LMHR/Keto CTA CONTROVERSY - YOU WON'T BELIEVE THIS! with Feldman & Dr Norwitz

If you've been part of the ketogenic or ketoore or carnivore community for any length of a time, you have heard about the lean mass hyper respponder phenotype. And you've also heard about the study that my friends Dave Felman, Dr. Nick Norwitz, Adrien Sodto have been working on. And uh there's some breaking news that's quite disconcerting and disappointing. And I've got Dave Felman with me today and Dr. Nick Noritz, I should call him Dr. Doctor, uh, who we're gonna talk about this and unpack this. You're not going to believe some of the stuff that you're about to hear with regards to this. I think many of us h have the suspicion that mainstream medicine is in a worrisome position right now. Many people think that it is perhaps compromised and some of the things we talk about today I think are going to not going to really quail that uh theory at all. So let me bring them on without further ado. Dave Felman and Dr. Dr. Nick Norwitz, welcome gentlemen. >> Thanks for having us. >> Nice to be here Ken. >> All right. So who wants to go first and bring us up to date on the latest developments? Dr. Norwitz, I see your hand up. >> Yeah. So, I I I want to just actually frame this before we even get into the data. Responding to something you just said about the worry state worrisome state of like medicine and science because coming from a world of academia, people don't know my background like Dartmouth undergrad, Harvard med school, Oxford for my PhD like I have been born and bred in the Jade Tower. So, it's very difficult for me. You're about as PhD as somebody can be. >> Let let me just read a section from part four of the tweet I put out this morning. At multiple stages, it has become painfully and increasingly clear to me that our scientific system, which presents itself as purely meritocratic, is far more political than most would imagine. These are really difficult words for me to say as someone who comes from a family of doctors and scientists and who has spent his entire career in academic institutions. Harvard, Dartmouth, I have two doctorates. I was groomed in conventional academic medicine and if I have any bias to see the best in conventional medicine in the modern scientific process. Most of my loved ones make their living in this ecosystem and I truly respect them as like healthcare heroes. But when you pull back the curtain like on the process we just went through the reality is sobering. I just I become so disillusioned and I'm passionate about it because what Dave and I and our colleagues Adrian have in common is like we just want the freaking answers and the degree of obstruction to get there and the lack of meritocracy, the obscene bureaucracy. It's just you it's hard to express it without coming off like a conspiracy theorist, but it really is that bad. >> Yeah. Now, let me let me just break this down for because not everybody may be aware of this. So, I'm a country boy who went to a state university. I do not have a PhD. I have never been to Yale, Oxford, Princeton, or any of the other Ivy Leagues, not even to visit, much less to attend. And so when somebody comes at me with a with a conspiratorial idea like, you know, I'm I'm afraid that medicine at the top has been compromised by by, you know, all the promises, maybe the money, maybe the prestige. For me, that's not that big of a jump. But Dr. Nick Noritz, who's a PhD and an MD, literally every family member, Nick, almost without exception, is either a PhD of my >> five out of five, right? And so this guy grew up, he literally cut his teeth >> on Ivy League uh biscuits. I don't know how to put, you know what I'm saying? Like this guy, if he says there's a problem in academic medicine, you better just drop whatever you're doing and pay attention because this is not something you hear every day. >> Can I just say also like the more I dig into this, the more this is part of a pattern. I was responding recently on a rumor about one new weight loss drug, Red True Tai, that had kind of been propagated and there was some like very almost like intentionally deceptive wording in the paper. It was in Lancet diabetes and endocrinology. And then I looked in the paper and it said the sponsor, it said this in the paper, which actually credit to them for transparency. It said the sponsor, which was Eli Liy, not only funded and helped design the study, but they helped with data analysis and writing the report. It literally said in the paper, the drug company helped write the words that went in to the medical zeitgeist. And you can see that how therefore how the seeds of information are planted to bias the narrative in a particular direction. It's >> because 99.99% of regular people will never read to the end of that paper. But here's the here's the concerning thing. 97% of MDs will never get to the end of that paper to read that. Oh my god, the drug company literally wrote this paper that it says that at the end of the paper >> in the middle of the paper. >> Yeah. Yeah. But the average doctor is just I would say our experience recently and we're not even going to be able to talk about all of it is the worst I've experienced but it is part of a broader pattern. I'm zipping it because actually for for what it's worth you would think all like people behind the scenes have all the information. There's a ton of information I got yesterday. Dave filmed my reaction, but Dave, for the better part of the last year, has been taking the brute of it behind the scenes, and I've stayed out of it just because certain things I can't keep my mouth shut about, as you probably can tell. Um, so now I am going to be quiet because I think Dave deserves to um break some headlines here. >> Yep. And Dave, before you bring the the latest headlines, give everybody because not everybody's familiar with just a maybe a twominut summary of your how we got here, why this all began in the first place and then kind of bring us through the lean mass hyperresponder story so that everybody watching this, we've got,00 people already watching this and everybody watching this, if you know somebody who's been low carb, keto, keto or carnivore, please shoot them a text message, a DM, or share this on your favorite social media because when you hear what these two gentlemen are about to tell you, you're going to be like, I suspected this, but are you for real? Go ahead, Dave. >> Yeah. So, here's kind of the setup. Uh, effectively the there's number >> Can you hear Dave? >> Can you not hear me? >> I can hear. >> Oh, you can hear weird. All right. So this is this is effectively the setup. Basically for those people who go on a ketogenic diet and are like myself, like Nick Norwitz, we tend to be leaner, more metabolically healthy, there tends to be an increase in LDL cholesterol, often coupled with an increase in HDL cholesterol and low triglycerides. Nick, your keyboard is quite loud. Just giving you a heads up. Actually, I think I'm I'm kidding. >> Anyway, so the gist of it is is that effectively we've known for a while that we wanted to study it. And so in 2019, I founded the Citizen Science Foundation, a scientific public charity that I raised money through in a uh basically crowdsourced a study. And that study recruited 100 participants who would then fly to UCLA and at the Lungquist Institute would get a high resolution heart scan known as a CT angagram or CTA. They would get it at say [laughter] they would get it say day zero and then a year later they would get a second scan. So that basically we would have a 100 scans from these 100 participants that are baseline and [clears throat] then there would be a follow-up set of 100 scans for every single