Smokeless Tobacco Users Are Not Dying from Diseases Associated with Smoking

American health authorities for years failed to directly compare the health effects of smoking with those of smokeless tobacco (ST) use, as it would have meant acknowledging the large difference in deaths attributable to these products. 

That changed last year, when Altria’s Michael Fisher and colleagues published the first-ever follow-up mortality study of cigarette smokers and ST users, using the U.S. Government’s national surveys and National Death Index.

My colleague Nantaporn Plurphanswat and I conducted a similar study, which was published last fall in Harm Reduction Journal.  Like Fisher et al., we analyzed data for dipping/chewing and smoking participants from the eight years of National Health Interview Surveys (NHIS), between 1987 and 2010, in which ST users were counted.  The fact that the NHIS rarely calculated ST users suggests that the government didn’t think ST use was important.

We had access to cause-of-death information from federal data through 2015.  Smokers and ST users are always compared with never users of either product using the hazard ratio (HR), which is interpreted similarly to relative risk (i.e. a multiplier).  Current and former smokers are in the top two sections of each chart, while exclusive current ST users are highlighted by open green boxes.  Squares are men 40-59 years old; circles are men 60-79 years.

The first chart above displays results for all causes of death.  Note that current smokers have double the odds of death, while former smokers’ odds are elevated around 30% (It pays to quit!)  Also note the 44% elevation among current ST users, which is explained in the second chart (click on it for a larger version) with information about specific diseases.

Smokers have elevated death rates for all diseases.  They are twice as likely to die of heart diseases and cancer, and 6-13 times of respiratory diseases.  On the other hand, current exclusive ST users do not have significant elevations for any of these diseases. 

The third chart contains results divided into two mutually exclusive and exhaustive categories, smoking-related and everything else.  It shows that ST users’ death rates are primarily elevated by other causes; this is true especially among younger ST users, circled in red.  These causes included accidents, Alzheimer’s disease, kidney diseases, suicides and drug overdoses.      

Our analysis, studying only men age 40+ years, was designed to maximize the chance of finding significant results.  All previous studies had included women, who rarely use ST, and young men, among whom death is rare; those groups do not produce relevant information.  Consider: If a researcher wants to accurately measure the rate of breast cancer, they don’t count men.  Breast cancer occurs in men, but at such a minuscule rate that it would cut the rate among women in half, making it grossly inaccurate.

In summary, our study demonstrates that exclusive ST users do not demonstrate significantly elevated mortality from any smoking-related diseases.  Younger ST users, however, had elevated deaths from all other causes.  While we were unable to determine which specific diseases were involved, our findings for other causes are consistent with a recent CDC report and a recent study in JAMA showing increased mortality among adults age 25 to 64 years, which specified  drug overdoses, suicides and organ system diseases.

 

Indefensible Inaction by JAHA Editors on Obvious Research Misconduct

For six months, Journal of the American Heart Association editors Drs. Barry London (barry-london@uiowa.edu), Daniel T. Eitzman (deitzman@umich.edu) and Janice Weinberg (janicew@bu.edu) have refused to correct demonstrably false research results published in the June issue. The work was authored by Drs. Dharma Bhatta and Stanton Glantz.

As reported in USA Today, the study “claimed adult vaping was ‘associated with’ a doubled risk of heart attack, but Glantz went further in a blog post, saying the study represented ‘more evidence that e-cigs cause heart attacks.’”

“However, when [Dr. Brad] Rodu obtained the federal data, he found the majority of the 38 patients in the study who had heart attacks had them before they started vaping — by an average of 10 years earlier. In his [two] letter[s] to the editors [here and here], Rodu called Glantz's findings ‘false and invalid…Their analysis was an indefensible breach of any reasonable standard for research on association or causation…We urge you to take appropriate action on this article, including retraction.’”

O’Donnell’s article continued, “the American Heart Association says it follows the Committee on Publication Ethics [COPE] guidelines, meaning editors ask the author to respond to any questions brought to its attention… The journal may revise the publication record, if it's determined necessary.”

