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Mountain Vapor Blog

Welcome to the blog area of our site where we hope to keep you updated on the trends of the e-cigarette industry as well as product reviews.

Tobacco Research Is Not Immune to Scientific Scrutiny


Recently, the authors of a research article on e-cigarettes groundlessly attacked my credentials and academic independence after I noted, in a letter to journal editors, a lack of scientific rigor in their reporting. The article falsely claimed that e-cigarette use caused experimental smokers to become regular smokers.  In response to my critical remarks, the authors made these charges in their own letter to the editors: “This recent comment is another in a long series of letters or comments from Dr. Rodu…in which he has criticized research that is inconsistent with the tobacco industry’s interests in promoting e-cigarettes and smokeless tobacco.”

As an academician, I have both authored articles and scrutinized tobacco research for many years, advising journal editors on those occasions when I found factual deficiencies in published articles.  This effort has served the interests of science and the pursuit of truth.

Professional medical journals position themselves as platforms for the publication of honest, transparent, reproducible research.  In an effort to identify inaccuracies and other defects, submissions are subjected to review by editors and multiple external authorities who are experts in relevant fields.

Over the last 24 years, in addition to my authorship of 54 peer-reviewed articles for medical and scientific journals (here), I have had 11 letters of scientific criticism published in leading journals, linked below.               

1.  Rodu B, Cole P.  Excess Mortality in Smokeless Tobacco Users Not Meaningful.  American Journal of Public Health85:118, 1995.

2. Rodu B, Cole P. Smokeless Tobacco and Periodontal Disease. Letters to the Editor. Journal of Dental Research84:1086-1088, 2005.

3. Rodu B, Cole P. A deficient study of smokeless tobacco use and cancer (letter).  International Journal of Cancer 118: 1585, 2005.

4. Rodu B. Snus and the risk of cancer of the mouth, lung, and pancreas.  Lancet 370: 1207, 2007.

5. Rodu B.  Smokeless tobacco: Society response debatable (electronic letter).  CA: A Cancer Journal for Clinicians 2008; 58. 

6. Rodu B, Heavner KK.  Errors and omissions in the study of snuff use and hypertension (letter).  Journal of Internal Medicine 265: 507-8, 2009.

7. Rodu B, Heavner KK, Phillips CV.  Snuff use and stroke (letter).  Epidemiology 20: 468-9, 2009.

8. Rodu B.  Dual use (letter).  Nicotine & Tobacco Research 13: 221, 2011.

9. Rodu B, Plurphanswat N, Phillips CV.  Discrepant results for smoking and cessation among electronic cigarette users (letter).  Cancer 2015 Mar 4. doi: 10.1002/cncr.29307. [Epub ahead of print]

10. Rodu B, Phillips CV.  Regarding “Discontinuation of Smokeless Tobacco and Mortality Risk after Myocardial Infarction” (letter).  Circulation 2015 Apr 28;131(17):e422. doi: 10.1161/CIRCULATIONAHA.114.012038.

11. Rodu B.  Re: Smokeless tobacco use and the risk of head and neck cancer: pooled analysis of US studies in the INHANCE consortium.  American Journal of Epidemiology2017  DOI: 10.1093/aje/kwx211

All scientific research should be subjected to rigorous objective review. On those occasions when pre-publication editorial and peer review fail to identify deficiencies, honest criticism should be encouraged and acknowledged by offending publications.





Original author: Brad Rodu
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Pediatrics Editors Claim Compliance with – But Instead Violate Publication Ethics Guidelines


In previous blog posts I described how Pediatrics editors refused to retract a fatally flawed study by University of California San Francisco authors (hereand here).  I also described how they allowed publication of unsubstantiated ad hominem attacks, then tried to cover them up by scrubbing the journal website (here). 

Carl Phillips afforded the editors a chance to account for their unprofessional actions in an article at The Daily Vaper (here).  They responded by saying that their actions were consistent with the Committee on Publication Ethics (COPE) guidelines for journals.  This is demonstrably false.  The editors violated three of the guidelines (available here).

