Worth reading: Carl Phillips testimony at the FDA tobacco center meeting

reprinted from Epology

My testimony at today’s FDA tobacco center meeting

Today I departed from my usual practice of fiercely avoiding any “science by committee” setting or engaging with government overlord-types, and gave some testimony at the Center for Tobacco Products TPSAC meeting. Greg Conley and Bill Godshall talked me into make the trip as an advisor to the tobacco harm reduction advocacy group CASAA. It was worth it — there were several great presentations by harm reduction advocates in the “citizen comments” that our public mastersservants grudgingly allow because they have to. Greg recruited several people who had quit smoking by switching to low-risk products, and there were great THR presentations also by Greg, Bill, Elaine Keller, Jeff Stier, Gil Ross, and others. I was pretty pleased with mine too, given that I wrote it while sitting through the talks earlier in the day (something to do during the tedious and pointless presentations by the well-paid consultants and others who were invited to speak by the hosts).

To appreciate my talk, I need to offer some background (which kind of spoils the freshness, I know, so if you are familiar with all this, you might want to skip right to the text of my talk).

Background for those who know nothing about CTP etc.: The US FDA was fairly recently given authority over tobacco products. The unit that formed is dominated by dedicated anti-tobacco extremists who are opposed to harm reduction, and its external scientific advisory group (TPSAC) is stacked with extremists and junk scientists, and contains no harm reduction experts even though most of their role is to evaluate harm reduction products. There is a serious threat that FDA will substantially restrict, one way or another, low-risk alternatives to cigarettes. They are particularly notorious for playing the chemophobia game, obsessing (or pretending to obsess) about detectable chemicals in products, implying that these have health effects even though the evidence about actually effects suggests otherwise. No doubt they are annoyed about having to deal with public comments, because (in a complete perversion of the term) they consider the stakeholders to be the busybody activist groups and not include the actual primary stakeholders, the product users. Public comments also are a challenge to their preferred way of dealing with information they do not like, which is to declare it to not exist and claim we do not really have any information (they still do that, of course, but they probably momentarily feel worried that someone is going to realize they are bullshitting). Indeed, the defining characteristic of this whole process seems to be to pretend that evidence about THR does not exist, because it is not exactly the “right” form of evidence, or is not collected by the “right” people, or whatever. That is the same old game used by the anti-harm-reduction extremists for a decade, but now it is official government policy.

Bits of background on this meeting: Today’s meeting was dedicated to dissolvable tobacco products, smokeless tobacco mixed with confectionary which dissolve in the mouth. These face particularly great existential threat from the regulators, probably because they compete with the almost identical products from the pharma companies who many of the extremists carry water for. The citizen comments period allowed for only 16 of us, and only for 3 minutes each — “government for/by the people” in action! It was quite clear from various comments and questions from the floor that many members of the committee did not understand key points about THR, despite supposed expertise and a year on the committee, and even more clear that they had never talked to any actual product users. (They appeared genuinely astonished to hear one of the presenters say that he has kept using an e-cigarette, even though he is sure he could quit, because he likes it.)

In yesterday’s session, the committee had been offered a lesson in the Swedish experience, about how smokeless tobacco use had caused the world’s best reduction in smoking and had been shown to have trivial health risks. They then tried to make up every possible reason about why that is not a good reason to encourage (i.e., allow) the marketing of new smokeless products in the US — because that is just not the same thing, so we really have no idea whether something similar could happen. Oh, and there was a trumped-up obsession with how children might get poisoned by these products (never mind that it had never happened, or the question of why they should be worse than existing pharma products that are almost exactly the same but much easier to unpackage, or other medicines) and resulting tangents about safe packaging.