However, the journal editors never responded to me in a substantive manner.  In October, the journal sent me an unresponsive letter about COPE guidelines.  The letter was unsigned, a discourtesy suggesting that the editors found our objections unworthy of consideration.

In November, I invited the broad research community to counter the falsified research; that blog post has been viewed over 2,300 times.  Andrew Gelman, widely respected professor of statistics and political science, and director of Columbia University’s Applied Statistics Center, conducted his own analysis.  He commented in his blog that “Rodu’s criticism seems more serious.  Bhatta and Glantz are making causal claims based on correlation between heart problems and e-cigarette use…It seems like a real article with a data issue that Rodu found, and the solution would seem to be to perform a corrected analysis removing the data from the people who had heart problems before they started vaping.”

Dr. Gelman’s comment was followed by a January 20 letter from 16 prominent tobacco researchers, led by Dr. David Abrams of the New York University, to the JAHA editors (here).  Abrams and colleagues wrote that the Rodu and Gelman analyses suggest “that the published findings are unreliable and that there is a case to answer…a proper investigation and response.”

Three days later, the editors sent a reply that was a Xerox copy of their October unsigned (non)response to me (here).

Abrams et al. pushed back.  In a January 29 letter they said the editors’ correspondence “does not amount to a substantive response to the concerns we raised about (1) critical failures in the published paper…(2) the conduct of [Bhatta and Glantz] in failing to make adjustments to their analysis with data they knew were available…(3) the process followed by the journal in the light of the whistleblower complaint made by Dr. Brad Rodu in July 2019…”  The Abrams group noted that the journal is not in compliance with COPE guidelines, and they bluntly ask the editors:

“Does the journal accept the findings are unreliable and what does the journal propose to do about the published paper?  Can you confirm whether there is or has been an investigation into this complaint, outline its current status and set out the outcome of the investigation if there is one so far?”

Documentation regarding this academic misfeasance is available at this PubPeer link.

The Surgeon General’s Bogus Report on Smoking Cessation

The U.S. Surgeon General’s new 700-page report on smoking cessation includes a foreword by former CDC director Robert Redfield that succinctly describes the government’s tobacco prohibition objective: “we remain committed to…end the tobacco use epidemic and provide all Americans with the opportunity to live tobacco-free.”

The report’s “major conclusion” with respect to e-cigarettes is that “there is presently inadequate evidence to conclude that e-cigarettes, in general, increase smoking cessation.” 

This is the standard position of prohibitionists.  They state with absolute certainty that vapor injures cells, animals and people; and it causes addiction, teen epidemics and a host of other nasty problems.  But with respect to positive impact like smoking cessation, well, there’s just not enough evidence.  Federal authorities minimize as mere “anecdotes” the millions of cases of former smokers who have quit via vaping.

Far more difficult to ignore are the many well-conducted clinical trials published in prestigious medical journals.  For example, Hajek et al. published the results of a British trial in the New England Journal of Medicine, reporting that e-cigarette users are more likely to quit smoking than smokers using nicotine medicines (Relative risk = 1.83; 95% confidence interval [CI], 1.30 to 2.58).  Commenting on this research, the Surgeon General emphasized largely vaporous caveats.  The UK, he said, is different than the U.S.  More research needs to be done, he argued, and most importantly, “80% of participants in the e-cigarette group were using e-cigarettes at 52 weeks follow-up [versus] 9%...in the [nicotine medicine] group.”  In other words, the Surgeon General was more impressed with the 4 subjects (out of 44) who achieved complete abstinence than the 63 (of 79) who were vaping, but NOT SMOKING, at one year.

The Surgeon General also shortchanged epidemiologic evidence published by me in 2017.  I found population-level proof in an FDA survey that e-cigarettes are not only popular, they are the only aid more likely to make one a former smoker (i.e., a successful quitter) than quitting cold-turkey.

While, to his credit, the Surgeon General cited my study twice in his report, he never mentioned my main finding.

The Surgeon General’s bogus claim of “inadequate evidence … that e-cigarettes … increase smoking cessation” and his failure to stem smokers’ deaths by encouraging switching to vaping are a disservice to the cause of public health.