Health Canada’s anti-cigarette stance: Cui bono

Thanks to Health Canada, the e-cigarette climate in this country is an inhospitable one to say the least. There is no problem vaping if you can get them but availability is hit and miss.

Though the view in the community has been that Health Canada does not understand the nature of the product and thus are wielding inapplicable arguments against suppliers and vendors, what remains somewhat confusing is trying to understand what Health Canada has to gain in its actions. (We will assume for the sake of debate that it is purposeful in its ways – we would like to think but cannot presume that it acts in the public interest).

There is no doubt that vaping is massively safer than smoking. It is so much safer that if the whole population vaped rather than just a small portion of the population smoked you would still have a great reduction in smoking related disease. Were there no impediments to obtaining e-cigarettes it is likely that many smokers would switch.

So why the anti-vaping stance of Health Canada? Or to put it this way – who stands to lose if vaping becomes more popular than smoking?

1. The cigarette industry – dropping sales.
2. The pharmaceutical industry – a superior alternative to products that are both less effective and more dangerous. Again dropping sales.
3. The anti-smoking groups – less smoking means less need for activist anti-smoking groups.
4. Government revenues – less collected from smokers and less from tobacco settlements.
5. Health budgets – people living longer lives means increasing the national health burden.

Many of these would not hurt Health Canada. They might face budget cuts along with other departments due to shrinking tobacco revenues but that should be offset by their increased responsibility with more older but ailing folks to take care of.

So again, what do they gain by protecting tobacco and pharmaceutical interests? Do they not chafe from the internal contradictions which arise from encouraging harm reduction in every area except this one?

Note: I am pleased to announce that I have begun consulting for ECTA. While I do not anticipate any conflicts of interest (our goals are the same – improve the availability of e-cigarettes for vapers and smokers in this country) I should stress that my writing here should not be construed as communication from ECTA, These are my opinions.

What I will be doing however is writing more and more about the Canadian situation (perhaps eventually a dedicated blog). It is clear that, even in countries where strong infrastructures supporting vaping exist, attempts at banning continue. One of the great challenges in this country is to build those supports and knowing that every day that goes by more smokers develop a smoking related disease. Hopefully the day will come when Health Canada bestows on smokers the same respect it bestows on every other citizen. The true hope is for collaboration rather than conflict.

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.

There’s more elephants in the room or on contemplating the new user red herring.

Forgive the proliferation of other life forms in this title (and post) but it seems that whenever nicotine or tobacco are discussed, we end up wading knee deep through a bog of misinformation and ANTZ (thank you again Kristin Noll-Marsh for this most appropriate acronym for anti-nicotine and tobacco zealots). So we end up talking of caffeine and automobiles and unlike most other health related topics having to dress the discussion in children’s clothing so as not to enrage or offend.

Some time ago, Elaine Keller wrote in these pages about the nicotine as self medication elephant. But it is just one out of this herd thundering about and for the most part ignored by diligent and blinkered prohibitionists. One of the other pachyderms is that nicotine use is just another human behavior and a particularly popular one if history is a guide (and shouldn’t history constitute better evidence than utopian (or is it dystopian) fantasies?). But the tusker today is one that even many pro-THR activists and vaping communities are not talking about.

This elephant is the likely increase in the numbers of never before nicotine users trying snus or vaping.

From the ANTZ side this seems worse than smoking. After all, the promise of low risk nicotine use can only result in more people trying it and more people staying with it. Once health risks are no longer a sticking point, it won’t matter if the nicotine using proportion of the population goes up or down (as Carl Phillips has pointed out time and again, the economics of the case are that when you lower the cost of something, in this case the health risks, consumption will increase).

From their point of view nicotine use is intrinsically bad and any associated health risks are a side issue. We know this because if they did care about health risks they would be agitating for THR on every street corner.

But to the point at hand.

The central hope of THR is that low risk nicotine use supplants smoking. Currently more smokers than ever are switching and this is good. Every survey of vapers seems to come back with a result that implies that almost every vaper is an ex-smoker or a smoker trying to quit. Snus users (outside of Sweden) seem to be more of a mixed bag but the proportion of switchers seems to be getting larger there as well.

And if there is one thing both camps agree on, nicotine is not for kids.

But here’s the thing. The presaging of victory will be when we see more would be nicotine users starting with these products. ANTZ will be up in arms but if we accept that nicotine use is with us for the foreseeable future then only once initiation is typically with low risk products will that future be a better one.

