An overlooked lesson from Glantz harassment and fraud cases: tobacco is way out of FDA’s skill-set

by Carl V Phillips

I have written repeatedly about how FDA is totally outside their comfort zone and skill-set in dealing with tobacco products. The most obvious example might be them trying to deal with data from e-cigarette manufacturers, which caused their computer systems to melt down multiple times. I would guess it is a bigger database than every other database they have, combined, and is still growing. Similarly, their comically quaint attitude toward illicit markets, apparently genuinely thinking that the huge illicit market they would create by banning e-cigarettes or most e-liquid flavors, or removing the nicotine from cigarettes, will be as easy to handle as the tiny markets they deal with (not really very effectively) in counterfeit drugs and raw cheese. But the Glantz affair (see this post and what it links back to) brings up a more subtle problem.

FDA is used to dealing with criminals in the iron triangle they share with pharma and other big businesses. But it is the genteel world of halls-of-power crime.  People in that world clean up their own messes, cover up, and pay hush money and fines when necessary, and always create plausible deniability. But the tobacco portfolio puts FDA in bed with tobacco control, who are more like the Sopranos: They also get away with what they are doing, but not because create an image of respectability that deflects allegations. Their behavior is obvious for all to see, but they use intimidation, omerta, and corruption of those who should be policing to let them to get away with it.

This is not FDA’s preferred kind of crime. It puts them in a position for which they are not prepared.

A new BuzzFeed article by Stephanie M. Lee claims that FDA has no policy in place for dealing with sexual harassment charges against extramural researchers. Since this is a direct quote from an FDA spox, I suspect it is probably accurate, even though so much of the rest of Lee’s article is naive or out-and-out wrong.

(My personal favorite is when she credits Retraction Watch with breaking the story of the Glantz settlement in an article that came out… a mere week after I published my much deeper and more accurate analysis of the settlement. And I read at least three other stories about it in between those. My seven-year-old also sometimes does that too — thinking that whoever he first heard about something from is the one who discovered it — so I guess he is ready to write for BuzzFeed. I am still ok giving her a link, though, because she gets legacy credit for originally publicizing the story last year.)

More interesting is Lee’s naivety that probably generalizes to other observers, that FDA’s lack of a policy should be seen as nothing deeper than an outgrowth of NIH’s less-than-muscular response to situations like this. A key bit of background here (which Lee and most others may not realize) is that because doing grants is outside of FDA’s comfort zone, they were officially outsourced to NIH and thus are subject to NIH rules. NIH recently put a stronger policy in place and put out an article that at least says all the right stuff about #MeToo. It is not difficult to connect the dots here: It would not be surprising if UCSF raced to get this case against Glantz settled without an admission of guilt because of NIH’s new positions. (As I noted in my analysis of the settlement, the plaintiff got rolled into agreeing to get almost nothing, perhaps because her lawyer decided she would not be convincing on the stand.) The alleged acts of sexual harassment are actually a minor part of what Glantz is accused of in that and another suit, but they are what pop press readers understand.

But today’s point is how FDA itself has no institutional capacity for dealing with such matters. NIH is not exactly good at dealing with these issues, but at least they have experience creating subsidiary shops at universities and thus with all the potential complications this creates. It seems safe to assume that there is plenty of harassment in the companies FDA works for …er, regulates, to say nothing of scientific fraud, but they cover their own messes and FDA can pretend it does not exist. They cannot ignore what happens in their subsidiary shops, and have no idea how to deal with it.

Lacking institutional capacity, and given that the Commissioner is a stuffed shirt, FDA’s response to this matter will probably default to the Center for Tobacco Products leadership. That is, it will default to career tobacco controllers. Chances are they will do what they usually do about fraud and other misdeeds: pretend they do not exist. Oh, but oops, tobacco controllers are also out of their element here too: Normally nobody looks closely at their misdeeds and they can bedazzle the press with faux-science. But a government-funded sexual harasser (to look at this case with the inaccurate simplicity of the pop press) gets traction.

It could be hard for both FDA and tobacco controllers to ignore if it is a recurring tangent in everything anyone writes about FDA for a while. They will have no clue how to deal with it. It will be amusing to watch.

Peer review of: Michal Stoklosa (American Cancer Society), No surge in illicit cigarettes after implementation of menthol ban in Nova Scotia, Tobacco Control 2018

For an explanation of what this post is, please see this brief footnote post.

The paper reviewed here is available, open access, here.


 

It is vaguely embarrassing to write a review of this piece, which is effectively a bad local newspaper story, dressed up as if it were scientific research (though not nearly as embarrassing as being the the journal that published it). However, it is worth a few minutes because it will inevitably be used in the absurd-but-persistent propaganda efforts to claim that bans — in particular, flavor bans — do not create alternative supply chains. The open access status of the article, unlike most articles at the journal, is a bit of a giveaway about its purpose.

On the upside, it is a good quick teaching example about the standard public health research practice of ignoring competing hypotheses and explanations. There are three layers of that in this case. Continue reading

Peer review of: Dunbar et al. (Rand Corp), Disentangling Within- and Between-Person Effects of Shared Risk Factors on E-cigarette and Cigarette Use Trajectories From Late Adolescence to Young Adulthood, Nicotine & Tobacco Research, 2018

by Carl V Phillips

For an explanation of what this post is, please see this brief footnote post.

The paper reviewed here is available at Sci-Hub. The paywalled link is here.

—–

The typical “gateway” paper consists of observing the exposure of whether subjects (typically teenagers) have, at baseline, engaged in a particular behavior (vaping, in this case), and then observing the association with an outcome behavior (in this case, smoking). There is also an even worse collection of papers that do not even assess the order of events and simply look at whether prevalent ever-exposed status is associated with prevalent smoking. All of these suffer from the obvious fatal problem that a positive association is inevitable because inclination to ever vape is associated with inclination to ever smoke. In a counterfactual world in which vapor products did not exist, someone who vaped in the real world would be more likely to smoke than average, and this would obviously not be caused by (nonexistent) vaping. In short, since a positive association is inevitable, regardless of whether the hypothesis “vaping causes smoking” is true, observing a positive association obviously tells us nothing about about the hypothesis.

