Tag Archives: “no evidence”

“Smoking” and “nicotine” are not synonyms

posted by Elaine Keller

The truthful statements in Justin Rohrlich’s story Smokeless Tobacco Advocate Rails Against ‘Frauds, Extremists, Liars’  were based on a two-hour-and-ten-minute phone interview with Smokefree Pennsylvania’s Bill Godshall. (How Rohrlich managed to gather so much information from Godshall in such a short phone call escapes me, but I digress.)

As a representative of one of the “Frauds, Extremists, Liars,” Danny McGoldrick, the Vice President of Research for the Campaign for Tobacco-Free Kids, was invited to comment, probably with the intention of bringing “balance” to the story.

To make any sense whatsoever of McGoldrick’s statements, you need the trANTZlator  that Carl recently introduced for the common Anti-Nicotine and Tobacco Zealot (ANTZ)  phrase, “smoking cessation.” Anyone who applies the common meanings of the words “smoking” and “cessation,” would think it is obvious that this phrase refers to the stopping (i.e. “cessation”) of the inhaling and exhaling of smoke.

*Gong* Wrong. When ANTZ people say “smoking cessation”, what they really mean is the act of stopping the use of any form of nicotine. Get it? Smoking = nicotine. Nicotine = smoking.

This is how Danny McGoldrick managed to testify at a legislative hearing on Tobacco Harm Reduction (THR) in Oklahoma with a straight face:

“…if the tobacco companies want to promote smokeless tobacco or anything else as a smoking cessation product, they can do this through the Food and Drug Administration like other cessation products by demonstrating with science that their products are a safe and effective way to quit smoking.”

“If the evidence is anywhere near what they claim, this should not present a problem for them,” he told the panel of lawmakers.

“There’s no evidence that people use smokeless tobacco to quit.”

There’s that bugaboo that Carl discussed in two previous posts: There is never no evidence (Part 1) and There is never no evidence (Part 2.) McGoldrick’s claim is nonsense from a scientific perspective.

If by “quit,” McGoldrick means “quit inhaling smoke,” it’s hard to believe that a man who holds the title of “Vice President of Research” was unable to track down any of the following articles, published in peer-reviewed scientific journals.

Effect of smokeless tobacco (snus) on smoking and public health in Sweden: “Snus availability in Sweden appears to have contributed to the unusually low rates of smoking among Swedish men by helping them transfer to a notably less harmful form of nicotine dependence.”

Is Swedish snus associated with smoking initiation or smoking cessation? “We investigated whether Swedish snus (snuff) use was associated with smoking cessation among males participating in a large population based twin study in Sweden. Snus use was associated with smoking cessation but not initiation.”

Randomized, placebo-controlled, double-blind trial of Swedish snus for smoking reduction and cessation: “Swedish snus could promote smoking cessation among smokers in Serbia, that is, in a cultural setting without traditional use of oral, smokeless tobacco.”

The association of snus and smoking behaviour: a cohort analysis of Swedish males in the 1990s: “We found clear associations between the two habits. For the younger cohort (age 16-44 years), snus use contributed to approximately six smoking quitters per smoking starter attributable to snus. For the older cohort (age 45-84) there were slightly more than two quitters per starter.”

These are far from the only published scientific evidence that snus can be used for smoking cessation. If what McGoldrick really meant was that it is unlikely or unknown whether snus can be used for nicotine cessation, that’s another story. But what he said was “smoking cessation.” So either he is lying about there not being any evidence, or he is extremely incompetent at his job.

Even respected government agencies are guilty of using “smoking” and “nicotine” interchangeably, and therefore misleading the public. All FDA-approved “smoking cessation” products are aimed at a goal of nicotine cessation. There are three problems with this approach: 1) It doesn’t work for over 90% of smokers that try to quit, 2) It isn’t necessary to become abstinent from nicotine to achieve smoking abstinence, and 3) Smokers who switch to a low-risk alternative enjoy the same health improvements as those that used nicotine abstinence to stop smoking.