Right now, vaping is almost considered as a post-smoking activity. While it is great that smokers have switched, isn’t it a little odd that smoking be thought of as a precondition for vaping? Should you be allowed only to vape or snus if you have first exposed yourself to a high risk nicotine delivery system? Should we only let you use seatbelts after driving for a while without?

No.

When you think that very little smoking will expose you to the same total risk as a lifetime of low risk nicotine use, you should be glad to see an uptick in new users. It is the only way that the transition to low risk nicotine use being dominant will occur.

And that is why, and we have already discussed this point often enough, low risk alternatives need to be at least as accessible as cigarettes. If someone (old or young) is about to try nicotine for the first time, that choice should not be weighted, as it now is, toward the one choice that might have serious consequences. As we have already seen in Sweden, once safer alternatives are both accessible and socially acceptable, cigarettes can become the less favoured option. The would be smoker turning instead to snus or e-cigarettes is not only virtually eliminating any health risks but is also making it more likely others will do the same.

We need to reach that tipping point.

(Just a note for the ANTZ: you can only ignore elephants for so long. Once you factor in the size difference, safety in numbers no longer applies.)

World No Tobacco Day 2011

World No Tobacco Day is soon upon us and I thought it might be useful to translate the original press release to reflect the real world implications of the FCTC treaty.

Some of us will be following this up with a blog post or two on how this treaty helps to maintain high levels of smoking-related disease. We do have a bit of a soft spot for this particular date since we launched our website, TobaccoHarmReduction.org on this day five years ago specifically to respond to WHO’s statement/position that all tobacco was equally harmful. In fact, locally we got more press on that day than WHO did for that year’s No Tobacco Day. (Assuming that they ever learned to swim in the first place, could they already have been jumping the shark?)

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The WHO Framework Convention on Tobacco Control (WHO FCTC) is the world’s foremost tobacco control instrument (hammer). The first treaty ever negotiated under the auspices of WHO, it represents signal achievements in the suppression of harm reduction and also in the oppression of all nicotine users regardless of whether or not such use has health consequences. In force since 2005, it is already one of the most rapidly and widely embraced treaties in the history of the United Nations, with more than 170 Parties. An evidence-unencumbered treaty, it reaffirms the right to restrict all nicotine users to only the most dangerous form of delivery and provides new legal tools to strengthen abstinence-only policies and wage a war on tobacco.

World No Tobacco Day 2011 will be designed to highlight the treaty’s overall self-importance, to stress signatories’ obligations under the treaty and to promote the essential role of the FCTC and WHO in demanding that countries meet those obligations.

Countries will be expected to obey the WHO FCTC as much as, if not more, than it did in 1996 when a resolution calling for this treaty was first adopted. Preventing tobacco use is the priority of this treaty. This year, thanks in part to FCTC efforts in obstructing access to safer alternatives, more than 5 million people will die from a smoking-related heart attack, stroke, cancer, lung ailment or other disease. That does not include the more than 600,000 people – more than a quarter of them children – who we will claim will die from exposure to second-hand smoke (according to the studies we prefer to accept).

As with any other treaty, the WHO FCTC confers legal obligations on its Parties – that is, on the countries (and the European Union) that have formally acceded to it.

Among these obligations are those to:
• Prevent public health policies from embracing harm reduction options.
• Adopt price and tax measures to strengthen the black market.
• Foster intolerance to even negligible exposure to tobacco smoke.
• Prevent safer (smokeless) tobacco products from being promoted as any more appealing than cigarettes.
• Work to eliminate any additives or processes that make any form of tobacco use pleasurable.
• Prevent any packaging information describing one tobacco product as safer than another.
• Nag people about the dangers of tobacco use.
• Promote and subsidize pharmaceutical products to smokers.
• Complain about the illicit trade in tobacco products created by our other actions.
• Ban sales (that are already banned) to and by minors.
• Pretend to support economically viable alternatives to tobacco
• Ignore that for in some economies tobacco is the most viable crop.

The treaty also recognizes the importance of international coercion in forcing low- and middle-income countries to meet their treaty obligations. The campaign will focus on the following key message: that countries must fully implement the treaty even if most of the early mortality in those countries has other causes and even if implementing this treaty will deplete funding initiatives addressing those concerns.

