Monthly Archives: May 2013

J-F Etter’s new video (or: Roberto Bertolini is a liar)

Yes, I have not been keeping up with posting.  So I will do a quick outsource for those who have not seek the video that John-Francois Etter made.  Yes, I realize no one has any idea who Bertolini is.  Also, in his video John-Francois does not do justice to his own thorough ripping of Bertolini’s dumb anti-ecig comments at the WHO hearing that is shown.  But it is a nice short video blog for people who like videos (I am a fan of text myself):

https://www.youtube.com/watch?feature=player_embedded&v=duVDY9oBb7Q#!

Updates: FDA, ACS, and CASAA

by Carl V Phillips

A few days ago, we reported about FDA CTP’s moves toward reducing the anti-THR lies in their public statements and otherwise shifting toward supporting the public interest.  I missed an important change that had appeared a week before, the elimination of one of the most blatant anti-THR lies to appear in FDA materials, one that stated an out-and-out falsehood that could not be cloaked in terms of being technically true like the “tobacco” conjunction lie emphasized in the previous post.

(The conjunction lie is to create a list that includes one bad exposure and implicitly blame everything on the list.  Example:  “Car and plane crashes are the leading killer of young people in America.”  Of course that toll is approximately 100% from car crashes, so it is a lie because it implies that plane crashes contribute importantly.  Similarly, anytime “tobacco” or some other conjunction of products is blamed for the toll from inhaling smoke, it constitutes the most common anti-THR lie.)

At this page, this older statement:

 To date, no tobacco products have been scientifically proven to reduce risk of tobacco-related disease, improve safety or cause less harm than other tobacco products.

was replaced with this:

To date, no tobacco products have met the requirements that would permit them to make claims of reduced risk or harm to users and nonusers of their regulated tobacco products. These requirements were put in place so that American tobacco consumers are not misled about the harms of tobacco products.

To provide context, this appears on a page title “Health Fraud” — rather ironically, given that the old statement was about as clear a fraud against health that someone could ever perpetuate — which contains information that is really directed at merchants of low-risk tobacco products.  It tells them that they are forbidden from telling anyone that everyone with half a clue knows that those products are much less risky than smoking.  That is obviously bad for public health, but it is true — they are forbidden.  However, this is presented in a child-friendly format that seems to be directed at consumers.  Given the “if you see… contact us” statement at the bottom, it seems that FDA is channeling the Stasi.

But though it seems unlikely they recruited any informants that are not already paid by the tobacco control industry, they did succeed in misleading a lot of consumers.  In fairness, it seems reasonably likely that whoever wrote the first version of this page was trying to communicate the message that was properly clarified in the second version.  But obviously the original author failed to communicate the truth to an unforgivable degree.  (Unforgivable, but not difficult to explain:  Many FDA careerists clearly do not understand the fact that there is a huge difference between “no scientific evidence” and “no FDA approval”, nor do they understand that “FDA approval” is not the same as “proof” of anything.)

Some observers still do not like the new message.  It would certainly be more precise and truthful to say “we have not approved any ‘modified risk tobacco product’ applications” or “we have not agreed to accept any such claim.”  The actor-free version of the statement, as if the institutional author of the web page is not the one making the decision and it is somehow an existential phenomenon, is rather misleading.

Also, attributing the MRTP requirement to a genuine concern about public health seems like rather a stretch, given that it was crafted by a coalition of cigarette manufacturers and anti-tobacco extremists.  But I trust that anyone seeking the truth already knows to pay no attention to “we were doing this to protect Americans” claims, whether about “public health” efforts to tax soda, ban salt, or ban e-cigarettes, or about drone aircraft assassinations, or subsidizing alternative electricity generation, or reading people’s emails; so that is kind of just a throw away.  (Note to readers: If you find yourself having a conversation with someone from another political “tribe” about such points, you should be able to identify something from this list where they agree that the government claims about doing something to protect us are bullshit.  Use that!)

But to circle back, let’s not let the details of the analysis distract from the main point:  FDA replaced a prominent, explicit anti-THR lie with something that is basically accurate.  Kudos.

