by Carl V Phillips
I will resume several more posts about my take on the FDA CTP shortly. In the meantime…
by Carl V Phillips
I will resume several more posts about my take on the FDA CTP shortly. In the meantime…
by Carl V Phillips
Chris Snowdon understands what constitutes true conflict of interest, and provides us with two critical observations about it relating to THR. I point out that he understands it because most people who invoke the concept, especially those who make it a centerpiece of their rhetoric, clearly do not have a clue about what it means.
Conflict of interest occurs, to put it clearly enough that even those who harp on the concept might understand, when there is an interest someone is supposed to be serving (perhaps due to their job description, but possibly just because of how they are representing themselves), but there is something about that individual that might cause them to favor some other interest that is conflict with the one they are supposed to be serving. Notice that this is not remotely similar to the usual naive misunderstanding of the concept, that COI exists iff and only if someone has received funding from industry. Indeed, notice the funding is not only not sufficient for COI to exist, but it is not necessary.
For example, when Stanton Glantz humorously tried to take on Igor Burstyn’s science, he had a severe conflict of interest: He was pretending to offer a scientific analysis, and thus was obliged to fulfill the interest of being an honest scientific analyst, but because Glantz is really motivated entirely by personal politics when he is pretending to be a scientist, there is a conflict of interest. By contrast, if Glantz has published his screed and had made clear his real goal — “here are some talking points that those of you who wish to deny what this study demonstrated can use” — then there would have been no COI. This is because his personal politics would be perfectly aligned with the interest he claimed to be serving, so there could be no conflict. Whether some interest creates a conflict obviously depends on what interest you are claiming to serve. That should seem rather obvious, but again seems completely over the head of almost everyone who presumes to make a big deal about COI.
In this brief but completely damning post, which he quite rightly describes as the “conflict of interest of the week”, Snowdon reports on a director at a smoking cessation clinic complaining about the success of e-cigarettes in taking away his clients. The director includes an attack on vaping as part of that. So, what interest is a government-funded smoking cessation employee suppose to be pursuing? Smoking cessation, of course. If he is objecting to successful smoking cessation it must be because he is more interested in serving some other interest, say, keeping his job.
In this much longer post, Snowdon explores how COI seems to being the defining factor in government decision-making about e-cigarettes. The interest of a government official is supposed to be the interests of her constituents or the people. Snowdon recounts a recent story that, by itself, is the typical naive COI story: The expert panel that advised the UK MHRA on e-cigarettes included people who had gotten grants and contracts from pharma companies. Left by itself, that is a major *yawn* — everyone with any skills in health research has gotten grants/contracts from pharma companies. But treating that as if it were somehow noteworthy in isolation is exactly what most commentators did. Would the influence from such funding alone cause someone to lie? Doubtful.
But contrast, Snowdon goes on to put this in the context of the outright bribery that seems to dominate EU parliament votes related to tobacco and THR. Of course, the EU is pretty much purpose-built for COI. The representatives are so incredibly far from their constituents, and barely monitored by them or the press, and live in a disconnected world that is all about power and connections and prestige (and thus the handing out of material benefits). Europe still loves monarchy (though if you have real monarchy there is no COI because there is no obligation to the people — l’etat c’est moi).
Snowdon leaves it to us to connect the dots, but I think he is pointing out that perhaps we should be rather more wary about observations that might suggest there might be a hidden COI (even though they do not themselves represent a real COI) among decision makers. A history of a few grants and contracts means nothing, unless it is a corner of a serious COI scandal. It is as if we were considering tobacco industry behavior and we were still living in 1975 (which, apparently, most of tobacco control thinks is the case) and there were subtle hints of tobacco company influence over decision makers. That would be in the context of definitive evidence of improper influence elsewhere, and would suggest extra scrutiny. Except in this century, of course, it is everyone other than the tobacco industry that seems to warrant the extra scrutiny.