Other key messages will include:
• The treaty embodies the desire and commitment of many anti-tobacco organizations and thousands of activists to have a tobacco- and tolerance-free world.
• Individuals should encourage and help their governments in their own oppression.
• The treaty should be duly appreciated by institutions and individuals alike as a landmark in the history of demonizing a plant and drug rather than addressing the variable health consequences of the delivery methods.
• WHO and the FCTC stand ready to browbeat countries into meeting their obligations under the treaty and its related guidelines.

The treaty has already proved its efficacy in political posturing and selling the concept of prohibition to the general public. In itself a success, this treaty has already formed a template and inspiration to globally address other public health issues such as alcohol consumption and inexpensive convenience foods. Nevertheless, more must be done for the treaty to reach its full potential. At their recent meeting in Uruguay, the Conference of the Parties urged all countries to progress beyond outmoded conceptualizations of public health and individual welfare and to adopt its guidelines instead. Furthermore, they reaffirmed their commitment to prioritize the implementation of intolerance designed to control and demonize non-pharmaceutical nicotine consumption.

On World No Tobacco Day 2011, and throughout the following year, WHO will urge countries to put the treaty at the heart of their efforts to control the global spread of effective harm reduction and the threat of low risk nicotine consumption.

By bowing to WHO’s call, countries will enhance their ability to significantly reduce any harm reduction efforts, maintain the high burden of smoking-related diseases and deaths to keep the FCTC viable, and to remove the possibility of safe nicotine consumption.

What these maps imply about tobacco control in the developing world

I ran across a fascinating resource (Worldmapper.org) which maps various health outcomes onto regions of the world and thus produces a global picture which when compared against the typical map indicates imbalances or concentrations depending on your outlook.

This first map is one of prostate cancer deaths; that is, a cancer unrelated to smoking history. What you notice is that Africa roughly approximates its shape on a typical map.

Now take a look at lung cancer deaths ( see map below).

What you see in an Africa attenuated to the point of almost disappearing. Not of course if you look at something like malaria (again see map below).

This of course is quite a simplistic observation to make with just a few specifically chosen maps but I think the point is valid. When the FCTC targets regions like Africa and asks (demands) that health resources be used for tobacco control operations, the money that would make a difference if applied toward malaria (or countless other endemic diseases …see more maps on the site), that would save many lives, is funnelled off into satisfying political aims with little effect on mortality.

What’s so wrong with being “second best”, anyways?

As discussed in a recent post on this blog, tobacco control advocates tend to think dichotomously when it comes to tobacco use: they lump behaviour into either abstention or use (with abstention being good, and use being bad).  Most people I talk to (and it seems, even many tobacco harm reduction advocates) seem to consider THR as a second best option to abstinence (creating three categories: smoking, THR, and abstention).  The general consensus seems to be that if you can’t quit smoking, then using a low-risk form of nicotine is acceptable.  If, however, you’re capable of quitting entirely, then abstention should be your only goal.

This categorization makes sense when you consider the political positions that people are in.  If your goal is eliminating the use of nicotine rather than improving public health (as it is with most anti-tobacco groups), then THR isn’t even second best… it’s no better than smoking.  Which is, indeed, the message being sent out by anti-tobacco zealots (with the dichotomies of abstention vs use).  For the THR advocates – who actually factor health into the equation rather than the all-or-nothing goal of nicotine abstinence – it’s a little trickier.  My own opinion on this tendency to place THR in the second best category is that it’s probably the result of trying to be as politically correct as possible in a politically incorrect field.  THR is the “fine, if you absolutely must use nicotine, then at least do it in this safer form” category.  Most of the people who I’ve talked to and who are aware of THR also think that it is the second best option.  The majority of smokers I know who have managed to switch would still like to quit nicotine entirely at some point (although for the years I’ve known them they have not been successful, and some feel a sense of failure about this fact).

From our view, however, THR can be the best option for many people. We’ve discussed the welfare perspective a few times on this blog and elsewhere (like here, here, here, and here), the idea being that abstinence is not necessarily the best idea if you consider a person’s quality of life.  Forcing someone to quit a relatively innocuous drug that provides them with cognitive benefits seems particularly unnecessary; if people benefit from nicotine and have the option to switch to a safer delivery mechanism (and find it satisfying), then using low-risk nicotine products is no longer the second best option, but the best option (this goes even for some people who don’t smoke at all).  In fact, for some, nicotine is such a boon to their quality of life that to go without it would inhibit their ability to function on a day-to-day basis, making the adoption of THR a clear win for them.

