The Atom Bomb Speaks: Tracy Høeg on COVID, Myocarditis, and the FDA From the Inside

Episode Summary

Dr. Tracy Høeg — physician, epidemiologist, and former Acting Director of the FDA's Center for Drug Evaluation and Research — joins Drs. Koka and DiGiorgio for her first interview since being fired from the agency in May 2025. She traces her unusual path from ophthalmology dropout to professional ultramarathoner to one of the most consequential and contested researchers of the COVID era, walking through her school transmission studies, the myocarditis preprint that detonated on social media, and what she actually found when she got inside the FDA: career scientists who were sharp, collegial, and largely aligned with her — not the entrenched bureaucratic resistance she expected. She also gives the most detailed account yet of how her firing went down, why she refused to resign, and what she thinks it signals about pharmaceutical industry influence over the agency.

Chapter Markers

00:00 Introduction and Tracy's bio

02:19 Origin story: French major, med school, ophthalmology dropout

07:42 Seven years in Denmark: PhD, clinical work, ultra marathon racing

10:55 Back to the US: PM&R, interventional spine, and the start of COVID research

13:43 Funding research outside the NIH pipeline

17:18 How government funding crowds out independent science

20:59 Evidence-based medicine, spine, and the N-of-one problem

25:35 The Wisconsin school transmission study

28:32 If masks were a drug, would they pass FDA approval?

30:04 Testifying before Congress three times

32:46 The myocarditis preprint: origins, backlash, and vindication

38:34 Post-vaccine myocarditis: what the data actually showed

43:01 Regulatory failure, COVID vaccine risk-benefit, and the pediatric question

45:09 How Europe and Scandinavia got it right earlier

47:58 Cancel culture in academia and the chilling effect on scientific questions

51:18 Joining the FDA: how it happened and what she expected

53:50 What the FDA looks like from the inside vs. the outside

56:38 Where real philosophical disagreements lived within the agency

58:58 Reducing animal testing and CNPV pilot: what actually got done

1:01:45 Leaks to the media: where they came from and what they meant

1:05:17 What the FDA's role should be

1:06:23 Pharmaceutical industry influence and the Wall Street Journal editorial board

1:14:48 The firing: why she refused to resign

1:18:53 The chain of command and who is responsible

1:21:08 What the firing signals about FDA reform

1:27:42 Advice for anyone thinking about taking a leadership role in government

Co-Host Handles

@anish_koka and @drdigiorgio

Show Handle

@drsloungepod

Resource link: Anish's substack: https://open.substack.com/pub/anishkokamd/p/they-were-fixing-the-fda-then-they?r=6chj5&utm_campaign=post-expanded-share&utm_medium=web

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Transcript

SPEAKER_00 0:00

If you like your healthcare plan, you keep your healthcare plan. Nobody knew that healthcare could be so complicated. It could only be Medicare. This is the Doctor's Lounge.

SPEAKER_01 0:16

Welcome to the Doctor's Lounge. This is a special episode because we have a very special guest, Dr. Tracy Hoog. How'd I do, Tracy?

SPEAKER_03 0:25

Very well.

SPEAKER_01 0:26

I've been practicing that all day.

SPEAKER_03 0:30

Okay. Yeah, but Hoog is fine. So as before.

SPEAKER_01 0:33

Oh, yeah, that was right. I knew that. You told me this. Shoot, Tracy. Hug. Okay. She is Dr. Tracy Hoog. She's a physician and epidemiologist. All right, an MD from the Medical College of Wisconsin, residency at UC Davis, a PhD in epidemiology from the University of Copenhagen. She built her clinical career in physical medicine, inventor spine, sports medicine before becoming one of the more consequential and contested figures in American public health over the last five years. If you follow the COVID era, who did not, you already know her work, even if you don't know her name. In early 2021, she was the senior author in the CDC study finding limited in school transmission in rural Wisconsin schools. Later that year, she co-authored with an unnamed cardiologist, Alison Krug and Josh Stevenson, the stratified VARES analysis of post-vaccination myocarditis and adolescent boys, the paper that detonated on social media and put her squarely in the middle of the risk-benefit fight over the pediatric and young adult mRNA vaccines and the university booster mandates. She advised Florida General Surgeon General Joseph Ladapo. And in 2022, she was also one of the physicians who sued California over its law penalizing doctors for so-called COVID in quotes misinformation. She then, after critiquing, spending her time critiquing what the FDA essentially had been doing and green lighting, she joined the FDA in April 2025 as a special assistant to then Commissioner Marty Macri. And in December 2025, she was named Acting Director of the Center for Drug Evaluation Research, CEDER, the division that reviews every new drug application in the country. That appointment made a lot of career staff very nervous. One source told CBS, it was like dropping an atom bomb. You are an atom bomb, an atom bomb from from from a Scandinavian country dropped in the United States. Um so she was she was unf she was there for almost exactly six months. A few days after Dr. McCarey resigned, she was she was fired. She has said she's refused to, she was asked to resign, but she refused and was ultimately pushed out. So she comes to this conversation having I mean, it's such an interesting time to be talking uh to her. She you Tracy, you're coming to this from both sides. You've been on the other side, you've been within the regulatory uh apparatus, and I'm incredibly excited to talk to you about all sorts of things. So, Tracy, welcome.

SPEAKER_03 2:45

Well, thank you so much. It's really great to be here. I have been listening to your show since I guess almost the beginning. When did you start the show? Do you remember? When was your your very first show? I should have actually looked that up, but I've really I've been listening for the last many months.

SPEAKER_00 2:58

It's been about a year, I think.

SPEAKER_03 3:00

I think we were philosophically very, very aligned. So I really I really appreciate what you what you're doing and and in medicine and and and for patients. So that's I I haven't done any interviews yet, uh, you know, podcasts or live streams since I was fired from the FDA. So I um I was excited to get your invitation. I will point out I've had a number of invitations to be on podcast, but yours was the one I said yes to. So I'm really, really grateful for all the shows that you've done. And you and also for your recent article, Anish, uh, about Marty Vinai and me uh and our work at the FDA, I just felt like you hit on so many points that we haven't really been able to communicate to the public. And I I think that's that that's one of the that was one of the frustrations from being within the FDA seeing all the media coverage and feeling continuously like we're not able to get our side of the story out. And honestly, by the time that article came out about me being like being continued and compared to an atomic bomb, I'm like, I just listened to Blondie's Atomic, which is a great song, and just like laugh about it because I actually know I got along really well with the people in the FDA. And to me, it was like it just evidence that they don't actually really know what was happening within the agency. And like you say, if they based our articles in a few anonymous sources, how how can they know that that's reflective of what people actually think within the agency? So I could go on and on. But thank you for that really kind introduction.

SPEAKER_01 4:25

No, I uh yeah, that thank you so much for for agreeing to do this and in the maelstrom uh that uh hurricane uh that kind of gale force winds that you're kind of being buffeted with right now. I'm not even sure, you know, you I know you're you you know your boys are in California, you're in uh you you've been in DC kind of half and half. So anyway, thank thanks again for taking the time. I really appreciate it, and we're honored to be the first person the first show to uh to get you. But so let's start with the origin story. Walk me through the path because it's not it's not a straight line. Uh you did a BA in French at Wisconsin, correct?

SPEAKER_03 4:56

Then you decide to go to the English as well. I was one class short from the English major. Sorry, yeah. Can you hear me? Sorry.

SPEAKER_01 5:03

And then you match into op yeah, I can hear you. And then you match into ophthalmology. So then what happens, what happens next?

