Source: Salon
Date: July 20th, 2021
Author: Jon Skolnik
Facing the imminent threat of corporate death, the embattled e-cigarette maker Juul is pulling out all the stops in its fight to convince the Food and Drug Administration that its vaping products are more beneficial than harmful.
If that sounds like a stretch, it probably is. Last month, Juul settled a $40 million lawsuit that accused the company of luring in teens to use its flavored vape products, allowing Juul to avoid the potential PR nightmare of a widely covered jury trial. Juul has also spent tens of millions in federal lobbying efforts over the past several years, presumably in an effort to block comprehensive regulations on the sale of e-cigarettes.
But the most bizarre Juul news came two weeks ago, when the New York Times reported that the company had funded an entire issue of a scientific journal, in which every article presented evidence that vaping is a beneficial harm-reduction practice that can wean smokers off tobacco cigarettes.
Last month, the American Journal of Health and Behavior (AJHB), a 44-year-old academic journal that has published many nationally recognized scholars, released a special edition specifically devoted to the question of whether e-cigarettes are harmful or helpful. The 219-page issue is unusual not just by virtue of its niche subject matter — e-cigarettes are a relatively new phenomenon in the field of health behavior — but also because its publication was bankrolled entirely by one source: Juul Labs.
This fraught episode comes at an exceptionally tumultuous time for the vape maker. In early 2019, Juul, a company founded just four years earlier, was riding a wave of explosive success, boasting $1 billion in revenue. Sales had grown by 641% from 2016 to 2017 alone. A national survey in 2019 found that nearly 30% of U.S. high school students reported using e-cigarettes in the last month, with 60% of them naming Juul as their preferred brand.
In 2018, the tobacco giant Altria — previously known as Philip Morris — took a 35% stake in Juul, believing the acquisition might help recover some of the company’s losses from an overall decline in U.S. cigarette sales over the past several decades. Only a few months later, however, disaster struck. A mysterious respiratory ailment, clearly linked to vaping, sickened more than 1,000 people in the U.S., and by the fall of 2019, 34 vape users had died from lung injuries. Facing an array of potentially devastating lawsuits and pressure from the Food and Drug Administration (FDA), Juul voluntarily pulled its products from many store shelves and canceled its youth advertising campaigns, rapidly losing more than 30% of its market share.
Now Juul remains in something like corporate limbo, awaiting FDA approval to continue selling its vape products in the U.S. The agency will likely decide this year whether the alleged health benefits of Juul products outweigh their potentially addictive qualities. It’s not entirely surprising, then, that Juul wanted to subsidize an entire edition of a medical journal: Its survival as a corporation is on the line.
But is the Juul-sponsored journal ethical? That’s a murkier question than it might appear. The special issue of AJHB makes no attempt to conceal the fact that essentially all the studies it contains were funded and facilitated by Juul. As The American Prospect notes, a cursory glance at the journal’s “Conflict of Interest” statements reveals that 18 co-authors of articles in the special issue are Juul employees.
Five other co-authors work at PinneyAssociates, a firm that “provides consulting on harm reduction exclusively to JUUL Labs,” as its senior scientific adviser, Dr. Saul Shiffman, told Salon by e-mail. “We participate in JUUL’s work to publish their scientific research to inform the public dialogue about tobacco harm reduction,” he added. An additional three co-authors are involved in the Centre for Substance Use Research, another consulting firm that has a contract with Juul. Nearly every study in the issue features the brand name in its title, and all of them effectively conclude that Juul’s products are a safe form of harm reduction.
As one paper in the journal, a study based on population modeling, puts it, “after considering both potentially beneficial and potentially harmful transitions and based on the available evidence to date — the (continued) availability of ENDS [i.e., vape products such as Juul’s] in the US is likely to have a positive impact on population mortality.”
The edition’s closing perspective, written by Dr. Karl O. Fagerström, a Swedish psychologist who specializes in smoking cessation and “tobacco harm reduction,” waxes a bit more philosophical. “Because it is unlikely that humankind will give up drugs, nicotine included,” he writes, “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.” (It is duly noted that Fagerström has served as a paid consultant to Philip Morris International and British American Tobacco.)
