is significantly safer than smoking.Unlike cigarette smoking, e-cigarette use does not expose users to the products of combustion, and most of the toxicants causing smoking-related disease are absent or significantly reduced in e-cigarette vapour.Indications to date are that complete switching can lead to improvements in the levels of toxins and carcinogens in urine similar to that in smokers who switch completely to NRT (nicotine replacement therapies)..nobr br { display: none } td { text-align: center} Comparison of Laboratory Values: IQOS Users Versus Continuing Smokers and Versus Complete Quitters After 3 MonthsLab MarkerIQOS Versus SmokingIQOS Versus Complete Quitting*InflammationWhite blood cell countIQOS significantly lowerNSC-reactive proteinNSNSSoluble ICAMIQOS significantly lowerNSFibrinogenNSNSOxidative StressProstaglandin F2 alphaIQOS significantly lowerNS11-DTX-B2NSNSCholesterol, TriglyceridesHigh density lipoproteinIQOS significantly higherNSLow density lipoproteinNSNSTotal cholesterolNSNSTriglyceridesNSIQOS significantly lowerBlood pressureSystolicNSNSDiastolicNSNSLung functionForced expiratory vol, 1 sec.NSNSCarbon monoxideIQOS significantly lowerNSCarboxyhemoglobinIQOS significantly lowerNSNicotineNS*IQOS significantly higherCarcinogens**Nicotine-derived nitrosamine ketone (NNK)IQOS significantly lowerQuitting significantly lowerButadiene (MHBMA)IQOS significantly lowerNSAcrolein (3-HPMA)IQOS significantly lowerQuitting significantly lowerAcrolein (HMPMA)IQOS significantly lowerNSBenzene (S-PMA)IQOS significantly lowerNSPolycyclic aromatic hydrocarbons (1-OHP)IQOS significantly lowerNSPolycyclic aromatic hydrocarbons (CYP 1A2)IQOS significantly lowerNSN-nitrosonornicotineIQOS significantly lowerQuitting significantly lower4-aminobiphenylIQOS significantly lowerNS1-aminonaphthaleneIQOS significantly lowerNS2-aminonaphthaleneIQOS significantly lowerNSo-toluidineIQOS significantly lowerNSAcrylonitrile (CEMA)IQOS significantly lowerNSStyrene (HEMA)IQOS significantly lowerNSBenzo(a)pyreneIQOS significantly lowerNSToluene (S-BMA)NSNSNS, No significant difference* IQOS results in nicotine levels that are similar to smoking** carcinogen (chemical metabolites)Original author: Brad Rodu
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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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