When I wrote “Surprise! Juul publishes a paper concluding that e-cigs save lives” criticizing a paper in American Journal of Health Behavior for being based on questionable risk estimates, my first draft said I was surprised that the paper got past independent peer reviewers.
But then I realized that all but one of the 13 papers that comprised the entire May 2021 issue of AJHB ( V. 45:3 ) were written by employees of Juul Labs itself (which is 35% owned by Altria Group) or by employees of Pinney Associates, which is “working exclusively with JUUL Labs, Inc. to advance relative risk-based regulation of nicotine and tobacco products.”
So the paper wasn’t so surprising after all.
The issue was put together by Saul Shiffman and Erik Auguston. Their overview briefly describes the papers in the issue, ending with the population study, and concludes, that Juul will contribute to better public health because “Population modeling integrating impacts on diverse populations indicates that availability of ENDS [electronic nicotine delivery systems, which includes Juul] is expected to avert millions of premature deaths in the US.”
Their conflict of interest statement says:
Through Pinney Associates, Saul Shiffman provides consulting services on tobacco harm reduction on an exclusive basis to Juul Labs Inc. In that role, he acted as internal editor and coordinator for the papers in this special issue. (Within the last 2 years, Pinney Associates has also consulted for British American Tobacco and Reynolds American Inc and subsidiaries on tobacco harm reduction.) Erik Augustson is a full-time employee of Juul Labs Inc. As Senior Director of Behavioral Affairs at JLI, he oversaw the conduct of the behavioral research reported in this special issue.
The one paper not written by a Juul or Pinney employee is the closing perspective by harm reduction advocate Karl Fagerström, who, not surprisingly, concludes, “Because it is unlikely that humankind will give up drugs, nicotine included, the findings from the studies presented in this issue suggest that ENDS, and JUUL in particular, can be an acceptable substitute for more harmful cigarette alternatives.”
Fagerström conflict of interest statement says:
K.O.F. has received consulting and speaking fees from many companies that develop or market pharmacological and behavioral treatments for smoking cessation. He currently receives consulting fees from Swedish Match and has received fees in the past from Philip Morris International and British American Tobacco to assist their efforts to develop less-risky tobacco products. K.O.F. has not received funding or other support from JUUL Labs, Inc., which did not commission or review this commentary. [emphasis in original]
The statement he italicized in his disclosure raises the question of who commissioned and reviewed his commentary. Since Shiffman “acted as internal editor and coordinator for the papers in this special issue,” it would appear that it was invited by Shiffman. While Shiffman works for Pinney (not Juul directly), this statement could be correct, albeit misleading because Pinney worked “exclusively” for Juul labs. The question is: Who invited Fagerström to write the perspective?
A secondary question is: Did Fagerström receive any consulting fees or honorarium to write the perspective?
The fact that Shiffman organized the special issue is, in itself, not unusual. Special issues (also known as journal supplements) are often organized by someone other than the journal’s regular editor. For example, I organized supplements in Tobacco Control on what the tobacco industry documents indicated the companies knew about menthol in 2011 and independent analysis of Philip Morris’ modified risk tobacco product application to FDA and other research on IQOS in 2018.
The process was that I prepared proposals for the supplement and submitted them to Ruth Malone, the Tobacco Control editor. She consulted with the other editors and BMJ (the publisher) before accepting the proposals. In the case of the IQOS supplement they suggested adding some papers. Most important, the journal managed the peer review independent of me and the other authors.
This process raises three questions about the AJHB Juul issue: (1) What was the process for approving the content of the issue? More important: (2) Who selected the peer reviewers and managed the peer review process? (3) What role, if any, did Juul or Pinney have in approving the editor(s) who handled the peer review?
It is also common that a sponsor pay the costs of publishing the special issue or supplement to cover the journal’s added costs. (The CDC paid the publication costs for the menthol issue and our UCSF TCORS (which is funded by NIH using FDA money) covered the IQOS issue.) This raises two questions regarding the Juul special issue: (1) How much was the AJHB paid to publish the special issue? (2) Who paid this cost?
(UPDATE: On July 5, 2021, the New York Times reported that Juul paid $51,000 for the special issue. For comparison, Dunn and Bradstreet estimates that AJHB revenues totaled $60,530 for 2021. Three members of AJHB resigned over this issue.)
A related question is: Were the peer reviewers paid and, if so, by whom?
