Monthly Archives: April 2014

CDC Director Frieden explains that he hates ecigs because he is clueless

by Carl V Phillips

I interrupt the analysis of the deeming regulation, because this article simply must be commented on.  CDC Director Tom Frieden “explains what he hates about electronic cigarettes” to the Los Angeles Times.  That is the actual headline — I paraphrased based on what he actually said. Continue reading

Scientific claims in the FDA deeming regulation (part 1 of ???)

by Carl V Phillips

[Update — this series continues with:

Some closely related posts include:

  • The three-part series about a recent collection of papers by FDA that starts here
  • Analysis of the naivety on this topic displayed in a letter by FDA Commissioner Hamburg here
  • My comments on behalf of CASAA about the inappropriateness of the economic impact statement in the context of the Paperwork Reduction Act, linked from here


As presumably every regular reader knows, the FDA CTP has published their draft “deeming” regulations that will bring e-cigarettes, dissolvable nicotine products, and some hypothetical other THR products (as well as some combustible products) under their jurisdiction.  You can find more about that, including our ongoing analysis of our overall assessment of the regulations, at the CASAA blog.

This post begins a series of unknown length that will analyze the scientific claims being made in the draft regulation[Update: That link is now dead, so here is the file; I prefer it because I was already using the page numbering, and it is much easier to read], the associated economic impact statement, and any other partially-scientific documents that are produced. While there is substantial unhappiness about the proposed regulations, and protests that it is just not the right thing to do, it is unlikely that these will have a large influence on FDA’s final decision or any adjudication of it.  Third party reviewers of FDA’s actions (i.e., courts) will probably be much more concerned with details of whether the science supports the claims and whether the claims support the policies.  This series focuses on those questions and attempts to avoid any normative analysis (other than about epistemology). Continue reading

FDA reveals its views on ecigs in new publication (part 3), and some thoughts on their new deadlines

by Carl V Phillips

This continues from the previous post, in a series that started here.

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. Continue reading

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.

Quick outsources to Rodu and Grant

by Carl V Phillips

I will resume several more posts about my take on the FDA CTP shortly.  In the meantime…

Read this post by Brad Rodu.  It offers some great additional insight about the failings of the Dutra-Glantz paper that claimed to find a gateway effect from e-cigarettes to smoking. Continue reading

FDA reveals its views on ecigs in new publication

by Carl V. Phillips

[Update: This post begins a series that continues with part 2 and part 3]

The new special issue of the “journal”, Tobacco Control, has already been cited as a comprehensive review of what is known about e-cigarettes.  It is very much not that.  A glance at the table of contents makes this clear (hint: if a collection does not include among its authors any of the leading experts, it probably is not a comprehensive review) and further reading confirms it.  What it is, however, is something far more useful than that, and far more troubling:  It is effectively a position statement by the U.S. FDA, the institutional author of all the papers, about how they feel about e-cigarettes. Continue reading

Sunday scientist lesson: The extra effort required for ethical study of oppressed people

by Carl V Phillips

We are very dependent on the ethics of some groups in society.  Trade contracts exist, and governments exist to enforce them and other regulations, because we assume that many actors would skew transactions to their own benefit, or default on their promises completely.  The failure to impose such regulations on bankers, as if they could be trusted, has caused a bit of trouble.  By contrast, we depend on the assumption that people will act ethically within their family.

We tend to trust scholarly researchers to show the ethical non-self-centeredness we assume in families.  Readers of this blog know how well that works in public health science, and how much worse still it is in for “public health” (the extremist political faction that masquerades as a science).  Anyone who thinks the peer review process solves this problem knows little about how badly peer review works, or is pretending to not know, taking advantage of those who do not know.

Outside of public health, things work rather better.  Continue reading

Why using the term “ENDS” for e-cigarettes is unwise and unethical

by Carl V Phillips

I have previously pointed out that the use of the term “ENDS” (electronic nicotine delivery system) as a substitute for “e-cigarette” is a mistake for THR supporters and an unethical act for scholars.  Most recently I did so in the exchange about the new Nutt paper mentioned here.  But the questions that ensue when I state this make it apparent that I need to write down a more complete exposition of the point.  It is apparently very far from obvious to many readers (which I have to say, I find a bit dismaying; on the other hand, the fact that it is not obvious is one of the reasons it is so insidious). Continue reading