Emilia Javorsky
speaker
1,653 appearances
2 recordings
1 series
first heard Mar 2026
last heard 20 Mar
Emilia Javorsky’s voice in public audio — every appearance, attributed to the second.
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recordings per month · last 12 monthsRecordings per month over the last 12 months — 2 in all, peaking in Mar 2026 with 2.
Appearances
And so in order to make sense of this, because people were dying because there were toxic ingredients in these things, people said, well, we need to understand the safety of these products.
Like what is the safety of that?
And the first sort of iteration of the FDA was in terms of safety.
Then over the years, it became, well, we need safety and efficacy, right?
Because we can't actually understand safety in isolation unless we actually understand how effective it is because there's always side effects.
And over the years, there sort of became more and more requirements of what you had to demonstrate.
And from the perspective of wanting to make sure something is safe and effective, that is...
understandable as to why that regulatory process sort of unfolded.
What I think is not seen is the cost of taking that process.
And again, as an agency whose job it is to sort of weigh risks and benefits, we also have to do a meta weighing of the risks and benefits of what has happened from those regulatory decisions.
And what we've ended up with is a system that
mandates a level of understanding that is not actually what medicine or science can have to offer, right?
So you can only have a drug approved if it meets a certain disease category.
Well, these disease categories were established decades ago, right?
And now we understand that some of those disease categories are too broad, some are too narrow, right?
And you might actually have a
clinical trial where you do a study and in that disease category, 30% of patients do amazing and 70% of patients don't actually get any benefit.
Well, you look at that and you start to understand, well, these 30% of people who did really well were of a specific subtype, right?
And that was what was driving their doing well.
that drug is actually may not make it through the FDA because the clinical endpoint was just developed for everybody.
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