Dear FDA


Vaping was created by smokers for smokers including the flavors.

Vaping was around for over 10 years before Tobacco control started taking out ads telling kids about all the wonderful flavors available. And the CEI showed that the so called uptick in youth vaping was due to anti tobacco groups, Not “Big Tobacco”!

But, as this paper seeks to demonstrate, it was not the vapor industry that reignited youth interest in vaping; it was anti-vaping advocacy. Evidence from developmental psychology, the determinants that push youth toward risky behaviors, and the reasons public messaging campaigns can backfire all indicate that the most viable explanation is not that more youths began vaping in spite of anti-vaping campaigns, but because of them. Therefore, devoting even more money and attention to anti-vaping campaigns is unlikely to solve the issue of youth vaping. More likely, it will make the problem, insomuch that there is a problem, worse.”

Vaping was around for over 10 years before Tobacco control started taking out ads telling kids about all the wonderful flavors available. And the CEI showed that the so called uptick in youth vaping was due to anti tobacco groups, Not “Big Tobacco”!

“Congress has held dozens of hearings and introduced multiple bills, while state authorities across the country have taken steps toward banning most e-cigarette products, with various degrees of success. Yet, none of this has stopped adolescents from using e-cigarettes.

Since the initiation of this war on e-cigarettes, youth interest in vaping, including the vaping of nicotine, non-nicotine, and cannabis derivatives, has surged. Rather than ask why this might have happened—after years of waning youth interest in e-cigarettes and in spite of increasingly omnipresent warnings against using e-cigarettes—advocates blamed the vaping industry. They have asserted that the popularity of Juul, the availability of supposedly “kid-friendly” flavors, and unscrupulous advertising by the vapor industry has caused this uptick, and held this up as evidence for the need to increase funding to anti- vaping efforts, raise taxes on vapor products, and impose restrictions on the market even more onerous than those faced by traditional tobacco.

“Congress has held dozens of hearings and introduced multiple bills, while state authorities across the country have taken steps toward banning most e-cigarette products, with various degrees of success. Yet, none of this has stopped adolescents from using e-cigarettes.

Since the initiation of this war on e-cigarettes, youth interest in vaping, including the vaping of nicotine, non-nicotine, and cannabis derivatives, has surged. Rather than ask why this might have happened—after years of waning youth interest in e-cigarettes and in spite of increasingly omnipresent warnings against using e-cigarettes—advocates blamed the vaping industry. They have asserted that the popularity of Juul, the availability of supposedly “kid-friendly” flavors, and unscrupulous advertising by the vapor industry has caused this uptick, and held this up as evidence for the need to increase funding to anti- vaping efforts, raise taxes on vapor products, and impose restrictions on the market even more onerous than those faced by traditional tobacco.

I freely admit that I first started vaping with less than honorable intentions. I started vaping because of the smoking bans and because of the abusive taxes put on smoking which in part funded the “anti smoking campaigns. The so called Tobacco flavors did not taste like Tobacco and to me tasted like shit! And most of the people who used these products felt the same way. It was the diversity of the flavors and the advancement of the technology that allowed me to quit. Since then the FDA has taken out ads to sway public opinion based on lies. Can you show anything remotely related to “Brain Worms” That was the theme of the national ad that you took out. Here’s an ad taken out by anti vaping groups 4 years before the so called “vaping epidemic” telling kids about all the wonderful flavors and how all the “Cool Kids” are doing it. can you show advertising that vape companies used to target kids in a similar fashion?

Is it the job of the FDA to put out “Propaganda” to distort public perception in order to achieve a political agenda? Can you show that vaping is a gateway to smoking? In spite of the fact that smoking rates are at a historic low amongst teens, not just teens but adults as a result of vaping? Can you justify giving activist like Stanton Glantz 20 million dollars Knowing that he has been involved in Junk Science for decades?

“Stan has always been an advocate and ideologue willing to twist the science,” says David Abrams, a New York University professor and veteran tobacco researcher. He says that some scientists ignored flaws in his work when Glantz focused on combustible tobacco because they, too, strongly opposed smoking. “Frankly, none of us cared if he was a little bit sloppy with his research because the ends justified the means,” Abrams says.

