(828) 698-5795 

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.

The US media is losing its mind over vaping and Juul – the questions a credible journalist should ask

April 9th, 2018

...
Continue reading
318 Hits
0 Comments

Principal Investigator of Alcohol Clinical Trial is Hiding its Industry Funding from the Public and Potential Research Subjects

I have already explained why I think the Moderate Alcohol and Cardiovascular Health (MACH15) clinical trial should be immediately halted because of both scientific and ethical breaches in the way the research was planned. Today, I reveal what I believe is misconduct in the actual conduct of the trial: namely, in the communication of the research sponsors to the public.

I believe that the public -- and especially research subjects -- have the right to know who is funding a clinical trial that is seeking their participation. In fact, there are rules requiring the sponsors of such studies to be revealed to the public. However, I believe the MACH15 study is violating these principles by hiding its true sponsors from the public.

The Rest of the Story

On the study web site, the study sponsor is reported as being the "National Institute on Alcohol Abuse and Alcoholism (NIAAA)." However, nowhere on the site does it disclose that the real sponsor behind the research are alcohol companies, which have ponied up to cover two-thirds of the cost of the entire research project. The alcohol money is being funneled through a "middle man" (the NIH Foundation) on its way to NIAAA, but the source of the money is clear: this is an alcohol industry-funded study. In violation of ethical principles for the conduct of research, this critical information is not being disclosed to the public on the project web site.

Therefore, I am calling both the Department of Health and Human Services (through the Inspector General) and Congressional oversight committees to require the study researchers to disclose to the public and potential participants that this study is being funded by the alcohol industry.

This is too reminiscent of the unethical behavior of tobacco-funded researchers in the past who failed to disclose the industry funding of their research. In fact, it was this behavior that contributed heavily to the implementation of conflict of interest disclosure rules.

The rest of the story is that the principal investigator of the MACH15 trial is hiding from the public the fact that this is an industry-funded study. I believe the trial should be halted, but if it is allowed to continue, the researchers should be forced to disclose the industry funding to the public and to any potential research participants.
Original author: Michael Siegel
265 Hits
0 Comments

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

...
Continue reading
397 Hits
0 Comments

UC San Francisco Authors Inadvertently Validate Our Call for Retraction


In the previous post I described fatal flaws in a study by University of California San Francisco’s Benjamin W. Chaffee, Shannon Lea Watkins and Stanton A. Glantz in the journal Pediatrics(here).  Their published response (here) validates my criticism.

Chaffee et al. correctly observed that I have frequently challenged flawed research, and they kindly provided three examples of my published letters to editors of scientific and medical journals.  My professional blog is replete with fact checks of published claims by federal officials (here, here, here, here, here, here) and government-funded researchers (here, here, here, here, here, herehere, here) that e-cigarettes are a gateway to teen smoking.  My criticism has extended to research published by UCSF faculty (here, here, and here)

The recent Pediatricsanalysis by Chaffee et al. showed that teen e-cigarette users in the Wave 1 FDA Population Assessment of Tobacco and Health (PATH) survey had higher odds of consuming 100+ cigarettes or past 30-day smoking one year later at follow-up.  I noted that the authors ignored important information about lifetime cigarette consumption (LCC), from as little as “1 puff but never a whole cigarette” all the way to having smoked 99 cigarettes.  When my research team applied LCC data to Dr. Chaffee’s analysis, his positive results for an e-cigarette “gateway” essentially disappeared. 

In response, Chaffee et al. called our addition of the LCC information a “statistical trick.”  By using that term, it appears that they believe, incorrectly, that the LCC variable is an outcome rather than a confounding factor.  Inexplicably, they described our analysis as “akin to suggesting that a study of hypertension should adjust for confounding by systolic blood pressure.” 

In this, Chaffee et al. prove our case. 

Let’s say we are studying the effect of dietary salt consumption on development of hypertension (systolic blood pressure, bp >140 mm) after one year of follow-up among participants who were not hypertensive at baseline (that is, they had a systolic bp = 90 to 139 mm).  If someone has a baseline bp of 139 mm, it is much more likely that they will have a bp of >140 mm after one year, compared to a person who had a baseline bp of 90.  It would be negligent to blame salt for causing hypertension while completely ignoring baseline systolic bp values in this example. 

The same principle applies to Dr. Chaffee’s e-cigarette study. 

The chart below clearly illustrates the large differences in LCC that Chaffee et al. ignored between never e-cigarette users and past 30 day users or triers.