The present paper attempts to improve upon the standard worthless analysis. This is a commendable goal, and there is information value in what was done (unlike most gateway papers). However, the contributed information is very modest and does not actually support the authors’ conclusions. In particular, they claim that their results support the gateway hypothesis, and that they do so in ways that the usual longitudinal studies do not. This is simply false. Continue reading

Footnote: Paper review posts

This is a prepositioned footnote to explain a series of posts I will be publishing.

I expect to soon be launching a major project that will publish a large number of proper peer-reviews of recent journal articles and some other papers in the THR space. (Fair warning to anyone planning to publish junk in the near future!) So, in order to lay in some material for that, develop protocols, learn-by-doing, and such, I am writing some entries for that collection now. Given that I am doing it, I might as well post them here. To find those posts, look in the comments section below for pingbacks.

The publications in this collection will not read like a typical blog essay, though they will be readable and reasonably free-standing, unlike a peer-review for a journal. For those familiar with the latter genre, think of them as a thorough and high-quality journal review — a rarity, I know — with a few hundred words added here and there to make it readable as an essay for someone not intimately familiar with the original paper. (And also with what would have been “the authors should fix this” phrasing changed to be phrased in terms of “the authors made this mistake”, because they also made the mistake of finalizing their paper before seeking the advice they needed to fix it.)

For those not familiar with journal reviews, just know that these pieces will not just address one or a few interesting points, in a narrative style, and not bother with the rest of the paper, as an essay would. They will have those interesting bits, but they will also step through a protocol for addressing each aspect of the paper (e.g., is the literature review in the Introduction legitimate, are the Methods adequately presented, etc.). Some of the bits will probably require reading the original paper to make sense of. For the reviews that I write, I will try to put any interesting narrative bits first, and make those free-standing. This will offer something to casual readers, and if you are not interested in the full review; you can stop reading when you get to the disjoint bits about other aspects of the paper.

That is basically what you need to know to make sense of what you are reading. Once I have the guidelines more developed, I will post a link here if you want to delve deeper. In particular, I will be recruiting freelance contributors to write reviews, so if you are qualified and interested, please take note.

Glantz settles academic fraud and sexual harassment lawsuit

by Carl V Phillips

As my regular readers — or anyone who appreciates some really awesome schadenfreude — will know, two lawsuits were filed by female students against UCSF anti-tobacco nutcase and faux-scientist Stanton Glantz (technically they were postdoctoral fellows, but there is no relevant difference here between a graduate student and a postdoc). They were billed as sexual harassment suits, though the real payloads were about other abuses by Glantz. I covered it at The Daily Vaper, here, here, and here, and did a video interview about what I wrote here.

Mine account for approximately half the newspaper articles written about the story. That pattern does not quite constitute a coverup, but it is pretty close. Compare the number of stories about any similar accusations a professor who is not a pet of the US government and a favorite of institutions with political influence over the mainstream press. (Sexual harassment suits are a topic that, for obvious reasons, you cannot count on the right-wing press to pick up on, even if suits them politically.)

As I noted in my previous coverage, the most striking aspect of the story is that not a single person in tobacco control expressed so much as a lame “troubling if true” comment. At the same time, not one expressed doubt about the allegations and tried to defend Glantz. Presumably they did not actually doubt that the claims were true, but just did not care.

Also as I noted in my previous coverage, the salacious #MeToo allegations in the complaints are not really the biggest allegations. The sexual (and racial) harassment allegations in the lawsuits were pretty weak. They consisted of rude and boorish behavior by Glantz, and do not paint a picture of a sustained environment of this. Even that much is grossly inappropriate for any employer, let alone an academic mentor, of course. But we are not talking “high-ranking Republican official”-level behavior; more like Al Franken behavior. (In keeping with my running observations about the parallels between the GOP/Trump and tobacco control, it is worth noting that Franken’s party forced him to resign over one boorish incident from his past, while tobacco controllers’ ignoring of the Glantz allegations parallels the GOP practice of ignoring credible criminal-level allegations against Trump and other officials.) Of course, it is possible that the lawsuit filings do not fully capture just how pervasive and oppressive the behavior was, though it seems extremely unlikely there were worse specific acts that were not mentioned.

If the plaintiffs could not produce much more about that than the filings included, it seemed really unlikely they could get it to stick. But this is not true for the less salacious allegations that most observers overlook. The first lawsuit, by Eunice Neeley, said that Glantz stole credit for a paper she wrote and even submitted it to a journal under his name. This is extremely serious bright-line academic fraud, and very easy to prove. The second lawsuit included a claim about Glantz defrauding the U.S. government in order to get funding. This was presented less clearly, but seems like it is probably also bright-line and easy to prove. Of course, if the U.S. government cared about Glantz committing fraud, they would not be happy about his “research” in the first place. (Narrator: “They are actually quite delighted with his fraudulent research.”)

It was recently noticed (not actually announced) that UCSF and Glantz settled the Neeley lawsuit a few weeks ago. UCSF has posted the settlement agreement (h/t @jkelovuori). It is not clear whether they posted it because of transparency requirements or if they agreed to do it as part of the settlement. It could be they think it makes them look a lot better than a pending lawsuit, which is arguably true.

