Episode 290: The ChemoCentryx Saga With Anish Koka

Cardiologist and “The Doctor's Lounge” host Anish Koka, MD, joins the show to examine the extraordinary ChemoCentryx and Tavneos (avacopan) controversy, including the retraction of a New England Journal of Medicine clinical trial that played a key role in the drug's FDA approval for ANCA-associated vasculitis. Based on his Substack investigation, Dr. Koka breaks down the timeline of events, the concerns surrounding post hoc changes to trial endpoints, the FDA's response, and the far-reaching implications for clinical trial integrity, drug development, pharmaceutical regulation, and evidence-based medicine. Tune in for a thought-provoking discussion on scientific transparency, regulatory oversight, and what this high-profile case means for physicians, researchers, the pharmaceutical industry, and patients alike.

Read the substack article.
https://anishkokamd.substack.com/p/we-cannot-afford-to-miss-a-superiority

Subscribe to The Doctor's Lounge.
https://podcasts.apple.com/us/podcast/the-doctors-lounge/id1832097658

Check out Chadi’s website for all Healthcare Unfiltered episodes and other content. https://www.chadinabhan.com/

Watch all Healthcare Unfiltered episodes on YouTube. https://www.youtube.com/channel/UCjiJPTpIJdIiukcq0UaMFsA

Transcript

SPEAKER_02 0:12

Welcome to Healthcare Unfiltered. This is your host, Chaddy Nabhan. I'm a hematologist and a medical oncologist, and I appreciate you tuning in this week to Healthcare Unfiltered. Today's podcast is with Dr. Anish Koka. Anish is a cardiologist, but he also is a podcaster, has a podcast called The Doctor's Lounge, where he actually discusses issues pertaining to practicing physicians and what affects their practice and healthcare policy and so on with several other colleagues and physicians, and they do a great job at it. I'm a I listen to their podcast often. He also writes at Substack, and I came across one of his pieces that he wrote in the beginning of July 2026. It addresses an article that was retracted by the New England Journal of Medicine. The article was on a therapy that was approved for NCA vasculitis, which is a rare disease, anti-neutrophil, cytoplasmic, antibody-associated vasculitis. And the therapy is called Tavinos, T-A-V-N-E-O-S, Tavinos. So the New England German medicine retracts this article, and this piques Anish's interest. So he investigates along with other folks why this was retracted, and uh it led to a piece that really uh you need to read on his HubStack, and this is the topic of today's podcast. The chemocentrix saga. What actually happened that led to the retraction of this article, which was instrumental in the FDA approval of this therapy for anchovasculitis? So I'm not gonna give away everything. You have to hopefully listen to this podcast so you actually know what we are talking about. Folks, uh, before I uh start the show, I want to make sure that you uh subscribe to it. You can write a brief review, let your friends and colleagues know about this show, and also uh check out my website, chattynabhan.com, and you will know about my books, Toxic Exposure: The True Story Behind the Monsanto Trials and the Search for Justice, and The Cancer Journey, Understanding, Diagnosis, Treatment, Recovery, and Prevention. My third book, AI and Cancer Care, When Machines Meet Modern Medicine, is coming out on December 1st, 2026, published by Johns Hopkins University Press. And my first fiction is coming out in February 2027, so stay tuned for that. I can't wait to share more details with you about my first fiction. Without further ado, Dr. Anish Koka on the chemocentrics saga. Well, Dr. Anish Koka is on Healthcare Unfiltered, and he is a podcaster himself. I'm a subscriber to the Doctor's Lounge, where you guys really discuss some really interesting topics, you and Tonio and the crew. Um by the way, before we get started, I know you've come on this show before, but uh how has it been um doing your podcast? What's uh how has your experience been?

SPEAKER_00 3:22

Oh, it's been great. It's been really good. I mean, there's been uh, you know, I mean I think I think for me, uh whether it be writing or podcasting, I do think there's people that are professionals that do it all the time that are way better at it. But but but I just feel like there's this uh narrative um that uh there's this point of view, I should say, that isn't out there. And it's an important point of view in terms of uh the practicing physician uh view on health policy and medicine more broadly. So and just it's not out there. Like the I wish I wish the science journalists would do it. I wish there were other health policy folks, I wish the wonks, you know, the the MD MPHs from these various places would do it, but they don't do it. So, you know, so it's been great to have these conversations because I feel like these conversations that we're having on the Doctor's Lounge, uh, whether it be with Stanley Goldfarb from the Duno Hormor Organization, whether it be Tracy, Tracy Who, uh, who was you know the recent FDA head, these these conversations are not happening uh the the way I'd like to see it. So so yeah, it's been it's been great. It's been great to get a lot of good guests and get get a certain perspective out there that I don't think is out there.

