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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.

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.


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Key Dates for General Snus, IQOS and Camel Snus MRTP Applications




EventGeneral Snus (Swedish Match)IQOS (PMI)Camel Snus (R.J. Reynolds)




Submission DateJune 6, 2014November 18, 2016March 31, 2017
Time to next step2 months6 months9 months
FDA AcceptanceAugust 27, 2014May 24, 2017December 18, 2017
Time 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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International Scientific Forum on Alcohol Research (ISFAR) is Still Hiding Conflicts of Interest of Its Members

The International Scientific Forum on Alcohol Research (ISFAR) claims to be "an independent organization of scientists that prepares critiques of emerging research reports on alcohol and health." The Forum describes itself as "an international group of invited physicians and scientists who are specialists in their fields and committed to balanced and well researched analysis regarding alcohol and health." It is "a joint undertaking of Boston University School of Medicine in the United States and Alcohol in Moderation (AIM) of the United Kingdom. Its Co-Directors are R. Curtis Ellison, MD, Professor of Medicine & Public Health, Boston University School of Medicine, and Helena Conibear, Executive Director, Alcohol-in-Moderation (AIM), UK."

The Rest of the Story

About a year and a half ago, I reported that ISFAR was hiding its conflicts of interest with Big Alcohol. At that time, ISFAR published a scathing review of a meta-analysis which concluded that moderate alcohol consumption does not reduce mortality as previously thought. The review contained statements from 14 members of ISFAR, and every one of the 14 blasted the study, with the review concluding that the study "markedly distorts the accumulated scientific evidence on alcohol and CVD [cardiovascular disease]."

It turns out that five of the Forum members who reviewed the article had conflicts of interest by virtue of either their having received research funding from the alcohol industry or serving on advisory boards of alcohol industry-funded organizations, yet none of these conflicts were disclosed.

Not only did ISFAR hide its conflicts of interest with alcohol companies on its web site, but it also hid these conflicts in a public interview.

More recently, one of the Forum members and reviewers was forced to publish a correction to a journal article because he failed to disclose that he is a beer industry consultant.

Has ISFAR reformed itself, and is it now disclosing the conflicts of interests of the reviewers who write its critiques?

The answer, unfortunately, is no.

Nowhere on its website does it list the specific conflicts of interest of its members/reviewers. Nowhere in its critiques does it disclose these conflicts of interest. And to top it all off, the biographies provided for its members do not disclose their conflicts of interest.

For example, Dr. de Gaetano's bibliography fails to disclose that he consults for the beer industry -- the precise conflict of interest for which he was forced to publish a correction in the Journal of the American College of Cardiology.

Dr. Estruth's biography states that he is a member of the Advisory Board for "ERAB." The reader is not told what ERAB stands for, hiding from the public the fact that ERAB is "supported by The Brewers of Europe, the voice of the brewing industry in Europe, whose members are the national brewing trade associations, representing more than 90% of European beer production."

Ms. Stockley's biography states that she works for the Australian Wine Research Institute, which it states is "an independent, not-for–profit research institution." But it hides the fact that this Institute is funded by the alcohol industry. Far from being independent, the Australian Wine Research Institute is actually the "wine industry’s own research organisation."

Dr. Teissedre's biography fails to disclose that his research group received alcohol industry funding.

Dr. Waterhouse's biography hides the fact that he has received alcohol industry research funding.

Dr. Skovenborg's biography fails to disclose that he was on the Board of ERAB, which is funded by the alcohol industry.

Dr. Mattivi's biography fails to disclose that he has received alcohol industry research funding.

Dr. Klatsky's biography fails to disclose that in the past, he received alcohol industry funding.

Dr. Lanzmann-Petithory's biography fails to disclose that in the past, she has received alcohol funding.

Dr. Gretkowsky's biography fails to disclose that in the past, she has received alcohol funding.

So of the supposedly "independent" and "balanced" reviewers, at least 10 of them have conflicts of interest with the alcohol industry that are not disclosed on the web site, even in their own biographies.

Unfortunately, ISFAR continues to be essentially an industry front group that is providing highly biased reviews without readily disclosing the intricate details of the financial connections of many of its reviewers to the alcohol industry.

They should not fool anybody any longer. The time to end this scam operation is now. Especially in a period in which the federal government has basically tossed scientific objectivity out the window.