By contrast, the American Cancer Society continues to damage public health.  As explored here extensively (like back from here), ACS is leading the fight to block state laws that would ban the sales of e-cigarettes to minors.  This seems to be because they want to create a situation where lots of kids are using them as an excuse for restricting adult access to these lifesaving (and cancer-eliminating) products.

Their most recent “victory” came in Oklahoma on Thursday, when such a bill was voted down.  This case is a bit more complicated than the Rhode Island or Arizona cases noted in the previous posts — there was some tinkering with the tax laws built into the bill also.  This bill was originally written by R.J. Reynolds and included provisions that would have given them a competitive advantage over other e-cigarette merchants (which CASAA opposed because we believe diversity in the marketplace is in the best interests of the consumer). CASAA worked closely with the sponsor to remove the provisions that would have favored RJR over its competitors.  (For those who do not know, this is typical — most bills are crafted by stakeholders and other interested parties, not by lawmakers themselves.  Though many merchants do support consumer-friendly bills in this arena, it is CASAA that is actually working in the legislative process to make sure bills are in consumers’ interests.)

Those of us who had the misfortune to watch the floor debate heard the opponents repeatedly identify nothing bad about the bill, but rather just kept repeating that ACS (and the American Lung Association and the American Heart Association) opposed it, so it must be bad.  After all, we should all trust them, right?

Obviously not.  They are liars who are willing to sacrifice children in order to impose harmful restrictions on adults in a free society.  Something really needs to be done about them.

So, to recap, the scoreboard for the week:

Government: removing lies, moving toward real public-interest stakeholder involvement.

Private “public health” charities: blatantly lying, ensuring children’s access to nicotine, trying to create harm in order to impose severe restrictions on the public.

CASAA and other real public health consumer advocates:  Got FDA’s attention and action.  Lost the final vote in Oklahoma, but killed the anti-competitive original version which mattered more in the long run.

Aside

If I gave into my urge to cite every parallel between the experience of fighting for THR and Paul Krugman’s fights to get us out of the economics depression — against hoards of powerful and fact-averse opponents who become even … Continue reading

Siegel takes up the charge on ACS efforts to keep e-cigarettes in the hands of children

by Carl V Phillips

Most of you recall our two posts from about a month ago, analyzing the American Cancer Society’s efforts to block laws that would ban e-cigarette sales to minors.  (At least I assume you have, since they are about the most read entries on this blog.)  You might also have seen CASAA’s recent call to action about a proposal in Arizona that would ban sales to minors — we urge support of it, while the ACS is leading the opposition.

This week, Mike Siegel took up the charge on this issue.  Yesterday, he published a post that reviewed our posts here and endorsed my argument (based on careful elimination of all other apparent explanations) that ACS was actively trying to maximize children’s use of e-cigarettes in order to make e-cigarettes look bad.  This would support a real (anti-health) agenda of creating rules that would restrict adults’ access to e-cigarettes and THR more generally.

Today, Dr. Siegel further analyzed the situation and concludes:

that the American Cancer Society has admitted that Dr. Phillips is correct. This is no longer just a theory. This is a bona fide explanation for the ACS position on this issue. And the ACS admits it.

Based on a letter from the ACS (also signed by the American Lung Association and American Heart Association) to Arizona senators, which CASAA published as part of our Arizona call-to-action, Siegel argues that a smoking gun in support of my theory is their statement that having a minor ban:

“sets the stage for tobacco companies to claim they are protecting children via this legislation…”

This is certainly consistent with the content of ACS’s Rhode Island testimony that I analyzed in the first post.  Siegel goes on to argue that their motive for wanting adult bans (and thus for wanting children to keep using) is found in their statement:

“The use of these products by adults could have a serious negative impact on the social norms around smoking especially around children.”

and argues that this shows,

Thus, the ACS opposition to e-cigarettes is ideological: they can’t stand the idea of a behavior that looks like smoking, even if that behavior is helping to save thousands of lives.

No doubt this is part of their motivation, but as harsh as this accusation is, I am actually rather less charitable about the real motives of anti-THR liars, as readers will recall from previous posts.

