Jason Karlawish
speaker
1,378 appearances
5 recordings
1 series
first heard Feb 2021
last heard Dec 2023
Jason Karlawish’s voice in public audio — every appearance, attributed to the second.
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Appearances
The issue was the degree that that translates into benefit for patients.
And that I think is still in equipoise.
Yeah, well yeah, well if it isn't Bruce Springsteen there'll be John Le Care novels because or some other story of sort of uh
what just happened and who knew what when, pick your uh
espionage and or whatever uh stories because
I think that that that's event number one.
When I went to bed on the evening of June sixth, the idea of reducing amyloid as a surrogate measure, the way we reduce LDL with a drug, was a provocative hypothesis and need of further testing.
By the evening of June seventh, it was clinical practice.
And that was not because of a breakthrough study.
It was because of this imperious decision by the FDA.
And as Aaron points out,
The the way they
dismiss that topic in November and never reconvene the advisory board or any discussion of this regulatory approach and uh uh uh is blow number one of several blows against the reputation of the FDA and has raised real concerns about the process that the FDA engaged in.
And accusations, for example, that
You know, well, claims by say Alfred Sandrock at Biogen, the head of research and development, you know, that science proceeds in public discussion and debate.
I totally agree with Dr.
Sandrock, but there was no public discussion or debate of the particular approval that was given.
That's exactly what Aaron said.
And I think that it raises real concerns about what FDA's decisions are, their decision making, and casts a real pall on this particular decision as well.
about Aaron then going and using a different set of regulations too.
Showing 821–840 of 1,378 · page 42 of 69
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