participant. So it's a total of 200 scans two for each participant. That's important because this is what's known as a longitudinal study which is to say you get a you get a two uh multiple time points and in this case two time points so that we could track plaque presentation what it shows up as in the baseline and then also what its progression is by the follow-up to see what the differences were. Now, when this happened, it was great because after we had collected the baseline data, it was already looking uh pretty good with regard to what the baseline levels of plaque were for our participants, it was actually relatively low. And we started publishing even with the baseline data. And this includes a match analysis, which you could find at cholesterolcode.com/papers. The match analysis already was very interesting to us within the low carb community, but only eventually did we get the longitudinal data and the longitudinal data also looked really good with regard to the first analysis that was done. This will be the first of four, but that first analysis is called a semiquantitative. It's usually kind of the horseshoes and hand grenades version, let's just say, but it was looking fairly good. And um that's actually what we wrapped the movie with is we were reporting on it at that time. Then we ended up getting a second analysis through an AI company called Clearly and this was the first quantitative analysis. The quantitative analysis uses um computerbased versions of analysis. I'm trying to speak for a lay audience. Well, let's just say it can involve AI and it can involve various levels of analysis that what it's trying to do is it's trying to do a higher resolution level of quantification of plaque. And the most important thing is that it both of those analyses now that we have two they agreed broadly on two major findings. One is that baseline plaque your your plaque levels at your baseline that was very predictive of your future plaque progression. The more plaque you had in your first baseline scan, the more likely you had more plaque in your second your follow-up scan. The second one was that there was no association between Apo B levels or LDL and future plaque progression. [clears throat] Both of those data sets agreed with each other on that. And so that ended up being the basis of the April 7th paper from last year. There was however one place where the two data sets weren't in as strong agreement as you would expect. and that you would see in these other studies and that's that the second one the clearly data set did seem to have a higher magnitude of plaque relative to the first and there also just was a greater ubiquity there wasn't uh there was one regressor that we had in the original data set but only one and by the final analysis it actually turned out that that regressor wasn't a true regressor there was a there was a bit of a lab error as far as the accounting goes And so in truth, there were no regressors. And and by regressors, I mean where they have less plaque on the second scan, on the follow-up than on the first. So I realize that's a that's a bit of a setup, but it's an important one because after the publication of that um after the April 7th paper, as everybody inside the team knows, I was particularly interested in seeing the raw anonymized data. And only at the point where we published the April 7th paper was it contractually required that that Lquist would then deliver to the Citizen Science Foundation me that data set. And then I went into a bit of analysis and pretty quickly I started seeing patterns that you don't typically see in these other studies and I started bringing this to the attention of Lungquist and Clearly and at that point um as Nick knows I had to go a bit quiet with the rest of the team because at that point the citizen science foundation and clearly and some of the major donors had to have a lot of closed door let's say virtual meetings. if you will. Um, here's the thing, Ken, that I'm I'm just going to say right now, and I can kind of say it now that the video's been posted on it. I genuinely thought that that was going to be a short amount of time. [clears throat] I thought that I thought that we would get to an understanding between all of us as to what the right way was forward for transparency of the data. And the biggest most important thing was that we needed to have a fully blinded analysis through the clearly platform. And because there were these uh patterns that were not easy to explain, I suspected that it's that was possible. I don't know if this is the case that it's possible that it would be different if indeed there was a fully blinded analysis since a fully blinded analysis would be what would be properly required for these longitudinal studies. They're supposed to be blinded >> and you you as the one of the lead researchers would absolutely expect and want all of the all of the data to be blinded. Correct. >> Always. Always. It's it's a it's a scientific standard that should be expected >> and it was only found later that there was something with the delivery of the data too clearly for which what they received were not fully blinded uh scans. And so in the in the metadata was the exposure of the dates. Not saying that I know that this was acted upon or anything along those lines, just that it was not fully blinded. So, we effectively said, you know, behind the scenes, we said, could you just run a quality control check, run the scans again? We're not asking for any changes beyond the fact that it's just a blinded reanalysis. The blinded reanalysis again if the measurements are stable should be pretty close to what the original set of data was. >> Correct. >> And short answer is that their answer was no. And that they um and I want to be fair to them and I want to steal away their position. What they would say is it's an irregular uh request and for all I knew it was an irregular request and that I'm taking them for what they're saying to me then. Um, >> can I interject? >> Yeah, go ahead. >> It is not an irregular request and I want to like stand up for my friend on his behalf that throughout this process, bear in mind who Dave is and this is one of the reasons I respect him so much. He's coming from the outside world into academia and I think there have been a lot of times in this process where people have taken advantage of his naivee because he just didn't come up in this process. So >> right >> at multiple times. Well, that would be exactly what somebody who knows the inside baseball, so to speak, they would that's exactly what they would say to someone like Dave Filman, thinking he wouldn't know any better. Oh, that's a that's irregular request. We we never do such a thing. Is that >> only a regular request? Because it's irregular for them to have unblinded scans. >> Well, it's why it's irregular. >> I have a spoiler alert. >> And you weren't asking for charity, right? You were gonna pay them, >> correct, >> their company to do the thing again. >> Yes. in. And listen, we're talking literally in April, like we published in April, within a matter of days at least, I don't know, a week or two at most, we were realizing we not only wanted to do this blinded uh analysis, but on top of that, we if if money was a consideration, like we wanted to be absolutely upfront, we volunteered that we would pay for it fully. It was. >> So, you weren't asking them, you weren't asking them to do this for free. You were like, "We need this to be blinded. We're happy to pay you to redo a sample that's truly blinded to see if the data was the findings were correct." Is that correct? >> Yes. But there's there's also something else which, you know, I've never gotten a chance to talk