Tag Archives: FDA

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.

Sure quitting tobacco products entirely was theoretically an option for every smoker in 1989, but how many did it? (Hint: not many.) E-cigarettes had already been manufactured starting in the 1960s (and even designed on paper in the 1930s, though we are aware of no evidence a device was ever constructed). Quitting tobacco products entirely was still an option in 1999, but how many did that? (Hint: more, but still not many.) That was about the time that a major tobacco company tried to bring a more modern e-cigarette to market, but, again, they were quashed by regulators. What would have happened if those options had not been banned? Some of the answer can be found in Elaine’s story and some in Carl’s New Year post here. Of course, low-risk tobacco products were on the market. By 1989 it was adequately clear that smokeless tobacco was low risk, and by 1999 there was no legitimate doubt. But that fact was hidden from smokers by a concerted disinformation campaign which was almost as effective at preventing harm reduction as  the repeated bans of e-cigarettes.

If smokers had been allowed access to e-cigarettes and knowledge of other low-risk alternatives decades ago, millions would have switched decades ago. It is not difficult to imagine that the majority of those now smoking would have quit via THR, or would have picked up a low-risk product instead. (It is particularly easy to imagine it when you observe that it actually occurred in Sweden.) The lowest risk alternative clearly was promoting THR in 1989, not pushing for total elimination of tobacco products.

Some of those behind the disinformation, bans, and attempted bans — both today and historically — are genuinely evil or at least sociopathic. They have a personal preference for a world that is free from all tobacco products (for some baffling reason that they never explain), and they lie and otherwise violate social norms, causing people to suffer and die, in pursuit of that goal. (Indeed, some of them clearly relish that suffering.) But they are a small minority of those responsible for this. They would not have the power without the much larger cadre of useful idiots. Most people who consider themselves to be “tobacco control” are not evil or sociopaths, but given the turn that the tobacco control industry has taken — in particular, that its defining characteristic today is being anti-harm-reduction — they have become the useful idiots serving the goals of the extremists. They typically actually believe that trying to dissuade people from THR is good for public health. Why? Because they believe that pursuing THR poses a higher risk to smokers than does pursuing complete cessation.

They are wrong. Badly wrong. This is obvious to anyone who actually thinks about this issue in even a slightly sophisticated manner.

Their naive notion seems to stem from the fact that, technically, from a purely medicinal standpoint, using a smoke-free tobacco product seems to pose some health risk (though we do not know that for sure) while abstinence poses none. Thus, they (mistakenly) conclude, THR must be the higher risk alternative. But this is only true if all else is equal — in particular if they would have both come to pass on the same day — and that is seldom the case. Someone who really would just quit on a given day in 1989 will have done so. Everyone else would have been safer had they switched, as emphasized by EK in her testimonial, as calculated in CVP’s cited paper, and as appears in the calculation for CVP’s New Year post.

In short, promoting abstinence is not a safe alternative to harm reduction.

Of course, anyone with an understanding of public health should know this already. Is demanding sexual abstinence a safe alternative to encouraging condom use? Is banning a popular drug a safe alternative to regulating it? Is mandating the use of an extremely awkward safety device, that technically offers slightly better protection to those using it than a pleasant alternative, a safer alternative? The empirical answer to the latter requires a bit of technical knowledge, but anyone familiar with occupational health or the use of safety gear more generally knows the answer: Offer only a highly unpleasant choice and people will just not comply, choosing the riskiest option of foregoing safety equipment entirely instead.

Sound familiar?

If non-sociopathic tobacco control people only understood the simplest 101-level lessons from their own field, public health, they would recognize this. But instead they are manipulated by the extremists into being useful idiots. They are tricked into not even thinking through what they are doing and saying.

One additional observation is necessary for fully understanding EK’s personal note and fully appreciating the preceding passages: Abstinence is a very unpleasant alternative for many. A few (like EK) can articulate this and openly explain that being able to function — to be happy, productive, employed — depends on continuing to consume nicotine. Given a choice of smoking, with all its costs and benefits, versus abstinence, smoking is better. Many other smokers basically get this, and do not seriously want to quit, even if they cannot quite articulate it. No observer has any excuse for not understanding this. It is simple social science or, for that matter, basic understanding of the behavior of sentient beings: Given only the two choices, if people choose smoking rather than abstinence, then they clearly like smoking (all costs considered) better than abstinence. Anyone who wants to dissuade people from smoking, then, who observes this — and who has even half a clue — will immediately figure out that he needs a third option.

And if he has a little human compassion, in addition to having a little clue, this will not just be because promoting THR lowers risk compared to promoting abstinence. It will be because THR gives smokers who benefit hugely from tobacco use (or just nicotine) a lot of benefit in addition to getting them off of smoking.

But even for those who do not care about people and only care about risks, the answer is the same. You have been duped by extremists who care neither about people nor even about people’s health, but are just bizarrely obsessed with the N. tabacum plant. Demanding the elimination of all tobacco product use is simply not the lowest risk alternative.

Smokers do not have the luxury of waiting for some perfect solution. Those who presume for themselves the right to control tobacco users do not have the luxury of pretending otherwise, pretending they are not killing people. Those who effectively prevented THR for decades are responsible for the lung cancers of Elaine Keller and tens of thousands of others.

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.]

 

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

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.

 

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 they 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 go out of this business a while ago and sold the brand to a new company started by their former employees).

You would be wrong.