Thursday, October 28, 2021

E-Cigarette Opponents Torture PATH “One-Puff” Relapse Data to Deny E-Cigarettes’ Cessation Impact


You may have seen headlines like this from CNN: “Using e-cigarettes to prevent smoking relapse doesn’t work well, study finds,” with quotes from the study’s lead author, Dr. John Pierce of the University of California San Diego. 

The research, which appeared in the journal JAMA Network Open (here), relied on data from the FDA’s Population Assessment of Tobacco and Health (PATH) Survey, which for five years has followed smokers and other tobacco users. 

Dr. Pierce generated news coverage largely by making a number of hyperbolic claims: 

“This is the first study to report on whether cigarette smokers can switch to e-cigarettes without relapsing to cigarette smoking…[Smokers] who switched to e-cigarettes (or indeed another form of tobacco) were 8.5 percentage points more likely to relapse to cigarettes…If switching to e-cigarettes was a viable way to quit cigarette smoking, then those who switched to e-cigarettes should have much lower relapse rates to cigarette smoking. We found no evidence of this.”

I have worked extensively with the PATH data.  Two years ago, I found that the authors of one study knowingly included vapers who had heart attacks 10 years before picking up an e-cigarette.  That article was retracted by the journal editors. 

In the new JAMA Network Open report, the authors took a different approach to mischaracterize the facts.  They teased and tortured PATH survey data, which collected information on thousands of factors, to fit their pre-conceived narrative about e-cigarettes and smoking relapse.

Pierce and colleagues focused on 13,000 participants who were adult established smokers the first year they participated in the PATH survey.  Pierce then identified 1,228 (9.4%) who became former smokers one year later (Year 1); at that time, 459 were using e-cigarettes and/or other tobacco products, while 769 were not.  A year after that (Year 2), the researchers used this question to determine who had smoked: “In the past 12 months, have you smoked a cigarette even 1 or 2 puffs?”

That’s right, at Year 2 Pierce counted anyone who even took 1 or 2 puffs on a cigarette as a failure.  Using this yardstick, about 50% of former smokers who weren’t using a tobacco product at Year 1 were still totally cigarette-free at Year 2, compared with 42% of those who had been using e-cigarettes or tobacco at Year 1. 

But here is a fact from Pierce’s study that they did not promote: Former smokers who were using e-cigarettes at Year 1 were “more likely to requit and be abstinent for 3 months at [Year 2] (17.0% vs. 10.4%).”

Adding the results for complete and 3-month abstinence, there was virtually no difference between e-cigarette users (42% + 17%) and non-users (50% + 10%). 

This brings up another issue with Pierce’s media statements.  He said that smokers “who switched to e-cigarettes should have much lower relapse rates to cigarette smoking.”  That ignores the fact that 769 former smokers in his study used no tobacco at Year 1, while 459 different former smokers used e-cigarettes/tobacco.  Both produced complete and 3-month abstinence rates that are similar, and both added to the former smoker pool.  It doesn’t matter how they got there. 

Throughout the article and in his public comments, Pierce referenced smokers “who switched to e-cigarettes.”  That is misleading.  PATH collects information on aids that former smokers used to quit.  (My group published a study on this here.)  The only information Pierce et al. reported was whether former smokers at Year 1 were using or not using e-cigarettes/tobacco.  By ignoring the quitting information, they undercut the positive results for e-cigarettes and distorted the public health message.

Finally, most people know that some former smokers, including those who used e-cigarettes, return to smoking.  Given the drumbeat of misleading negative statements about e-cigarettes – they’re toxic, they enslave children, and now, “E-cigarettes don't help smokers stay off combustible cigs” – it is a small wonder that anyone quits smoking and stays smoke-free with vapor.



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.