Finally, it is worth noting that while the prospects of personal financial gain might explain the behavior of the MEPs, I actually think it is way down the list of important COIs that caused people to lie about e-cigarettes in the other cases. Tobacco control and smoking cessation people are probably much more conflicted by the desire to personally be responsible for health benefits, a self-centered but not precisely selfish motive. That is, they are desperately afraid that the goal will be achieved in spite of them rather than instead of them. This interest conflict severely with the goal itself when the world moves on and the goal is better served by what others are doing.
background analysis, posted by Carl V Phillips
A couple of recent posts here have identified as a lie an author’s statement about what should be done. This might seem a bit odd. After all, it would seem that someone’s opinion about what ought to be done in the world cannot be wrong. That is indeed true, so long as they make clear that they are basing their normative statement on their own opinion per se. (Normative = philosophy or economics jargon for a “should” claim.) A statement like, “I would prefer a world in which smokers do not have low-risk options, and therefore X should be done to interfere with adoption of THR,” cannot be a lie.
But when a normative statement is made based on some stated goal other than the whim of the author, then it can be false. And if the author knows the claim is false — or claims to be sufficiently expert that he should know — then it is a lie.
If someone claims that an anti-THR action (product bans, message to smokers, etc.) is justified by public health concerns, they are lying. (Alternatively, they are utterly clueless and are just some other liar’s useful idiots — but I will set them aside for this analysis and just focus on those who claim expertise.) It is theoretically possible to concoct a scenario in which promoting THR could be bad for public health, and if someone actually does that, then they are not lying about the “should” (though they might be lying when they describe the scenario). But lacking such a tortured scenario as part of the analysis, THR is so clearly pro-public-health that the “should” is a lie.
Similarly, if someone states “e-cigarettes contain chemical X and therefore should be avoided” or “…should be prohibited from public use”, it is a lie if the quantity of chemical X creates no known risk, or a risk down in the range of the thousands of exposures that are normally accepted.
Of course, most of the time someone makes a normative statement, they offer no explicit explanation for the normative standards (ethical rules) that they are using. Typically, however, this can be inferred from context. If the discussion surrounding the normative statement is about public health, we can infer that the normative claim is about what would be best for public health. If it is about individual users’ health, that is the implied basis for judging what is best and thus the “should”.
Someone is free to explicitly state their normative standard is something other than what the reader would naturally infer. But if that is what they are doing, they are obliged to be specific and argue that their normative claim is supported in spite of the lack of a normal public health argument. In general, if someone is arguing based on a motive or ethic that is hidden, they need to make that explicit.
If that last sentence sounds familiar, it should. It is really just another way of bringing up the issue of conflict of interest that was the subject of last week’s background post. So, for example, when the American Lung Association advocates against THR (see previous post), they are lying to most readers, who reasonably assume they are taking a position that would tend to improve lung health, when in reality their position is bad for lung health. It turns out that buried in their mission statement is an incongruous anti-t0bacco extremist (and thus anti-THR) position. But unless they make clear they are acting based on that extremist mission, rather than a goal of promoting public health (let alone lung health) then they are lying. Moreover, they should make clear that they are acting based on a clear conflict of interest: anti-tobacco extremism conflicts with the missions of lung health and public health in general.
An honest author is obliged to make clear their motive and its downsides and COIs. The ALA cannot be honest unless they explicitly say “we oppose low-risk alternatives to smoking in spite of the fact that promoting such alternatives is good for lung health.” Obviously they cannot fit this into everything they write on the subject, but because they do not make that clear in any of their writings — but instead pretend that being anti-THR is part of their lung health mission — then everything they write on the subject is a lie.
Compare: No one who honestly writes about THR fails to acknowledge that even low-risk nicotine products probably pose some small risk of premature mortality compared to complete abstinence. Sophisticated writers on the subject further acknowledge that more people will (quite rationally) use tobacco/nicotine when low-risk products are an option, rather than just cigarettes. We then argue that THR is good for public health (among other things) in spite of those facts.
