Category Archives: fda

Bad apple studies – pt 2 (and Josey Wales too)

Following from Part 1

There is something else that is special about the Winn and FDA studies.

Typically when one study becomes a standard citation it is an examplar of some sort. It either represents best some aspect of the ideas being expressed or it summarizes much of the knowledge acquired to date in the field. While these need not be perfect studies they should be of a fairly high caliber. They do not need to be universally accepted but disagreements will tend to centre on the interpretation of the results.

Just about anyone looking at the Winn and FDA studies conclude that they are methodologically unsound. And if you don’t trust the method how can you trust the results.

And yet they are presented as pillars of evidence.

Perhaps it is better to think of them as mantras.

They function quite well as articles of faith. Words repeated by believers.

Because these are so central to the ANTZ messages it feels as though we have to critically respond to them time and time again when in fact they are so poor that they should be ignored. Were it not for the timing, or their usefulness to anti-nicotine forces these studies would never have caused the slightest ripple.

And this is where we can easily claim the superior moral ground. We take these bad studies seriously enough to think about them, to accept them as possible evidence.

Both sides are guilty of assembling lists of references to support a particular position but one main difference is that pro-tobacco harm reduction researchers accept that studies not supporting their position exist. You won’t hear a pro-THR researcher denying that any study does not exist. On the other hand rather than doing the work and critically engaging opposing studies ANTZ will simply say they don’t exist.

One lesson we can all learn from this though is that as much as we like a particular conclusion or result we should remain critical.

I like both coffee and alcohol and will have an immediate reaction of “of course” to any popular report of either of them being beneficial and an “as if” to any report of them being harmful to health. I would like to think however that if I was professionally studying either that I would be critical of both pro and con studies.

And this is another reason these studies were taken up so quickly and became so persistent. They supported existing views.

While the health effects of chewing tobacco were not certain, the practice was seen as reprehensible as most people now see smoking. In films the dastardly villain might be a spitter, rarely the hero (though see anti-hero Josey Wales below).

If it is gross it must be bad for you. Winn played to popular sentiment. And the FDA study played to the folks who thought that anything that looked like smoking had to be bad for you (also the reason the exploding battery made such a news splash).

On some level we are all looking for substantial arguments against things we dislike but can’t really make a good case against. Its an understandable impulse but it is a luxury no one with any influence over public health should be allowed.

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Bad apple studies – pt 1

I was thinking about the persistence of that FDA assay despite the rounds of criticism from all the right quarters. Just about every article or health web site arguing against vaping will cite this one study and often no others. This became quite evident to me when I was writing about a possible ban on e-cigarettes in the Gulf states (curiously enough two years ago to the day).

Not only did I think it odd that it was that one study that kept getting referenced (as though none other existed) but that an American study would be used half way across the world as authoritative in a culture that not only has its own resources but that often as not decries American influence. And reversing the situation, can you imagine the American Lung Association using an e-cigarette study out of Qatar as the sole citation on a post?

However, as odd as this situation is, it is tobacco harm reduction history repeating itself.

In 1981 the New England Journal of Medicine published Deborah Winn et al’s Snuff dipping and oral cancer among women in the southern United States. I won’t retread old ground about the shortcomings of this article – see Brad Rodu’s excellent summary – however let’s just say that the paper makes better reading as anthropology than health risks. The authors managed to run down a group of white women who had used an antiquated version of powdered dry snuff for most of the hours of the day for over fifty years. In comparison to non-users, this group was determined to have about 50 times the risk of developing oral cancer. The figure mentioned in this deeply flawed study ended up being used to represent the typical risk to the average user using products that had little in common with the product in that study.

It used to be that every site warning off smokers who were thinking of switching to smokeless tobacco would cite this figure. Looking again for the first time in a couple of years I see that little has changed (see Web MD or Illinois Department of Public Health). Their overall message much like the one that attends bad vaping articles is that smokeless tobacco is as or possibly even more harmful than smoking.

Just as with the FDA case, there were plenty of other studies out there. In fact the situation was much more pronounced. As well as other American studies there existed a body of strong research from Sweden where more people were using snus than smoking and where the shift resulted in a decline in smoking related disease rates. You think that would have clinched the deal but rather than this one bizarre outlier being consigned to ignominy there seemed to be no effect at all on the messages that public health resources were giving out.

(In addition to other studies, it is this same Swedish data that allows us to be pretty sure that e-cigarettes are so very much safer than smoking).

Paralleling the situation with e-cigarettes you would typically also read that the authors felt there were no studies demonstrating that these alternatives were any safer than smoking.

So what you have are the bad apples, the early studies that don’t seem to be replicated or supported by any other studies, which go against everything that follows, and yet remain the official sources. Even more upsetting (and detrimental to public health), these official messages ended up becoming common knowledge – basic truths everyone “knows”.

The other thing to note is that both the Winn and FDA reports were obviously flawed in themselves. You did not require other information to know that these lacked credibility. And yet these bad apples stuck.

Part 2 will explore possible reasons why these zombie studies would not die.

More on this tomorrow….