SPEAKER_03 5:10

Yeah, so I should say I actually spent a year living in France after medical school because I applied I decided at the very end of uh of my college education to apply to medical school. And I actually I took the MCAT before I had taken any of the pre-med classes, I just want to say. And uh I did fine. I got in the first time I applied, but I ended up teaching for a year in France. And so I will say that that really gave me great perspective. I ended up living almost two years in France because I did almost a year there during undergrad as well. And then so medical college in Wisconsin, I matched into ophthalmology, my top choice program, ended up finding finding out I was pregnant the week before I started. Um at it I was in a different state than my now husband, and um, we were basically trying to figure out I was trying to figure out how am I going to pay the rent, the medical bills, so get someone to take care of this baby. And is this really the sort of life that I want to bring my first child into being raised at someone by someone that's not me, that's not their parent? And basically kind of and at the time, you know, we were offered 15 days of maternity leave, which is really, it's really not a lot. And so my husband is Danish, and you know, compared to really the nine, nine months plus, depending on how you divide it between the mother and the father, that you can get a maternity leave there, it was really a big difference. So it was suggested to me. And the reason I don't say the name of the program is because of the circumstances that they really kind of suggested to me that I get an abortion. And just I didn't have the greatest reaction to that. And I I thought it wasn't really what I expected. It was I expected maybe a little bit more support, but you know, it is what it is. And so I thought maybe this doesn't, this doesn't seem right. Like it felt like if I didn't make that decision that I wasn't gonna be supported and and having a child. So I thought, okay, I I'll just drop out. And which was really, really hard, as you know, because you invest so much time and money applying for these residencies and flying all over the place and going to different programs and figuring out where you think you're gonna fit best. And and I really wanted to be an oculoplastic surgeon at that time. That was like my big, big dream. Uh, but I dropped out. I um ended up working in urgent care for about a year while I learned Danish and moved to Denmark with my husband. And it was it was a really uh it ended up being a really good experience. We were there for a total of seven years, and I worked in internal medicine, I worked in ophthalmology. In order to start working there as a physician, they have really sort of strict rules, just like when you when four medical grads come to the US. So we had to take a number of tests where it this is all in Danish, where you had to get 100% on the tests, and they have so like if you're from outside of the EU, it's extremely difficult and competitive to be able to work as a physician in Denmark. So kind of went through all of that and then started seeing patients, really wanted to continue my ophthalmology education. And then I was offered to basically do this really large population study in in a small town called Nestville, Denmark, which is where we were living, which is about an hour south of Copenhagen, and uh raised the money to do that study, got into the PhD program uh in epidemiology and public health, and then did my PhD there while I could basically continue clinical work in ophthalmology really the the entire time that that we were there. Uh, started my own business in endurance sports coaching while we were there as well. And after my second pregnancy, I started winning ultramarathon races and got a became like a professional runner for Solomon and uh ran for the American ultra marathon running team and the Danish ultra marathon running team. And so running what became like a big interest of mine and started doing research in that. And my first real big research study in that was in the the vision loss among ultramarathon runners, and then basically ended up figuring out what that was. I can go into detail if you want, but it's a form of corneal edema and and still sort of working out the mechanism behind that, but it is transient. But I'm kind of going off on a tangent here. After seven years there, we moved back to the US and I decided I wanted to do sports medicine. And so I chose the PM and R uh physiotry residency route to do that. And I was super glad I did because then I got to do interventional spine uh as well, which unexpectedly is such a love of mine. Uh and I I really love doing spine procedures, and I know Anthony and I can can talk about and can geek out on spondylolithesis and things like that. Since I know that's come up in a few shows. But uh, I don't know. That's and then a lot. So I finished um fellowship in in 2018 and then was really only in practice a year before I started doing all the COVID research. And I guess I published like 30 plus epi studies in during COVID times in peer-reviewed journals. So it was kind of a prolific research time because I was in clinic at at the same time and with the kids and everything. But I felt like it was really important because I felt like our government was really not doing the work and people really weren't kind of standing up and and looking into the important questions, especially regarding children, school, sports, COVID vaccines, things like that. So that's I really believe that we should research the most pressing issues of the day and and get answers. And so I I I stand by that and hope to continue to do that work.

SPEAKER_01 10:11

So Anthony, we've had some uh very heavy hitters uh on the show. We've had that, and I mean, this is this is an incredibly impressive resume. I didn't even realize I mean, I've known you, Tracy, on and off for the last ever since COVID, we kind of uh were introduced to each other, but I had no idea that of how actually the of the stuff you were doing actually prior to COVID. My goodness, that is yeah, incredibly impressive. And you did all that while being a mom of two young boys. Yeah, again, I mean I you must not sleep. Yeah, I guess that's when you do your ultra marathon stuff, right? You do that from like 11 p.m. to six a.m. You're like, all right, I'm done with my my PhD and my uh funding my own study, and now I'm gonna run all night and then at 6 a.m.

SPEAKER_03 10:50

I I don't know. I've been really fortunate and life is life is different in Denmark. I don't know. I felt very productive there, very supported, and I I have very worked with I've been blessed to work with wonderful colleagues that have amazing family, husband, parents, like all those things make such a difference. So yeah.

SPEAKER_01 11:08

So you you actually funded, I mean, a lot of people do PhD theses, uh, and it's typ some of them who who do PhDs in Epi are are kind not casting shade, uh, but it's uh stuff that you can do sitting in a room with a computer and and crunching a bunch of numbers and writing up some interesting uh theories. You actually funded your own clinical trial. Is that right?

SPEAKER_03 11:31

Yeah, it was a population study, so we didn't have an intervention. We were basically doing basic observational epi epi work, but uh so not a clinical trial, but yes, I did have to raise all the funding for to get the equipment to do the studies, to have nine assistants working with me, nurses uh who were qualified to do these ophthalmology exams. And you know, it was about I got about half of the funding from the government and half of funding from private institutions in in Denmark. Uh so it was kind of fun to learn that system of uh funding research in another country. And I certainly didn't know how it worked in the US until I got back, but I learned.

SPEAKER_01 12:09

What are the contrasts? How how is it how is it different?

SPEAKER_03 12:12

Well, I mean, I feel like a lot of researchers here kind of rely on on NIH grants. And when I got back to the US and I was in PM and R residency, I was was part of this what's called a rehab MSTP program, and uh which it was basically a group of people where they get you connected with uh NIH researchers so you can get get funding for your research through the NIH. And I I really quickly realized how how limiting it can be. Like you basically need to find an NIH funded researcher who is doing the research that you are interested in doing and and you kind of have to tag along with them for a long time. And I thought it was very inefficient because I thought, well, I I I have a lot of experience already doing research. I'd rather be in a position where I can sort of do what I want to do and not have to wait and wait and wait and just tag along with someone else doing research. Like there may, there are likely many benefits to doing that. You can learn a lot. But I thought I just, I really at that time I was interested in researching ultramarathon effects on human physiology. And I thought that's really cool. I'm not gonna get an NIH grant to do that. So I just ended up getting private funding to do that, and then was working on doing a study on uh ACL tears and doing bone marrow aspirate concentrate injections to repair lessons one centimeter uh retracted ACL uh tears in athletes using bone marrow aspirate concentrate with some initial, we had initial promising results with that. But so I I just basically ended up getting private funding and it's a lot harder. It's harder in the US, I think, to have a topic that you really want to look at that's that's urgent. And that's what I found out during COVID was that I couldn't like I didn't know how to really apply to get research funding, like at the drop of a hat, like uh to do the Wisconsin study and to do like the myocarditis research. So that was just unfunded. It was like we just have to do this, we have to get an answer to this because the government is not giving us these answers. So I feel like that's so interesting. So you think the government countries have faster mechanism. So go ahead.

SPEAKER_01 14:12

That's interesting. You think the government kind of crowds out private uh research in some in some sense? Like have having so much government spending. I'm like teeing up the ball for uh Anthony.

SPEAKER_03 14:22

Yeah, I'm curious to get your take on this, but that was my impression.

SPEAKER_00 14:26

I do agree with that statement. Yeah, it's uh part of it is in academia, you know, your success is largely tied to the amount of government funding you can bring in, not necessarily private funding, right? And that's that largely that ties because of the indirect rates that are allowed through the federal government. Uh, whereas private institutions that will uh usually cap themselves at how much of that money actually goes to the institution versus your specific research. So I think a lot of that uh is this like self-perpetuating cycle. So but I I'm actually more interested in the fact that you went from PMR and spine medicine and tied in epidemiology. I mean, you're you're going from one of the like the least evidence-based areas, which is spine, and I fully admit that we have very low quality evidence in our field because it's tough, right? It's very heterogeneous, the outcomes are purely subjective, right? So that there's a lot of difficulty in getting high-quality studies out. Was that some of your motivation to go into epidemiology? Because it fascinates me the fact that we have such low quality data. Did that play into any of that?

