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.
December 6, 2018
Heikki Hiilamo and I recently published Limited implementation of the framework convention on tobacco control's tobacco tax provision: global comparison in BMJ Open. This paper, the latest in a series of papers we have done to assess the quantitative effects of the FCTC on tobacco control policies around the world, shows that the FCTC has had an effect on tax policy, but it has been limited and more likely to be in the richer countries.
The other papers are on the effect of the FCTC on advertising bans, smoke-free laws, and health warning labels in low and middle income countries and in general (with voluntary industry agreements slowing down progress).
Here is the abstract:
November 30, 2018
The New York Times recently reported that Juul is working to develop a pod with lower nicotine content that will deliver the same “hit” by increasing the voltage in the device. Running at a higher temperature increases nicotine delivery, as well as generation of the other toxic chemicals in e-cigarettes.
This effort to sidestep EU rules on nicotine in e-cigarettes is one more illustration of how Juul is acting like any other tobacco company in working to get around the rules. The fact that they are modifying the product in a way that increases the risks is especially cynical given that they claim to be interested in harm reduction.
Alan Shihadeh and Tom Eissenberg at VCU identified this loophole in the EU regulations way back in 2015 in their paper “Electronic Cigarette Effectiveness and Abuse Liability: Predicting and Regulating Nicotine Flux” when they wrote:
November 30, 2018
Recently David Levy and colleagues published “Examining the relationship of vaping to smoking initiation among US youth and young adults: a reality check” in Tobacco Control. In this paper they used data from all the surveys over time that measured youth and young adult e-cigarette use and smoking and concluded
There was a substantial increase in youth vaping prevalence beginning in about 2014. Time trend analyses showed that the decline in past 30-day smoking prevalence accelerated by two to four times after 2014. Indicators of more established smoking rates, including the proportion of daily smokers among past 30-day smokers, also decreased more rapidly as vaping became more prevalent.
The inverse relationship between vaping and smoking was robust across different data sets for both youth and young adults and for current and more established smoking. While trying electronic cigarettes may causally increase smoking among some youth, the aggregate effect at the population level appears to be negligible given the reduction in smoking initiation during the period of vaping's ascendance.