Worth reading: Carl Phillips testimony at the FDA tobacco center meeting

reprinted from Epology

My testimony at today’s FDA tobacco center meeting

Today I departed from my usual practice of fiercely avoiding any “science by committee” setting or engaging with government overlord-types, and gave some testimony at the Center for Tobacco Products TPSAC meeting. Greg Conley and Bill Godshall talked me into make the trip as an advisor to the tobacco harm reduction advocacy group CASAA. It was worth it — there were several great presentations by harm reduction advocates in the “citizen comments” that our public mastersservants grudgingly allow because they have to. Greg recruited several people who had quit smoking by switching to low-risk products, and there were great THR presentations also by Greg, Bill, Elaine Keller, Jeff Stier, Gil Ross, and others. I was pretty pleased with mine too, given that I wrote it while sitting through the talks earlier in the day (something to do during the tedious and pointless presentations by the well-paid consultants and others who were invited to speak by the hosts).

To appreciate my talk, I need to offer some background (which kind of spoils the freshness, I know, so if you are familiar with all this, you might want to skip right to the text of my talk).

Background for those who know nothing about CTP etc.: The US FDA was fairly recently given authority over tobacco products. The unit that formed is dominated by dedicated anti-tobacco extremists who are opposed to harm reduction, and its external scientific advisory group (TPSAC) is stacked with extremists and junk scientists, and contains no harm reduction experts even though most of their role is to evaluate harm reduction products. There is a serious threat that FDA will substantially restrict, one way or another, low-risk alternatives to cigarettes. They are particularly notorious for playing the chemophobia game, obsessing (or pretending to obsess) about detectable chemicals in products, implying that these have health effects even though the evidence about actually effects suggests otherwise. No doubt they are annoyed about having to deal with public comments, because (in a complete perversion of the term) they consider the stakeholders to be the busybody activist groups and not include the actual primary stakeholders, the product users. Public comments also are a challenge to their preferred way of dealing with information they do not like, which is to declare it to not exist and claim we do not really have any information (they still do that, of course, but they probably momentarily feel worried that someone is going to realize they are bullshitting). Indeed, the defining characteristic of this whole process seems to be to pretend that evidence about THR does not exist, because it is not exactly the “right” form of evidence, or is not collected by the “right” people, or whatever. That is the same old game used by the anti-harm-reduction extremists for a decade, but now it is official government policy.

Bits of background on this meeting: Today’s meeting was dedicated to dissolvable tobacco products, smokeless tobacco mixed with confectionary which dissolve in the mouth. These face particularly great existential threat from the regulators, probably because they compete with the almost identical products from the pharma companies who many of the extremists carry water for. The citizen comments period allowed for only 16 of us, and only for 3 minutes each — “government for/by the people” in action! It was quite clear from various comments and questions from the floor that many members of the committee did not understand key points about THR, despite supposed expertise and a year on the committee, and even more clear that they had never talked to any actual product users. (They appeared genuinely astonished to hear one of the presenters say that he has kept using an e-cigarette, even though he is sure he could quit, because he likes it.)

In yesterday’s session, the committee had been offered a lesson in the Swedish experience, about how smokeless tobacco use had caused the world’s best reduction in smoking and had been shown to have trivial health risks. They then tried to make up every possible reason about why that is not a good reason to encourage (i.e., allow) the marketing of new smokeless products in the US — because that is just not the same thing, so we really have no idea whether something similar could happen. Oh, and there was a trumped-up obsession with how children might get poisoned by these products (never mind that it had never happened, or the question of why they should be worse than existing pharma products that are almost exactly the same but much easier to unpackage, or other medicines) and resulting tangents about safe packaging.

