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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.

Looking back, but forwards too – guest posting by Louise Ross

Out there, on your side – Louise Ross puts the public back into public health

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Correspondence Between NIAAA and the Alcohol Industry

Correspondence obtained as the result of my FOIA request to the NIAAA.
Original author: Michael Siegel
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Smokers Deserve Improved FDA E-Cigarette Regulation: Pass Cole-Bishop

It’s no secret: E-cigarettes are vastly safer, increasingly popular and successful substitutes for traditional tobacco cigarettes.  More and more smokers are replacing combustible tobacco with vapor technology to reduce their health risks (here), or even to ultimately eliminate their nicotine consumption.  This is a particularly important development for my home state Kentucky, where smoking and lung cancer rates are among the highest in the country.

Unfortunately, government bureaucrats, dreaming of a tobacco-free society (read: prohibition), are trying to condemn the emerging e-cigarette industry to regulatory purgatory. The FDA’s plan to retroactively enforce cigarette-style regulations on vapor could decimate e-cigarettes, which are cigarettes’ greatest potential adversary. 

Cigarettes burn tobacco, creating smoke that contains thousands of harmful toxins. Vaping products, on the other hand, heat e-liquid into an aerosol.  They eliminate combustion, which significantly reduces toxic byproducts.  Many e-cigarettes don’t even contain nicotine.  

E-cigarettes barely existed in 2009 when Congress passed the tobacco legislation that the FDA is trying to retro-fit to vapor.  Furthermore, the agency interpreted the law to require that any e-cigarette or vapor product not on the market in February 2007 – in other words, every product on the market today – pass an onerous, expensive and time-consuming review.  Similar regulatory hurdles would apply even when a manufacturer only wants to upgrade a battery, develop a new e-liquid or make even minor improvements. 

E-cigarettes are among Americans’ most commonly used quit-smoking aids. In fact, they are the only aid more likely to make one a former smoker (that is, a successful quitter) than quitting cold-turkey, according to an analysis I recently published using FDA survey data (here and here).  Without these products, smokers face a difficult choice: try FDA-approved smoking cessation products that have a documented 93% failure rate, go cold turkey, or remain a smoker.  FDA regulation should not subject smokers to such a quit-or-die predicament when alternatives like e-cigarettes are available.

Congress must intervene in the interest of public health, by passing the Cole-Bishop Amendment, which contains provisions to ensure that smokers across the U.S. continue to have access to safer cigarette substitutes.   

The Cole-Bishop Amendment would grandfather products that are already on the market.  It supports consumer safeguards such as manufacturing standards and accurate product labeling. Bottom line: Cole-Bishop provisions recognize the scientific and technological differences between vapor and smoke and the significant differences in their risk profiles.  It has broad consumer support, including a coalition of sixteen center-right public policy organizations and think tanks (here) and all major vaping groups.

Vapor products represent a vital “fire escape” for millions of inveterate smokers. FDA regulations should not make it more difficult for people to stop smoking, and stay smoke-free. 

Original author: Brad Rodu
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Public health experts rally to support US legislative initiative on vaping

March 13th, 2018

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Beyond the Headlines: Trace Toxins, Present in All Teens, Improperly Blamed on E-Cigarettes

The University of California San Francisco publicized a study on March 5, asserting that “Adolescents who smoke e-cigarettes are exposed to significant levels of potentially cancer-causing chemicals.” (here)  The study’s lead author, Mark Rubinstein, M.D., said, “Teenagers need to be warned that the vapor produced by e-cigarettes…actually contains some of the same toxic chemicals found in smoke from traditional cigarettes.”

This led to messaging that vaping is just as dangerous as smoking -- “Teens Using E-Cigarette Have the Same Toxic Chemicals Found in Smokers” (here), “E-Cigarette Users Ingest High Levels of Cancer-Causing Chemicals” (here).

In fact, the research, published in Pediatrics, analyzed urine, not vapor.  The study reports the presence of minute amounts of volatile organic compounds (VOCs) in the urine of teens who didn’t smoke or vape (i.e., controls), e-cigarette users, and dual users of e-cigarettes and cigarettes.

Here are the study results:

.nobr br { display: none } td { text-align: center}
Median VOC Levels (ng/mg*) in the Urine of Controls, E-Cig Users and Dual Users

Parent CompoundControlsE-Cig UsersDual Users

Ethylene Oxide1.30.51.0
Propylene Oxide152940
*ng/mg = parts per MILLION (creatinine)

Significantly, there were no cigarette smokers in the study.  Existing research tells us that their VOC levels would have been far higher, undercutting the UCSF anti-e-cigarette narrative.

Note that there are no alarming elevations in benzene or butadiene, and levels of ethylene oxide were actually lower among users than controls.  This data indicates that teens virtually no exposure to these chemicals.