The settlement included UCSF paying Neeley (which really means mostly or entirely her attorney) $150,000. This is about what it would have cost the defendants to go to court and win, let alone risk losing. As is usually the case, the settlement document includes the defendants’ denials of all the allegations. The pro forma denial and the limited dollars do mean that the settlement document makes UCSF look pretty good. Neeley’s lawyer may have decided that the case was unwinnable. The part that was bright-line misconduct is something (real) scholars would care deeply about, but a court probably would not. Or perhaps she was just looking to collect her pay and move on, and so convinced Neeley that it was unwinnable. Neeley seems pretty adamant in her feelings (read on), so it does not seem like she lost interest in pursuing it.

The only thing she got from the settlement, other than whatever loose change her lawyer did not keep, was the right to the one paper Glantz stole from her and an agreement that Glantz would not touch it again. There is little doubt she could have gotten that without a lawsuit, given how obvious Glantz’s academic fraud was. Indeed, even that concession came with enough administrative strings attached that she probably could have done better just by relying on the court of academic public opinion. (Interestingly missing is mention of any other work by Neeley, even though her complaint claimed that this was not the only work of hers that Glantz was trying to steal.) One might conclude this was the one thing Neeley wanted, a matter of credit and honor. Some of her past statements support that honorable interpretation. But she has made clear that this is not the case (read on).

It is impossible to feel sorry for Neeley. She is a tobacco controller of the worst sort (read on). She went to work for a known sociopathic fraudster who has no respect for science and scholarship. Even if he has never committed any actionable sexual abuse, it is well-established that he is an abuser. We might be able to say “just a kid, could not recognize that” about Neeley regarding the latter. But she took the job after getting a doctorate (*smirk/snort*) in public health, and so has no excuse for not understanding the former.

Absent from the settlement was a gag clause (you have to spend a lot more than 150K to buy a woman’s silence — just ask any number of right-wing “family values” types). So a few weeks ago, Neeley joined Twitter to post her allegations about Glantz in random responses to tweets by his funders and others. No link, unfortunately, because literally minutes before I was about to publish this she deleted her account. So now I am even more annoyed at her, for making me re-edit.

Her tweets made it clear she was adamantly committed to the belief that Glantz is an ongoing threat to young women, and that she wants to warn and inform about that. If Glantz and UCSF really believed their denials, they would already be threatening to sue her for libel (and, I suppose, that may have been what just happened).

I am not sure whether Neeley uses other platforms. Her tweets never linked to any essay-length statement, which you think she would have written. Her tweets did not link to any other social media. Perhaps it exists — she was amazingly bad at Twitter for a millennial, so maybe it did not occur to her to mention it. I offered her some advice about some easy ways to do better in her mission, but she seems to have ignored that.

I did not mention in that advice that she came across as a raving loon in most of her tweet replies. If that represents her demeanor and level of focus in person (I have no idea whether it does), her attorney definitely would not have wanted to put her on the stand. I am obviously not saying that presenting that way invalidates a #MeToo complaint (as a certain disgusting ilk do), let alone that the mere act of accusing a powerful man of sexual harassment makes someone sound like she is raving (again, as that ilk do). I am specifically saying that most of her tweets were not what anyone would take seriously. They make her allegations seems less plausible. Thus my advice to her.

But it gets worse (or better, depending on how you choose to relate to this story). Greg Conley noticed that one of Neeley’s tweets claimed that a UCSF investigation confirmed her allegations. (That thread is now missing her tweets, of course, but he was responding to one that said what I just paraphrased.) Conley naturally asked if there was a copy of that report available. You might think that someone who was intent on making her case, and interested in being at least a little bit credible, would have an easy answer to that. Presumably it would be “Unfortunately I don’t have a written report and none is public. I am aware of their findings because….” (you have to assume, as bad as she is at this, she would have linked to it if she could have). But no. Here is her (now deleted) reply:

I do not support vaping, Mr. Conley I know who you are. But, I brought this up because I want to protect individuals working with Stan.

I laugh every time I read that (and not about the typo since I average about .5 typos per tweet, though that did bring to mind HRH Conley the First writing “Counterblaste to Tobacco Control”). “I know who you are” is presented as if it is some kind of accusation. Um, someone working in that area better know who he is. She better know who I am too, though I did not get the courtesy of an “I know who you are.”

(*author pauses to laugh some more, and ponders himself writing Counterblaste to Tobacco Control*)

Anyway, Conley responded sensibly and politely that differences about other politics should not interfere with the shared concern about Glantz hurting his students. In another thread, he offered some other advice, pointed out to her that I was the only reporter who had followed the story, and noted that zero tobacco controllers follow her on Twitter because they want to suppress this. As of today, she had 17 followers; 14 were anti-TC people of various stripes and the other 3 were bots. She did not respond to him.

I chimed in with this observation:

“I am terribly worried about other women, but not enough that I will talk to someone who supports harm reduction” is quite the remarkable position. Says a lot about the brainwashing that led to the omertà silence.

It is truly remarkable. Neither of us explicitly pointed out to her the common practice of narrow alliances, or merely taking advantages of resources when you can. The government that paid for her education is responsible for killing a million people in a war of aggression recent enough for her to remember it. Few of us refuse government services as a result. However much someone might quite reasonably despise the cops, they tend to call on them to perform the legitimate part of their job when needed. I heartily welcome Neeley’s exposure of one tiny corner of one individual’s deplorable behavior, even though I think her political views are also deplorable. Someone should probably point this out to her rather than thinking it is so obvious it goes without saying. Tobacco control lives so far up their own asses that they may be the only people who do not get this.

She is obviously adamant and genuine about her concern, but is such a tobacco controller at heart that she will not actually do anything useful. She is effectively silencing herself (and not just be deleting her useless tweets). She plays at getting the word out, but does not actually want to get the word out because it might interfere with tobacco control’s efforts to ruin people’s lives. She somehow thinks that harm reduction supporters getting the word out will benefit harm reduction, but that her getting the same word out (which is really beyond her ability) would not. But how does that even work? (A doctorate in public health does not exactly teach scientific or logical thinking.)