It is negligent to ignore cigarette consumption at baseline while placing all the blame for smoking one year later on e-cigarette use. 

The Chafee article must be retracted.
 






Original author: Brad Rodu
302 Hits
0 Comments

Retract the UC San Francisco E-Cigarette “Gateway” Study


Some published articles are so flawed that they deserve retraction.   

A case in point is the Pediatrics article by University of California San Francisco's Benjamin W. Chaffee, Shannon Lea Watkins, and Stanton A. Glantz (here) that features a totally baseless claim: “Among adolescent cigarette experimenters, using e-cigarettes was positively and independently associated with progression to current established smoking.” 

Using Wave 1 of the FDA Population Assessment of Tobacco and Health (PATH) survey, Chaffee et al. define teen experimental smokers as having smoked “in your entire life” anywhere from “1 or more puffs but never a whole cigarette” up to 99 cigarettes.  They divide experimental smokers into three groups according to e-cigarette use: never users, past 30-day users and ever triers.  In their analysis, controlling for numerous variables, e-cigarette users at Wave 1 had higher odds of having consumed 100+ cigarettes or having smoked in the past 30 days at follow-up one year later.

The findings and the claim are false. In their analysis, the authors ignore the fact that their study group consisted entirely of experimental smokers with widely varied experience – one or more puffs but never a whole cigarette, one cigarette, 2-10, 11-20, 21-50 and 51-99 cigarettes. 

Using the PATH data, my research team reproduced Chaffee’s analysis and Pediatrics published our results online (here).  The table we submitted to the journal was published in an unreadable fashion, so we offer it here.
.nobr br { display: none } td { text-align: center}
Odds Ratios (95% Confidence Interval) for Smoking Outcomes in the Wave 2 PATH Survey, According to E-Cigarette Use at Wave 1




MetalChaffee’s ResultsBR-NPBR-NP + Wave 1 LCC




Outcome: Smoked 100+ Cigarettes


Never E-CigReferentReferentReferent
E-Cig Past 30 Days2.56 (1.58 – 4.14)2.60 (1.61 – 4.19)1.21 (0.69 – 2.13)
E-Cig Trier2.13 (1.43 – 3.18)2.16 (1.46 – 3.22)1.45 (0.88 – 2.38)
Outcome: Smoked Past 30 Days


Never E-CigReferentReferentReferent
E-Cig Past 30 Days2.29 (1.64 – 3.19)2.12 (1.52 – 2.96)1.41 (0.998 – 2.00)
E-Cig Trier1.56 (1.15 – 2.12)1.43 (1.05 – 1.95)1.09 (0.78 – 1.52)
Outcome: Smoked 100+ Cigarettes and Smoked Past 30 Days


Never E-CigReferentReferentReferent
E-Cig Past 30 Days2.56 (1.52 – 4.32)2.55 (1.51 – 4.31)1.32 (0.75 – 2.30)
E-Cig Trier2.41 (1.46 – 3.97)2.45 (1.49 – 4.03)1.70 (0.96 – 3.01)
BR-NP, Rodu-Plurphanswat reproduction of Chaffee et al. odds ratios
 
When we added lifetime cigarette consumption (LCC), the positive results for e-cigarettes essentially disappeared, negating Chaffee’s core claim.
 
It is well established that past smoking (in this case, LCC at Wave 1) predicts future smoking (one year later).  Chaffee, Watkins and Glantz ignored this information in order to claim that e-cigarettes are a gateway to smoking.  Their study should be retracted.  


I will review in my next post Chafee’s published response to our comment.



Original author: Brad Rodu
295 Hits
0 Comments

Alcohol Clinical Trial Should be Halted Because It Was Designed to Promote Drinking, Not to Answer a Research Question

Digging Deeper into the Harvard/NIAAA Solicitation of Alcohol Company Funding

In a previous post, I noted that I had reviewed materials obtained by the New York Times and shared with me for the article revealing that the NIAAA solicited funding from alcohol companies for the clinical trial of potential benefits of alcohol. A deeper examination of those materials allows me to now reveal that the real purpose of the clinical trial is not to conduct research to answer a question, but to help the alcohol industry sell beer, wine, and liquor by producing newspaper headlines to get doctors to start recommending moderate drinking to their patients.

