Tag Archives: press release

Another study confirms lack of concern about vapor toxicity – too bad about that press release and some of the details

posted by Carl V Phillips

I have to leave my series on what constitutes useful evidence as a cliffhanger for another day or two, because people are clamoring for my comments on the latest in the series of studies about e-cigarette vapor chemistry that was recently published.  (Article summary here; full version is paywalled.)  The study tends to confirm what we already knew about vapor, and the fact that it does not contain important quantities of unexpected toxins.  This is certainly good news for e-cigarette users (vapers) and THR advocates.

Before continuing with the study, though, it is worth tying this in to the current series I interrupted and asking, “How did we know that?”  The bulk of the evidence comes not from the half-dozen or so lab studies that have been done, but from the basic chemistry and physics of the situation.

That is, how do we know that e-cigarette vapor is not similar to cigarette smoke?  The same way that we know that it is not similar to monkey urine — with our scientific reasoning process that says, “Why would we ever even expect it to be similar?”  Cigarette smoke is produced by burning complex plant matter which produces a lot of the many known products of combustion and a little bit of more chemicals than we could ever count.  E-cigarette vapor is produced by heating a liquid of (mostly) known chemistry, very much not like plant matter, into a vapor phase with little change in the chemistry other than its physical state.  The best evidence that we have that they are different is right there in that reasoning.

One of the biggest mistakes that THR advocates can make is to implicitly endorse the anti-scientific tactics of anti-THR activists, who would pretend that most of the evidence does not exist.  In other words, it is a potentially fatal error to send the message, “Because of this study and the handful that came before, we know…” rather than the more accurate and useful observation, “Before the first study was ever done, we were 99% sure that…, and these studies show that, indeed, we did not overlook anything in our previous reasoning.”

If you live by the one-off little study, you will die by the one-off little study.  There is an obvious response, by those who seek to prevent harm reduction, to all of the chemistry studies that have been done (including those spun by the anti-THR liars, which have actually shown the same good news as the others).  They can say, “these only looked at a few samples of the product, and we do not know what might be in other or current products.”  This is a reasonable response, though ultimately not true.

It would be completely true if I had phrased it differently, substituting “they do not provide observations about what might be in…” rather than “we do not know what might be in…”.  “We do not know” is a lie is because of all the rest of our knowledge, apart from the handful of studies.  But if we seem to be claiming the handful of studies are what really matters, we are arguing the liars’ case — after all, eventually one of these little studies will get a bad result due to lab error or real contamination.

Circling back, what is contained in the “…” a few paragraphs back?  The main observation there is that e-cigarette vapor contains the same stuff as e-cigarette liquid (disbursed into air), in obvious contrast to cigarette smoke, which is obviously not just the contents of an unlit cigarette plus air.

Should we be worried about unwanted chemicals in e-cigarette vapor, then?  Well, basically: garbage in, garbage out.  That is, whatever is in the liquid will end up in the vapor.  If the liquid is contaminated with something that should not be there, it will also be the vapor (though this creates approximately a zillion times as much concern for the vaper herself as for any bystanders for reasons elaborated upon below).

Is there some chemical activity that might depart from this observation?  Not much, but perhaps some.  And therein lies the very unfortunate limitation of the new study.  Its value would have been dramatically increased had they analyzed the chemistry of the same liquid that was used to produce the vapor, a step that would have been quite easy and inexpensive.  Any important differences would give us new (because it would be unexpected) information that might help in creating better products.  If there result were the expected correspondence, however, it would help reassure us that studying only the liquid chemistry (much easier and quite practical to do for samples from every large-scale production run, and for some portion of small batches) would be roughly as useful as more complicated aerosol studies.

Of course, that tells us what the vaper is exposed to, rather than those sharing space with the vaper (who we expect will breathe some of whatever was exhaled by the vaper, just as we always breathe whatever people around us are exhaling).  This is important because much of the rhetoric coming from the anti-THR liars claims that the exposure of bystanders justifies enacting bans on the use of e-cigarettes in public, and even private, places.  But the exposures of bystanders are going to be attenuated compared to vapers by both dilution (a little bit of vapor in a lot of air) and absorption (most of the content stays in the user unless he is intentionally quick-puffing in order to make a cloud rather than to more effectively deliver nicotine by holding the vapor longer).