Anyway, since (a) I figured several of the other presenters were already covering any basic information that I could communicate in 3 minutes, (b) Bill submitted 200 pages of written testimony (which they clearly did not read), and (c) the members of the Center and committee have had months to learn things, and if they did not already know them it was not because they had not heard them. In short, they either already knew what I could tell them as a THR expert, or the reason they did not know is that they were intentionally ignoring the information. So, I decided to go a different direction with my testimony. Here it is (in full — 3 minutes is a very short time):
I speak today as an educator with an interest in the nature of science and its role in the functioning of our society, and from that perspective would like to say, “won’t someone please think of the children?”
If an impressionable young mind stumbled across how science is often portrayed in this corner of our nation’s government, he would be at risk of never becoming scientifically literate, let alone to wanting to be a scientist.
First, science is supposed to be an honest truth-seeking process that attempts to figure out the best possible answer to a question, often via methods that require innovative thinking. Our impressionable young mind, however, might come away:
-believing that science consists of just a few narrowly-defined recipes, rather than taking in all the information we have in myriad forms, available from many forums, and thoughtfully making the best use of it;
-believing that health science focuses on looking only under streetlamps and obsessing about easy but not directly informative work like chemistry, rather than trying to do the more difficult work to translate this and other information into what we really want to know about health effects;
-from today’s session, he might believe that science involves such methods as manipulating children into giving the answers you want, speculation-laden anecdotes, limiting reviews of the evidence to exclude any evidence that you wish did not exist, and counting unsupported assertions by authors as evidence;
-and he would be taught that science it is not about identifying how we maximize our knowledge, but that it is involves declaring that we just do not know anything, when in fact we know quite a lot.
Our impressionable young mind is not going to think very highly of science, and he might reasonably conclude that the best way to get involved America’s version of science is to go to law school. And, yes, that means that misguided ways of looking at science may be a gateway to more dangerous behaviors.
Second, this poor child would get the impression that a hypothetical cardiovascular condition or cancer 40 years from now will be just as harmful as a near-term case in a current smoker, a case that was caused because smokers are discouraged from switching to low-risk alternatives. Do we really want to tell that child that we expect so little of him, that his generation’s health science will be so lousy that the 40-year-out cancer will be no more treatable that it would be today?
Finally, at the very least, I would urge this committee and Center to make sure that any such anti-scientific writing is kept in child-proof packaging, rather that being left laying around on the internet where anyone could stumble across it and damage their developing minds.
In case you are wondering, still more background re that third bullett (explaining the joke does not make it funny, but it can clarify): The “manipulating children” refers to the the Indiana Health Department who presented there and are the darling of the anti-tobacco extremist nutcase faction; their infamous “study” consisted of assembling some children, mixing dissolvable tobacco products (which the children had never seen or heard of before) in with some candies, and asking the children what they thought they were looking at. Obviously, they “discovered” that the kids thought the dissolvables were candies like the other items they were presented with. This is what passes for evidence for these people. I suspect it would be possible to convince the kids that the dissolvables were cats if you worked at it.

The “anecdotes” point refers to someone who presented statistics about thousands of tobacco poisonings which were meant to imply that dissolvable products were dangerous, but in fact showed the poisonings were from other products. Perhaps realizing how worthless her data was, she threw in a single story about a mild poisoning that might have possibly maybe been the result of dissolvables that someone had unpackaged and left around, maybe. The “unsupported assertions” referred to a really stupid report presented by someone from RTI (for which they probably got paid a fortune of our government’s money) reviewing some of the studies on the topic; the report highlighted whatever random conclusions the authors asserted, regardless of the fact that most were unrelated to the evidence reported in the study. In other words, they did work at the level of a bad MPH student (which I suspect is exactly what most of the researchers were). The “limiting reviews” referred to that RTI report, in which they every-so-conveniently had reasons to not include all papers not written by opponents of harm reduction, as well as similar behavior in all the other reviews of the day.

Unlike some of the other presenters, I did not get any questions from the committee. What could they say? The one question/comment I thought might come was something like “do you think this committee is some kind of joke”. I was prepared with an answer — “well, if you really cannot understand the seriousness of what I was communicating, then, I guess the answer is yes”. Alas, no one asked the question.

But I still wonder how many of them even began to understand what I was saying. I know that many of my THR-expert colleagues got it, but I kind of doubt a sufficient level of intellect is common among the officials and committee members. Long-standing science committees are generally populated by political hacks and former scientists who cannot or do not want to think hard any more. I was told that the top FDA guys looked like they were amused at least part of it (but whether that is a good sign or just a smug “yes, you caught us, but who cares — we are still the ones in power” is not clear). I noticed that at least one committee member, Jonathan Samet, perhaps was also getting it, but he knows my style from crossing paths over the years and, though I am pretty sure he does not like me, he gets it. He a clever guy, albeit someone who has risen to seemingly dominate institutionalized American epidemiology, due to position and connections, not scientific skill, and then perverted it with politics, further damaging and already shaky field. (No mystery why he might not like me, huh?)

Anyway, I am pretty sure they missed my final bit of satire. Before the citizen comments, the chair read this ridiculously long statement about how we are encouraged to start by disclosing our conflicts of interest, who paid for us to be there, etc. This is in keeping with the “look for any excuse to dismiss what someone has to say” mentality. It is ironic, since that committee is notorious for being stacked with people with enormous conflicts of interest. Anyway, I was not about to waste time from three minutes with that, but since I spoke a bit faster than I expected, I had 15 seconds left at the end. So I added,
Oh, and no one has ever paid me for my work doing history and philosophy of science like this.
And CASAA paid the two-figure cost of me coming here.
I am guessing that they had no idea that I was ridiculing their conflict of interest obsession.

The meeting was painful, but it is good to be reminded sometimes: I generally know with how little wisdom the world is governed, but sometimes it is useful to remind myself of some of the details. It was just so absurd. The committee would ask presenters questions the presenter could not answer but which (a) everyone on the committee should have already known and (b) someone in the audience was clearly the top expert on. But we peons in the audience were not asked to solve the conundrum, because science-by-committee does not allow for stepping outside the box (or in this case, beyond the plastic chain with “no one past this point” signs that separated the audience — I am not kidding). Several of the answers were in Bill’s submission, but they could not be bothered with looking at that. My favorite was when the committee was asking about some details of what one company had reported and the speaker was not sure; representatives of that company who undoubtedly knew the answer were sitting in the room, and no doubt some or all of the committee knew that, but the people up front went around and around without being able to figure out the answer rather than actually doing the research (asking) needed.