SPEAKER_02 4:29

I think I listened to most of you your podcasts. They're there I'm and I watch them sometimes on Twitter. Um, and I always try, I mean, I think there are times I've been doing my podcast for almost seven years now. I do feel sometimes I'm I'm not very focused. Like I do a lot of topics, right? Sometimes trials, sometimes things. What you you're actually more focused. Like I can tell that what you're focused on, your niche is addressing issues pertaining to physicians specifically as they're practicing medicine. Um, I don't think you're married to a particular specialty. I don't think, I mean, I, you know, I mean, I've heard the episodes of the ER physician, the neurosurgeon physician. You have a lot of great topics. So um, for those who are listening to me who have not listened to Dr. Coca and the crowd, please look at Doctor's Lounge. It's really a great podcast. But dude, the reason I got you on this podcast because I am a subscriber to your Substack, and I read um most of what you write. And I was just reading the latest thing about the chemocentrics, and I was baffled. Because about a couple of weeks ago, we all saw a retraction of a paper in the new Nigeria medicine. And of course, you know, you raise your eyebrows and you wonder a little bit, but frankly, I did not pay much attention personally because it wasn't in an area I'm even familiar with. Like I don't even know what that disease is. It wasn't a therapy I was familiar with either. And I did not understand the background and the repercussions. You clearly saw the same. What made you dig deep into that retraction to and and investigate the story? I want to start from the beginning.

SPEAKER_00 6:14

Yeah, that's uh that's a great question. Uh, you know, it it just happened a few days ago. It was June 30th. I said, you know, this blurb that comes across your screen saying this this drug is retracted. And I'm not a rheumatologist, um, but I've been writing for the last six months or so. It's gone on my radar that there's this arbitrage that seems to be happening um with a certain type of biotech company um with the FDA to get um therapies on the market that have questionable efficacy and have unknown toxicity. And that specific arbitrage appears to me uh uh to be related to rare diseases. So rare diseases are rare because there's a small group of folks that have it, and it's a huge problem, right? It's like, why would anyone put in billions and billions of dollars of RD when the market is so small for um for for whatever therapy you're doing? So understandably, uh, you know, uh the the FDA, the regulatory pathway has shifted to say, hey, look, we we we can't do our randomized control trials for this group of patients. Uh we need to have some type, you know, you need to have some type of surrogate because otherwise you have these poor patients that have this horrible rare diseases that are dying, and we need to do something about it. And we need to have, we need to accept and bend and be flexible about you know, not having 20,000 uh uh size randomized control trials, which is totally reasonable. But what I've seen happen, and this is what I've been writing about for the last six months to a year, is that there are these companies that that are not the large Amgen, Pfizer, Lilly, you know, five, six, you know, whatever, $40 billion a year companies. They're these small companies that are focused on just rare diseases and just the just have one working product. I mean, and so the these companies are the ones that are running these relatively small trials, um, and it's with surrogates, and they get the FDA to approve it, and then they get on, they get on the market. And there's been a little bit of a track record now. You know, Serepta is a company that had a have has had multiple therapies now over the last 10 years that have been really questionable. There's been a ton of debate on the FDA side about whether or not these drugs should be allowed to go, you know, they they meet the standard of efficacy. They've been put out there, and the drugs have either not worked or not worked and been harmful, and people have died from it. So Serepta's um uh therapy for gene therapy for Duchamp's muscular disease called Elevidis. Um, you know, it was a very controversial decision. Peter Marks, who was this FDA CBER head, kind of you know, said, Oh, no, no, we're gonna go ahead and approve it, and kind of overruling staff. And uh, and since then, uh, you know, multiple kids have died uh with this particular gene therapy. Um, so I've been writing about that. There's a couple other, you know, drug drugs and companies as well. Um, and the and it's in it's an interesting pattern. So what happens is, you know, you they they get these approvals, and then if if there's a hint that they're not getting an approval, or if like a regulator at the FDA is saying, hey, you know, I don't, I don't think this is this is right, we're gonna, we're gonna, you know, we're gonna stop you, then there's this massive pressure campaign for patient advocacy groups, senators, congresspeople that are saying, oh my God, there are these patients that are dying, you're preventing this drug from getting on the market. And I mean, you know, in the case of Sarepta, that was the first, that was one of the catalysts for why Vinet Prasad was essentially fired the first time, which is which was insane to me. So when I saw that, that was the thing that piqued my interest. I was like, oh my God, like here we have a small biotech company that is essentially deciding whether or not the regulator that is supposed to be regulating them uh uh uh uh can stay or not, right? Um and it's not done because, you know, it's not it's not like this direct line where somebody Serepta person picks up the phone and and the and someone's gone. It's like this big pressure campaign, right? Like I'm describing, the media, the senators, the well, you know, the uh the pharmaceutical uh company, uh the pharmaceutical uh uh uh uh media coverage, like stat news and endpoint news. And ultimately a guy like Vinay Prasad, who was regulating, who was trying to pull one of the drugs, you know, Elevidis, which is a gene therapy uh that Serepta was marketing, that had killed some boys, and he was trying to get the get the drug withdrawn. And it turns out, you know, Vinay Prasad, the regulator, ends up ends up being uh gone, right? And so fast forward now, and you have Tracy, Tracy Who, who's the FDA CDER director, another division of the FDA, who's all in the center of drug uh evaluation and research, and and uh and and she was fired uh you know um May uh May 18th or something like that, right? So that's the context, right? That's the background, right? And I I I've had Tracy uh who on the on the on the podcast a couple times to the podcast, yeah. To talk to her. She's she's really smart, really bright, and nobody quite understands why she was terminated, why she was fired. Uh there's some suspicion.