The recent German study — which was spun by the authors’  and others’ anti-THR lies (links above) as showing a serious risk to bystanders when it actually showed quite the opposite — looked at exhaled vapor, providing a better measure of the actual environmental exposure.  The new study, unfortunately, just diluted the vapor that the vaper would inhale, a rather odd arbitrary methodology.  This was apparently supposed to offer some measure of what a bystander would be exposed to, but it fails to do that.  Mostly what it does is make all of the quantitative results meaningless, except in relation to each other.  The arbitrariness is clearly illustrated by considering what would happen if, instead of diluting the vapor into roughly half a cubic meter of air [the rest of the paragraph is UPDATED based on first comment] and then apparently multiplying the concentrations as if this were diluted to a 40 m^3 room, they had diluted it into a different volume.  In an alternative scenario, the concentrations would have all been changed by some multiplicative factor, assuming we ignore any actual effects of the room (gravity, adherence to solid surfaces).  Moreover, even if they chose the “right” dilution factor (whatever that might be), this would still not mimic the exposure of a bystander (read on).

This means that only the relative results matter.  The relative comparison is made is to cigarettes smoke, but we already knew that there was a big difference.  The comparison does not answer the question about whether the real-world concentration of chemicals from e-cigarettes is “too much” (whatever that might be judged to be by a hypothetical rational and honest policy process).  A similar observation about the sensitivity to the dilution mattering is true for any study of vapor (or smoke) also, but in this case the dilution factor was utterly arbitrary.  It was far smaller than a room['s dilution given that that large number of puffs represents a lot of vaping time], but far larger than someone’s lungs.

I bring up lungs again because, despite how this study was spun, this was a study of “first hand vapor” not “second hand vapor”.  The methodology description is a bit incomplete, but it is pretty clear that there was no attempt to simulate the process of the vaper absorbing most of the content of the vapor or a smoker absorbing the smoke to which it was being compared.  Yet the press release had the very unfortunate headline, “New e-cigarette study show no risk from environmental vapor exposure”.  The second-biggest flaw in this headline is the reference to environmental exposure, which was not studied.  Unfortunately, two of the people quoted in the press release make the same mistake as the headline, with one of them even making the error of referring to “second hand vapor”.

Of course, if what the user is exposed to does not contain anything we should be worried about, then the much lower exposure of the bystander is even less worrisome.  But, again, we know that because it is obvious for numerous reasons, not because of this study.

Finally, there is that “no risk” claim.  This is another example of the overblown claims that — as I argued previously — will ultimately harm the cause, not help it.  First, a chemistry study is not a health study, and does not include any measures of health outcomes.  This study looked at more results than the example of overblown claims I cited in the previous post, but that other study had the advantage of measuring health outcomes.  A claim like “found levels of environmental exposure that are not considered worrisome for health” would be fine, but no actual health claim can be made based on chemistry results like these.

Second, the claim “no” (as in “no effect”) is never a legitimate scientific claim.  “Too small to measure” — great.  “Showed no evidence of an effect” — fine.  But we can never be sure there is no effect.  It is generally suspected that nicotine is a little bit harmful, though the effects are too small to measure.  Some people are definitely sensitive to polypropylene glycol exposure.  Further similar observations can be made about the contaminants.  So if someone breathes enough of the vapor (and, again, the absolute concentrations that were measured were totally arbitrary), there could well be some harm.  Nothing is gained by pretending otherwise.

Finally, as a policy analyst, I have to strongly object to treating natural science results as if they provide policy analysis as was done in the press release (though not in the actual article).  Do these results show that we should not ban vaping in any indoor spaces?  Definitely not.  Nor would have less-reassuring results shown that we should ban indoor vaping in some indoor spaces.  Such claims require both a statement of the ethical basis for imposing restrictions on people’s choices and the accompanying economics (assessment of costs and benefits) which would be informed by the natural science results.  That requires several more steps than are ever included in a research report.

Gratziou ERS press release – where is the science?

posted by Carl V Phillips

In the previous posts we pointed out how Christina Gratziou’s anti-THR politics-disguised-as-science could be recognized as lies (even by someone who did not understand the science) and explained why her concluding about real disease outcomes from a short-term biomarker study were inherently flawed.  This did not even address the what she reported about the research, which I will do today.

Here is the content (all of it):

The study included 8 people who had never smoked and 24 smokers, 11 with normal lung function and 13 people with either chronic obstructive pulmonary disease (COPD) or asthma.

Each person used an electronic cigarette for 10 minutes. The researchers then measured their airway resistance using a number of tests, including a spirometry test.

The results showed that for all people included in the study, the e-cigarette caused an immediate increase in airway resistance, lasting for 10 minutes. In healthy subjects (never smokers) there was a statistically significant increase in airway resistance from a mean average of 182% to 206%.

In smokers with normal spirometry there was a statistically significant increase from a mean average of 176% to 220%. In COPD and asthma patients the use of one e-cigarette seemed to have no immediate effect to airway resistance.