Sadly, what ISFAR is doing bears a strong resemblance to the fraudulent public relations activities of the tobacco industry many years ago. 

On a personal note, I feel somewhat ashamed that the Boston University School of Medicine has been playing a role in this scam, as ISFAR has been hosted, in part, by our medical center.

On a larger note, this story illustrates why the alcohol industry-funded NIAAA study of the potential cardiovascular benefits of moderate drinking is so problematic. The background research that informs the study is tainted by serious conflicts of interest. But the worst is yet to come -- as I will reveal shortly, the research is not an objective attempt to get at the answer to this research question.
Original author: Michael Siegel
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The travesties that are Glantz, epidemiology modeling, and PubMed Commons

by Carl V Phillips

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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.

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Odds Ratios (ORs) And Numbers of Teens Smoking Cigarettes After One Year, According to Ever Tobacco Status at Baseline
Ever 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.

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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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The academic scandal hiding within the Stanton Glantz sexual harassment scandal

by Carl V Phillips

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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:

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Single Quit Aids Used By American Smokers, 2013-2014
AidCurrent Smokers*Former Smokers*All*% FormerOdds Ratio** (95% Confidence Interval






No aid5,546,0001,429,0006,975,00020.5Referent
Support, 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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First Major Action of Foundation for a "Smoke-Free World" Shows that It is Largely a Scam

I have already written about why I refused to participate in the activities of the Foundation for a Smoke-Free World, which I believe is essentially a front-group created by Philip Morris International (PMI) primarily to promote its business interests. I explained that if PMI were serious about creating a smoke-free world, it would stop aggressively marketing its deadly products throughout the world and stop opposing public health policies to reduce tobacco use.

The Foundation for a Smoke-Free World recently released a call for research proposals for preliminary projects that entail research to help the Foundation obtain the background information necessary for it to proceed effectively in its supposed mission to create a smoke-free world. By reviewing the call for proposals, we are now able to understand just how the Foundation is essentially a scam operation.

The Foundation calls for “scoping projects” to study strategies to reduce smoking. But nowhere in the five-page document does it mention anything about interventions to: (1) severely restrict or curtail cigarette advertising and marketing; (2) require plain packaging; (3) substantially increase cigarette taxes; (4) promote 100% smoke-free environments; and (5) heavily fund aggressive, state-of-the-art anti-smoking media campaigns.

In fact, the word “industry” appears only once, and it is not clear that marketing, taxation, clean indoor air, or counter-advertising are what the Foundation has in mind (especially since it groups “industry” with “farming”).

In contrast, the Foundation does want to support research on the role of genetics, physiology, individual choices and activities and environmental influences.

Frankly, this is all essentially a waste of time. We already know what interventions are most effective in reducing smoking rates. We don’t need more research to find out what works. What we need to do is to heavily fund programs to promote these tried and true policy strategies.

If the Foundation were serious about wanting to create a smoke-free world, then instead of wasting this money on research into topics like genetics and individual choices and activities, it would use its money to fund programs to implement – worldwide – policies and programs that we know are effective. These are: 1) severely restrict or curtail cigarette advertising and marketing; (2) require plain packaging; (3) substantially increase cigarette taxes; (4) promote 100% smoke-free environments; and (5) heavily fund aggressive, state-of-the-art anti-smoking media campaigns. It would also provide funding to create or supplement tobacco control infrastructure in countries throughout the world and to support the development of grassroots coalitions to promote policies to fight the tobacco industry.

In other words, these are all the programs that the Foundation fails to mention at all in its call for proposals.

Sometimes, what you don’t say is more important than what you do say. That is certainly the case here. The Foundation says nothing about the most effective interventions to reduce smoking, while focusing almost exclusively on areas that have little to no relevance.

You might argue that the Foundation can’t fund programs to promote bans on cigarette marketing, high cigarette taxes, plain packaging, and aggressive anti-smoking media campaigns that attack the industry because it is funded by the tobacco industry. Well … that’s exactly the point. A foundation funded by a large, multinational tobacco company is not in a position to carry out the types of initiatives that are most effective in reducing smoking. This is why I believe the Foundation is essentially a scam operation.
Original author: Michael Siegel
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Gateway effect denial claims are a target-rich environment

by Carl V Phillips

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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).


