Tag Archives: UCSF

Credit where due: FDA

Posted on 22 May 2013 by | 4 Comments

by Carl V Phillips

I’m back.  Sorry for the long absence — for obvious reasons, the blog loses out to paid work, family vacation, and (the only bit that is actually of interest to you) preparing a presentation for and attending the Tobacco Merchants Association meeting last week.  A bit more about TMA in a later post.  Today I want to focus on what was said about and by FDA at that meeting.

First, the good news:  In a presentation at the meeting, the head of TMA, Farrell Delman, pointed out that FDA had changed their website in a few places to make clear that the CDC estimated deaths from smoking are from smoking and not tobacco.  (I did not note which specific pages Farrell showed in his talk, but here (pdf) is one example I just found.)  As regular readers know, blaming “tobacco” or “tobacco products” for the risks from smoking is probably the most pervasive anti-THR lie.  It perpetuates the misperception that smoke-free tobacco/nicotine products create a substantial health risk.

Unfortunately, the change is not universal, but I will choose to embrace Farrell’s optimism for the moment.  We can hope that the remaining instances of the misleading “tobacco” bundling language are either dated info releases that would not be appropriate to change (the government is really not allowed to memory hole past statements) or places where they have just not yet noticed they need to make the change (like here or the sidebar here — hint, hint!).

And, of course, no doubt if you followed those links you noticed various other bits of anti-THR misinformation that still remain.  But any steps in the right direction are good news.  Pervasive myths are not fixed in a day.

Also on the frustrating side was the continued emphasis, as seen in the presentation of David Ashley, the CTP science chief, of the supposed possibility that low-risk products could lead to an increase in total population health risk by attracting new users who avoid smoking because of the risks (my liberal paraphrase of a couple of much less detailed bullet points).  Simple arithmetic shows that is impossible, but FDA has to emphasize it because it is so clearly enshrined in their enabling legislation.  This relates closely to my presentation at TMA, so I will comment more in a post about that (probably at EP-ology, but I will cross-post something here).

Back to the good news:  Mitch Zeller, the new head of the FDA’s tobacco unit (CTP) presented at the meeting and took questions.  So did Ashley.  Kathy Crosby, the new head of communications, had a prominent role in a panel.  The significance of this should not be underestimated.

During the Q&A for Zeller’s presentation, CASAA questioned CTP about the lack of consumer (i.e., the primary stakeholders in all of this) representation in their proceedings.  He invited us to submit a formal request, which we will send today or tomorrow.  It appears certain that this will give us a chance to present the consumer views to CTP in a special meeting.  It is less certain whether we will have a spot on the agenda for future hearings where other stakeholder presentations (industry, etc.) are included, but we are making every effort to ensure that consumers are given a place at the table.  We will keep you posted (and might recruit you to support our request should it seem useful).

In his presentation, Zeller made clear that the top priorities for the CTP currently include the “deeming regulation” that would bring e-cigarettes and some other products under FDA jurisdiction.  (Contrary to what you sometimes read, they are not currently regulated by FDA as a tobacco product, but probably will be.)  Whether this is done in a way that makes e-cigarettes better (i.e., serves the consumers’ interest, as FDA regulation is supposed to do) or in a way that threatens innovation or their very existence (serving the interests of the anti-tobacco extremists, who want to prevent harm reduction) remains to be seen.

Another stated priority is to get through some of the backlog of applications.  Unfortunately this does not matter much for real consumer interests, since as far as we can tell the overwhelming majority of these are just “substantial equivalence” applications by cigarette makers who just want approval for some insignificant change of their products.  It does not appear that there are any “MRTP” applications pending.  (That is the misnamed category that would allow harm reduction claims about a product — it is “modified risk tobacco products”, though the products that really matter are not modifications of existing products, but entire categories that have always been very low risk compared to smoking.  The misnomer itself is an anti-THR lie because it is designed to hide the fact that different categories of products have hugely different risks, though that is not the fault of FDA, but rather of the ANTZ that wrote the legislation that created CTP and their mission.  At least lawmakers changed the ANTZ’s proposed wording that would have completely forbidden any claims comparing low risk products to smoking, an obvious attempt to prevent THR.)  We believe there is at least one MRTP application in the pipeline, though unfortunately it is not for a low-risk product.