about publicly and I feel like I should have latitude to say it now in this circumstance, which is just that I don't know another way of putting this. I feel like a lot of times I've been living in a real life parable of the emperor's new clothes. for an engineer when you're seeing only positive values and I'm working with a lot of genuinely well-meaning people on all sides and all teams who go well but this was an untreated population with sky-high LDL so it makes sense that they would all have progression plaque progression and I'm saying you could absolutely believe that's true but if you're talking about low levels of plaque just like if you're talking about low levels of anything that you're measuring for which the resolution [clears throat] is not that tight, you expect a wobble. You expect what's known as birectional scatter. It would it would be like if it would be like if I went to your bathroom scale and I tried to measure marbles, I would have a tougher time than if I were trying to measure bowling balls, right? >> And that's all that I was saying at the time. And I felt like it was just a communication problem to try to get across that no there should be some expectation given how many of our participants have low levels of plaque that it should [clears throat] have some amount at those lowest levels of birectional scatter because that's below what we would call the noise floor. you expect >> and that's one of the when I first read the study that's one of the things because I have interacted with literally thousands upon thousands of people eating real keto real carnivore real ketoore and I have seen plaque regression hundreds of times and so when you when the results came out and there was only one person that had regression out of the what hundred I was like that's not what I'm seeing in reality but I mean this is This is a control blinded study. So that must be right. I think Nick's going to pop a spring if we don't let him jump in. Go Nick. >> Sorry. So I'm hoping I don't repeat anything because I heard like only the end of what Dave said. So I popped out popped in. So tech issues. Apologies to everybody in the chat resolved. Um before we get on to like what happened next, I I want to emphasize because people are like confused about hey why didn't you check this before the paper came out? And the irony here is that because we are a affiliated Dave and I, with the study via the funding group, there were blocks in place to ironically protect the integrity of the process, which is >> which makes perfect sense. >> Appropriate. Yes. >> Yes. Yes. >> It's it's it's the Sorry, I'm just I'm just going to make this abundantly clear because people seem to not play this out in the in the counterfactual. What would it look like if an engineer who spearheaded this study said, "Wait a sec. I'm not sure if I agree with you guys. I'm not sure if I have as high a confidence as you do in this data set." And this is a talk I already gave at PHC last year after the Clearly data came out and before the other data sets we're about to talk about. How would it how would you take it if somebody obstructed a study because they said, "I don't like how the data looks. It doesn't seem plausible to me. I need you guys to keep reworking it. No, that's why you want them blinded and that's why it makes sense that we need to get to the point where we release the final paper. The two major findings are stable and still are stable with regard to plaque predicting plaque and with regard to April B not predicting it. So, make no mistake that was still publishable. Go ahead, Nick. >> Yes. >> So, what I was going to add on to that is exactly what you said. There's two things. One is we, you and I, didn't have access to certain bits of data to try to in the protect the integrity of the process, but it also means we couldn't check certain things. Then when it was coming time to write and publish the paper, I can attest before it was published, Dave was like, there are a couple oddities here, but we're also again in the situation of the funding body where it would be weird if we're like, hey, we're going to push really hard on a particular narrative. So what we did on a first paper and there were always going to be more was emphasize what was the key novel finding which was that LDL exposure and Applebe did not predict plaque progression that is a huge and novel finding and as Dave said it has been consistent across every single analysis even the original clearly plus heart flow plus Qangio that is the most robust finding and it's actually very important and novel and it occurs despite the largest LDL spread of any prospective study ever published, which is actually a big finding that people keep on trying to look over to sort of brush it under the rug with with what appeared to be this clearly debacle, which now we have a little bit more information on. >> Yep. Now, everybody watching this, please take one second to hit the thumbs up or the heart. Make sure you're subscribed to this channel and then tell me in the comments where you're watching from. We need as many people to hear this as possible and I want to see where the YouTube algorithm is feeding this out. So tell me what city, state, country you're watching this from right now. Uh while we continue to break down these really it's really astounding uh the and I think egregious is not too strong of a word. Uh so this was supposed to be blinded and it turns out it was not blinded. It was blinded to you guys, but it was not blinded to Clearly and then some others who may have been involved. Uh, take us from there, Nick. What's What's the next step of your OMG? Wait, what moment? >> Well, well, I'll pass it to Dave in terms of like what happened next with the properly blinded analysis with Heart Flow and Qangio. Dave, you want to take us through that? >> Yeah. So, getting back to the timeline real quick, once it became obvious that we likely were not going to get the fully blinded reanalysis with Clearly, we connected with the um it could be argued the a the leader in AICT angography in the year. It's the most validated of all of the platforms known as heart flow. And full disclosure, I hadn't been acquainted with Heartflow before because I was only being acquainted with the technologies that all the teams were connecting me with. After we connected with Heart Flow, um it it was a just to be pretty frank, it was a very different experience. They they were extremely um interested not only in our study, but I was already out of the gate saying, "Hey, I want to be sure that this is properly blinded." to which their response was like that's actually exactly how we want it to be. And we worked out what is known in the field as operational blinding which is to say quite literally the data they're getting it's impossible for them to know what the order of the scans are. So heartflow is able to complete their analysis ahead of the fourth analysis and the third and final quantitative analysis which was our pre-registered endpoint for the whole study called metisqangio. Now, this was great because had we gone without going with heart flow, there would have been only one more analysis, and that was the pre-registered analysis with Qangio. I don't know about you guys, but I wouldn't have wanted there to be just two quantitative analyses at the end, and the last one would have been our pre-registered, even if it turned out to be at odds with clearly, which we didn't know if it would be. If there were two analyses that were somewhat at odds with each other in this one way being the semiquantitative and clearly I wanted there to be at least two more. I wanted to see how much these agreed with each other. So here's the spoiler