Monthly Archives: December 2012

“Craving” and other annoyances from the FDA meeting

by Carl V Phillips

The FDA hearings that I mentioned previously went fairly well.  Two of the panel members were anti-tobacco extremists from the Center for Tobacco Products (CTP), and were looking for any excuse to further their crusade.  But the majority of the panel appeared to entirely professional and interested in doing their job.  They paid attention to the testimony, and seemed to consider almost all of it to be productive and almost all of it to represent useful contributions to a shared cause.  In other words, it was really refreshing, and very unlike the CTP; notice in particular that I am not suggesting that this corner of FDA are liars.

Not that there were no liars present.  The most striking thing about the meeting was that the speakers representing the tobacco industry and the pharmaceutical industry, as well as the consumer advocates (in my obviously biased opinion) were all serious, honest, and science-oriented.  They all had their own agendas, of course, but all were on the side of public health, as was the majority of the panel as far as I could tell.  This contrasted markedly with the NGO representatives (American Cancer Society, American Legacy Foundations, and a few others) who were doing anti-scientific rhetorical backflips in their dishonest attempts to claim that allowing broader marketing of pharma products for THR was a good idea, but the exact same logic somehow did not apply to smokeless tobacco or e-cigarettes.  I have to think that any honest observer could see right through their lies.

One particular annoyance, a fundamental anti-THR lie that FDA was dealing with (though not their own fault, except perhaps historically) was the concept of “cravings”.  This shows up in claims like, “NRT products are designed to reduce smokers’ cravings for nicotine.”  What is interesting about this concept is that in a better world, it would be spot-on and potentially useful.  That is, the common language meaning of the word does have relevance and particular usefulness:  It could be that someone genuinely would prefer to be abstinent from tobacco and nicotine, but keeps coming back because of some short-term urge that is different from a genuine preference.  The word is not well-defined, but you could see how it could be wrapped up with withdrawal symptoms rather than what we would call benefits of using the products.  In that case, offering a drug that eliminates that craving would have obvious value.

The reason that this is a backdoor invocation of one of the fundamental anti-THR lies (specifically, that there are no benefits from nicotine) is because that “different from a genuine preference” caveat is ignored by the tobacco control industry.  Instead they use the word “craving” as part of their fiction that no one actually prefers to use nicotine, and that there are no benefits of smoking and other product use, and so users smoke just because of something the call a craving.

I was surprised to learn that the FDA, in this context, is statutorily required to deal with the concept of craving.  That explained why they asked a series of seemingly nonsense questions about cravings to Johnathan Foulds, who answered in the same terms before finally getting a bit frustrated and pointing out that there was no definition of the term that set it apart from “a desire to smoke”.  (Prof. Foulds, a good scientist who is a long-time supporter of THR, was there representing the Society for Research on Nicotine and Tobacco, which is very much an ANTZ group posing as a scientific organization.  Thus, he might have felt a bit trapped in terms of what he could say.)

If there was honest research on this topic, then maybe we could make use of the specific concept of craving and deal with it.  But given that most of the “researchers” (e.g., most members of SRNT) are just activists who are pretending to do science, such words just create problems, not value.  There is certainly something to the notion of craving, but it is less important than normal consumer preference.  As I had already noted in my testimony, nicotine is much more like any other high-value consumer product than it is different.  Low-risk nicotine products are a good substitute that fulfills that preference, but NRT as a method to merely reduce cravings fails miserably as a method for stopping smoking.  Why?  Because those cravings are largely unimportant compared to the preferences.

This brings up a lie that lay just beneath the surface of the whole discussion, mentioned only by the consumer advocates and vividly recounted in the personal testimony of individuals who testified as stakeholders:  NRT does not work for its currently stated purpose, even though it works pretty well (though not nearly as well as higher-quality products) as a substitute.  But this initiative is progress in terms of dealing with that.

More generally, it was frustrating to observe the FDA panel asking questions as if there is legitimate and useful science not just on “cravings” but in a variety of areas related to the topic.  The representative from Legacy, in particular, presented testimony and answered questions for longer than anyone, pushing the lie that most of what is published by the tobacco control industry is science and not junk.  The ANTZ can get away with that when being judged only by their fellow ANTZ, including the CTP unit of FDA.  But it might be that the more serious and scientific side of FDA, the drug regulators whose policy on NRT could carve out space for other THR products, will not fall for it.  We shall see.

Phillips testimony for FDA hearing on recognizing tobacco harm reduction

by Carl V Phillips

The title overstates a bit, but next week’s FDA hearings (official government announcement here) on whether to allow pharma nicotine products to be able to officially (“on label”) be used for long-term THR rather than just for the magical rapid weaning off of nicotine that they are supposed to accomplish.  Since they are approximately useless for the latter and are mostly used for the former anyway, this is not a huge stretch.  But recognizing the reality of THR would be a big step for the FDA, similar to what the UK’s MHRA has already done.