And on a less recent note, many of you may recall that FDA rebuffed attempts by the ANTZ at University of California San Francisco to make CTP their own private activist organization by threatening to boycott if stakeholders (in that case, industry) were allowed to even present their views.  (Though, of course, they showed up at the hearing to announce they were not showing up at the hearing.  We cannot expect them to be honest even in their protests, after all.)  CTP did not make any public response to this attempt to subvert the American political system, but they clearly did not give in.

I guess the bottom line is that we are in far from a perfect world, with regard to THR-related regulation, but it looks like a much better world than existed a year ago.

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ANTZ and the mirror-image delusion

Posted on 17 February 2013 by | 3 Comments

by Carl V Phillips

Last week there was a flurry of discussion about a call by UCSF’s ANTZ queen, Ruth Malone (and endorsed by that institutions chief ANTZ liar, Stanton Glantz), for a boycott of FDA proceedings that involved a dialog with tobacco companies.  The demand that actual stakeholders be excluded from policy, in favor of just leaving it to the self-appointed busybodies, is so utterly insane that I am not even going to bother to respond to it.  Others have done so.  And I certainly do not want to try to talk them out of the boycott like others have — if they want to let their megalomania and obsessions lead them to stay out of the discussion, but all means let them.

But the discussion surrounding this has starkly illustrated one particular delusion that seems endemic among the ANTZ, something that is common among non-thinking fanatics, and can be observed in various areas where people let their ideology determine their “facts”:  the belief that the one’s opponents are just like oneself, only in support of an opposing ideology, the mirror image delusion.  As a genuine delusion, this is not actually a lie, though it is the cause of numerous lies.  (Recall the position of this blog that actively affirming a false claim out of ignorance is still a lie if there is an explicit or implicit claim of expertise; even if you view inexcusable ignorance as different from a lie, there is still the lie about the expertise.  But this does not represent a claim of expertise.)

The clearest example of the mirror image delusion is that the ANTZ do not hesitate to corrupt scientific inquiry, lie about scientific results, and otherwise produce stinking pools of junk- and pseudo-science, and so they assume that their opponents have the same lack of concern about good science and ethics.  The calls by Malone and company to forbid stakeholder involvement are obviously transparent attempts to keep everyone but their fanatical minority out of the policy process.  But they attempt to justify the claim with something they seem to actually believe:  that the tobacco companies, and even the consumers (see, e.g., the previous posts about Glantz trying to censor consumers’ own testimonials about their success with THR), are liars.

The reality, of course, is that both the tobacco industry and THR consumer advocates conduct high-quality scientific research which is basically never challenged by the ANTZ.  Despite how glaringly clear this is, and despite the fact that the ANTZ surly must be aware that they never, in fact, find any evidence of lying or even aggressive spinning by the tobacco industry and other serious researchers and commentators, for many ANTZ these claims seem to be more than a mere tactic.  They seem to really believe them.  The only apparent explanation is that the ANTZ’s delusion leads them to assume that the people they are attacking must be as dishonest as they are, despite no evidence to support that claim.

One of the reasons the ANTZ never challenge the accuracy and honesty of their opponent’s research and analysis is that they would lose.  They have no ground to stand on.  As far as I am aware, no ANTZ has ever even tried to refute the arguments presented in this blog, and that is perfectly typical of their behavior.  However, I believe that another explanation is that they really do not think there is any point in disputing a claim because they do not pay any attention when someone disproves one of their claims, and they (falsely) assume their opponents act the same way.  I, and most of us in THR, would withdraw a claim (whether it be a scientific claim, an analysis that shows someone is a liar, or anything else) if it were shown to be wrong or even merely seriously disputable.

But the ANTZ basically never withdraw anything they have ever said, no matter how obviously false, and their mirror image delusion means that they are incapable of understanding that others act differently.  That is, they do not fail to debate merely because they would lose the debate (they would, but they often clearly are so clueless that they do not realize that), but because they live in an echo chamber and ignore everyone else, and so think that is true of everyone else also.