So, what does this mean (other than the obvious conclusion from the first paragraph: that this was a ridiculously small study to be drawing any conclusions from)?  One good answer is “nothing”.  That is, this was sent out to newspaper reporters who passed it on to the general public, and what it meant to them was absolutely nothing.  So those readers skipped past the science and read only the lying assertions that were tacked onto it, assuming that those complicated bits supported the assertions; the lab results were simply there to camouflage the fact that the press release was little more than a political statement.

How can there be any honest motive for sending this information to the general public?  I am in well into the 99th percentile of the population in terms of ability to understand this science — easily more like 99.99th  — and I could not make much sense of it.  Fortunately, I know people in the 99.9999th, so I could ask a few question.

Also, before I started writing about this I asked a few questions of Gratziou, via the press contact listed on her press release.  The contact assured me that she would get the questions to Gratziou and I would hear back.  I did not hear back.  Real scientists generally like to explain their work to other scientists; liars, on the other hand, do not like follow-up questions.  (In case it is not obvious, my questions were simple and technical (and thus in no way impolite), and only about the scientific bits.)

What did the researchers do and find?  That is not clear even to the expert readers.  “Spirometry” is not an adequate description of the measurement method.  It is also not clear even to experts what the units of measure mean.  Absolute measures would have been more useful, especially lacking any definition for the “100%” that the percentages are based on.  It could be that the first of each pair of percentages was the baseline and the second was the result after the exposure, or it could be that the baseline was called 100% and these are the ranges of the final results.  The former is the natural way to read the sentences, but would mean that the smokers had clearer airways to start with than the nonsmokers, which seems unlikely.

So even for experts, the information about results presented to the world was meaningless.  That does not, however, mean there is not useful information about what was wrong with what they did.

As noted in the previous post, the biggest limitation (even worse than the size of the study) is that it was based on just the immediate reaction to a first exposure.  Moreover, the subjects were exclusively people who were not used to vaping, and were given the exposure under contrived and medicalized (and thus disconcerting) circumstances.  Would an experienced vaper get the same effect?  There is reason to believe not, since vapers quite often report that they had some airway irritation (which would cause the observed effect) when they first started vaping, but it seemed to disappear.  This would have been useful to report, though it is not clear whether Gratziou failed to report it because she was hiding it or because her knowledge is so limited that she does not even know it.  It is similarly not clear whether these lab-technicians-posing-as-scientists intentionally chose only subjects that would produce uninformative results, or did so out of ignorance.

That “lab technicians” remark is not a slight against techs — we would not get anywhere in lab and clinical sciences without good techs.  But scientists need to think beyond, “I have a machine, I have a person, let’s see what happens.”  In particular, in a case like this, they need some calibration (aka “controls”).  A scientist knows (contrary to popular belief) that it is not always necessary to have a null exposure control group or trial (“placebo control”), but sometimes, like in this case, the results will be impossible to make sense of without it.

Airway resistance measurement is finicky, sensitive to exactly what is being done and subjects’ behavior, as well as anxiety and other factors.  We really do not know what the methodology was, in terms of exactly what tools were used and how they were administered, or how they dealt with the challenge of finicky results.  (This has led some optimistic commentators to say that we need to wait for the paper to come out; I will wager that we will not know even then — any takers?)  But we do know that a lot of things could have produced the results, and there is no comparison group or trial to help deal with that.

A comparison trial where the subjects just sucked slightly flavored air through a tube — ideally without knowing they were merely doing that, but at the very least even without such blinding — and then were measured would have been a useful comparison.  Also useful would have been a comparison where the subjects inhaled just steam (water vapor), which creates short-term airway irritation for many people.  This would have provided a meaningful comparison for the quantitative results.  Instead of reporting utterly meaningless numbers, they could have reported, for example, that the effects were basically the same as someone vaping pure water.

A more subtle point is hidden in the phrase “a number of tests”.  Dishonest researchers who are trying to get a particular result — and we have established that this describes the present case — frequently take multiple measures and report only the results they like.  In toxicology, this consists of doing lots of different trials with minor variations of the exposure and reporting the one that finally produces the “right” results.  In epidemiology or econometrics this consists of running multiple statistical models on the data and only reporting one of them.  In this case, it sounds like multiple lab tests were run, but only one of them was reported.  The mathematical analysis of the results of such cheating is complicated and usually oversimplified, but with only intuitive math it should be easy to see that any method that creates a scattering of results and reports only the “best” one will bias the results in the direction of the dishonest author’s political preferences.

So, to summarize, we do not merely have a case where the authors made dramatic claims that were not supported by the reported results.  Rather, we basically have no results, since they are meaningless as presented and highly suspect also.  The only thing that we know for sure is that the methodology was never designed to produce useful information, or at least not useful at more than the pilot “let’s see if we can even do these lab measurements before designing some useful research that uses them” level.  This means that the most fundamental lie in all of this is not the bald political assertions about there being “harm” or that you might as well smoke which were not supported by the science; rather, it is the implicit claim that any science at all was being reported.

