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
Yeah.
I you know, I uh look, my take on the drug is this drug has real benefit and real risk.
And um I think the biggest problem I see is
After F Day approval, if it gets widely used
by clinicians not skilled in how to use it.
We're gonna see problems with it.
I think actually FDA should put under a risk evaluation mitigation strategy or a REM strategy.
And a REM strategy allows FDA
To create criteria for who's a prescriber.
It allows FDA to um set standards for gathering data for risk in a registry, in a in a in a database.
So it ri it's been used for drugs just like this.
There's benefit, but there's also risk.
In the early days of MS, it was used for the early MS drugs that caught could cause uh uh uh pi PML in addition in the brain, just very similar kind of side effect in some sense.
Um the concern I have is without a REMS, especially in America, wide use by you know frisky prescribers could cause some real problems here for patients.
I worry about those.
I disagree.
What I say Jared just needs to get on board with this drug.
That means get on board with using biomarkers to understand what the cause of someone's disease is, in this case Alzheimer's, and then using MRI technology to better diagnose the disease and look at some of the comorbidities like microhemorrhages.
In the case of using this drug
Um, if someone develops microhemorrhes or micro edema.
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