This kind of consultation among the privileged ignorant, which never actually seeks data, passed for scientific inquiry in the Dark Ages. But dark ages never really die. They just take refuge in government and religious institutions. So try not to think too much about the children — it is just too damn depressing.

More on menthol: contradictions and implications

As a followup to Carl’s post on the menthol issue and specifically in regards to his paragraph on how someone in harm reduction could be torn between supporting any drop in quality of cigarettes (since that would drive people to lower harm alternatives) and the wish to maintain individual liberty, I would like to add a few related (and unrelated) points.

If you pressure people to safer use by reducing cigarette smoking pleasure there is no reason to believe that such actions will remain specific even to tobacco. As the world generally becomes safer, the minimum standards for safety become ever more stringent and relatively low risk and common every day behaviors might end up generating similar regulatory responses. And then you start worrying about the loss of overall quality of life (as in the salt free future of Demolition Man).

Recall that the argument here has been not that menthol cigarettes are more harmful but that for enough people they are more appealing. Or as one Jonathan Turley put it: “The message seems to be: you can sell tobacco products unless they are too popular with consumers”. But you could just as well argue that for even more people non-menthol cigarettes are more appealing so in a sense you are penalizing smokers who happen to exhibit a certain taste preference. Much has been made of menthol cigarettes being the cigarette of choice in the African American community but could it not have been just as easily concluded that Caucasian Americans overwhelmingly preferred non-menthol cigarettes and perhaps that would be a more effective prohibition? The harm reduction argument of course is that some menthol smokers might stop or switch because they cannot abide non-menthol smoking but I would bet the same would be true of non-menthol smokers contemplating a future of undesired freshness.

If removing menthol products actually resulted in some people quitting (and thus lowering their health risks) this would end up as a benefit. However, it would be a cost if all that happens is that menthol smokers keep smoking but enjoy it less. So if there really is that racial divide on this, nobody is telling African Americans they can’t smoke, just that they won’t be allowed to enjoy it as much as everyone else. I doubt that anyone was really thinking this but it should have popped up on the radar considering that only a few decades ago, it was not uncommon to limit that same community to lower quality goods than would otherwise be the rule.

But to move this up to the level of a more general health-relevant concern, people who advocate reducing product quality have as their purpose reducing consumption and not shifting users to safer sources. What we have seen in tobacco is that the FDA flavoured cigarette ban has ended up being the impetus for attempted bans of all flavoured tobacco products and e-cigarettes. If the menthol debate results in menthol reduction demands for cigarettes, it is pretty well certain that it will generalize to smokeless products as well.

What would resolve the issue (from the harm reduction point of view) is if the same voice that promoted reducing the quality of harmful products would also promote high quality in the less risky products. Lower the menthol in cigarettes but leave it untouched in the safer products and actively promote them as mentholated products.

You need to make switching appealing and not just good for you. Safer alternatives should be given all the leeway in the world to be the tastiest nicotine products available. If product appeal drops across the board, there is less of an incentive for anyone to switch; you might as well then just keep on smoking.

By Paul L. Bergen

Obama criticized for use of unapproved anti-smoking therapy

Reported recently at FoxNews:

US President Barack Obama has a secret weapon in his battle against his smoking habit — celery, he revealed in an interview gaining traction Thursday.

First Lady Michelle Obama said earlier this month that her husband had not smoked a cigarette for almost a year.

In an interview posted late Wednesday, Obama confirmed to 4029tv.com that he had given up smoking for good — however the stresses of being commander-in-chief have seen him adopt a healthier addiction.

“There’s certainly days where I’ve got to grab a lot of celery sticks to make up for that bad habit that I gave up,” Obama said.

The POTUS has joined the legions of ex-smokers who have switched to using celery but officials at the FDA and some of the leading voices in public health warn that celery is not a proven anti-smoking therapy and is not a safe alternative to smoking.

Researcher Thomas Eissenburg who has investigated celery as a cessation aid described the results of that work as being inconclusive and not that promising. “We found smokers who had never used celery before and had them try it but found that most of them found it difficult to get a substantial amount of smoke while drawing on the stalk and subsequent cotinine testing found that not enough nicotine was being gleaned for this to really function as a satisfactory substitute for smoking.

Noted urinanalysis specialist Stefan Hesht warned that it has long been know that celery contains harmful chemicals.

Celery has always been known as a salty plant, containing a high level of what is knows as celery-specific salt, or CSNa. Consumption of CSNa has declared by major health organizations, like the Office of the Mayor of New York, to be a deadly hazard. To put the risk in perspective, if you consumed your entire calorie intake for the day in the form of celery you would eat well over 10 grams of CSNa, more than five times the recommended safe level.

When asked to comment on this, Leif Stock, a spokesman for the celery industry, responded that celery was historically considered salty tasting, but modern research has shown that it is actually contains more potassium, known as the “good salt”. He added that no epidemiology had ever shown a danger from celery and that the only tests of CSNa that had ever suggested any risk were animal tests, such as pouring large quantities of isolated CSNa on a garden slug. He added “when eaten in its natural form, the celery stalk poses no measurable risk, even to slugs.”

