Exposing Defective Research, But Denied Credit: Case 3

 

Over the years, I have documented cases in which my colleague and I exposed fatal errors in published articles about smoke-free products, but neither authors nor editors acknowledged our efforts.

The first case involved researchers at the National Cancer Institute and the University of Minnesota, whose Journal of the National Cancer Institute Cancer Spectrum article (here) reported on overall and cause-specific mortality among users of various tobacco products. The second instance involved an article about e-cigarettes and respiratory diseases in which the authors, including a former member of an FDA Tobacco advisory panel, had deleted data on over 27,000 ever e-cigarette users with no mention or explanation, among other problems (here.

In both cases, our criticism was accepted as legitimate by the authors and editors, but the parties defied medical publishing ethics when they failed to publicly acknowledge our work and, instead, made it appear that the errors were discovered by the authors.

That same sequence is now playing out again.

Dayawa Agoons and coauthors published a study on November 22, 2021, in the American Journal of Medicine Open claiming, “There was a graded increase in the prevalence of fragility fractures among sole conventional cigarette smokers and dual users of traditional and e-cigarettes [among 5,569 men and women in their sample].  Electronic cigarette use may be detrimental to bone health.”  They used data from the 2017-18 National Health and Nutrition Examination Survey (NHANES). 

Working with the same data, my colleague Nantaporn Plurphanswat and I discovered that Agoons had overcounted the eligible sample.  There were only 3,069 participants, not the reported 5,569.  On December 22, we submitted a letter to the editor calling for retraction, since none of the study results could survive a sample change of this magnitude.

Six months later, on June 8, I was informed by the editor-in-chief that our letter was accepted.  On June 29, I reviewed and proofed our letter in the Elsevier system, but then it disappeared. 

I wrote to Elsevier on October 18, saying, “I made these [copy editing] changes almost 4 months ago.  Please let me know why this article has not been published.”  I received the following reply on October 19:

“Dear Dr. Rodu,

“Many thanks for your email. Your article has not yet been finalised as we are still waiting for the Editor in Chief to submit their proof of your article. I have sent them a reminder that this needs to be done and will let you know of any updates.

“Best wishes,

Poppy Biggs

Journal Manager

ELSEVIER | Operations | Research Content Operations”

Today I learned that Agoons and colleagues published a corrigendum that includes completely revised tables and figure.  It was “Available online 16 June 2022,” which was eight days after the editor accepted our letter. 

The corrigendum states, “it has been discovered that the study included subjects that should have been excluded.”  Our letter forced the authors to delete nearly 45% of their original study sample, yet they wrote, “the magnitude/significance of [the original] results remains unchanged.”

Authors and editors who behave this way undermine the quality of their work.  We don’t have the resources to conduct a full re-analysis of Agoons’s corrigendum, but one glaring item suggests its poor quality: Their new figure is labeled with the NHANES years analyzed “2107-2018.” 

When editors and authors collaborate to cover up egregious mistakes, they undermine the integrity and scientific value of their work.

              

 

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.

 

 

Vapers Can Draw Inspiration from this Type 1 Diabetes Story: We Are Not Waiting

 

Vapers, I hope you are inspired by the following story.  It’s about how do-it-yourselfers in the Type 1 diabetes community have achieved advances in treatment that are entirely independent of the medical and pharmaceutical industries, and of FDA regulation.  The manner in which these advancements were obtained mirrors how DIYs in the smoking community have promoted vaping devices that are substantially replacing deadly cigarettes.

People with Type 1 diabetes (PWDs for short) lack a functioning pancreas, making them reliant on a continuous external source of insulin.  There have been considerable advances in managing Type 1 over the past two decades, including better forms of insulin, small wearable pumps that provide the essential hormone 24/7, and continuous glucose monitors (CGMs) – tiny sensors that provide blood sugar levels day and night.  Remarkable as these advances are, PWDs must still be on guard 24/7 – even in the middle of the night – to maintain a normal blood sugar range.  With Type 1, blood sugar levels can soar or plunge in an instant.  Too much time at the high end can damage blood vessels, kidneys and other organs, while low blood sugars can trigger brain shutdown, coma and even death.

Of late, PWDs were convinced that insulin pumps and CGMs could be integrated into an “artificial pancreas”, but device manufacturers and the FDA were not moving fast enough.  In response, DIYs went into action (as described in a recent article in Healthline), and in 2013 the hashtag #WeAreNotWaiting became “the rally cry of folks in the diabetes community who are taking matters into their own hands by developing platforms, apps, and cloud-based solutions, and reverse-engineering existing products,” with a focus on developing an artificial pancreas.

Artificial pancreas systems (insulin pump, CGM and controller) have been available for several years.  One app, called Loop, is used by 10-15,000 people worldwide (here).  In my own 18-month experience with it I have found it truly life-changing.    

A DIY artificial pancreas program called Tidepool has just been submitted for FDA review.  If approved, it would be the first DIY product to have passed FDA scrutiny.  PWDs are hopeful, but those already using artificial pancreas solutions will never give them up.

 The reason this story is important for vapers is that you have been using unapproved devices as substitutes for cigarettes in order to lead longer and healthier lives.  Like PWDs, you are not waiting for FDA-approved options to step away from the fire. 

E-cigarettes and vapor products are scheduled for daunting reviews by the FDA, but vapers, you have demonstrated that, in order to quit smoking and stay smoke-free, you are not waiting.  Take heart with this diabetes story.