SPEAKER_03 15:22

So I did epidemiology first and then PMR and sports and spine. And yes, I mean, it is it, but it's, I would say in my specialty, I got a lot of pushback for doing things like PRP and BMAC. And I think people would be surprised to know when they look into the data, also prolotherapy, how many randomized control trials there are. Now, there are limitations to those studies, but they they are there. I I would also say that it is so heterogeneous. I think you're so right because some people have really dramatic responses to treatments that are relatively cheap, very safe. And then it's really hard to identify those patient populations and then to find the funding to do the study. And so when you when you have a treatment that that is relatively safe and that uh observational data is showing that it works, and and then the patient is willing to try that and you go through the the benefits and risks of that treatment that are known and it works for them, and it's like a dramatic result that they've not seen before. I mean, I I'm like I believe strongly in evidence-based medicine, but I also believe like patients' experiences truly do mean something, and it could be the placebo effect, but it's also like, well, if this is giving them what they need, I mean, there is something to be said for that. So I feel like in physician, PM and R spine, it's like you need to find the happy medium there. And it's like, it's also with some something like a knee replacement, right? I mean, you have patients who like they cannot take a step. They really cannot ambulate without that knee replacement and they have a knee replacement and they're like walking and they're maybe their pain's like a one or two out of ten. And you're like, well, do do we really do we do we need to do the randomized study if we have a reasonable threshold for doing this uh procedure? And and the real question is what should that threshold be, right? So it's randomized studies are not always they're not always equipoise, let's put it that way. And it's debatable when it's there, and then it's also sometimes very hard to find the funding and we have to work with the information that we have to do the best thing for our patients, right?

SPEAKER_00 17:25

Yeah, it's it's interesting how the the funding mechanism works too, just you know, with the the structure of the NIH really directs, you know, what sort of projects get funded, right? So for like example, again, for spine, uh, it's typically contained with an ortho, but most of the ortho dollars go towards, you know, the hips and knees and other arthritis, arthritides, and then neuro tends to cover more things like stroke, brain tumor. And so it's you know, you end up with these sort of orphans within NIH where it's a little bit difficult to get funding. And then of course, with spine, there's a lot of industry involvement, and so it's it is oftentimes easier to get private funding for things like spine. But anyway, we digress.

SPEAKER_01 18:00

Sticking on that, Tracy, if you you have that experience as a practicing person in terms of this N of one someone improving, or not just N of one, but you do this a bunch and you patients appear to get better. Do you do you feel that pull? So you have a you have a particular you must have a particular soft spot then for clinicians that say, look, I've treated a thousand patients with vitamin C or I've treated a thousand patients ivermectin and they got better. How how does one how do you navigate that?

SPEAKER_03 18:27

Yeah, I mean, actually, I think about this a lot. And there's something about sort of mechanistic data, but then there's also like you have to keep in mind what the chance of it being placebo effect really is. And I mean, it's such a tough question, right? And ivermectin, I mean, we could go on and on about that. And I think there are some meta-analyses that show that probably early in the pandemic, before there was natural immunity, that it may have had some impact on mortality. And we never really got a super good study to delineate that. I think later we got more information when natural immunity was widespread that it really wasn't doing anything. But you know, that's that's a whole that's a whole different story. Um, this is this is tough because I feel like with supplements, we have had so many randomized studies that basically show that they don't do anything that I assume with most supplements that unless there's a kind of dramatic response and you're treating an underlying like nutritional deficiency that is really obvious, like you're lacking intrinsic factor and you're in a B12, like is a B12 deficiency or some uh severe vitamin D deficiency that that we shouldn't just assume because a patient says they get better, that they are uh, you know, getting better from that. So I I think it's I think it's very tough with with supplements. And in general, with with my patients, unless I had a randomized study showing that it was beneficial for whatever they were looking to treat, I would kind of steer away from from supplements. And some of that may be like my some my Scandinavian background that you know, supplements just are so rarely used there. Like it's it's a society that just does not medicalize things, right? And so it would be like you would use this supplement as a treatment for very specific thing that you have a diagnosis for, and it's like directly treating that that particular problem. I don't know if that's answering the question, but I'm not I'm not super big into supplements. But if it's yeah, if it's something like if it's something more like a a device and it's a knee replacement or a hip replacement, and you see, you see with your own eyes this really dramatic effect in terms of improvement of function and pain level, and that you feel it's extremely unlikely that patient would be faking or maybe even physically incapable of faking. I mean, that's a different level of evidence.

SPEAKER_01 20:41

Yeah, epistemology is just so incredibly hard to come up with some like unified theory of like how things should be, right? And anyone that wants to try to say that is that's why I think you need a lot of humility. And again, it it's it's always this question about like who who has the burden of proof to, you know, where's the burden of proof lie, correct? So coming to COVID, right? Well, I mean, the thing that you kind of that started you on your path, I mean, you started doing these studies looking at, say, um, the point of school closures, right? Like, why did you even come to that, right? Because you obviously the reason you're look you're doing those studies is not because you're like, oh yeah, we should keep the schools closed for 18 months, right? There's something in you that's saying there there's some prior that you've developed for some reason that says, this is crazy. There's no way this is working.

SPEAKER_03 21:27

Right. That's right. I mean, getting exactly to the point of burden of proof is that, you know, we needed evidence that this was like doing something beneficial to close the schools. I mean, and we never, we never had that evidence. And in fact, we had so much evidence from Europe that they were able to reopen schools and kids were not dying from COVID. They were not, you know, seeing, they were not seeing these issues that the New York Times was saying we were going to see if we opened the schools. Sweden very early on. We're talking early June of 2020. I mean, they're putting out their data that are very convincing. And then people's arguments are like, well, that's Europe. And as someone who had lived in France and then Denmark, I lived for seven years and I had my kids going to school there. I was like, well, they're also just schools. They're kids that are in rooms that are schools. Like, I I just didn't understand the argument that the United States would be so different. And so but it took, like, I thought it was going to take doing a study in schools in the United States that, of course, ended up finding the same thing that they had found in Sweden and Norway, that there was extremely limited transmission that was traced back to the schools. I mean, it it still amazes me how low the transmission rates were for child for from children and especially children to teachers. I mean, it's something to the this day. It fascinates me why, you know, COVID wasn't spreading in schools. I don't know why it was, but we needed that information. So but yeah, I felt like it was such an important public health issue that we needed to get answers and um and and evidence that could be used to reopen schools. And I thought people would apply that to sports as well. I'm like, well, these sports are also like they're outdoors. And in our Wisconsin study, the kids were inside eating their lunch, no masks on. And we saw like this seven cases of spread between children that were traced back to the school, none to the teachers, the entire fall semester of over 5,000 students and staff, right? And I'm like, and then after that study comes out, people are still arguing that like children who are out in a soccer field, like it's too dangerous, or they need to wear masks, they shouldn't be playing, competing. And it's like, I mean, there was absolutely no logic to it, but we can't say the evidence wasn't there because we did do the study.

SPEAKER_01 23:39

So Yeah. But as you sorry, go ahead. Go ahead, Anthony.

SPEAKER_00 23:42

So I was just gonna say, so if school closures or masks were a drug that had to go through the the randomized trial or the the regulatory burden that an FDA regulated drug, would I mean would school closures or masks ever be allowed to be implemented on the population?

SPEAKER_03 23:57

I mean, so great question. So we have a Cochrane review of masks, N95 masks. We don't have evidence that they work. So of course, mandating that for children, that that would that would never pass the bar of something that that could be done from a regulatory perspective. I mean, we're talking mandates now, right? I mean, you might fit N95 that's fit tested that's worn for a certain amount of time, you know. I imagine the jet the data could be generated for for that, but like using them in a hospital or in a community setting, we we haven't seen the evidence of benefit. And so, yeah, for it FDA approval, you need to show substantial evidence of effectiveness. And so that, yeah, I mean, we're talking about like one clinical trial, right? But what was the the Cochran review? It was either seven or nine randomized controlled trials that were all negative. So, you know, we I think we we at the time being, we would say that that would not pass the bar for for for FDA approval in the in the way that those masks were used in those populations.

SPEAKER_01 24:55

So you you eventually testified in Congress, actually a number of times on school closures, right? Yeah. What was the reception? Yeah. Were you right? Were you were you treated as a scientist presenting data or as something else?

SPEAKER_03 25:07

That's a leading question. I mean, I I think I was treated like a scientist presenting data, but now I'm wondering. I mean, it depends. If you're on X, I don't feel like I'm treated kindly all the time, but hey, that's life. So I mean, I do feel like I have my credentials misrepresented often on on X, but you know, whatever.

SPEAKER_01 25:28

So you I mean so the reception was mostly positive or or or people kind of essentially say, oh, this is something positive? Yeah. Okay. But I think so. I mean, did did you feel like the trajectory of of school closures were was affected, or did you f were you effective in in in communicating to folks that weren't already in the on your side?