I will add a couple of observations about that ACS quote.  First, though the tobacco companies who are in the e-cigarette sector all support sales bans to kids, these efforts have been led by (real) public health people and CASAA, not industry.  And with “claim they are protecting children” ACS is trying to try to keep the reader from realizing that the full statement is that they could “accurately claim they are protecting children”.  Or put in normal human language, that they/we “are protecting children”.  But since ANTZ live in a world where claims matter more than reality, they may not have even realized that their wording was a lie.

Siegel also adds this additional observation to CASAA’s previous analyses of ACS:

On its web site, the ACS asserts as follows: “We do know that e-cigarettes can lead to nicotine addiction, especially in young people who may be experimenting with them, and may lead kids to try other tobacco products, many of which are known to cause life-threatening diseases.”

So according to the ACS, we have the scientific evidence needed to conclude that e-cigarettes can lead to nicotine addiction in young people who are experimenting with them.

However, in its letter to the Arizona Senate, the ACS claims: “Very little is known about the use of electronic smoking devices by youth…”.

Well, which is it?

In the former statement, the ACS’ goal is to scare the public about how much of a threat electronic cigarettes pose to minors. So they manufacture evidence (which doesn’t exist) to show that these products are leading to nicotine addiction among young people.

In the latter statement, the ACS’ goal is different. Here, they want to convince the Arizona Senate that e-cigarette use among youth is not a problem, negating the need for this new legislation. So the ACS now claims that there is no evidence that youth are actually using these products.

Often, all it takes to show that the anti-THR activists are liars is to accurately quote them twice.  Keeping up an internally consistent web of lies takes a lot more care, intelligence, and planning than they are capable of.

Credit where due: FDA

by Carl V Phillips

I’m back.  Sorry for the long absence — for obvious reasons, the blog loses out to paid work, family vacation, and (the only bit that is actually of interest to you) preparing a presentation for and attending the Tobacco Merchants Association meeting last week.  A bit more about TMA in a later post.  Today I want to focus on what was said about and by FDA at that meeting.

First, the good news:  In a presentation at the meeting, the head of TMA, Farrell Delman, pointed out that FDA had changed their website in a few places to make clear that the CDC estimated deaths from smoking are from smoking and not tobacco.  (I did not note which specific pages Farrell showed in his talk, but here (pdf) is one example I just found.)  As regular readers know, blaming “tobacco” or “tobacco products” for the risks from smoking is probably the most pervasive anti-THR lie.  It perpetuates the misperception that smoke-free tobacco/nicotine products create a substantial health risk.

Unfortunately, the change is not universal, but I will choose to embrace Farrell’s optimism for the moment.  We can hope that the remaining instances of the misleading “tobacco” bundling language are either dated info releases that would not be appropriate to change (the government is really not allowed to memory hole past statements) or places where they have just not yet noticed they need to make the change (like here or the sidebar here — hint, hint!).

And, of course, no doubt if you followed those links you noticed various other bits of anti-THR misinformation that still remain.  But any steps in the right direction are good news.  Pervasive myths are not fixed in a day.

Also on the frustrating side was the continued emphasis, as seen in the presentation of David Ashley, the CTP science chief, of the supposed possibility that low-risk products could lead to an increase in total population health risk by attracting new users who avoid smoking because of the risks (my liberal paraphrase of a couple of much less detailed bullet points).  Simple arithmetic shows that is impossible, but FDA has to emphasize it because it is so clearly enshrined in their enabling legislation.  This relates closely to my presentation at TMA, so I will comment more in a post about that (probably at EP-ology, but I will cross-post something here).

Back to the good news:  Mitch Zeller, the new head of the FDA’s tobacco unit (CTP) presented at the meeting and took questions.  So did Ashley.  Kathy Crosby, the new head of communications, had a prominent role in a panel.  The significance of this should not be underestimated.

During the Q&A for Zeller’s presentation, CASAA questioned CTP about the lack of consumer (i.e., the primary stakeholders in all of this) representation in their proceedings.  He invited us to submit a formal request, which we will send today or tomorrow.  It appears certain that this will give us a chance to present the consumer views to CTP in a special meeting.  It is less certain whether we will have a spot on the agenda for future hearings where other stakeholder presentations (industry, etc.) are included, but we are making every effort to ensure that consumers are given a place at the table.  We will keep you posted (and might recruit you to support our request should it seem useful).

