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.
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Carl, thank you for an interesting and detailed analysis. Of particular interest was your perception of the FDA people. I had been thinking of them as likely being simply an extension of the Antis, but you evidently saw them as behaving/thinking more like actual scientists.
Re craving: The craving I get for chocolate is very similar to the craving I get for smoking. The time frames are a bit different but the “feeling” is quite alike.
Here’s a bit more background on how nicotine products are regulated in the U.S. by two different divisions of the FDA. The nicotine products made by Big Pharma (e.g. nicotine patch, gum, lozenges, inhaler, nasal spray) as well as the drugs varenacline (Chantix/Champix) and bupropion (Zyban/Wellbutrin) are regulated by the Center for Drug and Evaluation and Research (CDER). Tobacco products are regulated by the Center for Tobacco Products (CTP), an organization that was created under the 2009 Family Smoking Prevention and Tobacco Control Act (Tobacco Act.)
Section 918 of the Tobacco Act requires “that the Secretary of HHS, after consultation with recognized scientific, medical, and public health experts, submit a report to Congress examining how best to regulate, promote, and encourage the development of `’innovative products and treatments (including nicotine-based and non-nicotine-based products and treatments)” to better achieve the following three goals: (1) Total abstinence from tobacco use, (2) reductions in consumption of tobacco, and (3) reductions in the harm associated with continued tobacco use.'”
When we have testified in the past, the audience has been the tobacco regulatory side of the house–employees of CTP and members of the Tobacco Products Scientific Advisory Committee (TPSAC). Since this report involves products used for “treatment of tobacco addiction,” many of the panel members are CDER employees, with only two employees of CTP participating.
One of the points I made in my presentation is that the Section 918 of the Tobacco Act calls for a “fast track” for approval of the products regulated by CDER that could be considered “breakthrough products” or “innovative”.
Section 911 of the law called for the tobacco side of FDA (CTP) to come up with a plan for approval of “modified risk tobacco products (MRTPs).” There was no requirement for these to be “fast tracked,” so the regulatory guidance that the CTP issued for approval of MRTPs was so detailed and complex that it would take years and cost millions for any products to be considered MRTP. Some of us suspect that this process purposely was made cumbersome and expensive to try to prevent the spread of Tobacco Harm Reduction (THR).
So think about that. Originally, we didn’t want the FDA to regulate e-cigarettes as drugs because that approval process takes so long and costs so much. But if being a regulated as an “innovative” or “breakthrough” product by CDER means that you can get on a fast-track, might that not be preferable to the MRTP process that CTP decided to lay out?
We don’t know for sure where all this is going, but we need to keep all our options open, and educate both sides of the FDA on the benefits of THR. So far, the CTP doesn’t appear to be “getting it.”
If nicotine were a recently discovered chemical found in some plant, and tobacco did not exist, we would not be having this discussion. It would be treated like caffeine. This is what most annoys me. A chinese smoker invented the ecig. For whatever reason, smokers use them in their millions. If they were harmful, we would know by now. In the UK they and their contents are currently regulated like any other electronic device and chemicals sold to the public; and ECITA, the industry trade association has been praised by several local trading standards authorities. But Governments have to meddle. I think this is partly because they are after taxing them, but mainly because of the influence of the pharmaceutical industry: both directly and via anti smoking industry organisations such as ASH UK. They make me sick. “Efficacy” seems to be their favourite word now. That came from the same dictionary of **** as “evidence based.” They are concerned about the efficacy of these devices. I’m touched. I didn’t know they cared. Well, since people use them for a variety of reasons, the anti smoking industry cannot define efficacy. They are obviously effective because they get repeat purchases. Leave it alone. If they don’t, the result will be a massive online black market in pure nicotine, not 2.4% nicotine tested in Swiss laboratories; and it won’t be kept in 20ml childproof botttles.
That’s funny because none of their products reduce said “cravings” while e-cigarettes do.
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