The document I reviewed is a slide presentation and accompanying summary information apparently intended for a sales pitch to alcohol companies to fund this clinical trial. According to the New York Times: "two prominent scientists and a senior federal health official pitched the project during a presentation at the luxurious Breakers Hotel in Palm Beach, Fla., in 2014." The lead scientist on the "presentation team" was Dr. Kenneth Mukamal, who is now the Principal Investigator of the clinical trial. The senior federal health official on the "presentation team" was Dr. Lorraine Gunzerath, the Senior Advisor to the Director of the NIAAA.

Importantly, according to the New York Times, Dr. Gunzerath stated that this research would not have been conducted without the support of the alcohol companies because "We were supposed to be preventing alcoholism, so to spend that kind of money on research for a possible good use of alcohol was something that would never fly."

Also, according to a previous New York Times article: "Dr. Mukamal, who has published dozens of papers on the health benefits of alcohol consumption, said he was not aware that alcohol companies were supporting the trial financially. “This isn’t anything other than a good old-fashioned N.I.H. trial,” he said. “We have had literally no contact with anyone in the alcohol industry in the planning of this.”"
 
Based on this information, it appears that we already have three areas of misconduct in this research study before the trial itself has even been initiated:

1. The NIAAA violated NIH policy by soliciting funding from the alcohol industry. The NIH policy does not allow institutes to solicit funding. (NIH Policy Manual 1135 [Gifts Administration] - "NIH policy prohibits employees, either directly or through another party, from requesting or suggesting donations to the NIH or to any of its components, of funds or other resources intended to support activities.")

2. The NIAAA also violated NIH policy by accepting funding for a study that would not have been conducted were it not for the alcohol company money. Institutes of the NIH may accept a contribution, but only to conduct research that is either already underway or that would have been conducted even in the absence of that contribution. (NIH Policy Manual 1135 [Gifts Administration] - "the NIH may accept a gift to support a mission-related priority if it is already conducting the activity or is prepared to conduct the activity even without the gift. However, the NIH is precluded from accepting a gift to support an activity that would not be conducted but for the gift and thereby reorders the programmatic priorities of the agency and diverts the use of appropriated dollars from activities with higher priorities.")

3. The trial's principal investigator appears to have lied about not knowing that alcohol companies were supporting the trial and "literally" not having had any contact with alcohol companies.

The Rest of the Story

These facts alone are sufficient to warrant an immediate halt to the clinical trial. But today, I am revealing that the story gets even worse.

The stated purpose of the clinical trial, according to the presentation materials, was not to conduct an impartial investigation into the health effects of moderate drinking, but to produce newspaper headlines that would get doctors to recommend that their patients start drinking. Here is how the primary aim of the research was described:

"The proposed clinical trial is designed to provide doctors with the scientific/medical justification to incorporate a moderate drinking recommendation into their advice to patients."

To execute the sales pitch, the presentation includes a slide entitled "The Ultimate Goal." What is the ultimate goal? The slide shows three newspaper headlines touting the health benefits of an olive oil diet and a Mediterranean diet. Apparently, the ultimate goal is to generate news headlines reporting that moderate drinking is part of a health diet.

In another slide, entitled "The Bottom Line," the presentation again explains that the primary purpose for the study is to "convince clinicians, patients, and policymakers that alcohol consumption in moderation is safe and a healthy part of diet..."

Yet another slide emphasizes that "What's missing" is "the type of convincing evidence that will show that moderate drinking is: 1) Safe 2) Part of a healthy diet to lower risk of common, important health problems. How do we do that?"

The rest of the story is that beyond even the violation of NIH policies and the ethical breaches committed in the planning of the study, the trial is scientifically compromised from the start because the researchers have essentially promised positive results to the alcohol industry, have demonstrated a substantial bias that undermines the objectivity of the study, and have stated that its purpose is not to answer a research question objectively but to provide the opportunity for newspaper headlines in order to convince doctors to start recommending moderate drinking to their patients.

That's a great sales pitch, and it's no surprise that it worked. If I were running an alcohol company, I would have been in on this marketing investment all the way. That the federal government -- and the nation's leading alcohol research agency to boot -- is offering this marketing opportunity is disillusioning.
Original author: Michael Siegel
303 Hits
0 Comments

Instead of Greenlighting IQOS Sales, FDA Continues to Slow-Walk Safer Cigarette Substitutes


The introduction of heat-not-burn cigarette substitutes in Japan has led to a precipitous reduction in cigarette consumption.  

