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.      




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