There are many published scientific reports on the beneficial health effects of switching to smokeless tobacco.

Smokeless tobacco: a gateway to smoking or a way away from smoking: “Sweden has low rates of smoking and a lower rate of respiratory diseases and lung cancers by comparison to other developed countries.”

Health risks of smoking compared to Swedish snus: “Although few in number, these seven studies do provide quantitative evidence that, for certain health outcomes, the health risks associated with snus are lower than those associated with smoking. Specifically, this is true for lung cancer (based on one study), for oral cancer (based on one study), for gastric cancer (based on one study), for cardiovascular disease (based on three of four studies), and for all-cause mortality (based on one study).”

Lung cancer mortality: comparing Sweden with other countries in the European Union: “There were 172,000 lung cancer deaths among men in the EU in 2002. If all EU countries had the LCMR of men in Sweden, there would have been 92,000 (54%) fewer deaths.”

Summary of the epidemiological evidence relating snus to health: “After smoking adjustment, snus is unassociated with cancer of the oropharynx (meta-analysis RR 0.97, 95% CI 0.68-1.37), oesophagus (1.10, 0.92-1.33), stomach (0.98, 0.82-1.17), pancreas (1.20, 0.66-2.20), lung (0.71, 0.66-0.76) or other sites, or with heart disease (1.01, 0.91-1.12) or stroke (1.05, 0.95-1.15). No clear associations are evident in never smokers, any possible risk from snus being much less than from smoking. “Snuff-dipper’s lesion” does not predict oral cancer. Snus users have increased weight, but diabetes and chronic hypertension seem unaffected. Notwithstanding unconfirmed reports of associations with reduced birthweight, and some other conditions, the evidence provides scant support for any major adverse health effect of snus.”

Again, the above are just examples. Anyone can access PubMed’s search system and find many more studies.

Rohrlich’s story states, “Danny McGoldrick just can’t wrap his head around the idea of Big Tobacco’s collective conscience telling it to guide people to smokeless for their health.”

Actually, what McGoldrick can’t wrap his head around is the concept of how Tobacco Harm Reduction works. Or perhaps he just doesn’t want to.

There is never no evidence (part 2)

posted by Carl V Phillips

This post continues the general discussion of how claims that there is “no evidence” to evaluate a particular claim are always nonsense from a scientific perspective.  It picks up directly from Part 1, so if you have not read that, you might want to.

Of the three scenarios presented in Part 1, it should be immediately evident that they constitute a randomized clinical trial or RCT (the second), a typical observational epidemiologic study (the third), and a series of what might be called “adverse event reports”, “case studies”, or “anecdotes” depending on how someone was trying to spin the result (the first).  Many people who speak the language of science, but do not actually understand science, would insist that the RCT necessarily provides the best evidence; I will come back to that.  They would also insist that the “anecdotes” do not provide any useful information because “anecdotes”…, well…, um, because they just don’t!  If forced to try to explain why, they would not be able to, because they do not really understand what they are talking about.

If they did, they would realize that another descriptor for the series of adverse event reports is “a collection of very compelling experiments”.  Recall the (real life) example from Part 1:

Thousands of people living near electric generating wind turbines have reported experiencing a particular pattern of serious health problems that began when the turbines started operating.  A large portion of those reports describe how the problems abate when someone spends days away from home and reverse when they move away.  The conclusion is that the wind turbines are causing the health problems.

Before dissecting that, consider how this is very similar to a familiar observation in the context of THR with the (also true) variation on the theme:

Thousands of former smokers have reported that they quit by switching to e-cigarettes or smokeless tobacco, and have published their stories.  A large portion of those reports describe how the former smokers tried many of the officially sanctioned (sometimes called “proven”) methods for quitting but always returned to smoking and were generally quite unhappy until they did, and how they are very happy using the alternative.  The conclusion is that switching to low-risk alternatives is an effective way for many people to quit smoking.

