Truth Initiative Stumbles in JUUL Study

It’s surprising how many fundamentally flawed e-cigarette studies are aggressively promoted by their authors and allied organizations as grounds for FDA regulatory action.  It is also concerning when authors refuse to acknowledge or respond to honest scientific inquiries about their research.  Here is a representative case involving researchers associated with Truth Initiative, a non-profit anti-tobacco organization.

Researchers led by Donna Vallone, Ph.D., recently published a study in Tobacco Control on the “prevalence and correlates of JUUL [e-cigarette] use among a national sample of youth and young adults (here).”  While they reported that the overall prevalence of ever and current (past 30-day) JUUL use was 6.0% and 3.3% respectively, they failed to disclose information about the most important correlate of JUUL use – other e-cigarette use.

The authors noted that among underage children (15-17 years), current JUUL use was 6% and current use of combustible tobacco was 7%.  They connected these, finding that children who were currently smoking were five times more likely to use JUUL than non-smokers.  However, 11% of children in that age group currently used e-cigarettes.  They ignored this important correlate in their analyses.  Instead, they inexplicably included e-cig use among other members of the youths’ households.

There are other significant problems with this study.  First, youths and young adults were asked: “…on how many days did you smoke a Juul vape?” (emphasis added)  That wording likely confused participants. 

Second, the authors didn’t define current use of e-cigarettes, nor did they even give any description of the question in their survey. 

Third, the survey flow for JUUL and e-cigarette questions was not provided.  Were separate questions about these products asked of all participants, or did researchers ask first about e-cigarettes, and then only ask current e-cig users if they used JUULs? 

Fourth, Vallone et. al. defined JUUL “regular use” as 10-30 days in the past month, and they reported that 25% of youth fell into this category.  That percentage is grossly inflated.  The CDC and other authorities use a more credible “frequent” category of 20+ days (here and here), which would generate a lower percentage of users at risk.    

In summary, Vallone et. al. produced an error-ridden study focused on JUUL “smoking,” while ignoring the effect of other e-cigarette use.  The obvious problems ought to have been resolved in peer review.  Additional questions remain, owing to the fact that the authors used a private dataset.  When Truth Initiative posted the study on the Society for Nicotine and Tobacco Research listserv, I asked the authors to resolve some of these problems; they did not acknowledge my listserv post.

CDC Data Reveal Many Far More Dangerous Teen Behaviors Than Vaping

In the hierarchy of teenage risk behaviors, government data shows that vaping pales compared to drinking-, driving- and weapon-related activities. It is remarkable that public health officials and the media focus so greatly on the former, to the detriment of teen safety and health.

A report from the CDC earlier this year (here), based on the 2017 Youth Risk Behavior Survey (YRBS), allows us to put the data in context.

The prevalence of past-month e-cigarette use in the 2017 YRBS was 13%.  That rate is higher than those for cigarettes (8.8%), cigars (8.0%) and smokeless tobacco (5.5%).  However, as I discussed recently (here), the vaping rate pales next to those for marijuana (19.8%) and alcohol (29.8%).  In fact, the e-cigarette rate is nearly identical to the rate for binge drinking (4 or 5 drinks within a couple hours).

These rates of drug use are troubling, but there is much worse in the federal report for parents and policymakers to be concerned about.  Following is a list of other risky behaviors by high school students in the past 30 days.

Prevalence (%) of Risky Behaviors Among American High School Students (YRBS, 2017)
Past 30 Days
Rarely/never wore a seatbelt (as an occupant)	5.9%
Rode with driver who had been drinking	16.5%
Drove after drinking	5.5%
Drove after marijuana use	13.0%
Texted or emailed while driving	39.2%
Carried a weapon (e.g. gun, knife, club)	15.7%
Past 90 Days
Had sexual intercourse	28.7%
..…and used condom, 53.8% of previous
Past Year
Involved in physical fight	23.6%
Physically bullied on school property	19.0%
Electronically bullied	14.9%
Felt sad or hopeless	31.5%
Considered suicide	17.2%
Made suicide plan	13.6%
Attempted suicide	7.4%

Media coverage of the CDC YRBS report (here) was largely confined to the sensational -- “Fewer teens having sex and using drugs, CDC says.”

