CDC lies about ecigs and children again (wait, have I used that title before?)

by Carl V Phillips

The CDC issued a press release about children and e-cigarettes again today (which is basically just another way of repeating the title of this post). Their headline claim itself is actually true (assuming they know how to count — not a foregone conclusion): More than 16 million children live in states where they can buy e-cigarettes legally. Of course, they don’t happen to mention why this is the case, and they go on to offer other lies. Continue reading

New York Times Editorial Board lies about smokeless tobacco labeling

by Carl V Phillips

The New York Times Editorial Board has come out against allowing the “warning” label changes that Swedish Match requested in their MRTP application. They probably did not set out to actively mislead their readers like, say, ANTZ “researchers” do. But when they summoned up all their expertise and experience as, um, reporters on politics and current events, somehow they got this bit of scientific analysis wrong. Shocking. Their lies appear to be the “claim to be expert on something you do not actually understand” type, though I suppose we cannot rule out that they were intentionally trying to mislead. This is combined with them clearly not having a clue about who to believe in this arena. (Hint: The industry tends to be almost impeccably honest and maximally knowledgeable when it comes to the science. Regulators fail on both those counts. And the vast majority of academic “researchers” in this area do not even try to be either honest or knowledgeable.) Continue reading

Don’t annoy us with the facts, we got us some regulatin’ to do

by Carl V Phillips

Sometimes parody is hard. For example, in their page requesting public comments associated with their upcoming workshops on the science of e-cigarettes, FDA states (repeating what they said in their Federal Register notice on the matter):

[T]he workshops are not intended to inform the Agency’s deeming rulemaking. The workshops are intended to better inform FDA about these products. Should the Agency move forward as proposed to regulate e-cigarettes, additional information about the products would assist the Agency in carrying out its responsibilities under the law.

Continue reading

What is peer review really? (part 4a – case study followup)

by Carl V Phillips

I thought it would be worth taking this series non-linear to follow up on Part 4, which used the recent Popova-Ling “peer-reviewed journal article” as a case-study to illustrate much of what is wrong with journal peer review and the fetishizing thereof in “public health”. Popova and Glantz relied on that paper in the comment to the FDA that I discussed in yesterday’s post about Swedish Match’s MRTP application, which asks permission to remove the false and misleading “warning” labels from their products. This is a great illustration of why the fetishization, “it is in a peer-reviewed journal, so it must be right”, is such a dangerous travesty. (H/t to Brian Carter inspiring some of the observations that appear here.) Continue reading

More on the FDA and MRTP

by Carl V Phillips

In the previous post, I linked to CASAA’s comment to the FDA re Swedish Match’s MRTP application, wherein they ask to be able to change the “warning” labels on their smokeless tobacco products to not “warn” about risks that do not exist and to move a bit(!) closer to communicating the low risk of these products as compared to smoking. Clive Bates also weighed in on this, via this post and his own comment to FDA on the application. It is worth following up on some of his points and some others. Continue reading

CASAA comment on Swedish Match’s MRTP application

by Carl V Phillips

As most readers probably know, the FDA tobacco regulation include the “modified risk tobacco product” (MRTP) process, through which a manufacturer can apply to be able to make risk claims about their products (which basically boils down to: can communicate that they are lower risk than standard cigarettes). It has always been clear this process is (a) misnamed (nothing has to be modified to make this true) and (b) silly (when it is obviously true, why is this even necessary?). What has not been clear is whether FDA intends for it to work at all, or whether it just lets them pretend to offer an option and a formal process while just imposing whatever rules they want, as seems to be the case with the “substantial equivalence” process. Swedish Match has decided to invest an enormous effort in finding out, filing the only MRTP application that FDA has considered. (There have been a few other applications in the past but FDA refused to consider them, including at least one case where they basically changed their own rules to avoid doing so and then changed them back again later.)

Swedish Match filed over 100K pages (!) to basically request permission to stop printing false and misleading warning labels on their snus in the USA. They wish to remove the two currently mandated warning labels that are clearly unsubstantiated (that the products cause oral cancer and dental diseases) and change the grossly misleading “not a safe alternative to cigarettes” warning to say, “No tobacco product is safe, but this product presents substantially lower risks to health than cigarettes.” FDA asked for comments on the application, and CASAA submitted our assessment of the implications of the label change, which you can read at our main blog at this link.

 

New Phillips-Nissen-Rodu working paper

by Carl V Phillips

Those of you who read this blog might be interested in the new working paper by myself, Catherine Nissen, and Brad Rodu that I just posted at my other blog. It is not about THR per se, but it is closely related and has key THR aspects. Mostly it shows how the almost the entire enterprise of smoking cessation — as both an individual or policy matter — is misguided because of a few identifiable points of confusion, and a bit about how to fix this. (Yes, that is a rather ambitious characterization. You can tell me if you think it is wrong.)

This works in practice, now we just need to see if it works in theory

by Carl V Phillips

The title refers to a classic joke about economists, describing a common practice in the field: Something is observed in the real world — say, the collapse of the Greek economy, insurance prices dropping under the ACA, or people lining up to buy new iPhones in spite of already owning perfectly good old iPhones — and the theoretical economists scramble to figure out if their models can show that it can really happen. In fairness, that way of thinking is not as absurd as it sounds. Developing a theory to explain an observation is good science, so long as it is being done to try to improve our models and thus better understand reality and perhaps make better predictions. Obviously, the ability or inability to work out the model does not change what has happened in reality. Continue reading