A huge portion of all scientific knowledge comes not from formalized studies and statistical analysis, but from simple experiments that address exactly what we want to know.  People who naively think that RCTs are always the best source of information have sort of learned this lesson, but in a perverted form that actually reduces their understanding of science.  They think a complicated stylized experiment that addresses some variation of what we really want to know is always best, whereas a more useful, less formalized experiment tells us nothing.

In both of the above scenarios — wind turbines and THR — people have performed experiments on themselves, experiments that address exactly the question that is being answered:  Is spending days and nights close to the turbines causing these diseases?  Can I successfully quit smoking if I use a low-risk alternative instead?

This study method is no different from the most basic study method familiar to all of us in our everyday lives.  For example, if you think that a particular food gives you stomach pain, you note whether that pain begins after eating the food; you then avoid eating the food for a while and see if that pain is absent, and then try it again to see if the pain returns.  It is obvious how to translate the resulting observations into a causal conclusion about the food and the pain.  For an even simpler illustration, our usual study design to figure out if a particular switch turns on a particular light is to flip the switch – nothing more complicated is needed.  If there was any doubt about the result, a few more flips of the switch provide overwhelming evidence.

Careful readers might have noticed that the wind turbine experiments provide a bit more data in one way, with the same people switching back and forth.  This contrasts with a smoker who successfully switches, and is obviously not likely to start smoking again to see if the e-cigarettes will help her quit again.  But the smokers have more data in the form of trying to quit using other methods, which allows the additional conclusion “…effective even for people for whom trying to quit other ways does not work…”.  Science does not have easy rules of thumb — you make use of what you have.

That is the main lesson here.

Anyone who believes that we do not have evidence of these products helping smokers quit is a complete idiot.  Anyone who asserts that as a scientific conclusion is a liar.  There is just no way to sugar coat that.  They can legitimately argue that the individual reports cannot tell us what portion of smokers will find switching to be an effective and welfare-enhancing way to quit.  They can even argue that, based on these reports alone, we cannot be sure that there is not some other tool for quitting that is better by some measure.  (We can make a good case that this is not true based on other information — it is pretty clear that just deciding to be abstinent by just stopping cold turkey or adopting THR are by far the most effective and most pleasant options for more people than other methods — but that does require other evidence.)

But it is totally obvious that a single one of these reports represents evidence that for someone, THR is a preferred option, and (depending on the details of the report) works when everything else seems to fail.  Multiple that by thousands of reports and we have a lot of evidence that this is true for many people.

Oh, and when I say “evidence”, that means scientific evidence.  Any evidence that lets us evaluate worldly phenomena is scientific evidence.  Scientific evidence is anything that lets us answer scientific questions.  It does not matter what form it takes if it addresses the questions, and it certainly does not matter where it is published.

…in the continuation, I will contrast this definitive evidence from simple individual reports with the near-uselessness of some complicated studies…

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.

There is never no evidence (part 1)

posted by Carl V Phillips

I just finished submitting some testimony on another matter where this topic came up, and I thought I would expand upon it for a few posts while I am thinking about it.  Rather than identifying any specific liar or statement, this is a generic debunking of any claim that there is no evidence that allows us to assess the answer to a question.  This is what is being claimed by anti-THR liars when they say something like “there is no evidence that e-cigarettes pose lower risk than smoking” or “there is no evidence that low-risk alternatives help people to quit smoking”.

There are legitimate uses of the phrase “no evidence”, such as “having evaluated the available evidence, I have seen no evidence that advising people that snus is a low-risk alternative to smoking causes anyone to start smoking.”  But when anti-THR activists use the phrase “no evidence” they saying “there is no evidence to evaluate” not “the evidence that exists does not support this claim” (if there are any exceptions to this usage by them, I have not noticed them).

It is obvious why they want to do this:  The evidence has a strongly pro-THR bias, so they would prefer to say that it does not exist.  But it is also obvious that when they do this they are lying.  That is (in keeping with the use of term in this blog) they are either saying something they know to be false, or they are claiming to understand science and are making assertions about it, but they really do not know what they are talking about, and so are lying in their implicit claim that they are qualified to be making subject matter claims (or, to put it more bluntly, that they have a clue what they are talking about).