The COPE guidelines say that “Editors are accountable and should take responsibility for everything they publish.” 

However, instead of taking responsibility for publishing an ad hominem attack, they simply erased the attack from the Pediatrics website with no retraction or apology (here).  To make matters worse, they also deleted another comment by Bates and colleagues (here), which violated another COPE principle:

“Editors should adopt editorial policies that encourage maximum transparency and complete, honest reporting.”

Carl Phillips described another instance of zero transparency:

“During the dispute over the comments, the editors informed Rodu that they were commissioning an independent ‘expert’ review of the dispute. Clearly there was no genuinely expert review, because that would have concluded that Rodu was right and Chaffee’s comment was nonsense. The editors did not post the review to the comments thread, as they should have, and refused a request by The Daily Vaperto see a copy of it.”

Finally, as Phillips and I have documented in detail, the Pediatrics editors violated a third principle:

“Editors should guard the integrity of the published record by issuing corrections and retractions when needed and pursuing suspected or alleged research and publication misconduct.”

The original manuscript from Benjamin W. Chaffee, Shannon Lea Watkins, and Stanton A. Glantz was never retracted after it was clearly demonstrated to be deficient, and the Pediatricseditors – Drs. Lewis First (University of Vermont), Alex Kemper (Nationwide Children’s Hospital, Columbus Ohio) and Mark Neuman (Harvard) – are guilty of publication misconduct.



Original author: Brad Rodu
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E-Cigarette Opponents Still Making Up False "Facts" to Demonize Vaping

We're well into 2018 and there is now substantial research on the health effects of vaping as well as a decade of experience with large numbers of vapers, yet e-cigarette opponents are still making up false claims to buttress their demonization of vaping.

In an article by Jia Tolentino published yesterday in the New Yorker, a Harvard professor was quoted as claiming that: "vaping can cause something called bronchiolitis obliterans, or popcorn lung."

He also stated that Juul is "a massive public-health disaster," likened e-cigarettes to “bioterrorism,” and "predicted that, eventually, a state’s attorney general would sue Juul 'for willfully designing and pushing a product that will cause harm to the children of the United States.'"

The Rest of the Story

While he may be able to fool the public, this professor was no match for the likes of Jia Tolentino, who did extensive background research and therefore pointed out that: "Popcorn lung has been linked to diacetyl, an organic compound that some companies use in their e-liquid, and that has been detected as a by-product of e-cigarette vapor. But diacetyl has also been detected in cigarette smoke, at a level hundreds of times greater, and no feasible amount of smoking has been found to cause popcorn lung."

Moreover, there has not been a single reported case of bronchiolitis obliterans linked to vaping in the United States, despite millions of users and a decade worth of experience with heavy use of the product.

Claiming that vaping causes popcorn lung is irresponsible, as there is no evidence to back up the claim. If you're going to tell the public that vaping causes a serious and often deadly progressive respiratory disease, you ought to have at least one -- just one -- case to back it up.

The truth is that there is no evidence that vaping causes bronchiolitis obliterans and despite having levels of diacetyl that are hundreds of times higher, smoking itself has not been linked to bronchiolitis obliterans.

As I've said before, there's plenty of room for differing perspectives on the net public health benefits of electronic cigarettes, but making up false information is not acceptable, nor is it consistent with the ethical principles of public health practice.

The comparison to "bioterrorism" is also irresponsible and inappropriate. Vaping companies are doing a tremendous service to millions of smokers throughout the U.S. who have been unable to quit using pharmaceuticals, but have succeeded in quitting thanks to electronic cigarettes. To call these companies bioterrorists is despicable.

It is also inappropriate to call Juul a massive public health disaster. True, Juul is a major problem because it is leading to widespread youth use with a significant potential for addiction. But Juul is also helping millions of adults quit smoking. Its market share is up to close to 60%, so it appears to be the most commonly used strategy for quitting smoking in the United States. That's hardly a public health disaster.