(In fact, we can argue that adopting THR is probably the best immediate option for any current smoker, period, since the health benefit of switching to a low-risk product right away is actually better than repeatedly trying to quit and failing over a few months.)

Viewing things in black-and-white reflects a tendency in our society to view things as either winning-or-losing.  Second best is not exactly what most people strive for in a competition; if THR is considered second place to abstention, it seems to infer that since you’ve only merely switched to a low-risk product instead of quit entirely, you’ve lost the race (in particular, the purity race).  And if you think that first place is simply not achievable (abstinence being first place in the mind of tobacco control), or you end up trying to achieve abstinence several times and fail miserably in the process (even though you’ve been told time and again by anti-smoking groups that abstinence is possible for everyone), it’s going to feel pretty damn discouraging (and may end up resulting in learned helplessness).

If, however, the THR option of “second best” is promoted as more of a desirable option (and in fact the best option for many people) rather than just a sad second place to abstinence, we may have more people warming up to the idea.  Since THR doesn’t ask people to make the huge adjustment that abstinence demands (because so many low-risk nicotine products are indeed still satisfying), it’s much easier to adopt.  And because using low-risk products is roughly the same as abstention from a health perspective, then whoever has the biggest number wins.

So why not put smokers in a win-win situation with a quit or switch message?  Either one gets you to a healthier place.

CMNissen

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

If you pretend to be doing honest research, don’t punish people for believing you

Elaine Keller forwarded me this posting (at e-cigarette-forum) recounting the experience of someone who made the “mistake” of bringing up harm reduction concepts at a “Tobacco Cessation Summit”.

At the first of the three sessions, participants were asked to come back with some new ideas on how to decrease smoking rates. Our writer took the assignment seriously, did a little research, and ran across some of the same ideas and information that we regularly discuss on this blog. At the second meeting, assuming that the request for thoughtful and creative input was genuine, he shared what he had learned. It is important to note that he did not actually promote an approach, did not say that he supported harm reduction but simply that it was out there and should be introduced as a potential partial solution.

Before the third meeting took place, the person running the summit sent a letter to our writer’s superior and asked that he not attend further. She accused him of promoting harm reduction and e-cigarettes and misleading the group. This writer, like most of us who once thought that anti-smoking activists are really motivated by improving public health, had to revise his ideas about both the goals and the transparency and morality of anti-smoking organizations. In his words:

This whole thing is sad on so many levels. If an organization just wants to say that they have a narrow agenda and only wants to do certain things, fine. Just say that and don’t say that you want people to get new ideas and present them.

What happened here just shows me firsthand what we have all been saying: health isn’t even on the agenda anymore.

As I say above, most of us have had to revise our ideas about these groups. Since like everyone else we consume the same information, we also start with the view that these groups are working hard to pursue all possible means of improving the health outcomes of smokers, that they genuinely care about not only people and health but about the free exchange of information. I have many personal experiences of being shut out of smoking and health discussions but will recount just one – about the time I also made it two days into a three day conference. And like our writer above, I too was ejected on the third day. (Sounds almost biblical that….and on the third day…)

I was relatively new to the field and not as cynical as I have become since. I really thought that if we all got into the same room and just talked that not only would they see what seemed so obvious to me but also that I might learn something from them. After all, these people were not just activists but physicians and academics, people who had spent considerable time in arenas that championed the acquisition of knowledge and being open to new ideas but still tempered with a sense of social justice.

In 2006, I was attending the World Congress on Internet in Medicine (in Toronto) which covered everything from educating through the net, to net based research to remote surgery. Still back in Edmonton, I found that if I flew out a few days earlier I might be able to attend a satellite conference, a workshop, on web assisted tobacco intervention. It was described as:

will provide an opportunity for those engaged in WATI to meet with eHealth specialists to exchange ideas and share knowledge, promoting collaboration opportunities globally between sectors and between practitioners, researchers, and funders.
The aim is to lay the foundations for developing a global community of practice within WATI and eHealth by drawing both tobacco control and eHealth researchers together working on areas of common interest. (Link)

The larger conference was open to anyone willing to pay the cost of admission and fill out a normal registration form but this workshop also asked that you sign a disclaimer that you or the institution you were part of, had not received any support now or before from a tobacco company. Being new to the area, I was uncertain about how (or whether) to fill this out. I knew I had been hired for my capabilities and not any ideological orientation but also that my position existed due to a large unrestricted research grant to the University of Alberta School of Public Health from a tobacco company that was administered through the university. My paychecks were normal U of A School of Public Health paychecks. I was also uncertain as to whether this was a request or a demand (surely not an actual barrier to participation? This was the open access world of science, was it not?)