SPEAKER_02 11:16

But but but but when you but but when you read the retraction, is it yes, but is is it because it was a rare disease that made you like for example, if this was a retraction about heart failure, would you have even been interested in it?

SPEAKER_00 11:31

No, well, obviously, obviously I'm a cardiologist, so I would have been interested to see what happened and why I got retracted and stuff. So I mean it's always interesting to see why things got retracted. Is it is it is it you know fraudulent or what? But no, but this would not be on my radar as a cardiologist for this coming out, if not for this context of like rare diseases, these drugs that are getting on market. And now suddenly you have like some a drug that's targeted as ciancovasculitis. I mean, I'm not again cardiologist, but I know sian covasculitis is pretty darn rare. And you have a retraction. And then when you read the retraction, that retraction comment, that's not like most retraction comments, right? That retraction comment says we, the senior authors, were not aware that someone went behind, went, went, went, oh, went, uh, went over everything and and uh and actually manipulated the data, right? And that that's that that to me, and that's an individual image.

SPEAKER_02 12:19

Did they say manipulated? Yeah, right. I was trying to remember if it said manipulated, but I do remember when I read that, I was like, wow, like you know, these are these folks are saying that the data was I I don't remember if they used manipulated, but probably they did.

SPEAKER_00 12:32

Sorry, you're you're you're right. Uh without the knowledge of these two authors, the primary endpoint assessments in nine patients were read adjudicate adjudicated after database lock-in trial unblinding. So you have these databases that get locked, right? And so they're basically saying someone without their knowledge, right, unlock the database, unblinded, you know. Okay, manipulated as my word.

SPEAKER_02 12:56

You got interested. You got yeah, I got interested, yeah. You got interested in this, but but what how do you even because look, I mean, to me, when I read your piece, which we'll go over, yeah, it sounded like literally investigative journalism. And I'm um no, genuinely, I mean, I'm very fascinated by this because I've I've always liked journalism. I just never had the talent to be a journalist. But how do you go from this? I mean, like how much time do you spend? Where do you get the data? Where do you where do you start to investigate?