In his presentation, Zeller made clear that the top priorities for the CTP currently include the “deeming regulation” that would bring e-cigarettes and some other products under FDA jurisdiction.  (Contrary to what you sometimes read, they are not currently regulated by FDA as a tobacco product, but probably will be.)  Whether this is done in a way that makes e-cigarettes better (i.e., serves the consumers’ interest, as FDA regulation is supposed to do) or in a way that threatens innovation or their very existence (serving the interests of the anti-tobacco extremists, who want to prevent harm reduction) remains to be seen.

Another stated priority is to get through some of the backlog of applications.  Unfortunately this does not matter much for real consumer interests, since as far as we can tell the overwhelming majority of these are just “substantial equivalence” applications by cigarette makers who just want approval for some insignificant change of their products.  It does not appear that there are any “MRTP” applications pending.  (That is the misnamed category that would allow harm reduction claims about a product — it is “modified risk tobacco products”, though the products that really matter are not modifications of existing products, but entire categories that have always been very low risk compared to smoking.  The misnomer itself is an anti-THR lie because it is designed to hide the fact that different categories of products have hugely different risks, though that is not the fault of FDA, but rather of the ANTZ that wrote the legislation that created CTP and their mission.  At least lawmakers changed the ANTZ’s proposed wording that would have completely forbidden any claims comparing low risk products to smoking, an obvious attempt to prevent THR.)  We believe there is at least one MRTP application in the pipeline, though unfortunately it is not for a low-risk product.

And on a less recent note, many of you may recall that FDA rebuffed attempts by the ANTZ at University of California San Francisco to make CTP their own private activist organization by threatening to boycott if stakeholders (in that case, industry) were allowed to even present their views.  (Though, of course, they showed up at the hearing to announce they were not showing up at the hearing.  We cannot expect them to be honest even in their protests, after all.)  CTP did not make any public response to this attempt to subvert the American political system, but they clearly did not give in.

I guess the bottom line is that we are in far from a perfect world, with regard to THR-related regulation, but it looks like a much better world than existed a year ago.

This is what anti-THR networking looks like, Part 2

In the previous post, we presented some thoughts on a webcast that was designed to empower (with innuendo, ad hominem attacks, disinformation, and suggested dirty tricks) local “public health” officials and activists to harm the public’s health, specifically by restricting access to e-cigarettes.  Following on that, some additional observations (a random series, followed by the most interesting part of the whole conversation).

As we noted in the previous post, one of the speakers made clear that nothing that local or state governments did could interfere with eventual FDA regulations.  They could impose stronger restrictions than the feds, but there is no way they could weaken them.  This put the lie to the American Cancer Society’s claim that they have been opposing regulations to ban sales of e-cigarettes to minors out of concern that it would interfere with FDA regulation.  Of course, we had already identified that as a lie, nothing that the ACS must know the truth, and went on to surmise their real motives.

All but one of the questions during the question period were about the chiiiiiildren.  Probably almost none of the people watching the webcast were even aware that ACS et al.’s policies are the main reason that children can legally buy e-cigarettes some places in the USA.  (Presumably the insiders who savvy enough to know the real game that the anti-THR people are pursuing has sense enough to not waste time listening to webcasts — score one for them over us on that point.)  Interestingly, however, one of the questions sounded like it came from someone who had just read our posts about ACS.  Maybe the ANTZ are getting smart enough to read things.

Comments that smoking is no worse for you than vaping were rampant.  Of course that is not quite how they phrased it.  They said “we do not know that these are safer than smoking”, but those statements are exactly equivalent.

Someone — I believe it was Jeanne Finberg, California Attorney General’s Office — asked the listeners to start reporting, for purposes of legal action, examples of e-cigarette vendors making cessation claims.  Never mind the stupidity of living in a world where merchants cannot make simple nonspecific true statements about how one consumer product competes with another.  Her examples of “cessation claims” included statements that if you use an e-cigarette you will not smell like smoke, as well as the fact that you can blow vapor rings with them unlike with a nicotine patch.  Um, yeah.  By those standards, ads for pizza are making smoking cessation claims.

