14 July 2021
Ryan Basen. Source: MED Page Today
— E-cig maker sponsored nearly a dozen studies, took over journal as it awaits FDA ruling
As e-cigarette manufacturer Juul Labs waits for the FDA to rule on its products’ public health benefits, it is facing scrutiny for funding and working on studies of those products, and paying a journal to publish them.
Juul teamed up with healthcare consultants Pinney Associates and the Centre for Substance Use Research (CSUR), chiefly, to examine its tobacco vaping device, as FDA weighs whether to grant the company a Premarket Tobacco Product Application (PMTA) as a safer alternative to cigarettes.
The American Journal of Health Behavior (AJHB) published 11 such studies in a recent special edition limited exclusively to these studies — and Juul paid $51,000 for the issue, including $6,500 to make it open access, according to the New York Times.
Juul staff contributed to every article, according to a MedPage Today analysis, while Pinney staff worked on 10 of them and CSUR staff conducted data analyses for seven.
A Juul spokesperson told MedPage Today Pinney approached AJHB to make the deal on Juul’s behalf.
AJHB regularly charges researchers to publish, according to bylaws printed on its site. The issue’s articles feature conflict of interest statements for each author. What is unusual is for a company — or any entity — to buy an entire issue’s worth of articles and being granted publication at such a scale.
The Times reported that Elbert Glover, PhD, who was AJHB‘s executive editor at the time, has since retired, and that three AJHB editorial board members have resigned since the special issue was published.
Glover was the founding director of the Center for Health Behavior Research at the University of Maryland School of Public Health, according to his bio on the AJHB site, which calls him “an internationally recognized authority on the topics of smoking cessation & smokeless tobacco.” The bio also credited Glover as being a consulting editor of Health Behavior and Policy Review and executive editor of Tobacco Regulatory Science.
The journal charges contributors to publish studies because “journals owned by small organizations, groups, or individuals have no other choice without incurring financial jeopardy,” according to an FAQ page on its site. “The recent proliferation of journals whose obvious focus is the for-profit generation of revenue without regard to science constitutes a development that creates a major problem for reputable journals that must charge to deliver its service to the academic and practice communities.”
The studies were conducted with proper scientific rigor, according to a letter to the editor in the BMJ penned by Erik Augustson, PhD, Juul’s senior director of behavioral affairs, and Saul Shiffman, PhD, senior scientific advisor of Pinney.
“We urge readers to use this as a prompt to read the papers, both to judge for themselves the quality of the science, and also to see the implications for reducing adult smoking,” they wrote. “All of the papers were subjected to the journal’s standard peer-review and editorial process and we believe the underlying science is strong. The research contributes to the understanding of vaping products and their role in public health.”
Shiffman told MedPage Today in an email that special issues “are a normal part of the science publishing process. In this particular case, most of the papers derive from a single large study that followed a cohort of adult JUUL users for a year.”
An April news release from Juul about the 11 studies said that “following the PMTA filing last summer, our Regulatory team turned their attention to publishing some of the key research underlying our application through peer-reviewed manuscripts.”
To encourage “much-needed scientific dialogue about the harm reduction potential of ENDS [Electronic Nicotine Delivery Systems] products, including JUUL, we must engage with the public health community on the science and facts underlying our products,” a Juul spokesperson wrote in an emailed statement to MedPage Today. “Publication of a special issue, versus individual articles published over the course of many months, provides a more comprehensive and integrated account of our studies.”
But critics are concerned by the publication. David Dayen, executive editor of The American Prospect, wrote, “Pretty much all the articles take the Juul party line that e-cigarettes help convert smokers away from combustible tobacco products, and thus aid public health.”
Pinney, jointly based in Pittsburgh and suburban Washington, D.C., has been working “on research and policies to minimize the death and disease associated with smoking conventional cigarettes” for 25 years, according to its website.
“Starting October 17, 2019, Pinney Associates is working exclusively with JUUL Labs, Inc. to advance relative risk-based regulation of nicotine and tobacco products,” the website states. “We believe our work with JUUL Labs can help accelerate the market away from combustible tobacco.”
CSUR, of Glasgow, Scotland, lists Juul as a funder on its website. CSUR describes itself as a “wholly independent research centre” conducting regulatory research “assessing the contribution of ENDS in reducing tobacco related health harm.”
On their “about us” page, they tout: “The research team within CSUR have experience in working alongside regulatory authorities including FDA to ensure that the studies executed can meet the needs of regulatory and public health bodies.”
On its research page, the company notes that it provides “analytic support to JUUL Labs PMTA submission” and “Research in support of JUUL PMTA.”
CSUR and AJHB did not return queries for comment.
The FDA’s deadline for deciding whether Juul’s products offer enough of a health benefit in terms of being a safer alternative to cigarettes to stay on the market is Sept. 9. Numerous medical organizations, including the American Heart Association, the American Academy of Pediatrics, and the American Cancer Society’s Cancer Action Network, have asked the agency to reject the application, according to the Times.