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Vinay Prasad MD MPH Profile picture
@VPrasadMDMPH
Oct 1, 2021 β€’ 10 tweets β€’ 5 min read β€’ Read on X
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Led by UCLA chief resident @uclaimchiefs Jack Sharp & with my friend @arkhaki our NEW paper is now OUT in @JAMANetworkOpen!! @vkprasadlab

Check it out πŸ‘‡πŸ‘‡πŸ§΅

We analyze second line therapies in trials that seek to replace sunitinib as front line RCC Rx
jamanetwork.com/journals/jaman… Image
These are the 6 studies we focus on
They will be no surprise to RCC folks

Our question is simple:

Did pts assigned to the control arm get appropriate post protocol care?

I pray the answer is yes! Image
Here is the key figure πŸ‘‡πŸ‘‡πŸ‘‡

Let me walk you through it... Image
The top color is acceptable
Obviously if you are still on TKI front line, that's fine Image
The bottom bar is also good
Post protocol IO is the standard of care second line treatment Image
This color is not ideal
Come on, we all know the other post protocol options lack the desirable feature of durability & we have some head to head trials.
Come on... you know it is not ideal... Image
And this color is very problematic
These trial patients should largely be getting second line therapy

And PLEASE do not reply to me with real world data on subsequent lines, as this is not all comers, but TRIAL pts, it should be higher than RWD Image
What is the point?

If companies want to move their costly combos to the front line, they should prove that routine front-line administration of the combo is superior to sequencing--

that is literally the Q facing doctors & patients...

BUT...
... it is much easier to show that when you provide inappropriately poor post-protocol care in the control arm... and the easiest way to achieve that is...

recruit in countries where post protocol therapy is beneath the US standard.

It is shocking US FDA accepts this!
This is our take home message

Billions of dollars on the line
Loads of patient toxicity and we still don't have a trial that seeks the honest scientific answer

Read the full paper here:
jamanetwork.com/journals/jaman…
SAD! Image

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More from @VPrasadMDMPH

Vinay Prasad MD MPH Profile picture
Nov 22
Every single one of these garbage papers use the denominator of PCR+ covid infections, and not the actual denominator of people who had covid-- many do not present to the doc. Every single one of these papers is shit. I would be embarrassed to be an author. Incompetent work. Image
People with covid who are so sick they have to go to the doctor have poorer health than people who don't. That should be in the journal of obvious things. All of these authors are extrapolating beyond the evidence. They're creating a body of trash calling itself science
Is there a single paper that uses a sero prevalence denominator? Is there a single researcher in this field whose brain is working? Just one. That's all I ask for.
Read 7 tweets
Vinay Prasad MD MPH Profile picture
Oct 3
Totally wrong. Because Vincent is not thinking about the counterfactual correctly.
*Teachable moment*

1 These drugs were approved by accelerated approval in the LAST line. Some later improved survival & others didn't in an EARLIER line.

2 The counterfactual to AA... 🧡
is demanding RCTs powered for say, OS (survival). If a company couldn't use RR to get AA, they wouldn't run a trial in the 2nd line or 3rd line setting powered for OS, they would run it in the 7th or 8th line

Why? more dire = faster result
3. We have proven that in these v late lines RR and median DOR (the current AA criteria) result just as fast as OS
pubmed.ncbi.nlm.nih.gov/30933235/
Read 10 tweets
Vinay Prasad MD MPH Profile picture
Sep 29
Many people want covid to be worse than it is. They imagine it has long-term consequences that are worse than other respiratory viruses. Adjusting for severity of illness, it doesn't. Only anosmia is unusual. Why do they want it to be worse than it is? 🧡
For some reason, some people want to live with perennial precautions. They don't want to take off the mask, they want their children to mask, they want to keep getting booster after booster. I don't know why but they want to live in fear.
They have...
A mountain of retrospective observational data that they think supports their claim that covid has long-term disability. That it's a vascular disease. And all sorts of other claims. Nearly all these studies are flawed. They don't have good controls.
Read 15 tweets
Vinay Prasad MD MPH Profile picture
Sep 25
I spent a lot of time today reading this paper, the criticism, the rebuttal, the retraction notice. OMG! My head hurts.

But... An important point no one has said is that the entire premise of the study & criticism is flawed. 🧡 Here is a short summary
Lots of prior studies show many psychological findings don't reproduce. Obviously that's because so much of this science is bullshit. Small sample size, weak methods. Entire fields struggling to justify their existence & people p hacking and exaggerating to be on @HiddenBrain
How do you fix this problem? No one really knows. All of academia is incentivized for hype and discovery, actually being a thoughtful student, criticizing things, pushing for better methods that's unpopular.
Read 17 tweets
Vinay Prasad MD MPH Profile picture
Sep 14
Thank you @Erman_Akkus for ur reply it is a good learning opportunity for #ESMO24

In 15 tweets, I will summarize the trial, my criticism, and why this reply contains 3 common errors that oncologists make because our training doesn't teach these ideas.

First, the trial... Image
The trial is #LEEP-012 and randomizes pts with INCURABLE (see pic) liver cancer to TACE (embolization) plus costly drugs or embolization alone.

These 2 drugs are TOXIC (lenva is horrible) and cost a FORTUNE 200-300k per annum per person
#ESMO24 Image
Every single person has the cancer return. It is non-metastatic, as @Erman_Akkus says, but it is not curable.

Here is the time until measured lesions grow 20% or new lesions present or the patient dies

That's what he and others are excited by #ESMO24
a 4 months PFS Image
Read 16 tweets
Vinay Prasad MD MPH Profile picture
Sep 11
Just out on @medrxivpreprint and @CityJournal
We analyzed all COVID19 corrections in the @nytimes
We show that 2:1 the Times OVERSOLD covid risk or FALSELY HYPED the benefit of restrictions
1 reporter alone was 7% of all corrections
Let's take a look 🧡Image
Image
Naturally, in times of crisis, newspapers won't get everything right

Corrections are inevitable and forgivable

But corrections should occur at random

Sometimes they are too high and sometimes too low

If they tend to be in one direction...

That's bias
Here is the key figure
When the New York Times made mistake those mistakes were TWICE as likely to OVERSTATE the harm of COVID, particularly to kids, than UNDERSTATE

This is evidence of systematic BIAS in their reporting

But it gets worse Image
Read 11 tweets

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