Outside the world of corporate-sponsored research, the existing scientific literature is mixed, at best, on the question of whether products like Juul offer effective means of smoking cessation. One study from the University of California, San Francisco, found last year that Juul’s products deliver “more nicotine to the blood per puff than cigarettes or previous-generation e-cigarettes (e-cigs) and [impair] blood vessel function comparable to cigarette smoke.”
Another study published this year in Pediatrics, the official journal of the American Academy of Pediatrics, found that e-cigarette smokers are three times more likely to switch to tobacco cigarettes later on. Other studies have found that e-cigarettes elevate the risk of heart disease, high cholesterol and depression.
To get a better sense of how this strange edition of a previously respected journal came into being, Salon contacted dozens of people listed as associate editors or senior associate editors at AJHB — none of whom are paid for their work there. Virtually none of them knew about the Juul-sponsored edition prior to its release.
“There was certainly no email sent out to any of the editors that this was going to happen,” Dr. Richard Olmstead, a research psychologist at UCLA’s Semel Institute for Neuroscience and Human Behavior, and an associate editor of AJHB, told Salon. “I think there would have been quite a bit of pushback had there been some forewarning about it.”
Dr. Carl Fertman, a professor emeritus at the University of Pittsburgh’s School of Education and an associate editor at the journal, described the special issue as a “complete surprise.”
“There was no transparency,” he said in an interview with Salon. “I don’t want to be associated with this journal. It’s upsetting.”
“I think it’s fairly unusual that a single company would sponsor a special issue,” another associate editor told Salon, asking not to be identified by name. “I was surprised to see they called out a specific company in every article.” This person added that was “different” from anything they’d seen before in “any scientific behavioral journal.”
A number of editors, however, acknowledged that there’s nothing new about seeing corporations sponsor scientific research they believe will be favorable to their bottom line.
For decades, the tobacco industry worked diligently to steer the scientific consensus away from the conclusion — now universally accepted — that cigarette smoking causes lung cancer, emphysema and other serious or life-threatening health problems. Central to that strategy was ginning up fake controversy by pushing junk science that appeared to contradict the overwhelming weight of scientific and medical evidence. Tobacco companies poured money into shadowy front groups that supported dubious science, paid consultants to prepare “expert” testimony to Congress and regulatory bodies and suppressed internal research findings that made clear that the companies themselves understood their products were killing people.
In 1998, a torrent of secret internal documents from a number of tobacco giants was released to the public as part of the Tobacco Master Settlement Agreement. By the early 2000s, the veil was just about lifted. Ruling on a landmark Justice Department suit back in 2006, U.S. District Judge Gladys E. Kessler found that several big-name tobacco companies, including Philip Morris, had systematically defrauded the American public with a decades-long effort to launder pro-tobacco “science” through academic and government channels.
To be clear, Juul is not a tobacco company. It makes and sells e-cigarettes, aka “vapes,” which contain no tobacco and are meant to simulate the experience of smoking cigarettes. They deliver high doses of nicotine to the brain through water vapor, often flavored in various ways. Whether vaping is “safe” remains an unsettled question, but it’s not the same thing as smoking.
Still, the fact Altria holds a significant interest in Juul creates an uncomfortable parallel, even if the two companies’ products would seem to be in competition. Juul’s decision to bankroll an entire edition of a medical journal struck many people as reminiscent of the Big Tobacco playbook.
Following AJHB’s publication of the special edition, a number of editors resigned from the journal, according to New York Times reporting later confirmed by Salon. Most editors declined to comment on the scientific merit of the papers published in the special edition. But there are reasons to be dubious about how the journal’s peer-review process worked in this case.
Before studies are published in any scientific journal, they are typically subject to peer review, in which experts in the relevant field read the papers and offer comments. As AHJB states in its ethical guidelines: “To decrease bias during the editorial process, we employ the classic double-blind peer review process. … The Editor-in-Chief transmits reviewer evaluations and comments to the corresponding author, usually within 4 weeks.”