While levels of other agents are higher in e-cigarette users and especially in dual users, levels in controls are not zero. 

The authors are on shaky ground in their attribution of higher toxin levels among e-cigarette users to the vapor.  A previous study (co-authored by one of the current authors, here) that they cite failed to find any acrolein and crotonaldehyde in vapor from 12 e-cigarettes.  A Centers for Disease Control and Prevention study (here) found that nonsmokers’ urine had up to 245 ng/g of acrolein and up to 158 ng/g of propylene oxide (smokers had far higher levels of both).  Thus, toxin levels seen in e-cigarette users in the new UCSF report are not necessarily due to vapor.

The UCSF research ignores a possible alternative source of these contaminants: recent marijuana smoking, as shown in a CDC study that identified elevated VOC levels among tokers (here).  As I recently noted (here), marijuana use is more prevalent among teens than vaping or cigarette smoking; data from one federal survey shows that about 40% of teen vapers are current marijuana users.  These findings increase the odds that toking impacted results in the new study.

The UCSF research was supported by four grants totaling some $32 million from the National Institutes of Health to authors Rubenstein, Neal Benowitz and Stanton Glantz. 

Original author: Brad Rodu
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Foundation for a Smoke-Free World and the mindless mob behaviour of tobacco control

An update from the World Conference on Tobacco or Health, Cape Town

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Tobacco control and the tobacco industry – a failure of understanding and imagination

What about the war on disease and premature death? They just aren’t the same thing.

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Beyond the Headlines, E-Cigarette Vapor Has Only Trace Amounts of Metals

The American media have been obsessed with a new study (here)claiming that “e-cigarettes are a potential source of exposure to toxic metals (chromium, nickel, and lead), and to metals that are toxic when inhaled (manganese and zinc).”

The headlines misrepresent or overdramatize the facts:      

“E-Cig Vapors May Contain Brain-Damaging Toxic Metals, Says New Study” Tech Times

“E-Cigarette Vapor Filled With Dangerous Toxins Like Lead, Study Finds” Newsweek

“E-cigarettes leak toxic metals, study finds” Medical News Today

“Are E-Cigarettes Safe? Alarming Levels Of Metal Found In Its Heating Coils” International Business Times

The research, published in the journal Environmental Health Perspectives, was authored by faculty at Johns Hopkins University, Columbia University, and the Universities of Granada (Spain) and Graz (Austria). 

They reported the metals’ median levels and range (from the 25th to the 75th percentile) in 56 e-cigarette devices’ aerosols.  All values are in micrograms (ug, one-millionth of a gram) of metal per kilogram (kg, one thousand grams) of vape aerosol.  For reference, there are 454 grams in a pound. 

The following table shows how much liquid an e-cigarette user must vape per day to exceed either the FDA’s daily exposure limit for inhaled medicines (here), or the CDC’s minimal risk levels (MRLs) for workplace inhalation (here).  I used the upper level (75thpercentile) of the range, so the results below are not underestimates. 

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Maximum Levels of Metals in E-Cigarette Vapors, and Amount of Liquid Used Daily to Exceed FDA Maximum Levels for Inhaled Medicines And/Or CDC Minimal Risk Levels (MRLs)
MetalMaximum Vapor Level (ug/kg)Daily FDA Maximum or CDC MRL* (ug)Volume of Vaping Liquid Exceeding FDA Max or CDC MRL*
Cadmium0.13215.4 LITERS
0.136*1.1 LITER*
Chromium43.9368 milliliters
Copper51.030588 milliliters
Manganese9.564.08*427 milliliters*
Nickel289517.3 milliliters
Lead37.15135 milliliters
30*808 milliliters*
Antimony1.932010.4 LITERS
Tin19.4603.1 LITERS
NA, not available

One thing is crystal clear: an e-cig user could be exposed to excessive metal levels only by consuming high volumes of vape liquids.  For example, vapers would have to use 15.4 liters (nearly four gallons) of liquid per day to achieve exposure to 2 micrograms of cadmium. 

Nickel is an outlier because at a high 75thpercentile value (289 ug/kg), the exposure limit is 17 milliliters (the typical vaper uses 10 milliliters or less daily).  However, the median value for nickel in all samples was much lower (6 ug/kg), meaning that users could consume 800 milliliters before reaching the recommended exposure limit.

The authors emphasize that some of these metals, notably cadmium, chromium, nickel and lead, are toxic.  However, they fail to mention that toxicity is proportional to dose and duration.  The metal doses delivered by e-cigarette liquids in this study are trivial.

Note: Thanks to Dr. Konstantinos Farsalinos, a researcher at the Onassis Cardiac Surgery Center,
the University of Patras and the National School of Public Health in Greece, for his expert assistance with this entry.