alert. the fully operationally blinded uh heart flow data came back and it was all the patterns I was saying I was concerned about that I was seeing in clearly and I'm on record at the PHC doing a speech on this laying this out >> they showed up in heart flow they were the patterns that I was expecting things that I couldn't have known had I not gotten a hold of the raw data unless I just kept peppering you know the the statistitians or team with it forever Another example is for examp is is if you divide the whole like the whole group of of people who progressed in plaque into thirds, those with the lowest baseline actually had the highest magnitude of percent change increase. Right? So the lower your baseline plaque, the more percentage increase in plaque for your next scan would be. Right? these kinds of things you you only get to see after you've like had a chance to get your hands on the raw data, get get a little bit more into the follow-up. Anyway, heartflow gets done and then we learned our lesson with regard to the roll out with April 7th. Um I once again had to turn to my good friend Nick who's hyper transparent. It's very difficult to keep. He he literally gave us an emoji to send to him when I needed him to be quiet. I said, even though we have heart flow, even though it's in hand, we're going to put out Budov's talk on it, which granted looks really good because it agreed with the semi-quantitative. It showed that the the overall PLA progression for our cohort was very low, at least cohortwide. Um, but we're going to wait until Qangio. Qangio finally comes in and now we have four analyses. Three of them agree with each other. low overall plaque progression cohortwide. However, it is a heterogeneous group. There are some who are more rapid progressors. But importantly, Ken importantly, all three of those analyses saved clearly had regressors. All of them in well two of the quantitives in the double digits, right? Had regressors. And >> and when you say well just for the people watching when he says regressors he means people whose uh plaque score went down >> correct had less even though their LDL cholesterol skyh high apo skyh high and they're eating fat like a literal keto u connoisseur their plaque went down let me summarize just like what we've come through thus far which was okay one thing that's consistent across all the findings is that LDL and apple B in this cohort does not predict plaque progression any of the analyses then what we have is clearly over here which we thought was blinded turns out it isn't and it has kind of one magnitude of change with some oddities in it and then we have multiple other independent analyses including the prespecified methodology a semi-quantitative and fully blinded AI analysis which largely all agree with each other and then there's the oddball that was the unblinded one and oh the company won't check their work and do it in a blinded fashion and and you alluded to it and I'm going to speak very carefully here because there's still things I can't say but I can present what information is very publicly available which is you're right there are conflicts of interest that were not previously disclosed that I didn't even know about Dave can say whether he knew about it but if you go to the paper the original April 7th paper. Feel free to go to the conflicts of interest statement, see what was disclosed. Dave disclosed his conflicts of interest. I disclosed my conflicts of interest. I even said I had like a cookbook that I have royalties from that I give charity. Like we gave our conflicts of interest. There was someone on the seauite of Clearly who didn't mention they were on the seauite of Clearly. >> Am I right in my in my conspiratorial mind? Am I right in saying that? Is that the person who recommended to you guys that you use? Clearly >> this predate honestly that predated me in the study design. So I'm not going to comment on it. I'm just presenting like what is googleable information and and when I found out I was like wait why was this not disclosed? Like this seems at minimum something that should be disclosed. >> I'll leave it at that. That's the facts thus far. And just to prime everybody, everything up to this point isn't even the big news yet. >> The big news happen. >> Let me ask the question a different way, Dave. Let me ask this a different way so that we're not casting dispersions. Who recommended that you use clearly for this study? >> I I'm pretty sure right now I can't comment on that and it's for two reasons. And one of them to be fair is that I don't know fully everything about that. Um there's there's more but I know the um the legal team would prefer that uh I not discuss on that. >> So for those of you watching this means that Dave is afraid he'll get sued if he says too much. That's what that's what Dave's saying right now. It's but it's a lot of that Ken is that we reduce our options on decisions we decide to make. >> So >> Dave Dave is incredibly strategic. He's also, if you don't know, like literally a worldclass poker player. He has played the Poker World Series. I was reacting to him releasing this information to me in a recorded video and I'm watching it. If he ever releases my full reaction, you'll see me be like, I don't know how you're dead pan. I understand now why you're such a good poker player because I am doing literal back flips. This is so remarkable. Dave's just like delivering it like this very dead pan and not reacting at all. So he's playing his poker face now which has served us well. We can compliment each other. But yes, people can read between the lines as they see fit. Well, >> so the way the way I understand this, the heart flow and the Q angio both showed 50% regression stable cases versus clearly showed effectively 0%. >> No, I have to I'd have to correct you on that one. So the um >> yeah so Q&A if I'm remembering correctly had 15 cases out of 99 that regressed and um and uh heart flow had 33 out of 95. The >> we hadn't gotten to the new news yet but there's a new sample which we're getting >> let's get to that. That's where the 50% comes from. It's probably >> okay. Well, there's a there's a stretch a lot of people might genuinely wonder about which we've not been able to talk about publicly. What the heck happened between when QAngio came in and these several months uh up until now? Well, Nick and Adrian know but are not quite fully able to comment on it. I'm not fully able to comment on it. um a lot of it they don't know about. But there was more, let's just say, uh a push to to say, I think we've got enough information to really give this a strong consideration on doing the quality control check. Um I it it would be be great for all of us and I think it it could you know be very beneficial. Now then there's this larger question and I'll concede there was an internal debate which was do we just go ahead and move forward with the publication of Harpllo and Qangio without um making any decisions I'll just say with regard to the original April 7th paper or does that need to be part of the conversation and I think we made the best most honest decision that it all needs to be part of the conversation and that's really all I can say about that in the moment as as Nick knows. Why >> I can I add one thing and this isn't despoiling anything really. I just want to say Dave, Adrian and I are in complete consensus about what we want to do >> and that's all I'm going to say on that right now. Yeah, they the the hardest part, Ken, is um I've worked so closely with these guys and one of the most difficult things for me is to wear this hat as the president of the Citizen Science Foundation and have these official duties in order for me to accomplish