Finally, it is irresponsible and inappropriate to accuse Juul of "willfully designing and pushing a product that will cause harm to the children of the United States." First of all, Juul did not design the product with the intention of causing harm to children. The product was designed to help adult smokers quit smoking. That is a laudable goal, not an evil one. In fact, the Juul represents a major advance in the effort to promote smoking cessation because it is the first electronic cigarette to deliver nicotine in a manner that is similar to real cigarettes and therefore is acceptable to a larger number of smokers who reject traditional e-cigarettes because they fail to deliver a nicotine hit.

Second of all, if you're going to sue Juul, you ought to also sue every single alcohol company as well. Their products are also causing harm to the children of the United States. And what about the tobacco companies themselves? Their products are causing far more harm to the children of the United States than all e-cigarettes combined. Why would we even think about suing Juul but not file suit against the cigarette companies as well?

Sadly, the scientific evidence doesn't matter any more in tobacco control. Our pre-determined conclusion that vaping is terrible, based on an almost puritanical ideology, is now running the show. Worse still, the actual truth about the harm being caused by products like Juul is not enough. We have to make up false and alarming information to support our pre-determined conclusions.

Let's be clear. There are at least 2 million ex-smokers in the U.S. who have quit smoking because of electronic cigarettes. To call this a public health disaster is to throw these 2 million former smokers under the bus and to essentially conclude that their lives don't matter.

I, too, have been outspoken about the risks posed by the widespread adoption of Juuling. But you have to have a sense of perspective. Yes, this is a serious concern. Yes, action needs to be taken to try to stem the tide of Juuling. But the Juul isn't causing substantial health damage. There is no evidence that even long-term Juuling increases the risk for disease. And Juul is helping hundreds of thousands of smokers to quit and perhaps save their lives.

The rest of the story is that this Harvard professor has now misled the entire nation into thinking that vaping causes a serious, often fatal, progressive respiratory disease, without a shred of evidence that this is the case and with overwhelming evidence that it simply is not true. Whatever you think about vaping and Juuling, lying to the public is not what we do in public health.
Original author: Michael Siegel
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Pediatrics Journal Ignores Its Stated Editorial Standards


The journal Pediatricsin March published an article by University of California San Francisco’s Benjamin Chaffee, Shannon Lea Watkins and Stanton Glantz claiming that e-cigarettes lead to smoking. The claim was baseless; the authors ignored subjects’ past smoking activity, as I explained in an earlier blog post (here).

On March 15, I submitted a comment to the journal with a re-analysis of Chaffee’s data using the omitted variable and demonstrating the invalidity of Chaffee’s claim.  On the basis of this flaw, I requested retraction of the article. 

Our comment was published on the Pediatrics website March 30, along with a response from Chaffee et al. that further validated a retraction (here).  Their response included an attack on my independence, veracity and transparency.  Clive Bates, David Sweanor, David Abrams and Raymond Niaura endorsed our analysis in an April 11 comment, labeling Chaffee’s response “inadequate, disappointing and surprising.”  They pointed out that it was “disappointing because the authors, apparently with the approval of the journal, have resorted to an ad hominem attack on Rodu and without showing any improper conduct or incomplete disclosure.” 

I had responded to the attack by Chaffee et al. with an email to the Pediatrics editors on April 9:

“Chaffee et al. stated that my ‘financial ties to the tobacco industry are much more extensive than the posted disclosures suggest.’ This is false, defamatory and potentially libelous on two accounts, alleging that I made an inadequate disclosure, and that I have more ‘financial ties.’ My disclosure was accurate and complete. In addition, the website they cited contains no supporting evidence for their allegation, because I have no other financial ties or conflicts of interest. The journal has specific policies prohibiting both defamatory/libelous comments and weblinks. These policies also provide guidance for your immediate attention to this matter.” (here)

On or about April 24, Pediatricspublished a revised response from Chaffee et al.  Their fictitious claims about “financial ties” had disappeared, but the revised text carried the same date as the authors’ original comment.  The editors failed to indicate a correction had been made, and that erroneous and disparaging remarks had been removed.  The editors had allowed the libelous statements to remain on the journal site for nearly a month; the offending remarks are still available elsewhere on the Internet (here).