Why this is important
This special issue has generated a lot of discussion among my colleagues around the world and even led to a news story in BMJ, “Academic journal is criticised for publishing special issue funded by tobacco industry.” BMJ quoted Matthew Myers, president of Campaign for Tobacco-Free Kids as saying, “After decades of tobacco companies paying previously credible scientists to produce studies designed to reach a predetermined outcome to foster their marketing goals and mislead the public about the overall state of the evidence, one thing should be abundantly clear: research funded by tobacco companies cannot be treated as a credible source of science or evidence. No credible scientific journal should allow a tobacco company to use it for this purpose.”
Also in the BMJ article, Elbert Glover, AJHB editor-in-chief defended the publication of the special issue using standard industry rhetoric:
“To reject a paper on who funded the work rather than science is wrong. We periodically have published tobacco funded papers with no little concern from anyone. However, an entire issue seems to have created a minor stir with overzealous tobacco researchers who do not tolerate any tobacco industry manuscript to be published,” he said.
“We do not condone discriminatory censorship as evidenced by the fact that not all papers submitted were accepted,” Glover added. “Moreover, all the manuscripts were sent through the full review process and not treated any differently than any other paper. There was nothing special with the issue other than being funded by the tobacco industry.
He added, “It was clearly stated in the review process and in the special issue who the sponsor was, nothing was hidden. In addition, every paper clearly noted who the funder was—again, nothing was hidden. Anti-tobacco people are missing the point of research, one should attack the science not the funder or the journal.”
This all seems pretty reasonable on its face. The problem is that the tobacco industry has a decades long history of spinning science to meet its regulatory, legal and PR needs.
Indeed, this history of manipulating science was a key element in federal Judge Gladys Kessler’s 2016 decision that Philip Morris and other the major cigarette companies created an illegal racketeering enterprise to defraud the public. This ruling is particularly relevant when thinking about the AJHB Juul issue because one part of Altria buying into Juul was that it would help Juul deal with FDA regulation.
Here are some of the papers that we have written using previously secret internal tobacco industry documents to learn the backstory about the tobacco industry spins results in peer reviewed papers to support the conclusions it wants:
- The toxic effects of cigarette additives. Philip Morris’ project mix reconsidered: an analysis of documents released through litigation
- A tobacco industry study of airline cabin air quality: dropping inconvenient findings
- The tobacco industry’s role in the 16 Cities Study of secondhand tobacco smoke: do the data support the stated conclusions?
- Changing conclusions on secondhand smoke in a sudden infant death syndrome review funded by the tobacco industry
- Cigarette smoking is a risk factor for Alzheimer’s Disease: an analysis controlling for tobacco industry affiliation
- Endotoxins in tobacco smoke: shifting tobacco industry positions
- Tobacco papers and tobacco industry ties in regulatory toxicology and pharmacology
There are many other papers providing other examples of how tobacco industry funding affects conclusions. For example, Lisa Bero’s paper “Sponsored symposia on environmental tobacco smoke [secondhand smoke]” found that symposium articles on secondhand smoke differ from journal articles and consensus documents in ways that suggest that industry-sponsored symposia are not balanced and “Why review articles on the health effects of passive smoking reach different conclusions” found that “the only factor associated with concluding that passive smoking is not harmful was whether an author was affiliated with the tobacco industry.”
Indeed, this experience with tobacco is just a special (and perhaps more extreme) example of the fact that industry funding, including from the pharmaceutical industry where “[s]ponsorship of drug and device studies by the manufacturing company leads to more favorable efficacy results and conclusions than sponsorship by other sources.”
If this situation was not difficult enough, the tobacco industry is getting smarter about hiding the true source of money, as described in two April 2021 papers in Tobacco Control about Philip Morris’ Foundation for a Smokefree World financed research, including special issues: “Paying lip service to publication ethics: scientific publishing practices and the Foundation for a Smoke-Free World” and “Under the influence.”
Papers like the Juul issue of AJHB have long lives. They are cited to policy makers and regulators and are likely to appear in reviews and meta-analyses, particularly when authored by even independent scientists who are not aware of the industry’s tricks. Indeed, discounting them out leaves authors open to accusations of “reject[ing] a paper on who funded the work rather than science is wrong.”
Why this is timely
The timing of the AJHB issue is particularly important since the FDA is now considering whether to authorize the sale of Juul and other e-cigarettes. Given the well-established history of publishing misleading science, the FDA and other regulators should not take these papers at face value and probably discount them completely.
In addition, the broader scientific community needs to re-engage the issues of tobacco industry funded research to avoid allowing it to continue polluting the literature.
On July 20, 2021, Salon.com published an analysis of the AJHB special issue that provides more details on what happened.