the legal and formal mechanations that I've had to leave everybody else outside the room with. For months, that's been super difficult. But that includes something else that was happening on another corner in that there were a number of participants who took it upon themselves to uh request their scans their diccom scans that are part of the study which is their right to do participants in the study >> in individual study members said hey I want to take my results and go to my personal cardiologist and have them reassess is that >> yes they they were taking their scans to their cardio iologist and a number of them submitted them back to Clearly. Now, even though I said it wasn't fully blinded the original data set, I believe that there's no names that were part of the existing Clearly data set. So in a roundabout way, these participants who chose to do this effectively um were getting the data in a kind of individual level of a blinded reanalysis at least with with regard to their own scans and then >> because clearly clearly did not know that they had previously analyzed that scan. It it looked like it was a fresh scan coming in. Correct. I can't say I know that for sure, but I would speculate that they were probably unaware of that. And so to that extent, if different data were coming back, we would be very interested in that. Presumably, it would be close. if it's going to the same platform, you know, I I would I don't know for sure and I don't know how much these algorithms change, but I would be of course quite surprised if it was say, you know, a delta beyond 5% or maybe even 10%. Right? Some some change in >> in my mind I'm thinking gluconometer or something, right? Um that said, I would be very curious because it's a test retest, which is a thing in science by the way, particularly with devices. So this is this has to be emphasized here, Ken. This is the same participants sending in their study scans. So same scans that they're sending in too clearly, but it's through their cardiologist, which is appropriate since the cardiologist is able to provide that right on behalf of their patient, >> right? >> And so Nick, it looks like you're really wanting to say something. >> No, no, no. I'm waiting for it. So, we are 35 minutes in and you haven't even dropped the bomb yet. And I'm like, I've heard the news and I'm anxious for you to get to it. Anyway, continue your story. I'm just being incredibly impatient because it's been a year waiting for what Dave was about to say. >> Yes. Uh so these scans they're basically getting shared back to me or rather not the scans but the uh data that came back from clearly is getting be getting shared back to me in this kind of network and that's where we needed to this is where it gets back to u my role as the president of citizen science foundation I wanted to be sure everything was above board that we got agreements in place that um everything was you know appropriately arms length on like my end and so forth with regard to what I could know and when and so forth. And um it it took a while because it's very staggered and things are kind of going at different you know rates and so forth. But as more and more data accumulated um while I can't fully go into it, Nick knows and cannot talk about it yet. We had reason to determine that this was the time this was the time where we needed to share that data. Um, the catch is that while Nick knows why, Nick and Adrian themselves literally did not know what I just explained to you was happening at all. They were unaware that these participants were effectively because it was outside the study >> and was something that they could do on their own and that they could, if they chose to share it back to the citizen science foundation. But again, I wanted to keep everything uh totally legal and totally formal. And then at the point that we determined why it was that we would need to release this data, I literally went so far as to actually put it all together, work with the um work with the legal team, um work with the internal team, and then ultimately put it together in a video. It quite literally showed Nick the video. It's like the most produced um information. [clears throat] So yeah, >> I've known for 21 hours exactly. >> Yes. >> What you're about to tell us, which we haven't even gotten to yet. >> Yeah. Did you end up loading up the slides? >> I've got the slides you posted on Twitter. >> Yeah. >> And then I've got um the reaction of a prominent lipidologist should you want to um show that as well. Let me see here if I can do this. >> And thank you for everyone who's been able to hang through this story. Let me tell you, it's felt like an eternity to us. It's this has been one of the longest 10 months you can imagine. But while you're loading that up, I just I really want to emphasize I still want as as kindly as I can say this. It's just got to be about getting to the truth, right? >> Yes. Okay. Can you see that on the screen? >> Yes. So, >> okay. >> What everyone is looking at right now is a collection of red bars and blue bars. That zero line that runs through the middle is the zero change. So if a bar is running above it, that means that there is an increase from baseline to followup. And since our population is predominantly middle-aged, there's the expectation that overall plaque is going up. And before we get into this, let me just restate what I said before. All of the participants from the original Clearly analysis, none of them are regressors. They're all progressors. So you see that in these red bars. The red bars, as you can see by the legend, are the clearly studied data. That is what was provided to us in the study. And you can see above the bars what the amount of plaque change was in millimeters cubed. So for example with P1 they had a change of plus 17.5 millimeters cubed from their baseline to their followup. And you can see on the next one it's plus 2.4 22.4 and so forth. Now on the left side the first four it's sorted going from the highest plaque change to the lowest plaque change. They are all progressors. But three of the four progressors are actually substantially lower than what their clearly data set said. And even the one that is an increase, it's a modest increase. >> Yes. >> But the most incredibly relevant data to us in conjunction with this are the ones on the right. You can see all of those blue bars are going below the zero. That's because there was less plaque in the follow-up scan per the individual submissions to clearly [clears throat] than there was for the same participants in the same scans for what was provided to us for the study. And so we we quite literally have half progressors versus half regressors. Now, do you have the um mean and medians? Um yes. Okay. So, here's the median. So, if you calculated the median, which is to say you look at the the middle single uh bar, but in this case, it's the middle two bars. And so, you average between the two, >> that's an increase of 20.6 6 mm cubed or a 31% from baseline which by the way if you're looking for people who don't know if you're looking at a population and you're looking at these longitudinal plaque uh studies that is a fairly sizable increase if you're looking at these eight participants to reemphasize we're not looking at the whole study just these eight participants this would be you know worth consideration however these same scans when going through individual submission When you put them together for a median, it's plus 0.7 millime 2% increase from baseline, which would be quite low for a middle-aged population. Uh, and then you want to go to the mean average. Can I just say one thing in uh kind of apples to apples analysis which is people were very