These particular lies, unlike some of the claims about toxic chemicals and such, probably skew more toward the latter type than the former.  That is, most of the people making these claims seem to have no understanding of how science works and what constitutes evidence, and so their lie is not so much that they know what they are saying is false, and more that they are claiming to know what they are talking about when they really do not.

Scientific inference is a process of drawing conclusions about some question of interest based on all available information.  High school debate contests and other stylized games may have specific rules about what constitutes allowable evidence, but science does not. Science makes use of whatever information is available (in addition to trying to create more information, of course).  So anytime someone claims that we do not know anything because we do not have a particular type of study result available, either they are lying or they are clueless about science.

To further motivate this point, consider three collections of evidence and conclusions based upon them (the first is real, the other two are stylized but I suspect one could find real studies that were quite similar with only a bit of searching)

Thousands of people living near electric generating wind turbines have reported experiencing a particular pattern of serious health problems that began when the turbines started operating.  A large portion of those reports describe how the problems abate when someone spends days away from home and reverse when they move away.  The conclusion is that the wind turbines are causing the health problems.

A group of a hundred overweight volunteers were randomized into one group that was given standard weight-loss advice and a second group that was assigned to eat a vegan diet.  At the end of two months, the vegan group had lost statistically significantly more weight on average.  The conclusion is that adopting a vegan dies is more effective than standard weight-loss techniques.

A large dataset with information on health and behavior was analyzed to estimate the health effects of television viewing.  After controlling for other behaviors, including alcohol consumption, those who watched more than 4.5 hours per day of television had a RR of 1.7 (95% CI 1.1, 2.6) for serious liver disease compared to those who watched less than 0.5 hours.  The conclusion is that watching television causes liver disease.

Which of these conclusions seem compelling, and why?

In the next part, I will assess that and relate the examples back to specific anti-THR lies (and explain a bit more about them for those who might not understand what all the jargon means).


Americans for Nonsmokers’ Rights shamelessly promotes continued smoking

posted by Elaine Keller

AUTHORS NOTE: This is Part 1 of 2. On September 26, the anti-smoker group, Americans for Nonsmokers’ Rights (ANR) issued a press release making false claims about e-cigarette vendors misleading the public about the safety of e-cigarettes and their efficacy for smoking cessation. CASAA has responded with a rebuttal press release (go read it, and then hit the tweet etc. buttons to raise its profile!).  Our rebuttal had to be drastically shortened for the press release version, however, so here we share the original. Today’s post addresses the smoking cessation issue. Tomorrow’s post will address the ANR’s misleading statements about the safety of vapor.

SPRINGFIELD, VA, October 1, 2012

–Americans for Nonsmokers’ Rights (ANR) and other proponents of the extremely ineffective abstinence-only approach to smoking cessation are misleading the public about hazards of electronic cigarettes through paid press releases, social media, and even scientific publications and conferences. A recent press release by ANR also falsely claims that there is “a lack of independent peer-reviewed scientific evidence demonstrating the safety or efficacy” of electronic cigarettes for smoking cessation.

The problem with their preferred abstinence-only approach is simple: It doesn’t work. Every medically-approved method of smoking cessation is based on becoming 100% abstinent from any form of nicotine. FDA-approved nicotine patches, gum, lozenges, nasal sprays, and oral inhalers are referred to as Nicotine Replacement Therapy (NRT) products, but all these products are accompanied by directions to gradually reduce the daily intake of nicotine to zero.

A study published in 2003 found that in the real world, over-the-counter NRT has a 93% mid-year failure rate. A 2012 study conducted by researchers at the Harvard School of Public Health and the University of Massachusetts found that the relapse rate was the same for those using NRT as those who had not, regardless of whether they received counseling support.

In contrast, a growing body of scientific evidence is showing that providing smokers with a low-risk alternative such as electronic cigarettes is a much more effective way than nicotine-abstinence to achieve abstinence from smoking.