I was also uncomfortable about the idea of having to sign what seemed like a loyalty oath just to be admitted to a scientific discussion. It reminded me of years earlier on a visit to the States being asked to sign a declaration that I was not now nor had ever been a member of the Communist party. Whether or not I had been, seemed to have absolutely nothing to do with my purpose nor was it any business of theirs. (I did fill it out and sign it at the time. I was a teenager and it seemed too ludicrous to jeopardize my visit to Portland and filling it out felt like participating in a bizarre and outdated ritual from a strange land).

Since that time I have discovered that tobacco harm reduction is so disfavoured that, if you wish to work in the area, the tobacco industry is the only source of funding. If you are exploring safer alternatives you need to examine tobacco products and to not engage with industry is to cut off the only entities that actually conduct research into these products as products that people use rather than as abstract political points.

To return to the narrative thread here, what I ended up doing was faxing (yes, we were still faxing in those days) in my form but without including the disclaimer. I did not receive notice that I had been accepted but just thought I would show up and see what happened. I did and just as Woody Allen observed “80% of success is showing up”.

The first night was a showing of Thank You for Smoking where I raised the point that I thought that in this case the progress made in getting smoking out of films resulted in eviscerating the anti-smoking message. (For those who have not seen it, though the book contains many smoked cigarettes, the film has next to none: read the book by Christopher Buckley, it is better). Nobody really responded to my comment but no one argued against it either.

The next day, and by this point I felt the administrating secretary eyeing me, we alternated hearing reports on cessation operations and forming small groups to come up with new ideas. Though I did not parade tobacco harm reduction in front of the crowd, if directly asked about my area, I did volunteer THR as my interest. In the meanwhile, I held my tongue when faced with dogma rather than information but in general took the approach that I was there, as I thought the others were, to learn from each other. A couple of them even brought up the idea that maybe they should be considering smokeless tobacco as an option and while the idea did not go far, neither was it shouted down. Unfortunately, I also got the impression that these same people would never have admitted such broadmindedness outside of a closed small group meeting.

Later that day, I was approached by the secretary saying that they still needed the disclaimer signed. I said that I was not sure I could do that, that I really was not sure what I should put. The head of the conference was called in and when he heard I was from the U of A School of Public Health said I would have to leave since tobacco money had been accepted by that institution. I tried to argue the point, asking whether we weren’t all really after the same end, less smoking and better health, but that, as well as the entreaties of some others in the group who appeared to think it would be better if remained, did not seem to matter much.

What I discovered later was that though the conference was Canadian, and I was Canadian, my right to free association in my own country was taken away because the major funders of the conference included the U.S. government and closely associated American quasi-NGOs, and they had insisted on the disclaimer as one of the conditions to their support. This is not uncommon. I, and my colleagues, have never been able to attend the major, albeit grammatically challenged, conferences on Smoking Or Health, including the one that was held in Edmonton (our city, clearly chosen to harass us) even though we were the largest tobacco and health (the correct grammar) research group and only internationally-known researchers on the topic in that city.

On the bright side, while waiting for an elevator during the conference following that workshop, I was approached by someone from The American Cancer Society saying they were strongly in favour of THR, and so were many of their colleagues but they still had to toe the party line. This to me was the high point of sessions; there were cracks in the facade, new voices were rising in the organizations, things could change.

But that was five years ago and that organization has since become even more adamantly anti-harm reduction.

Though support for THR has exploded during that period, anti-tobacco groups have solidified in their extremism. Apparently their loyalty oaths, intimidation of any dissidents, and wielding of their enormous wealth have succeeded in shutting down or driving away any independent thinkers among their younger personnel. This includes those that are ostensibly focused on preventing diseases rather than being anti-tobacco per se. As the forum poster noted, if an organization wants to call itself simply anti-tobacco (or anti-nicotine if they also oppose e-cigarettes), so be it, but it approaches being fraud for an organization to call itself the American Cancer Association, but to oppose substitution of low-risk nicotine products that cause no measurable cancer risk, let alone to claim to be the American Lung Association but to fiercely oppose low-risk substitutes for smoking that have absolutely no effect on the lungs.

