The Chaos Report

Trump calls the FDA’s approach to safety a “political hit job”. So let’s be clear on what they’re doing.

You might’ve missed this, since the President’s Tweeting has been so fast and furious—and often changing—over the last couple of days. As if to make up for lost time for the 3 days he was in the hospital. Or squeezing as much possible in before some other shoe drops:

So here’s what’s behind this:

1. President Trump multiple times promises a Coronavirus vaccine by Election Day. Even when people in or close to his own administration say that’s unlikely or impossible, he says they are wrong, and often that the vaccine will come even sooner.
2. The FDA sets up some steps under which it would consider allowing pharmaceutical companies to distribute a vaccine under an Emergency Use Authorization order or EUA. That is, far faster than it’d ever be allowed under the agency’s normal approval process.
3. The White House, realizing this indeed means no vaccine before Election Day—though very likely multiple vaccines before the end of the year—pushes back and threatens to throw out those guidelines.
4. The FDA—for now—prevails. The reason we say “for now” is the guidelines are “nonbinding”. The strongest language the FDA uses is that it “does not expect to be able to make a favorable benefit-risk determination that would support an EUA”, without the data it requests.
5. Trump calls it a “political hit job”.

Now that you’re caught up on the timeline, let’s look at what the FDA proposes for potentially clearing Emergency Use Authorization of a COVID-19 vaccine. And what the President says is horrible and politically motivated:

• The FDA says participants in Phase 3 clinical trials should be followed-up on for at least 2 months after receiving the vaccine. That’s both to ensure the vaccine is safe, and that it actually works.
• In order to demonstrate the vaccine actually works, data must show proof of COVID-19 exposure among participants in trials. This is tricky: because if the vaccine’s really good, no test subjects should be getting sick. But then, how do you know if they’d even been exposed? That’s why in clinical trials some participants receive an actual vaccine, while some receive a placebo. If at least a small number of participants in the clinical trials who received the placebo instead of the vaccine become seriously ill, the FDA will be able to infer that participants who received the vaccine but did not fall ill had actually been exposed to the virus.

So now let me ask you this: would you want to take a vaccine with no evidence it is safe, or it even works, 2 months out from when you get the vaccine? And/or with no evidence that the people on whom the vaccine was tested actually had exposure to the disease? And more generally, should scientists base their timelines on political events when they’re already considering approving a vaccine at unprecedented speed?

If your answer to any or all 3 of those questions is “yes”, then you could’ve gone out and signed up for one of the vaccine trials.

Of course any President would prefer having a vaccine before Election Day. But only a President who does not care if the vaccine actually works, just that it might make him look good, would call what would seem to most sane people logical safety measures a “political hit job”. That might be part of the reason the New England Journal of Medicine, in a very unusual editorial, and without mentioning Trump by name, condemns the U.S. government’s response to COVID-19 as a failure of leadership, and that:

“Our leaders have….taken a crisis and turned it into a tragedy.”

Meanwhile, the President put out another of the little videos he’s been doing, where he talks excitedly about his COVID-19 experience. In this one, he credits an experimental product from Regeneron almost completely for his apparent speedy recovery. He even adds that it was his idea to take it, not his doctors’. Thing is, the Regeneron antibody product is something almost nobody except a President can get right now. The reason for that was a choice made by this administration to prioritize accelerating a vaccine, and not much else. So while the federal government has invested some in the development of Regeneron’s and similar products, when the President in the video makes a promise to people who might get sick: “you’re going to get better. You’re going to get better really fast”. Not so fast. Not right now, unless you’re a President or something like that.

One side note: according to the MIT Technology Review, the Regeneron product is made from fetal tissue, and the Trump administration’s been trying to virtually ban that in medical research by cutting off federal funding to labs that use it.

Anyway, even if the President’s enthusiasm speeds along Emergency Use Authorization for the Regeneron product, the company says it might be able to have doses available for 300,000 patients within a few months, and right away can probably line up enough to treat about 50,000 patients. Problem is, that’d only cover about one day’s worth of infections in this country at current rates. So who’d get access to it?

Which brings us back to Trump’s apparent willingness to inject millions or even hundreds of millions of Americans with a not even somewhat properly tested vaccine. Only because it might help him politically. For that, he’s willing to turn us all into guinea pigs.