So she attacks the only useful potential allies she has in the world, now that her lawyer took the money and skated.

Oh, and a few last bits of bathos. Her response to me:

I am for harm reduction because I do not want anyone to use any nicotine-containing product. I am well aware of the harms of nicotine and that is why I have advised the FDA to lower the nicotine in all nicotine containing products.

I am pretty sure that, despite being a supposed scholar and researcher in the field, she genuinely does not understand that her described position is roughly the diametric opposite of harm reduction. This is what I meant by “a tobacco controller of the worst sort”.

And another random other tweet by her:

For all you vapers and tobacco companies, I am strongly anti-tobacco and anti-vaping. I am only complaining about @ProfGlantz because of his decades of sexual harassment. So if you are pro-nicotine, I would not follow me because I advise the FDA to protect public health.

I guess she only liked her bot followers.

Since her deleting her account ruined the ending I had written, I will instead go all-in with the bathos and treat you to a couple of pictures Greg Conley sent me while preparing this. Trigger warning: Once you see these, you cannot unsee them. (Yeah, I know, you saw the pictures before you read this paragraph. I did not mean it.)

bHTquwzJWait, where is his right hand?

OAocjo3MYes, that really is a screenshot of his phone wallpaper.

 

 

 

 

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Public health publishing is fundamentally unserious: evidence from a single measure of area

by Carl V Phillips

Sometimes an error matters because of its effects. Sometime it matters because what it says about its causes.

I was late to this nice piece by Roberto Sussman (a guest post at Brad Rodu’s blog) that takes down a recent silly paper out of University of California about environmental deposition on surfaces resulting from vaping exhalate. They do not actually call it “third-hand vapor”, though they all but do so, explicitly likening it to the myths (which they endorse, of course) about “third-hand smoke”. For the analysis of the science, please read Roberto’s piece, because here I am just focusing on a single gaffe and its implications.

As background, note that this that this came from the supposedly respectable tobacco controllers at UC, including Benowitz and Talbot, not the utter loons in Glantz’s shop. It was published not in some random online journal, but in the supposedly respectable flagship journal of the tobacco control movement, BMJ’s Tobacco Control.

Reading Sussman’s piece, I came across this, which he quoted from the original paper:

After 35 days in the field site, a cotton towel collected 4.571 micrograms of nicotine. If a toddler mouthed on 0.3 m2[squared meters] or about 1 squared feet of cotton fabric from suite #1, they [sic] would be exposed to 81.26 m[micrograms] of nicotine”. 

Sussman’s post is analytic, but it was written as an essay and so I was reading it fairly casually. That is, I was not trying to actively check each bit of the math as I read it, as I would when reading a research report. But even a quick glance across that passage was enough for me to trip up and notice the error. A square meter is about ten square feet, and thus 0.3 m^2  is about 3 square feet. Sussman, who was reading the original paper carefully for purposes of criticizing it, of course also caught this error and noted it in his next paragraph.

In theory this affects the thesis of the paper, which is based on the premise of a toddler sucking out all the nicotine that has accumulated in a towel that has sat untouched in a vape shop for a month. (Yes, believe it or not, that is really the premise of the analysis.) So the error means that the magical vacuuming toddler is given credit for extracting 3 ft^2 worth of accumulation by sucking the heck out of a mere 1 ft^2 of fabric.

However, this is not one of those convenient errors that creates artifactual results that matter First, every bit of this scenario is obvious nonsense, as Sussman explains, and every step grossly exaggerates the real-world exposures. And, second, even with all that, the tripled quantity is still trivial. So it is not like was the common type of “error” from tobacco control research, one done intentionally to get the result the authors want. It merely changes the result from “a silly premise that despite its huge overstatement still only yields a trivial exposure” to “a silly premise that yields an exposure that is three times as high, but is still trivial.” It is obvious that the conclusions of the paper (“environmental hazard” — i.e., landlords should be pressured to not host vape shops) were in no way influenced by the results.

In addition, it is a pretty stupid intentional “error” to make. It is a bright-line error, which appears right there in the text, as if someone had written 2+2=5. The typical tobacco controller “errors” consist of such tricks as conveniently not mentioning that a crucial variable makes the entire result go away (which only very careful readers catch), or fishing for a model that produces the most politically favorable result and pretending it was the only version of the model ever run (which is easy to detect, but impossible to prove).

No, it is clear that this was a mere goof. Someone who is not so good with numbers was thinking “a meter is about three feet, so it must be that a m^2 is about three ft^2”. Oops.

But here’s the thing: Whoever was doing the calculations for the paper made that goof, but more significantly did not catch it on further passes through the material. In other words, no one ever thought carefully about the calculations. Then someone transferred the calculation notes into text of the paper without noticing the error at that point. The other authors of the paper (there were four total) reviewed the calculation and the paper without ever engaging their brains enough to notice the error, and let it go out the door. Or perhaps they never even reviewed the calculations they were signing-off on, and perhaps not even the paper.

Keep in mind that perhaps you, dear reader, might not notice this error on a quick read. Perhaps you did not even know that a m^2 is about 10 ft^2. But anyone who does science, and is burdened with the hassle of dealing with stupid non-SI American units of measure, knows stuff like this intuitively. As I said, I noticed it without even thinking about it, just like you would notice a misspelling even though you are not actively looking for mispelings as you read. Sussman noticed it, and he is a scientist who probably never sees mention of non-SI units in his work, and who lives in a normal country that uses SI units (i.e., “the metric system”) in everyday communication. It is apparent that none of the authors of the paper ever read it as carefully as he did.