I am reminded of any of several quotations along these lines:

“As soon as men decide that all means are permitted to fight an evil, then their good becomes indistinguishable from the evil that they set out to destroy.”
– Christopher Dawson

Of course, it is not so clear that anything these groups are fighting is actually evil, but there can be little doubt that their censorship and politics of personal destruction are.

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

Saying one puff can kill is saying you might as well smoke

If you are going to approach the issue of tobacco as a war, that is as a political rather than a health issue, then best your chief physician should be a general, and in that respect Regina Benjamin does not disappoint. Though her one puff claims are quite dramatic, she still has some way to go to match her predecessor, Richard Carmona’s statement of “No matter what you may hear today or read in press reports later, I cannot conclude that the use of any tobacco product is a safer alternative to smoking.” (congressional testimony at “Can Tobacco Cure Smoking? A Review of Tobacco Harm Reduction” (2003)). Possessing the strength of character to dismiss all possible future evidence that might be laid in front of him, he also was at least forthright enough to admit that he would work toward banning tobacco altogether.

But she has a good start here.

The one puff theory falls into the fine old tradition of taking infrequent and highly improbable events and presenting them as likely. The first that came to mind was the one time trying cocaine causing a heart attack in healthy individuals scare from some time ago but even within tobacco there are other variations such as 15 minutes near a smoker can kill you to the that one cigarette will hook you (thoroughly debunked in a recent article in Harm Reduction Journal and forthcoming followup by Carl Phillips in the same journal) and it is really not too much of a stretch to connect this to the Californian belief that even an image of smoking in a movie (as opposed to murdering or speeding) will create a smoker (but not a murderer or speeder).

So one puff can kill a never smoker.

So if I am a really subtle assassin I will do the research that determines that my target is vulnerable to cigarette smoke and then just hire a few smokers to stroll by. But like the hitman who is slyly sends his victim out golfing in the rain, I would end up as the extremely subtle but also unemployed hitman.

Like any ludicrous anti-tobacco claim this one puff claim is being uncritically repeated from coast to coast and I’m sure that some of the people buying in must be smokers themselves who are the greatest evidence against this claim meaning anything at all.

If you take a ten cigarette a day smoker and accept the general idea that the average smoker takes ten puffs off of a cigarette that gives you 100 death defying puffs a day. Since the idea of smoking leading to premature death and disease comes from the concept of a lifetime chronic smoker (let’s say from 18 to 68 years old), we now have just over 1.8 million puffs. We also have an accepted notion that it is only 1 out 2 or 1 out of 3 smokers who die from smoking so if it is a fatal puff that kills, we have an occurrence of between 1 out of 3.6 million to 1 out of 5.4 million puffs. And even suggesting that 1 out of 5 million puffs kills assumes that there is no cumulation of damage from one puff or year to the next, which is obviously incorrect.

The only reasonable conclusion from this is if one puff can kill a non smoker then smokers must be the hardiest people on the planet. (And looking at it another way, despite the long term risk, smoking could be interpreted as being protective against the sudden premature traumatic one puff death the non smoker would be vulnerable to.)

In fact, if you have already survived 100,000 puffs that might be some indication that you will survive the rest (if you buy into the one puff idea). In other words why quit ever? And even if you are a never smoker, it is quite likely that you have already been exposed many times to a puff here and there, and not died, so maybe starting is less dangerous than you thought.

Even if it was one specific puff that was the trigger of fatal events in the smoker, it makes much more sense to think of smoking as a combination of wear and tear with some smaller risk of a trigger component. We are pretty sure that the more you smoke not only does your likelihood of disease increase, so does the everyday sort of annoyances like shortness of breath, sore throat, etc. And we know that when you quit smoking some of these effects disappear and over time your risk of dying from tobacco use diminishes drastically. And it does so over time.

It is sometimes useful to note, for purposes of theoretical analysis, that for any given smoker there must one particular puff that will be the point of no return [Phillips Harm Reduction Journal 2009]. But this is not because that puff was uniquely bad and if the smoker had waited until that day to start it still would have killed him. That puff is fatal because of the wear and tear from the previous few hundred thousand or million puffs have brought the smoker up to the point where just one trigger is needed.