When asked to respond to this, Hesht replied:

Look, the fact is that when I test the urine of celery eaters, I find high levels of CSNa! It varies a little depending on where your celery comes from, Swedish celery for instance is quite a bit lower in CSNas but I can still measure it and if I can measure it, that means it cannot be healthy.

Among others commenting on this latest action by the President was Johnathan Winickoff, well known for his tireless advocacy in regards to public safety:

Of course being such an influential figure Obama places us in a difficult spot but the bottom line is that celery has not been submitted to the FDA for testing as a cessation aid. We really have no idea of what the long term effects of daily celery consumption are. Is it safer than smoking? Maybe. Do we know for sure? No, Nobody has done the tests that need to be done. I guess one thing I do know as a pediatrician is that celery seems tailor made for kids.

Roni Rabid, previously at the NYT and now at Legacy said that:

this sets a bad example for the kids. Our research has determined that if children see anything stick-like and particularly anything tubular being put in and out of the mouth, those kids are much more likely to end up smoking. This is why often as not you will see me sitting in the dark with Slanton Glance watching those scenes in those movies so we can better save the kids.

However, Jack Amis of the National Grocers Association said that while celery had no official clearance as a cessation aid, he himself was a previous smoker and was now entering his third year as a smoke-free but daily celery user. He said many celery buyers were former smokers or smokers who were curious about whether this would work for them. “We don’t really see kids buying these things” he added.

The FDA’s Larry Ditton said:

We realize that because Obama is Commander in Chief and thus technically part of the armed forces he is not allowed to use Champix or others of the class that could lead to a psychotic breakdown but it really is just a question of semantics. Champix is a proven cessation aid that has worked for a few people and celery is just a vegetable.

We cannot really promote celery in this regard and anyone who does is contravening WHO guidelines. And given the listeria outbreak of last year, our concern for public health means that we will keep fighting to take celery off the shelves until more testing has been done.

Could arguably the most powerful person in the world do a lot of damage due to an adverse reaction to this drug? Of course, and we or our good friends at Phizer would not feel any responsibility for any such actions but, we still believe that this sets the wrong example when instead of a vegetable he could be using one of the many fine drugs available to help him in these difficult times.

But it is not only presidents looking to this alternative. For those on the street, there are many who have found this to be the answer, at least for the time being. One long time celery user who preferred to remain anonymous said:

Other celery users I know feel a bit of pressure to then give up the celery as well but I don’t plan to. If its not hurting me and I enjoy it, why stop? I think what and the shape of what I put in and out of my mouth is my business and nobody else’s. And you know, I could never go back to smoking. Its just not as fresh and after you’ve used celery for a while you get to liking that crunch. I would miss the crunch.

But if they took it off the shelf. I don’t know. There’s a lot of us now and you take it off the shelves and you’ll just have some shady types setting up a green market, and then all these government types will have managed to do is make criminals out of many of us and back to smoking for the rest.

Nobody wants a President enslaved to Big Tobacco but is the tradeoff thousands of kids taking up the evil weed because they saw the big man on the stalk? Given his prominence this might be one case where a private hidden vice is more in the national interest than publicly flaunting an unproven substitute.

-Paul L. Bergen (with input from Carl V. Phillips)

One ban deserves another….

When the FDA banned flavored cigarettes in 2009, an action that resulted in quite a bit of press and plaudits but affected a negligible portion of the tobacco market, one wonders given the lack of any real evidence supporting that action, if it was simply to leverage more substantial actions.

Now we see the threat of a ban on menthol which since it actually affects many smokers is generating some resistance. Unlike ‘fruity” cigarettes which even most smokers did not know existed, menthol is huge. (I am sure the shadowy types invested in the black market are crossing their fingers hoping to see the ban happen.)

But even if the flavored cigarette ban seemed like a lot of ado about nothing, anything the FDA publishes is interpreted as grounds for like and extended actions (such as when their laughable e-cig assay was used to support a potential e-cig ban in the Middle East).

In the first iteration, in New York City, the ban was supersized to include all flavored tobacco products. The same is currently being considered in Washington state but Utah is where the real action is.

In Utah, the ban is being considered for not only smokeless tobacco products but also e-cigarette liquid. And addition to this, only e-cigarettes that have an on/off switch will remain legal.

Apart from our obvious concerns about smokers losing access to good and safer alternatives, these red herring child scare statements, and the nonsense that adults don’t appreciate flavor (because if you argue that flavor is targeted at children you are kind of implying that), this removal of flavor (and that e-cig switch) which are presented as “reasonable” conditions are anything but. They function as de facto prohibitions. (So far the only real complaints have been that pipe tobacco is at risk; Representative Ray suggested they buy it when they are travelling in other states but wasn’t concerned “flavored tobacco is flavored tobacco”.

Vapers and snus users are much more attuned to flavor than smokers. If you look at the user boards and blogs you have a plethora of talk about flavor and experimentation. In contrast, most smoker discussions (other than cigar and pipe) center on rights more than anything. It does not really matter whether this flavor orientation is a function of the products themselves or of how users are contextualizing them but that they appear to be intrinsic to the use. Remove the flavor and you are removing what appears to be quite important to just about everybody using them.