Another example relates specifically to their attempts to censor the stories of ex-smokers who have successfully used THR.  They claim that somehow all of the consumers reporting this evidence are corrupt and are only doing it on behalf of “industry”.  This seems to reflect several different bits of mirror image delusion.  Most of the ANTZ would never take the time to do anything they were not being paid for, and are themselves often doing the bidding of their paymasters.  For many, their delusions make them incapable of understanding that consumers and the rest of us who are genuinely concerned with public health do not behave that way.  Even more important, they know that most of the “public health” people who repeat the ANTZ lies are unthinking useful idiots who are acting entirely due to the manipulation by others (i.e., by the ANTZ leaders), and so they assume it must be true of the consumers too.

Perhaps most important, returning to the topic of junk science, the ANTZ do not actually care what information their “research” provides, and so they assume the same is true for their opponents.  They do not care whether or not a study shows some genuine reason to be concerned about a health effect; they just want to cook up results that seem to show a bad effect in order to support their ideology.  Their mirror image delusion prevents them from understanding that actual stakeholders — the people who have some real stake in THR, as opposed to the busybodies who have no stake and so are happy to sit on the outside and lob bombs at it — care quite a lot about the science.  Their failure to grasp this obvious non-similarity means that they assume that our scientific analysis must be like theirs — an attempt to support an ideology, rather than an attempt to understand and perhaps improve people’s health.

I suspect there are other good examples.  If any come to mind, I welcome them in the comments.

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Political philosophy is not a matter of personal opinion

Posted on 24 September 2012 by | Leave a comment

posted by Carl V Phillips (with help from Julie Woessner)

I was not going to follow up on yesterday’s post about how normative statements can be lies, but Elaine Keller called my attention to this comment on the lies by Glantz that helped anchor that analysis.  It brought up a particular additional point on the subject that is worth making.

We see a lot of false statements about natural science because people do not understand the material.  [Note: natural science is basically the study of anything that would exist even if human society did not, and social science is the rest.]  But we see false statements about social science because of that but also, somewhat ironically, because people think they understand it better than they do because it does not use so many words they have never heard.  Moreover, discourse on both social science and political philosophy further suffers from sounding similar to topics where everyone is entitled to his or her own opinion (personal preferences and morality), which causes some people to make the mistake of thinking that their opinions are worth something even when the statement cannot be based on personal opinion.  Today’s example is a good illustration.

As I pointed out yesterday, Glantz wandered close to the neighborhood of avoiding his lie about what should be done (based on some accepted norm), replacing the lie with a true statement that he just has an extreme idiosyncratic view and his normative claim is based on that.  He did not get anywhere near close enough, but there was actually a hint there that he understood that he was basing his claim on a particular extremist viewpoint and not on anyone else’s measure of what constitutes the good.

Not so the anonymous commenter who, by comparison, managed to make Glantz’s grasp on reality look quite good.

We have every right to ban the unregulated use of any delivery method for a toxic recreational drug that has any potential to harm others whatsoever.

Yes, some idiot[*] really wrote that.  “We have every right to ban”.

[*Note: If you think I am being too hard on this guy, you can read the rest of the comment and see that I am not; I am just focused on one of several very stupid statements.  In fairness, this commentator, unlike Glantz, is not claiming to be an expert of any sort.  Still, anyone with grade-school level civics behind them should not have made the error in question.]

I will leave more in-depth analysis of such idiocy to those who write about liberty in the context of substance use.  (If you are interested in that topic but not sure who to read, start with Snowdon and branch out from there).  Suffice to say that a core part of post-Enlightenment Western political philosophy is about the rights of the individual to be free from tyranny and the very limited ways in which society should intervene in spite of those rights.  Notice that the word “rights” only shows up on one side of this equation, and it is not the nannying side championed by that writer.

Moreover, we can look at the specifics of the issue at hand.  Recall the context:  Glantz asserts that e-cigarettes should be banned anywhere that smoking is banned.  But there is no question that smoking bans are an extreme exception in the context of rights.  Smoking is one of the very few things that is not banned outright (like, say, punching someone in the face) but that private businesses (in many jurisdictions) cannot freely allow on their premises if they so choose, even if they make sure that everyone present is aware of that fact and even if all are required to explicitly declare they accept the situation before entering.  Indeed, most things that are banned outright are allowed under carefully constructed private agreements (you can enter into a contract to allow someone to punch you in the face, or hire someone whose job description includes allowing that to happen).  It is difficult to think of another example — outside of the rest of the Drug War and bans on sex work — where core freedoms are so thoroughly abrogated as with smoking bans.