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Comparison of Laboratory Values: IQOS Users Versus Continuing Smokers and Versus Complete Quitters After 3 Months
Lab MarkerIQOS Versus SmokingIQOS Versus Complete Quitting*



Inflammation

White blood cell countIQOS significantly lowerNS
C-reactive proteinNSNS
Soluble ICAMIQOS significantly lowerNS
FibrinogenNSNS



Oxidative Stress

Prostaglandin F2 alphaIQOS significantly lowerNS
11-DTX-B2NSNS



Cholesterol, Triglycerides

High density lipoproteinIQOS significantly higherNS
Low density lipoproteinNSNS
Total cholesterolNSNS
TriglyceridesNSIQOS significantly lower



Blood pressure

SystolicNSNS
DiastolicNSNS



Lung function

Forced expiratory vol, 1 sec.NSNS



Carbon monoxideIQOS significantly lowerNS
CarboxyhemoglobinIQOS significantly lowerNS



NicotineNS*IQOS significantly higher



Carcinogens**

Nicotine-derived nitrosamine ketone (NNK)IQOS significantly lowerQuitting significantly lower
Butadiene (MHBMA)IQOS significantly lowerNS
Acrolein (3-HPMA)IQOS significantly lowerQuitting significantly lower
Acrolein (HMPMA)IQOS significantly lowerNS
Benzene (S-PMA)IQOS significantly lowerNS
Polycyclic aromatic hydrocarbons (1-OHP)IQOS significantly lowerNS
Polycyclic aromatic hydrocarbons (CYP 1A2)IQOS significantly lowerNS
N-nitrosonornicotineIQOS significantly lowerQuitting significantly lower
4-aminobiphenylIQOS significantly lowerNS
1-aminonaphthaleneIQOS significantly lowerNS
2-aminonaphthaleneIQOS significantly lowerNS
o-toluidineIQOS significantly lowerNS
Acrylonitrile (CEMA)IQOS significantly lowerNS
Styrene (HEMA)IQOS significantly lowerNS
Benzo(a)pyreneIQOS significantly lowerNS
Toluene (S-BMA)NSNS



NS, 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 Control Researcher Calls for Boycott of Journal, Apparently Because the Editor Supports E-Cigarettes for Harm Reduction

In a comment posted on Dr. Stan Glantz's blog yesterday, Dr. Thomas Eissenberg--a researcher studying electronic cigarettes at Virginia Commonwealth University--called for a boycott of the journal Addiction because of his claim that the editor of the journal exhibited bias in fast-tracking an article that reported low levels of aldehydes in e-cigarette aerosol.

Specifically, Dr. Eissenberg called for researchers to boycott the journal by not submitting articles to it and not reviewing for it "until it has published the means by which it will manage the apparent conflicts of conscience among its editorial staff...". Presumably, Dr. Eissenberg is referring to what he views as a significant conflict of interest of the journal's editor--Dr. Robert West--who he claims violated the peer review process in fast-tracking a 2015 article that defended e-cigarettes against the claim that they expose users to high levels of formaldehyde.

The situation is a bit complex, so let me try to summarize the background as best as I understand it:

In May 2015, Dr. Konstantinos Farsalinos and colleagues published an article in Addiction which reported the results of an experiment showing that e-cigarettes only produce aldehydes (such as formaldehyde, a carcinogen) under dry puff conditions. A dry puff occurs when a vaping device overheats the e-liquid, resulting in an unpleasant taste. Most vapers will discontinue vaping when they experience a dry puff. Therefore, if aldehydes are present only under dry puff conditions, then they do not present a major health concern for vapers.

In September 2015, Dr. Eissenberg--along with Dr. Alan Shihadeh and Soha Talih--published a letter to the editor of Addiction in which they accused him of having a "conflict of conscience" that led to a lack of rigorous peer review and inappropriate fast-tracking of the Farsalinos et al. article. The authors' complaint was two-fold: (1) that the review period was only 11 days, which is uniquely brief for this journal; and (2) that the editor--Dr. West--has a significant conflict of interest because he was once quoted in a newspaper article as (according to Eissenberg et al.) stating that: "E-cigarettes are about as safe as you can get… E-cigarettes are probably about as safe as drinking coffee."