SPEAKER_00 13:26

Yeah, so it all of it, so it didn't take much time at all. So I so I I Googled, right? And it took like five or ten minutes of Googling to figure out that oh holy crap, this this retraction is actually based on a letter that was written from the FDA to Amgen, the company that eventually buys chemocentrics. That letter is um I forget the terminal, it's NOOH, the notice and opportunity of hearing. That's a letter that was sent by the FDA to to uh uh Amgen. And that letter is so incredibly detailed. It's linked in my Substack piece, right? Yeah, so that letter is it. So, I mean, you're right. I mean, the the this came out Tuesday, right? I I published my thing Thursday morning, and uh, and the the only reason I'm able to do that that quickly is because I'm literally all I'm doing is summarizing the letter that the FDA wrote to Amgen, because that letter in great detail lays out all of this, right?

SPEAKER_02 14:22

Um so you know it doesn't take much to do because take us back now, take us back because you do a good job, you go back about the company and so on. Take us back to understand the background of this, so at least listeners and viewers have some context into what we're talking about, because we're we're throwing a lot at them um right away.

SPEAKER_00 14:43

Yeah, so so you know cyanovasculitis is a rare disease, pretty, pretty severe, pretty terrible um when uh you know for uh a group of patients, and and there really aren't tremendous uh amount of good options. There's some immunosuppressants, there's a lot of steroids that ends up being used. And so a company called chemocentrics comes comes in to comes in with uh with a drug that mechanistically uh at least appears that it could have benefit. Um, and so you know, all discussions are had all the time between FDA and companies about, okay, if we want to get this drug to market, like what would you, the FDA, accept, right? And the FDA early on said, hey, look, we're we want we want you to show superiority over if you want to get on market, uh get on the market, you need to show superiority compared to standard of care, standard of care being being steroid. So they start this trial, it's a randomized control trial, 331 patients, 143 centers across five continents. So they randomize one-to-one to have a to have a copan or prednisone. Um, everyone is on some uh background immunosuppression because it wouldn't be you know ethical to just take people off. All right. So um there was some attempt, and I go, I go into this detail actually in the X article, um, not the Substack, about specifically why that becomes very messy in terms of trying to separate out steroids, you know, immunosuppression plus steroids versus immunosuppress inobsorption plus avocapan. And and that that's actually very messy because a lot of the patients that were in the treatment treatment arm of Avocapan actually ended up being on steroids. Um but anyway, uh this trial trial finishes, and this is November 5th, 2019. The database is locked and all the data is confirmed clean by the third party uh you know contractor. Um uh and then you know, when they run the analysis after the database is locked, right, um uh the the results are negative. The p-value is 0.1. So that so these so November 8, 20, 2019, it comes to the attention of this the chief medical officer, uh gentleman named Dr. Pierre O'Becker, that that that the week 52 uh sustained remission uh fails to reach significance um this this this fact is never disclosed to the FDA. So the FDA never knows about this, okay? The next things that happen, and this is this is the part that's crazy, and this is the part that's detailed. Again, it didn't take much investigative journals on my part. It's the part that's detailed in that NOOH letter. Um, is that the next thing that happens is that Becker uh emails uh uh you who's a bio, I think he's a biostatistician statistician at the firm saying it's of paramount importance that the data are correct, especially the p-value for superiority. We cannot afford to miss a superiority outcome here, right? Because remember, he knows the FDA has told him that you're not getting on market unless you show superiority at 52 weeks, right? So he's running this email. Yes, it is of paramount importance, yes. So so they they run a quality check. A quality check returns clean, right? Um so meaning data is confirmed to be accurate, right? So having confirmed nothing's wrong, Becker and you go hunting, right? And that's when you know they run an unblinded search. They unblind, so now they know who got what, right? And and they unblind and they find nine candidates for readjudication. Six are in the abacapon arm, three are in the control arm.

SPEAKER_02 18:16

Were they allowed to unblind, essentially? Like that?

SPEAKER_00 18:19

They were not, right? They did this on. Yeah, no, they're not allowed to unblind, right? I mean, that this is yeah, per multiple different things. So they unblind, they decide to unblind some patients. Right. And so they say, okay, um they go to uh the statistician um and say, well, before like you know, what's the hypothetical p-value if if this read if we readjudicate and the statistician says it's significant. And so they um they reclassify five of the six Avocap and patients to sustained remission from non-remission. And now the new p-value is 0.0132.

SPEAKER_02 19:01

Remember, tell me what does that mean, reclassify? It means that they basically made up the fact that they're in remission while they were not in remission.