In addition, when someone presents a basis for making a normative claim that is likely to be controversial, they are obliged to make that clear rather than trying to hide it. Consider the example from the previous post, where Standon Glantz called for vaping to be banned wherever smoking is banned. He was clearly misrepresenting the science of the study he cited, and that was an indefensible lie. But setting that aside, he also hinted at an ethic that could make his normative claim defensible: “No one should have to breathe these chemicals, whether they come out of a conventional or e-cigarette.” Not “no one should have to breath these chemicals when produced by someone else”, but specifically if they come out of one of those products (which, I noted, are what he really cares about: products, not people).
So, he could have written: “There is no reason to believe that environmental e-cigarette vapor causes any health problems. But I believe that unlike a thousand other minor sources of air pollution that people inflict upon each other, which should not be banned when they are trivial and have no apparent health effect, any bit of air pollution from an e-cigarette should not be allowed.” That would have been honest. But it then would have been his obligation to convince people that this position is acceptable to take in a free society where most people do not share his personal pique.
Moreover, he would also be obliged to explain why this value of accomplishing this one goal — eliminating any bit of emission from this one particular source — outweighs the costs. In particular, why is the supposed value of this goal sufficient to outweigh the public health costs of encouraging smokers to continue smoking. In addition, he would need to argue that his personal goal justifies depriving people of private property rights and a host of other considerations.
Indeed, that last point brings up a further important consideration: Not only is “getting rid of products that a few people find objectionable” not an accepted basis for normative judgment, but “improving public health” alone (absent a consideration of the myriad other preferences that people have) is not either. More on that another day (or just read the tens of thousands of words that I and others write on that subject every year). But even starting from the absurd normative position that public health trumps all other human preferences, anti-THR “should” statements are almost always lies.
posted by Carl V Phillips
A background post today, on the topic of conflict of interest (COI; aka “competing interests”). This is a critical topic to understanding when identifying and critiquing lies. It is a favorite topic of some commentators. But it is also woefully misunderstood, and almost never discussed accurately.
About 90% of the time that someone mentions COI in the context of THR, they really do not care about COI at all. It is just one of the anti-THR liars looking for an ad hominem attack on a political opponent because they have no honest arguments and factual lies can only take them so far. But that is actually just one example of the misuse of the concept that occurs about 99.9% of the time that the term is used in related contexts (and, as far as I can tell, many other contexts).
To understand what COI really means, we need to start with the term itself: What is conflicting or competing with what? I suspect that most people who write about COI have never even thought that through. The interest that most authors, particularly a scientists/researchers, are supposed to be motivated by is communicating the truth. Any desire to support a particular worldly political goal is another interest that may compete with that. Researchers who are anti-THR liars are clearly more motivated by their desire to discourage THR than they are by the ethics of doing honest research (and there is no enforcement or system of rewards in this area that compels them to do honest research).
Notice one immediate implication of this: If it is unambiguous that someone is communicating from an advocacy perspective, then their interest in advocating does not represent a conflict. When CASAA advocates that people should get honest information and that smoke-free alternative should be available, there cannot be a COI because promoting those are our stated interests. By contrast, when Christina Gratziou or Stephen Hecht conducts and reports research that is primarily motivated by political (anti-THR) goals, but pretends they are just motivated by scientific truth-seeking, there is a clear COI. When people like Gratziou or Ellen Hahn produce anti-THR broadsides and statements to the press, they could avoid the COI problem by identifying themselves as being political activists rather than scientists (they would still be liars because their claims are false, but at least they would not be liars with unreported COI). However, when they pretend to be acting merely as scientific purveyors of information — implying that their primary interest is that of honest researchers or academics — then they create a COI with that lie.