The American authors, who need to be literate in translating from American units to scientific units, should have noticed it. It is a safe bet that if prompted, “there is an error in that sentence,” they would figure it out in a few seconds. So the point here is not that they do not know the units or how to do arithmetic, but that they did not pay enough attention to their own calculations to notice the simple error. They never really cared about the calculations, as evidenced by the conclusions that are not actually supported by the results.

They were not the only ones. The reviewers and editor(s) at BMJ Tobacco Control also did not read the paper carefully enough to catch the error. As I have noted at length on this page, journal peer-review in public health is approximately useless. A generalist copy editor would probably have caught it, but presumably BMJ TC does not employ one despite being hugely profitable.

This also means that no one other than the aforementioned seven or eight individuals read the paper carefully. Indeed, it is quite possible that no one else read the paper at all before it appeared in the journal. From the perspective of serious science, is actually the biggest problem in public health research evident here: not circulating a paper for comments before etching it in stone, but rather creating a “peer-reviewed journal article” out of what is effectively a superficially polished first-draft of a scientific analysis. Anyone who actually wants to get something right makes sure a lot of people read it critically before they commit to it.

Many errors in public health articles are a bit complicated, and pretty clearly happen because the authors and reviewers do not know enough science to know they were errors. Many others are pretty clearly intentional on the part of the authors, and signed off on by reviewers because they are incompetent, inattentive, and/or complicit in wanting to disseminate the disinformation. But a stupid error like this illustrates something different: Public health authors and journals are simply not even trying to do legitimate analysis.

Sunday Science Lesson: Calling vaping/tobacco use an “epidemic”: it’s even stupider than you might think

by Carl V Phillips

A correspondent suggested to me that those who are not population health experts have a gut feeling that all this rhetoric about “epidemics” — of tobacco use, of teen vaping, and such — is an innumerate misuse of the term. But few really understand why.

The first problem with these claims, which I think most people get, is that “epidemic” refers to a disease, and these behavioral choices are not diseases. Of course, words get used metaphorically, and it is a somewhat complicated technical term that thus has hundreds of pop-level dictionary definitions floating around. But keep in mind that the people misusing the word in this case are supposed health science experts: The WHO entitles its flagship semi-annual reports on anti-tobacco policies, “WHO report on the global tobacco epidemic 20xx”. The U.S. FDA has been banging on about an epidemic of teenage vaping. This misuse of the terms frequently appears in public health journals. This is not ok.

Yes there are colloquial common-language uses of the term that are not limited to actual diseases (and there are also those that are narrower still and use the word to refer to infectious disease outbreaks specifically). But health “experts” and officials should not be using sloppy colloquial definitions of technical scientific words. It would be like economists using “efficient” to mean “quick and effective” or geneticists using “fitness” to refer to someone’s cardio statistics. (In case you do not know, each of those is an important technical term in its field, with a particular meaning.) It it similar to a physician using “cancer” or “poisoning” metaphorically when talking to a patient — “I’m afraid that you have cancer…. Of your motivation, which is keeping you from really focusing on your physical therapy.” (I have a recollection of Dr. Hibbert on The Simpsons having a conversation in which he keeps saying things like this, alarming the family for a beat before he makes clear he is not really meaning the words. Anyone know how to find a clip of that?)

So that alone is a simple, obvious fatal error in this usage. Anyone misusing the word to refer to a behavior they dislike, rather than a disease, and doing so in the context of health science, is engaging in propaganda rather than an attempt at accurate communication. But even if we set that aside — ignore the inappropriate metaphor of calling a behavior a disease — the use of the term is still blatantly incorrect.

For a disease to be in an epidemic state, it needs to have an incidence rate that is not necessarily high, but that is spiking above the normal baseline. (It also needs to be affecting a fairly broad population and not have a single source of exposure, as often happens with foodborne disease, or we instead call it an “outbreak”. But that is not really relevant for present purposes.) So, even though there are always a lot more heart attacks and HIV infections compared to Zika infections, Zika has recently been epidemic in some populations, while the others were not. The big numbers for the others are (usually) just the normal incidence rate. Exactly what is enough of a spike to qualify as epidemic is not precisely defined, but it is safe to say that (genuine) experts would not call a sudden jump of merely 10 or 20%, let alone a steady upward trend with similar increases, an epidemic.

So is tobacco use a global epidemic (accepting the metaphorical non-disease use of the word), as suggested by the WHO? Clearly not. It is actually in decline. In almost every population, the prevalence of tobacco use and, more importantly, the incidence of initiation are declining. I am pretty sure that there is not a single country where the current increases in tobacco use would qualify as an epidemic, though I might have overlooked somewhere. If you drill down enough, undoubtedly there are some subpopulations with recent spikes that would qualify as epidemic. But you have to look hard, and it is clearly not global.

(Aside: The number of smokers in the world has continued to increase, despite the decline in incidence and prevalence. The population is increasing faster than smoking rates decrease in all but the substitution-miracle countries. And of course, “tobacco use” does not decrease when product substitution reduces smoking. In addition, in a few large populations — extremely poor people who finally have enough income to afford tobacco products — rates are increasing, though not at epidemic levels. Bottom line: do not get misled by tobacco controllers when they temporarily switch their rhetoric from “epidemic!!!” to “we are close to eliminating smoking!!!” They are not.)

But how about more specific claims like FDA’s “epidemic of vaping among U.S. teenagers”? For that claim, the metaphor is even more strained (and, again, clearly inappropriate coming from an ostensibly scientific health agency): At least smoking can be metaphorically likened to a disease because it causes a lot of disease outcomes and so is similar to not-yet-morbidity-causing cases of an often-harmful infection. But vaping and other smoke-free tobacco use are approximately harmless. Saying “vaping epidemic” is a lot like saying “Fortnite epidemic”; yes, I suppose you can metaphorically refer to a sharp increase in the initiation of any consumption choice, but when the serious disease risks are trivial, it seems like a pretty stupid choice. You should just go with “sharp increase”. Though in cases like these, where the sharp increase in consumption is inevitable because no one was using the product a few years ago, even that is kind of stupid to say.