SPEAKER_03 25:47

So I mean that's such a good question because I was really kind of part of a round table that may have affected school closures, but that wasn't something that was open to the public. That was really early on. By the time I the first time I testified before Congress, it was really about masks and tests to stay and sort of returning to normalcy for kids. So it was basically at this time schools were open, but I even at that time it was like I was being portrayed as someone who was right-wing, ergo, doesn't really understand science, um, but was our was presenting data essentially like the lack of data that we have in terms of efficacy for mask mandates uh for children. I but I believe at that time we were even talking about vaccine mandates. So I'm not actually sure the first time I testified. The second two times I testified, it was basically looking back on the pandemic, like what did we do wrong? So even though I I feel like I got was part of studies that were brought to the public's attention in a timely way, in terms of the congressional testimonies, it really happened sort of after the fact, which is unfortunate, but it is what it is. Because I think it's also important to set the record straight.

SPEAKER_01 26:55

Yeah. No, no, it was uh it was very important work that you did. You then, of course, went to something that was not as controversial. You started examining the vaccine.

SPEAKER_02 27:04

Yeah.

SPEAKER_01 27:06

So in 2020 in 2021, you you wrote the preprint that uh that kind of uh that was that I mean that's I don't know, that's the an atom bomb, Hiroshima, Nagasaki combined, which which basically suggested that post-vaccination myocolitis in adult boys, that the rates of that, that the that the side effects related to that were going to be greater than any benefit that same population of healthy boys would accrue. And your and that was it. Yours was the paper that kind of first suggested it. It was, I believe it was uh mentioned by the great and all powerful Joe Rogan, who's has a podcast that is slightly more popular than ours.

SPEAKER_03 27:45

Yeah, I I I mean this is so what yeah, go on. Sorry, I'll let you finish.

SPEAKER_01 27:49

How how does so how does that so I'll get to my question because I just keep going on and on, but how how does how does the how that looking back, right? How does that signal hold up? Do you feel like were you vindicated?

SPEAKER_03 28:00

Yes. I mean, you can see in the peer-reviewed version of our article that we compare our estimates of myocarditis to inner estimates from inner internationally done studies, like multiple different countries. And and if anything, our estimates of the myocarditis rate were like an underestimate of what they truly were after the Pfizer vaccine in adolescent boys. So this was 12 to 17. And and so I want to step back and say that the reason that I got interested in this was, I mean, initially it was my own reaction to the vaccine that I had a very severe sort of cardiac reaction to the vaccine with tachycardia to the point where I was like running two days after and I blacked out on a run and like woke up on the trail, like didn't know what happened. And I had a friend who was an emergency medicine physician in the Tahoe area who had a like a really sort of similar reaction where it was like super short of breath, tachycardic. And we both got vaccinated in December with the Moderna vaccine. And so it was like I I was just I I felt like something something was up. And then the and then the Israel Israel data came out, and I thought, okay, all right, um, this is like there's some cardiac effect going on here. Like this is real. It was very clear from the beginning from Israel that this was real. And and then by the time the CDC store sort of started publishing their estimates of the rates, like you could see early, like first week in June, I think it was the Verpak or the ACP meeting, like the rates of myocarditis that they were seeing in adolescence. And our country was the first country to vaccinate the adolescents, were above what was expected, like the baseline myocarditis rate. And so I was like, wow, crap, like this is really bad because these boys, like especially if they don't have any underlying risk factors, they're so low risk. So, you know, I I posted about that on X, and then that got within like 12 hours, it was censored. And so it was like the the whole like tweet was deactivated, so no one could like share it or respond or anything like that. And then Tucker Carlson like featured that on his show then the next day. And then I thought, wow, something really kind of crazy is going on here because I was really just posting the CDC's data. And then anyway, so so I thought, okay, this is something that parents would love to know, doctors would love to know. Like, what rates of myocarditis are we seeing just in in various? And you know, how does that compare to these kids' risks of hospitalization from COVID? So we did 120 days of COVID hospitalization rates, high, medium, low, because we didn't know how how prevalent it was going to be, and compared that to the risk of developing myocarditis after the vaccine using the CDC's case definition of myocarditis, and as you said, cardiologist involved in the study from COVID. So in my mind, I thought, okay, this this is gonna make people go, whoa, like what are we even doing here? Like this is this is very concerning. But it was weird. I mean, I must be so naive because it was like there was so much just there was this mixture of like love, like, thank you, this is a great study, like Joe Rogan, like all these, but then like it just extreme hatred of of just sort of studying this uh can, you know, this vaccine that was gonna be given to millions of children this age. Like, what what and still to this day, I think, well, what what happened there? And yes, our rates were not an overestimate at all. And I just looked at that study again today because I knew we were gonna talk about it, and I thought, this was so good. I I honestly think I'm very proud that I was in in involved in that and grateful for my co-authors. And I think it has withstood the test of time. It's not it's not perfect, but I mean, I don't know. Of course, it can't be perfect. I mean, it's verse, uh, but again, verse is usually an underestimate of the true race, and indeed that is what we saw. I am so I I mean, yeah, okay, I'll stop there.

SPEAKER_01 31:44

Yeah, and that was that was shown. That was shown. So so you were you were yeah, you know, you you were vindicated on a number of important points. You were attacked because I think there was this political divide about vaccine versus anti-vaxxers. Now, anti-vaxxers are folks that are zealously against all vaccines, regardless of what they are. It it doesn't matter what it is, an anti-vaccine advocate would say there's something wrong with that, there's something wrong with the data, you know, there's harm that's coming from this, and we shouldn't be doing it, right? And so I think the the pro-vaccine folks view anyone who questions a vaccine as being in an anti-vaxxer camp. And they just automatically put you in an anti-vaxxer camp if you are going to raise any doubts about any vaccine that is out, that that is out and has been kind of approved by the by the FDA. And so I think that's what happened to you, Tracy. You were basically put in the camp of, oh, she must be a right-wing, you know, MAGA anti-vaxxer. Even though anti-vaccine communities, it's like the Democrat, right?

SPEAKER_03 32:42

It's like the heart.

SPEAKER_01 32:43

Yeah, yeah. It's a very, it's a very lefty, you know, they're the left, the the left really the you know, the the the LA, you know, highfalutiness circles. Yes, uh, you know, they clearly are have a lot of vaccine hesitancy, as does, you know, the different socioeconomic status on the right side. But anyway, so I think you were just booted into that camp. And so that was the uh that was I think the couple things to say.

SPEAKER_03 33:04

But no, but later I mean, I was just gonna say vaccines are just treated differently than drugs, right? Which is like which is a little bit crazy because we're actually using them to prevent problems in otherwise healthy people. So we should really have the same standard. We should really have an even more skeptical, critical eye of these products, you know, because we and honestly at the time we didn't know like how long were these even gonna last and how well did they even work against severe disease. Like those, those were those were unknowns. And I I I just want to put numbers on it just so people understand. Like with our VARES, um, with our estimates of the myocarditis, like we were estimating between one in 6,200 to 1 in 10,000 risk of myocarditis after the second dose of the vaccine in adolescent boys. And the data that we have from Hong Kong, where they actually ended up hospitalizing all these boys, where they prospectively followed them, it was one in 2800. It was just under one in just sorry, just higher than one in 2800. So it was like we actually way underestimated how common myocarditis after the vaccine, after the second dose of the Pfizer vaccine was in adolescents. But sorry, that I just wanted to.

SPEAKER_01 34:08

Yeah, no, and it but it didn't matter because then suddenly once you established that myocarditis was happening, once you established that people were going to the hospital, you want to establish there was some hospitalization rate related to vaccine myocarditis, then it became well, myocarditis, this is the a mild version of myocarditis. It's just it's no revealing.

SPEAKER_03 34:27

But like over 90% of them were hospitalized.

SPEAKER_01 34:30

And of course you're the cardiologist.

SPEAKER_03 34:32

No, no, it's clearly need to say something now because I mean myocarditis, this is how serious of a diagnosis that is in an adolescent. Like you would not, you would do anything to have your child not know that. I mean, when I mean, so of course, my children, I was like, no, no, you are not touching them, you're not letting them breathe in this vaccine. Like, I mean, I'm I'm not this type of person who believes you get it from like being near people, but any effects that what I'm saying is like when I found out that that was a potential side effect, I was like, no way. Like myocarditis is very serious. And of course, this wasn't just, I mean, there may have, I don't want to make parents afraid if their child had myocarditis in the past, but it is a diagnosis that should be taken seriously because it's linked to sudden cardiac death later in life. You know this. I mean, I shouldn't say this because you're the cardiologist. I should let you speak about myocarditis.