SPEAKER_00 19:10

Well, I mean, I think they would say that look, we relooked at it, and and and actually when we relook at it, we made a mistake in the b and we made a mistake in the beginning or something. Correct, correct, exactly. They would say they would say, yeah. So they would say that this was this was a mistake initially, and you know, we don't want to uh we don't want to uh you know we want to get this right. And so that's what they would say, I think. So so they they they relock it. This is November 5th, they relock it. Um and they uh you know they submit it. Uh the FDA asks about the database lock dates. Chemocentric says the database was frozen November 20th, 2019, right? The never the November 5th database lock and that initial non-significant p-value, they never tell the FDA about and emit it entirely. New Journal of Medicine, February 2021, publishes the advocate trial results and uh you know report that P of 0.01. Um no disclosure of that failed first analysis. Um and and this is the and and this is when this is when things start to go haywire, right? They the FDA releases uh publishes its adcon briefing. Um an advisory expert advisory committee meets to look over the advoc uh the uh advocate trial results. And again, there's lots and lots of problems with the advocate trial results, even with that 52-week p-value being significant, right? One of the big issues is is you know, how do we know that the drug has any efficacy in part because a large portion of the folks that were in the Avocat and arm had steroids on board. The other thing is the subgroup analysis of folks that were on background uh immunosuppression with cyclophosphamide and rituxan, that group there was no there was no benefit you know in that in that subgroup. So a lot of folks on the adcom are have great questions about is this is this effective or not. And so they split like 9-9. So it's not I don't want to say that like it was 18-0 that everyone thought it didn't work, but there's a number of folks that raised some pretty significant concerns about about this. And the adcom, and again, this is all public, the adcom report is out there and it looks really bad for the on uh you know so the FDA adcom is essentially saying, we've got a lot of issues here. This is even with not even not knowing about this, about this manipulation and stuff, right? So when that happens, right, the stock of chemocentrics that was trading uh that was trading uh publicly, you know, it was trading at forty eight dollars, eighty two cents, it drops to twenty six dollars in a single session. Right. Because now, you know, the the market is getting the sense that, uh oh, this is this is not this is not gonna get the market. And you you have one drug. So so if you if if this doesn't work then you're not your company doesn't have any any val any value. And so that adcom briefing that led to the stock price drop is what ultimately bro blows this open because you have this other ecosystem of of lawyers that deal with securities fraud all they do all the time.

SPEAKER_02 22:24

This was this was interesting because that's for the first time I mean obviously I know there are lawyers for security frauds. What I did not know is there are folks like automatically there's like an algorithm if the algorithm drops the share price these law firms get notified I've never heard of that.

SPEAKER_00 22:42

Yeah because why else why because it it it's it's an it's an irr irregularity right why would a stock price suddenly go from 48 to 20 unless there was something that was falsely boosting the price before right so you know so so the base so that's a that's an opportunity for these lawyers to say hey is there something funky going on right around that time that stock drops you have the um these securities fraud lawyers file a lawsuit immediately right um so that happens and interestingly enough um you know months later this is this is may 2021 october right five months later october of 2021 the FDA approves the drug you know there's a whole long list of price goes back up well yeah the yes the stock price goes back up and more importantly it says that okay this is a this is a company that has revenue and okay every company that has revenue now has a valuation and now can be now has a cash exit right and so amgen you know acquires chemocentrix the company for 3.7 billion dollars um five months after approval so so um so yeah so appear and the founders and early investors get their exit um and uh and and but in the background that lawsuit that was filed by these security lawyers remember they from their standpoint they always work on contingency right these folks they actually solicit the the the folks that lost money in that you know so they go to pension funds and everyone else who had exposure to it and they say hey we we will allow us to do this for you on contingency and uh perceived you used you used the term in your sub stack ambulance chasers you said if these are ambulance you said you're not wrong yeah it it certainly it is that but though of course in this case you know it's it's it's it's it's it's it's the regulatory thing that finally blew it open so so these folks have a lot of money invested in trying to you know they have a lot of money they have some costs that they have to recover yeah so they are they are so they subpoena the company you know now within Amgen they subpoena the company for all their emails or all their internal documentation to look and see okay what happened here right and when they and and then they get an expert this guy I'd love to speak to this guy Mark Walton who's an MD PhD uh who's an independent expert that peruse that goes through all these emails and he's the one that constructs this this timeline that is not easily found publicly I think it's it was anyway so Walton files the the this this Walton the Walton report this is three years after right chemocent uh two years after chemocentrics was was acquired the walton report is completed so the Walton report took couple of took a couple of years probably to to to come out now we're like 24 right I mean something like that correct yeah so now we're into September 2024 which is when the Walton report gets completed but then it's not till May 29th 2025 that that report becomes public. Okay.