Anyway, since (a) I figured several of the other presenters were already covering any basic information that I could communicate in 3 minutes, (b) Bill submitted 200 pages of written testimony (which they clearly did not read), and (c) the members of the Center and committee have had months to learn things, and if they did not already know them it was not because they had not heard them. In short, they either already knew what I could tell them as a THR expert, or the reason they did not know is that they were intentionally ignoring the information. So, I decided to go a different direction with my testimony. Here it is (in full — 3 minutes is a very short time):
I speak today as an educator with an interest in the nature of science and its role in the functioning of our society, and from that perspective would like to say, “won’t someone please think of the children?”
If an impressionable young mind stumbled across how science is often portrayed in this corner of our nation’s government, he would be at risk of never becoming scientifically literate, let alone to wanting to be a scientist.
First, science is supposed to be an honest truth-seeking process that attempts to figure out the best possible answer to a question, often via methods that require innovative thinking. Our impressionable young mind, however, might come away:
-believing that science consists of just a few narrowly-defined recipes, rather than taking in all the information we have in myriad forms, available from many forums, and thoughtfully making the best use of it;
-believing that health science focuses on looking only under streetlamps and obsessing about easy but not directly informative work like chemistry, rather than trying to do the more difficult work to translate this and other information into what we really want to know about health effects;
-from today’s session, he might believe that science involves such methods as manipulating children into giving the answers you want, speculation-laden anecdotes, limiting reviews of the evidence to exclude any evidence that you wish did not exist, and counting unsupported assertions by authors as evidence;
-and he would be taught that science it is not about identifying how we maximize our knowledge, but that it is involves declaring that we just do not know anything, when in fact we know quite a lot.
Our impressionable young mind is not going to think very highly of science, and he might reasonably conclude that the best way to get involved America’s version of science is to go to law school. And, yes, that means that misguided ways of looking at science may be a gateway to more dangerous behaviors.
Second, this poor child would get the impression that a hypothetical cardiovascular condition or cancer 40 years from now will be just as harmful as a near-term case in a current smoker, a case that was caused because smokers are discouraged from switching to low-risk alternatives. Do we really want to tell that child that we expect so little of him, that his generation’s health science will be so lousy that the 40-year-out cancer will be no more treatable that it would be today?
Finally, at the very least, I would urge this committee and Center to make sure that any such anti-scientific writing is kept in child-proof packaging, rather that being left laying around on the internet where anyone could stumble across it and damage their developing minds.
In case you are wondering, still more background re that third bullett (explaining the joke does not make it funny, but it can clarify): The “manipulating children” refers to the the Indiana Health Department who presented there and are the darling of the anti-tobacco extremist nutcase faction; their infamous “study” consisted of assembling some children, mixing dissolvable tobacco products (which the children had never seen or heard of before) in with some candies, and asking the children what they thought they were looking at. Obviously, they “discovered” that the kids thought the dissolvables were candies like the other items they were presented with. This is what passes for evidence for these people. I suspect it would be possible to convince the kids that the dissolvables were cats if you worked at it.

The “anecdotes” point refers to someone who presented statistics about thousands of tobacco poisonings which were meant to imply that dissolvable products were dangerous, but in fact showed the poisonings were from other products. Perhaps realizing how worthless her data was, she threw in a single story about a mild poisoning that might have possibly maybe been the result of dissolvables that someone had unpackaged and left around, maybe. The “unsupported assertions” referred to a really stupid report presented by someone from RTI (for which they probably got paid a fortune of our government’s money) reviewing some of the studies on the topic; the report highlighted whatever random conclusions the authors asserted, regardless of the fact that most were unrelated to the evidence reported in the study. In other words, they did work at the level of a bad MPH student (which I suspect is exactly what most of the researchers were). The “limiting reviews” referred to that RTI report, in which they every-so-conveniently had reasons to not include all papers not written by opponents of harm reduction, as well as similar behavior in all the other reviews of the day.

Unlike some of the other presenters, I did not get any questions from the committee. What could they say? The one question/comment I thought might come was something like “do you think this committee is some kind of joke”. I was prepared with an answer — “well, if you really cannot understand the seriousness of what I was communicating, then, I guess the answer is yes”. Alas, no one asked the question.

