Tag Archives: FDA

California ecig “regulation” hearing: a catalog of lies (part 2)

by Carl V Phillips

Continuing from the previous post, you will recall that we established that California Senator Mark Leno is absolutely hilarious when he tries to talk about science — assuming you can maintain a sense of humor about someone who is spouting lies in support of a bill that would inflict a great deal of harm with no apparent benefits. He continues by suggesting he also does not understand how lawmaking works, or even his own bill. Sadly, it is not nearly as funny as his attempts to talk science. Continue reading

TPSAC meeting on Swedish Match MRTP application: is there a scientist in the house?

by Carl V Phillips

The FDA just concluded the meeting of their Tobacco Product Scientific Advisory Committee (TPSAC) to review the MRTP application by Swedish Match to change the incorrect warning labels on their smokeless tobacco products. They applied for removal of the warnings that say that the products cause diseases that they do not actually seem to cause (meaning: to a measurable degree, of course) and to replace them with a warning statement that says while no tobacco product is safe, these are substantially lower risk than smoking. (Background on that here, here, and here.) In other words, they were asking to be able to state something that is beyond doubt and not be forced to make claims that are not supported by the science.

So how do you think this extremely reasonable and clearly valid supplication to the FDA went? Continue reading

New study: profound ignorance about the basic facts of the potential for tobacco harm reduction

by Carl V Phillips

A new research report by Kaufman et al., a group of anti-tobacco people, primarily working for the National Cancer Institute (NCI), confirms how effective anti-THR lies have been in dissuading American smokers from switching to low-risk alternatives. It is not too surprising — though still utterly pathetic — that you would never know that from reading the abstract at the link. Still, Kaufman is apparently more honest than some of her coauthors and bosses, and the useful information is clearly presented in the paper itself. Continue reading

Hatsukami completes her descent into Hecht-dom?

by Carl V Phillips

Dorothy Hatsukami has long been mostly honest, not bad by tobacco control standards anyway, and one of the few ANTZ careerists who acts more like a genuine research professor and less like a busybody sociopath who happens to have landed a job in a school of “public health”. Of course, she was second author with Mitch Zeller in the attempt to co-opt the term “tobacco harm reduction” to mean “moving toward abstinence, by means our cabal approves of”, and has earned no forgiveness for that. And she has often signed on to some of the anti-smokeless-tobacco lies penned by her University of Minnesota colleague, Stephen Hecht. But now she seems to be taking the lead. Continue reading

FDA thinks antifreeze is ok — for kids’ medicine (and other accidentally useful observations in the NYTimes)

by Carl V Phillips

The New York Times is a reliable mouthpiece for various powerful political factions but, frustratingly, is also a great source of information. As a result, we are forced to read it much the way that Soviet citizens learned to read Pravda — the information is there, but you have to learn how to read between the lines. A clever reader (h/t Gil Ross) spotted the NYT pointing out that FDA was blatantly hypocritical when they hyped the claim that “e-cigarettes contained antifreeze” during their attempt to ban them in 2009 (and — even worse — keep reporting that lie).

Background: In 2009, in an attempt to smear the e-cigarette companies that were suing them for illegally seizing products, FDA conducted studies of some of their liquids. They discovered a trivial contamination with diethylene glycol (DEG), in one unit, at a level that Burstyn has pointed out posed no concern. They tried to fool the public into believing this was a substantial hazard. Continue reading

Tobacco abstinence is not a safe alternative to harm reduction

by Carl V Phillips and Elaine Keller

In honor of the birthday of one of us (EK), we are using the great title that the other of us wishes he had thought to use for his 2009 paper. In acknowledgement of her birthday, Elaine posted this yesterday on the Facebook CASAA members group:

Today is my birthday. My birthday wish is that e-cigarettes had been invented in 1983 instead of 2003. I was reluctant to share with the world that I was diagnosed with lung cancer last summer. I was afraid that some tobacco control liars might use that information to falsely accuse e-cigarettes of causing cancer. But an important fact is that for ex-smokers, the excess risk for lung cancer doesn’t go away the day you quit. In fact, it hangs around for a good TWENTY YEARS after you quit smoking.

So if I had been able to quit smoking in 1989 instead of 2009, perhaps I would not have needed to have the lower left lobe of my lung removed in July, and to go through chemotherapy. I’m happy to share with you all that my follow-up CT scan on December 4, showed no evidence of cancer. So I am officially in remission. To those who want smokers to wait around for 10 or 20 years for scientific proof that e-cigarettes are 100% safe, I say this, smokers don’t have that luxury.

Dr. Carl Phillips, CASAA’s Chief Scientific Officer, brilliantly analyzed the difference between being able to quit smoking immediately via switching to a reduced risk alternative source of nicotine (Tobacco Harm Reduction – THR) and postponing quitting until ready to “quit completely” (e.g., not needing to earn a paycheck after reaching the age of retirement) in “Debunking the claim that abstinence is usually healthier for smokers than switching to a low-risk alternative, and other observations about anti-tobacco-harm-reduction arguments.”http://www.harmreductionjournal.com/content/6/1/29

Most lung cancers are not diagnosed until Stage 4, when survival rates are grim. I thank God, and credit e-cigarettes, for the fact that mine was caught at Stage 1.

Continue reading

Over 10,000 more Americans get to ring in 2015 thanks to e-cigarettes

by Carl V Phillips

This blog closed last year with a countdown of the worst liars of the year. This year, I decided to go for a more positive note.

We know that every time a smoker switches to e-cigarettes, there is a good chance she is saving herself from an eventual smoking-caused premature death. But this also means that, for someone who has quit smoking thanks to e-cigarettes, there is a chance she has already avoided premature death. Several months ago, a journalist posed this interesting questions to me: How many lives have already been saved thanks to e-cigarettes (h/t Maxim Lott). It is a very tough question, but I finally figured out how to estimate it based on the methodology I used in my 2009 paper, “Debunking the claim that abstinence is usually healthier for smokers than switching to a low-risk alternative, and other observations about anti-tobacco-harm-reduction arguments.” I have completed a working paper that calculates the estimate, which appears at EP-ology. 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.]