January 3, 2019
To much fanfare (New York Times, Washington Post, CNN), on November 15, 2018 FDA announced several actions (Statement from FDA Commissioner Scott Gottlieb)to address dramatic increases (link1, link2) in youth e-cigarette and nicotine use. FDA wants to reduce kids’ access to flavored tobacco products and even talked about finally banning menthol in cigarettes and other tobacco products.
The good news is that FDA is recognizing that flavors and e-cigarettes are a big problem for kids, but, on closer inspection, most of FDA’s proposals will have little immediate impact.
January 1, 2019
Charlotta Pisinger, Nina Godtfredsen, and Anne Mette Bender recently published “A conflict of interest is strongly associated with tobacco industry-favourable results, indicating no harm of e-cigarettes” in Preventive Medicine. The title says it all; like research funded by cigarette companies (and a range of other corporate interests), research funded by e-cigarette interests makes e-cigs look (relatively) good. Work not funded by industry showed higher dangers.
Policymakers and practitioners need to pay attention to these conflicts when assessing what they read.
Here is the abstract:
December 27, 2018
Maciej Goniewicz and a large team of collaborators published an extensive analysis of the biomarker data collected in the FDA/NIH PATH study. Their paper “Comparison on Nicotine and Toxicant Exposure in Users of Electronic Cigarettes and Combustible Cigarettes” reports on data collected in a large nationally-representative sample of 5105 people.
They measured a panel of 50 measures of exposure to nicotine as well carcinogens and heavy metals.
The point that e-cigarette enthusiasts will likely emphasize from the paper is that the measures of many of these toxins were lower in the e-cigarette users than the smokers. (They were also higher than in people who did not use any product, as expected.)
The most interesting and troubling finding is that the levels of 47 of the 50 chemicals were higher in the dual users (people who used both products at the same time) and 76% of the e-cigarette users were dual users (i.e., still smoking cigarettes). Of these 47, 28 were statistically significantly higher in the dual users than the people who just smoked cigarettes. (The levels of the other 3 chemicals were about the same in both groups.)
December 21, 2018
PMI finally responded to my paper in Tobacco Control1 showing that the data submitted in their MRTP application to the FDA to market IQOS with reduced risk claims did not actually support claims of reduced risks.
Specifically, PMI’s MRTP application included their 3-month study of 24 non-cancer biomarkers of potential harm (which PMI calls “clinical risk endpoints,” CRE) in humans using IQOS compared to conventional cigarettes. These biomarkers include measures of inflammation, oxidative stress, lipids, blood pressure, and lung function. (PMI did separate studies of biomarkers of exposure, several of which are carcinogens.) While PMI’s application emphasizes that these biomarkers generally changed in positive directions, my examination of the data revealed no statistically detectable difference between IQOS and conventional cigarettes for 23 of the 24 BOPH in Americans and 10 of 13 in Japanese. Moreover, it is likely that the few significant differences were false positives. Thus, despite delivering lower levels of some toxicants, PMI’s own data failed to show consistently lower risks of harm in humans using IQOS compared to conventional cigarettes.
December 21, 2018
Here is what VCU Professor and expert on e-cig products Thomas E Eissenberg has to say about Juul and how its formulation can spread:
Actually, and perhaps worringly, I don't think JUUL is exceptional at all. Their innovation, such as it is, is the observation that protonated nicotine ("salt") is more palatable in aerosol form than freebase nicotine, making their ~60 mg protonated liquid easier to inhale than if it were freebase (I doubt anyone would willingly inhale aerosolized 60 mg/ml freebase liquid at 8W; 36 mg is borderline aversive). The scary thing for those of us worried about nicotine dependence is that salt liquids are now available on the market (at least in the US) such that ANY device can now be used to produce this highly palatable, high nicotine content aerosol. And, perhaps more concerning, those highly palatable, high nicotine content liquids can be used in devices that achieve much greater power output than the current ~8W JUUL. So, if JUUL were to disappear tomorrow, users could migrate to protonated liquids that they buy in bottles, put them in their high wattage devices, and achieve even greater nicotine delivery than JUUL provides today.