SPEAKER_02 26:04

Interesting that report has like a timeline of what happened at chemocentrix.

SPEAKER_00 26:10

Exactly and so that's when that's when that's when the FDA learns about it that's when the world learns about it and I mean I you know so and the FDA someone gives it to the FDA and the FDA and of course for the FDA this is like a bombshell right because it's like oh my God you have all these and and so and the nice thing is uh that's when so right so that's when the FDA now the FDA is under Tracy Who and Marty and and Vene and all those folks are there and they take that and and this and I found out after the fact so I I just had Tracy on the podcast you know days before and I'm reading this summary letter this NOOH letter that the FDA wrote and I get to the end of it and it says signed by Tracy Ho. I'm like oh my God Tracy who signed this letter right so she writes a letter to Amgen basically saying uh and it's a letter basically it's it's a it's a way of progressing on towards withdrawal right and that letter is April 27th 2026 so I mean it's a very very long process um in in the meantime you know in between then and that letter in January 2026 this is again really soon letter FDA privately asked Amgen to withdraw the drug um you know once that happens the you know this um the the the Amgen reaches a settlement uh tries to reach a settlement with with the folks that were suing for $35 million then you know things get worse in March 31st 2026 this is the really terrible part right um you have this drug that is questionable efficacy data manipulation the FDA puts out a safety communication March 31st 2026 saying there's 76 severe injury liver cases eight deaths seven cases of biopsy confirmed vanishing bile duct syndrome um uh and and you know that's March 2026 april 2026 is when this formal notice of opportunity for hearing from Tracy Bethu comes out and that's the one that's easily accessible to everyone that's what I used to basically construct construct this this whole this whole timeline. So yeah so that's and then then apparently when you have this notice of opportunity for hearing there's a window of time where there's a public comment period that public comment period I guess went till June the 29th and the next day after that public comment hearing ends the next day the New England Journal of Medicine retracts the paper.

SPEAKER_02 28:35

But well is the drug available now still commercial yeah the drug the drug is available yeah it is very hard it's not right amgen has amgen has refused to voluntarily voluntarily withdraw the drug um and uh it is still available right now yeah still available the authors the authors who withdrew so when when when you had to write that paper so the the authors were just provided the data by chemocentrix and then they published it like there there was no there was no QA or QC process right to check whether the data provided is accurate you just throw the paper.

SPEAKER_00 29:13

Correct yeah I mean yeah I mean it's it speaks to a lot of these academic you know so what funded so what but but what what made then the authors know that there was something in the data was it the FDA letter that uh I I mean I I assume so right I assume that the FDA letter is what kind of put it put them on notice to say hey this you know this has been a manipulated trial I I don't know you know this retraction I don't know if it works by the NAGM reaching out to them to say hey do you did you know this do you want to do something about it? Because I know I know like when other other retractions I've seen in the Union Journal of Medicine frequently involve that right there's like some AI data manipulation or something like that and the NAGM then contacts the authors then the authors say okay we're gonna formally retract you know so I don't know what exactly who who initiated that process but certainly there's lots of authors on this paper. Only two of those authors are kind of mentioned in in that whole retraction piece.

SPEAKER_02 30:08

So I mean I I think I think what was disturbing in reading this look uh I guess we all know that there's always fraud in every profession unfortunately um it is what it is but what's so disturbing about this is that we've always felt that whenever it comes to medicine and medications is going to treat people we've always felt that this carries a very different standard than whatever financial fraud or anything else because now we've got like people's lives at stake and um I was I was very disturbed by this so the first question is how what was the reaction that you've seen for the piece that you wrote have you had people reach out to you have you had like I mean am I am I like a was there a lot of people like me who are very disturbed by this compared to other things that we hear about yeah I mean of course like you know there's other things and other things that get a lot more uh uh on on on X there's uh many other things that get a lot more uh eyeball certainly but no I I think for for a for a very detailed kind of medical piece there's a fair number of interest fair amount of interest among the physician community um and among you know the the lay public that does follow some of this stuff so you know there's a fair amount of interest I think I think the other the real other story about this that I that I touched on I didn't want I didn't want to it was already a long piece and I wanted to focus on this but the other thing that's upsetting that I think you're alluding to is the fact that the media that covers the FDA and covers science the science journalists that do this that they seemingly have been sitting on the story for a long time and haven't written the story.