The editors violated the journal’s stated policy: “Once a comment has been posted on the website, you will not have the right to have it removed or edited… Be sure to follow all of the consideration criteria below; you will not be able to modify your comment after submission.” (emphasis in original)

Compounding this journalistic failure, the editors encouraged Clive Bates and colleagues to edit their published comment and delete language countering Chaffee et al.’s defamatory remarks.  When Bates did not immediately comply, the editors deleted the entire Bates comment.  However, it is still available here.

Journal editors Drs. Lewis First (University of Vermont), Alex Kemper (Nationwide Children’s Hospital, Columbus Ohio) and Mark Neuman (Harvard) owe Pediatrics readers full compliance with their journal’s editorial standards, including a detailed correction notice and republication of the full text of the Bates et al. comment.


Original author: Brad Rodu
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Poison Control Centers' Data Puts E-Cigarette Exposure Risk in Perspective


The journal Pediatricsrecently reported that “there were more than 8,200 calls to US poison centers regarding exposures to liquid nicotine and e-cigarettes among children younger than 6 years of age from January 2012 through April 2017, averaging 129 calls each month or more than 4 a day.” (here) As I previously noted (here), annual exposures (which were 1,548 according to the Pediatrics article) should be considered in appropriate perspective. 

While the journal article acknowledged that e-cigarette exposures “decreased by about 20% from 2015 to 2016,” its senior author called for additional regulation.  If children’s exposure to products should guide regulatory priorities, the following chart from the American Association of Poison Control Centers (2016 report available here) may be instructive.

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Non-Pharmaceutical Exposures Reported To Poison Control Centers in the U.S., 2016




Product CategoryNumber Among Children Under 6 YearsNumber Among All AgesDeaths Per 100,000 Exposures*




Cosmetics, personal care products136,004180,0653
Household cleaners111,445179,82813
Foreign bodies65,86490,6671
Pesticides33,45877,57322
Plants27,56545,15024
Arts, crafts, office supplies20,09627,3190
Deodorizers17,39821,26614
Essential oils (clove, etc.)13,26418,9970
Tobacco11,35813,3190
Cigarettes6,3316,699--
E-Cigarettes2,0752,827--
Chewing tobacco1,2201,357--
Other1,7322,436--
Foods, additives, spoilage10,83933,9099
Alcohols9,56222,289117
Chemicals9,32833,91080
Gasoline, other hydrocarbons8,82127,80776
Bites, venom6,70846,98915
Paint, strippers6,60112,2380
Batteries5,4839,65141
Adhesives, glue4,6929,6220
Fumes, vapors3,67331,337214
Fertilizers2,7594,59080
Other35,85994,02444




All540,777980,55026

* All Ages

Of the half million exposures among children under 6 years of age recorded by poison control centers in 2016, 45.8% involved cosmetics, personal care products or household cleaners, while e-cigarettes accounted for just 0.4%. 

Looking at product-related deaths per 100,000 exposures, rates were highest for fumes and vapors (which included carbon monoxide) and for alcohols, but there were no deaths recorded for tobacco exposures, including e-cigarettes.

Public health generally and children’s health in particular may benefit from regulatory reform that is keyed to demonstrated risk exposure.



Original author: Brad Rodu
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The urge to ban: 10 questions to ask first

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FDA Blocks Consumer Access to New Smokeless Products


When Congress gave the FDA regulatory authority over tobacco in 2009, it specified that manufacturers wanting to sell a new product must get a “substantial equivalence” (SE) order demonstrating to the FDA that the product has the “same characteristics as a predicate tobacco product [i.e. on the market before February 15, 2007]; or has different characteristics than the predicate tobacco product but…does not raise different questions of public health.” (here)



Copenhagen brand moist snuff has been available in the U.S. since 1822.  The U.S. Tobacco Company (UST) had 17 different styles of the brand, including 5 pouches and 4 with wintergreen flavoring on the market in 2007.



