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.




Monday, November 12, 2018

Tobacco Control Special Issue Yields Smoke But No Hazard for IQOS Aerosol


Recently a special issue of the journal Tobacco Control offered 22 articles on Philip Morris International’s (PMI) IQOS heat-not-burn tobacco product (here), aiming to dissuade the FDA from allowing IQOS sales as reduced risk products for smokers.  In the words of editor Stanton Glantz: “Policy makers should give greater weight to the advice provided by public health scientists than to submissions from industry when it comes to regulating tobacco products such as heated tobacco products.”



Dr. Glantz’s advice has been inaccurate in the past. A year ago, when he argued that “PMI’s own data fails to support a modified risk claim in people who are actually using [IQOS],”  I detailed the errors in his analysis (here).  This new collection of anti-IQOS articles deserves the same scrutiny.



One treatise, by UCSF’s Gideon St. Helen and colleagues, acknowledges that “All substances in PMI’s list of 58 constituents (PMI-58) were lower in IQOS emissions compared with mainstream smoke of reference cigarettes.”  That accurate statement is followed by the suggestion that PMI ignored that “levels of 56 other constituents, which are not included in the PMI-58 list or FDA’s list of [harmful and potentially harmful constituents], were higher in IQOS emissions.”  The authors criticize PMI for not undertaking “non-targeted chemical analysis” to identify these compounds.



Dr. St. Helen et al. are mistaken.  The chart above, taken from PMI’s presentation to the FDA advisory committee last January (here), documents that the company performed that analysis.  PMI’s extensive investigation of “other” substances is confirmed on the FDA website, where a chart labeled “non-targeted screening” appears in a document submitted by PMI on December 8, 2017, and published by FDA on January 12, 2018 (here). 



The December filing acknowledged that “80 compounds were found to be of higher concentration or new in [IQOS] aerosols…compared to cigarette smoke.  A toxicological assessment was performed and identified 68 of those that do not present specific toxicological concern. 8 compounds present potential genotoxic concerns based on structure-activity computational alerts and 4 compounds are classified mutagens/carcinogens.” 



PMI scientists did not dismiss the findings: “Although a minor subset of compounds identified in this study show intrinsic (potential) toxicological hazards, overall toxicity of the THS generated aerosol was lower compared to cigarette [smoke]. In vitro studies demonstrated a marked decreased biological activity of [IQOS] aerosol compared to smoke. An in vivo 90 days inhalation study showed in general a lower biological activity of the mainstream aerosol from [IQOS] when compared to mainstream smoke.”



Importantly, PMI is undertaking more research: “Additional investigations are ongoing to further characterize the impact of the [mutagens/carcinogens] on the overall toxicity of [IQOS] products.”