Thread by @ASlavitt

COVID Update July 28: There’s a reason we don’t crowdsource our open heart surgery.

It’s the same reason we shouldn’t crowdsource which medicine we take. 1/

I know studies can be confusing: observational, double blind, small, large, early stage, late stage, confounding factors.

Thankfully we don’t have a system where each of us needs to be an expert in figuring it out for ourselves. Someone does that. 2/

And that system isn’t to poll test the answer with our friends or neighbors. Or rely on a Twitter article from a politician or even a doctor we trust. 3/

It turns out that our system for approving drugs is based on a simple premise: evidence.

Evidence is hard for us each to collect individually. It’s also hard for each of us to interpret. 4/

I’m no expert in interpreting evidence. You know who else isn’t? Here’s a partial list:

People who post on Twitter
Newsweek
The president’s son
The president’s daughter in law
The president
Any president
Any Politician
The drug company
A single researcher

5/

As we know by now the majority of people have the baseline tools: an opinion, thumbs & a phone. That’s where the bar is set.

And some of those people may have informed opinions. But do you really want to be in the business of opinion shopping? 6/

As much as you may like or dislike a politician I assume you don’t want then deciding your treatment for you.

7/

Put it this way. If you wanted to talk for 45 minutes without anyone listening or vote on something you had never read, you wouldn’t go to a virologist. It’s not what they do.

8/

If you want to mix your belief system with evidence in your political decisions, that makes a lot of sense.

If you think your member of Congress can tell the difference between a well designed trial result & real world evidence, identity politics may be consuming you too much.9/

Look, I know we’re in different camps a lot these days. But are we really going to evolve to a world where Democrats take one medicine & Republicans another? 10/

There’s another thing. Remember Citizens-United?

Are you really going to do the work to track down which drug company is part of which dark money PAC who gave to which politician?

Seems like the hard way to figure out who to trust. 11/

Yes, I realize we elected a man for president who has never said the words “I don’t know” in his life (except probably during a deposition).

I also get that in scary times like these we want people we can trust. And I know many people trust the president. 12/

Maybe he’s lowered your estate taxes. Maybe he’s eliminated a regulation you felt was getting in the way. Maybe he appeals to you on an emotional level because you think he gets you. Terrific.

That’s not me. But if it was, I still wouldn’t let him make medical decisions. 13/

I assume if we had our wits about us we would bring scientists together who could evaluate the safety of drug and the effectiveness of drugs. We would design trials that would have appropriate rigor.

We would call it the @US_FDA.14/

https://twitter.com/aslavitt/status/1288138263048474624

Let me pre-empt. The FDA is not perfect. It messes up sometimes. It is be too slow sometimes. Occasionally it approves something that looked fine when 30,000 people took it but wasn’t fine when 3 million people took it.

We can be frustrated every time it messes up. 15/

But we are better off criticizing it & fixing it than abandoning all reason.

The one thing we wouldn’t want is an FDA that could be influenced by politicians. Only by evidence. More and better evidence. 16/

In the case of Hydroxy, it’s not as if the FDA has been too cautious. In fact it did something it does only in dire emergencies. It authorized it to be used without the evidence. 17/

An EUA is rare. But can be useful. There are times for it.

But when evidence mounts, the FDA needs to make decisions based on the best evidence. That’s why they withdrew the EUA (emergency use authorization).

Those pushing this drug can’t accuse them on not being bold.18/

Trial & error is going to happen when there is a novel virus. And we adjusted. If the original EUA was politically motivated (I don’t know that it was), they along with international bodies, reached the conclusion that it was not effective. And not safe. 19/

Now I expect them to keep looking at studies. There are doctors & scientists who think it works. They may be right. If so and they mount the evidence, the FDA should examine & adjust. There are lots of ways to parse it— dosage, combo therapy, severity, staging. 20/

Let’s say a study produces evidence that it works on males w type A blood & diabetes who have had the disease for less than a week. If so, it would be wonderful for that group. The FDA examines evidence like that for a living— to save Lara Trump and me the trouble. 21/

Here I am asked to address Lara Trump’s push of this drug & you can hear my response.

I don’t know Lara Trump. And God bless her. But God has better sources of scientific information. 22/

npr.org/sections/coron…

If your doctor disagrees with the FDA they can provide it to you “off label.” I hope they & patients recognize That given the shortages of the drug, it provides a real hazard for people with Lupus & others who need it right now. Just ask @morethanmySLE. 23/

Selling miracle cures, rather than gathering real evidence, is sadly part of a pattern with Trump as @davidfrum points out here. 24/

Smarturl.it/in the bubble

Since @ScottGottliebMD and before him @califf001 left the FDA, I’ve had concerns about its political leadership.

But that doesn’t carry over to the career scientists, clinicians & researchers. They have a tough job here. If you want to know who to believe, start there. /end

Wrong link to @davidfrum

Smarturl.it/inthebubble

This is the wrong link. The right one is at the end of the thread.