For those who read this blog but not the main CASAA blog, you might be interested in our assessment of the UK MHRA’s move to require that e-cigarettes be approved as medicines. You may find our analysis of what regulation by MHRA would look like to be somewhat more optimistic than what you might have read elsewhere. However, we are rather more concerned than some other commentators about its implications for the EU.
You can find more of my sciences lessons at Patreon
My Patreon page is here. For just $1/month you can have access to that content and be able to participate in discussions. The modest donations help support the content here too.
And thanks again to those of you who have already done this.
- The unfortunate case of the Cochrane Review of vaping-based smoking cessation trials
- Sunday Science Lesson: Smoking protects against COVID-19, but most of the related “science” is badly misguided
- Sunday Science Lesson: How are deaths counted (for pandemics, smoking, etc.)?
- Can smoking protect you against COVID-19?
- New Glover-Phillips paper: “Potential effects of using non-combustible tobacco and nicotine products during pregnancy: a systematic review”
Carl V Phillips on The unfortunate case of the Co… Bernd Mayer on The unfortunate case of the Co… Carl V Phillips on The unfortunate case of the Co… Allen Speck on The unfortunate case of the Co… The unfortunate case… on Sunday Science Lesson: What is…
Follow this blogYou can subscribe using one of the usual methods. Posts will be announced in the primary author's Twitter: @carlvphillips.
Tags"no evidence" "passive vaping" 95% ACS addiction AHA ALA ANR ASH-UK Bates big picture biomarkers Burstyn carcinogens CDC censorship chemicals chiiiildren citations classic COI comparative risk conjunction CTFK demonic possession Dutra economics Ellen Hahn environmental vapor ERS ethics EU FCTC FDA fundamental lies gateway Glantz Gratziou gutka Hecht innumeracy Kelvin Choi Legacy logic meta-analysis motives MRTP non sequitur NRT NYTimes outsource particulates peer review policy recommendations Popova press release RCTs second-order preferences self policing Siegel statistiLie ST variants Swedish Match toxicology trANTZlator Trump parallels UAthens UBath UCSF UKY UMN US govt vapor chemistry WHO why anti-THR?
- Aside (18)
- Background (19)
- Lies (225)
- Science lesson (58)
- Testimonial (3)
- truths (203)
- Uncategorized (15)
- White Paper (7)
I was thinking along some similar lines yesterday reading through the various supporting docs on the MHRA site.
There are some apparent, but not huge, concessions to full-on medicines regulation (large scale efficacy RCTs ‘might not’ be required for each application, but smaller clinical pharmacodynamic-type studies definitely would be). The MHRA are also obliged to comply with requirements of other EU medicines regulation, which mandate certain standards and inspections in the place of manufacture, which could be problematic for the current supply chain. The exact process for device variants, including stuff unique to e-cigs like flavourings, wasn’t clear, though I didn’t get an overwhelmingly positive reading from it.
However, an interesting point was that in some of the ‘impact assessment’ type documentation, there was explicit acknowledgement that, if regulatory practice retarded the market enough to restricted availability and use – even by a relatively small amount – there was potential for large public health losses.
If (barring things going a different way in Europe, or a legal challenge by existing vendors) we approach a 2016 deadline and there are only a handful of products licensed due to the high burdens set, there could be significant pressure to reappraise the process, lightening up on requirements. Really it will only become clear once the first applications start going in though.
The UK anti tobacco industry has finally shown its true colours. They care nothing about health. Discussing this issue seriously is pointless. MHRA medicine approval is funded by the Pharmaceutical Industry (see my comment below the article link below), whose gum and patches are now obselete. For details of the nonsense, read the Free Society article referred to here