Category Archives: Science lesson

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

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

What is peer review really? (part 9 — it is really a crapshoot)

by Carl V Phillips

I haven’t done a Sunday Science Lesson in a while, and have not added to this series about peer review for more than two years, so here goes. (What, you thought that just because I halted two years ago I was done? Nah — I consider everything I have worked on since graduate school to be still a work in progress. Well, except for my stuff about what is and is not possible with private health insurance markets; reality and the surrounding scholarship has pretty much left that as dust. But everything else is disturbingly unresolved.) Continue reading

Extraordinary claims

by Carl V Phillips

Fairly often (e.g., in the previous post) I make reference to the concept that extraordinary claims require extraordinary evidence. That is, if something seems extremely unlikely based on a great deal of accumulated knowledge or an understanding about how the world works, and you wish to claim it is true, you really need to have done some tight work. It is a good principle in science. Research does not produce scientific knowledge without adherence to principles like this (note that there are no “rules” in science, so we have to make do with evolved principles).

Today I am thinking of that in terms of a new study that was reported in this BBC story, “E-cigarettes ‘help more smokers quit'” (quotes from there). Continue reading

Sunday Science Lesson: Misconceptions about the gateway effect

by Carl V Phillips

Disturbingly close to 100% of writings about whether there is a gateway effect among tobacco products, particularly about e-cigarettes being a gateway to smoking, are nonsense. That includes most metas on the topic, where someone tries to explain what mistakes others are making. Perhaps addressing a few simple misconceptions can clear some of this up (and it is a favor to a few of my tweeps — I hope I have addressed all the points our conversation left hanging). I have written about all of this much more extensively and comprehensively (see this in particular), but not in soundbite form. Continue reading