By now you have probably noticed the lack of any mention of funding in all of this. That is because — contrary to the common naive view — funding is not COI. This is perhaps the most important thing to understand about COI: It is about preference or belief — and willingness to act on those preferences when it is unethical to do so — not about what motivates someone to those actions.
Receiving funding from an entity with an interest in THR is neither a necessary nor sufficient condition for having a COI. The relationship of funding to COI is very similar to the relationship between toxicology and real world outcomes that I discussed before: Funding is one possible explanation for why someone might have a COI, but it is not the COI. The COI is the motivation to get a particular result from research or to communicate particular claims apart from their truth, no matter what the motive.
Indeed, it is actually quite naive to think that research grants create much COI. There has been a lot written recently about how Gratziou and Hahn have both been paid by pharmaceutical companies who stand to lose revenue when THR succeeds. But I really doubt that this funding had much effect on those people’s anti-THR positions. I have little doubt that their primary motives, like those of most anti-THR liars, are the non-funder-related motives we identified when this blog was started. It might be that funding has some influence at the margin, but I lived in that world long enough to know that funding generally chases true believers, rather than creating them.
The exception to the “funding is not sufficient to cause COI” observation is when someone is employed by an organization with a position on the matter at hand (THR or whatever) or the rarer case when someone owns intellectual property or other substantial assets that will dramatically change in value based on research results. Someone who invented a product obviously should not be the one we trust to do the research on whether it works. Employees of anti-THR organizations like, say, the American Cancer Society or most units of the US government, would probably suffer serious consequences if they told the truth about THR. Such individuals have such extreme COI that if they wanted to try to be honest scientists, they would need to go to great lengths — making sure their work was extremely transparent, thoroughly reviewed by anyone who wants to review it, etc.
For an example of that, consider the scientific research that comes out of BAT. The researchers there know that they have a clear COI because of their employment status, but are intent on doing honest research that contributes to our understanding of the health impacts of tobacco products (THR and otherwise), and having it taken seriously. (I can testify to these motives based on extensive communication with many of them; this contrasts with those who casually make declarations about people’s motives with neither material evidence nor any familiarity with the people in question.) Knowing that they have to deal with that COI, the researchers openly share their research to the extent possible and are very conservative in their conclusions. Contrast that with most research from anti-THR organizations and individuals that is secretive, never seriously reviewed, and overstated.
Notice also that I mentioned the US government. As noted in yesterday’s post, and as will become further apparent from future posts, the US government is and has been the most aggressive anti-THR liar in the world. The EU government and the UN are similarly anti-THR and similarly dishonest. So if funding were tantamount to COI, then anyone receiving funds from the US government or most other large governments or quasi-governments would have a COI. Indeed, it is rather more likely that a government would cut off someone’s funding for taking the “wrong” position than would a pharmaceutical or tobacco company. Governments and their puppets and puppet masters are all about politics, after all, while manufacturers have a real stake in good science, and are generally capable of distinguishing between someone’s scientific contribution and their political views.
You might notice that the only people who could be seen as being without sin — those who never take any money to work on THR (pro or con) and do not anticipate that their work on the subject will affect their income in any way — do not seem to make a big deal about COI. The only people who come to mind are Bill Godshall and most of the CASAA board of directors. Pretty much every complaint about funding in this arena comes from people who are lavishly funded by someone with an interest in the outcome, and who are trying to keep it that way.
Still not convinced? How about a personal example. A plurality of my recent income has come from the pharmaceutical industry, as has a solid majority of my family’s income. Over the course of my life, weighted by how much value the marginal income had to me, I have gotten more from pharma than any other industry (not counting universities themselves as an industry). So that explains why I am so biased in favor of pharma when I write about THR, huh? Um, yeah, right. Also solidly in the top few industries for providing my lifetime income is the energy industry, and those who are familiar with some of my other work will notice that I am oh so positive about them. [These last few sentences were all sarcasm, in case it was not obvious.] The key is that, in contrast with government grants and hiring which are almost always heavily motivated by politics, it is my experience (and the reported experience of everyone I know who has worked in all of these realms) that most corporations — pharma, tobacco, or otherwise — are interested in the learned input of anyone who is honest and productive, even if they are often on the wrong “side”.