Tobacco industry analyst Michael Livery of Piper Jaffray recently issued a report on the Japanese market, citing 2017 sales data. The chart at left suggests that Philip Morris International’s IQOS heat sticks (green) and BAT’s Glo products (blue) caused a 13% decline in cigarette consumption for the year.  Livery deliberately underestimated the number of heat sticks sold because of evidence that up “to 20% (4th Quarter 2017) of iQOS HeatStick volumes…is getting re-sold in China, Thailand, and Hong Kong, and likely other parts of Asia.”

I suggested (here) that a similar result could be possible in the U.S., if the FDA grants marketing approval for such products. The agency, however, appears to be in no rush to make a decision.

Philip Morris submitted a premarket tobacco application (PMTA) to the FDA on March 31, 2017; it has been pending ever since.

According to the FDA (here), if a PMTA is accepted and found to be complete, the agency will file it and begin substantive review.  “After completing its review, FDA intends to issue an order within 180 days after receipt of the Premarket Tobacco Application that the new product may or may not be introduced or delivered for introduction to consumers.” (emphasis added)

The FDA took eight months to grant Swedish Match a PMTA for eight snus products in 2015 (here).  This week marks the twelfth month of FDA consideration of the IQOS PMTA submitted March 31, 2017.

It is often said that regulation is a slow, deliberate process.  But in this instance the FDA is in apparent violation of its own procedural guidelines.  The FDA simply slow walks any decision on safer options for smokers: it took 2.5 years (here) and 4 years (here) to reject requests to correct inaccurate smokeless tobacco warnings.  All of these are examples of regulatory purgatory that I warned about six years ago (here). 

Our country’s smokers and their loved ones deserve better.



Original author: Brad Rodu
315 Hits
0 Comments

Congressional Investigation Needed into Scientific and Ethical Corruption at NIAAA

I used to think of the National Institutes of Alcohol Abuse and Alcoholism (NIAAA) as a highly-reputed, objective, science-based agency whose primary goal was to reduce alcohol consumption to improve the public’s health. The scientific integrity of the NIAAA is critical, as it describes itself as “the largest funder of alcohol research in the world.” The agency is funded by taxpayers to the tune of $480 million a year.

But then one day, all of that changed. On January 16, 2015, I was called into the office of the Director of NIAAA and was essentially reprimanded for conducting NIAAA-funded research that was detrimental to the alcohol industry. My NIAAA grant was focused on studying alcohol marketing and its possible link to underage youth drinking behavior. We identifiedthe brands of alcohol that underage youth are consuming and found that their brand choices were relatedto their brand-specific advertising exposure. At the meeting, I was told that I would never again be funded to conduct research on alcohol marketing, regardless of how highly my research proposal was scored by the scientific review panel.

I later found out that the NIAAA director had extensive contact with the alcohol industry and that he promisedthe Distilled Spirits Council that this type of research would never be funded again: “For the record. This will NOT happen again. … I will NOT be funding this type of work under my tenure.”

Not only had the NIAAA director privately told an alcohol lobbying group that his agency would never fund research on alcohol marketing, but he then went on to participate in the industry’s marketing activities himself by appearing in a promotional video (at 3:17) for Anheuser-Busch InBev, creating the impression that the NIAAA is endorsing the alcohol company and its programs, which is a violation of NIH policy. 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."

Finally, the truth about the relationship between the NIAAA and the alcohol industry has come out. In a New York Times articlepublished last Saturday, Roni Caryn Rabin revealed that the NIAAA actually solicited funding from alcohol companies to conduct a study to demonstrate the “benefits” of alcohol consumption and industry officials were essentially promised positive results.

The Times reported having obtained slides from a presentation by a Harvard researcher to alcohol executives in which he makes a pitch for funding to study the health benefits of alcohol. The NIAAA apparently facilitated the meeting, at which a senior agency official was present. In the slides, the researcher suggests that the study could result in newspaper headlines reporting that alcohol is now part of a healthy diet. Promising positive results before even initiating a study and pitching the study based on its potential economic benefits to the industry violate standards of scientific integrity.

The NIAAA’s solicitation of donations for this research from the alcohol industry was a clear violation of NIH policy, not only because NIH officials are not allowed to solicit donations, but also because they are not allowed to accept funding for a study unless the agency would conduct the research even without the donation. However, a former NIAAA official apparently admittedto telling alcohol industry executives that “the research could not be done without their support.”