fixated on the percent change originally right percentage and we were saying the whole time that the denominator matters well apples to apples here the error here the delta if we do 20.6 6 divided by 0.7 what is it on the order of >> a 30fold >> error >> thousand% >> if you want to you know play that same game so like the magnitude of difference here is astronomical I mean even if you go with a median >> of 20 look at participant 8 they went from plus 32 to minus 48 that is four times the median change what people which people [clears throat] were saying was gargantuan So, it's like taking a bowling ball that's 10 pounds, putting it on a scale, and then taking it off the scale and putting it back on the scale. The first time it says 10 pounds, the next time it says minus 30 pounds. Like, these aren't small differences. >> Yeah. And just the the three uh the three the three participants on the right uh like they completely call into question clearly's even utility as an AI image analysis tool. If it said that the plaque progression was plus 32 and it was really minus 48 you that has to call into question the entire tool because even in any individual study there should never be that much difference between what they said and what actually was. I I wanna I want to interject. I want to interject because this is I'm 100% going to steal man on behalf of of clearly in this case that it's possible that there's just something that happened with the data set that came to us in the study and that it's possible that actually their modality is fairly accurate. I would want to see test retests that are fully blinded. my concern and I'm and again I've got to be careful because I do want to emphasize I don't want to I don't know as I say in the video I don't know what happened but the most charitable take that I think is worth emphasizing is that it could be that there was just something that happened with our original data set which only furthers our case for wanting to do a a blinded reanalysis right >> and that's what you asked for you asked for a blinded reanalysis for at least a part of the participants and you offered to pay for that and clearly declined >> and we still are by the way we I if I mean I don't know I I'd have to check with the donors they may have changed their opinion on how confident they feel in the process itself but part of why I want to say this is because my opinion on imaging hasn't shifted that much and a lot of that frankly is thanks to heart flow heart flow let me just be sure I plug this in right now heart flow has never once deferred to uh a blind degree analysis. I asked that coming in the door. I said if you if you give us data and it seems implausible against other existing studies that are out there, which is the piece we didn't get a chance to go into, but there's a lot of things about the existing Clearly data set that was provided to us by the study beyond what we've even talked about yet, like the power of zero. But if we got something like that, could you do a blinded reanalysis, not because we think it'll change that much, but because it'll help confirm if it did. That's why you do test retests. You want to find out what that variability is. And I'm I'm literally here saying for all that we've gone through that I believe it's possible that uh Clearly's analysis is not that inaccurate and that there may in fact just be something with the data set itself. It's possible. >> Even even with that steelman though, I need to point out that what is unequivocally true is that there is imprecision. We here have the same exact scans read twice and have a gargantuan discrepancy. So, as far as concerned, >> I I do not think a reasonable human and and this isn't like an this is just laying out the facts. I don't think a reasonable human could take the initial clearly results and have any confidence in them because what we have is multiple analyses that agree with each other disagree with clearly clearly stands out as the unblinded analysis they refuse to repeat. >> So and and then when there is actually a subset that you can repeat via their own platform their results don't even agree with themselves and agree with the other scans. That's highly suspicious. Highly suspicious. And the fact that they evidently now they hate money. They don't want to take your money to to redo these in a truly blinded fashion. I'm sorry guys, but the the country boy in me is calling fish on this. That's very fishy. >> Maybe we should go to the next slide and get the means too. >> Okay. >> All right. >> Uh so yes, this is the mean average. This is where of course you're adding all of the plaque together from both sets rather the change in plaque together. And in this case it actually even goes toward the negative as in the study provided for these eight participants a plus 20.9 millime cubed for 42% from baseline. But the mean average actually dips below. And to be fair, it could be P8 over there on the right side is more anomalous in just how far a he or she regresses such that it's pulling down the mean. But again, as with the median, both of them are close at least with regard to being close to the zero. But but the fact that we these these are the complete set of eight participants that brought the data and and they were not selected. We were aware at the time that they were getting scanned and we waited until it came back, but we said we're going to bring whatever that data is once it arrives. And this is the complete set. So at random, these eight participants all together on the plaque change, if you added all of their plaque from baseline to followup, there is a net lower plaque mean average. And that's actually quite astonishing. And and I do need to emphasize this appropriately from a scientific standpoint. Anybody could say correctly, hey, this is a small sample. We don't know how much this represents the larger hole. That's fair. But something that's very >> it's a dodge. >> It's not fair. It's >> for the for the larger for the larger hole, Nick. Right. For the larger hole, I absolutely push back, as I'm sure you would, for people who go, "Well, this is a random set of eight people that you can't base any information on at all." That we've been seeing on Twitter, but there are four regressors in here, which is four more regressors randomly determined than there are in the entire data set >> clearly provided to us. But but but why I say it's inappropriate and it's a dodge is because it's not actually addressing the question at hand which is a reliability of the initial scan. So first of all to have all 100 show basically no regression then to have eight at random show 50% regression the probability on that happening at random is less than the probability of me punting a pingpong ball a full basketball ball courts length into a red solo cup. I have more confidence in that occurring on my first try than I have in this occurring by chance. Second of all, and this is where I really get ticked off, as you can tell, I am ticked off because people are, it almost seems, willfully trying to shut down their brains and not engage with the argument at hand. I have had cardiologists today telling me, well, you know, why would we rely on an N equals 8 that's not peer-reviewed? My response to this is first of all, you don't need to peerreview CT scans. These are the AI reads. Second of all, we're not building a case on eight random scans. We're building a case on eight scans that are concurrent with three independent analyses that are concurrent with each other that include blinded analyses and that are not concurrent with the original clearly scans which were unblinded that they refuse to check and now disagree with their own data which now agree with