Business Insider on 2/23/2019 by Erin Brodwin
- On Saturday for the first time in its roughly two-year history, e-cigarette company Juul shared some limited data from a clinical trial with the press.
- In general, that kind of research is considered a key way to protect public health by ensuring a product does not cause undo harm.
- As a startup, Juul developed a reputation for aggressively marketing its dessert-flavored nicotine products to teens, some of whom may now be at a higher risk of using regular cigarettes, research suggests.
- Then last fall in a $13 billion deal, Juul became partially owned by the tobacco giant behind Marlboro cigarettes.
- The part of Juul’s study that was made public suggests its devices could be healthier than traditional burned cigarettes. It does not assess vaping’s overall health impacts or the issue of teen use.
Juul, a former Silicon Valley startup with a reputation for aggressively marketing its dessert-flavored e-cigarettes to teens, is now doing health research.
On Saturday the company, which is now partially owned by tobacco giant and Marlboro maker Altria, presented a poster summary of a clinical trial comparing people who exclusively used its devices against people who smoked traditional cigarettes. Juul presented the poster at an annual meeting for the Society for Research on Nicotine and Tobacco and posted it online.
The poster is the first clinical research that Juul has shared publicly. The full Juul-sponsored study has not yet been made public, but Juul is preparing a manuscript for peer-review.
For the research presented on Saturday, Juul scientists and an outside researcher looked at what happened to the levels of a specific set of biological clues when a group of smokers quit for five days and either used Juul devices or used nothing. Known as biomarkers, those clues are known to be acutely affected by tobacco use and have been linked to cancer.
The findings suggested positive results for the smokers who quit and completely transitioned to Juul devices. In these participants, the levels of tobacco-related biomarkers dropped almost exactly as much as they did in the people who quit cold turkey.
One limitation of the study, however, is that it excluded e-cig users who both vape and smoke traditional cigarettes — a group that some researchers say represents the majority of people who use e-cigarettes.
In addition, e-cigarettes do not contain tobacco, which is known to influence the biomarkers that Juul evaluated. However, federal regulators at the US Food and Drug Administration previously identified these biomarkers as items that could “potentially cause health hazards” and recommended that companies developing e-cigarettes evaluate how their products impact them.
Juul devices are not linked with a set of biomarkers tied to tobacco
Juul’s study could be interpreted as good news for adults who are looking to switch completely away from traditional cigarettes and onto e-cigs.
That’s also how Juul presented the work. A press release summarizing Juul’s paper suggested that the study “reaffirm[ed] the potential for vapor products as a viable alternative to combustible cigarettes.”
However, e-cigarettes do not contain tobacco, which is known to have a strong effect on the biomarkers that Juul analyzed. Some experts told Business Insider that because of that, the findings were not surprising nor hugely significant.
That said, in FDA documents outlining how e-cigarette companies should present their devices to the agency, the agency recommended analyzing the biomarkers that Juul studied, calling them “harmful and potentially harmful constituents.”
Juul’s sponsored study suggests these biomarkers are not negatively impacted by their product.
To come to those findings, the researchers divided 90 participants into groups. Then over five days, the researchers had some groups abstain from nicotine completely. Others were directed to smoke normally. Still others were directed to only use Juul e-cigs.
In both the abstinence group and the Juul group, all of the measured biomarkers decreased dramatically. On average, the levels dropped by 85.3% in the non-vaping, non-smoking group and 85% in the Juul group. That suggests that using Juul e-cigarettes in isolation is not linked with some of the potentially cancer-causing effects of smoking regular tobacco cigarettes, the authors concluded.
Unanswered questions about vaping and health
For years, experts have said that when compared against traditional smoking — which involves inhaling literal burned tobacco and tar — vaping likely comes out on top. That’s good news for adults who want to transition completely away from traditional cigarettes and exclusively use e-cigs instead.
Yet a growing body of research also indicates that e-cigarettes come with health risks of their own. That’s especially a problem for teens and other young people who may never have smoked traditional cigarettes but who are now using products like Juul.
“The concern is with adolescents and young adults who were never going to use cigarettes in the first place,” Bonnie Halpern-Felsher, a professor of pediatrics at Stanford University who studies nicotine, told Business Insider.
Juul’s analysis did not look at the overall health impacts of using e-cigarettes or analyze other biomarkers that may be negatively impacted by e-cig use. It also did not address the issue of teen vaping or address something known as dual use, where people switch back and forth between e-cigarettes and traditional cigarettes.
In order to compare the overall impacts of cigarettes and e-cigarettes, researchers must conduct larger and longer studies that take place over the course of several years and include thousands of participants. That size and length is necessary to provide researchers with the statistical power they need to draw overall conclusions about the health impacts of each product.
Juul’s study was neither large enough nor long enough to draw those conclusions, experts said.
In addition, Juul did not assess other biomarkers that previous research has identified as having potentially negative health effects. Instead, the study looked only at some of the biomarkers identified by the FDA.
For example, a recent analysis of biomarkers affected by e-cigarettes other than the Juul suggested that users were inhaling toxic substances like lead, nickel, chromium, and manganese in levels higher than what’s considered safe by the EPA. Inhaling those metals has been tied to health problems in the lungs, liver, immune system, heart, and brain, as well as some cancers, according to the US Department of Labor’s Occupational Health and Safety Administration (OSHA).
Limited data from the aerosol modeling study Juul released last year suggested that chromium was the only toxicant observed in levels higher than what their machine was capable of measuring. Still it was found to be significantly below OSHA’s “permissible exposure” limits.
Another big concern experts have raised with previous e-cigarette research is when scientists exclude users who switch between vaping and smoking, the group of people whom they say make up the majority of e-cig users.
For the vaping portion of Juul’s study, the researchers looked only at people who exclusively vaped, not people who switch back and forth. That could mean that it ignores the health impacts of real vape use, which could include vaping and smoking rather than just vaping, experts said.
The study also leaves unaddressed the issue of teen vaping, which recent studies suggest were in large part a result of Juul’s skyrocketing popularity. A single Juul pod, the refillable cartridge in the Juul e-cig, contains the same amount of highly addictive nicotine as a pack of traditional cigarettes.
“Youth are being targeted by the flavors, novel products, cool designs, and enticing ads seen in e-cigs, and are very vulnerable to use and addiction,” Halpern-Felsher said.
Several studies have suggested that teens who use e-cigarettes eventually transition to regular cigarettes, and these may be young people who otherwise would not have smoked.
Juul does have other research in the works, however.
According to ClinicalTrials.gov, the government’s database for such research, Juul recently completed at least five other clinical trials including its devices, which have been on the market since 2017. The company is in the process of conducting at least three more, according to the database.