Dr. Joseph Fraiman

He was very clear cut and that he was showing that we're uncertain.

And, but that is the, it's like, thank you that we have a rational human being in charge of the approvals of these biologics.

Yeah, it's a pretty dangerous viewpoint on how we're going to deal with novel substances that we're going to inject into people.

I think that in general, we need to...

And in this letter, you know, there's actually it's an incredible letter I found that and he made so many great points in it and what he took from this and this idea that we don't know if the vaccine harmed or saved more, you know, which this mystery, I guess.

And he took that and he pushing it into our policy and saying, we cannot allow this to happen anymore.

And he gives very, you know, he gives specific ways that we can prevent this from happening.

And it's, we've always known how to do it.

And it's, we know that what you need, and he clearly demonstrates this is that we need randomized trials.

We can no longer be using surrogate markers such as, uh,

In vaccine trials, it would be antibodies.

They have to be clinical outcomes.

And is what he was saying, which means a surrogate outcome is a thing that

you would never know unless your doctor told it to you.

And what I mean by that is if you could take the surrogate outcome for any drug and cancer, for example, it would be how big is your tumor?

You have to get a CAT scan and then your doctor tells you your CAT scan is bigger and you're like, oh God, that's bad news.

So it seems logical that a drug that makes your cancer smaller

would be a good thing but actually surrogate markers are actually just sort of the first step in terms of figuring out if a drug works because you know how the drug you have an idea of how the drug works you need it to then do the surrogate it needs to change it needs to make the tumor smaller for example but if your tumor is smaller and then you die of liver failure that really doesn't matter right because the reason you're taking that cancer drug is to live longer

and so if you just are looking at the tumor size you're you're going to get it wrong because and the same is true with vaccines is that if you're only looking at antibodies or things that are you could even use a clinical outcome but if it's not a relevant one such as do you get a case of the sniffles that is actually going to if the answer if the reason for the vaccine is to prevent hospitalizations prevent death

If you don't do a study that shows it prevents hospitalizations or death, then we don't know if it reduced hospitalizations or death.