In light of the fact that the vaping industry is forbidden to bring up the harm reduction aspect but you and anti vaping groups can out and out lie to the public. This is the erroneous results of both your advertising campaigns and the anti vaping community. Are we to assume that your agency follows actual science or propaganda?

Our analysis revealed a consistent pattern and a change in perceived relative harm of e-cigarettes among US adults in both surveys, which showed that a large proportion of US adults perceived e-cigarettes as equally or more harmful than cigarettes, and this proportion has increased substantially from 2012 to 2017.

https://clivebates.com/vaping-risk-compared-to-smoking-challenging-false-dangerous-claim-by-stanton-glantz/

A paper on risk perceptions has disturbing results

The story starts with a report in JAMA Open that confirms what we already knew: (1) that a majority of the American public believes that e-cigarettes are as harmful or more harmful than cigarettes and; (2) only a small proportion believe, correctly, that they are much less harmful than cigarettes.  Not only that, the accuracy of public perception is deteriorating and the misunderstandings are becoming more pronounced over time. This deterioration is happening despite hundreds of millions of dollars in research grants and despite FDA recognition of a ‘continuum of risk’ in nicotine delivery products.

For navigation, there is a table of contents.

If you read the entire article above you would see how the so called youth epidemic is wrong headed. But I will let Clive Bates the author of the article explain it.

Claim 12: the explosion of youth use outweighs any benefits to adults

Increased perceived risks of e-cigarettes is also an important element for curbing their use by youth. Youth who believe that e-cigarettes are not harmful or are less harmful than cigarettes are more likely to use e-cigarettes than youth with more negative views of e-cigarettes.14 In terms of overall public health effects, this explosion of youth use swamps any potential harm reduction that may accompany adults switching from cigarettes to e-cigarettes.15 

14. Gorukanti  A, Delucchi  K, Ling  P, Fisher-Travis  R, Halpern-Felsher  B.  Adolescents’ attitudes towards e-cigarette ingredients, safety, addictive properties, social norms, and regulation.  Prev Med. 2017;94:65-71. [link]

15. Soneji  SS, Sung  HY, Primack  BA, Pierce  JP, Sargent  JD.  Quantifying population-level health benefits and harms of e-cigarette use in the United States.  PLoS One. 2018;13(3):e0193328. [link]

Response – this is a blunt disclosure of a propaganda motive. Reference 14, Gorukanti et al. neatly betrays an activist agenda by rather blatantly making a case for a propaganda approach to risk communications:

Increased perceived risks of e-cigarettes is also an important element for curbing their use by youth. Youth who believe that e-cigarettes are not harmful or are less harmful than cigarettes are more likely to use e-cigarettes than youth with more negative views of e-cigarettes.

This study indicates that adolescents are aware of some of the risks of e-cigarettes, although many harbor misperceptions and hold more favorable attitudes towards e-cigarettes than cigarettes. Of concern is the relationship between favorable e-cigarette attitudes and use. Findings suggest the need to provide adolescents with correct information about e-cigarette ingredients, risks, and the insufficient evidence of their role in cigarette cessation. 

This is an extraordinary attitude when you think about it. They are starting from the premise it is wrong for adolescents to have a more favourable view of e-cigarettes than cigarettes – even though on any rational basis a favourable view is exactly what you would expect. This is because the authors think teens should not use e-cigarettes and this matters more than addressing them truthfully.  In the face of the inconvenient truth about relative risk, the authors argue for convincing adolescents that e-cigarettes are no better than smoking. This is the mindset of the omniscient public health authority figure – but what if they are wrong? What is the effect of their approach is to deter a teenager who would otherwise be a smoker from being a vaper? What if they persuade adults that their switch from smoking to vaping is doing them no less harm? What if people use this false information in ways not intended by public health authorities?  Who would be accountable and how?

Response – models produce results that depend on their input assumptions. Reference 15 (Soneji et al., 2018) is a case study in modelling being subject to ‘garbage-in, garbage-out’ problems.  Yes, it is true if a modeller builds in highly negative assumptions into a model, then, hey presto! it can make a safer product look more dangerous.  For example, if you run a model that assumes e-cigarettes reduce smoking cessation among adults and act as a gateway to smoking for adolescents, then it doesn’t take much to show: “e-cigarette use currently represents more population-level harm than benefit.”    This is exactly what Soneji et al do. It doesn’t matter how safe e-cigarettes are – they could be 100% safe – if they trigger more smoking via these mechanisms then the model will show net harm.