BMC Public Health is a peer-reviewed scientific journal that published the results of an Italian pilot study in November, 2011, that monitored modifications in smoking habits of 40 smokers unwilling to quit, hoping to see a reduction in the number of cigarettes per day (CPD) smoked. The researchers were pleased to observe a 50% CPD reduction in 32.5% of subjects and an 80% reduction in 12.5% of subjects. But they were astonished to discover that at the end of the 6 month study, 22.5% of these unwilling-to-quit subjects had completely stopped smoking.

Among smokers that want to quit, the results are even more remarkable. Another peer-reviewed scientific journal, the American Journal of Public Health published the results of an online survey of first-time buyers of a particular brand of e-cigarette. The 6-month point prevalence smoking abstinence rate was 31% among this group.

In June 2011, the peer-reviewed medical journal, Addiction, published the results of an internet survey of over 3,500 e-cigarette users who used a variety of brands and nicotine strengths. The survey found that 77% of daily e-cigarette users had become former smokers.

E-cigarette users who have achieved smoking abstinence report improvements in their health ranging from a reduction in COPD and asthma symptoms to better markers of cardiovascular health such as blood pressure and lipid measures. Researchers have found no increase in blood pressure or heart rate among subjects trying e-cigarettes for the first time.


FDA does not understand how science and knowing work

posted by Carl V Phillips

Epistemology (roughly, how we know what we know) is at the core of scientific inquiry.  Some of the most profoundly anti-scientific claims that you will ever see — certainly among the most frustrating — are attempts to replace the complicated epistemic processes in science with simplistic rules of evidence.  Typically these are so oversimplified as to be suitable only for a stylized game like high school debate contests.  The rules are too simplified even for a courtroom, the context for which they are often designed.

As I noted in the first of this series of posts on the US FDA, FDA’s epistemic toolbox pretty much contains only one tool: their standard recipe for doing clinical trials of new pharmaceuticals.  That works pretty well for what it does, but it obviously represents only one little tiny corner of scientific methodology, let alone scientific knowledge.  The FDA document that I started discussing yesterday makes clear how unsuitable FDA’s limited understanding of science is when it comes to studying THR.  It includes:

Because clinical studies about the safety and efficacy of these products [e-cigarettes] have not been submitted to FDA, consumers currently have no way of knowing

This is followed by some bullet points, which I will address shortly.  But for now, just consider that sentence fragment.  No way of knowing?  Are they kidding? There is no way to complete that sentence truthfully, other than with something circular like “…no way of knowing what clinical studies submitted to FDA do say.”

The mind boggles at the arrogance.  The typical epistemic error is to claim that there is no evidence in the absence of studies that follow a particular clinical study recipe.  That is also completely wrong.  But there is something extra special about a unit of the government claiming that knowledge does not exist until it is formally submitted to them.  That is downright Soviet, or maybe even more l’état, c’est moi.

Since I cannot think of much to say about that other than shaking my head in disbelief, I am just going to pretend they said, “Because clinical studies have not been done….” and explain why this — the all-too common misconception that clinical trials are the best way to answer every single scientific question — is a lie.

The bullet points that complete the sentence are:

  • whether e-cigarettes are safe for their intended use,
  • what types or concentrations of potentially harmful chemicals are found in these products, or
  • how much nicotine they are inhaling when they use these products.

For some questions it takes a bit of work to explain why clinical studies are not the most useful method for finding an answer.  For example, clinical trials are not very good at answering the most important questions about whether smokers will switch to a THR alternative.  But that takes a bit of explaining (which I am sure I will eventually cover in this series).  But for now, FDA has provided examples that are so obviously wrong that there is no such challenge.

How do we know how much of what chemicals (nicotine and others) are in the vapor?  A clinical study is not well suited to answering this at all.  Instead, we need a method for drawing out and analyzing vapor that avoids the complication of the user absorbing some unknown portion of the chemicals (i.e., which does not include a clinical component).  And that has, of course, been done.  FDA even did it themselves (though they lied about the results).