SPEAKER_00 31:51

Why have they not I heard it was covered by Fierce Biotech and other I mean I heard I was reading on XI I was watching the World Cup today but I heard I saw some people talking about exits has been covered by Fierce or even Stat on other other outlets but I didn't really verify that I didn't really go and look yeah no I think Fierce had a nice article actually I saw afterwards somebody sent it to me uh where they actually went through some of the text messages the fierce article is actually really interesting from 2025 uh uh which actually talks about the suppression uh that chemocentrics did for the hepatotoxicity um so there was a hepatotoxicity signal there was folks at the company that wanted to uh you know raise it and essentially it was quashed and suppressed and there's a bunch of text messages back and forth and they essentially sidelined one of the folks who was you know saying hey this is a concerning signal that we need to really worry about and so the fierce biotech article was was a good one but nobody I mean my point is April 2026 when Tracy Ho's letter uh uh is written right and that details and lays out very clearly and the FDA letter is very important because for the first time the FDA is because they what the FDA did is went to Amgen and said hey we have this Walton expert report can you provide us the background information to see if this is true or not because you know an independent expert from one side is going to make the other side look bad right so who knows right but that's the significance of the FDA letter the FDA letter says they went to Amgen and Amgen they're saying Amgen corroborates what happened in terms of the the the the the unlocking of the database the unblinding the readjudication none of that now is con is is a oh you know he said she said that is Amgen saying that so what I'm saying is that yes Fierce Batter covered covered the Walton stuff you know in 2025 great I don't know what stat news endpoint news some of the other folks did but why is it I mean I didn't hear about this April 2026 what you know Tracy O's letter to to this notice of opportunity uh um letter NOOH letter that is the one that has not has gotten zero coverage and then once the retraction happens you know which put it on my radar like I have also haven't seen seen much there. So I think there's a real deficit in terms of how this is being covered and I'm not entirely sure why why that is. I mean okay fine you could say that stat news and endpoint news some of these places are you know get a lot of pharma funding and maybe there's a lot of bias there and maybe they have you know blinders on it's okay to have biases by the way I don't have a problem with people having biases everyone has some bias or the other but but why is the New York Times Washington Post I mean this is a big this is a big story because it what it suggests what it what it questions is what it what it lays bare is the fact that so much of what the FDA the vaunted FDA US regulatory process is based on trust right if companies are running around unlocking locking databases that are sitting on their servers and then just presenting only the stuff that looks good to the FDA that's a huge problem. I mean that's that's represents a systemic problem and when you're talking about billions and billions of dollars at risk okay um yeah of course people are going to have big time incentives to do things like this. So the question is how often does this happen?

SPEAKER_02 35:17

You know everyone who's right now a lot of people are saying oh this happens rarely you know this is unbelievable I can't believe this happened this happens rarely I have no idea so so at the risk of sounding like we're Monday morning quarterbacking here in hindsight like where where where were the missed opportunities to figure this out early on like it's it seems to me that um that it's really the I I don't know like where where where do what did we do wrong?

SPEAKER_00 35:51

Well I think it's a systemic problem. I think it describes it it represents it shows that there's a lot of trust that the FDA has in in the process in in the data handling process when it comes to uh large companies and I think perhaps large companies are fearful of massive verdict I I don't know I honestly don't know I have no idea I think what what what we have to really address and I saw one of the reporters um say oh this is a one-off and one shot and like it's ridiculous that anyone would say that based on this anything is systemically wrong. I I don't I don't think that's the case. Like look it's one thing if there was one neurosurgeon somewhere that does terrible does does something terrible and bad things happen, right? But to say that that neurosurgeon who put you know created a lot of harm for patients because he didn't know what he was doing, to say that is representative system systemically of what's going on with neurosurgical training in the United States, that won't be right because we know that systematically the vast majority of neurosurgeons are taking people who have decks falling on their and and and doing all kinds of crazy stuff and people are like being saved, right? Here we don't have a great way of verifying what is going on. So I think I think it really speaks to I think there needs to be a significant investigation about how how often this is happening if this is happening and also does the FDA should the FDA have more power uh to uh get data uh or or should we have a different system where you have an independent where the data lives independent of the servers for the company um and so you can see an audit every time a database is locked and up yeah I mean I think I think what you what you allude to is really important because often many of these agencies review data that are provided by the manufacturer.

