Last month, we acquired a “confidential - for internal use only” FDA review of the evidence on vaping. The document covers every bit of data the agency had on health effects, teen use and smoking cessation up to March 31, 2020. THREAD 🧵
FDA is committed to "the integrity and application of science," promises @DrCaliff_FDA. After comparing @FDA's public statements about vaping to its “confidential” analysis, it's clear to us that the agency has little integrity and even less interest in science.
The 193-page study contains lots of qualifications and bureaucratic meandering, but it also features some stunning admissions. Below are some of the most startling excerpts, contrasted with public statements the agency made during the same period.
First up: “Dangerous chemicals” in e-cigarette vapor, from an April 3, 2019 FDA blog post. fda.gov/news-events/fd…
Now, here’s what FDA said privately about these same “dangerous chemicals.” The two studies cited in this paragraph (Goniewicz et al., Margham et al.) were published in 2014 and 2016, respectively—long before the agency completed its 2020 review.
FDA speculated in that same 2019 blog post about vaping and cancer risk.
But FDA knew there was no evidence linking vaping to cancer, which the National Academies of Sciences, Engineering and Medicine (NASEM) reported in 2018. That's still true today. No study has linked vaping to cancer in humans.
It’s the same story on respiratory health. Here’s what FDA said in its April 2019 blog post on that subject.
Compare that conclusion to the internal FDA analysis of vaping and respiratory health. Again, both conclusions are based on *the same* research. Note the summary dismissal of EVALI as a risk of nicotine vaping.
Our final bombshell for today. Should vaping be used to quit smoking? Here’s what FDA told the public on March 28, 2019. fda.gov/consumers/cons…
FDA made those assertions publicly about smoking cessation and nicotine replacement therapy (NRT) despite having this data at its disposal:
FDA also knew that most people who vape are former smokers or smokers trying to quit. Crucially, these numbers are from studies that span 2014 to 2018.
In sum, FDA knew:
1. That vaping is far safer than smoking.
2. That smokers prefer vapes to NRT
3. And that most people who vape are trying to or have quit smoking.
Yet as of today, they continue to discourage smokers from switching.
There's much more to come. Until then, ponder this question: why would a public health agency, ostensibly committed to the "integrity and application of science," so badly mislead Americans about nicotine vaping?
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After years of mismanagement, incompetence, and intransigence that has harmed countless Americans, accountability is finally coming to @FDATobacco. But why are the agency's water-carriers at @AP so dismayed? Let's have a look.
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When whistleblowers told agency auditors that @FDATobacco was a "toxic workplace" corrupted by politicized influence and rigged science, AP reporters Matt Perrone @AP_FDAwriter and Mike Stobbe @MikeStobbe made zero effort to tell their story. Suddenly there's plenty of space.
There's lots of authoritative sources and millions of Americans that think downsizing FDA is a great idea. Including us! But none are quoted this article. It's all just moaning and whining from agency apologists.
🥊This is one of the most hard-hitting legal filings we've ever seen in vape advocacy. Just delivered to the U.S. Supreme Court on behalf of Florida vape maker Johnny Copper by @vapelawguy. 1/ theavm.org/s/Motion-for-S…
Not only could this filing help color the way that the justices will confer on the White Lion v. FDA case that is currently pending at SCOTUS, it cuts right to the heart of the matter.
As we say in the High Plains, this is the whole shooting match.
Doctors routinely mislead smokers about the benefits of vaping. How do we know? A member of our team was just subjected to a misinfo-laden lecture during a doctor's appointment. Let's dissect some of the myths health care providers are passing off as medical advice. THREAD 🧵
The "information" sheet we were given after the appointment (pictured above) was produced by academic publishing giant @ElsevierConnect, and it's an absolute train wreck. It's also more than two years out of date.
The first and worst bit of nonsense in the document is that nicotine is "thought to" increase your cancer risk. Exactly who thinks this and why isn't explained.
🔎⚖️ Solid forecast just posted on the legal undercurrents at issue before the Supreme Court in the upcoming Triton v. FDA case. tobaccoreporter.com/2024/09/09/vap…
Features incisive analysis from our @GregTHR.
Also quotes US Solicitor General, Elizabeth Prelogar. NB: If she ends up arguing the case at SCOTUS herself, we'll take it as a sign the government has confidence in FDA's actions and is sending in their ace pitcher. OTOH, her absence *could* indicate FDA is on shaky stilts.
🔎 Let's talk for a minute about why the Supreme Court amicus brief from Sen. Dick Durbin might actually be a good thing. It's because Durbin's fanaticism and hyperbole are on such lurid display that it'll give the Court a clear sense of just who's pushing vape prohibition.
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The first thing SCOTUS law clerks will notice is the Durbin brief is strictly partisan -- all the signatories are part of Durbin's particular wing of the Democratic party. On political issues, that's fine -- but in this context it signals there's no unanimity, as Durbin pretends.
The Court will also see that Durbin is not deploying measured persuasion but instead the most hyperbolic rhetoric he can dream up.
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We need to talk about the debacle of 22nd Century's bet on low-nicotine cigarettes -- not only as an asinine business model but what the implosion says about @FDATobacco and the news media that covers nicotine policy. 1/ 🪡
Here is the company's stock chart for the last year and it's a complete wipeout. It's hard to overstate just how bad this is -- but if you invested in this company, you have basically lost your shirt.
But there was once a time, not long ago, when this stock was flying high -- selling for more than $1,200 per share with a market cap of nearly a billion dollars! What explains that? Why were investors flocking to this company?