So, what is the point of Hecht’s latest press release?

posted by Carl V Phillips

I have been asked two very good questions about this topic:  (1) Is it really fair to treat Hecht as if his new claims reflect the same type of serial anti-THR lying found in Ellen Hahn?  (2) What exactly was the research that Hecht was touting in this press release?  The two questions are closely related, and one of them can be answered.

“This is the first example of a strong oral cavity carcinogen that’s in smokeless tobacco,” said Stephen Hecht, Ph.D., who led the study. “Our results are very important in regard to the growing use of smokeless tobacco in the world, especially among younger people who think it is a safer form of tobacco than cigarettes. We now have the identity of the only known strong oral carcinogen in these products.”

The answer to (1) is right there, in “…who think it is a safer form of tobacco than cigarettes.”  Out-of-control activists like Hahn might actually know very little about the relevant science they claim to be expert about, but Hecht has been at the center of anti-tobacco politics and research for many years.  There is no possibility he has failed to learn that smokeless tobacco is indisputably a safer form of tobacco than cigarettes.  Even in the unlikely event that he believes everything else he claims, the much lower risk of smokeless would still be obvious to him.  Perhaps his lies about the epidemiology, analyzed yesterday, could be seen as merely trying to puff up the perceived importance of his unimportant research rather than primarily being an active anti-THR effort.  But that “…who think…” lie is clear and obvious evidence of anti-THR activism disguised as science, which perfectly represents Hecht’s behavior over the years.

Notice also the “first” wording.  This is clearly meant to imply something like, “up until now, we were not really worried about smokeless tobacco causing oral cancer, but now we should look into it.”  The thing is, Hecht has been claiming that smokeless tobacco causes oral cancer for over a decade, claiming that the nitrosamines he has repeatedly reported on (particularly the chemicals known as NNN and NNK) were sufficient proof of that.  He has reported lab studies of basically the same thing, over and over and over again, and whatever the study result, his conclusions remained based on his politics.  His studies never changed the fact that the actual health science shows no measurable risk of cancer.  But that evidence never stopped Hecht from claiming that each of his non-new results provided new evidence that smokeless tobacco causes a high risk of cancer.

So what did he do this time?  It is very difficult to figure out because all we have is the press release.  Issuing a press release without making a working paper available is anti-scientific behavior in itself; even if everything presented were true, we are being asked to accept someone’s asserted conclusions without knowing their basis for those conclusions.  Some commentators focus on the lack of “peer review” in press releases, but this is really a red herring (peer review in health science is almost worthless — a topic for another day).  The real problem is the lack of information that would allow a reader to assess what was done and whether the methods and the conclusions seem reasonable.  All we actually know from the press release is that Hecht subjected rats to a mega-dose of a nitrosamine called (S)-NNN, presumably in a way that does not closely resemble smokeless tobacco use, though we do not know.  Some of the rats got cancer.

That is all we know.  We do not know what Hecht meant when he called this the first identification of a strong oral carcinogen in smokeless tobacco.  Is he admitting that his claims over the last decade about the other chemicals were lies?  Or are we supposed to conclude that “strong” has some subtle meaning, such that his previous claims were based on “non-strong” carcinogens and so he was not lying then about all of his claims then, but this is somehow different so he is not lying now about “first”?

Also we do not know how many trials Hecht ran, with how many different animals, with how many different chemicals administered in different doses and different ways, before he found a single result that made for good propaganda.  Actually, chances are we will never know that, even when this ends up in a journal.  When I said that toxicology was not inherently junk science, I glossed over the fact that this “hunt the carcinogen” branch of toxicology seems to have as its primary methodology, “keep doing ever-so-slightly different things until random error produces an outlier result for one trial, and then report on that result as if it were the only experiment that was done.”  That approach definitely qualifies as junk science.

The reader is not even told what (S)-NNN is, or how it differs from the NNN Hecht has been over-concluding about for years.  I could not easily find anything about it (e.g., it is not even clear whether this research represents Hecht discovering the chemical), though I am not a chemist so I might be missing something that the experts in that field could figure out.  But you know who are not experts in this entire area of chemistry?  Approximately everyone who reads the press release and the pseudo-news stories that resulted from it, who can thus be easily tricked by Hecht’s assertions.  All they came away “learning” were that Hecht and his ilk were not too worried about smokeless tobacco causing oral cancer last month, but based on this exciting new breakthrough, we should immediately take action.  More on that last aspect of the lies in the next post.