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The Food and Drug Administration will soon decide whether to allow e-cigarette maker Juul to continue selling its products in the U.S.
For years, I’ve followed the story of Juul, which came out of nowhere to control nearly the entire market for e-cigarettes. Altria, maker of Marlboros, purchased 35 percent of Juul in late 2018, valuing it at the same level as Target, Delta Airlines, and the Ford Motor Company at the time.
Juul’s dominance dissipated around the time that over a thousand people contracted a mysterious vaping-related sickness in the fall of 2019, and state and federal regulators started to investigate the company’s blatantly obvious marketing to teenagers. Within weeks, Walmart stopped stocking e-cigarettes, television ads for the product came down, cities and states banned sales, and Juul eliminated the flavored vape pods that were most clearly designed to attract young people. Juul’s market share in e-cigarettes shriveled from around 75 percent to 42 percent.
Now the company is in a fight for survival. The Food and Drug Administration (FDA) will soon decide whether to allow Juul to continue selling its products in the U.S. At issue is whether the public-health benefit for converting cigarette smokers to vaping outweighs introducing an entirely new generation to nicotine addiction. The decision will be made by early September.
Juul is spending millions in lobbying and persuasion to get the FDA’s green light to continue operations. But a Tuesday New York Times article on the subject contained a fascinating nugget midway through, which could be described as a buried lede (journalese for putting the most explosive part of a story in the middle of the piece). Juul, the Times reports, “paid $51,000 to have the entire May/June issue of the American Journal of Health Behavior devoted to publishing 11 studies funded by the company offering evidence that Juul products help smokers quit.”
The corruption of academic research is not a new subject. Corporations fund third-party studies and benefit from “independent” validation of their perspectives all the time. But this is a new wrinkle. Juul didn’t just front money for a couple of academic papers; it bought an entire edition of the American Journal of Health Behavior (AJHB), which it can then point to as “proof” that its product has a public-health benefit, the key question currently before the FDA.
And the more you look at this story, the stranger it gets.
The $51,000 fee included $6,500 to unlock the entire journal for public access—so you can read the entire special 219-page Juul issue here. It’s fascinating. There are 26 named co-authors on the 11 studies. According to the “Conflict of Interest” statements associated with them, 18 of the co-authors are either current full-time employees of Juul, or were full-time employees at the time they conducted the research. Five others are consultants with PinneyAssociates, working “on an exclusive basis to Juul Labs.” And the final three, who co-authored one of the 11 studies, are employees of the Centre for Substance Use Research, an “independent” consultancy that designed that study under a contract with … Juul Labs.
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. Pretty much none of the articles mention that Juul and other vaping companies make their money by attracting countless new people to nicotine addiction. And it’s barely worth even commenting on the quality of the research when it all comes from the same corporate source.
Saul Shiffman, one of the PinneyAssociates consultants, took a co-author credit on ten of the 11 studies. “In that role, he acted as the internal editor and coordinator for the papers in this special issue,” reads the Conflict of Interest statement on the introductory note. So not only were these studies all funded by Juul, not only was everyone who wrote them on the Juul payroll, either indirectly or (in most cases) directly, but the internal editor of the “outside” journal was under contract with Juul as well.
Juul has not yet responded to a request for comment. In response to a query, PinneyAssociates referred the Prospect to a previous response from Shiffman and Erik Augustson, one of the former Juul employees. “Our intention with these publications was to provide the nicotine and tobacco research community—as well as the broader public health community—with the opportunity to evaluate the research for themselves,” 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.” They added that Dr. Elbert Glover, editor in chief of the journal, oversaw all content.
But the American Journal of Health Behavior also bears some scrutiny, beyond their selling a special issue to a corporation. The journal has been around for 45 years, and prides itself on scrupulous ethical guidelines, including the mandatory listing of conflict-of-interest disclosures within all articles. But the AJHB follows a trend among a handful of academic and scientific journals: Its authors must pay to publish.
There’s a whole fee schedule at the journal’s website. Authors pay $895 per article, and if they want the article to be made Open Access so that everyone can read it, that jumps to $1,595. (Only a portion of articles are accepted for Open Access, as most of the AJHB is gated.) If you want more than six tables and figures in your article, that’ll cost you $150 a pop. And a “theme issue,” similar to the kind that Juul bought, costs $2,500 per article, with an additional $500 to make each article ungated, not including the $195-per-article service fee for copyediting.
In this context, the $51,000 that Juul paid for the May/June issue is not that far from what the AJHB would normally charge for a theme issue with 11 studies ($33,000, plus extra for copy check and any additional tables and figures above the prescribed limit). This turns the work of a scientific journal into what looks like advertising.
I asked Rebecca Tushnet of Harvard Law School, who specializes in advertising law, about the propriety of this arrangement. “If Juul’s sponsorship is adequately disclosed, that would address most advertising law questions,” she said. Tushnet added that marketing can be charged as misleading if the target is general consumers, but here the publication, a scholarly journal, is designed for experts. “One might wonder whether experts are in fact all that resistant to bullshit—it’s common wisdom among scammers that doctors are among the easiest to fool because of their self-confidence and expectations of deference,” she noted, “but courts are understandably reluctant to weigh in on publishing battles of the experts.”
FDA officials might not be aware of the degree of the pay-to-play relationship in this Juul special issue.
There are multiple rip-offs going on here at once. Academics are desperate to publish in journals to prove to their universities that they are working diligently. Corporations recognize the opportunity to underwrite research and produce independent validation of their goals. And they turn around and use that research to persuade policymakers, who presume themselves sophisticated about spotting fake research, but probably are not.
At its FAQ page, the AJHB acknowledges that pay-to-publish scholarly journals have become a real scourge in the scientific community: “[T]he 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.” Indeed, the Federal Trade Commission put out a formal warning about “predatory” journal publishers in 2016. But the AJHB justifies the charges by saying that, as a small organization without a large membership base, it has “no other choice without incurring financial jeopardy.” The American Journal of Health Behavior did not respond to a request for comment.
To my eye, there looks to be little difference between the corruption of for-profit scientific journals that degrade the quality of available research, and the corruption in this particular scenario, where an entire issue of a decades-old scholarly journal goes directly into the hands of a private company that will use it to persuade a federal regulator about the efficacy of its product. FDA officials might not be aware of the degree of the pay-to-play relationship in this Juul special issue, and how that might compromise the science.
Clearly, some people associated with the American Journal of Health Behavior were uncomfortable with the arrangement; according to the Times, three editorial board members resigned in the wake of the special issue.
I don’t know if this academic journal gambit will save Juul’s business or not. I do know that Juul did its part to innovate in the area of corrupting the very notion of scientific inquiry. So thanks for that.