the other scans. So it's not eight random scans >> and that's [clears throat] the point >> and and what Nick brings up I bring up in the video which is that and actually you know you could go to the next slide I think it's ready it's the >> okay >> it's the pie charts so compositionally proportionally this is where it does become very relevant which is on the left you see the clearly studied analysis with regard to the proportion of progressors to no change to regressors. Well, of course, they're virtually all progressors save two and two of them are no change. No, no regressors in the clearly study analysis. Then you have the clearly individual submissions which granted is a small sample size but you can compare the sample to the heartflow study analysis on the right which is roughly close to around 50% progressors and regressors and no change on the left side of the pie chart. The proportions are close to what we would expect particularly for for folks who have very low levels of plaque. again that that I given how many of our participants did have low baseline plaque low baseline plaque I'm not surprised if it turns out that we have that biirectional scatter that we see a lot of noise and and Ken I mean that's like I would argue a good problem to have we didn't know until we were getting our participants just how many of them would actually be so low of plaque levels that these technologies have a difficult time they're they're the marbles on the uh the weight scale right in the bathroom. So then that can help inform us for our coming studies. But in the meantime, how much can we assess it versus risk today? Well, unfortunately, this has been a bit more of a distraction than I wish it were for us to get to the better answers. No, it it's got to be so frustrating for you because none of this is your fault, but yet you guys I mean Twitter's going to come for you. Uh and I'm already seeing calls that this paper should be retracted, which it probably should be, but it's not your fault. It's not the fault of of anybody on this live right now that the the paper should probably be retracted because obviously when you look at the pie chart on the left and you look at the pie chart on the right which is the that's the heart flow study analysis that was blinded. That was truly blinded. That's the results you get. That looks nothing like the pie chart on the left where we've already intimated that there's perhaps some foolishness going on in the background with conflicts of interest and other stuff. What do you what I mean what do you do with this? >> I I'm just going to say I want I'm going to quote myself from earlier in saying that for a long time Dave Adrian and I have had a consensus on what we want to do. Hence the t pay attention to the tense on what we want to do. >> Yes. >> What we did >> and apply some basic logic everybody listening please. >> I can repeat what I said in the video which is many will wonder if we've taken steps with regard to this information [clears throat] and that we are in contact with the journal. We'll have news on that soon. That's I think I'm literally quoting myself verbatim from the video. And this is where I'd love to say more but can't be frank. >> Come on, Nick. Do it. >> I promised Dave I wouldn't. And I do keep my promises. [laughter] But but I think everybody who's listening and genuinely trying to follow this story and the complexities can at least intuitit what the next evolution is. I guess the positive way to spin it if people are getting a a positive rise out of this is yeah, I'm animated. Yes, I was dead honest in my post this morning which I said like basically for the first time in a year I can breathe on this but also there are other levels that will be coming. This is not Dave often says and I agree the science isn't settled. It's still not settled. So, >> agreed. Agreed. And >> the most important thing, >> the most important thing is that we just >> we just get to the truth, right? Like >> it's a it's it sounds a bit tright, but it really is ultimately the goal and it's we felt a lot of frustrations. I'll just echo what Nick said. We felt a lot of frustrations which feels to me like a lot of process unnecessary process and bureaucracy. >> Totally agree. And and so one of the preeminent lipidologists in the world had this to say about the lean mass hyperresponder studies. And I I want everybody watching this, if you're not obviously you're not a lipidologist or an MD or a PhD, this statement, this is not how science is supposed to work. You're anytime a novel hypothesis comes up that that perhaps questions the current worldview or paradigm. You should, if you're a good scientist, you should be intrigued by that. You may still think it's wrong. That's fine to have your own personals, but but to go on on a public forum like Twitter and just make fun of a a competing hypothesis which is steadily gaining ground and I predict over the next one to five years will gain much more ground. Uh this this kind of foolishness this this has no place in medicine or science. But yet everybody watching this, you know that since about 2020, we continue to see this sort of behavior come from science and medicine and then to later find out, oh well actually Dave and Nick were right all along, but I'm jumping the gun there. I know we haven't decided that or proven that yet, but uh let me just ask given the complete absence of any LDL APOB plaque association in your studies despite extreme exposure differences, [snorts] isn't this direct perspective evidence that LDL is not causal in metabolically healthy healthy individuals? Is this not >> No, no, no. So, so I think causal is one of the most abused terms. I know people like Peter get all obsessed with it and that's not ad hom like he says I am obsessed with it. >> Causal does not even mean important. Causal means part of a causal cascade. >> Yeah. >> You know for transmission of sexual disease as a biological male. My my penis is causal but I don't want to amputate it to avoid STDs. In fact, Peter himself in his podcast with Dave from 2018, you can go back, uses the following analogy that LDL cholesterol is like oxygen to fire. It's necessary but not sufficient. So, let's run with a TIA's analogy. You reduce oxygen levels like isolated, yeah, you're reducing fire risk. So, if you reduce oxygen to zero, your fire risk goes to zero, but you also suffocate and die. So, the point here is causal. People over interpret that word. I would say if we want to talk about LDL and apple B, LDL and apple B are necessary for atherosclerosis to occur. That does not mean they're the most important. And critically, reduction of LDL and applebe doesn't happen in a vacuum ever in the real world. So when you're doing an intervention to lower them, you have to say, okay, what is the actual risk reduction and what are the tradeoffs there? I almost wish the word causal would just disappear from this discussion entirely because I think it causes more confusion than it provides any sort of benefit. >> So what what what are the viewers to take from the fact that the clearly analysis was not blinded? There was perhaps some conflict of interest that I'm not privy to. I'm just I'm just guess gueststimating here. No. >> And when that was when that was truly blinded and reanalyzed by the other company showed distinctly obviously different results. >> What's the average viewer to take from that? >> I think you just >> Go ahead. >> I I think that what we what we have is we have four data sets at this point in time. We are we're one of the most uh robust analyses for the same four or for the same 200 scans. I'm going to say what I've said in presentations and on podcasts. I'll say it one more time