But, of course, the likes of Glantz have been telling us for years that there is something unique about smoking.  There is a bit of merit to this.  For the many people who object to the smell of cigarette smoke, smoking is among the worst aesthetic insults someone nearby is likely to inflict, up there with talking loudly on the phone, blasting music, never bathing, or making racist/homophobic/anti-Islamic/etc. comments.  Private employers, hosts, etc. very often disallow all of these in the venues they control — as is their right as private actors — but are also free to allow them.  Indeed, some entities would have a hard time prohibiting the last on the list if they wanted to.  So smoking bans already defy normal notions of rights.

Then there is the health argument.  But there, the claims go, smoking is absolutely unique.  If you believe the common claims, it is several orders of magnitude worse than the next-worst thing that people inflict on their neighbors.  And even setting aside the exaggerations, it is still plausible to claim that it is an order of magnitude or two worse than any other common neighbor’s-health-affecting activity other than driving.

But even with all of that, the ethical case for taking away the rights of individual actors to decide whether to allow the exposure is very dicey.  It is quite controversial among the populace and even more so among people who seriously study such matters as rights.  Thus, it is obviously absurd to claim “every right” to ban something else that has a comparatively trivial impact.  There is no such right.  In fact, every notion of rights in our society cuts in the other direction.

This example illustrates that someone can be unambiguously lying when making claims in a non-scientific field.  It is possible to make a statement in political philosophy or some other area of ethics that is clearly false as a false scientific claim.  Someone saying “I personally think it is ok to….” is not a lie.  But misrepresenting the entire basis on which our society is built?  I would have to say that this is a rather worse lie (and a rather worse commentary on our educational system) than merely falsely claiming that something causes cancer.

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Stanton Glantz is a liar (as if that’s news)

Posted on 21 September 2012 by | 8 Comments

posted by Carl V. Phillips

Recently the Stanton Glantz, of the anti-tobacco activist organization that goes by the misleading name, “University of California San Francisco”, jumped fully into anti-THR lying.  Many of you will know Glantz as one of the most unabashed anti-smoking liars[*] in the world.

[*In fairness, unlike with some of the others featured in this blog, there is some debate about whether Glantz is knowingly lying or is just so clueless that the lie the fact he is claiming to be expert in the matters he is spouting off about.  There is also the possibility that he falls into the "so incompetent that he does not even realize he is clueless" category.  It is not clear which would be better.]

Glantz is the most aggressive pusher of absurd claims that small reductions in second hand smoke exposure (e.g., merely banning smoking in bars) result in 10% or 20% or even 40% reduction in heart attacks in the population.  That should perhaps be thought of as an final exam question rather than a serious claim:  If you think the claim is even remotely plausible, then you should have your diploma revoked — your high school diploma.

Glantz’s other favorite is claiming that if there were no smoking in movies then 50,000 or 100,000 or even 200,000 fewer American youth would start smoking each year.  I suppose someone might believe that and still deserve their diploma — but only if they were monastically home schooled.  Anyone who has actually spent time around teenagers and still believes that also fails badly.

In a recent blog post, Glantz referred to the German study that measured the gasses released into the air from e-cigarette use, the study whose conclusions Elaine Keller thoroughly debunked previously on this page.  Since we have already covered the debunking of the claims made by the authors, and showed that their results did not suggest there is a hint of a risk of hazard from “second hand vapor”, I will not repeat those points.  The previous post stands as a pre-debunking of what Glantz just wrote and thus is all the more embarrassing for him.  (Chances are he never read it; people like him have no interest in the truth, and so do not read to learn.)

I refer to you back to our debunking with this quote from Glantz’s statement:

putting detectable levels of several significant carcinogens and toxins in the air

Glantz — like the study’s authors — apparently does not realize that “so utterly trivial that it cannot possibly be viewed as being worth worrying about” is a subset of “detectable”.  In this case, that is exactly what was found.

But Glantz’s lies and errors were not limited to not understanding that the study helped confirm there is nothing to worry about.

there were still elevated levels of acetic acid, acetone, isoprene, formaldehyde and acetaldehyde, averaging around 20% of what the conventional cigarette put into the air

We have already covered much about this (hey! progress!) in previous posts with the tag “chemicals”.  Though, I am not sure we ever mentioned that more of that evil acetic acid he is so worried about is emitted by a salad than by an e-cigarette (most people call it vinegar).