Eissenberg et al. went on to accuse Dr. West of exhibiting bias in handling what they call a "flawed" manuscript: "These statements suggest a potential conflict of conscience in the handling of a flawed report that reinforces Dr West's professed faith in e-cigarette safety...".

Addiction published the extremely long letter by Eissenberg et al. (which itself is unusual), along with a response from Dr. West stating that the accusation is false because he didn't even handle the paper: he designated the review to a different editor. Moreover, the paper went through the same peer review process as any other paper (although it was fast-tracked because of particular urgency of this topic). In fact, the authors went through not one, but two rounds of revisions before the manuscript was accepted for publication.

That is where the story stood until yesterday, when Dr. Eissenberg called for the boycott of the journal, apparently sticking to his accusation against Dr. West despite West's response.

The Rest of the Story

Ironically, while Dr. Eissenberg is accusing Addiction of unscientific and biased actions that threaten scientific integrity, it is actually Dr. Eissenberg's actions here that are inappropriate, biased, and a threat to scientific integrity.

First, Dr. Eissenberg makes a serious accusation against the editor of Addiction without sufficient evidence to justify the claim. He (and his co-authors) provide no substantial evidence that the peer review process was botched, that the Farsalinos et al. article was seriously flawed, or that a severe bias on the part of the editor led to a botched review and acceptance of an article that should not have been published.

As it turns out, Dr. West apparently had no role in the review of the manuscript, so Dr. Eissenberg's accusation was incorrect. Moreover, the paper did go through the normal review process, although in expedited fashion. It is perfectly legitimate for journals to fast-track articles of particular interest, and many journals do that all the time. The article was peer reviewed and the authors were required to respond to reviewer comments twice. Thus, there was nothing qualitatively different about this peer review process from the review of any other paper submitted to the journal. No evidence is provided to support the accusation that the review process was flawed in any way.

Dr. West ended his response by stating: "I hope that this will give them (Eissenberg et al.) pause for thought before making serious accusations about colleagues." I agree. The allegations against the editor and the journal were serious but no evidence was provided to support them. Making an unjustified accusation and then calling for a boycott of the journal based on that unsupported allegation is the threat to scientific integrity in this story.

Second, Eissenberg et al.'s claim that Dr. West has a "conflict of conscience" because he believes e-cigarettes are relatively safe is a perversion of the concept of conflict of interest. In fact, it would be impossible for any journal editor not to have a "conflict of conscience" according to the definition that Dr. Eissenberg and colleagues are asking us to accept. Everyone involved in tobacco control has some personal view on the relative safety of e-cigarettes. The idea that researchers should boycott the journal because the editor has expressed his personal views on the relative safety of e-cigarettes is ludicrous.

Interestingly, in making their accusation that Dr. West has some sort of unusual "conflict of conscience" that would make it inappropriate for the journal to consider papers on e-cigarettes, Eissenberg et al. only quoted a small portion of Dr. West's comments in the newspaper article. I could just have easily accused Dr. West of having a strong personal bias against e-cigarettes by selectively quoting him from the newspaper article as stating:

"This is a danger. Regulators should monitor this."

In fact, Dr. West's views as expressed in the newspaper article appear to me to be balanced and evidence-based. His full comment to the paper explains the scientific reasoning behind his view, which I find quite reasonable:

"We have such a massive opportunity here. It would be a shame to let it slip away by being overly cautious. E-cigarettes are about as safe as you can get. We know about the health risks of nicotine from studies in Sweden into the use of "Snus", a smokeless tobacco. Nicotine is not what kills you when you smoke tobacco. E-cigarettes are probably about as safe as drinking coffee. All they contain is water vapour, nicotine and propylene glycol [which is used to help vaporise the liquid nicotine]."

But more to the point, the entire concept of suggesting that researchers boycott a journal based on the scientific views of the journal editor is a dangerous one. It is basically setting up a system where the only journals that survive would be ones whose editors express opinions that are in line with the mainstream scientific opinion. In fact, the very idea that researchers should boycott journals based on the opinions of the journal editor is nonsensical. Should we boycott the journal Tobacco Control because the editor does not personally believe that e-cigarettes are orders of magnitude safer than real cigarettes? Once we start going down that path, we end up challenging the existence of scientific integrity in research reporting.