The story gets worse. The principal investigator of the study apparently lied about having met with the alcohol industry. In a July 2017 New York Times article, he was quoted as stating: “We have had literally no contact with anyone in the alcohol industry in the planning of this.” However, his name is on a presentation delivered directly to alcohol companies to convince them that they had “a unique opportunity to show that moderate alcohol consumption is safe and lowers risk of common diseases.”

Apparently, the director of NIAAA was also dishonest, as he appears to have told the New York Times that the NIAAA did not solicit alcohol industry funds. This conflicts with the testimony of at least two high-level NIAAA officials—one of whom was the former director—who admitted that the meetings between NIAAA and the alcohol companies were “to determine if they had interest in taking part” as funders.

In fact, the advisor to the former NIAAA director apparently recognized that studying the benefits of alcohol was not even within the scope of legitimate NIAAA research: “We were supposed to be preventing alcoholism, so to spend that kind of money on research for a possible good use of alcohol was something that would never fly.” This is why it was so essential for the agency to convince the alcohol industry to fund the clinical trial.

The solicitation was successful. The NIAAA is now funding a $100 million clinical trial—largely funded by alcohol companies— designed to demonstrate the health benefits of alcohol, and the principal investigator is the researcher who gave the presentation.

Even if the study were a legitimate use of agency funds, it would still be inappropriate because many of its primary investigators have substantial financial conflicts of interest with the alcohol industry. At my institution, such researchers would not even be allowed to be involved in a clinical trial in which they have a significant conflict of interest. Our general policy is that an investigator with a significant conflict of interest cannot conduct a clinical trial on a product made by the relevant company. We do allow conflicted investigators to conduct pre-clinical studies, such as laboratory research; however, the line is drawn definitively at the level of a clinical trial. Thus, the NIAAA also appears to be violating the NIH conflict of interest policy.

Finally, the study itself is misguided and a waste of money. Even if it were to find that moderate drinking can reduce heart disease risk, it would still not be clear that recommending that people who don’t drink start to drink is warranted. Alcohol is a known carcinogen that causes breast cancer even when consumed in extreme moderation. Recommending that people consume a known carcinogen is not something that we do in public health.

In short, the NIAAA is assisting the alcohol industry in a marketing ploy to increase the sales of its products. The research has no scientific integrity and is tainted from the start. Its principal investigator solicited money from the industry and boasted of a positive outcome before the research was even started. Multiple NIH policies have been violated in the planning of the research alone.

That the NIAAA was involved in this corruption is inexcusable. This behavior risks damaging not only the reputation of the alcohol institute, but of the entire NIH. Congress should initiate an investigation immediately to protect the scientific integrity of federal health research. Further, it is imperative that this clinical trial be immediately halted on both scientific and ethical grounds.

Disclosure: I was a recipient of a grant from the NIAAA for a project to study the effects of brand-specific alcohol advertising on youth alcohol brand consumption (R01 020309 – September 20, 2011 through June 30, 2015).
Original author: Michael Siegel
287 Hits
0 Comments

Kentucky Tobacco Taxes: The Rest of the Story


Kentucky’s tobacco opponents are furious.  Their coalition crusaded for big tax increases on all tobacco products, but the State House of Representatives instead passed a 50-cent tax increase on cigarettes and left chew/dip products and e-cigarettes alone.  That is in keeping with the rational tax plan (here) authored by me, released by the Pegasus Institute last Fall and supported by 16 tobacco research and policy experts from Kentucky and across the U.S.

Coalition member Al Cross objected in a March 2 commentary in the Louisville Courier-Journal that we “didn’t know or tell the whole story.”  He is wrong, and here’s why.

Cross implied that our proposal was linked to tobacco companies, alleging, “It appears that tobacco companies ‘came out with the 50-cent proposal to kind of blunt the effort to go to a dollar or higher,’ said Ben Chandler, president of the Foundation for a Healthy Kentucky.”

This is false.  Tobacco companies had nothing to do with our proposal; it was the result of years of work in the field of tobacco harm reduction and health economics.  I first described this approach in the Tallahassee Democrat15 years ago (here).  We based our current Kentucky tax plan on a 2015 article in the New England Journal of Medicine written by three prestigious tobacco policy experts.  Two of them supported our proposal, along with fourteen other experts. 