Original author: Brad Rodu
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New Study Concludes that Vaping Causes Heart Attacks

A new study presented Saturday at the annual meeting of the Society for Research on Nicotine and Tobacco (SRNT) concludes that vaping causes heart attacks, increasing the heart attack risk for dual users beyond that of smoking alone. The research has not yet been published but was presented as a poster at the conference.

The study was a cross-sectional analysis of nearly 70,000 respondents to the combined 2014 and 2016 National Health Interview Surveys (NHIS), a nationally representative survey of health risk factors and outcomes in U.S. adults. Respondents were asked to report their current vaping and smoking statuses and to report whether they had ever had a heart attack. The researchers found that there was a significant association (odds ratio = 1.8) between daily e-cigarette use and having experienced a heart attack. The analysis controlled for level of current cigarette use.

Based on this observation, the study concludes that daily e-cigarette use doubles the risk of heart attacks.

The Rest of the Story

Hold your horses.

Before accepting the conclusion that vaping causes heart attacks in unsuspecting smokers, remember the old adage: correlation does not equal causation. This study is a perfect demonstration of that phenomenon.

Because this is a cross-sectional study, and because respondents were asked whether they had ever had a heart attack, one cannot determine whether the heart attacks followed e-cigarette use or preceded it. In other words, we do not know that vaping preceded the heart attack for any of the subjects. It is entirely possible that in most of these cases, the smokers suffered a heart attack and then started vaping in an attempt to quit smoking. In fact, I believe that is the most likely explanation for the observed study findings.

It is not even biologically plausible that vaping could increase the risk of cardiovascular disease beyond that of smoking. Why? Because the cardiovascular effects of tobacco smoke saturate at a very low level, meaning that it takes only a little exposure to increase your risk. But beyond that, there is little additional risk.

On the other hand, it is quite plausible that smokers make quit attempts after experiencing a heart attack and that in recent years, these quit attempts have often involved the use of e-cigarettes.

It is true that many of the adverse effects of smoking were first observed in cross-sectional studies. However, these were followed up with longitudinal studies that confirmed the findings. Before we reach a conclusion on whether vaping poses a heart attack risk, we need longitudinal studies. This single cross-sectional study is not enough because there is no way to tell the direction of the observed association between current use of e-cigarettes and having experienced a heart attack in the past.

Although I question the validity of the study's conclusions, it is still important to emphasize that smokers who use e-cigarettes should aim to quit smoking completely. The full health benefits of vaping will not accrue to smokers unless they quit smoking completely. Dual use - if the cigarette consumption drops substantially - will reduce respiratory disease risks, but it will not reduce cardiovascular disease risk because of the saturation phenomenon noted above.
Original author: Michael Siegel
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Federal Officials, Please Pay Attention to Federal Surveys: E-Cigarettes Are Not Gateway Products

I noted in 2013 that the CDC director’s claim – that “many kids are starting out with e-cigarettes and then going on to smoke conventional cigarettes” – was pure gateway speculation (here).  Youth surveys had just started collecting information that teens were using e-cigarettes, but there was zero evidence that they were “going on to smoke.”

In January I presented data from the CDC’s National Youth Tobacco Survey showing that e-cigarette experimentation since 2011 did not produce an epidemic of teen smoking (here).  The 2017 Monitoring the Future survey, illustrated in the chart at left, provides further evidence of a steady decline in cigarette smoking among high school seniors.  In 2017, the smoking rate in MTF dropped below 10% for the first time in history.  At 9.7%, the rate is almost half that of 2011 (18.7%), while the vaping rate remained at 16-17%.  Meanwhile, high school seniors used alcohol and marijuana at far higher rates than cigarettes (33% and 23% respectively).  Nineteen percent of seniors reported being drunk in the past month.

MTF vaping data in 2014-2016 didn’t specify the liquids used; in 2017 MTF collected information on non-specific vaping and vaping nicotine and marijuana in the past month.  Nonspecific vaping, illustrated by the green line in the chart, was around 16%, nicotine vaping was 11%, and marijuana vaping was 4.9% in the past month.

Federal officials are still obsessed with the vape-to-smoke gateway, despite virtually no evidence.  FDA Commissioner Scott Gottlieb recently tweeted a warning: “The [e-cigarette] industry isn’t sustainable if it leads to a whole generation of youth initiation on tobacco.” (here

I tweeted a reply urging Dr. Gottlieb to look at his agency’s data from the “…PATH survey of 9,909 never-smoking teens. One year later, 219 (2.2%) had smoked in past 30 days. All awful, but 175 (80%) had no prior tobacco product use; only 11 had used e-cigs. FDA data shows vaping not major gateway to teen smoking [here].” (emphasis added)

Federal officials should stop claiming that vaping is a gateway to smoking, because evidence is absent in all federal surveys.

