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Love the smell of burning credibility in the morning! To celebrate this crisp autumn day, the White House has decided to throw the last crumbs of the public trust on the Rose Garden bonfire and shitcan the FDA's safety guidelines for for the release of a coronavirus vaccine. Because the important thing isn't whether Americans feel confident enough to take it — it's whether the vaccine is announced before the election. Obviously!

The New York Times reports that the FDA hoped to publish the guidelines that vaccine candidates have agreed to meet before their COVID vaccines will be approved for market use, but the White House won't let the agency put them out because of a mandatory two-month observation period after vaccination. The extra time would postpone announcement until after the election, which is double plus UNALLOWEDABLE!

Already half the country says they're leery of getting vaccinated because they don't trust the Trump administration not to shove a bunch of syringes into America's arms while shouting MISSION ACCOMPLISHED. And now the White House wants to ditch that pesky eight weeks where the drug companies monitor recipients for side effects and duration of immunity? Cool, cool.

Fresh off that superspreader event for Judge Amy Coney Barrett. where the White House used the wrong test and blithely told a hundred distinguished guests to go lick each other's faces with abandon, the White House is hellbent on repeating the error nationwide. Wouldn't you like to know whether the vaccine actually works by looking at the the control group to see if anyone actually gets sick there? Or like, whether it wears off after a month? Or if it causes rectal bleeding or heart palpitations? Well, too bad, because Donald Trump needs to run as the guy who fixed coronavirus, even if it's not actually true.

Politico has the best HHS sources, and they report that the story is even weirder. Because apparently the pharma execs had a pact that none of them would try to reap a windfall by shortcutting the testing, with Pfizer CEO Albert Bourla going so far as to publish an open letter after last week's presidential debate excoriating the candidates for politicizing the sacred drug review process and promising that "we would never succumb to political pressure."

Keen observers will note that this is not the same as promising that he wouldn't exert political pressure himself. And with Pfizer the closest to a viable vaccine and the White House saying that it refused to bless the FDA's new guidelines because of private-sector opposition, well ... yeah, that's interesting.

The fact that the White House is even talking to the pharma bros is nuts. But because the publication or withholding doesn't change the guidelines themselves, it's not entirely clear what the net effect of the White House blockade will be. Remember, the rules are already written, and the purpose of putting them out there is to reassure the public that the vaccine is safe while guaranteeing the multiple drug companies racing to market that they'll be held to a common standard.

"What the commissioner is proposing to put out is public emergency use authorization guidance on a vaccine that would be consistent with letters already sent to the manufacturers," HHS Secretary Alex Azar said. "The FDA has already told the manufacturers what they're going to look for."

Which is all well and good, but doesn't explain why the White House is hellbent on making sure the public never sees the standards that have been communicated to the drug companies. Almost like they're leaving themselves an opening to announce on October 29 that they're saving America by issuing an emergency use authorization for some drug company that will allow it to beat its rivals to market in exchange for a gazillion dollar payoff.

Oh, what's that, Politico?

Pfizer spokesperson Sharon Castillo told POLITICO that the company speaks regularly with Trump and other White House officials about health policy issues including its work on a Covid-19 vaccine.

She declined to provide specifics of Pfizer's conversations with Trump, but said the company has not voiced objections to the FDA's plan for more stringent guidelines, and has pledged publicly to abide by the standards the agency sets out.


Meanwhile, the Times reports that the FDA is trying desperately to leverage its credibility by getting more eyes on the process while keeping out of Commander Dexamethasone's crosshairs.

Facing a White House blockade, the Food and Drug Administration is seeking other avenues to ensure that vaccines meet the guidelines. That includes sharing the standards with an outside advisory committee of experts — perhaps as soon as this week — that is supposed to meet publicly before any vaccine is authorized for emergency use. The hope is that the committee will enforce the guidelines, regardless of the White House's reaction.

And so here we are, with a lunatic hopped up on steroids trapped in the White House with nothing to do but watch his polls plummet. He needs a Hail Mary pass, and he's already told his followers that the White House might eighty-six the FDA's standards, calling them "a political move more than anything else."

On the plus side, now we all get to do our part by participating in a nationwide vaccine drug trial. Don't worry, this won't hurt a bit.

Well, probably not, anyway.

[NYT / Politico]

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Liz Dye

Liz Dye lives in Baltimore with her wonderful husband and a houseful of teenagers. When she isn't being mad about a thing on the internet, she's hiding in plain sight in the carpool line. She's the one wearing yoga pants glaring at her phone.


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