But I still wonder how many of them even began to understand what I was saying. I know that many of my THR-expert colleagues got it, but I kind of doubt a sufficient level of intellect is common among the officials and committee members. Long-standing science committees are generally populated by political hacks and former scientists who cannot or do not want to think hard any more. I was told that the top FDA guys looked like they were amused at least part of it (but whether that is a good sign or just a smug “yes, you caught us, but who cares — we are still the ones in power” is not clear). I noticed that at least one committee member, Jonathan Samet, perhaps was also getting it, but he knows my style from crossing paths over the years and, though I am pretty sure he does not like me, he gets it. He a clever guy, albeit someone who has risen to seemingly dominate institutionalized American epidemiology, due to position and connections, not scientific skill, and then perverted it with politics, further damaging and already shaky field. (No mystery why he might not like me, huh?)

Anyway, I am pretty sure they missed my final bit of satire. Before the citizen comments, the chair read this ridiculously long statement about how we are encouraged to start by disclosing our conflicts of interest, who paid for us to be there, etc. This is in keeping with the “look for any excuse to dismiss what someone has to say” mentality. It is ironic, since that committee is notorious for being stacked with people with enormous conflicts of interest. Anyway, I was not about to waste time from three minutes with that, but since I spoke a bit faster than I expected, I had 15 seconds left at the end. So I added,
Oh, and no one has ever paid me for my work doing history and philosophy of science like this.
And CASAA paid the two-figure cost of me coming here.
I am guessing that they had no idea that I was ridiculing their conflict of interest obsession.

The meeting was painful, but it is good to be reminded sometimes: I generally know with how little wisdom the world is governed, but sometimes it is useful to remind myself of some of the details. It was just so absurd. The committee would ask presenters questions the presenter could not answer but which (a) everyone on the committee should have already known and (b) someone in the audience was clearly the top expert on. But we peons in the audience were not asked to solve the conundrum, because science-by-committee does not allow for stepping outside the box (or in this case, beyond the plastic chain with “no one past this point” signs that separated the audience — I am not kidding). Several of the answers were in Bill’s submission, but they could not be bothered with looking at that. My favorite was when the committee was asking about some details of what one company had reported and the speaker was not sure; representatives of that company who undoubtedly knew the answer were sitting in the room, and no doubt some or all of the committee knew that, but the people up front went around and around without being able to figure out the answer rather than actually doing the research (asking) needed.

This kind of consultation among the privileged ignorant, which never actually seeks data, passed for scientific inquiry in the Dark Ages. But dark ages never really die. They just take refuge in government and religious institutions. So try not to think too much about the children — it is just too damn depressing.

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Comments

  • Rolygate  On January 20, 2012 at 7:49 pm

    Well, at least some of those present will have been amused, Carl. Don’t take it so hard. You just have to keep on keeping on – what else is there to do?

    This is not a free society, in any way, shape, or form – but it could be a lot worse. Perhaps in fifty years time, things will change. Just think of the children.

  • Elaine Keller  On January 21, 2012 at 12:04 pm

    Carl: Many thanks for your participation in the (admittedly painful) process. Regarding Dr. li-Lun Chen’s presentation (http://www.fda.gov/downloads/AdvisoryCommittees/CommitteesMeetingMaterials/TobaccoProductsScientificAdvisoryCommittee/UCM288441.pdf):

    On slide 6 she explains the reason why there appears to be a slight increase in exposures from tobacco and from NRTs (separating out cases where alcohol was involved), but then ignores this when she tries to imply that Star entering the market in 2003 and RJR entering the market in 2009 caused a significant jump in tobacco poison exposures (slide 14). The fact that (as far as Dr. Chen knows) there was only ONE exposure due to a dissolvable during that entire 10 year period proves that Star and RJR had no effect whatsoever on exposures.

    For that matter, the graph she uses to show this upward trend is for all tobacco exposures with all ages of subjects. Theoretically the issue is supposed to be poisonings in children under age 6 by “smokeless” tobacco products. Even so, the increase from 8,000 to 8,500 represents only a 6% rise, whereas the population increased by 15% and the total number of exposures grew from 2.2 million to 2.5 million, an increase of 14% from the years 2000 to 2009.

