Monthly Archives: November 2014

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

FDA proudly harasses retailers for selling lowest-risk products

by Carl V Phillips

This is basically an update of this post, in which I analyzed FDA’s banning of new flavors of Ariva/Stonewall products by declaring them “not substantially equivalent” to the previous flavors. But I thought it deserved a post of its own.

You will recall that I noted (a) that the banned products were from a family of products that might well be the lowest-risk products on the market, (b) the stated reason for the ban was that they contained more (presumably an inconsequential amount) of one chemical, and (c) if a bit more of one chemical constitutes “not substantially equivalent” then basically nothing is ever substantially equivalent.

Today FDA proudly announced that they are also harassing retailers who still have some of the banned products still on their shelves (and posting their names and addresses, no less). The manufacturer has presumably stopped shipping these products, but these products are slow-moving (they never really caught on, despite having some dedicated adherents and probably being ultra-low risk) so it is not surprising that retailers still have some on the shelf.

You might think that an agency whose job it is to protect the public’s health would not spend government money (and waste perfectly good product) by hassling retailers who are innocently selling off their remaining stock of a very-low-risk product, probably completely unaware of the ban. Moreover, you might think that a regulatory agency in charge of this would know who actually manufactures the products (they list Star Scientific Inc. on the webpage, but Star got out of this business a while ago and sold the brand to a new company started by their former employees).

You would be wrong.

What is peer review really? (part 6)

by Carl V Phillips

A quick finish to the theme I was working on in the last post in the series, before moving on to a definitive example of the failure of journal peer review in public health. Recall from that post Myth 2: Health science reviewers have the skills and incentive to do the job they are assumed to be doing. I expanded a lot on Submyth 2a, about how they are often simply not qualified. Here I look at the other half of this:

Submyth 2b: Journal reviewers have an incentive to do a good job. Continue reading

What is wrong with ecig particulate claims – the simple version

by Carl V Phillips

One of the two blogs (excluding this one — I will leave that judgment to others) you should read every word of, if you are interested in understanding the sciences surrounding THR, is Clive Bates’s. So I suspect most of my reader have already seen this impressive piece he wrote about the series of nonsense claims about e-cigarettes producing dangerous exposure to tiny airborne particulates. However, I found myself thinking “that is so long and goes into so much detail that I think the point might be lost.” You know that you are being wordy if you provoke that from me! :-) Clive joked that I was going to write a haiku version of it, but I don’t think I could pull that off, so here is merely a shorter summary of the main point and an additional fatal flaw that he did not address. Continue reading