The absence of focus on the more prevalent and dangerous behaviors in part reflects the FDA-led public health community fixation on vaping.  This may stem from the fact that, of the many greater-risk categories outlined by the CDC, the FDA’s regulatory authority only extends to tobacco. To a federal agency with a hammer, everything is a nail.

The Answers to FDA’s Tobacco Questions Are Obvious, But Perhaps Unwanted

In his recent Nicotine & Tobacco Research commentary, “The Future of Nicotine Regulation,” FDA Center for Tobacco Products director Mitch Zeller listed five “challenging questions.”  I offer the following answers.

1. How comfortable are we with long-term, or possibly permanent, use of less harmful nicotine delivery mechanisms by adults, if they help keep currently addicted smokers from relapsing to combustible tobacco products?

If addicted smokers stay smoke-free by using less harmful smoke-free alternatives, everyone who is not a tobacco prohibitionist is probably comfortable with long-term use.  The harm of permanent nicotine use is of the same magnitude as that of permanent caffeine consumption.  Most are comfortable with chronic consumption of caffeinated drinks, by adults and teens.

While the FDA does now acknowledge tobacco harm reduction, the agency still does not adequately distinguish the harm differential between smoke and smoke-free products, nor does it promote smokers’ transition to vastly safer products that have been on the market during the nine years of FDA regulation. 

2. How much weight should be placed on diminished interest in quitting nicotine altogether?

None.

3. Given the potential health impacts of dual use of tobacco, how acceptable is a short period of dual use while transitioning to less harmful nicotine-containing products? What if many current smokers engage in dual use on a long-term or permanent basis?

For smokers trying to quit, dual use of cigarettes and smoke-free products is a common practice which can occur over varying periods of time. 

Currently, owing to nonstop campaigning by federal authorities and health organizations, most American smokers believe incorrectly that smokeless tobacco and e-cigarettes are as dangerous as cigarettes (here and here).  Nine years ago I wrote in this blog: “In 2005, there were 1.4 million American men who were dual users of both cigarettes and ST [smokeless tobacco] products. These men consumed nicotine both from cigarettes and from ST, and the latter clearly resulted in lower consumption of the former. In both 2000 and 2005, every-day smokers who also used ST every day consumed significantly fewer cigarettes on average than exclusive smokers (13 cigarettes per day vs. 20 cigarettes). If these dual users knew that ST products were only 1% as hazardous as cigarettes, it is possible that many would have chosen to use only ST.” (here)

4. Can we revise labeling and indications for medicinal nicotine to increase quitting?

Of course, but this question is unrelated to tobacco harm reduction.  Medicinal nicotine is regulated by the FDA Center for Drug Evaluation and Research, not the Center for Tobacco Products, and the former has been futzing and diddling around with medicinal nicotine for decades (here).  In 1995, the Pittsburgh Tribune-Review published my open letter to FDA commissioner David Kessler, urging him to make medicinal nicotine products more available to smokers (here). The FDA did nothing to make them more effective or more affordable.

In February 2008, New York State Health Commissioner Richard Daines petitioned the FDA for revised package labeling and sales regulations for nicotine products – changes that would have greatly expanded product availability and consumer awareness. The petition was supported by numerous tobacco research and policy experts and organizations. The FDA failed to issue a response.

5. How might youth initiation be affected by the availability of different nicotine-containing products and how should we account for youth uptake of these products?

Teenagers have always been attracted to adult-oriented products and adult behaviors.  Teens are drawn to tobacco and alcohol, which are illegal for those under 21; many teens use marijuana, which is illegal for all or age-restricted in the various states (here).  It is not uncommon for teens to drive cars and have sex, two adult behaviors that can be high-risk.

Uniquely, tobacco use is regulated by a federal agency, the FDA, which now asserts that tobacco manufacturers are responsible for teen tobacco use. 

Everyone has a role to play in limiting teenage risk-taking, but focusing blame on manufacturers while ignoring other regulatory and information-sharing solutions ill serves the entire population.

October 24.  Clive Bates has just published his answers to Mr. Zeller's questions.  Please read them here.