Tuesday, October 19, 2021

More Bad Behavior from Journal Authors & Editors on A Fatally Flawed Study of Vaping & COPD

Following is another example of junk science published by anti-tobacco crusaders, abetted by negligent journal editors.

The journal Tobacco Induced Diseases on April 7 published an article by Emine Bircan and colleagues at the University of Arkansas.  They claimed that e-cigarette use “is associated with increased odds of self-reported asthma, COPD, and [asthma-COPD overlap syndrome] among never combustible cigarette smokers.” In their abstract, the authors assert that “the age of those at risk in our study was 18–24 years.” 

First, take a look at the chart.  It is axiomatic that COPD is mostly seen in current and former smokers age 55+ years.  Now look at Bircan’s vapers in the last column: the distribution is completely upside down! This led me to examine the article in greater detail, whereupon I discovered numerous obvious errors.

Since the journal prohibits submissions from industry-funded scientists (my research is supported by unrestricted grants to the University of Louisville from tobacco companies), the only avenue to attempt to correct the errors was to write the authors directly.  I exchanged numerous emails with corresponding author Mohammed Orloff and journal editor James Scott over the period April 22 – May 12. Copies of this correspondence are available here.

In addition to raising the issue of young adults with COPD, I listed these significant errors:

1. There were two obvious wrong numbers of never cigarette smokers.

2. The inaccurate and non-standard term “e-cigarette smokers” was used throughout the article.

3. The authors referred to a question (“Do you still have COPD?”) that did not appear in the analyzed surveys.

4. The authors reversed two numbers in a flow chart describing important exclusions.

5. The authors failed to define “missing variables”.

These egregious errors should have been discovered and corrected by the authors, and by the journal’s reviewers and editors. Among the five authors is Pebbles Fagan, Ph.D., a former member of the FDA Tobacco Products Scientific Advisory Committee.

Dr. Orloff responded to my letter: “I should say I feel very embarrassed. Indeed this was sloppy on our side and we will fix and connect with the Editors in Chief on how to move forward.”

Still, the mess wasn’t immediately resolved. I downloaded the datasets from the U.S. government’s Behavioral Risk Factor Surveillance System (BRFSS).  But I was unable to reproduce the article’s study groups, the first basic step of any serious review. When Dr. Orloff disclosed further details of the analysis, I discovered that the authors had deleted 27,000 participants from the BRFSS data who had “ever” used an e-cigarette – even just one time – but did not use them at all at the time of the survey. This critical deletion was made without mention or explanation anywhere in the article. I advised Dr. Orloff that this large cohort should be classified as non-users of e-cigarettes, and the analysis should be re-run.

Dr. Orloff ended the correspondence shortly thereafter, around May 12.

Fast forward to the week of October 12, when the journal published a completely new version of the article, accompanied by the following statement: “The authors would like to express their apologies and regret for the errors in the original published version of the abovementioned article. The corrected article follows.”

The authors corrected their obvious errors, but failed to correct or add any reference to the 27,000 excluded ever vapers. Instead, they added the following brand new text to the discussion section to explain it away, as if it had been part of their research plan:

“Additionally, participants who reported having used e-cigarettes in their lifetime and currently do not use e-cigarettes (defined as former e-cigarette users) were excluded from the study population because of lack of clarity of exposure status and residual effects that have resulted from the e-cigarette derived chemical exposure which contribute to changes in the continuum of the disease progression leading to molecular changes detectable by biomarker analysis rather than reports. These former e-cigarette users have used e-cigarettes sometime in their entire life and have quit for different reasons. Studies have shown that while cessation of tobacco use diminishes the risk of experiencing long-term adverse health effects, past history of tobacco use is still associated with increased risk of lung diseases compared to never having smoked [citation here to a 1997 article ‘Smoking, alcohol consumption, and leukocyte counts.’]”

This explanation makes no sense. It is not valid to define someone who ever used an e-cigarette – even one time -- as a former user. The authors, post-hoc, unsuccessfully defended tossing out 27,000 ever vapers by inventing a “chemical exposure…leading to molecular changes… sometime in their entire life.”  But they kept in their study people who smoked up to 100 cigarettes – a far more toxic product. 

While Tobacco Induced Diseases inappropriately deleted the original article from their website, it is still available at the U.S. National Library of Medicine (here). I have also placed a copy of that original work here.

If the authors had adhered to professional standards, they would have acknowledged my major contributions in their corrective comments, but they did not.

I subsequently learned that Riccardo Polosa, a University of Catania (Italy) physician specializing in respiratory diseases, submitted a letter to the editor of Tobacco Induced Diseases, strongly questioning the validity of respiratory diseases in 18- to 24-year-old e-cigarette users. His letter was rejected.      




Wednesday, October 6, 2021

CDC Releases 2020 Adult Smoking & Vaping Data


The Centers for Disease Control and Prevention has released data from the 2020 National Health Interview Survey (NHIS). 

The prevalence of current smoking was 12.4%; that’s 30.7 million.  Twenty-two percent of Americans were former smokers, the same as the year before. 