You know they also tried this in Wisconsin but when it was suggested that state money be used to persuade local governments to support a ban, ran up against a spoilsport Representative with with common sense, who said “the state shouldn’t be paying groups to influence local governments or public opinion”.

Now I am not one for conspiracy theories but if I were I just might tie together the facts that:
1. the board of the FDA Center for Tobacco was dominated by individuals with one foot in pharmaceutical products and the other in general anti-harm reduction and
2. Utah is specifically exempting flavored nicotine replacement products from the ban (because there is no way that kids would find candy flavored nicorette appealing) and
3. there seems to be a rising demand across the country that public funds subsidize these nicotine replacement products at the same time that
4. these safer alternatives that seem to actually help people quit smoking are being systematically attacked.

No. That just can’t be right because all those good people really care about you and me and they are working day and night to make sure we don’t make the awful mistake of quitting smoking the wrong way.

-Paul L, Bergen

Statements made at the Scientific Standards for Studies on Reduced Risk Tobacco Products meeting

Thanks to Bill Godshall, we can give you the links to some of the statements made at the Scientific Standards for Studies on Reduced Risk Tobacco Products meeting to advise the FDA on the minimum standards for scientific studies to allow the marketing of modified risk tobacco products, and for post-market studies of marketed products.

1. Statement from Scott Ballin

Excerpt:

I also suggest that we consider redefining our terms about the spectrum of products in the market place. Calling any tobacco product that is a not burned a ‘smokeless product’ is no longer accurate or even useful. I prefer to use the term Smoking Replacement Product or SRP because that allows us to look at the growing spectrum of noncombustible products (tobacco, nicotine, and alternatives) in terms of risks and relative risks and intended use, and to label and set marketing standards for such products based on those risks.

2. Statement from Bill Godshall

Excerpt:

Requiring additional scientific studies before a company can make these types of modified risk or reduced exposure claims would be a “truth tax” for far less hazardous smokefree alternatives, would unfairly protect cigarettes from market competition by lower risk alternatives, and would threaten instead of improve public health.

3. Statement from Elaine Keller

Excerpt:

We were astonished and outraged to learn that, decades before the invention of electronic cigarettes, we could have stopped inflicting smoke-related damage to our bodies without becoming nicotine-abstinent. We were deceived about the relative safety of non-combusted tobacco products. The government and so-called public health organizations misapplied the word “safe” in the messages, “This product is not a safe alternative to smoking” and “There is no safe form of tobacco.” Most folks think they’re saying there is no safer form of tobacco than smoking. These messages encouraged smokers who did not want to give up nicotine to keep inhaling smoke, when they could have switched to products that reduce smoking-related disease risks by up to 99%! Their half-truths have killed millions of smokers and continue to do so today.

To provide your own feedback on this project…

Gulf States discussing total ban of e-cigarettes

Just yesterday the GCC Health Ministers Council (Bahrain, Kuwait, Oman, Qatar, Saudi Arabia, and UAE) set the stage for a total ban of e-cigarettes.

A statement issued by the conference underlined the “necessity for imposing a total ban” on e-cigarettes in line with the WHO guidelines and the findings of recent studies on the product.

Anti-smoking activists in the region have been campaigning for a ban on e-cigarettes, which are used as an alternative for traditional cigarettes, on grounds that it is more dangerous to the users compared to the traditional cigarettes.

I’m not sure why the level of misinformation regarding e-cigarettes is so astonishingly high in this part of the world but every few weeks there seems to be another outrageous statement such as:

Water vapour is absorbed by lungs, which can cause even lung cancer, says WHO report.

The US Food and Drug Administration (FDA) recently issued a warning to e-cigarettes users after it found the sticks contain carcinogens and toxic chemicals such as diethylene glycol, an ingredient used in antifreezes.

The recurring two items that seem to show up in almost every one of these articles out of this region are the FDA findings and the WHO advisory.

Oddly enough, the WHO advisory simply stated that there was no evidence yet for long term safety, and no non-anecdotal evidence that would support producers making cessation claims. This now close to three year old and rather restrained communication has through the wonder of the embellishment machine we call the media become a howling warning of danger.

And quite similarly, despite being widely dismissed as substandard work, the FDA report has become the official word on e-cigarette safety. What I fail to appreciate is why this report ever assumed the stature it did, and why (in the world) it achieved any prominence outside the borders of the United States. (Yes, I know they are a big country, and the FDA is well known but still, these are independent countries with their own research facilities, and some sense of national pride, are they not?)

Now of course it is quite possible that, just like most everyone else, the powers that be have an end in mind and then cast about for supporting (and tweakable) views.

One of the issues here is that we have authoritarian or tending toward authoritarian governments using tools generated in regions that are less so. As misguided as the FDA is, various agencies and the population itself act as checks on them, and as cynical as we might be about that process, it is still much more likely to end up benefiting the many than what happens in many other parts of the world. But then, these same tools generated in a democratic context, even if discarded on the home front, are then picked up by others to use.