To summarize: COI is not about funding, it is about interests, and it is much more common than generally perceived. Lying by an ostensible scientist or expert is definitive evidence that she has a COI, whereas having a COI certainly does not mean that someone is lying. Moreover, if you do decided to look at funding sources for clues about who might have a COI and thus be lying, you should be somewhat less concerned about corporate funding than the usual rhetoric implies, and way more concerned about government and advocacy group funding and employment.
posted by Carl V Phillips
Today I will start an analysis of the buzz-generating press release by Christina Gratziou (University of Athens) et al., based on their presentation at the recent European Respiratory Society (ERS) meetings. Much has been written about this non-result that was blown up into the unsupported claim that e-cigarettes damage the lungs. I call your attention in particular to a post by Katherine Devlin (ECITA) which does an excellent job of analyzing the situation, as well as presenting the analysis with verve that I cannot hope to improve on (see her letters to newspapers that naively reported on this, which are linked from the post, for more detail).
While it would be tempting to just yield this topic to Katherine (especially since she even used “lies” as the first word of her title), I think I have a few views on this that have not been covered and a few useful clarifications. Also, I hope to make this blog a catalog of both anti-THR lies and issues related to anti-THR lying, and there are some points to be covered on that here. With that, I start with the question of “why should the lay reader (or a reporter who does not understand the subject but wants to transcribe the press release) know that Gratziou is a liar?”
Start with the official abstract of her presentation:
Electronic-cigarette is marketed as potentially safer tobacco exposure product, but there are not enough data concerning its impact on the respiratory system. Therefore, we set out to investigate the acute effects of an e-cigarette on respiratory functions in healthy subjects and in smokers with and without chronic airway obstruction (COPD and asthma).
The basic statement is not too terrible. To make it accurate would require only the minor change to saying e-cigarettes are a safer product. Alternatively, to hedge and not make unnecessary claims in the introduction, that they are potentially safer or that they are widely believed to be safer. Perhaps the poor wording just reflects the author not being a native English speaker; after all, “tobacco exposure product” is clearly garbled.
But, wait: “marketed”? Why would a scientist care how they are marketed, even if she is inclined to mention how they are perceived. The only time anyone ever uses that nefarious-sounding word, marketed, is when they are actively setting out to dispute the marketing claim. But someone doing vaguely-informative biomarker research should not be in the business of addressing such claims. Someone writing a summary of all the knowledge on a topic can engage in such pursuits, but a single bit of lab research can only ever be about that single bit of lab research.
Now consider the press release (reporting on the exact same results covered in the abstract):
New research has shown that despite electronic cigarettes being marketed as a potentially safer alternative to normal cigarettes, they are still causing harm to the lungs.
This includes similar downplaying of the existing knowledge that they are safer. But, wait: “despite”? That word conveys the message that the belief is wrong because the research provides evidence of that fact. But this is obviously a lie; even someone who somehow honestly believes that we lack sufficient evidence that e-cigarettes are less harmful than smoking, and whose caveats and other wording meant that she was just being a hyper-cautious about drawing any such conclusion, would know that finding one specific harm from e-cigarettes would not justify that “despite”. Not unless the discovered harm were somehow worse than the combined harms from smoking, which this one obviously was not. (Indeed, it was not apparently much of anything, but I will come back to that in a later post.)
But Gratziou is not hyper-cautious, nor a careful scientist. Consider, for example, this interview she gave at the conference (h/t “elpatron83″ at ECF for the link)
We don’t suggest anybody to take and use e-cigarette as an alternative tool for smoking [broken English in the original -- not a criticism, just trying to quote accurately]
(Aside: Viewing the video, and even reading her text, one cannot help but be struck by her apparent glee when claiming that a tool that is helpful to so many people is bad for you. She was not sad to be the bearer this unfortunate news; she reveled in it and clearly thought it was wonderful to report it. Such glee — which can be observed in many anti-THR and anti-tobacco activists — is not the mark of a mere liar, but of something much much worse.)
