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Oncologists and Policy makers do not even realize the problem with today's @FDAOncology approval of Pembro for TMB-high tumors
Are you ready to hear it?
It will blow your mind, and someday will end the FDA as we know it.
It is a deep deep problem.
[thread]
![Oncologists and Policy makers do not even realize the problem with today's @FDAOncology approval of Pembro for TMB-high tumorsAre you ready to hear it? It will blow your mind, and someday will end the FDA as we know it. It is a deep deep problem.[thread]](https://pbs.twimg.com/media/EarAlF2VAAAM4ss.jpg "Oncologists and Policy makers do not even realize the problem with today's @FDAOncology approval of Pembro for TMB-high tumorsAre you ready to hear it? It will blow your mind, and someday will end the FDA as we know it. It is a deep deep problem.[thread]")
Are you ready to hear it?
It will blow your mind, and someday will end the FDA as we know it.
It is a deep deep problem.
[thread]
A logical way to approve cancer drugs is if they improve survival or quality of life over best available care
That's rational
That's defensible
That's sound
That's consistent
That's rational
That's defensible
That's sound
That's consistent
Here, the FDA approves a drug because 24% of people with MSI-low, TMB-high tumors have a response
A response means the tumor shrinks 30% or more
Do people live longer than if they take alternative therapy?
Who knows!
A response means the tumor shrinks 30% or more
Do people live longer than if they take alternative therapy?
Who knows!
The logic is we do know for these patients, a fraction has shrinkage of cancer;
So, it's a personal choice.
Yes, I do not know if I will live longer or live better, but I can decide if a 1/4 chance of 30% tumor shrinking is worth it to me.
Why should government stop that?
So, it's a personal choice.
Yes, I do not know if I will live longer or live better, but I can decide if a 1/4 chance of 30% tumor shrinking is worth it to me.
Why should government stop that?
Notably the FDA has even approved drugs with lower response rate.
FDA approved nivolumab in small cell lung cancer with a 12% response rate
FDA approved nivolumab in small cell lung cancer with a 12% response rate
Again, it's a personal choice.
12% of people might have tumors shrink 30% or more.
Why should a regulator demand survival benefits?
Let patient's decide for themselves
Why should government stop people dying of cancer?
12% of people might have tumors shrink 30% or more.
Why should a regulator demand survival benefits?
Let patient's decide for themselves
Why should government stop people dying of cancer?
Ok, now here is the BIG problem
The FDA did not approve pembro for MSI-low, TMB-low tumors even though 6.7% of patient's had tumor shrinkage!!
6.7%!!!
The FDA did not approve pembro for MSI-low, TMB-low tumors even though 6.7% of patient's had tumor shrinkage!!
6.7%!!!
What gives them that right?
Why is 12% ok for patients to choose but 6.7% is not ok?
Why should a government bureaucrat decide that I can take a 12% chance but not a 6.7% chance?
It should be a personal choice, as well.
Why is 12% ok for patients to choose but 6.7% is not ok?
Why should a government bureaucrat decide that I can take a 12% chance but not a 6.7% chance?
It should be a personal choice, as well.
Not to mention survival was higher in the 6.7% group!!!
( I know all the problems with it tnx, v much)
( I know all the problems with it tnx, v much)
And that is why @FDAOncology is destroying itself
For decades the agency has not picked benchmarks that ensure living longer or living better
(a rational cut-off, a logical standard)
It accepts lower and lower surrogate values, and plays the "patient choice" card
For decades the agency has not picked benchmarks that ensure living longer or living better
(a rational cut-off, a logical standard)
It accepts lower and lower surrogate values, and plays the "patient choice" card
But there is no logical reason, no reason on earth, why 12% is ok to choose but 6.7% is not ok to choose
That is a personal choice.
And we can take it down to 0% or no study at all b/c that is also the personal choice.
That is a personal choice.
And we can take it down to 0% or no study at all b/c that is also the personal choice.
When you build a house on the steep face of a mountain, it will only slide down.
The FDA has positioned itself in a place where extreme libertarians, folks like @balajis will carve them up, and they should for not being logically consistent, for being irrational
The FDA has positioned itself in a place where extreme libertarians, folks like @balajis will carve them up, and they should for not being logically consistent, for being irrational
They set arbitrary, capricious and frivolous benchmarks that hinder free market capitalism and choice.
I and others prefer rational benchmarks (FTR)
But if 12% is ok, why is 6.7% not ok?
In 2 years, 6.7% will be ok (btw standards lowering)
I and others prefer rational benchmarks (FTR)
But if 12% is ok, why is 6.7% not ok?
In 2 years, 6.7% will be ok (btw standards lowering)
The FDA is making a powerful case against its own legitimacy, for dissolving the agency; for returning to pre 1962 USA.
There are a LOT of people who want that, and the FDA is helping them.
They just don't see it yet.
There are a LOT of people who want that, and the FDA is helping them.
They just don't see it yet.
If you want to learn more
Read Malignant or listen to the audiobook https://www.amazon.com/Malignant-Policy-Evidence-People-Cancer/dp/1421437635
Read Malignant or listen to the audiobook https://www.amazon.com/Malignant-Policy-Evidence-People-Cancer/dp/1421437635