here. The scans are the scans are the scans. They are the ultimate source of truth. This cannot be overstated. Those 200 scans are what all of these analyses are looking at like like lenses all pointing to the same scene, right? And so if one of these analyses seems wrong, it's not like an actual new set of scans for the heart. It's an analysis of those same scans. I'm heartened by the fact that three of these four agree with each other broadly. Not perfectly, but broadly. >> Yes. Which is what you would expect. You wouldn't expect them to agree exactly. That's also not how science works. There's going to be some little variability, >> right? But do we do have one that stands out not because it's 25% more or 50% more or even 100% more. It's severalfold more than all of these other sister analyses. I'm proud of the fact that we got all of these and then got to run them against LDL and APOB to see if there's an established relationship yet. And I want to be intellectually honest and say it's possible when we get to the fiveyear scans. It's possible that some amount of correlation might emerge with LDL and APOB. It's possible. Would I bet a lot of money on it? I don't know about that, but it's possible. And that's why we shouldn't shy away from doing it. If if we can and we're in the works of trying to do it, we want to get fiveyear scans or it might end up being sixear scans depending on when all of this is resolved. Yes, >> I I believe that'll be powerful data because we have a number of people like Nick Norwitz who have very high levels of LDL cholesterol and I mean without getting people like Nick Norwitz getting another CTO after years and years um if choosing not to you know bring down their LDL levels for whatever their reasons are that they choose to do it why wouldn't we want that data We want it >> 100%. Absolutely. Nick, do you have any final thoughts that you can actually share? >> Yeah. A challenge of sorts. I think throughout this process, it's become abundantly clear to me that there are many people who feain interests in finding scientific truth, but when data are presented that don't align with their worldview, they do mental gymnastics to avoid it. This has been nowhere more true than with this keto CTA project, especially after the heart flu and flow and Qangio came out. So here is another litmus test with the days these data dropping to see who can suck up their ego and come to the only reasonable conclusion that an intellectual could come to. So I don't even need to name names because we all know the set of people I'm talking about. Let's see what they do. Let's see if they're quiet. Let's see if they try to throw weak stones. Quite honestly, I'm in the mood that I will happily run through a series of brick walls. So, anybody who wants to get in our way and challenge us, I welcome it. >> I tweeted this this morning, Thomas Dpring, you brought up a tweet from him before. I think not only has he been incredibly disingenuous, he's been immature >> with his treatment of here in my case, Dave Feldman, and he's completely ignorant on this topic. So if he wants to actually walk the walk, I will pay for his flight to Cooi to debate him live in two weeks if he wants to. >> Let's just issue this. Yeah, I love this. Let's just if if Dr. Daypring is watching, which I doubt he is, but maybe somebody who knows him will share this with with him. If he would like an all expenses paid trip, you'll pay for his airline, his hotel, and his pay for his hotel. Like this is just about like people are getting up on X behind their avatars and saying things that they can't defend and they're resting on their laurels. I mean, I probably shouldn't say this, but I'm going to say it anyway. Dave has more papers than Tom in this decade on lipidology. Like stop talking your ass off and show up and have an actual intellectual engagement rather than throwing ad hominemum attacks when you don't understand the data and you're not even willing to try. Yep. And I'll even sweeten the pot. I'll throw in a $100 in chips at the casino of his choice if Dr. Daypring will come to Vegas for COSI and debate Nick Norwood's on stage. There will be many MDs and PhDs and other paramedical people there. So, I don't think you'll be too offended by the the crowd. Dr. Dpring, I think that you'll feel like you're probably in pretty good company. Uh, and then we would love to hear you and Dr. Noritz discuss the lean mass hyperresponder, the CTA, and the this this entire fi I think it's I think it'll turn out to be a huge fiasco. That's just my spidey sense. uh the detecting what you guys are unable to say. Dave, any final thoughts? >> Uh I'll actually expand on that. So, of course, you guys are talking about COI. All three of us awesomely are going to be here in Las Vegas. Uh it's a charity fundraising event for this thing we're talking about for the research for the next study, which we've almost closed the funding on. But my expansion is I we have had a lean mass hypersponder panel every single COSI and this will be the third and final COI if Dr. Daypring can't make it but there's another prominent lipidologist or cardiologist who you know we could count on to have a cordial and productive conversation. I would love for them to come and I think I think it'd be great to continue to have a wide spectrum of opinions. You know, one thing that we really need to draw attention to, Ken, and I don't I don't mean for this to sound antagonistic because it really isn't. There are a lot of interests in saying things on social media and then exiting the room. And one thing I'm very proud of is Nick and I are very proactive about engagement. We'd love to have conversations including with some of our strongest critics. Again, provided that they are, you know, provided it's worth our time and theirs, right? Provided it's productive and it's useful. We invite people regularly to have these conversations with us. We want to talk about the data. We want to talk about the challenges, right? >> Yep. >> I believe that >> as always, Dave, since the first time I met you back in 2017, Repeat the statement. You're happy to be proven wrong. >> Yes. >> I think I think all three of us, we actually we like it when we're proven wrong because then we learn something new. But just making fun of people on Twitter or or or completely denigrating a a novel hypothesis that's very compelling. That's not science. That's it. That's really You should be embarrassed by that behavior. Uh Dr. Day Springs mom. I hope she's still alive. If she is, she should really cuff him behind the ears. This is ridiculous. >> Are you bringing up the mom example intentionally? >> Of of course. Yes. Guys, thanks so much. Thank you, Dave Felman, for being so persistent and so stoic in your pursuit of this hypothesis. Dr. Norwoods, thank you so much uh for your um self-composure today because I know that there's so much more. so much more that you would like to say right now and that you will say in the future. And I would just tell everybody watching, watch this space. This is this is not going to be boring over the next uh few months and few years. This is going to be quite interesting and exciting, I predict. Thank you gentlemen so much. Uh follow Dave and Nick on Twitter or X. that's where they do most of their uh communications and I'll put links to everything including all of the studies that have been published so far uh from the lean mass hyperresponder hypothesis in the show notes so you guys can check it out and stay tuned watch this space I predict this is going to be fun coming up over the next few months or few years thank you very much gentlemen >> thank you for having

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