AJHB editor-in-chief Dr. Elbert Glover, however, apparently told reviewers that the issue was about e-cigarettes in general — and then offered them cash rewards to complete their reviews within a week, according the the Philadelphia Inquirer. Many editors told Salon that in itself was unusual. Only after reviewers reportedly began to ask questions about “fishy” aspects of the studies did Glover reveal that the entire issue was funded by Juul. One reviewer told the Inquirer that the design of one particular study seemed so biased that she recommended it be rejected outright. “I thought, ‘No way it wasn’t funded by Juul,'” she said.
In an email exchange with Salon, Glover acknowledged that he had been privately approached by Juul, who personally paid him $57,500 to publish the edition. (Glover is the sole owner of the publication.) He maintained, however, that the peer review process was conducted in good faith.
“Reviewers were not initially notified regarding the funder of the special issue as it has been journal policy to not identify the funder of special issues during the review process,” Glover wrote to Salon. “However, during the review process, one reviewer requested the identity of the funder. As a result of the reviewer’s response, I decided to share the identity of the funder with all the reviewers of the special issue.”
Asked whether he believed it was appropriate to publish a corporate-sponsored special issue without consulting the other listed editors, Glover responded that it had not occurred to him, saying he “was more concerned about the science and did not consider who funded this issue.”
“I should have been more perceptive to their issue,” he said. “In retrospect, it was probably an error but I still do not understand the ability to ignore science and allow negative bias to enter into the decision.
“My philosophy is to allow the scientific merit to determine publication, not personal bias. Just because the tobacco industry lied, manipulated data and currently promote a product that causes death, does not mean that I have to compromise my values.”
But it’s precisely because of the tobacco industry’s dark history of lies and manipulative spin that Glover should have come clean about Juul’s sponsorship from the beginning, say experts on the other side of the issue.
“The problem is that the tobacco industry has a decades long history of spinning science to meet its regulatory, legal and PR needs,” wrote Dr. Stanton Glantz, former director of the Center for Tobacco Control Research and Education, in a blog post responding to AJHB’s special issue.
As one meta-analysis of research data found in 1998, “the only factor associated with concluding that passive smoking is not harmful was whether an author was affiliated with the tobacco industry.”
A number of AJHB editors told Salon that any study funded by an interested party, especially a large corporation, should be met with heightened scrutiny. One said it was “a red flag when the authors are part of the organization that sponsored the research,” adding: “It doesn’t mean that one can dismiss all of the findings, but it needs to be carefully scrutinized.”
It remains unclear which way the wind is blowing for Juul. In September 2019, the FDA issued a formal warning to the company, making clear that “before marketing tobacco products for reduced risk, companies must demonstrate with scientific evidence that their specific product does in fact pose less risk or is less harmful.”
“JUUL has ignored the law,” the department added, “and very concerningly, has made some of these statements in school to our nation’s youth.”
Months later, it was reported that Juul had begun beefing up its scientific staff, hiring a number of former FDA officials and recruiting researchers in hopes of clearing potential regulatory hurdles. Last July, Juul submitted a Premarket Tobacco Product Application (PMTA) to the FDA, providing “detailed scientific data from over 110 studies totaling over 125,000 pages evaluating the product’s impact on both current users of tobacco products and nonusers, including those who are underage.”
The Juul-sponsored special issue of AJHB is one aspect one part of the company’s PMTA, a Juul spokesperson told Salon in a statement.
“The research in the special issue derives from an extensive research program designed to provide the US Food and Drug Administration’s Center for Tobacco Products with information, scientific data, and analysis to determine whether JUUL products are appropriate for the protection of public health,” the statement read. “This determination, through the submission of Premarket Tobacco Product Applications (PMTAs), is based on a rigorous, science-based process. Indeed, FDA has received not only the findings and reports reflected in the published papers, but also the subject-level data and other supporting information required through the PMTA process.”
In April of this year, six major health organizations — including the American Academy of Pediatrics, the American Cancer Society, the American Heart Association and the American Lung Association — wrote a letter to the FDA urging the agency to reject Juul’s Premarket Tobacco Product Application.
The FDA is expected to rule on Juul’s application by Sept. 9.
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