FDA is not really admitting that this opens the door to properly recognizing THR, but it does, and so several of us who are interested in THR are testifying on various points.  Annoyingly, the government wanted us to submit not just our slides, but an actual text of our statements a week in advance.  There are various conspiracy theories about the reason for that, but mostly I just find it a bother since I never write out the text of my talks, but usually put a lot of detail in the slides.  But since I had to do it, I might as well make use of it here, so….

Testimony for: FDA Actions Related to Nicotine Replacement Therapies and Smoking Cessation Products; Report to Congress on Innovative Products and Treatments for Tobacco Dependence; Public Hearing

by Carl V Phillips PhD

17 December 2012; Silver Spring, Maryland

I am testifying as a private citizen and stakeholder, speaking for myself based on extensive professional experience and expertise.  I am a long-time advocate and researcher on tobacco harm reduction.  I have worked in this field for more than a decade as a researcher and educator, and have published roughly a million words on the topic.  I am also an informed, consciously-motivated, occasional user of low-risk tobacco products, which I find to be quite beneficial, and clearly worth the unmeasurably small risk that they pose.

In response to Question 4.4, which asks about identifying harm in this context and identifying which harms are of particular importance, I have the following observations:

[Note:  Full text is: 4.4. With regard to innovative products and treatments for ``reduction in the harm associated with continued tobacco use'': a. How should the ``harm'' be identified and measured? b. Is there a range of harms that might be addressed, and if so, which are the most important to address?]

Harm should refer to actual harmful effects.  This seems rather obviously, but there is a remarkable failure to follow this guideline in the discourse on this issue.  Life-threatening disease risk is an important harm.  Immediate problems of functioning are also an important harm.  “Addiction” is not a harm in itself (even setting aside that it is not even scientifically defined).  It might be a reason that people do something that actually causes harm, but it is only that actual harm that should be counted.

“Harm” must be considered in net term, as is done for treatment drugs or anything else the government properly regulates.  Nothing is harm-free, but harm may be low (or trivial) compared to benefits.  The common approach of naïve extremist activists approach, saying “this has a harm and therefore is bad” makes terrible public policy, but that is what you get if you do not consider full net costs and benefits.

To consider net effects, first requires considering the health benefits of using a tobacco harm reduction (THR) product as compared to abstinence.  There are psychological benefits and aids to basic functioning from nicotine use for a non-trivial minority of the population, and this is a highly important consideration.  Second, the net must consider health benefits that may not be considered “health”.  Acting as if nicotine is purely a treatment for disease, rather than recognizing it as a consumer good that serves other preferences, is simply out of touch with the obvious reality.  Many people use nicotine because they like the effects, and this is another highly important consideration.  If the “D” side of FDA are not accustomed to dealing with such goods, perhaps those on the “F” side could help (or anyone else in government who regulates any non-drug consumer goods).

Third, net health benefits need to based on the probability-weighted “but for” choices.  For example, if there is a 20% chance someone would be abstinent, but for the promotion of the THR option, and 80% they would continue smoke, then you need to compare any harms from the THR to .8 times the risk of smoking (a comparison that overwhelmingly favors the latter).  It is simply out-and-out wrong thinking to compare the harm from one option to some unrealistic world that some people consider a best-case.  This is not an odd concept: treatment drugs are evaluated based on their net effects, considering the harm from not getting the treatment.  Moreover, the calculation of the net harm needs to recognize that some of the methods for pursuing abstinence (e.g., Chantix) are quite hazardous in themselves.  And, most important, if someone tries to achieve abstinence but relapsing for a while, and as a result smokes for just a couple of more months, the resulting risk is (for the average smoker) greater than from than using a low-risk alternative for a lifetime, as I argued in my 2009 Harm Reduction Journal paper.  This means that pursuit of abstinence is often a higher risk alternative to THR.

In response to Question 4.6, which asks about how FDA and other HHS agencies can help promote public health in this context,…

[Full text: 4.6 In regulating the innovative products and treatments referenced in section 918(b), how can FDA and other HHS Agencies act to ensure that the three effects mentioned in section 918(b)--total abstinence from tobacco use, reductions in consumption of tobacco, and reductions in the harm associated with continued tobacco use--are achieved as broader outcomes, in a manner that best protects and promotes the public health?]

…far and away the most important thing to do is:

Stop lying!

Units of HHS are the world’s biggest anti-THR liars, and have been since I started documenting anti-THR disinformation campaigns about a decade ago.  The pervasive message to smokers about low risk tobacco and nicotine alternatives coming out of HHS has been and still is “you might as well smoke” (a phrase that was the title of my 2005 BMC Public Health paper that reports some of my research on this disinformation).  FDA has now joined other agencies in publishing disinformation designed to discourage smokers from switching to low-risk alternatives by grossly exaggerating the risks of those alternatives using false and intentionally misleading claims.

These anti-THR messages encourage people to smoke when they would otherwise use a smoke-free alternative that poses risks that are two orders of magnitude lower.  No conceivable amount of low-risk product usage could cause as much health harm as the smoking this causes.  Following the phrases from Question 4.6, respectively “total abstinence from tobacco use” and “reductions in the harm associated with continued tobacco use”, the current practice of promoting the former at the expense of encouraging the latter is guaranteed to be bad for public health.  Obvious and simple arithmetic makes that clear.