Of course, even more bothersome was the mere fact that the state Attorney General’s office was actively campaigning for particular policies.  The claim was that rampant lawbreaking is going on.  And yet no one has taken legal action against e-cigarette vendors — other than workplace safety claims and, interestingly, a few cases (or maybe just one) of failing to enforce minor sales bans — since the FDA lost their attempt to ban e-cigarettes.  I thought it was the job of attorneys general to act against lawbreakers — apparently in California it is to ignore that and to try to make policy.

The only audience question not about the chiiiiildren that the moderator chose to read (i.e., planted) was about what the research priorities on e-cigarettes should be.  A valid question, but not such valid answers.  It was a bit of a muddle as to which of the panelists were talking (there is no transcript of the meeting, of course), but one claimed we needed clinical data about whether e-cigarettes help people quit smoking.  That is the standard “clinical” lie (which shows up in lots of contexts, not just e-cigarettes):  Clinical evidence is great for assessing clinical activity — say, which of two drugs is best for treating a particular cancer — but  completely inappropriate for assessing social phenomena.  We do not judge particular methods of reducing traffic hazards or how consumer confidence affects the housing market by creating an artificial laboratory situation.  Similarly we cannot judge the effectiveness of e-cigarettes that way.  (If the question is, “if you recommend e-cigarettes to enrollees in clinical smoking cessation program, what happens?” then clinical research is useful, but that is a much less important question than what is happening in the real world.)

Another answer was that we need to learn more about dual use because it is “giving people the false impression that they are reducing harm when they are not.”  Of course, if people are substituting e-cigarettes for some of their cigarettes (and especially if they are trending toward even more substitution) they are reducing their risk.  But the phrasing of this response was quite telling.  This and other response included the subtext “we need to do more research in order to find more ways to attack THR”.  This reflects the standard ANTZ relationship to research — the same way a drunk uses a lamppost (for support, not for enlightenment).

Someone actually said, “if we had the answer to these, we would know what policies would be possible.”  Notice the statement was not “we would know if we should pursue these policies” or “if these policies are a good idea” – that is not a question that even occurs to them.

This leads to the one bit of honesty, from two employees of the Tacoma/Pierce County (Washington state) health department, reporting on the blocking of that department’s attempt to restrict e-cigarettes.  They wanted to do it, of course, but their presentation was an honest report with little or no editorializing that they were stopped from doing The Right Thing (though undoubtedly many of the listeners supplied that as their own personal subtext).  The restrictions did not happen, they reported, because the public did not support them, except for the one on sales to minors, which everyone supported — apparently the ACS and friends were too busy elsewhere to jump in on that.

To their enormous credit, the officials did not mimic the games of ANR et al. (mentioned in the previous post) of trying to blame the public’s views on manipulation by evil corporations or evil consumer advocacy groups.  They matter-of-factly stated “we did not have a lot of community support” and moreover that “we do not have evidence-based research to back up our concerns.”   The latter is a borderline case of assuming that if the research were done it would support their policy, but about as good as can be expected.

Indeed, they acknowledged that they faced a challenge, as a public health department, because they could not show that e-cigarettes posed any threat to the public health.  Perhaps, then, they should not have been trying to act in the first place, you might be thinking.  But at least the Board of Health ultimately reached that conclusion and stopped the effort.  The bad news is that even these fairly honest presenters emphasized that they “were left in the lurch” by the lack of support and evidence, rather than suggesting that perhaps the lack of support and evidence means that they should not have been doing this.

Perhaps the worst of the honest messages in their presentation was that they endeavored to “strike a balance”.  Among what or whom, you might ask.  They did not clearly say, but reading between the lines it was a balance between, on one side, the genuine preferences of the real stakeholders, along with those who do not think a public health department should interfere with something that does not hurt public health (and, incidentally, those who realize that e-cigarettes are beneficial for public health), and on the other side the ANTZ busybodies and their anti-THR agenda.

And that is what is so toxic about the entire taxpayer-funded project that we witnessed.  A tiny minority of a few thousand busybody activists with no legitimate stake in the matter are considered (by themselves, anyway, and since they have money and power, that matters) to have a legitimate voice, whereas the similar number of people who comprise the industry are treated as a vague malevolent force and the 1000 times that many people who benefit from e-cigarettes are completely ignored.