It's worth examining UST's SE application submitted on November 13, 2015 for a variant to be called Copenhagen Bold Wintergreen Pouches.  According to the Troutman Sanders law firm blog (here):



“The Copenhagen Bold [WG Pouches] SE submission compared the new product, a portioned smokeless tobacco in pouches with a grandfathered product in the same format (pouched smokeless tobacco) but containing different tobacco.  UST had considered using a different grandfathered product – a loose tobacco product with the exact same blend and formula as Copenhagen Bold – but the FDA discouraged UST from doing so because the grandfathered product was in a different format.  At the FDA’s suggestion, UST designated the grandfathered loose tobacco product with the exact same tobacco blend and formula as Copenhagen Bold as a ‘surrogate’ product.”



Despite the company’s acquiescence in using its loose wintergreen snuff as the predicate product, the FDA denied the SE on July 13, 2017.  UST’s appeal of that decision was denied by the agency on January 2, 2018. The company sued the FDA on February 2, seeking to overturn the agency’s action. The filing is available here.



This lengthy, so far futile attempt to gain marketing approval for a simple variation of a moist snuff product that is associated with nearly zero health risks underscores the broken state of the FDA review process.



To be clear, my criticism of FDA is not intended to further the interests of any company, but rather to advance the health interests of American smokers who should be encouraged to switch to safer smoke-free cigarette substitutes. Limiting the market entry of potentially attractive cigarette alternatives reduces the chance that smokers will give up their dangerous habit.




Original author: Brad Rodu
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FDA Is Targeting E-Cigarette Retailers, But They’re Not Teens’ Primary E-Cigarette Source


FDA Commissioner Scott Gottlieb reportedlytestified at a House Appropriations subcommittee April 17 about “excessive use of e-cigarettes among youths…Gottlieb said the FDA will crack down on youths' use of e-cigarettes in the coming weeks.  ‘We are going to take some vigorous enforcement steps to try to perceive what we see is inappropriate use by youth,’ Gottlieb said, refusing to elaborate on when the action will happen.  The agency has several avenues for targeting retailers that are selling to minors.  Those include a warning letter, massive fines, or banning the retailer from selling any tobacco or e-cigarettes.”

A common theme among e-cigarette prohibitionists is that the protection of children justifies all forms of regulation.  Beyond that, the commissioner’s remarks are undercut by the fact that only a small percentage of children have tried e-cigarettes, and only a tiny fraction of those youths bought c-cigarettes from retailers.  Support for this is seen in the FDA’s Population Assessment of Tobacco and Health (PATH) survey.  The PATH youth survey collected detailed information about tobacco use from 13,628 participants age 12-17 years in 2013-2014.  Based on the survey’s sophisticated weighting formula, the figures below are estimates for 25 million teens across the U.S.

The data reveal that about 2.6 million teens had ever used an e-cigarette in 2013-14.  Of these, about 771,000 had used e-cigarettes in the past 30 days – the widely accepted definition of “current” use among youth and consistent with another federal survey of teen tobacco use (discussed here).  This means that there were far fewer current e-cig users in PATH than currently used alcohol (1.83 million) or marijuana (1.24 million), which is also consistent with other federal surveys (discussed here).

Current e-cig users were asked: “In the past 30 days, how did you usually get your own e-cigarettes/cartridges and e-liquid?”  Here are the results:


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PATH Survey: How Did You Get Your E-Cigarettes?
HowNumber of teensPercentage



Someone offered me one353,70046%
Gave someone else money to buy them126,50016%
Bought them myself75,7009.9%
Asked someone to give me one73,7009.7%
Got them some other way52,5006.9%
Took them from a store or another person31,6004.1%
Bought them from another person24,7003.2%
Don’t know, refused to answer32,4004.2%



All770,800100%





The table shows that only 10% of current teen users, about 76,000, bought e-cigarettes for themselves.  In other words, while the FDA and other government agencies pursue vaping manufacturers and retailers, the vast majority of teens get e-cigarettes from unregulated sources.  Of course, even more teens use alcohol, which is only sold to adults age 21+ years, and marijuana, the sale of which is legal to adults only in limited states.