So we have to look where the modellers have found their input assumptions.  Firstly, the assumption that vaping reduces smoking cessation.  Who would have guessed? It is Kalkhoran & Glantz .

Table 1 describes the data source of each model parameter. S1 Appendix describes how the difference in transition probabilities of ≥6-month cigarette smoking cessation between current e-cigarette users and non-current e-cigarette users was estimated based on various parameters such as the proportion of current cigarette smokers who used pharmaceutical aids during quit attempt and the pooled odds ratio of quitting smoking among smokers interested in quitting reported by the meta-analysis of Kalkhoran & Glantz (emphasis added).

Kalkhoran & Glantz is discussed (and dismissed) in the previous section.

Response: modelling should not build in a gateway effect. The next assumption that Soneji et al build in is a gateway effect – teen vaping causes smoking initiation.   The authors also assume that e-cigarette uptake by adolescents is a ‘gateway’ to smoking and therefore that e-cigarette use increases smoking initiation.

We assessed three outcomes of interest: […] (2) the additional number of adolescents and young adults who will initiate cigarette smoking through the ever use of e-cigarettes and eventually become daily cigarette smokers at age 35–39, compared to those who never used e-cigarettes […]

It turns out that the plug-in gateway effect number for the Soneji et al modelling comes from a ‘systematic review’ in which Soneji himself was the lead author (Soneji et al, 2017). What these studies tend to do is to find that being a young e-cigarette user is associated with being a subsequent smoker. After some statistical wizardry, they determine that the vaping caused the smoking.  This association is real – the studies do show this association.  But there are two rival explanations for the observed associations:

  1. A gateway effect – that taking up the e-cigarette and starting to vape is the reason why they went onto smoke and they would not have smoked otherwise. The vaping caused the smoking.
  2. Common liability – the common factors about the individual (the home environment and role models,  educational performance, delinquency, mental health, community norms etc) that incline a young person to be interested in both smoking and vaping. Both the vaping and the smoking were caused by these factors.  The vaping didn’t cause the smoking.

Statisticians try to isolate the effect of all the common liabilities to leave only the effect of using the e-cigarette. In the effort to isolate the effect of e-cigarettes, these other factors are referred to as ‘confounders’, and statisticians try to adjust for their effect by ‘deconfounding’ using the information they have collected about the people in the study. But full deconfounding is impossible in practice. This because no-one knows what all the confounders are and what questions would be necessary to characterise the common liabilities fully – probably hundreds. Possible confounding factors like ‘mental illness’ or ‘delinquent behaviour’ are very complicated in themselves and in their interaction with smoking and these can never be thoroughly adjusted for. So the statisticians are always left with ‘residual confounding’ – common factors that cause vaping and smoking that they have not been able to adjust for. So what may look like a gateway effect (the e-cigarette use in part caused the smoking) may just be residual confounding.  Adding them together in a ‘systematic review and meta-analysis’ does not solve this problem. In practice, it is likely combining studies that have very different approaches to measuring smoking and vaping, and very different approaches to addressing confounders. A recent analysis of the ‘gateway’ literature  (Lee PN et al., 2019) found that none of the studies purporting to demonstrate a gateway effect were adequately adjusted for confounding factors.  The authors concluded:

A true gateway effect in youths has not yet been demonstrated. Even if it were, e-cigarette introduction may well have had a beneficial population health impact.

For more background on the conflicting gateway and common liability theories and the difficulty of establishing gateway effects, please see:

  • Vanyukov, et al. Common liability to addiction and “gateway hypothesis” theoretical, empirical and evolutionary perspective. Drug Alcohol Depend. 2012. (here).
  • Phillips C V. Gateway Effects: Why the Cited Evidence Does Not Support Their Existence for Low-Risk Tobacco Products (and What Evidence Would). Int J Environ Res Public Health 2015;12:5439–64. [link]

Response: it is more likely that teenage vaping is forming an exit from smoking than increasing it. One study noted that the decline in youth smoking has accelerated as youth vaping increased:

There was a substantial increase in youth vaping prevalence beginning in about 2014. Time trend analyses showed that the decline in past 30-day smoking prevalence accelerated by two to four times after 2014. Indicators of more established smoking rates, including the proportion of daily smokers among past 30-day smokers, also decreased more rapidly as vaping became more prevalent. The inverse relationship between vaping and smoking was robust across different data sets for both youth and young adults and for current and more established smoking.