Worse is that this is an example of the “look at just one entry in the ledger” game that tobacco control rhetoric is notorious for. Compare their game when they pretend that smoking costs society money by toting up costs of treating (frequently fatal) smoking-caused diseases, ignoring the (almost exactly offsetting) reduction in the cost of treatment for some later disease that never happened because the person died from smoking. They also ignore other foregone consumption (housing, food, etc.) that results from earlier deaths, which add up to meaning that smoking’s health effects cause an enormous net savings in social resources. It is the same game used by those who say we cannot afford single-payer healthcare because it would cost $X trillion, and we cannot afford that — never mind that we are currently spending 30% more than that on healthcare, and would save that cost. It is as if someone said “I would eat out less, but I could not afford the resulting increase in my grocery expenditures.”

In the present case, FDA et al. ignore the decline in teenage smoking that offsets (and is pretty clearly caused by) the increase in vaping. What they are saying is equivalent to breathlessly panicking that we are experiencing an epidemic of a specific influenza strain, even though we were having an unusually mild flu season. It just happens that the year’s dominant strain is a relatively new mutation and there had not been many inflections with this particular strain in previous years, even though influenza is almost always more common and more harmful than in the present year.

FDA’s carve-out logic also means we are also experiencing an epidemic of teens smoking Marlboros that were manufactured in 2018, even though smoking is way down. I mean, no one was smoking those just a few years ago, and now they are, like, everywhere! Something must be done!

In short, it makes no sense to talk about an epidemic of a single option within a category of competing diseases/products. The entire category should be considered. (Notice the trap here for the crowd who seeks to die on the hill of “e-cigarettes are not in the tobacco products category.” This is a way you could actually die on that hill.)

The final problem with the use of “epidemic” — even ignoring for the inappropriate strained metaphor, the full-on falsity of the WHO’s version the claim, and the misleading tricks behind FDA’s usage — is more subtle. It is a question of what counts as a population.

An epidemic occurs when there is a spike in cases, across time, within a particular population. We do not say that Congo has an epidemic of malaria because they have a much higher incidence rate than Canada, or vice versa for frostbite. The word someone is probably looking for there is “endemic”. We only say “epidemic” if there is an increase in the numbers within the country. However, this is not about the place, but the group of people. So who constitutes the population, the group of people to compare over time, for tobacco product use?

Unlike influenza, tobacco product use is all about cohort replacement. That is, flu incidence changes from year to year because a different portion of the (mostly) same population get the disease. By contrast, population smoking prevalence changes mostly because the new cohort that is being added to the count (e.g., those turning 18 that year) has a different prevalence than those dying that year. Yes, there is smoking uptake by 19- to 25-year-olds (though that is still really a matter of cohort replacement, and would be clearly that if we took those FDA et al. like to call “youth” out of the adult population and looked only at prevalence for age 26+). Yes, there is also quitting at all ages. But year-to-year changes are driven by an entirely different engine as compared to infections sweeping through a population.

Notice that I have had to distinguish incidence (rate of new cases occurring) from prevalence (portion of the population who have the disease/behavior), a distinction that seems to baffle tobacco controllers even though it is first-semester public health. They can never decide which one they consider to be important. Sometimes they whine about rate of trialing (incidence of first-trying a product). Sometimes they whine about ever-use (prevalence of ever having ever trialed the product; this, of course, can only increase for a cohort over time), without seeming to understand the difference. Currently FDA seems to be making their “epidemic” claims about “used at least once in the last 30 days” prevalence.

Among their and WHO’s more subtle crimes against the word “epidemic” is that that word refers to spikes in incidence rates, not in prevalence. Consider that the prevalence of HIV is far higher now than ever before (thanks to maintenance treatments that let people live with it). Is this an epidemic? Similarly, the population prevalence of HPV-16 will peak when the vaccines become sufficiently widely used (and thus in future years the new cohorts are immune while some of those with the virus are dying off). So does this mean that the epidemic will be at its height at a time when the incidence rate is hitting its lowest point since the start of the sexual revolution? The innumerate use of the word that FDA is employing would say exactly that.

But getting back to the question of populations, the problem is more subtle still. Consider the population “Americans born in 2000”. When looking for epidemic-level increases, can we look at that cohort’s own incidence rate of vaping or even (ignoring the fatal problem noted in the previous paragraph) prevalence of recent usage? That obviously does not work, because of course those will be higher in last year’s statistics than they were in recent years when that population were little kids. That is like saying we are experiencing a huge increase in knowledge of simple calculus, because so many more in that cohort know it now than a few years ago. Is someone also going to whine that there is currently an epidemic of premarital sex among Americans born in 2000? (We should certainly hope there is!)

Even though this is really the only comparison that makes sense for properly using the word epidemic, it is obviously dysfunctional and so is not the comparison that gets made. Instead, incidence rates (or, more likely, prevalences) are compared, year-to-year, among 17-year-olds (or for whatever age cohort). But this is not a comparison within a population. It is, in fact, an entirely disjoint population, like comparing Congo and Canada; those who are 17 on a particular date in 2017 include no one from the population who was 17 on that date in 2016. So you can say, e.g., that vaping among this year’s 17-year-olds is much higher than among last year’s (just as you can say malaria is much more common among Congolese than Canadians), but that is not an epidemic. That is cohort replacement.

I realize this is subtle, and its importance is probably lost on many readers. But believe me when I say for anyone literate in population health science, it stands out as a far larger error in the use of the term than the simple fact that vaping is not a disease, or even the “looking at only one line in the ledger” game.

