I took part in the FDLI annual conference last month where I met Mitch Zeller. I also saw him present at the SFATA conference in Chicago two weeks later, and I so had the opportunity to contrast his statements to two different audiences.
My takeaway is this: Mitch genuinely wants to maximise the potential of e-cigarettes, and the decision will be made on the best available science currently available. BUT: read on.....
The problem are manifold. Firstly, the TCORS centres are, at their level of core-competence, designed to
find problems with tobacco products and not opportunities they present. So we have an inherent publication bias where the literature makes more salient the theoretical health risks e-cigs present, rather than the contextual opportunity (i.e. safety relative to smoking). It also takes the products "as they are" and not "as they may become through innovation and sensible regulation".
Secondly, what is being investigated is overwhelmingly focussed at the biological level. This isn't problematic in and of itself, but it does create a situation where the "reality as
we see it" barely even surfaces. That is to say, the socio-cultural momentum behind vaping (and it's really important) is completely ignored.
Further, where the science isn't focussed on the biological, it's focussed on population effects (eg, CDC data on youth). Unfortunately this is descriptive science, and not explanatory: So far, little has been done to understand the interplay behind the cultural community, the products, marketing etc and the degree to which smoking is reducing in favor of vaping. This is critical stuff, but it's simply not being funded by anyone.
And speaking of population level effects, it's important to note that behind the scenes there's a very important, very expensive piece of research being carried out: the PATH study. It's been criticised (fairly) by Dr. Farsalinos for making a
catastrophic error in one of its items, but overall it will be the best picture of tobacco and vaping related behaviour ever produced (and for $117m it damned well should!).
The FDA now has the first wave of baseline data and, I'm informed by my sources, it paints a
very good picture of vaping. But, and this is somewhat unfortunate, the next wave doesn't go out until later in the year, and it won't be until mid 2016 that the full thing is published.
So, back to Mitch - he's very positive on the continuum of risk, but we have no idea how he plans to steer the FDA towards regulations which actually create a positive impact from that insight.
One statement he made to SFATA, which Ihe didn't make at FDLI (although I did make the same point in
my FDLI presentation), is that there needs to be a widespread re-education of the public on nicotine. In Mitch's SFATA Q&A I submitted a written question which didn't get asked, annoyingly. It went like this:
"You've stated that there needs to be a public re-education on nicotine, so that the continuum of risk can actually have an impact. But it's unclear to me whose responsibility that might be. Is this something within the purview of the FDA, or would the FDA be able to influence other agencies to take responsibility?"