SPEAKER_01 35:22

Yeah, no, no, I and I made the point multiple times that, like, yes, like compared to typical viral myocarditis, vaccine myocarditis regarding mRNA was was not as bad, the troponin leak was not as high. But I was like, there is no cardiologist that's sitting around that is is excited about their child having a small amount of myocarditis or a small scar in their heart, right? Since I would say very concerned about the unknown effects of COVID, whether it be long COVID, whether it be MISC, right? I mean, there were or whether it be some other manifestations of COVID that we don't know that they were scared about. There were things to do, meaning, okay, fine, the rates of myocarditis are much higher after dose two. The Moderna vaccine has a much higher dose of the mRNA vaccine than Pfizer does. So maybe you recommend a half dose of a Pfizer. Anyway, there were a lot of things that could have been done on the regulatory, on the on the regulatory side, I think, that could have kind of spoken to the concerns of parents that perhaps were much more concerned about COVID than say maybe you were or other others were. You know, there was this different, there was this gradient of risk that people felt when it came to COVID and and when it came to the vaccine. And then the question was, how how does a regulatory regulatory authority kind of try to bridge that gap a little bit, right? Because that that was the important thing. And I think the regulatory authorities at the time were so interested in universal vaccination that they basically were like, safe and effective, safe and effective, safe and effective. We can't have anyone questioning this. Anyone who questions this is morally bad and is is is causing grandmas to die and stuff, which which all of that was not true, and all of that erodes trust in the institution. So getting to some the meaty parts of this, given what happened, given the given the response that occurred, the response that regulate regulators kind of arrived at, do you think that was a failure of institutions? Do you think there was a failure of academia, the academic ecosystem? What or what is it?

SPEAKER_03 37:11

Yeah. So I want to say first, so Europe almost immediately they said we don't recommend that either adults or adult males under the age of 30, it depended on the country, get Moderna vaccines. So they like acknowledged the concern in that way almost immediately. And then I want to say also that Denmark, by June of 2022, their like basically their equivalent of the head of the CDC came out and said vaccinating children was a mistake. And we no longer recommend that any children under the age of 18 get vaccinated. And in fact, you need a specific doctor's order to get this vaccine, and you have to have like a certain underlying medical condition to get it. Right.

SPEAKER_01 37:52

And so that was June of 2022 or 2022?

SPEAKER_03 37:55

June of 2022, 2022. So it took longer than I would have liked to see. But this gets back to my what I was going to say about feelings and uh your comment about feeling the risk and not actually looking at the data, you know, empirically. And I think that regulators throughout the world failed. And I have I have actually come to realize how much the world depends on the FDA and the CDC to make decisions. But to Europe's credit and really Scandinavia, I think they kind of they have a little bit more independence in the way that they look at drugs and vaccines. And so they were kind of the first ones to say, like, okay, wait a minute, we really need to look at this, like, do a good risk-benefit analysis here. And I think that's part of the reason that I think the Danish vaccination schedule is more defensible, but we can get into that's a whole different story. But the failure, so where does the failure come from? I mean, I think it's the combination of like our regulators, there is a whole culture of like it, you need to fall into line. Like you cannot sort of, you know, question, questioning what you're being told is not is not popular. It's a good way to lose your job. And then like it's the same in academia. Um, people don't feel comfortable questioning things when they see online that people get shamed for asking asking those questions. And I think a lot of the problem that we're seeing right now is social media and the media and like making certain questions, scientific questions off limits, certain conclusions off limits. Like it's really an it's anti-science, extremely anti-science. Um, so but I also think, you know, we see that in the social.

SPEAKER_01 39:31

So clarify what what you mean by that. You mean you mean there's are you are you saying there's misinformation that is uh creating this? Or what do you mean by I mean I I just think clarify that a little bit more?

SPEAKER_03 39:42

So I think it's like if you want to keep your academic position or your current job as a physician or a researcher, like you want to avoid questions that are going to be seen as like anti-vax, like right wing, like something that is gonna get people to want to to cancel you. And so I just feel like the entire like vaccine side effects. I mean, we can go on and on about how I think there are lots of exaggerated vaccine side effects and lots of poor quality science. And I definitely feel that way about like even COVID vaccines and cancer, for example. Um now I'm gonna get myself canceled the other way. But like I just feel I feel like there is a lot of cancel culture in academia, and I've really personally felt it and and uh it's a shame because I think that the way that science and public health can thrive is if people are allowed to ask questions without being shamed. And everyone we should all be allowed to like make mistakes and be wrong, and then also be able to come out and publicly admit, okay, maybe that wasn't right or whatever. But it's I do think we live in a culture right now where there are certain questions that are that are kind of too dangerous for people to ask, and and certainly vaccines is one of those falls into that category about vaccine side effects and questioning efficacy and things like that.

SPEAKER_00 40:54

I mean, you you clearly went from being skeptical of the COVID vaccine and now you of course want every child to get measles, right? That's that's the logical progression that happens with this.

SPEAKER_03 41:03

I'm so glad you brought that up because it it's yeah, no, I do not want every child to get children.

SPEAKER_00 41:12

Right, of course you don't. And I think the the larger th question is, you know, how do we get back on track? I think a lot of the pushback was against the the COVID vaccine, specifically, the lockdowns, the masking, this forced acceptance of the narrative with no questioning. And we want to take a step back and get back to a real back and forth debate. And how can we just not be so politicized about things like the measles vaccine? And so how how do we kind of get things back to more constructive debate?

SPEAKER_03 41:36

Yeah, I mean, I think people need to have sources of information that they they can trust. And once people have those, and that requires sort of a large group of people being free to honestly interpret the data and ask questions. And so, I mean, how we get back to that is like, yeah, I mean, I don't know how to force it to happen. If I knew that, I would do it. But maybe that's it's good we're having this discussion because very smart people who are listening can come up with a a solution for us.

SPEAKER_01 42:03

So getting to the FDA, uh, what made you decide to obviously you initially came on as a special assistant to doc uh to Marty McCary, who Dr. McCary, for those who don't know, uh Johns Hopkins transplant surgeon who was tapped to lead the FDA. And as I understand it, he brought you on as a special assistant to kind of advise him. Uh how how did that go? Why did why did you say yes? Did you have to be convinced to do it?

SPEAKER_03 42:29

No, I mean, no, I mean I did not. I I knew that I wanted to work with Marty, and I will clarify that I started before Marty did. So I actually started in March, uh, and I was appointed by the PPO, so really the the Trump's uh office, and that was the way, that was the way to be hired at that time during the Doge cut. So I I started like while the Doge cuts were were happening. And and so yeah, there were very few of us at the beginning who really started alongside of Marty. And yeah, so no, I I knew that that's what I wanted to do. Who did you know that uh who who did who did I know?

SPEAKER_01 43:05

Like in the in the P who did you know at the like how how did you come on the White House radar that they brought you on before uh Marty came on?

SPEAKER_03 43:13

Well, I mean, I I assume that Marty had something to do with it, although we kind of I mean, I don't know all of the details because I know I was being considered for multiple different um positions, and uh so it yeah, anyway. I I feel like some of this is like I look back and I think, are there ther certain things I'm not allowed to say? And so I usually when it comes to like the government and things, I I I just kind of I I don't say things if I'm in doubt. So yeah, no, that's what I'm saying.

SPEAKER_01 43:40

Yeah, no, no, no, no problem. No problem. So okay, so walk me through when you were uh when you did when you were eventually working at the FDA, can you walk me through what the FDA looks like from the outside versus like once you get inside what it looks like? Is there a gap there?

SPEAKER_03 43:55

And uh Yeah, I mean that's that's a great question because I I would often call. Close my talks about my job as the acting theater director with a statement about that, which was essentially before I started at the FDA, I was kind of under the impression that like it was the career staff scientists who were really sort of the issue in terms of approving products that shouldn't be approved, and maybe issue with the revolving door and wanting jobs at pharma. And I I guess one of the things that I would say is I was very pleasantly surprised in Cedar specifically how like high quality the scientists were and how really sort of they they understood clinical trials very well and observational data. And I was pleasantly surprised by how often we agreed, like basically essentially always agreed about whether or not to approve or not approve a product. And and in the rare circumstances where we didn't agree, it was like we had the best discussions. And so that was one of the reasons I I absolutely loved that job. And I will also say that there is so much good work going on there to protect like the public's health and and to just, I mean, they do not get credit, the scientists at the FDA, uh, for what they're doing. And I feel like a lot of people are just continuously angry with what's going on at the FDA. And it it's kind of like I think of it as a thankless job. But once you become part of the FDA, you realize why people don't want to leave because it's an extremely close-knit community and very challenging and new questions and every day. So I absolutely loved it. It was like it was a dream job for me to work there. So I didn't expect it would be like that. I didn't expect to make such close friends and colleagues and things like that and to learn so much from them.

