E-cigarettes are so dangerous, according to a study published by the Journal of the American Heart Association (JAHA), that they can reach back in time to cause heart attacks before people use them. It has been eight months since the study appeared and seven months since critics identified the crucial error underlying that logically impossible conclusion. So far, the journal's public response has consisted of nothing but boilerplate promises of scientific integrity.
Based on data from the Population Assessment of Tobacco and Health (PATH), Dharma Bhatta and Stanton Glantz claimed to find that "e-cigarette use is an independent risk factor for having had a myocardial infarction." Glantz, a longtime anti-smoking activist and e-cigarette opponent who directs the Center for Tobacco Research Control and Education at the University of California, San Francisco, said the results provided "more evidence that e-cigs cause heart attacks." Notwithstanding the evidence that vaping is much less hazardous than smoking, Glantz and Bhatta (an epidemiologist at the center) concluded that "e‐cigarettes should not be promoted or prescribed as a less risky alternative to combustible cigarettes and should not be recommended for smoking cessation among people with or at risk of myocardial infarction."
But as University of Louisville tobacco researcher Brad Rodu pointed out, the analysis that Bhatta and Glantz ran included former smokers who had heart attacks before they started vaping. Once those subjects were excluded, Rodu and University of Louisville economist Nantaporn Plurphanswat found, the association described by Bhatta and Glantz disappeared. "The main findings from the Bhatta-Glantz study are false and invalid," Rodu and Plurphanswat wrote in a July 11 letter to JAHA. "Their analysis was an indefensible breach of any reasonable standard for research on association or causation." In another letter a week later, Rodu and Plurphanswat urged the journal's editors to "take appropriate action on this article, including retraction."
JAHA replied three months later with a letter that did not address Rodu's criticism but assured him that "the American Heart Association is steadfastly committed to ensuring an objective and thorough evaluation of any and all inquiries received about studies published in any of our journals." A month after that substance-free response, Andrew Gelman, director of the Applied Statistics Center at Columbia University, looked into the controversy and concluded, "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."
In light of that "data issue," where is the "objective and thorough evaluation" that JAHA promised? Last month, 16 prominent tobacco researchers, led by David Abrams, a professor of social and behavioral sciences at New York University, put that question to the journal's editors.
"Many of the myocardial infarctions (MI) used in the calculation of the association between e-cigarette use and MI risk occurred before subjects first used e-cigarettes," they noted in a January 20 letter. "The PATH survey includes timing data for MI and first e-cigarette use that the authors should have used to exclude these cases from the analysis. Further, the authors went on to conclude that the association was causal and made policy recommendations regarding smoking cessation practice on that basis. When the cases in which the MI occurred before e-cigarette use are excluded, the analysis does not show an association. Any residual association is, in any case, likely due to incomplete adjustment for almost complete confounding by smoking history. It follows that the conclusion is not supported by the underlying data and, therefore, the published findings could mislead practitioners and policymakers."
Despite the glaring problem with Bhatta and Glantz's analysis, Abrams et al. wrote, "the journal has not so far provided a substantive response to these concerns." They noted that guidelines from the Committee on Publication Ethics, which JAHA claims to follow, say "journal editors should consider retracting a publication if they have clear evidence that the findings are unreliable, either as a result of misconduct (e.g. data fabrication) or falsification (e.g. image manipulation) or honest error (e.g. miscalculation or experimental error)." The guidelines also say that complaints from "whistle blowers" such as Rodu should be carefully investigated.
JAHA responded three days later with a boilerplate assurance similar to the one Rodu got. "Does the journal accept the findings are unreliable and what does the journal propose to do about the published paper?" Abrams and company asked in a follow-up letter last week. "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?"
I also have asked JAHA for responses to those questions and will update this post if I receive a reply.
The harm-reducing potential of e-cigarettes has been recognized by a wide range of public health agencies and organizations, including the Food and Drug Administration, the Royal College of Physicians, Public Health England, the American Cancer Society, and the National Academies of Sciences, Engineering, and Medicine. But the American Heart Association remains skeptical, and it warns that "the aerosol from e-cigarettes may be harmful to the lungs and the cardiovascular system." Bhatta and Glantz's study therefore reinforces the AHA's institutional prejudices. While that consideration has nothing to do with the study's scientific merits, it may help explain JAHA's reluctance to question the magical, time-bending powers that Bhatta and Glantz implicitly attribute to e-cigarettes.