Senator Rand Paul Highlights Fake Heart Attack Study in Government Waste Report

 

U.S. Senator Rand Paul just released his Festivus Report 2020, describing some $55 billion in “government waste”.  One stand-out example he cites is a fake heart attack study authored by Dharma Bhatta and Stanton Glantz (exposed by me here, here and here). 

Senator Paul mentions that “the NIH’s Office of Research Integrity has a process for banning individuals for ‘research misconduct’.”  Actually, I called for a federal investigation in June 2019 (here), and I laid out all of the evidence in a medical publication (here).  Despite the fact that one of the co-authors of that study retired early this year, an investigation is justified and overdue.

Following is Senator Paul’s verbatim description of the fake study:

“In the summer and fall of 2019, reports began popping up that a new fad among youth, vaping, was hospitalizing people.  According to The New York Times, reporting in August 2019, ‘[M]ore than 215... [patients] with mysterious and life-threatening vaping-related illnesses [were being treated] this summer.’  That same summer, the Journal of the American Heart Association (JAHA) published a bombshell article entitled ‘Electronic Cigarette Use and Myocardial Infarction Among Adults in the US Population Assessment of Tobacco and Health.’  To produce it, researchers at the University of California, San Francisco used three grants from the National Institutes of Health (NIH), totaling $31,522,244 to fund their work.  There’s just one problem: according to peers, the researchers faked the study!

“Just a month after it was originally published, one researcher at the University of Louisville, Dr. Brad Rodu, caught the flaws and was able to determine that a majority of the sample  population  (just 38 people) had heart attacks years before they started using e-cigarettes - a decade on average - and alleged the UC,  San Francisco researchers conducting the original study faked results.  How was Dr. Rodu able to make this allegation?  The UC-SF team accessed a public repository of information to populate their study, so he simply went back and looked at the original data. 

“Dr.  Rodu, evidence in hand, galvanized prominent tobacco researchers from 16 prestigious institutions around the world, including NYU, Yale, Stanford, the University of Michigan, and the University of Chicago, as well as institutions in England, Canada, and Greece, to send a letter  to the publishing journal demanding a review of the article for its veracity.

“Particularly, the cadre of researchers requested JAHA retract its publication of the study given ‘the analysis provided...strongly suggests that the published findings are unreliable and that there is a case to answer.’  According to research guidelines, retraction would be appropriate in the face of evidence of the sort that Dr. Rodu discovered - that is, ‘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).’ 

“Ultimately, JAHA conducted the review and retracted the study.

“This is hardly the first case of researchers allegedly faking studies, and I promise it will not be the last.  In fact, the NIH’s Office of Research Integrity has a process for banning individuals   for ‘research misconduct.’  According to ORI, “[R]esearch misconduct is defined as ‘fabrication, falsification or plagiarism in proposing, reviewing research, or in reporting research results,’ excluding honest errors and differences of opinion. 

“So do the UC, San Francisco professors fit this description?

“It’s actually impossible to figure out, at least for now.  As part of the retraction process, JAHA requested the researchers ‘conduct their analysis based on when specific respondents said they started using e-cigarettes.’  Reasonable enough, right?  Well, when faced with that request, the researchers said it ‘would require ongoing access to the PATH Wave 1 survey - a restricted-use   dataset - and...[they] have been unable to access that database.’  In other words, the UC-SF researchers are effectively claiming they cannot back up their claims because their subscription to a database has expired.

“Now, if I were a professional researcher accused of research misconduct, and all I had to do to clear my name was to access a dataset I had already accessed to prove my work, I would do anything I needed to do so I could refute the claims against my work. 

“But maybe that’s just me.”

 

 

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.

A False Connection Between E-Cigarettes and Heart Attacks

The Journal of the American Heart Association on June 5, 2019, published an article, “Electronic cigarette use and myocardial infarction among adults in the US Population Assessment of Tobacco and Health [PATH],” by Dharma N. Bhatta and Stanton A. Glantz (here).  In reading the article, I discovered that the authors misrepresented the research record;  presented a grossly inaccurate analysis of PATH Wave 1 survey data, and omitted critical information with respect to (a) when survey participants were first told that they had a heart attack, and (b) when participants first started using e-cigarettes.  The article reflected a significant departure from accepted research practices. 

The authors reported that current e-cigarette users were twice as likely as never users to have had a heart attack, based on information from 38 survey participants.  They reported odds ratios (ORs) of 2.25 (95% confidence interval, CI = 1.23 – 4.11) for 19 daily vapers, and 1.99 (CI = 1.11 – 3.58) for 19 some-day users (Abstract, Table 3 and Table S6).  Drs. Bhatta and Glantz claimed that their study confirmed that “e-cigarette use is an independent risk factor for having had a myocardial infarction…”  In a blog post on the University of California San Francisco website, Dr. Glantz cited the study as “more evidence that e-cigs cause heart attacks” (here).

I have extensive experience conducting research on the PATH data files.  I conducted an analysis of the Public Use Wave 1 data, which has no restrictions on release of results.  I found that at least 11 of the 38 current e-cigarette users were first told that they had a heart attack years before they first started using e-cigarettes. 

My research team conducted further analyses that were discussed in letters we sent to JAHA editors on July 11 and July 18; these letters were never acknowledged.  At the instruction of the Inter-university Consortium for Political and Social Research, I am not able to share those letters with you.