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.”

 

 

Re-Analysis of Retracted Research on Heart Attacks Before Vaping

Dharma Bhatta and Stanton Glantz last year published a study claiming that e-cigarettes cause heart attacks. That assertion was based on 38 heart attack incidents, but the authors knowingly included people who had heart attacks years before first using e-cigarettes.

My economist colleague Nantaporn Plurphanswat and I described that fatal error in two letters to editors of the Journal of the American Heart Association.  I applied pressure for the next seven months, and the editors retracted the study on February 18 of this year.

Although the incident was reported by USA Today’s Jayne O’Donnell, Ivan Oransky at Retraction Watch, Alex Norcia of Vice and others, the tobacco research community showed little interest. Despite the obvious research flaw, some insisted that we show the effect of correctly classifying vapers who had heart attacks years before starting e-cigarette use.

Dr. Plurphanswat and I have met that challenge, and we now report our results in the professional journal Addiction.

From the public-use dataset we know that at least 11 of Bhatta-Glantz’s reported 38 heart attacks occurred prior to e-cigarette use.  But there are many more.  For our re-analysis we determined the exact number of prior heart attacks, but we cannot disclose that figure due to restrictions imposed by the Inter-university Consortium for Political and Social Research. Following are our results after correctly classifying all of the prior heart attacks.

 

Adjusted Odds Ratios For Heart Attack According to E-Cigarette Use
E-Cigarette Use	Bhatta-Glantz Original Results	Results After Correct Classification
Never	Referent	Referent
Non-Daily Current	1.99 (1.11 – 3.58)	0.18 (0.05 – 0.66)
Daily Current	2.25 (1.23 – 4.11)	0.69 (0.22 – 2.12)

 

Our work reveals that Bhatta and Glantz’s doubled odds ratios disappear after correctly classifying the time-warped e-cigarette heart attacks. 

Our article describes additional problems with the Bhatta-Glantz study, such as the fact that their definitions were internally inconsistent. They excluded current experimental e-cigarette users and smokers, but they included former experimental e-cigarette users and smokers, with no justification. Additionally, participants were not counted correctly. Bhatta-Glantz used all 32,320 survey participants in their analyses, but 7,183 of those had missing information on key variables; we don’t know what Bhatta and Glantz did with them, but they should not have been counted.

We note, “[Bhatta and Glantz] appeared to know about detailed information regarding when participants were first told about the heart attack and when they first used e-cigarettes. On page 9 of their [retracted] article, the authors said that they used those specific PATH survey questions to ‘address this problem’ of temporality with a secondary analysis ‘to select only those people who had their first MIs [myocardial infarctions] at or after 2007’ (n = 16, their Supporting Information, Table S6). Glantz also told a journalist that the secondary analysis reflected the timing of the heart attacks. However, despite this knowledge and claim, their secondary analysis did not address the temporality problem. We found that more than one-third of the current 16 e-cigarette users who had a heart attack after 2007 occurred before they first used e-cigarettes.” 

We conclude, “…[Bhatta and Glantz] did not account for heart attacks that occurred before first e-cigarette use, even after the temporality problem was raised in pre-publication peer review…The analysis presented here supports the decision by editors of the Journal of the American Heart Association to retract Bhatta & Glantz’s article on 18 February 2020. It raises questions as to what analyses the authors may have undertaken that were not reported and why they did not conduct the analyses reported here or requested during peer review of the original article.”

As I noted previously, the retracted study was supported by $13.6 million from American taxpayers.  Our new research warrants an investigation by federal officials to determine if those funds were misused. 

 

 

E-Cigarettes and Respiratory Disease: NO EVIDENCE

Drs. Dharma Bhatta and Stanton Glantz published a study in February’s American Journal of Preventive Medicine claiming that “Use of e-cigarettes is an independent risk factor for respiratory disease in addition to combustible tobacco smoking.” (here)  In a University of California San Francisco press release, Professor Glantz made additional claims: “We concluded that e-cigarettes are harmful on their own, and the effects are independent of smoking conventional tobacco…This study contributes to the growing case that e-cigarettes have long-term adverse effects on health and are making the tobacco epidemic worse.”

Now Cornell University researchers, led by economics professor Don Kenkel, have published a comprehensive re-analysis of that study (here), concluding:

“We find no evidence that current or former e-cigarette use is associated with respiratory disease.”

Kenkel and his co-authors explain why the Bhatta and Glantz claims are bogus: “The statistical associations that Bhatta and Glantz find between e-cigarette use and respiratory disease are driven by e-cigarette users who are also current or former smokers of combustible tobacco…almost all e-cigarette users were either current or former smokers of combustible tobacco. In the longitudinal analysis sample with 17,601 observations, there were only 12 current e-cigarette users who had never smoked combustible tobacco. None of the 12 respondents had incident (new) respiratory disease.”

In other words, while Bhatta and Glantz asserted that e-cigarettes were an “independent” risk factor for respiratory disease, only 12 vapers had never smoked and none of them developed the illness.

Last year, Bhatta and Glantz claimed in the Journal of the American Heart Association that e-cigarettes cause heart attacks.  Informed by my research group that many of the vapers’ heart attacks occurred years before they picked up their first e-cigarette, JAHA editors retracted that study in February.

It is important to note that Bhatta and Glantz used the same federal grants, totaling $13.6 million, to fund both the retracted JAHA heart attack study and the bogus AJPM respiratory disease study.  As I said in February, massive amounts of taxpayer dollars flowing to U.S. researchers who are anti-tobacco, anti-harm-reduction, in service of the government’s stated objective “to create a world free of tobacco use.”  Still, it is intolerable for public funds to be used in the production of scientifically unsound research.

The re-analysis by Kenkel and colleagues should prompt the American Journal of Preventive Medicine’s editors to revisit their decision to publish Bhatta and Glantz’s latest study.

Regulator Watch Videos: JAHA Retraction and the Teen Vaping “Epidemic”

Last week, Regulator Watch’s Brent Stafford interviewed me for an hour on the Journal of the American Heart Association’s retraction of a research article that claimed falsely that e-cigarettes cause heart attacks.  We also discussed the teen vaping “epidemic” and how the CDC calculates deaths from smoking (i.e. The Big Kill). 

RegWatch has posted two-minute videos that capture two of the interview’s main themes.  The retraction short video is here, and the teen “epidemic” video is here.