This is the reason why journals screen for financial conflicts of interest, rather than conduct a McCarthy-like witch hunt to determine whether a researcher may be biased because of opinions they have expressed. Believe me, we don't want to go down that path.

There may be unusual situations in which an editor may have such a personal connection to an issue that it may be appropriate to recuse themselves from review and ask a deputy or assistant editor to handle the review, but that's certainly not true in this case. Here, the review was apparently handed off to a different editor anyway, even though I don't see any reason whatsoever why that would have been necessary.

What is perhaps most ironic about the letter to the editor by Eissenberg et al. is that although they accuse the editor and the journal of a serious conflict of interest, the letter itself fails to disclose an apparent financial conflict of interest of one of its authors. The letter fails to disclose any conflicts of interest among its authors (this link is to the PDF version of the letter which I checked to make sure a disclosure statement wasn't just missing in the online version). Thus, one would assume that none of the authors has any connection to the tobacco industry, such as -- for example -- having received funding from an organization chaired by a tobacco industry executive.

But it appears that Dr. Shihadeh -- the lead author of the letter to the editor -- has failed to disclose that he has, in the past, received funding from an organization chaired by a tobacco industry executive. Dr. Shihadeh is the co-author of several papers that acknowledge funding from the International Development Research Centre, which -- at the time -- was chaired by Barbara McDougall, who was on the Board of Directors of the Imperial Tobacco Company.

In addition, Dr. Eissenberg -- the senior author of the letter to the editor -- also acknowledged having received funding from the same organization, which was at the time chaired by a tobacco company executive.

I find it ironic that the only real conflict of interest in this story is the fact that two of the authors of the letter to the editor have, in the past, received funding from an organization that was chaired by a tobacco industry executive. And that conflict of interest is not disclosed by the authors.

Now, to be very clear, I am not accusing Dr. Shihadeh or Dr. Eissenberg of voluntarily accepting tobacco industry-related funding. They stated that they were unaware, at the time of the funding, that the chair of the organization was a tobacco industry executive. So I'm not blaming them for accepting that funding. However, they were certainly aware in 2015 - when they wrote the letter to the editor - that they had been funded by an organization chaired by a tobacco industry executive. It seems to me that is a fact that should have been disclosed. That lack of disclosure, by the way, stands in contrast to Dr. West's full disclosure of his industry-related funding from pharmaceutical companies and his clear statement that he has never been funded by the tobacco or e-cigarette industries.

The rest of the story is that in my view, Dr. Eissenberg is falsely accusing the journal Addiction of having violated scientific principles of peer review because of a personal bias on the part of the editor. Worse still, he has now called for a boycott of the journal based on these unsupported allegations.

It would truly be a shame if researchers followed this misguided recommendation.
Original author: Michael Siegel
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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.

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Comparison of Laboratory Values After 3 Months: IQOS Users Versus Continuing Smokers and Versus Complete Quitters in Japan
Lab MarkerIQOS Versus SmokingIQOS Versus Complete Quitting*



Inflammation

White blood cell countIQOS significantly lower**NS
C-reactive proteinNSNS
Soluble ICAMIQOS significantly lowerNS
FibrinogenNSNS



Oxidative Stress

Prostaglandin F2 alphaIQOS significantly lowerIQOS possibly lower
11-DTX-B2NSQuitting possibly lower



Cholesterol, Triglycerides

High density lipoproteinIQOS significantly higherNS
Low density lipoproteinNSNS
Total cholesterolNSNS
TriglyceridesNSIQOS possibly lower



Blood pressure

SystolicNSNS
SystolicNSNS



Lung function

Forced expiratory vol, 1 sec.NSNS
NS, 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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Index of my Daily Vaper articles (2)

by Carl V Phillips

...
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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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NIAAA Promotes Alcohol Industry Public Relations Program; Violates Ethical Standards by Appearing in Anheuser-Busch Promotional Video

In what I believe is a clear ethics code violation, senior employees of the National Institute on Alcohol Abuse and Alcoholism (NIAAA) have appeared in an Anheuser-Busch InBev promotional video that is designed primarily to serve the company's public relations interests.

The video was brought to light in an article by Miriam Shuchman at Wired which was published last Thursday.

