Simple Simon would refuse to meet the pieman

by Carl V Phillips

I prefer to write about science (or those pretending to do science, or those who cannot seem to report on it accurately) and the activities of government actors. I very much appreciate the efforts of those who take on blowhards who just pontificate their opinions, but it is just not my thing. However, every now and then, one of the blowhards says something that is really useful as social science. Case in point, a recent tweet by Australian Simon Chapman. Continue reading

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FDA’s proposed smokeless tobacco nitrosamine regulation: innumeracy and junk science (postscript)

by Carl V Phillips

For completion of this series (with this footnote), the following is what I submitted to FDA. My comment does not yet(?) appear on the public docket as of this writing. But I got a confirmation (confirmation code 1k1-8xfb-dhwh if you want to search for it later). It has a bit of extra content beyond what I already presented. Continue reading

Sunday Science Lesson: toxicology and “the chains” in American football

by Carl V Phillips

Those of you who read my series on fatal flaws in FDA’s proposed rule about limiting the nitrosamine NNN in smokeless tobacco (and presumably anyone reading this quick little tangent read those important and carefully crafted posts) might have tripped up over an oddity from the third post in the series. I quoted this from FDA’s proposed rule about how their key number, used for estimating the risk of cancer caused by some quantity of NNN, was calculated: Continue reading

FDA’s proposed smokeless tobacco nitrosamine regulation: innumeracy and junk science (part 3)

by Carl V Phillips

In Part 1 of this series, I described FDA’s proposed rule that would require smokeless tobacco products (ST) to have no more than 1 ppm of NNN (a tobacco-specific nitrosamine or TSNA) dry weight. I discussed some of the political and policy implications of this, and reasons why the rule will probably not survive. I also noted that almost no current products meet that standard, and that American-style ST probably cannot meet it. Despite the proposed rule probably being mooted, I noted there is still value in examining just how bad the ostensibly scientific analysis behind it is. In Part 2, I noted that the FDA’s estimate the standard would save 115 lives per year is premised on their estimate for the risk of oral cancer caused by ST use. But, in fact, the evidence does not support the claim that ST use causes any oral cancer risk. I then focused on why, even if one believes there is some such risk, the method used to calculate FDA’s quantitative estimate is utter junk science. Continue reading

FDA’s proposed smokeless tobacco nitrosamine regulation: innumeracy and junk science (part 2)

by Carl V Phillips

In the previous post, I gave some background about the new proposed rule from FDA’s Center for Tobacco Products (CTP) that would cap the concentration of the tobacco-specific nitrosamine (TSNA) known as NNN allowed in smokeless tobacco products (ST). Naturally, I think you should read that post, but to follow the scientific analysis which begins here, you do not need to.

Before even getting to the even worse nonsense about NNN itself, it is worth addressing CTP’s key premise here: They claim that ST causes enough cancer risk, specifically oral cancer, that reducing the quantity of the putatively carcinogenic NNN could avert a lot of cancer deaths. Continue reading

FDA’s proposed smokeless tobacco nitrosamine regulation: innumeracy and junk science (part 1)

by Carl V Phillips

I am a bit late to analyze this proposed FDA rule, which was promulgated on Inauguration Day. But it is still open for comments, and I will be submitting these posts (though for reasons I will get to shortly, these and all other comments are probably moot except as for-the-record background).

Before getting to the substance it is worth noting that this is really the first bit of genuine regulation proposed by the FDA Center for Tobacco Products (CTP) in its eight years. Despite CTP reportedly approaching $4 billion in cumulative expenditures, it has only implemented a few inconsequential rules that were specifically required by the enabling legislation, and has never actually created a standard or specific requirement like a real regulator. Instead, everything it has done has been what I have dubbed weaponized kafkaism. The variation on the word “kafkaesque” refers, of course, to Kafka’s horror stories of bureaucratic (in the pejorative sense) rules that create injustice via impossible procedural burdens. “Weaponized” refers to turning something that is harmful but not malign into a tool for intentionally inflicting harm. CTP has turned filing and paperwork hurdles into a weapon. Continue reading

Time to stop measuring risk as “fraction of risk from smoking”?

by Carl V Phillips

I ran across a tweet touting a press release out of the Global Forum on Nicotine (GFN) meeting (a networking meeting, mostly of e-cigarette boosters) that made the claim that snus is 95% less harmful than smoking. This was variously described as being based on “new data”, “new data analysis” and “the latest evidence”, but with no further explanation of where the number came from. Since the presenter was Peter Lee, those of us who know who’s who can surmise that it is a statistical summary of existing published studies, because that is what Peter does. There is nothing necessarily wrong with that (though for reasons I will explain in an upcoming post, it is potentially suspect in this context). but it is certainly not new data or the latest evidence.

Oh, and it is clearly wrong. Continue reading

Lying with literally true statements is the worst kind of lying

by Carl V Phillips

This is a reprise of points I have made here before, including in the mission statement of the blog. It was inspired by this recent post by Steven Raith in which he, a relative newcomer to the tobacco wars, describes his realization of just how often tobacco control’s lies consist of literally true statements. It is always nice to see people independently derive this observation, though I have been documenting that type of lie from “public health” (along with others) for most of two decades. Raith speculates that their use of such lies is increasing, but this does not seem to me to be the case; rather, once you become aware of the tactic, you notice it more. I will come back to the question of prevalence. Continue reading