4-12-24 : My comments at the FDA Advisory meeting on the irresponsible use of MRD for AA
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- Опубликовано: 30 июн 2024
- Vinay Prasad, MD MPH; Physician & Professor
Hematologist/ Oncologist
Professor of Epidemiology, Biostatistics and Medicine
Author of 450+ Peer Reviewed papers, 2 Books, 2 Podcasts, 100+ op-eds.
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An articulate and well reasoned position on this subject. Thank you for making this information available and for working as a tireless advocate for the safety and efficacy of drugs and procedures. It is to the great misfortune of the American populace that we don’t have you or likeminded people working for the FDA.
Thank you for your invaluable work. Heaven help us!
Thanks. It must be incredibly frustrating doing all this work knowing they aren't even listening.
Great comments Vinay, as always. Totally different perspective and agree there were no body to counter argue. They are proposing MRD as an earlier endpoint, giving reason that PFS is long and takes time, where they use PFS from earlier. However AA should only be applicable for later line 4 line and more. From KarMMa -3 trial PFS for CAR-T arm was 13 months and for standard of care was 4.4 months, therefore even if you use MRD at 12 months does not save time.
I think the lancet just had a paper that most accelerated approvals dont work
We need more Doctors like you. Thank you for continuing to fight the good fight.
AA for a treatment for patients with serious conditions may be questionable but not as questionable as AA for a treatment for everyone without a condition at all. Maybe I'm being a pain in the ass but there are much bigger things to get on the fda about. Trying to keep the memory alive here because it seems like we've already moved on only to repeat the same nonsense the next time around.
Yeah, but what about the PHARMA jobs waiting for the FDA operatives ... don't forget their priorities. If you get the chance, I would love to hear your take on the FDA's colchicine scam. Take a generic drug that has been in use for millennia and grant the equivalent of a patent to one company. I would sure like to see the bank accounts of the scum that pulled that one off.
And quinine.
But how is the pharma company gonna make a billion dollars if they don’t get this AA?
How do you stay sane in the face of such unethical and illogical absurdity? Many of us went crazy from the COVID response, and to see this ongoing level of decline in medical things and research hurts my psyche. You must have a insurmountable constitution.
Wow, what an amazing guy Vinay is. Very sharp and smart.
Why would the FDA NOT adopt a process that will allow them to aprove any drug as fast as possible so they can stack their resumes for their next job at a pharmaceutical company?🤷♀️
They are just trying to provide for thier families!
The cold hard truth is resource. They’re an under experienced institution with regards to where biological science is at. Similar to how AI is hard to regulate because it’s just too advanced.
FDA relies on consultants at institutions w. Drs at the bleeding edge of research. But even then, those Drs are under resourced and their staff is like 10, and studies they run have an N from 10s-100s.
Corporations are employing people who were trained under the same Drs at these institutions as post-docs, having staff in the 100s and studies with N in the 1000s.
Institutions aren’t the ones pushing science anymore. They might be the first to discover something novel. But to bring it to market enough to be clinically relevant… the landscape you need the 100s of millions to get it there.
Even though investigators initiated trials are increasing, institutions are eye gouging each other with insane overhead costs that make collaboration near impossible without a ton of money. Good will research between institutions isn’t a thing anymore, the cost to run multicenter IITs are cost prohibitive.
Love ur videos! Periodontist in Florida
You dadgum doggone done did it now son!
You ain’t never getting invited back now
how common is Myeloma? speaking of colonoscopy, 20% of my income is paying for Medicare and I'd probably live longer if I wasn't living in poverty paying for treatments I've never used. this all seems like business and entertainment for those who devoted their lives making a hobby of the human race.
I watched the 4 hr adcom on it. The argument comes in that survival with pts with MM is pretty good, but that creates a bottle neck in innovation to approve new drugs and improve health in these patients. MRD testing is supposed to be very specific for MRD- dx because once you hit the PFS it means disease is progressing further than MRD.
They’ve demonstrated in a meta analysis across 8,000 patients that MRD in a non inferior endpoint to PFS because PFS is poorly correlated to outcomes anyways.