SPEAKER_01 45:44

That's interesting because you seem to suggest that so maybe the FDA is so large, right? I mean, it's a huge organization. Are there pockets within the FDA where the philosophy perhaps your philosophy isn't aligned? Because it seems like you get there. You're like the super smart critical thinker type person who looks at stuff independently and kind of arrives at or decision. And the FDA staff are are basically similar to you, are arriving at the same kind of conclusions. You very rarely are disagreeing. But but I guess that are there pockets of the FDA maybe where philosophically there are more disagreements?

SPEAKER_03 46:15

For sure. And I actually want to say it's really different between the review division, sort of what their different philosophies are, and it depends on who's like who's leading that division and whether or not they tend to have a certain viewpoint. And I would say that an issue for for regulators, and it was also just for me as a director, is I think certain people tend to be more conservative and like to do things the way things used to be done in the past. And sometimes there's a good reason for that, but sometimes it's it's maybe a misunderstanding about the current state of the science. And I would use like reducing animal testing as a as an example of that. I mean, that was something that I was very interested in. And I felt like there are sort of multiple facets to this, but people really don't understand the extent of the animal testing that is being done and how much these animals are euthanized and you know, juvenile animals for all pediatric drugs and and just how many animals this involves. And I I honestly think Americans wouldn't want this testing in general to be done unless absolutely necessary. And and then it's at the same time, we're seeing these advances in NAMS new approach methodologies that can replace animal testing that I think haven't among many of the career staff at the FDA, they're very accepting of these, but sometimes people in charge are not fully accepting, and that and that can lead to issues with with change. And so that was one of the things Marty was sort of very good at, I think, was figuring out ways to change the agency quickly. And we did that with the roadmap to animal to reduce animal testing, and he did that with the CNPV program, as you discussed in your article. You reduced the the average uh approval times and we're we, you know, we're meeting all the PADUFA deadlines. And so there were ways to kind of get around the disagreements and and make things more efficient. And definitely Marty was a good leader because he was able to find find ways to do that and bring people together to in a way that worked.

SPEAKER_01 48:06

Do you think that you needed more buy-in on those programs from FDA staff? It sounds like FDA staff was not like it's not like this group of folks that the moment you get there, they're like out to get you and do bad things to you. They seem like most of them are working hard. They just kind of want to be left alone to do their work, and if you're there to help them, great.

SPEAKER_03 48:28

Yeah.

SPEAKER_01 48:28

So but on the same by the same token, yeah, it it seems it seems interesting that I'm sorry, I'm hedging, but beating around the bush, I should say. But there there seem to be a lot of leaks from the FDA to media that put all of you, you Vinet and Marty, in a in not a good light. So I guess I guess these are you're saying these are just these rare kind of bad apples that did not like you.

SPEAKER_03 48:50

Yeah, I mean, I don't know. I think there's there's a lot there's a lot to say about that, and I really did try to say in my all hands talks and things when I was acting director that I really did want to hear from people if they disagreed. And I in some ways I think it it was working. I think from Cedar we didn't really have that many leaks, but I I think it's kind of sad that, you know, that's the way that people, you know, get their frustrations across is by leaking to media and rather than I guess going to the leadership or wanting to discuss it in person. And I don't know if it sort of goes back to what happened during the Doge cuts and sort of frustration, if it's like a sense of political differences and I honestly I think it was very hard for a lot of the FDA staff to lose their colleagues like that. Like you said, it was like 20% of the FDA without in the way that it was done. And so I think that there was some bitterness and and I guess one of the ways to sort of exert control over the situation is to leak. And I I find in general that when people leak details to the press because they disagree with something, they haven't pursued changing it in a different way, and that the health of the public is not their core concern. What their core concern is, is like control and politics and and so it's just it yeah, it's just kind of sad to to see to see the leaking and I don't know. It is what it is, but I will say that it I it was rare. I mean, it was like it was relatively rare because I would say, you know, even though people I knew that people perceived that they disagreed with me politically, but they wouldn't they would treat me extremely respectfully and want to, they believe in the mission of the FDA and they were like there was no issue, you know? Uh and so it wasn't as big of a it's like it's almost like the media saying like this is all chaos. It's like by trying to resolve the chaos by getting rid of us, like like now I d I wonder like what what what is gonna happen, but like it certainly did not like feel chaotic while we were there. I mean, uh like it felt like things were really going well. Uh so anyway.

SPEAKER_00 50:55

Wait, wait, wait. You're you're saying that the media may over-exaggerate things and is not always entirely forthcoming.

SPEAKER_03 51:02

I mean, don't give me a lot of things. Yeah, yeah, big picture. Okay, I don't know. I actually I didn't want to say, I mean, it was crazy the way that things were misrepresented, but yeah, I mean that was we yeah, I I okay, I was about to say specific products. I don't want to go down that road, but uh yeah, I I do feel like the FDA needs to have a much better way of getting their side of the story out. I mean, because it's it's so it's so one-sided. Like, you know, the the new initiative to release the complete response letters to make those public, that was very successful in getting the the word out. I think my video like stopped, but anyway, uh I hope you can still hear me.

SPEAKER_01 51:41

Yeah, we can still hear you.

SPEAKER_03 51:42

Can you still hear me? Okay, great. Okay. So yeah, I mean, I think that getting the rejection letters out was super uh effective. But in general, I think the FDA should have a better way of communicating the pup with the public its thinking when there are those types of uh I'm sorry, I I think I think I I'm having connection issues, but maybe if you could let let me know. Can I if I'm still here, I'm I apologize. Yeah. Okay. No, you're okay. We can hear you.

SPEAKER_01 52:06

You're fine. I mean, that's one thing. But yeah, so you can't do it.

SPEAKER_03 52:08

Tell me what you're thinking in terms of big picture or what you're what you're wondering. Yeah.

SPEAKER_01 52:12

So right, so just the big picture. Uh of course I wrote the and I don't mean to make light of what you're talking about. The the media certainly in this case, they created the story. Rather than that's my opinion. This is my opinion, uh, this is my strong opinion. You know, the instead of being like somebody that kind of held holding the powerful to account, they they instead became kind of an amplification chamber for uh they became stenographers for a certain narrative and a certain view, and they were not very objective. And uh and I and I think that's to everyone's uh detriment. But zoom out a little bit now, uh because I mean this these are the the this is very the interesting part to me in terms of the FDA and what its role should be. Like for me, I I had this idea of what the FDA is, what the FDA does, and you guys going there and everything that happened and how things play out, the media and the the politics of the internal politics of it. Tell me about what you think the FDA should really be, given all that. Like, what is the role of the FDA?

SPEAKER_03 53:06

I mean, so the role of the FDA is to really be objective scientifically, right? Like I think that's it needs to have separation from politics, from influence from the pharmaceutical industry. There obviously needs to be a partnership between the FDA and the pharmaceutical industry to approve like appropriate products in a reasonable time frame. But I I think maintaining the scientific objectivity, and then I think on top of that, probably having a better way of communicating again, like how decisions were it would be a really good direction for the FDA to go.

SPEAKER_01 53:41

And I don't know, that's I I guess Tracy, do you think given the amount of influence that is applied to the FDA when it comes to determining efficacy, right? I mean, we saw, and this is why it relates to what we're talking about in terms of the media, right? We saw how many Wall Street Journal editorials that seemingly focused on one on one drug. Yeah. I mean, the darn people who sit on the Wall Street Journal editorial board seemingly cannot read a CRL letter to go through the various issues with the drug that they're pushing in terms of right to try and stuff. Meaning, there's some serious issues here. Look, there could be signal in lots of things. There could be signal in ivermectin, there could be signal in vitamin C, there could be signal all over the place. There's always a potential signal, right? The FTA's job is to try to sit down and be like, all right, what is the question you're trying to answer? What is your pre-specified endpoint in terms of what you've said? What are your methods? What's your data? Are there any irregularities in the data? Did you meet your pre-specified endpoint? If you're saying that a drug is working mechanistically based on I'm injecting something here, but it's working systemically, okay, let's examine the systemic places the cancer has spread and decide whether or not that's that those there is systemic activity or not. These are really basic questions, right? And if there's problems with any of that, those are red flags. And the FDA needs to come down and say, look, there may be efficacy here, but the study you didn't sh doesn't show that. And unfortunately, it's not mechanistically as obvious as can't walk with knee pain, can't walk with knee pain, and now you're playing tennis in terms of knee replacements or not. It's it's just not that simple, right? So that's right. Given the landscape is what it is, uh, given the landscape is massive amounts of influence. And this is not Pfizer or or Merck, right? Which are massive companies with a GDP of countries. These are like companies that have like, you know, $2 billion in revenue that are that are that are basically creating this massive amount of energy uh that that the Wall Street Journal is writing multiple editorials about. So I ask again, with with all that as as as a background, do you think the FDA should really have a role in determining efficacy? Like, can they actually do it without these type of influences coming to bear that affect the decision?

