Thread by @ASlavitt

COVID Update August 24: The folly with the FDA and the White House should tell us a lot about the chaos, the bullying and priorities of this president.

In case you missed it, Trump announced a breakthrough treatment for COVID! . . . that has been around for 100 years. And is only marginally beneficial. And is already available. And his announcement could make less available. And hurts the effort for better therapies.

It is not as though CP (Convalescent Plasma) doesn't meet the definition for approval of an EUA. (Practiically anything does if it doesn't harm you), its that it was a mistake to do.

First the good of CP shouldn't be missed. Convalescent Plasma is worth giving to some patients if within 3 days of diagnosis. But it's benefit is marginal & patients already have access to it. And this will jack up the demand as he surely jacks it up today & at the RNC this week.

This assumes he can fit it in with all the other good news. 176,000 people gone. Millions infected. More chronic disease. An effort to get rid of health care coverage. Millions losing coverage and jobs. Evictions. No umemployment insurance in sight.

My guess is it may come up.

It's cute that Trump says he "marshalled the power of the federal government" when almost the entirety of the federal government was against this. Trump tweeted that the FDA was actually the deep state for not following his orders.

Why didn't they like it? For some good reasons.

1. The study was weak and overstated & we didn't learn much

The data was cherry picked & the FDA was pushed to use a subset of the data. Fauci and Collins cried foul. The actual trials are still ongoing in England.

2. Trump lied.

I was called by the WH & asked if I would support the use of CP publicly. My response was if it wasn't over-stated, not politicized and came from FDA with transparent data of the exact benefit.

That's not what we got.

Trump said "mortality is reduced by 35%."

Not at all true. A tiny fraction benefitted.

When there are high levels of antibodies in the plasma, within 3 days of diagnosis, the patient wasn't on a ventilator & was under 80, they were 35% more likely to be alive after a month.

So there was a small relative benefit for a small part of the population, for certain population if they have high levels of antibodies.

So what? It's marginal, he's playing politics before the RNC. What's the harm?

Well there's more.

3. Availability won't go up. It will go down. You can't manufacture plasma. It comes from the human body & like with hydroxy, demand is going to go up while supply remains limited.

When hospitals have plasma, they have been able give it already under different rules.

4. This relates to another big problem. That's the supply of patients. 70,000 patients participated in this trial which generally means they couldn't participate in other drug or vaccine trial. And we have a limited number of hospitalized patients.

We really need patients for the game changing treatments like monoclonal antibodies which hone the antibody response in a much better way. Read up if interested as its beyond my abilities to explain here.

nih.gov/news-events/ne….

So why would we pull these patients into these observational trials when there is a real Randomized Clinical Trial (RCT) happening right now? And then why would someone cherry pick the data, toss out most of it & get it to the FDA.

5. The FDA should approve drugs with benefit under EUA, even with marginal benefit like this one. But while the country has a shortage of tests that work, a backlog of masks & other therapy trials, why would they waste their time on something of low value? The White House & RNC.

6. The FDA's most valuable asset is trust. Trust that they will do what's best for the public. Trust that they won't let politics overwhelm science.

@SteveFDA has failed that test at a particularly important time.

Steve, with vaccine trials underway, you made the FDA's decision-making process suspect & allowed Trump to demean FDA scientists.

If all it takes is for Trump to call you guys a name for you to buckle, then you can't stand the heat & you won't when it comes time for a vaccine.

Why not hold your ground? Is this a battle you should pick? Absolutely. Your constituent isn't the president Steve. Its the public. And when you did give in-- which is within your judgement to do-- why did you allow false numbers to go uncorrected?

Why harm prospects for a trial?
Why demean lifelong careers?
Do you understand you got the job because you say "yes sir" when this is not a "yes sir' job?

This is no time for weakness.

We already know we have a president not made for the moment. Who thrives on chaos. Who cherry picks facts & events for his narrative.

That's why we need strong independent minded leaders who don't aid and abet those bad instincts.

Vote for Biden & clean house of the unprincipled yes-men.

Expect that he will appoint people who will be led by science, energize & protect the work of staff experts, can stand up for what they believe & will work on behalf of the public. /end