In the video, Anheuser-Busch InBev boasts to the public about its "Smart Drinking Goals" program, which is purportedly designed to reduce "hazardous" drinking. Several Anheuser-Busch executives-- including its CEO, Chief "Health" Officer, and Chief Legal and Financial Officer--appear in the video, boasting about how wonderful this program is and implying how great a company Anheuser-Busch is for funding this program and how much it cares about the public's health.

But the Anheuser-Busch executives aren't the only ones who appear in this promotional, public relations video.

Shockingly, this Anheuser-Busch PR effort (i.e., public relations effort) is also endorsed and promoted by senior officials of the Executive Branch of the United States government. And even worse, those senior officials are the Director and the Director of Global Alcohol Research of the NIAAA!

The Director of Global Alcohol Research at NIAAA provides a glowing endorsement of the program, describing it as "wonderful" (see 0:27-0:34 in the video). The Director of NIAAA also endorses the program, asserting that it will "go far in moving the field forward" (see 3:17-3:26).

Brilliantly, Anheuser-Busch intersperses promotional statements from its own executives with promotional statements from the NIAAA officials, thus creating a clear endorsement of the program by the NIAAA itself, which is a public relations coup for the company.

The true purpose of the video is revealed at 3:42, when an Anheuser-Busch Global Advisory Council reveals the company's aspiration: "We're no longer a neighborhood's beer or a country's beer. We're in fact a corporation representing the world."

The video is clearly marketing Budweiser and other beers produced by Anheuser-Busch. As the company acknowledges, they are running this international program because they don't just want to be a neighborhood's beer or a country's beer; they want to be the world's beer.

There's nothing wrong with that aspiration. In fact, were I a shareholder, I would be very pleased with this amazing public relations ploy. I would be more than thrilled that the company was able to get the leadership of NIAAA to endorse this effort to make Anheuser-Busch the world's beer. However, there is something very wrong with NIAAA officials appearing in this promotional video and endorsing this marketing ploy.

The Rest of the Story

The rest of the story is that the Director of NIAAA and the Director of Global Research at NIAAA are essentially endorsing a public relations effort of the world's largest beer company by appearing in a promotional video whose true purpose is to expand Budweiser sales so that it becomes the world's beer.

This is entirely inappropriate, as the NIAAA has no business aiding Anheuser-Busch in its marketing efforts. Nor does the NIAAA have any business endorsing a public relations effort, or any other program, of this alcohol company.

Not only does the appearance of the Director of the NIAAA in this video undermine the public health mission of the National Institutes of Health, but in my view, it is a clear ethics violation.

According to Title 5, Chapter 45, Part 5501 of the Code of Federal Regulations--a section known as the Supplemental Standards of Ethical Conduct for Employees of the Department of Health and Human Services--no employee of the NIH may:

"Engage in any employment or self-employed business activity that involves the sale or promotion of products or services of a substantially affected organization or a health care provider or insurer, except for the purpose of commercializing invention rights obtained by the employee pursuant to Executive Order 10096, 15 U.S.C. 3710d, or implementing regulations." 

[Section 5501.109 - Prohibited outside activities applicable to employees of the National Institutes of Health - at (c)(1)(iii)].

The appearance of the NIH Director and the NIH Director of Global Research in this Anheuser-Busch InBev promotional video violates this standard because it involves the promotion of a product or service of Anheuser-Busch, which is a substantially affected organization because its profits may be directly impacted by an activity of the NIAAA (namely, the agency's research on the health benefits or risks of alcohol use).

In his defense, the NIAAA director told Wired: "It always surprises me when people are critical of us even talking to industry."

If NIAAA was merely talking to industry, it wouldn't be a problem. But appearing in an Anheuser-Busch promotional video is not merely talking to industry. It is actually promoting and endorsing a company product or service. By doing so, the NIAAA has participated in a marketing ploy of the company. Essentially, NIAAA is helping Anheuser-Busch to market beer and achieve its goal of becoming the world's beer.

In my view, NIAAA has been corrupted by the alcohol industry because it is acting as essentially a marketing branch for Anheuser-Busch. With the promotion of Anheuser-Busch's interests that NIAAA is providing, the company hardly needs its own marketing division. It can simply call the director of NIAAA it's de facto Director of Marketing and Public Relations. The alcohol industry couldn't have a better friend in a higher place.
Original author: Michael Siegel
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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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Five Flavor Review

Featured Review

Video Tour of Lab