SPEAKER_03 55:50

I mean, so that's a larger question, right? If FDA should acquire efficacy. My impression is that the the public expects.

SPEAKER_00 55:58

Oh no, she'll come back. I know, it's okay.

SPEAKER_01 56:02

Yeah, yeah. There you go. Yeah, yeah, yeah. So go ahead, keep going. Right, but it but it does seem like what the the rare No, no, it does. It does. It but it yeah. Well the media kind of and the and these and these interests that have a have a have a tremendous amount of game. It's like because it's existential for these companies. You know, if Merck can stand to lose, yeah. I mean, you know, Merck and Merck and Pfizer can can spend a lot of money on it. Yeah, right, right. Sorry, sorry, we're overlapping talking, but but Merck, that's okay. You know, Merck and Pfizer can stand to lose the drug that they spend a bunch of money on, but these companies, this is their sole drug. And if if they don't get this, if they don't get an FD approval or don't get efficacy shown, they're they're done. So they're gonna throw everything at uh you know influencers, they're gonna you know, I I put nothing by uh beyond that, right? They're they're gonna try to get people fired, they're gonna try to plant things and and they don't care, right? Whereas if Pfizer or Merck tried to plant something with Laura Loomer, Pfizer Merck does not want anything to do with like that getting back to them, you know, because that that's huge. So so it's a really, really interesting dynamic where like the rare disease community, which which is a where a lot of these smaller uh biotech ventures are targeting, and it's it's fascinating just to see how this is all kind of playing out. I don't know, maybe we should uh this is a great conversation, but uh unfortunately this has this has been great.

SPEAKER_00 57:12

Yeah, yeah, the the structural problems in the FDA I think are are real. We're not gonna solve them in uh one conversation.

SPEAKER_01 57:18

No, absolutely, absolutely. But it's been it's been a very eye-opening type of uh thing, thing to kind of see. But all right, well we'll we may have to bring back Dr. Dr. Hag Haig at a different uh at a different time uh to continue the conversation.

SPEAKER_00 57:31

But yeah, I'm not even gonna try the pronunciation.

SPEAKER_01 57:34

Yeah next time, next time uh we'll get let you do the we'll have you do the introduction. So anyway, anything anything interesting on uh your end in terms of uh hearing what Tracy has to say?

SPEAKER_00 57:43

Yeah, you know, I'm I was in a discussion with someone who may or may not have been the former Surgeon General about why uh the the shutdowns and everything were needed here, but not in uh you know the Scandinavian countries. And the argument essentially, if I could try to paraphrase his was that they had better social supports and better universal health care. And I just I don't see a virus that doesn't decide to transmit itself amongst children because the children have 100% insurance coverage by a government insurance program. That just makes no sense to me. So I love her perspective in that the we needed real evidence behind these interventions like closures and masks, and and none of the the evidence that we got really backed up the US method to it all. So I don't know.

SPEAKER_01 58:27

What what are your the no just think uh the uh sorry uh Dr. Ho Haig is trying to log back in. This keeps uh autocorrecting me to some stupid thing. I really hate uh what happened to the iPhone once Mr. Jobs decided to pursue alternative therapies for a slow-growing pancreatic cancer that could have been resected. Who knows? But anyway. He didn't trust the FDA either. Oh, there she is. Look at that. We were able to no no, it's totally okay. It's totally okay. All right.

SPEAKER_00 58:55

Well we'll we will magically edit that all out.

SPEAKER_01 58:58

Yes, yes, yes.

SPEAKER_02 58:59

Okay, great magic.

SPEAKER_01 59:01

So, okay, we'll we'll let's fast forward. So we we'll fast forward because uh we'll and we'll get we'll get get everyone uh get everyone home. Uh you know, so let so let's get to the the the the uh interesting one. So you were ultimately you were fired. You were terminated. You and and that decision was actually your decision to be fired because you could have chosen to just resign, sign the resignation letter, correct, and yet you said, no, I am not going to do that. Why? What what goes into that decision?

SPEAKER_03 59:27

Well, you know, it was it was so strange because honestly, like right before they came in, I had just been asked to, I was reviewing a legal document that I was working on with the team, and I had to verify that everything was correct, and I'm like extremely like picky about how we word things and whether or not it's accurate. And it turns out that's important since it was the very last thing that I signed, right? And then immediately after that, these two lawyers come into my office who whom I know and uh who I know, and they say, like, here's your resignation letter, and we're asking you to sign this. And I had been reading for hours about my resignation, supposed impending resignation in the media that day, and like joking with people in Cedar, like, no, I'm not not intending to resign, like just in case you happen to read in the media. And then they expect me to sign off on this. And I'm like, well, no, I mean, it's not my intention. Like, it just felt to me like it was a a lie. And um, I don't know. In in my mind, I didn't think that that was even an option to sign it if that wasn't what I wanted to do. And and so then it was honestly, I mean, one of them he got tears in his eyes, and and also because I said, This has been such an honor to work to serve the American public and for the president and the secretary and the commissioners, and and like, if you don't want me to be here, then then you should fire me because I certainly don't want to leave. And and then they were like, Okay, well, someone will come back. And and then they left. And then in the interim, like I sent one email and then I lost connection to the email, and and then someone from HR came and brought a computer and or took my computers, my ID, and everything, and I packed up my stuff and she came out with me and got my parking pass. And they I will just say that so there's been discussion about who actually fired me, but um, you know, it's very unclear. And the people who you would expect or have denied having any involvement in it. So I I'm just I don't know, but it is what it is. I I'm not working there anymore. I don't have access, I'm not being paid, so I know that much. And it's not I think it's kind of on them to say who it was or or what the reason was. I would also say that it was a bit strange considering I had just gotten like a basically nearly perfect performance evaluation. If it was based on my performance, like it, it just I I just wasn't aware of anything that would lead to a firing. And so whatever. I mean, not whatever. It's it's a it's a tough thing to deal with, but that's the status right now. And I mean, I'm I'm a Brazilian person, so of course I'm like happy to be back with my family. And but at the same time, I'm like, wow. But people should know that that's that's the way it went down, and and that sometimes it's you know, it seems things in the government happen without really people taking responsibility for it, and that that's concerning, right? Because you make a consequential decision like that, you should be able to take responsibility and put your name on it.

SPEAKER_01 1:02:28

Who sits who really is on the chain of command? Of course, it's Marty McCarey, and then above him is um, so there's also the chief of the thing.

SPEAKER_03 1:02:38

I mean, Marty wasn't there anymore, right? So there was the chief of staff at the FDA, and then there was Kyle Diamantis, who was the new commissioner who had just started when I started, and then there's Bobby Kennedy at HHS, and there's Chris Klomp, Susie Wiles, Chris Klomp working at at HHS, Susie Wiles, the chief of staff for for Trump. So there, but I I don't know. I mean, I I don't know. And I think it's not a good thing. Is it the case that is it the case that's speculate publicly?

SPEAKER_01 1:03:05

Right, right. But I mean, is it possible that well I guess okay, right? Yeah, I guess, yeah. I mean, so it but so you don't it doesn't need these type of decisions you're saying do not need RFK Bobby Kennedy to sign off on.

SPEAKER_03 1:03:18

These decisions can be made you know, so I'm reading about that he didn't know about it. I mean, you might you might have seen the article two days ago that three people said he didn't know. And so I I don't I don't know what's yeah, I don't know. I don't know what's required in these circumstances. And if people have answers, I I would I'm all yours.

SPEAKER_01 1:03:38

Yeah, no, I you know, I I'm I'm all yours. I'd like I'd very much like to know. I mean you were you were somebody that was brought in as an advisor, you're aligned with the kind of the Maha agenda, and it seems almost punitive because okay, fine, why not why not shift you to another role within within that ecosystem? Why necessarily do it this way?