So in summary, we have a substandard product assay from a far away country (otherwise often demonized in this part of the world) and a warning about proper product description from an international health agency being used as the main evidence to support the actions of a government to remove the availability to its people of a safer alternative to smoking.

And this too will be chalked up as a victory for the anti-smoking forces.

-Paul L. Bergen

Two Canadians scratch their heads over New York moving closer to banning e-cigarette

[Catherine and I write this with the warning to readers that we know just enough about U.S. politics to get at least something wrong. On the other hand, as we know from trying to understand our own country’s politics, being American might not have gotten us much closer to the truth.]

As most readers of this blog are now probably aware, just recently New York’s Assembly Health Committee overwhelmingly passed a measure (21-4) that would ban the e-cigarette until the FDA passes final judgment. This is, of course, terrible news not only for New York vapers, but also for all those would-eventually-switch smokers. Should this bill advance (it has yet to pass the Senate), a ban here could set a precedent for other states to follow.

Historically we (and we mean us two – we cannot speak for all Canadians) have always rooted for the Democrats in the United States, because being left-leaning ourselves, they have always seemed the better choice (just a little more like Canadians if that doesn’t offend anyone; we’d even say socialist, since up here that’s just another word, but we realize that down there it might cause some readers’ heads to explode). However, in light of the direction they seem to be going in recent years, both parties seem increasingly alien to us. As Carl explained in a previous blog posting, when it comes to drug wars and being anti-harm reduction (and too pushy in general when it comes to passing bills that limit people’s choices, ostensibly in the name of public health), the Democrats seem to be in the lead.

It’s strange that this bill has been passed by the same health committee that just last year defeated a bill that would have reduced abortion rights, on the ground of defending women’s choices. Now, a little over half a year later, this committee apparently feels that smokers do not deserve the right to reduce their own health risks by having access to a vastly safer nicotine product. So it would seem that they feel the need to protect women’s choices, but not the safer options for smokers? We’re baffled. All this, of course, is done in the name of public health. However, as Chris Snowdon has pointed out, Linda Rosenthal (the Democrat who sponsored the bill) has indicated that it actually has more to do with her own anecdotal experience with cigarettes. She has stated that because she quit smoking without the aid of e-cigarettes, so should everyone else. This does not quite seem in line with promoting a more equal society based on the acknowledgment that all people are different and that luck plays a part in whether we end up rich or poor, healthy or not healthy; this bill instead seems intent on punishing those engaging in something considered sinful. (At the very least it demands that only politically correct means of atonement – sorry, we mean “quitting cigarettes” – will be acceptable.)

Another crucial piece of this puzzle of course is that lawmakers seem to be unable to separate nicotine use from health effects. Fixated on the fact that these devices will allow people to continue using nicotine, it does not seem to matter to them, or they are too blinkered to see that what matters more is whether users are healthy or not.

In the January 18 Wall Street Journal Opinion Page, Barack Obama had an article published in which he wrote

I am signing an executive order that makes clear that this [striking the right balance] is the operating principle of our government. This order requires that federal agencies ensure that regulations protect our safety, health and environment while promoting economic growth.

In his e-letter, Bill Godshall pointed out that this could easily read as an endorsement of harm reduction and in particular, electronic cigarettes. Currently the amount of money and effort being spent (and much if not all of that being financed by the American public through taxation) to erect barriers to e-cigarettes and their use is at the best a colossal waste of money and at worst a betrayal of the public trust.

Unfortunately Obama’s seeming valuation of consensus over leadership, as further evidenced by yesterday’s State of the Union address, holds out few hopes of changing the present sorry state of affairs. In 2009, Ethan Nadelmann held out the hope that change for the better would arise out the recession; that tighter budgets meant, as he put it, “we can no longer afford to pay for our prejudices”. He was referring more to the drug war and the high rate of incarceration but the remark would aptly fit anti-tobacco policy as well.

America is still in recovery and has additional challenges to face at this time – a rocky road for the foreseeable future – and if Obama is like the driver, he is also suggesting that the others in the car (including the kids presently fighting in the back) should help steer. With any luck, he’ll pull over to have one of his rare smokes, maybe try an e-cigarette, and then maybe his anecdotal evidence might outweigh Rosenthal’s; when it comes to anecdotal evidence, as we all know the validity of anecdotal evidence is directly related to the fame of the expounder.

The promise of vaping, quite possibly the holy grail of tobacco harm reduction, should not be being sullied by the likes of Rosenthal, who does a little research and finds e-cigarettes “too mysterious” to be allowed. This is just a baby step up from the public warning on e-cigarettes from the Department of Health in Manila that these products not only might not help with quitting smoking but “worse, it could even deliver nicotine to the lungs”. It’s just sad when the person on the street seems to know so much more about these than the people who have the power to ban them.

At the end of the day, however, this bill has advanced whether we like it or not, and our disappointment in the the New York Assembly Health Committee is obviously great. It will be interesting to see if hope is revived through the Senate (currently held by the Republicans), where there is still a chance for some intelligence on this issue and thus its defeat. Considering the track records on this issue, it would be simple enough to continue castigating the Democrats and expecting more of the Republicans, but party memberships seem to be only one small indicator of where someone might stand on this issue.

