Author Archives: Carl V Phillips

What is peer review really? (part 7 – an amusing aside)

by Carl V Phillips

A couple of weeks ago, a funny story came out about a peer-reviewed journal accepting a “paper” which consists of nothing but the message (in the title, repeated in the text for pages, and in two figures), “Get me off your fucking mailing list”, laid out in the format of a research paper. The authors had created this to reply to the plethora of spam that scholars get, inviting them to submit papers, attend conferences, etc., and had been using it for a few years. So imagine their surprise when, after sending it in response to journal spam, they got the reply that it had been accepted for publication after it was favorably “peer-reviewed”. They merely needed to pay the $150 publication fee. (The rest of us were shocked that they apparently decided to not pay the fee and get the paper published. I mean, come on, how could you resist?) Continue reading

Burstyn comments at FDA workshop on ecig science

by Igor Burstyn

[Editor’s Note: As I mentioned previously, FDA refused CASAA’s application to have Igor appear on the agenda of the FDA workshop on e-cigarette chemistry and related science. After seeing who they did put on stage, it became doubly clear that they were intentionally avoiding Igor because he had the expertise and credibility to point out fundamental flaws in a solid majority of what was presented. Fortunately Greg Conley had three minutes on the agenda and gave it to Igor, so that he could present the following talk. It was not a lot of time, but it was enough for Igor to point out how absurd is most of what passes for science in this realm. His slides are here. I have inserted the slide advance marks in the text. –CVP]

[Slide 1] Good morning, folks. First, a small correction. Actually, my affiliations are on the slide now, not from the previous introduction.

[Slide 2] So what I’d like to talk to you about today very briefly is that there’s really not that much new under the Sun about e-cigarettes. I don’t come from the tobacco control world. I come from a very different area of academia and research. And I was surprised that so many things about electronic cigarettes were surprising to people. So that’s my story.

So we’re really not all that ignorant about toxicology of what comes out of electronic cigarettes. And I talk about it as somebody who’s trained in industrial hygiene, environmental health, who was taught to anticipate what would happen if my workplace had a source of environmental emission introduced to it that was very much like electronic cigarettes, and it was there, and it was exposing me. And I was trained through my undergraduate and my graduate training to recognize and deal with those situations and be able to make rational decisions about mitigating risks for myself, and my co-workers and my colleagues.

We have rich experimental experience from other areas of environmental and workplace emission controls and hazard assessments that are incredibly helpful and can be easily applied, and are portable to the world of electronic cigarettes and tobacco products. And there’s really no reason to assume this precautionary posture that really amounts to willful ignorance. We really know a lot more than we sometimes give ourselves credit for. And my claim to credibility, such as it is, is summarized in this paper, and if you’re really interested in what I have to say on this topic, it’s all published out there. You’re most welcome to contact me. I’m easily found.

[Slide 3] But this is my main point, which was made yesterday as well: The dose makes the poison. We have known that for a very, very long time, and it’s really not helpful for us to think otherwise because nothing really has changed in the truth of that statement since Paracelsus put it forward. And this is part of the story. [Slide 4] If we apply the standards that are admissible in workplaces to emissions from electronic cigarettes and look at about nine thousand chemical measurements that were available to me back last summer, we can see that across chemicals, we see individual exposures that are way below a threshold where we’d actually begin to worry about them. There’s really no reason to be concerned here. Most of them are in trace quantities. They’re present, but they’re not going to hurt you.

[Slide 5] And if you look at similar calculations based on emissions from vapers, you can reach the same conclusion. You can sit or stand near a vaper and experience emissions they generate, and you should not be worried or afraid for your life or health.

[Slide 6] So we do know a good deal about electronic cigarettes. If the word “cigarettes” was not in that title, we wouldn’t really be that worried about them because it’s just a name. And it’s not really appropriate to deal with these things as if we learned nothing since the 16th century. Scientists don’t try to avoid vials of chemicals; likewise, public should understand and treat chemicals with respect, but we should not be afraid of them.

Thank you very much for your attention.

[Slide 7 contains further observations that could not be fit in the limited time.]

 

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.