Levy DT, Warner KE, Cummings KM, Hammond D, Kuo C, Fong GT, et al. Examining the relationship of vaping to smoking initiation among US youth and young adults: a reality check. Tob Control. BMJ Publishing Group Ltd; 2018 Nov 20. [link]

Whilst this analysis cannot prove that the vaping caused the accelerated decline in smoking, it does make it difficult to argue that vaping is increasing the number of adolescent smokers and it does make modelling that relies on an assumption of a gateway effect feel unreliable and disconnected from reality.

Response: misleading citations can be combined through modelling to create a misleading big picture. So here we can see how this works: a trail of citations can be carefully laid down to provide input to subsequent analysis that looks internally coherent. However, because of the accumulated misunderstandings or misleading findings, the analysis slips its moorings from reality and becomes externally incoherent – i.e. not reality-based.

Response: other, more reality-based modelling is highly positive. Other modelling are at stark variance with the Soneji model.

Take Warner & Mendez, 2018 in modelling of a variety of scenarios to assess the impact of vaping products, under a range of assumptions.

With base-case assumptions, the population gains almost 3.3 million life-years by 2070. If all people who quit smoking by vaping lose 10% of the benefit of quitting smoking, the net life-year gain falls to 2.4 million. Under worst-case assumptions, in which vaping increases smoking initiation by 6% and cessation by 5%, and vaping-induced quitters lose 10% of the health benefits, the population gains over 580000 life-years.

Also, consider Levy et al, 2017 David Levy and colleagues modelled realistic scenarios for the replacement of smoking by vaping.  The results suggest very substantial public health benefits are likely in the United States even under a pessimistic scenario.

Compared with the status quo, replacement of cigarette by e-cigarette use over a 10-year period yields 6.6 million fewer premature deaths with 86.7 million fewer life years lost in the Optimistic Scenario. Under the Pessimistic Scenario, 1.6 million premature deaths are averted with 20.8 million fewer life years lost.

To show negative public health effects from vaping requires pessimistic assumptions about vaping reducing smoking cessation, vaping causing a gateway effect and/or vaping being much more harmful than it is.  The problem is that such assumptions have no substantiation in fact, and any modelling based on them is an aretfact of the assumptions.

Claim 13: the people are right and science is catching up

From this perspective, the declining public perception that e-cigarettes are less harmful than cigarettes is a good thing that may turn out to be where the scientific consensus lands as the new evidence on the harms of e-cigarettes continues to accumulate.

So is this about youth vaping or using youth as a political pawn to advance a political goal. If it is for a political goal why has “Big Tobacco’s” Juul been exempt from the chopping block. Could it be because of their political clout? Hasn’t all of your propaganda blamed Juul and “Big Tobacco” for the so called “Youth Epidemic” yet you put flavors and “Open Systems” The heart and soul of the vaping industry and the ones that got millions of us to quit smoking on the chopping block leaving the ones that you claim targeted youth in the market.

The recent actions by the FDA begs the question, is any of this based on legitimate science or political influence. If the later then it should be subject to judicial review.

Lawmakers’ Pressure On FDA Review Of New Tobacco Products Blurs Line Between Oversight And Undue Influence

FDA’s PMTA approval process is more adjudicative than it is rulemaking. The eventual outcome, a marketing or denial order, arises from a formal process based on a formal record, applying legal standards set in advance on a case-by-case basis. Thus, a plaintiff suing FDA would only need to show Members of Congress’s action cast doubt on the PMTA process’ impartiality.

The lawmakers’ pressure campaign on PMTA review featured multiple messages and messengers, as compared to the one Senate hearing in Pillsbury. And rather than Senators merely implying that FTC should have ruled differently in its Pillsbury case, Senators and Representatives over the past year have clearly demanded negative outcomes for specific PMTA applicants and dictated which factors should matter most during application reviews.

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For many of the PMTA applicants, an FDA denial effectively puts them out of business. That reality certainly creates a strong incentive for legal challenges. How ironic if Members of Congress’s own words and deeds undo what they campaigned so aggressively for: FDA’s removal of ENDS products from the market.

About Marshall Keith

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