National Academies Report On E-Cigs: Just What The FDA Ordered

Carl V. Phillips | Contributor

The much anticipated National Academies report on vaping and vapor products has just been released. The report, a massive review of the existing journal articles (only) that address various aspects of the subject, reaches most of the obvious conclusions. However, it is cleverly skewed to support the FDA agenda, and thus is about as anti-vaping as is possible without making blatantly absurd claims.

The National Academies of Science, Engineering, and Medicine is a semi-governmental organization whose main activity is to oversee review papers on topics like this. The report on e-cigarettes was ordered by the FDA. As with any official report, it is important to keep in mind that there is nothing special about it, other than the total resources devoted. It is just a very long review paper. Like any review paper, it is the subjective assessment of a small group of individuals who bring limitations and biases to the process. Moreover, the official nature of the report creates a greater than average risk that the choice of authors and what they write are skewed toward the government’s interests. The authors also know that they can give their opinions disproportionate influence if they can get them into the “official” report.

The report is being touted in the press and social media as laying to rest the notion that vaping is nearly as harmful as smoking. But no one familiar with the subject and capable of understanding the evidence ever believed otherwise. There is no informational content here. The more accurate take is that it will now be uncomfortable for anti-vaping activists who seek to align themselves with the U.S. government to continue to promote the disinformation that vaping might be as harmful as smoking. However, it seems likely that many will still persist in doing so.

The messaging about the comparative risk, while technically accurate, is still misleading. The report cleverly avoids even a rough quantitative estimate for the risk from vaping. Instead, it creates anchoring bias by comparing the risk to that from smoking. Even describing the risk as “far less harmful” than smoking still implies, incorrectly, that the best way to estimate the risk is to start with the risk from smoking and reduce it somewhat. Instead of reporting that the evidence suggests vaping is approximately harmless, especially in the context of smoking, the authors report that we are not sure about the exact level of risk (something that is always true), and pretend this means we cannot even make a best estimate. In addition, the report affirmatively asserts that there are health risks from vaping, despite the existing evidence not suggesting any measurable risks. It is actually quite plausible that the net health effects are positive.

The report also declares the nicotine in vapor products is addictive, but without ever offering a definition of “addictive.” Under the only apparent U.S. government definition of the term, which has been endorsed by the FDA Commissioner, nicotine is not addictive. Under that definition, addiction requires not merely dependence, which is conflated with addiction in the new report, but substantial disruption of someone’s life. Nicotine obviously causes no such disruption. Indeed, there is no accepted candidate definition for “addiction” that would apply to smoking, let alone research to show whether it also applies to vaping. While it is possible to coin a definition that does include vaping, the lack of any attempt to do so in the report makes use of the word mere inflammatory rhetoric.

The report notably departs from accuracy in asserting there is a “gateway effect,” that vaping causes minors and young adults to start smoking. As previously explained, while it is inevitable that vaping has caused at least one would-be nonsmoker to start smoking, there is no evidence that suggests that this happens to any substantial degree. The existing studies that supposedly support that claim blatantly ignore the obvious confounding — the fact that people who are more inclined to vape are more inclined to smoke, regardless of whether they ever vape — and are incapable of showing there is any causation. Unsurprisingly, some of the authors who were chosen to write the report are established proponents of this claim, and they have produced junk-science papers in support of it.

The combination of these four aspects of the report make it — presumably by design — an ideal tool for the FDA to use in pursuit of their politically-motivated goals. The summary of the report might as well be a draft of the preamble to the FDA’s next proposed vapor products regulation. Indeed, within hours after the release of the report, the FDA Commissioner and the Center for Tobacco Products were gleefully tweeting about it, and the agency emailed and posted press releases about it.

It is difficult to imagine a more perfect alignment.

The message that vaping is a lower-risk substitute for smoking is necessary to give the report any credibility, but it is also useful for the FDA’s goal of turning vaping into nothing more than a smoking cessation method. The implication that the risks are still substantial and the dreaded specter of “addiction” give the FDA all the excuse they need to tightly control vapor products and vaping, trying to prevent their use for anything other than smoking cessation. The additional innuendo about “secondhand” effects on bystanders further contributes to this. Most important, the claims about gateway effects are perfect for rationalizing attempts to lower the quality of products — particularly banning most flavors of e-liquid — in the name of protecting the children. Undoubtedly there are other gifts to the FDA’s lawyers and policymakers hidden in the 600-plus pages of the report that will only be noticed when the FDA weaponizes them.

It is important to understand this report for what it is: a policy-support document presented as if it were a scientific analysis, and an excuse to create press releases. It contributes little or no scientific understanding. It is possible for reviews like this to break new ground in science, but this one does not appear to make any attempt do so. It is extremely conservative, except where it is simply incorrect. One example of this is making no attempt to quantify the risk; while there is no such published analysis for them to review, the authors could have done their own. Similarly the report includes a section on pregnancy effects which concludes that there is no available evidence. But this is simply not true; it is possible to form a scientific opinion about the effects of nicotine (and thus vaping) in pregnancy, even though there is little evidence about vapers specifically.

The report comes across much like a Wikipedia article or legacy-style journalism, where the rules of the game are that any seemingly-authoritative claim from elsewhere can be repeated, but overt analysis by the author is not allowed. Supposedly this keeps the content “objective,” but in reality it just allows authors to make their case (by choosing what to repeat and what to ignore) while pretending they are not making a case, and to thus pretend that the resulting text is not a product of the authors’ personal analysis and biases.

Vapers and vaping advocates should take care not to grant this review paper undeserved deference as authoritative just because the government created it. (Others will naively do so, but vapers should avoid it.) It is just another paper. It is not even a very informative paper, beyond being an index. Declaring that it offers a definitive judgment that vaping is less harmful than smoking implies that it is also definitive in declaring there is a gateway effect and that vaping is addictive.

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Carl V. Phillips

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