Tuesday, December 4, 2018

Who Smokes Menthol Cigarettes?

FDA Commissioner Scott Gottlieb recently said, “I’m deeply concerned about the availability of menthol-flavored cigarettes.”  He noted that menthol represents “one of the most common and pernicious routes by which kids initiate on combustible cigarettes” and “menthol products disproportionately and adversely affect underserved communities. And as a matter of public health, they exacerbate troubling disparities in health related to race and socioeconomic status that are a major concern of mine…we need to address the impact that menthol in cigarettes has on the public health.” (here)

In a similar vein, the Truth Initiative’s latest menthol screed suggests that menthol smokers are primarily teens, females, minorities and those with mental illness (here).  Is that accurate?

The answer for adults can be found in the National Health Interview Survey, the main instrument used by the CDC to track smoking in the U.S.  The NHIS collects information on menthol about every five years.  The chart at left presents the characteristics of menthol smokers in 2015, the most recent year for which NHIS data is available. 

Of the 36.5 million American adult smokers, about 10.7 million reported that they smoked menthol cigarettes (22.4 million preferred plain cigarettes and the rest were uncommitted).  Women outnumbered men by a small margin, and menthol smokers were broadly distributed across the age spectrum.  Racial distribution figures stand out.  Although Black/African American smokers overwhelmingly favored menthol cigarettes, they were far outnumbered by White menthol smokers.

Sixty-one percent of menthol smokers and 55% of plain cigarette smokers were in the lowest income group.  Any difference in income distribution between menthol and plain cigarette smokers may be explained by differences in age, sex or race.  The claim that menthol use reflects a socioeconomic disparity is not valid without further investigation.

Last year I published research showing that smoking may contribute to depression, anxiety, or emotional problems (here).  But the association has nothing to do with menthol.  In the 2015 NHIS 11% of menthol smokers reported difficulty with activities because of these conditions.  The rate was the same among plain cigarette smokers.

Five years ago I noted in this blog that an “FDA preliminary evaluation – reflecting data from numerous studies – does not provide evidence of any significant differences between menthol and regular cigarettes with respect to smoking initiation, addiction to nicotine or cessation.  There is no justification for an evidence-based decision by the FDA to ban or otherwise restrict the menthol content in cigarettes.” (here)  

It is not clear that a stronger scientific rationale for FDA action on e-cigarettes presently exists.  If action is taken, this blog post has described the characteristics of the 10.7 million smokers it will affect.

Tuesday, November 27, 2018

Pediatrics Journal Wants to Rectify Teen “Inaccurate Beliefs” About Smoke-Free Tobacco Hazards

In the journal Pediatrics, University of Vermont’s Maria Parker, Ph.D., and 11 coauthors from four other institutions report that “Youth [age 12-17 years] who believed that noncombustible tobacco products posed ‘no or little harm’ at [wave 1 of the FDA Population Assessment of Tobacco and Health Study, PATH] were more likely to have tried those products at wave 2.” (here)

This finding is not particularly surprising.  It shows that, despite a relentless campaign against vastly safer smoke-free tobacco products, some youth recognize the truth: It’s the smoke that’s harmful.  Dr. Parker found that 85% of youth thought cigarettes conferred “a lot of harm,” while only 27% thought the same of e-cigarettes.  On the other hand, only 51% thought e-cigarettes were less harmful than cigarettes, 44% assessed them as equally harmful, and 5% believed them to be more harmful.

Skewing their findings against smoke-free products, Parker et. al. used “ever trying” the products between survey waves as their outcomes.  This is much less meaningful than “currently using”, which was not reported and might have produced negligible results.  

The take-away from the article is that youth who [correctly] believe that smoke-free tobacco products are less harmful than cigarettes are more likely to try the former.  Parker et al. imply that trying can be prevented by disabusing teens of their “inaccurate beliefs.”

Even though the study's findings are inconsequential, its 12 authors use them to justify aggressive intervention by authorities “across local, state, and national levels…to convey accurate information on and address inaccurate beliefs about the absolute and relative harms of tobacco products in an effort to reduce youth tobacco use.”  They highlight the FDA’s Real Cost Campaign, which conveys “accurate information” by depicting e-cigarette worms invading teen brains and bodies (here). 
Speaking of real costs, this study was supported by $62.3 million in NIH grants.    

The article’s recommendation was endorsed by the journal’s editor (here), who previously acted contrary to editorial standards for professional medical journals after publishing a flawed e-cigarette gateway study (here and here).


Tuesday, November 20, 2018

Detoxing the Heavy Metal Vape Scare

Jonathan Swift 300 years ago observed that “Falsehood flies, and the Truth comes limping after it; so that when Men come to be undeceiv’d, it is too late; the Jest is over, and the Tale has had its Effect.” (here)  That is the story of e-cigarettes and vaping today. 

Billions of dollars have been transferred from tobacco consumers to companies to the FDA in the form of user fees (here).  The FDA, via the NIH, has transferred hundreds of millions to fund university research on tobacco use and effects, in order to provide a “scientific basis” for FDA regulations (here).  With NIH making no attempt to hide our government’s objective – “a world free of tobacco use” (expressed here) – it is not surprising that much of the funded research and attendant publicity is biased to support the announced policy objective.

In March, anti-vaping researchers published a study claiming that metals in e-cigarette vapor are toxic when inhaled.  While the media headlined the findings “dangerous” and “alarming”, and termed vape products “brain-damaging,” I explained in this blog that the metal doses delivered by e-cigarette liquids in this study are trivial.  I estimated that an e-cigarette user could be exposed to excessive metal levels only by consuming high volumes of vape liquids.  For example, vapers would have to use 15.4 liters (nearly four gallons) of liquid per day to achieve exposure to 2 micrograms of cadmium. (here

I worked with Dr. Konstantinos Farsalinos, a prestigious vaping researcher at Greece’s Onassis Cardiac Surgery Center, the University of Patras and the National School of Public Health.  The findings of our risk assessment analysis of the metals study were just published in the journal Inhalation Toxicology (abstract here).

The original study referenced U.S. Environmental Protection Agency safety limits that apply to 24-hour air exposure, or to workers breathing factory air for 8 to 10 hours.  This standard is entirely invalid for e-cigarette analysis, as users do not inhale vapor continuously for such long periods of time. 

Dr. Farsalinos and I applied more realistic federal standards, such as established regulatory safety limits for inhaled medicines.  We calculated total daily exposure to metals by using an average daily vape liquid consumption of 3 to 5 milliliters (e.g., 3 to 5 grams, around 1 teaspoon).

The chart demonstrates that vapers would need to consume impossibly large volumes of liquid in order to exceed the safety limits for almost all metals.  The one exception is nickel, which requires only 17 grams of liquid, but even that is over three times normal daily consumption.

In this case, truth is limping in eight months after widespread false alarms flew about metals in e-cigarette vapor.  The Tale has had its Effect, but in the end, as Shakespeare assures us, truth will out.