We could replace the last point with something that actually does involve the user, like how much nicotine users are taking up?  That is possible to answer using clinical research methods.  Possible, but not necessary.  One way to measure nicotine uptake is blood chemistry.  But another is to just be the person taking up the nicotine and feeling the effects.  That will not answer some questions very well, but it is clearly a way of knowing.

How about whether e-cigarettes are safe (I am not sure what the “for their intended use” clause even means)?  Well, in that case some clinical studies would have been useful and would still be useful.  Indeed, we would have those if those in government “public health” thought of themselves as public servants (who would observe that the public wants this information and then try to provide it in order to possibly improve health) rather than public masters.  Nevertheless, clinical studies are obviously not the only way of knowing.

We have learned an enormous amount — in spite of governments’ uselessness in this matter — about the health effects of e-cigarettes.  We have ample data to rule out important negative acute effects, to be confident there are no non-rare major short-term health risks, to be optimistic about the lack of long-run effects, and to be quite sure that they are better than smoking by a lot.  This evidence comes from the experience of users as well as extensive data about other smoke-free nicotine sources and our knowledge from various sources about exposure to the other chemicals.

The general lesson here is that when someone claims “we know nothing” or “we have no evidence” about some scientific question, they either have no idea how scientific inquiry really works or they are lying.  Or both.

Classic lie: US Surgeon General, 2003

posted by Carl V Phillips

Despite the temptation to focus this blog on the latest and most clever lies, we realize that there is probably more practical value in writing about some of the classic and really stupid lies.  It is painful to deal with the stupidest claims, over and over again, but not everyone has seen responses to them, so it is useful.

As a first foray into that, I will address the testimony of US Surgeon General Richard Carmona before the a House of Representatives subcommittee hearing on smokeless tobacco in 2003.  That is the one that came up in a recent post because it was used as an especially stupid source citation.

The US government was the dominant anti-THR liar when I first started documenting anti-THR lies a decade ago, and they currently hold that position.  The United Nations might or might not have edged them out for a while during the years in between, but the FDA has put them solidly in the lead again.  Long before the lies about e-cigarette chemistry research from FDA, Samet, at al. became the most-cited anti-THR lie, it was Carmona lying about smokeless tobacco.

There was good testimony given to that subcommittee too (that by Brad Rodu, John Kalmar, me, in particular), but no one cites that anymore.  And they should not cite it, unless they are interested in documenting historical thinking.  Research study results do not necessarily lose value over time, but old summaries and expert opinions cease to be relevant because knowledge changes over time.

Not that Carmona’s opinion was expert.  Far from it.  The core claim was:

No matter what you may hear today or read in press reports later, I cannot conclude that the use of any tobacco product is a safer alternative to smoking.

Someone really has to be clueless to make a claim like this.  Even the preamble clause is an embarrassment, saying, “no matter what evidence I hear, my conclusion will not change”.  But deadly lie is the rest.

It is rather difficult to believe that Carmona was actually so stupid as to believe that smokeless tobacco was not less harmful than cigarettes.  Realizing the truth did not take an expert, a genius, or even education about health science (and you might expect a Surgeon General testifying about a topic to have one or two of those characteristics).  Someone just had to know enough to reason, “let’s see: about half of the deaths from smoking are from lung diseases, and no one claims that smokeless tobacco causes any measurable risk for those; the only claim anyone ever makes about smokeless tobacco causing more risk than smoking is for oral cancer, and that would be in the order of 1% of the total risk worst case”.  A bit of grade school arithmetic will then get you to “I can conclude the use of smokeless tobacco is safer than smoking.”

As it turns out, there was already ample evidence and expert assessment that the risk was in the low-single-digit percent range compared to smoking.  There was already clear evidence that the hypothetical oral cancer risk did not exist to a measurable degree.  Indeed, there was (and is) no disease for which any measurable risk had been demonstrated for popular Western forms of smokeless tobacco.  Someone who knew the science would not have to resort to the rough-cut reasoning I proposed.  Still, even someone with only rudimentary knowledge of maths and the subject matter could use that reasoning to figure out that the risk was lower than for smoking.