SPEAKER_03 1:04:00

Yeah, I mean, I I I had the I had the same thought. Like, am I not allowed to like apply to be a reviewer in the FDA? Like, I I just I yeah my impression is no, like I'm out, I'm out of the agency. So yeah.

SPEAKER_02 1:04:14

Yeah.

SPEAKER_03 1:04:14

But yeah, I mean, I think it's also it this gets back to a question of what do people vote for, right? And I think you brought that up too. Like if they wanted reform at the FDA, sort of like, and people were doing that, then what are the incentives here? Like, is this more incentive from the pharmaceutical industry, or is this did they feel like we were doing something that voters didn't want, or there was like performance issues or something like that? I think I think a lot of people in the public right now are sort of viewing this as, well, we were really trying to reform the agency. And if you look uh objectively at our performance, like it looks I think it looks very good. And so I think a lot of people are sort of wondering like if this is pharmaceutical industry influence or what's going on.

SPEAKER_01 1:04:57

Yeah, I mean, uh to me, this is chaos, right? To me, you have a very I highly competent group of folks who who did a lot of different things. Like, tell me, go ahead and tell me what was what you did wrong, or the group did wrong. I'm talking about because it it it it seems like it happened kind of together, right? You, Vinay, and Marty. Like, go ahead, tell me what exactly we were. What was the ridiculous decision you made scientifically that that what was the the drug that was really working that was amazing? Like, what was it, right? And and the fact that Vinay, the initial time he got fired, I think is he the only CBR director to be fired twice in the history of the United States? Probably. I mean, uh, but like literally the first time the guy gets fired is because probably he attempts to he attempts to pull a drug that was controversially approved to a large swath of really sick kids with uh Duchenne's muscular dystrophy, a gene therapy called Elevidis from a company called Serepta. And when he moves to try to get this drug that is now appears to be killing children. Who were getting this drug and it was approved the controversial it was a controversial approval. Peter Marks, the former CBR head, kind of overrode career staff in kind of approving the drug. It gets approved because because of we can only speculate as to the influences that that pushed Peter Marks to do that. Okay, fine. Maybe Peter Marks looked at the primary data and he saw the stuff and he was like, Oh, this is great. This is fine. Look, there was a lot, it was a very controversial decision, is my point. Okay, and I'm not to say that nobody can overrule FDA career staff. That's fine. Okay, let's see, let's see how it plays out. All right. And certainly a lot of very smart people were like, I don't know why you're doing that. I don't know why he's doing that. He's also approving it. The trial was run done in ambulatory boys, and he's approving it for non-ambulatory boys as well. And then you had multiple boys die. And now, years later, now under Vinay, you have these children that are dying. You have lots of these LFT abnormalities that are happening in these kids. And once you go to try to pull it, that's when Vinay gets fired. Again, that is not Vinay is not doing the wrong thing. Like in in your case, like go ahead, point out to me what it is. What is the Cedar approval process that you did that was so controversial? What you you had a I mean, all the the most I can get about you in terms of looking at everything is that you had a you had a uh you gave a uh presentation about uh vaccine side effects, vaccine, potential vaccine deaths in in children. Uh and and it was just a presentation talking about bears and stuff. I mean, you didn't say you want to pull the COVID vaccine, nothing. You were just trying to open an investigation into what was happening with regard to like can we get some better information on COVID vaccine deaths? Is that is that accurate?

SPEAKER_03 1:07:35

That's I mean, an internal discussion was basically leaked about VERS data, right? I mean, and so I know I'm not allowed to talk specifically about internal communications. I certainly don't think I did anything wrong in that in that circumstance. I mean, I would defend that any day. I mean, what what and so I I think what's what's going on is there it's basically a media sort of cancel culture situation where if there's a regulatory decision that's made, the media can like complain, complain, complain, and even fabricate stories about regulators as we saw that aren't true, and then end up getting them them fired. But what results is that why would the public trust the FDA if they see that people who stand by their beliefs and do what they believe is right then are just fired or uh canceled because of media articles? Like, how can people trust the FDA if that just continues to happen? Like they can't, and so I'm sure people in the public are like, well, uh, can we even trust these decisions right now? And how will they know? I mean, it's it's it's bad, it's very bad to just have like basically the media and the pharmaceutical industry just control who works there and who makes the decisions in that way and what decisions are made. But that's what's happening, apparently.

SPEAKER_01 1:08:56

Yeah, no, uh so it gets to this final question of, and then on top of this, when this does happen, right? How do you then advise anyone? Well, there are two questions. One is well, what what exactly did did one vote for when we're talking about reform or talking about all this stuff? I mean, you even already came to prominence because of your of your critical thinking when it came to COVID, because of the fact that you weren't just lemmings that were going along with the establishment came to school closure, came to math, when it came to vaccines for young boys. That's what brought you to the fore, right? You go there in an attempt and performance reviews are perfect uh for you. And uh, and yet, you know, this happens. What exactly uh what exactly would you tell somebody who is going to go work for the for the FDA?

SPEAKER_03 1:09:35

Like, don't, don't, if you're gonna take a leadership position, don't buy a house. Like, just know that you're gonna get fired if you stand up for what you believe in. No, I don't know. I mean, I don't want to come away from this having people think like I think I'm perfect or I did everything right. I certainly don't think I I'm very open to the fact that there could have been mistakes that were made. I mean, I think I think I did a good job. I would never claim to be perfect. And I'm sure people have different viewpoints of the story, but the the moral of the story, right, is like, you know, you can you can just, it's not, it's not a certain position. Like it's I don't know. I mean, my best advice would be to go in, commit to what you want to do, know who you are, know your values, like know learn the data of the studies, like make decisions that you can stand by, have integrity, and because in the end you're gonna get fired no matter what. And so at least when you go down, you go down like with honor, right? So that would be my advice. And be respectful and make friends. And it's like the same lesson I would give to someone, like just for life in general. I mean, you have to do the right thing given the chance, especially in a position like that.

SPEAKER_01 1:10:48

Well, uh, Dr. Hogue, uh Dr. Hay Hate Hogue's good, hoag's good. I know you're like, please stop, just say hogue. I uh I I mean this has been I you know, I'm laughing at the end of this, and you're you've been incredibly kind after what's happened. I mean, again, you're clearly an incredibly resilient person. Um, I'm sorry that this has all gone down the way it has for you. I was obviously I was very upset about how how this happened, and yeah, and uh that's why I've written a couple things on on you and Vinay in terms of and I'll try to link to that as well so that people can truly get a flavor for some of the data and stuff behind what we were saying in terms of like deadlines that were being met and new pilot ventures and no animal testing. I mean, there's a lot of stuff that was accomplished within six months, the framework is there, but it really does I've had a I've had a lot of folks reach out and say, you know what, if the FDA can't operate with these people, then really the FDA as it stands shouldn't exist. I think you've provided a really balanced kind of view of that, and and you've to your credit, you're not a lot of the folks who are working at the FDA seem to be very, very bright people who are making, doing the best they can for the American people, trying to kind of do the task that they have been assigned to them in terms of calling balls and strikes. So uh maybe there is hope, and perhaps this is something that will lead to something constructive uh down the road. I know one thing, I know that uh you are going to land on your feet uh regardless of what happens. Uh so I mean you're clearly a very resilient, brilliant person, honestly. So very happy. Thank you so much for coming and spending all the time with us. We'll try to get you a uh Starlink. Uh we'll talk to Elon about maybe getting you hooked up with Starlink so we can improve your internet connections and have you back on.

SPEAKER_03 1:12:27

That's great. Thanks for watching.

SPEAKER_00 1:12:28

After we start our R ASC, spine procedure ASC together. Yeah.

SPEAKER_03 1:12:32

Oh, that sounds great. Yeah, let's talk about that more. Yes, okay, very good. Thank you. Thanks. I just want to say I was super nervous, so thanks for asking all of these great questions and making me feel like I could tell the story. And your your podcast is is wonderful, as is your writing. And each Anthony, I don't even know if you have a Substack, but if you did if you do, I want to start reading it. But okay, great. Well then I will start. But yeah, thank you so much. Really appreciate both of you.

SPEAKER_01 1:13:00

And yeah, yeah. Thank thanks so much. Anthony Substack is is is excellent. He's got this amazing graphic novel, Health Policy. Your IQ will go up at least a hundred points, which for me would take me to around 110. But it would it'd be great. So all right, Dr. Dr. Hogue, I've given up pronouncing your name. It's been a pleasure. We will we I hope I hope we'll come back. I hope we get to I hope I hope at some point uh we can even meet. So alrighty. Take care. Thank you.