Original author: Brad Rodu
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NIH Director Grilled at Appropriations Hearing About NIAAA Collusion with Alcohol Industry

At the House Appropriations Committee hearing on the NIH Budget, NIH director Dr. Francis Collins was grilled about the collusion between the NIAAA and the alcohol industry in planning a clinical trial to study the health benefits of alcohol use. Congresswomen Lucille Roybal-Allard (D-CA) expressed concern about the fact that NIAAA violated NIH policy by soliciting funding from the alcohol companies and asked Dr. Collins who authorized the solicitation of funding. While Dr. Collins did not answer the question, he did say that his office is conducting an investigation and will provide the Inspector General with any uncovered materials that are of concern.

The questioning begins at 51:30 of the video.
Original author: Michael Siegel
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Another UC San Francisco E-Cigarette Gateway Claim, Based on Tiny Numbers


Last week I called for retraction of a flawed study by University of California San Francisco’s Benjamin W. Chaffee, Shannon Lea Watkins and Stanton A. Glantz that appeared in the journal Pediatrics (hereand here).  

Once again using the FDA Population Assessment of Tobacco and Health (PATH) survey, the same authors exaggerated the gateway effect of e-cigarettes, hookah and smokeless tobacco in a January JAMA Pediatrics article (here).  I criticized at that time the omission of information that would have provided context for their findings (here).  The exaggerations were amplified in the media.

In an interview with National Public Radio (here), Dr. Watkins failed to note the minuscule numbers used in her study to support the gateway claim.  I have inserted those numbers in bold in her quote, here:

“We found that kids who tried e-cigarettes [n=11] or hookah [n=8] or smokeless tobacco [n=3]or cigars [n=7] – any noncigarette tobacco product – were all twice as likely to try cigarettes a year later compared to kids who hadn’t used any of those other tobacco products [n=175].  Kids who were using two or more noncigarette products [n=15] were four times as likely to report using cigarettes a year later.” (I have confirmed these numbers in the FDA data; they are in the table below)

Dr. Watkins added the extraordinary claim that trying one tobacco product changes one’s perception of cigarettes: “Using these products might change a kid’s perception of the harm of cigarettes, and so they are perceived as less dangerous and they get used to using tobacco and so using conventional cigarettes is not so scary or ‘bad’.”

In her view, trying a tobacco product causes one to change friends: “It will expose them to different kinds of kids, maybe kids that are already using conventional cigarettes, and then they might go on to try them.”

Instead of sharing her conjecture on how e-cigarettes led 11 children to begin smoking, Dr. Watkins should have focused on the fact that 80% of the 219 new smokers [n=175] in her study had not previously used any tobacco product.



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Odds Ratios And Numbers of Teens Smoking Cigarettes After One Year, According to Ever Tobacco Status at Baseline
Ever Tobacco Status- Baseline (n)Odds RatioNumber Smoking At One Year (%)



Never tobacco use (9,058)Referent175 (79.9)
E-cigarettes (255)2.1211 (5.0)
Hookah (189)2.158 (3.7)
Other combustible (114)3.087 (3.2)
Smokeless tobacco (93)1.533 (1.4)
Two or more products (200)3.8115 (6.8)



All (9,909)
219 (100)
Original author: Brad Rodu
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The US media is losing its mind over vaping and Juul – the questions a credible journalist should ask

April 9th, 2018

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

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UC San Francisco Authors Inadvertently Validate Our Call for Retraction


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

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

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

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

In this, Chaffee et al. prove our case. 

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

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

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

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

The Chafee article must be retracted.
 






Original author: Brad Rodu
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Retract the UC San Francisco E-Cigarette “Gateway” Study


Some published articles are so flawed that they deserve retraction.   

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

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

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

Using the PATH data, my research team reproduced Chaffee’s analysis and Pediatrics published our results online (here).  The table we submitted to the journal was published in an unreadable fashion, so we offer it here.
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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
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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
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Instead of Greenlighting IQOS Sales, FDA Continues to Slow-Walk Safer Cigarette Substitutes


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

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

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

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

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

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

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

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



Original author: Brad Rodu
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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
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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
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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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