I work in pharma… non inferior studies are expedient. We all know that. And PFS is NOT valuable in oncology and MRD is equally insufficient. Regulators should raise the bar for companies not lower it. It’s quite bad.
@@reginamemoriesforever-vc8ql it’s not meant to be expedient. Their arguing across 8 years of studies far back as 2016, MRD has been an exploratory end point for each study that was ran, across 8000 subjects & 26+ studies. They are now at a point where the companies in the oncology space did a meta analysis to show MRD is an earlier indicator that can be used as an end point as compared to the standard of PFS (which is .39 correlated to outcomes). Analogy would be assessing for diabetes. It’s not like we’re tasting piss for sugary content anymore as an endpoint, we’re looking at A1c. MRD testing can be done with a blood test with either assay or NGS, the test output is continuous and can be measured with amazing accuracy. MRD- is very specific as a NPV.
Bringing experimental drugs to market without having been fully vetted through appropriate controls is pretty much medical experimentation on humans. Because humans become the quality control testing. The argument that "controls are preventing the innovation of drugs to improve patient lives" is pretty much "the ends justify the means" (i.e. we want to bring new drugs to market faster..."for the good of the people").
I think we've all heard that line before and know how it turned out.
@@Arielelian I agree with your argument. But the current standard of approval (PFS) is pretty ass already at a correlation of .39 to outcomes. And is a lagging indicator to disease progression. When you see PFS, disease has been already progressing months in advance before it’s caught by an assessment like an MRI scan, etc.
You could make the argument that MRD currently has no statistics to outcomes beyond 1 year, which is a faulty metric. I would even argue with 8 years of studies but they present only 1 year data is sus. They could either: not collect samples past 1 year OR have no statistical significance beyond 1 year and is censoring those results.
But as it stands their data for 8000 subjects is strong science, that’s a powered calculation most scientists wish they could make, which means MRD- is a strong NPV for up to 1 year data.
Edit: to be clear, on the adcom they acknowledge the MM space already has “good” outcomes. But the argument of approving drugs because they prevent disease progression once its picked up on an MRI is a completely different assessment of measuring active cancer cells by measuring the DNA of cancer cells in your blood which is already very accurate and specific. It’s not that the drugs aren’t beating out controls, it’s because the level of fidelity you’re assessing for in PFS is nothing compared to MRD.
Essentially you’re saying MM patients in remission is the end goal. But when you have tools that can measure the concentration of cancer cell DNA in your blood comes around and present an opportunity to show you’ve eradicated the disease in a patient, but choose not to use the only tool that can accurately assess for it, is a bad take. As it stands, they have strong data at 1 year.
Analogy, you can treat someone with stinky hands to ask them to wash their hands. PFS is checking for dirt under their fingernails. MRD assessment is doing a bacteria culture.
@@foodie5367 The FDA has been known to lie and censor, so I would not put that past them at this point.
Additionally, it's wonderful that they have great calculations, but has that data been made availble for others to review and scrutinize? Given their dubious scientific methods and calculations over the past several years, the trustworthiness of their claims isn't worth the paper its scratched on.
The scientific and medical community has given the FDA too much of a free pass to do whatever it wants, and it's shown that it'll exploit that to its own benefit (much to the detriment and harm of others). It's high time for the FDA to be held to actual scientific standards versus a "just trust us" metric.
I mean by this point, I do the complete opposite of what the FDA believes/says/does. I practice an existence that is on the opposite side of the spectrum of theirs.
Money!
👍
Vinay- are you available to consult?
Pharma: These people are living 10 to 15 years? We need a more expensive drug they can take the entire time.
Dr. Prasad: "Everything will be an unmet medical need and we'll have a bonanza of unproven drugs on the U.S. market."
FDA: 😏😈
😮
These FDA meetings are a masterclass deceit, spinning, gaslighting, dishonest disingenuous discourse. The meeting that authorised the COVID shots for children was particularly nauseating. They cynically ignored all the concerns and questions posed by independent professionals and scientists that attended the 8 hours long Circus show.
You forget that the goal is still population decrease.
I'm so glad you're destroying your credibility day by day, Prasad.
I'm hoping you're fired before the end of this year.