Prevalence of current vaping declined to 3.7% from 4.3% in 2019.  That translates to about 9.13 million American adult vapers in 2020. 

The 9.13 million current adult vapers includes 2.44 million who are also current smokers.  Think about this: If America’s public health leaders abandoned their war on vaping and instead adopted their British counterparts’ practice acknowledging that it’s vastly safer, those smokers might walk away from the fire. That would result in a one-year smoking decline of 8%.

Perhaps due to the misinformation campaign against smoke-free substitutes, the number of current vapers who were former smokers declined from 4.27 million in 2019 to 3.95 million in 2020.  However, that number represents the highest percentage (43%) of all vapers since 2014.  One wonders how federal officials can still pontificate – with a straight face – that there’s no evidence that vaping helps smokers quit.    

The best news is in the next chart, which shows the prevalence of smoking and vaping among young adults 18-24 years old.  Smoking has fallen in this group by more than half since 2014, from 16.6% to 7.4%. 


It is noteworthy that the prevalence of vaping in young adults never reflects the high prevalence in high school students.  High school vaping was 20% in 2020, but registered only 9.4% among young adults.  There are several reasons for this.  First, NYTS high school vaping rates are hyperinflated compared with other federal surveys, as I demonstrated here and here.  Second, current use of these products among teens is “once in the past month,” whereas current use among young adults is “every day or some days.”  Third, a small increase in tobacco use after high school is expected, as 18-year-olds escape parental and school supervision, and tobacco can be purchased legally.  It is likely that national adoption of Tobacco 21 will make further inroads into smoking and vaping.

The fact that young adult vaping rates are half of those among high schoolers falsifies federal officials’ claims that vaping is enslaving a whole generation of teens to nicotine.  Previously the claim was just an exaggeration.  Now the claim is being used by the FDA to eradicate a whole generation of life-saving e-cigarette and vaping businesses.


Monday, September 27, 2021

Denial Is Not Just a River in Egypt: FDA Damns the E-Cigarette Market


On September 14, the FDA Center for Tobacco Products denied Premarket Tobacco Applications from Turning Point Brands (TPB) for 525 flavored vaping liquids (here).

FDA’s letter to TPB is instructional, as it provides the rationale for ordering removal of these products from the marketplace.

The FDA acknowledges that TPB provided “clinical studies with abuse liability outcomes and a cross-sectional survey evaluating patterns of use,” but the agency judged these as “not sufficient to show a benefit to adult smokers of using these flavored [electronic nicotine delivery systems, or ENDS].”  Then the regulator drops the hammer: “FDA concludes that your application is insufficient to demonstrate that these products would provide an added benefit that is adequate to outweigh the risks to youth and, therefore, cannot find that permitting the marketing of your new tobacco products would be appropriate for the protection of the public health.”

What kind of evidence does the FDA require?  The kind that costs tens of millions of dollars and takes up to a decade to generate:

“All of your PMTAs lack sufficient evidence demonstrating that your flavored ENDS will provide a benefit to adult users that would be adequate to outweigh the risks to youth.  In light of the known risks to youth of marketing flavored ENDS, robust and reliable evidence is needed regarding the magnitude of the potential benefit to adult smokers.  This evidence could have been provided using a randomized controlled trial and/or longitudinal cohort study that demonstrated the benefit of your flavored ENDS products over an appropriate comparator tobacco-flavored ENDS.” (emphasis added)

What company is going to have the resources to fund a randomized controlled clinical trial – requiring medical-grade procedures and supervision – for one product, let alone 525?  Longitudinal cohort studies are daunting.  They take decades to produce results, require generations of researchers, and cost hundreds of millions of dollars.

The FDA exercises enormous power.  First, it issues minimal PMTA guidance, leaving it to the companies to interpret what they need to submit.  Then, if the agency believes that the benefit of any product to adult users is outweighed by the “risks to youth,” the agency can issue a market denial order (MDO).

Federal officials have for five years claimed that an entire generation of teens is being enslaved by e-cigarettes.  I am one of the few researchers to have critically reviewed these claims.

As I extensively documented, our government has grossly exaggerated the so-called teen vaping epidemic (here, here, here, here), basing their case on one cherry-picked federal survey (here).  They fail to distinguish between vaping nicotine and marijuana (here), and they elevate vaping over far more risky use of alcohol, marijuana (here) and other high-risk teen activities (here). 

The actual risks of vaping by teens are so minuscule that prohibitionists have had to concoct the fallacious argument that “nicotine in e-cigarettes can harm brain development.” (here)  Three years ago I challenged then FDA commissioner Stephen Hahn on twitter: “@SteveFDAm Please provide scientific evidence that people - not mice - show ‘impact nicotine has on [the] developing brain.’  Should be easy, there are ~90 million current/former adult smokers in the U.S. who started as teens. #vapormadness”

Three years later, I am still waiting for an answer.

In a filing to the US Court of Appeals for the Sixth Circuit (here), TPB “seeks review of the order on the grounds that it is arbitrary and capricious, an abuse of discretion…”  That is an understatement.