The SG actually delivers this “you might as well smoke all you want” more directly by stressing that light smoking is very bad for you. She is telling light smokers that they gain little by not being heavy smokers and she is telling heavy smokers to not bother to cut back.

Rather than hearing some new ideas on how to actively reduce the harms associated with smoking, all we are hearing amidst the thunder of the cannons of the last SG report, and the latest reports that second hand smoke is killing everyone in the world, is another “you’re all gonna die”.

– Paul L. Bergen

FDA Loses Appeal, Can’t Ban E-Cigarettes as unapproved therapy (yet!)

[Corrected Version — see end]

A U.S. Court of Appeals today issues a judgment prohibiting the FDA (and thus the police powers of the U.S. government it was employing) from keeping NJOY (and thus others) from importing e-cigarettes into the country as an unapproved medical device/drug.   This is good news indeed for public health.

But let’s not get too excited yet. No one wants to rain on a parade, in particular when most of the news regarding this truly remarkable alternative to smoking tends to be either composed from fabricated health concerns or just dismissive.   Had this ruling gone the other way, e-cigarettes in America would truly have been in jeopardy.   So the first instinct is to be elated (and you will find plenty of that in almost every other blog about this, we would guess) but, and the metaphors are starting to pile up here, the war is not yet won.

Law and facts can change.  The appeals court emphasized that FDA had produced no evidence that anyone had ever been harmed by an e-cigarette, but the extremists tend to find whatever they are looking for, whether it is there or not, so though the evidence may not change, the “evidence” may change and another case might follow. As the appeals court pointed out, Congress can always choose to change the law so that e-cigs can be regulated however the FDA prefers, or could even ban them outright.

The law is what it is, and need not have anything to do with what is good for people. Eventually in free societies most laws find their way to being good for people, but there can be a lot of detours on the way. The court said that the law says that FDA’s new authority over tobacco means that they can only regulate e-cigs as they do other tobacco products, not as therapeutic devices (so long as the manufacturers do not make therapeutic claims). Kind of an amusing irony. But our amateur reading of the law suggested that interpretation was far from certain, and we will admit that we are not entirely sure whether an appeal to the Supreme Court or some new case might change this.

We as scientists, policy analysts, educators, and THR advocates have strong opinions about what the law should say in this matter, but find it unclear what the law actually does, let alone will, say. We were asked to file a brief in this case but declined because the decision was about what is allowed under regulatory law –something that we have some knowledge about, certainly, but cannot claim expertise. Though public health concerns entered the discussion, this was not a decision about what is right for public health or liberty.

From a public health and good government perspective what FDA did was unconscionable anti-tobacco extremism, and Americans’ health, welfare, and liberty were well served by this decision.  But the same FDA that wanted to ban these products will be regulating them as tobacco products, and is likely to target them to discourage THR and to flex its muscles, especially after being embarrassed the first time around. Among the FDA arguments leading to the decision was

“The FDA has also offered a consequentialist argument, namely, that understanding Brown & Williamson in this fashion leaves the FDA severely thwarted in any effort to nudge e-cigarettes toward relatively healthful forms (or at least away from relatively unhealthful ones).”

On the face of it, this is a rational argument for making products safer which would be to the public good. But the power to regulate is the power to destroy, and FDA can easily create safety regulations that effectively bring about the ban they wanted. Moreover, we already know that in tobacco regulation the FDA seems intent on focusing on products in isolation, making cigarettes a little bit safer and perhaps making smokeless tobacco a little bit safer, but ignoring the fact that all smokeless tobacco (or e-cigarettes) are safer than all cigarettes. In other words, the FDA claims to want to promote harm reduction at the product level but not at a user or population level. And the extremists still call the shots there, and they are far more intent on stopping people from discovering low-risk products than they are about reducing use of high-risk products.

In summary, the news is good even if it is not perfect. This has been a very good day for e-cigarette users, for smokers, and for public health in general. Let’s hope it is more than just one good day.

[This version reflects a correction of an error: We thought that this decision meant that there had to be one more final decision in the legal process to confirm it, rather than it being the final world as it is (unless the Supreme Court weighs in). This is further evidence that we should not be offering opinions about what the law says!  We will stick to assessing what it should say.  That and our main points here: our concern that the law could easily change and the concern that FDA still gets the last word.]

– Carl V. Phillips