by Carl V Phillips
I realize that mining journal articles for insights gets a little dry, as important as it is. So I will start with something related. In a new statement FDA CTP established some timing “performance measures” (notice that they did not actually say “deadlines”) for themselves in evaluating applications. That seems like good news until you look at the details. They give themselves 90 days to act on SE applications (basically requests by manufacturers to make minor changes in products compared to those already on the market). Presumably this is not retroactive, given that they have a backlog of 4000 such applications and have only acted on a few dozen. They give themselves at 360 days to act on MRTP applications (the process that includes requests to be able to allow new low-risk products onto the market, as well as requests to be able to market products as lower risk than cigarettes), which is a very long time in the life of would-be switchers, but this not terribly unexpected.
It gets worse, however, when we notice that the performance goal is to meet those deadlines only 50% of the time for the year starting in October, increasing to 80% by 2018. So if there are two MRTP applications filed this year (there are none so far, so two seems about right for the currently regulated products), one will be acted upon by late next year, and the other will still be pending in 2016.
But what if there are 100 MRTP applications and another 10,000 SE applications? That is not so far-fetched if the e-cigarette deeming regulations (which many people expect will be released this week or shortly thereafter) prohibit product innovation or changes in the absence of one of those approvals, and especially if they include rolling back the baseline technology to some fixed date in the past. Most of the speculative scenarios about what the e-cigarette regulations will contain include e-cigarettes being subject to rules similar to cigarettes, which are a largely static product. If a cigarette manufacturer wants to change, say, the glue holding the paper together (perhaps because their supplier no longer makes exactly the product they had been using), an SE approval is required. I trust I do not have to explain how that would affect e-cigarette quality improvements.
Moreover, the dearth of MRTP applications is because the traditional tobacco companies are extremely conservative and careful (some would say plodding) large organizations, and thus have been spending years perfecting their applications. Also, they do not need MRTP approval to stay in business. By contrast, e-cigarette companies are nimble and might be existentially threatened by the regulations. The applications they submit might not be as solid as those from larger companies, but you can bet they will be filed, and fast, if they are necessary to stay in business.
Should be interesting.
Resuming the series on FDA’s recent papers about e-cigarettes, I will save the worst for last and skip to the eighth paper in the collection, “The impact of electronic cigarettes on the paediatric population”. (Why couldn’t they just say “the chiiildren”, which would have avoided both the British spelling as well as the implication that people are nothing more that objects for the medical industry?) I have little to say about this one because (a) we all know what the chiiilrden rhetoric usually sounds like and (b) this is not actually a particularly bad version of that. Mostly it says we do not know much of anything. That is about right.
Moving on to the ninth paper, “Electronic cigarettes: incorporating human factors engineering into risk assessments”. This is the one paper in the collection that actually tries to do something that has not already been done better elsewhere, and thus could contribute value to the world rather than just being tealeaves for us to read. Unfortunately, it only states the obvious facts in an unhelpful way. That is, it is well known that people use e-cigarettes and do not behave like mere biological systems or machines. Thus, any attempt to assess e-cigarettes needs to take into consideration actual behavior. It is too bad the authors of the other papers in the series did not read this paper before naively accepting the various studies they cited which treated people as if they are mere biological machines.
Unfortunately, because FDA is restricting itself to ivory tower sources of information, and avoiding most of the world’s collective knowledge, the paper offers little insight beyond pointing out that people’s behavior matters. So it fills the space by addressing package labeling, something that regulators are unnaturally obsessed with. Accurate labels are a good thing, of course — one very useful role for regulators — but we are not going to learn much about them by reading a few random journal articles.
The last paper in the collection is “Research gaps related to the environmental impacts of electronic cigarettes” which is a strange amalgam of environmental health issues (bystander exposure) and “eco” issues. The latter is outside of FDA’s purview (and expertise), and the fact that they looked at it is a bit disturbing about their understanding of their proper role. The former is extremely naive. It does not look at the one paper that tried to figure out those health effects (Burstyn) and naively believes authors’ assertions without actually looking at the content of the papers. (In particular, the only reference to Burstyn is about him pointing out how the McAuley study suffered from obvious fatal lab errors. But FDA seemed to miss the fact that the McAuley study really looked at the vaper’s own exposure, even though the authors misleadingly reported they were studying bystander exposure — something that anyone who actually read Burstyn, or McAuley for that matter, would know.)
Finally, I return to the seventh in the collection, “Electronic cigarettes: human health effects”. Even more than the other papers, this ignores most of what is known and inserts alarmism where there is ignorance (or pretend ignorance).
Rather than acknowledge that the evidence from millions of users shows there are no substantial short-term health costs. FDA fixates on the shocking news that PG/VG can cause mouth and throat irritation (a trivial problem that some vapers have, usually temporarily — to say nothing of the fact that it is easily self-diagnosed, and if it is a real problem, the vaper can choose to avoid it). They then pretend we know nothing more about short-term risks (i.e., that we know from experience that serious effects do not exist at a noticeable level). Indeed, if you read the actual content, rather than the conclusions, they find nothing but reassuring information about the risks, but they spin it into the usual “we just don’t know”.
The discussion of nicotine follows a similar pattern — alarmism based on nothing. Anyone reading the text would find it rather reassuring, but the conclusions do not match the content. When no less than three of the references in the paper are about one individual who committed suicide by injecting e-cigarette liquid, you know they are fishing to find harms. They appear to be unaware that people self-titrate their nicotine intake, so intentional variations in nicotine strength and hardware delivery are a good thing, and unintentional errors in reported strength, while not good, are not a big deal.
The paper reports the obvious point that we cannot yet observe long-term effects. However, it ignores analyses that show we have solid affirmative reasons to believe they are minor. (Burstyn is again not even mentioned. At least the author of the previous paper skimmed Burstyn enough to learn that McAuley’s results were wrong, unlike this author.) Had this author actually read Burstyn, she would have know that e-cigarettes do not produce the particulate matter she claimed was worrisome, among other things.
The paper uncritically repeats the “third-hand” exposure trope. The meandering and ridiculously long conclusion again has the mixed messages, admitting that we know a lot already but then also declaring we cannot know anything unless the products are heavily regulated. Worst of all, is the claim that we do not know that e-cigarettes are any less harmful than cigarettes.
No, I take that back. The worst of all is that all the FDA authors seem to be unaware of the fact that just because someone wrote something down does not mean it is right. There is no hint in any of these papers that they know how to distinguish good science from junk.
This paper in particular, and most of the other papers in the collection, suggest that the agency — which plans to start regulating these products in the near future — knows precious little about them, and are in full Dunning-Kruger delusion about their level of knowledge. They seem unwilling to seek any sources of knowledge that are inconvenient to access (as well as what many of us proactive have told them), and indeed want to change the knowledge to fit their preferred search strategies.
I feel sorry for whoever is going to be regulated by the agency that wrote these papers.
Oh, wait. Damn.