    If you were to plot a line representing smokeless expsoure values on Slide 8, it would be obvious that the magnitude of change is a lot smaller with smokeless than with NRT. By the way, there is not a category called “Smokeless” in the AAPCC annual reports. She has every other category represented in her graphs except for “snuff”. How do we know that AAPCC would not have included an exposure to dissolvables in the category “Other Types of Tobacco Product”?

    On slide 11, she names all the dissolvable tobacco products and implies that there are cases involving all these products included in the numbers of “smokeless” exposures. The truth is that the reports do not provide a break-down to this level of detail. She stated that it would cost $1 million to purchase the dataset from AAPCC. However, she left out the information that there IS data at that level of detail for three of those 10 years, thanks to the work of our good friend Dr. Gregory Connolly. Out of that three year period there was the one case involving Stonewall, and two cases involving snus.

    The case of Stonewall orbs exposure involved a father removing all 20 orbs from the individual blister packs, putting them into a screw-cap jar, and leaving the jar in the same room with an unattended 3-year old.

    Her summary slide (16) calls for FDA to take action to reverse “this trend”. What trend would that be? One dissolvable exposure out of over 80,000 tobacco exposures? She never refers back to Slide 6 that explained why there appeared to be an increase in tobacco product exposures after 2006 nor does she point out that the growth in tobacco exposures is less than half that of the population growth and the growth in all-cause poison exposures.

    Why isn’t she calling on FDA to reverse the trend of increase in children under age 6 exposure to NRTs, that went from ~275 to about 700 during the 10 year period? This is an increase of 154%.

  • Steve K  On January 23, 2012 at 12:36 pm

    I saw the comments live, and posted a comment on Dr. Phillips blog as well. While the comments amused me, I hope they have their intended effect of getting through to people who may be on the fence. A waekup call that the science is being thrown out with the bath water

  • jredheadgirl  On January 23, 2012 at 5:20 pm

    “No doubt they are annoyed about having to deal with public comments, because (in a complete perversion of the term) they consider the stakeholders to be the busybody activist groups and not include the actual primary stakeholders, the product users.”

    Imagine that. Thanks for all that you do Paul. I’m with Rolygate…don’t let it get you down.

  • Carl V Phillips  On January 24, 2012 at 10:03 am

    Thanks Juliette and Rolygate. It does not really get me down most of the time, but I appreciated your words. Actually some of the other stuff I work on (see my posts on industrial wind turbines) genuinely gets me down. But I have settled into a slow-moving optimism about THR, I guess I would say. Perhaps that makes me a little too patient and a little too accepting, considering what is at stake and what people are doing. Indeed, I fall into the trap of the same stupid rut that the FDA-types find perfectly acceptable, in their endless fiddling while tobacco burns. But being sure that the trend is on our side makes it easier.

    I responded to Steve’s comment over at EP-ology for anyone interested.

    Elaine, nice job doing a takedown of of the stupidity. That gives me an idea for a project that might get me out of my rut…. Stay tuned.

  • Gabriel E Cigarette Enthusiast  On September 29, 2012 at 8:25 pm

    It’s painful the way the FDA takes a stance on certain products… one being smokeless products. They tend to waiver quite a bit on what they consider safe or harmful… seemingly due to their wants and/or needs. But nonetheless it’s a long-term arguement with a lot of litigation in its wake.

  • Electronic Cigarettes / Vaporizers  On December 24, 2012 at 10:18 am

    The BIG tobacco companies are posting the negatives for everyone knows that if you intake three products out of the 150 or more in cigarettes, then you are automatically be better off.

  • Electronic Cigarettes / Vaporizers  On December 25, 2012 at 10:37 am

    The FDA is a joke when it comes to the publics safety and I have no idea why they have been giving so much power. The public knows that electronic cigarettes are better for your health, but they are in the pockets of the big tobacco companies.

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