Farsalinos questions FDA ‘unpublished preliminary data’ of so-called vaping epidemic
In a September 12 press release by the U.S. Food and Drug Administration (FDA), its chief makes the very bold and as-yet unproven claim that teen vaping has allegedly risen to epidemic proportions. In a series of mainstream press articles published on the same day, the Chicago Tribune refers to unpublished preliminary data that allegedly indicates a 75 percent rise in teen e-cigarette use within the past year.
“What prompted Gottlieb’s sudden call to arms? One possibility is new statistics that show an alarming rise in vaping. The FDA has unpublished preliminary data that shows a 75 percent increase in e-cigarette use among high school students this year compared with 2017, The Washington Post reports. ‘We cannot allow a whole new generation to become addicted to nicotine,’ Gottlieb said.”
What is this unpublished preliminary data? Who compiled it? What criteria was used to evaluate its contents? Why is the alleged data deemed “preliminary?” And perhaps most importantly, why is the FDA’s data still “unpublished?” These are just a few questions that world-renowned scientist, cardiologist, and e-cig advocate Dr. Konstantinos E Farsalinos wants immediately answered.
“It is extremely important to see detailed data on the ‘epidemic’ declared by the FDA. I emphasize that published data SHOULD include frequency of use and smoking status of e-cigarette users – and of course the prevalence of tobacco cigarette use. Everyone knows that ever e-cigarette use (experimental vaping but not daily use) is simply meaningless. Current e-cigarette use is also for the most part meaningless because (until now) most of never-smoking current e-cigarette users use them for 1-2 days of the past 30 days. However, until we see the data, I will assume that every pattern of e-cigarette use (ever and current use) has increased by 3-fold (200% instead of the reported 75%) compared to 2015. This is how the use of e-cigarettes in the past 30-days by never smoking adolescents would look like (I will not mention ever use because it is a waste of time).”
To label teen vaping as an “epidemic,” the FDA must – at the very least- provide documented evidence that supports these claims. Furthermore, the related statistics must be compiled, evaluated, and presented in a way that uses good, old-fashioned common sense. Dr. Farsalinos is suggesting that the unpublished preliminary data may be grossly inaccurate, especially if its evaluators did not differentiate between experimental teenage use and daily teenage use.
Teenage experimentation with vaping is not the same as daily use
So many of the prior published reports by both the FDA and the U.S. Centers for Disease Control and Prevention (CDC) do not follow this simple principle. Instead, their basis for analysis when interviewing thousands of middle and high school students across the country is to ask a very simplistic question: Have you used an e-cigarette within the past 30-days?
Teenagers experiment. They always have. For generations upon generations, teenagers have always rebelled against their parents in their adolescent impatience to enter adulthood. They perhaps change their style of dress, experiment with makeup, and occasionally miss their curfew every now and again. They push conventional boundaries. And for decades, typical teens have also experimented with booze, marijuana, sex, and of course smoking.
Related Article: Farsalinos blasts Johns Hopkins ‘study’ claiming e-cig vapor is high in arsenic, metals
But experimentation does not a daily user make. If a teen experiments with alcohol by drinking a beer or two at a weekend party, does that automatically make him or her an alcoholic? Should alcohol then be over-regulated by the FDA to include only a few flavors of beer and wine? America tried something like that in 1919 with the passage of the Eighteenth Amendment making alcohol illegal in the United States. It didn’t work, by the way. 14-years later, the Twenty-first Amendment lifted the alcohol ban forever.
If a teenager smokes a doobie at a party, does that automatically make him or her a marijuana addict? Should the FDA over-regulate marijuana out of existence, as well? Apparently not. In fact, nearly half of all states in American now legalize cannabis products in some way. Many of the other states have legislation in the works. Canada has even legalized marijuana at the national level. And the U.S. Congress has even recently legalized hemp on a national scale.
So, why does Gottlieb have such an issue with vaping? Dr. Farsalinos and many others in the vaping community are not convinced of the FDA arguments so far. Let’s see that unpublished preliminary data.
Related Article: Farsalinos vaping study compares nicotine levels of e-cigs, HnB, and cigarettes
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