This statement is not actually the stupidest thing in the testimony, though it is the only claim that is ever quoted (sometimes in a different form since the same basic claim was repeated multiple times — e.g., “Smokeless tobacco is not a safer substitute for cigarette smoking.”).  There is actually even clearer evidence that this guy — or whoever was putting words in his mouth — was a really poor thinker.

Let me start with a few statements that were once accepted throughout society that have now been relegated to the status of myth.

  • Men do not suffer from depression.
  • Domestic violence is a ‘family’ or ‘private’ matter.
  • The HIV-AIDS epidemic is of no concern to most Americans.

All of us here know that these three statements are very dangerous public health myths.  My remarks today will focus on a fourth public health myth which could have severe consequences in our nation, especially among our youth: smokeless tobacco is a good alternative to smoking. It is a myth. It is not true.

Think about the message here.  You can even set aside the really stupid list of historical “myths”, and the fact that one was a moral claim rather than a factual one, and thus cannot be called a myth, one of them was basically correct, and one of them was never really believed by experts.  (I will leave which is which as a simple exercise for the reader.)  Just consider his implicit logic:  “Some people have been wrong about things before, and that is a reason to believe that (a different group of) people are wrong about this.”

Of course, he was right about one thing:  The popular myth about the risks from smokeless tobacco did constitute a threat to public health.  But the popular belief was the very myth that he was espousing — that it is just as harmful as smoking, and therefore you might as well smoke.

The talk had a few other gems:

Each year, 440,000 people die of diseases caused by smoking or other form [sic] of tobacco use

This is another great example of the conjunction lie I noted previously — he could have said “…by smoking or other forms of tobacco use or gazing upon my face and turning to stone”, and it would still be accurate.  He was using word games to imply that some nontrivial part of that figure cited was the toll from smokeless tobacco.  Indeed, that figure was the official estimated toll from smoking alone, so he was actually saying that neither smokeless tobacco nor his gorgon-like powers were killing anyone.  That is a bit of accidental truth that is conveniently overlooked by the anti-THR liars who still quote this national embarrassment to this day.

It is difficult to not be reminded of another bit of testimony from the same year from another cabinet-level official, Colin Powell insisting that Iraq had weapons of mass destruction.  In later years, Powell has expressed serious regret and apology for making that claim, and it basically cost him his legacy as a respected statesman, though he deserves a lot of credit for the apology.  But whatever one thinks of Powell and the war, the key observation is this:  Who would be stupid enough, years later, to quote Powell’s testimony and say, “this testimony is evidence that there were WMDs in Iraq”?  And yet that is equivalent to what the anti-THR liars are doing when they quote Carmona’s embarrassing and false testimony a decade later.

Anti-Hahn poster

Today’s content is thanks to Kristin Noll-Marsh, who has created CASAA’s direct response to the Ellen Hahn poster that was the topic here for most of last week.  Taking a different tack from our letter to the University, Kristin created a consumer-friendly poster to directly compete with Hahn’s.  So anyone at or near the University of Kentucky, please print out some copies and post them next to Hahn’s!  Kristin’s document covers a lot of the same points that appeared here already, but it makes some additional points.  Moreover, even though it is a catchy poster, it also stands as more of a research paper (with specific sources cited for specific claims, in particular) than the blog — and probably more than anything Hahn has ever written.

Since it is all there at the link, I will not repeat it here.  (Aside:  Remember, the more links we have to the letter, poster, and blog posts, the higher those will be in searches compared to her lies.  Just sayin’.)

I know that a lot of readers are waiting for our response to the anti-THR press release about lung effects that was touted this week.  Since we have higher scientific standards than the author of that press release, it is taking a bit longer to finish.  It should appear in two or three parts starting later this week.