FDA reveals its views on ecigs in new publication (part 2)

by Carl V Phillips

This continues from the first post on the series (which you should read to understand what I am doing and why).

It has been an interesting few days in the world of rumor and inference about forthcoming FDA regulation of e-cigarettes.  It was amusing if you could momentarily step outside worrying about the outcome to focus on the process, and depressing otherwise.  It included a farcical dance in which publicity seekers set themselves up to get subpoenaed in the future (with a national news release and countdown timer, no less), the FDA shutting down that dance, and the designated jester of tobacco control, Glantz, swallowing the whole thing and characteristically making bold pronouncements based on reading a few sentences he did not really understand.  (We might consider the latter bad news:  Glantz declared that the regulations would be consumer-friendly — which, of course, he derided as a bad thing — and he is almost always wrong.) The week also include the TPSAC meetings, far more substantive and important, but probably under most people’s radar; I will post about them if I get a chance.

Meanwhile, back at the FDA-penned articles in that journal issue I was writing about:

The third article is “Chemical evaluation of electronic cigarettes”.  The quality of this effort can be summed up by a quick glance at the references:  By far the most useful paper about e-cigarette chemistry — in the context of health effects, which is what matters — is the CASAA-sponsored review by Burstyn.  It is not cited in the FDA paper.  Basically this paper is a partial (because the data collection was very incomplete) step that one would need to do on the way to doing a useful analysis, like Burstyn’s.  It is like publishing the notes of a background literature review rather than actually analyzing anything.

Had the author read Burstyn, not only would the review have been more complete, but many of the errors could have been avoided.  In particular, the paper includes naive reporting of elemental metals (without pointing out this is uninformative when the parent molecule is not known) and confuses droplets and their sizes (irrelevant) with particulate matter (sometimes harmful, and size matters).  This author and several of the others do deserve credit for using “e-cigarettes” and not ENDS.  Indeed, their search strategies to find papers included several variations on “e-cigarettes”, but not “ENDS” — a clear acknowledgement that real researchers are not using the latter term.

Since this is basically a publication of background notes, there is relatively little of interest.  The author points out a few truths that any expert in the field already knew, like the inconsistency of evaluation methods that have been used.  There are hints of FDA’s desire to standardize the products to make their own lives easier, though nothing like those that appeared in the previous paper.  Basically there is no value-added from this paper in a world that already contains Burstyn’s paper, but there is relatively little harm from it.

The fourth paper in the collection, “Electronic cigarettes in the USA: a summary of available toxicology data and suggestions for the future”, does cite Burstyn, fairly accurately, though the author is clearly trying to downplay it, understating the results, putting it at the end, and only citing the working paper version and not the final version.

Toxicology is frequently characterized by a group of people with labs looking for an excuse to do something that is perhaps slightly informative, and then vastly overstate their conclusions.  The present paper basically says there is no useful toxicology about e-cigarettes.  It did not add that this is likely to remain the case when more toxicology is done.  Perhaps that is because it conflates real health analysis (the passage about Burstyn), analytic chemistry (which sometimes toxicologists will claim as their own, but really fundamentally different from toxicology lab studies), and wet lab studies (which is what is what toxicology normally means in this context).  Indeed, it only spends two paragraphs on the latter (not counting the introduction and conclusions, which are longer than the analysis).

Mostly this paper is another version of the analytic chemistry from the previous paper in the collection, covering ground that Burstyn already did better.  The subtext is largely uninteresting, with little more than hints about the desire to standardize.  The paper signals a greater interest in toxicology rather than estimates of health effects, but this is hardly news from that quarter.  There is one intriguing line, “Are e-cigarette users exposed to higher or lower levels of toxicants than smokeless tobacco product users?”  This suggests that someone who had a hand in the paper is aware that the best way to estimate the (unmeasured) health impacts of e-cigarettes is to compared them to the (well measured) impacts of smokeless tobacco.

The fifth paper is “Electronic cigarettes and nicotine clinical pharmacology”. It is basically about how much nicotine you get from vaping, and is pretty much vacuous.  At least for the previous papers on analytic chemistry, a decent portion of it shows up in the ivory tower journals, particularly if you read Burstyn.  However, since the FDA was blatantly ignoring all other sources of knowledge, this review of nicotine consumption and the experience of it is worthless.  There is an enormous amount of knowledge about the nicotine experience from e-cigarettes, but almost none of it appears in journals.  Thus, the main message of this paper is that FDA wants to ignore common knowledge, even when it is obviously far more complete than the paltry information in journals.

In terms of the content, there is a hint that FDA is not willing to just accept the trope that “nicotine is addictive” that derives from observing that cigarettes are “addictive”.  That is, even setting aside the fact that “addictive” is either a meaningless or incorrect description of the cigarette experience, FDA hints that they realize this does not extrapolate to e-cigarettes.  Unfortunately, that is just a hint, and it is lost in the wordplay about “dependence” (which they assert occurs, based on no analysis) and “abuse liability”.  (Aside:  If cigarettes are “deadly when used as intended” etc., then they are not really being abused, are they?  They are being used, not abused, as are other tobacco products.)

The next paper is “Electronic cigarettes: human health effects”.  You might have thought that all the papers other than the one about characterizing the devices were about human health effects.  Apparently you would have been wrong.  I will pick up with this one in a subsequent post.