To summarize how I believe we should respond to these innumerate “epidemic” claims: First, we should push back against the use of the word to refer to a behavior rather than a disease. This is not, however, because of some naive language purity urge, a failure to recognize that words get used metaphorically. Rather, it is because this usage is part of tobacco controllers’ game of trying to define the behavior as a disease. They are not actually trying to expand the definition of “epidemic” here, but that of “disease”, and we should push back.

Second, the strongest substantive replies are as follows: The FDA version of the claim is based on carving out one particular product, which is taking away market share from other products (which, oh by the way, are a hundred times worse for you). Always go back to the entire category, and perhaps consider noting the analogy of “Marlboros manufactured in 2018”, whose usage is up by infinity percent. As for the WHO version of the claim, it is simply factually false.

Third, the FDA version of the claim is actually something worse than false: it is nonsense. It is one thing to say something that could be true but happens to be false. It is another to utter a string of words that simply make no sense. There cannot be an epidemic of anything among 17-year-olds, based on year-to-year comparisons, because these are entirely disjoint populations. Again, you may have to take my word for it, but this is actually the clearest misuse of the word in this entire embarrassing mess. The supposed health scientists at FDA should understand this, though I expect they do not understand and are clearly immune to embarrassment.

Science lesson: The absurdity of “n deaths per year” and “leading preventable cause” claims about smoking.

by Carl V Phillips

Smoking is quite harmful. Lots of people choose to do it. Given these facts, you would think that people who warn/scold/fret about smoking, at the individual or population level, would see no reason to exaggerate. Yet they do. They lie constantly and habitually. Still, in spite of the lying, you might think that they would avoid making mantras of claims that are simply nonsense. Yet they do not.

I have covered most of this before, highlighting some of it as one of the six impossible things tobacco controllers believe, but have not pulled it all together before.

Consider first claims like “smoking causes 483,456.7 deaths per year in the U.S.” What does this even mean? It obviously does not mean what it literally says, that but for smoking, these individuals would not have died. Occasionally someone asserting these figures phrases the claim in a way that highlights the implicit suggestion of immortality, and is rightly ridiculed for it. But in fact, even the standard phrasing implies this if treated as natural language.

Understanding what this might(!) really mean requires understanding the epidemiology definition of causing a death, which, it is safe to say, few of those reciting the claims about smoking understand. This definition is actually, like much of epidemiology, fundamentally flawed, but it gets us closer to something meaningful. The textbook definition is that something is a cause of death if it made the death occur earlier than it otherwise would have. Notice that this means that every death (like every event) has countless causes. E.g., a particular death may have been caused (in this sense of it occurring when it did and not later) by all of: smoking, being born male, not eating perfectly, occupational exposures, and choosing a low-quality physician. (Notice that if we extend to a broader definition of causation, other causes include the evolution of life on Earth and the individual’s grandfather making it home from the war.)

This typical version of the definition is fairly useless because it includes exposures that caused the death to occur only a few seconds sooner than it would have. We are seldom interested in those. Indeed, by that definition, smoking is a cause of death for almost every smoker and former smoker. It is very likely that any smoker who who is not killed instantly by trauma would have survived longer because whatever disease killed her would have developed more slowly, or simply because the body would have functioned for a few more minutes. So more useful definitions of a cause of death would be something that we estimate caused the death to occur a month, or a year, or five years earlier than it would have. Note that a far more useful measure, in light of these problems, is “years of potential life lost” (YPLL).

So which of those definitions is the “X deaths per year” claim based on, given that it is clearly neither the literal meaning (with its implication of immortality) nor the faulty textbook epidemiology definition (which would include approximately all deaths among ever-smokers)? The answer is: none of them. Those statistics are actually a toting up of deaths attributed to a particular list of diseases, each multiplied by an estimate of the portion of those cases that were caused by smoking, in historical U.S. populations. That is, it is the number of lung cancer deaths among smokers, multiplied by the portion of such deaths that are attributed to smoking, plus the number among former smokers multiplied by the attributable fraction for former smokers, plus those for heart attacks, plus those for a few dozen other specific declared causes of death.

As you might guess, based on who is doing the toting, these numbers are biased upwards in various ways. Still, it would be possible to estimate that sum honestly (no one has tried to do so for a few decades, but it would be possible). But the resulting measure would obviously not properly be described “deaths caused by smoking.” It would not be that hard to identify what the figure really is, especially in serious written material like research papers or government statements: “each year in the U.S. smoking is estimated by the CDC to cause X fatal cases among 29 diseases.” Of course, most “researchers” and “experts” in the field do not even know this is what they are trying to say.

There are also several problems with the numbers themselves, not just the phrasing. First there is the noted, um, shading upward of the numbers. Second, as I alluded to in the third paragraph, the statistic is always presented with too much precision. Even two significant digits (e.g., 480,000) is too much precision. The estimates of the smoking-attributable fraction of cases of those diseases are not precise within tens of percent for smokers, let alone former smokers, a much more heterogeneous category, at best, making even one significant digit (e.g., 400,000) an overstatement of the precision.

Third, and more important for most versions of the statistic is that “in historical U.S. populations” bit. The statistics you seen for other countries or the whole world are based on implicit assumptions that everyone share Americans’ health status and mix of exposures, because almost all the estimates come from U.S. studies (and those in the mix that do not are almost all from the countries that are most similar to the U.S.). At best, the estimated increase in risk for fatal cases of the disease ported to calculation for other populations, even though this varies across populations. That is, it is assumed that if the estimate is that half of all heart attacks among ever-smokers are caused by smoking, then that same multiplier is applied to heart attacks among ever-smokers in the other population. Worse, sometimes the attributable fraction itself is just ported, so if a quarter of all heart attacks in the U.S. are attributed to smoking, then that multiplier is applied to all heart attacks in other populations. That would mean, e.g., if a particular population has a lot of extra cases of cancers due to diet, the same fraction of those cancers that is due to smoking in the U.S. is attributed to smoking there.