To cover some new ground, consider that “20%” figure.  First, this is presumably intended to trick the reader into thinking that the trivial emissions from an e-cigarette are roughly 20% as bad as those from smoking.  But, these particular chemicals are not the ones that create much worry (whether well-founded or not) about environmental tobacco smoke.  It might also be that the emissions are about 20% of the exposure to those chemicals resulting from a nearby explosion of an artillery shell.  But that obviously does not make an e-cigarette 20% as bad as environmental artillery exposure.

But it is worse than that.  Let us imagine that the absurd falsehood that Glantz was (presumably intentionally) communicating were true, and that environmental vapor exposure were 20% as harmful as ETS.  Consider his conclusion (grammar muddle and incorrect reference to vapor as smoke in the original):

No one should smoke e-cigarettes indoors that are  free of other forms of tobacco smoke pollution.

This claim (the claim being the “should”) is obviously false.  If there is any rationality to no-smoking policies at all, then there are some venues where smoking clearly should be banned, but others where it is just barely on the positive side to have a ban (and, further along the spectrum are those where it is on the negative side to ban).  So if you now consider vaping, which produces virtually no aesthetic impact and only (even under this absurd hypothetical) 20% the risk from ETS, then clearly the venues that are just on the positive side for a smoking ban are not on the positive side for a vaping ban.

This is the most basic Economics 101 of honest and rational policy.  Of course, Glantz et al. are neither honest nor rational.  They are merely pushing any policy that inches toward prohibition.  But by pretending to be having an honest policy discussion, he opens himself up to honest policy analysis, and that analysis shows he is wrong (though probably merely clueless about what he is saying rather than lying in this case).

After receiving quite a few criticisms of his call for vaping bans by people with a better command of reality than his, Glantz responded to one observation, made by Elaine (and others too in other forums).  She pointed out, as in the previous post on this page, that the concentrations of the chemicals from exhaled vapor, even in a small unventilated space, were in the range of a fraction of 1% of the exposure limits that OSHA sets for workers.

Glantz, out of dishonesty or cluelessness, responded as if Elaine were saying, “these exposures sneak in under the OSHA limit and so that alone makes them ok”.  He argued that it is acceptable to expose workers to possibly mildly hazardous levels of chemicals because that is part of their job, and so exposure to bystanders should be held to a more restrictive standard.  His point is reasonable, but is not actually a response to the criticism.

Elaine was not saying “these are lower than the OSHA standards and that alone is what makes them unimportant”.  She was saying, in effect, “for those of you (basically everyone) who have no idea what these X ppb numbers mean, here is some perspective,” and saying, “this is so clearly below worrisome levels that OSHA allows more than 100 times that concentration before they require remedial action.”  So even if OSHA were allowing 10 times the harmful level (which they very much try to not do) there would still be a 10-fold margin before the measured exposure from vaping was harmful.

The absolute best part of this, though deserves its own post, but is a bit off-topic here, so I put it here.  If you found this interesting you will definitely want to read that.

Finally,

No one should have to breathe these chemicals, whether they come out of a conventional or e-cigarette.

What if they come out of an air freshener, which intentionally puts some of these chemicals into the air?  What if they come from a kitchen, a reliable source of some of them?  What if they come from cosmetics?

Oh, wait, those do not matter.  Glantz only pretends to care about these chemicals, or about people.  He only cares about cigarettes, and now apparently, about e-cigarettes.

But wait.  What if those chemicals came from Stanton Glantz?  After all, we have previously observed the vaper (i.e., a human body) seems to put out more formaldehyde than the vapor.  This applies to non-vapers too, including a puritanical busybody who is not smoking or vaping.  I think this is an utterly unacceptable health risk.  Moreover, having Glantz at large undermines efforts to denormalize junk science and dishonesty in the eyes of children.  Yes, I think it is pretty clear that we need to seal him up away from other humans.

Oh, and take away his computer too.  After all, letting him blog would also represent a dangerous exposure because….  Um, because….

Damn, I am just not as good at making up fake scientific claims as he is.

 

[UPDATE 27 Sept: More on the lies and liars on this topic at Dick Puddlecote.]

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