Original author: Brad Rodu
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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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My Op-Ed in U.S. News & World Report on the National Academy of Sciences Report on E-Cigarettes

Here is the link to my op-ed on the National Academy of Sciences report.
Original author: Michael Siegel
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WBUR Interview Regarding National Academy of Sciences E-Cigarette Report

Here is the link to an article on WBUR that includes edited excerpts from an interview I did regarding the new National Academy of Sciences report on electronic cigarettes.
Original author: Michael Siegel
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National Academy of Sciences Report on Electronic Cigarettes Confirms that Vaping is Much Safer than Smoking and Has No Known Long-Term Health Effects

My commentary on the conclusions and implications of the National Academy of Sciences report on electronic cigarettes was just accepted as an op-ed piece in U.S. News & World Report. I expect it to be published tomorrow. For this reason, I have had to take down the original commentary. However, below I have posted the parts of the original blog post that had to be cut from the op-ed because of length concerns. Also, I will post a link to the op-ed as soon as it appears.

The key findings of the report are:

1. "There is substantial evidence that except for nicotine, under typical conditions of use, exposure to potentially toxic substances from e-cigarettes is significantly lower compared with combustible tobacco cigarettes."

2. "There is conclusive evidence that completely substituting e-cigarettes for combustible tobacco cigarettes reduces users’ exposure to numerous toxicants and carcinogens present in combustible tobacco cigarettes."

3. "There is moderate evidence that risk and severity of dependence are lower for e-cigarettes than combustible tobacco cigarettes."

4. "There is moderate evidence that second-hand exposure to nicotine and particulates is lower from e-cigarettes compared with combustible tobacco cigarettes."

5. "There is no available evidence whether or not e-cigarette use is associated with clinical cardiovascular outcomes (coronary heart disease, stroke, and peripheral artery disease) and subclinical atherosclerosis (carotid intima media-thickness and coronary artery calcification)."

6. "There is insufficient evidence that e-cigarette use is associated with long-term changes in heart rate, blood pressure, and cardiac geometry and function."

7. "There is no available evidence whether or not e-cigarette use is associated with intermediate cancer endpoints in humans. This holds true for comparisons of e-cigarette use compared with combustible tobacco cigarettes and e-cigarette use compared with no use of tobacco products."

8. "There is no available evidence whether or not e-cigarettes cause respiratory diseases in humans."

9. "There is limited evidence for improvement in lung function and respiratory symptoms among adult smokers with asthma who switch to e-cigarettes completely or in part (dual use)."

10. "There is limited evidence for reduction of chronic obstructive pulmonary disease (COPD) exacerbations among adult smokers with COPD who switch to e-cigarettes completely or in part (dual use)."

11. "While the overall evidence from observational trials is mixed, there is moderate evidence from observational studies that more frequent use of e-cigarettes is associated with increased likelihood of cessation."

12. "There is substantial evidence that e-cigarette use increases risk of ever using combustible tobacco cigarettes among youth and young adults."

13. "There is conclusive evidence that, other than nicotine, the number, quantity, and characteristics of potentially toxic substances emitted from e-cigarettes is highly variable and depends on product characteristics (including device and e-liquid characteristics) and how the device is operated."

The Rest of the Story

I agree with all of the above conclusions, other than #11, which is not wrong on its face but needs careful interpretation.

Therefore, let me say a few words about conclusion #11 above ("There is substantial evidence that e-cigarette use increases risk of ever using combustible tobacco cigarettes among youth and young adults"). It is true that youth who experiment with e-cigarettes are more likely to also experiment with tobacco cigarettes and therefore, to become smokers. It would be shocking if this were not the case because we know that youth who experiment with one risky behavior are more likely to experiment with other risky behaviors. But this doesn't necessarily mean that the experimentation with e-cigarettes is causing the youth to start smoking.

For example, there probably are not many kids who use heroin who have never taken a sip of alcohol. If you did a study, you would find that alcohol use is associated with later use of heroin. But this doesn't support the conclusion that experimenting with alcohol causes kids to become heroin junkies. It simply reflects the fact that kids who take huge health risks are more likely to already have taken smaller health risks. A youth is not going to decide to rebel one day by injecting a drug into their veins. The rebellion process would likely start with a less hazardous behavior, such as taking a toke on a cigarette and then for a very small number of kids, they would end up progressing to hard drug use.

So the important question is not whether youth who experiment with e-cigarettes are more likely to end up smoking (of course they are!), but instead, whether youth who experiment with e-cigarettes are more likely to become addicted to vaping and then be led to smoking addiction, such that without having become addicted to vaping, they unlikely would have become smokers. So far, the evidence suggests that this is not the case: very few youth have been identified who started as nonsmokers, became regular vapers, and then progressed to smoking.
Original author: Michael Siegel
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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.

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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
157 Hits

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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