Regarding Question 4.7, about what to consider in FDA’s premarket evaluation of new product candidates,…

[Full text: 4.7. How can these broader outcomes be taken into account in FDA's premarket evaluation of new product candidates?]

…I reiterate that focusing on the net on smoking is most important.  Indeed, from a population health perspective, it is the only thing that matters.  Everything else is a rounding error.

In addition, premarket evaluation depends on having a correct basic model for what motivates consumers to choose particular products.  People act based on incentives which include health risks, of course, but also include many other factors.  Consumers making choices are not mere patients – sick people seeking treatment for a disease and nothing more.  If they are treated as such when predicting what they will do, the predictions will inevitably be wrong.  Even worse, if they are just treated as black boxes who are assumed to just make choices at particular rates because that is sort of what other consumers did in the past under difference circumstances, then you will have garbage in yielding garbage out.

I have a lot more to say about this, but only seven minutes total, so that is where I will end.

Fundamental lie: tobacco has no benefits, only marketing

by Carl V Phillips

The ANTZ often appeal to the “think of the children” argument.  But when they say that, what they are not saying is that they consider all tobacco and nicotine users to be children.  And not just children, but either mere toddlers or children who have not been raised in a commercial culture where merchants try to tout their wares and the rest of us work hard to ignore them (which is to say, they were somehow not raised in any post-agrarian human culture).  This is the only possible interpretation of their persistent claim that marketing by merchants is the reason that people use tobacco products.  It is a fundamental anti-THR lie because if there are actually no benefits, then it must be that everyone really wants to become abstinent, so there is no value in THR.

Yesterday, Brad Rodu posted a great analysis of the actual evidence about tobacco advertising and consumption in the US.  He notes that the persistent lie is backed by no evidence and goes on to present some of the evidence that affirmatively argues against it.  This begins with the observation that tobacco use was popular long before there was a marketing effort as well as the fact that Sweden (with a complete tobacco advertising ban) has usage levels that are similar to other rich countries.  His new analysis points out recent US Federal Trade Commission reports that show there is a strong correlation between advertising expenditures and changes in smoking.  A strong inverse (negative) correlation, that is:  advertising expenditures increased as total consumption decreased.

Of course, the ANTZ have a response to that:  Due to their own terribly impressive anti-smoking efforts (i.e., telling people smoking was unhealthy four decades ago and waiting for the obvious effect, plus a little fiddling around the margins) the cigarette companies were desperately spending on advertising to try to counter their efforts.  Indeed, Rodu partially concurs with that, suggesting that the sharp drop in advertising after 2004 was the result of the companies giving up on what they had discovered to be a futile effort.

But assuming that is true, it is clear evidence that the main conclusion (that marketing is the primary or only cause of consumption) is clearly false.  The perception by merchants that they could reverse the slow downward drift in consumption with a massive increase in advertising, even if they were right, would do nothing to support the original lie.  Given that they were wrong, it is affirmative evidence against it.

Further evidence can be found in the increasingly desperate and silly measure that the ANTZ are pursuing to defend it, like insisting that logos on packaging and even the tiny arcane batch identifying codes printed on the cigarette paper are the “advertising” that causes the consumption.  In case it was not clear that the ANTZ were just making this all up, their claim that it was not the glossy magazine ads and billboards (now banned) or television (long banned) or sponsorships that kept 1/5th of the population smoking, it was the three-letter codes printed just above the filter in 4-point type that kept tens of millions enthralled.  If only we had figured that out sooner!  (“Liars” really gives them too much credit sometimes, huh?)

Rodu points out that the situation with smokeless tobacco (again, in the US) is a bit more complicated.  Advertising for snuff/snus did increase at the same time that consumption was increasing.  He points out that snus consumption was increasing at about the same rate that chewing tobacco was decreasing, so that substitution explains a lot of the trend.  What he does not note is the common challenge in analyzing economic data, simultaneity problems.  These are cases where X may affect Y and also Y may affect X, and so it is difficult to measure the independent effects.  In this case, there is no doubt that the increasing popularity of spit-free smokeless tobacco, as people learned about THR and also sought an anywhere anytime alternative, caused more advertising.  Merchants have more incentive to advertise in a larger market, especially one that is emerging and brand loyalty has not yet been established.

Did the advertising also increase consumption of this low-risk alternative to smoking?  Perhaps, and if it did then it provided important public health benefits.  It would be possible to try to estimate how large this effect was, trying to sort out the causation in the other direction and other factors.  But it would require a rather sophisticated analysis that apparently no one has done.  Of course, the ANTZ are not interested in doing honest economic analysis any more than they are doing honest epidemiology.  To them, “science” is a rhetorical tool to be manipulated for activism, not a way to really find things out.  Moreover, as I have pointed out previously, they are clearly incapable of doing even remotely passable economic analysis.

The real economists who worked in tobacco control exited a long time ago.  They have been long-since replaced by people who assume that people pay a very high price for something that has no benefits for them because… er, well, um… Just Because!  Needless to say, sociology and “public health” curricula do not require even freshman-level economics.