Monday, December 28, 2020

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.”



Thursday, December 17, 2020

High School Seniors Vaping Less While Smoking, Drinking, Getting Drunk More


Just-released 2020 Monitoring the Future survey results (here) indicate that all forms of vaping among high school seniors declined (as seen in chart at left), even as alcohol use, getting drunk, and cigarette smoking all increased.

Prior to this year, the rate of current smoking (i.e., past 30 days) had been on a precipitous decline.  Smoking rates fell by half from 2015 to 2019, from 11.4% to 5.7%.  Unfortunately, smoking rose to 7.5% in 2020.  At the same time, general vaping declined from 31% to 28%, and nicotine vaping also dropped.

Past 30-day alcohol increased from 29% to 33%, accompanied by a similar rise in getting drunk.  The only good news for intoxicating drugs was a single percentage point decline in marijuana use.

Last year the Monitoring the Future survey reported JUUL use for the first time, noting that it was used by 20.8% of high school seniors.  JUUL use this year plummeted by almost 40%, to 12.9%.

Flavored products continue to be vaped far less frequently than marijuana and nicotine offerings, suggesting that teens vape primarily to get a buzz. 

Friday, December 11, 2020

How Federal Funding Influences Tobacco Research: GroupThink & Group Authorship


I recently critiqued a study by Dr. John Pierce and 35 co-authors of the FDA’s Population Assessment of Tobacco and Health (PATH) data that found, per their press release, “E-cigarettes Don’t Help Smokers Quit.”  My analysis showed their data supported a finding that e-cigarettes are as helpful as medicines and other aids promoted by anti-tobacco crusaders.

In my blog post, I advised that investigators at New York University, Ohio State, Georgetown and Columbia, led by Dr. Allison Glasser, concurrently co-authored another study finding that “…consistent and frequent e-cigarette use and increasing use over time, as well as flavors and device type, are associated with smoking cessation among adult smokers.”  Glasser was not a co-author of Pierce’s “Don’t Help” study, but two of Glasser’s colleagues were.

Pierce was not happy that Glasser’s findings were polar opposite to his.  In a letter to the editors of Nicotine & Tobacco Research, Pierce and three coauthors of the “Don’t Help” study asserted that Glasser’s results were invalid because the authors failed to adhere “to the best practices outlined in the National Academies of Science, Engineering and Medicine (NASEM) report on the public health consequences of e-cigarettes.”

In their reply, Glasser and co-authors wrote that Pierce et al. “are misguided.  Each study answers different questions…The two studies differ in a number of ways…we believe our study only adds to the range of studies available on this topic and offers a meaningful and more comprehensive perspective…To inform policy and interventions, we need evidence from studies of real-world use in addition to ideal, cessation-focused conditions.”

These letters, presenting radically different views on the impact of vaping on smoking, are based on conflicting methods of analyzing complex data.  They also raise other important issues.

 Given that Pierce’s “Don’t Help” study listed 35 co-authors, one may wonder how all of these people could have contributed to the final product.  The short answer is: They didn’t.

Why, then, did the study credit so many authors? A $243.6 million contract.

The U.S. Department of Health and Human Services (HHS) awarded that contract to Westat, a Rockville, Maryland, research corporation, to set up, manage and conduct research on the PATH survey.  Westat, in turn, awarded a total of $28.5 million to at least 18 universities and other contractors in support of the 36 coauthors.

Five years ago, I explained how NIH funding strongly influences some in the academic community to vigorously oppose – or ignore – tobacco harm reduction.  Government contracts like the one discussed here represent another source of funding that creates group authorship and groupthink about tobacco harm reduction.

In the present case, groupthink apparently broke down.  Pierce’s letter was signed by only three of his original 35 co-authors; Pierce added three new co-authors from his school, the University of California San Diego.  All signed on to the statement that Glasser’s study was invalid.

In his complaint letter, Pierce twice states that “the two senior authors [of the Glasser study] were also co-authors” of his study, implying that they had contradicted themselves.  Pierce has a point.

Also note how federal grants and contracts are intertwined in the tobacco research community.  The Glasser study was “funded in part by the National Cancer Institute (P01CA200512),” but this grant was to the Medical University of South Carolina, while Glasser and her co-authors were from New York University, Ohio State, Georgetown and Columbia.

Through convoluted funding programs, the U.S. Government continues to skew tobacco research to support prohibition rather than tobacco harm reduction, against the interests of inveterate smokers.