The hyper-careful scientist possibility goes out the window as soon as she starts making unequivocal policy/behavior recommendations. Even apart from the fact that she was telling people “you might as well smoke”, the fact that she was telling them what to do at all makes her an advocate.
There is nothing wrong with being an advocate, of course, nor with doing research when you are also an advocate. But if you are actively supportive of a particular relevant viewpoint, you need to make that conflict of interest clear. A researcher who gives no hint that she has that conflict of interest is implicitly communicating that she does not care which way her research comes out, which is clearly not the case here.
Moreover, if you are an advocate-researcher, then if your research tends to support your bias, you then need to be extra careful vigilant about presenting it in a way such that an honest expert reader of it would conclude, “I understand that the author preferred to get the answer that she got, but when looking at what she reported, unless she was simply lying about the data, she does indeed seem to have supported her conclusions.”
Gratziou failed both of these tests. She covered up her conflict of interest, and she presented nothing but vague descriptions of the research and assertions about the results.
As a contrast, those of you familiar with the bits of my research whose results argue in favor of THR might have noticed that I make clear my views (stating them, that is; giving unintentional clues about bias via weasel words obviously does not count to one’s favor) and do everything I can to make sure that every bit of information that could possibly be reported is reported. I have read plenty of whining about my research by people who wish it was not right, but I have never once read a challenge to my research by an anti-THR advocate or other ANTZ that identified any flaws in the research or reasoning, or that suggested there was something being hidden. Ironically, I did publish a correction to one paper based on an error spotted by someone who is pro-THR; for most anti-THR papers, spotting such errors, which are clearly rife, would be impossible because the authors just make assertions rather than showing their work.
It is also interesting to consider the previous posts in this blog from the perspective of the obligations of the advocate-researcher: Stephen Hecht has consistently covered up the fact that he is an anti-THR activist, and pretends to be doing unbiased research. Ellen Hahn does not actually do research, so there is no mistaking that she is merely acting as an anti-THR activist — so by this one measure, she is the least dishonest of the individuals we have discussed.
Returning to Gratziou, she is Chair of the ERS Tobacco Control Committee, which is apparently responsible for the ERS’s aggressively anti-THR statement on e-cigarettes; undoubtedly she approved it and quite probably she authored it. This moves her from advocate to activist. (Incidentally, that statement might well be the dumbest, most uneducated position statement I have ever read from a theoretically-respectable organization — I am not counting the American Pediatric Association or ANTZ groups in that category, of course. So it will be the topic of one or two future posts here.)
I will go on to analyze the science of her report — the few sentences worth of it that she actually reported — in the next couple of posts. But today’s post should demonstrate how even someone who knows basically nothing about science (like, say, a typical health reporter for a newspaper), someone who cannot even figure out that the transitory effect that she measured cannot legitimately be called “harm to the lungs”, should know that she is a liar: Her background statements made clear her activist agenda. Yet she never admitted to being an activist, let alone made sure her claims were credible in spite of her bias. Her grand sweeping conclusions about e-cigarettes could not possibly be supported by her research; even a health reporter should be able to figure out that unless she discovered an effect that might kill a third of all long-term users (which she obviously did not, nor did she even claim), then even if her results were completely definitive, she would not have support for her claim that you might as well smoke. Yet she aggressively used weasel wording to imply that her little result contradicted the conventional wisdom.
Given the clear evidence that she is a liar and intent on presenting biased results without admitting her biases, her assertions should not be accepted (let alone published in newspapers), and the substance of her report (such as it is) should be analyzed with that in mind. As I will do.
…to be continued….