If there is ever an issue that should transcend party lines, it is access to better health, and the protection of the right to choose that better health. Individual ideas about what people *should* be doing, and forcing them along that path in the name of public health (when it really has to do with purity), should simply not be on the agenda of any legislator, Republican or Democrat.

(Disclaimer: We cannot claim the slightest superiority in this issue. We speak from sad experience; we suffer because our “health experts” deemed e-cigarettes to be more dangerous than smoking banning them before most Canadians even knew what they were, and we also have a leader who, as much as we criticize Obama, would trade for him in a New York minute. )

-Paul L Bergen and Catherine M Nissen

Harm reduction needs to be easy: the case of RJR’s new switching campaign

As previously mentioned, we, like many others were quite pleased to see the R.J.Reynolds Tobacco Company Christmas season campaign suggesting that smokers switch to smokeless tobacco (report here). Since many people still think the turn of the year is a time for a turn of the leaf, the time is most appropriate to put forth a suggestion that just might make more of an impact than at other times of the year.

The ads make no health claims. The idea is simply to try the switch and see if you like it. The actual text for one of the ads reads:

If you’ve decided to quit tobacco use, we support you. But if you’re looking for smoke-free, spit-free, drama-free tobacco pleasure, Camel Snus is your answer. Logon to the Pleasure Switch Challenge and see how simple switching can be. Camel Snus _ it might just change the way you enjoy tobacco.

And despite this innocuous text, an FDA spokesman is reported to have said that they were “reviewing the claims”. Nice work if you can get it is all I can say. I just reviewed the claims (none) and it took about as long as it took to read the passage. I suspect the FDA charge will require a few professionals and a board meeting and a subsequent request for recompense from RJR.

Readers of this blog know that we wholeheartedly promote switching from smoking to smokeless forms of nicotine use and thus we experience a certain degree of frustration seeing that a company trying to do the right thing, that is the thing that advances public health, has to avoid mentioning any hint of this product being 99% safer than smoking. (Because even though it is true, it could run them afoul of some fairly strong regulations).

And not to mention (and what an odd phrase that is since it signals its exact opposite) that the only health references on these ads are huge banners implying severe danger. The ads mention a website where you can learn more (https://snus.tobaccopleasure.com/modules/security/Login.aspx) and there following content devoid of any positive health claims runs a huge banner saying Warning : This product can cause mouth cancer.

If I didn’t know any better, and time was I didn’t, that would have stopped me dead in my tracks. And if that is not enough there is a rather extensive sign in system (to make sure I am not a child I suppose), the which are known to severely reduce consumer participation. (A few of us have tried to get through this hurdle with little luck so we have not been able to evaluate what lies on the other side, whether truth does survive in the Matrix or not.)

This is a pretty important point. Though we do not know what lies in the promised land, there is some implication of valuable information (and information that is qualitatively different from what we already have been given). But getting there is not unlike the security requirements to board a plane (papers and pat down) except that when you are flying you know your destination and already have decided that the difficulties of negotiating security are worth the annoyance.

Given these requirements and the uncertainty of a payoff we would bet that almost no one has crossed over.

Several of us (and we are almost certainly more motivated than the average consumer or would be switcher) answered personal information questions for minutes, including asking for U.S. social security numbers (i.e., something Americans are constantly told not to share with anyone other than employers and banks for fear of identity theft; in Canada the government actually forbids the use of our version of that number for any non-tax purposes). But after going through all of that, it asked us to make a phone call and/or fax our identity papers to them. Riiiight. It is not like they are promising a coupon for anyone who gets in, or even a transaction — this is just to be able to read information. Those phone lines must be flooded with the, let’s guess, 1/1000th of interested consumers who are actually willing to go to all that trouble.

(Carl plans to post more on these ad later, so we will let you know what excitement lies beyond the barrier if one of us ever gets through.)

It would be easy to blame RJR for being too soft when they should be actively pushing the safer alternative but the fact is they have little choice. For simply revealing the same benefits known to anyone doing the research, they could be subject to substantial fines.

Kind of like trying to sell driving with seat belts not because it is safer but because it looks cooler or feels nice to have something around you while you drive.

The usual suspects have been quite vocal in criticizing the campaign, painting it as a competition for would be quitters. While it is true that some quitters might appreciate learning about this alternative, the tone of the ad clearly emphasizes those who have considered quitting but are not doing so. Moreover, since the health benefits of switching are effectively the same as those from quitting, the would-be-quitters lose little (and more than make up for it by getting to continue using a product they like) and their health costs (if there are any) are overwhelmed by the benefits seen by switchers who would not have quit.

That “more than make up for it” reflects the fact that if they freely chose switching when quitting was still an option, it must be because it makes their lives better, a point that Carl has analyzed at length. It brings to mind the sportsman’s assertion that “winners never quit”. I guess the paraphrase would be that those who choose not to quit must be winners. In any case, like winners, most smokers who want to quit do not do so either, at least not for a long while, though perhaps they would switch with these alternatives available.

– Paul L. Bergen