Fourth, and worse still, the forward-looking versions of the statistics would be innumerate nonsense even if none of the other problems existed. These include the infamous prediction of a billion deaths from smoking in the 21st century, as well as assertions about the fate of cohorts who are taking up smoking now. The number of deaths from a list of diseases that are attributable to smoking is going to vary hugely not just across populations, but time. This is first-week Epidemiology 101 stuff. Population and time matter. There are no constants in epidemiology. The number of deaths from particular diseases will vary with technology. The attributable fraction will vary with the prevalence of other risk factors. Oh, and for those other changes, good news often makes things “worse”: An asteroid destroys higher life on Earth, and smoking stops causing any deaths. War, hunger, and infections are reduced and smoking causes a lot more cases of fatal diseases.

In summary, these statistics are: (a) not actually the number of deaths caused by smoking, (b) exaggerated, (c) far less precise than claimed, even setting aside the intentional bias, (d) only valid for a few populations, and (e) only applicable to the present (or, really, the recent past).

Moving on to the “leading preventable cause of death” claims, this mantra is equally absurd if you pause to actually look at the words. What does “preventable” mean? Typically in such contexts, it means “some obvious top-down action could have averted it.” So, for example, of the 3000 deaths from Hurricane Maria, a few score were hard to do much about. Every one of these was “preventable” in some sense (fly the particular person to Miami in advance of the storm) but this is meaningless; preventing someone, probably a few dozen someones, from getting killed was not a real option. But the vast majority of those deaths were meaningfully preventable — in the sense that an operationalizable action could have kept them from happening — with a competent relief operation.

So if this normal use of the word is what tobacco controllers mean when they recite this mantra, then they are basically testifying that they are horrifically incompetent. They spend their lives trying to prevent this from happening, and they fail even though it is doable. But while it is true that they are generally horrifically incompetent at what they do, it is clearly not doable. Smoking is not preventable by this standard sense of the word.

Perhaps they are saying it is theoretically preventable, in that sense, but no one has figured out how to do it. At least that is plausible, but then the full statement is clearly false. There are more important causes of death that are theoretically preventable. Deterioration with age of cellular repair mechanisms seems to pretty clearly top the list. Humanity will figure out how to largely prevent that. This bit of prevention (in the “we will figure it out eventually” sense) dwarfs preventing the deaths by smoking. Indeed, it will prevent a lot of the fatal disease cases that are caused by smoking. (I have a vision of one of my kids find this post in an archive 200 years from now, and being sad that this technology came a few decades too late for me. And for most of you too — sorry.)

Most likely, what they are not-quite-saying is that each individual who “dies from smoking” (i.e., has a fatal case of a disease that was caused by smoking) could have made a choice to not have that happen. In some sense, this suffers from the same problem that such a claim about hurricanes or earthquakes does: Yes, every death from a collapsed building could have been prevented by the person choosing to be in a different building. But it has a bit more legitimacy since it is obvious what the safer choice is and the risk is high enough probability to influence the decision. The problem here is to make this meaningful statement, tobacco controllers would have to acknowledge that smoking and other tobacco product use is an individual choice. They are not willing to say that out loud — and thus admit that their entire enterprise is devoted to keeping people from making the choices they want — so they hide it behind weasel words like “preventable”.

But just because the statement “the leading cause of death among individual behavioral choices” is meaningful does not mean it is right. Indeed, it is obviously wrong. Go back to the epidemiology textbook definition of a cause of death. Smoking is a cause of death, by that definition, for approximately everyone who smokes. But eating a less-than-optimal diet is, for the same reason, a cause of death for everyone who eats less than optimally. Two or three times as many deaths occur among people who ate less than optimally (i.e., basically everyone), as compared to those who smoked, so smoking is clearly not “leading”. Of course, no one really thinks in terms of that textbook definition. So how about if we limit it to deaths that occurred a year earlier than they would have. It is pretty difficult to imagine figuring out the numbers, but I would expect diet still has the edge. How about five years? At that level, smoking might really be leading. How about putting it in terms of YPLLs? Yes, it is probably true that smoking costs more YPLL than any other individual choice.

Aha, so they are right!

Um, yeah. We just have to assume that these stupid phrases really represent deep and subtle thinking on the part of those using them. By “preventable” they actually mean resulting from individuals’ behavioral choices. By “cause of death” they actually mean cause of YPLLs. And their declaration that it is true, rather than speculation, is based on valid estimates of the comparative number of YPLLs from different behavioral choices, even though they never cite such evidence. Also, by “n deaths” they mean “n cases of particular fatal diseases attributed to smoking, if you believe our numbers, and assuming that future looks exactly like the past and all population are like the U.S.” Giving someone the benefit of the doubt is sometimes noble, but it would just be silly in this case.

The bottom line are that these mantras are just as false as much of the rest of what tobacco controllers claim. Moreover, they are not just factually wrong, but are a demonstration of just how thinking-free the whole endeavor is. At least things like “second-hand smoking causes 30% of all heart attacks” or “vaping is causing more kids to take up smoking” are meaningful claims. They are obviously false, but they are valid hypotheses and are only false because empirical evidence shows they are false, not because it is impossible for them to be true based on some simple fundamentals of how we know the world works.

Sure, people say things all the time such that, if anyone paused to think and ask the question, would not stand up to a “what does that even mean?” query. We are not always precise in all our thinking, let alone how it translates into words. But the claims in question are not fleeting thoughts or ad hoc word choices. They are mantras that getting written or said a thousand times per day by supposedly credible people in supposed credible contexts. The fact that they cannot pass a “what does that even mean?” test is one of the greatest overlooked testaments to the fundamental lack of seriousness in public health. The fact that they get repeated by others is a testament to how influential sloppy public health thinking is, even over those who are attempting to position themselves as opponents of it.