SPEAKER_02 37:49

I mean you know uh obviously this is completely out of scope because you know I've been involved in the Monsanto trials and one of the things that the APA for example reviews is just by law. I mean it's not like this is the law. You review the data that the company gives you and it's kind of the same here. Actually it is intriguing what you're saying. It would be very interesting to have this like independent almost um entity that stores that data that you nobody has access to I I would imagine maybe there's a way to do this in the age of AI and technology and so on.

SPEAKER_00 38:23

What other pieces are you working on you're becoming an investigative journalist no I I've I've been uh I've been way laid I've been I I couldn't I had to write about this because of uh my recent interest in this FDA story about the biopharma and these small biotech but no I I've been you know I've been writing a piece some pieces on medical malpractice so so that's my that's my next the next thing so there's a very long piece I wrote on medical malpractice and uh some of the terms and why why we have the crisis we do just to get physicians more informed. But there's there's another second part of that piece uh coming up. So that'll be the next one. Okay.

SPEAKER_02 39:00

Medical malpractice we'll stay tuned for it. Anish is there anything we should uh talk about or tell people who are watching or listening that I completely may have overlooked because I really wanted for people who may have not read your your piece to be aware of it because I think I think it's important. There's so much so much so many things to unpack in here.

SPEAKER_00 39:20

But uh this movement of a descriptive uh right so the one thing the one thing I want to I want to point out is that uh you know the the the the regime that kind of followed this up because what could have happened here okay is that you could have had this Walton expert opinion this civil private litigation thing and it could have stayed there okay it could have stayed there the company was paying them 35 million dollars that was done right and if if if the FDA if people if people at the FDA had not followed that up none of this happens all right but the fact that the FDA went to Amgen corroborated meaning Amgen then admits because once Amgen admits that this is happening then it's like there's no question about it. I saw I saw a stat news journalist you know I want to put it in quotes saying something about how you know it's still questionable whether that happened or not. It's like are you did you not read the letter the NO the letter says Amgen Amgen is saying yes this happened but Amgen is saying yes this happened but it should have happened because we want to get to objective truth and objective truth is getting the readjudication right. There's lots of issues there of course it's like okay then why don't we why don't we do the analysis you know 50 times and see how often it comes right I mean anyway so that that's a that's a separate debate to have but there's no debate that the data were were manipulated. And and and it is it is highly concerning to me that this FDA that followed this up look you could have you could have had a different FDA with an FDA chief that said hey just forget this you know you know I I'm not interested in following this up you're not allowed to do this right but you know you had Tracy who who who followed this up you had you know Marty McCarry who obviously must have known about it and kind of said okay yeah whatever you know follow this wherever it goes and once that letter comes out that's what leads to this and now all the that entire group is gone right Marty McCarry Vin Prasad Tracy who they're gone we don't know and Tracy who is firing we don't know why it is she was terminated. So I I you know there's certainly nothing there's no smoking gun to say that you know one is necessarily linked to the other but it's certainly you know it it's concerning to me that 15 days after Tracy who does this masterful letter where she lays this all out which allows all this stuff to happen afterwards that you know she's there you go that's your next investigation there you have it you will stay tuned while Dr.

SPEAKER_02 41:49

Anish Koka on health get unfiltered you can all right see his podcast and listen to his podcast on the Doctor's lounge and uh Substack at Anish Koka thank you so much Anish for coming on thanks so much folks thank you so much for listening I appreciate you tuning in thank you so much Anish for a very detailed piece I think it was fascinating disturbing but yet fascinating I really look forward to hearing from you folks who are listening or watching what you think about this show about this podcast episode other podcast episodes and um you know just you can reach me out on X, on Twitter, uh on my YouTube, on my Instagram, TikTok, Facebook and all other social media outlets. And before I leave let you go I'm gonna leave you with a saying success consists of going from failure to failure without loss of enthusiasm. Winston Churchill said that. Until next time take care