Cross’s article contained inconsistent statements.  He claimed that “50 cents more a pack wouldn’t be a big hit for most smokers,” but then wrote, “The big hit would be felt by lower-income people, who are more likely to be smokers.”  Chandler was even more insensitive: “you’ve got to have the sticker shock…”   

Indeed.  We acknowledged that even a 50-cent increase “could present a severe financial challenge to Kentucky smokers, many of whom have only limited resources.”  We made it clear that we are not interested in punishing smokers; our cigarette tax increase is not meant to force them to quit.  Instead, we “encourage and incentivize smokers to quit or switch to less expensive and vastly safer smoke-free tobacco products” like smokeless tobacco and e-cigarettes. 

Decades of epidemiologic studies document that the health risks of dipping and chewing tobacco are, at most, a mere two percent of those of smoking.  Unlike cigarettes, smokeless tobacco does not cause lung cancer, heart and circulatory diseases or emphysema.  A recent government-funded study conducted by federal researchers and experienced epidemiologists found that men who dip or chew tobacco have no excess risk for mouth cancer (here).    

Kentucky men will be especially interested in this information.  Federal survey data shows that 226,000 dip or chew tobacco, 90,000 of whom also smoke.  These dual users don’t know that smokeless is vastly safer; our proposal gives them information and a financial incentive to escape the smoke. 

Tax policy should encourage smokers to switch to e-cigarettes, which already are among the most common – and the most successful – quit aids in the U.S. (here).  While federal health agencies demonize these devices, United Kingdom government and health organizations endorse them based on solid science.  The prestigious British Royal College of Physicians has stated, “…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.”  Britain’s Department of Health last year formally endorsed the substitution of e-cigarettes by smokers.

Cross wrote that “Smoking-related health costs in the state are near $2 billion a year.”  We address that concern: “Federal and state spending for Medicaid in Kentucky for fiscal year 2016 was $9.66 billion; smoking was responsible for $1.47 billion. The only way for the Commonwealth to lower these high costs is to provide every option for smoking cessation, including vastly safer cigarette substitutes.”

Cross mentioned “retailers along the state’s border who sell lots of cigarettes to people from states where the taxes are higher.”  We addressed that by trying to “correct cross-border discrepancies in cigarette excise taxes affecting large populations across the Ohio and Indiana borders, and avoid creating other significant cross-border discrepancies.” (emphasis added)

It is well documented that traditional quit-smoking methods, which strive for complete nicotine and tobacco abstinence, fail to help over 90% of smokers.  Kentucky Medicaid currently spends millions on expensive and failure-prone FDA-approved stop-smoking medicines (nicotine patches, gum, lozenges, bupropion, varenicline, and nasal spray and inhalers).    

Our tax proposal offers a superior approach, at no additional cost to the commonwealth.  It incentivizes smokers to switch to smokeless tobacco or e-cigarettes.  The Senate should have acknowledged the substantial health risk differentials between combustible and smoke-free tobacco products, and endorsed the House bill.  Smokers who switch will spend less, and live longer, healthier lives. 


Original author: Brad Rodu
333 Hits
0 Comments

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

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

...
Continue reading
331 Hits
0 Comments

Correspondence Between NIAAA and the Alcohol Industry

Correspondence obtained as the result of my FOIA request to the NIAAA.
Original author: Michael Siegel
331 Hits
0 Comments

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
312 Hits
0 Comments

Public health experts rally to support US legislative initiative on vaping

March 13th, 2018

...
Continue reading
350 Hits
0 Comments

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




Benzene000.2
Butadiene000
Ethylene Oxide1.30.51.0
Acrylonitrile01.359
Acrolein193254440
Propylene Oxide152940
Acrylamide3567236
Crotonaldehyde100149185
*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
399 Hits
0 Comments

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

...
Continue reading
392 Hits
0 Comments

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.

...
Continue reading
375 Hits
0 Comments

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. 


.nobr br { display: none } td { text-align: center}
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*
Aluminum22.2NA--
Cadmium0.13215.4 LITERS
0.136*1.1 LITER*
Chromium43.9368 milliliters
Copper51.030588 milliliters
Iron23.6NA--
Manganese9.564.08*427 milliliters*
Nickel289517.3 milliliters
Lead37.15135 milliliters
30*808 milliliters*
Antimony1.932010.4 LITERS
Tin19.4603.1 LITERS
Zinc809NA--
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
423 Hits
0 Comments

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
440 Hits
0 Comments

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
336 Hits
0 Comments

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
350 Hits
0 Comments

Five Flavor Review

Featured Review

Video Tour of Lab