25.2 Deadly New Alzheimer's Drugs: Fraudulent Research, with Michael Shuman, PharmD

[00:00:00] The other example I thought of was, you're on the playground and you're playing basketball. You're playing against the bully in the class, right? And they're bigger than you, but you play a great game. We're using flashbacks here. You're playing a great game and you beat the bully, right? You beat him 10 to 9. And then, what does the bully do? He says, no, we were actually playing for who could get the least number of points. That's who wins. Golf rules, yes. It's like, what are you talking about? But I mean, that's, it's the same idea.

[00:00:33] Somebody get this guy some help.

[00:00:43] Disclaimer, this podcast is for informational purposes only. The information provided in this podcast and related materials are meant only to educate. This information is not intended as a substitute for professional medical advice. While I am a medical doctor and many of my guests have extensive medical training and experience, nothing stated in this podcast nor materials related to this podcast, including recommended websites, texts, graphics, images, or any other materials should be treated as a substitute for professional medical or psychological advice, diagnosis, or treatment. All listeners should consult with a medical professional, licensed mental health provider, or other healthcare provider if seeking medical advice, diagnosis, or treatment. Or, put more simply, If you need help like this guy, call your own doctor.

[00:01:08] Before we get to the monoclonal antibodies, let's review the absolutely tumultuous last 30 years of neurodegenerative disease research. This includes things like Alzheimer's and Parkinson's, primarily a motor disorder characterized by slowed movements, less expression on the face.

[00:01:32] And over time, if it progresses for mental health, and over time, if it progresses for long enough, it will develop into dementia. Just like an Alzheimer's patient, if they live long enough, they will develop signs of Parkinson's as well. So in 2022, Journal Science released this investigative report on a long-standing neurodegenerative disease researcher, very, very well respected in the field. His name is Sylvain Lesney.

[00:02:01] They found that since 2006, he had been photoshopping and copy and pasting multiple images to make the beta amyloid theory, which he's a big proponent of, seem like it is more likely as the cause for Alzheimer's.

[00:02:20] He did this in one very specific example where they pointed out that he used photoshopped images to show that it caused dementia in rats. And it has been going on essentially throughout his entire career. Historically, other researchers had extreme difficulty replicating any of his findings.

[00:02:44] There's a neuroscientist and physician at Vanderbilt named Matthew Schrag, who was tasked to actually review a different set of data and researcher. But he stumbled across Lesney's work, and he says that all of these had to be prepared by Lesney, that the consistency is Lesney was involved with all of them. There were several other co-authors, but it doesn't look like they were aware of what he was doing.

[00:03:12] Again, I mentioned there's such an emotional subject and knowingly building up a foundation that is questionable at best. The motivation behind that and just the implications of it, I just need to make a moment and say, wow, that's wow. If you're like me, if you're somebody who is really passionate about the truth and advancing our understanding, it fucking pisses me off.

[00:03:41] I mean, I'm just reading through this material, and it is such an egregious and repetitive thing that has been happening in this field of science for such a long time. You're talking about probably billions of dollars of misdirected funding because of being able to convince all these people in this field that your data is legitimate.

[00:04:07] Well, I guess not all of them, but enough people and the companies that fund this type of research. It's really thrown us off course for decades now and getting closer to the legitimate causes of Alzheimer's. Yeah, because a lot of these research things happen and all the drug companies follow, and something, whether it's phosphodesteroids or glutamate, everyone shifts. When one person has a failed trial in an area, everyone says, well, we're going to shift.

[00:04:34] And so you're propping up something that just turns out to just be a mirage. Like you said, the years, the dedication, I can only imagine just almost like feeling a betrayal within the community. This is not just Matthew Schrag saying this, because that would be a little bit suspect. There are a lot of other very well-respected neuroscientists, neuro-researchers who have come out and commented on this, and a lot of them in this article.

[00:05:00] One of them is Harvard's Dennis Selko, who was a 2006 co-author on a paper with Lesney and also a leading beta amyloid as a cause for Alzheimer's advocate. He said in 2008, he realized that he couldn't replicate Lesney's work. In reviewing the science investigative report, he was quoted as saying,

[00:05:25] there's certainly 12 to 15 images where no other explanation exists other than manipulation. Around the same time, cell biologist Denise Vivian withdrew a co-authored paper when his students were not able to replicate Lesney's findings. And he stated, in order to preserve my scientific integrity, and added, we're never safe from a student who would like to deceive us. We must remain vigilant.

[00:05:56] That goes back to the idea about replication is important, just how underutilized that is as a way to check our work. You know, if I write an exam question and said, this is the answer, and they say, well, how'd you get to that dose? Like, oh, turns out I made that up. You need to be able to, because that's how we build ourselves up. And there's accountability for that, too, that nobody gets to where they're so big and powerful that they're above reproach, that we can check each other and make sure that that foundation is solid. Yeah.

[00:06:23] And I mean, it speaks to, I think, a larger denigration of our society right now. We can't have conversations where we're on different sides of the aisle. They just turn into these screaming and yelling matches, but it's so imperative for us to move forward. And it's absolutely imperative in science. I mean, so we've talked about there's a lot of money on the line.

[00:06:46] If you are pursuing a certain theory and you find evidence that your theory is probably wrong or might be wrong, it's not going to bode well for you getting additional grants from pharmaceutical companies or from the NIH. And so there's a direct financial component, monetary component on the line. But I think the other aspect of this is there's a lot of academic prestige involved.

[00:07:15] Pressure to perform from an academic standpoint. There are people that were like in my position where they are doing research a little bit more short-sighted because they want to get, you know, added boost to their resume. So there's a lot of things that go into this beyond just the money that people get. People want their theory to be right. You always have that goal is I want to find out something no one else has discovered before.

[00:07:44] And again, that goes back to that's a lot sexier than me rubber stamping what you read and saying, yeah, I think his theory makes sense. But that's critical, though, for the progression of ideas. Some of the worst moods that I'll find myself in are when I'm reading data or research that is contradictory to the things that I think I know on a particular subject. But you have to do it.

[00:08:08] You have to put yourself out there and challenge yourself that, you know what, maybe I am wrong on this. And I'm going to incorporate as much information and knowledge as I can and be very critical and skeptical of all of it. And then take that wealth of knowledge and formulate an opinion based on it. We'll tell a great story about an absolute role model in the field of research in Nancy Olivieri.

[00:08:37] We'll tell you about her story in a little bit, but it's somebody who threw all the prestige out the window because it was the right thing to do for her patients. It really makes me wonder in reviewing all this, is there direct collusion involved or are these people just acting with their best personal interests in mind?

[00:09:02] A couple of aspects of that is, you know, we've got a system now where we've got all of these journals, right? I couldn't tell you how many there are, but there's hundreds and hundreds of different scientific academic journals. But they're absolutely failing to do one of their primary jobs, which is to regulate, to fact check, to peer review prior to publishing.

[00:09:27] When the investigators for this science article, before it came out, they reached out to all of these journals who had published Lesney's papers to try to get a comment. Journals including Nature, Science Signaling, the Journal of Neuroscience, and four others all declined to make a specific comment.

[00:09:51] There's also the NIH, the National Institutes of Health, the governmental body that we were saying really their job should be to independently verify that they can get the same results as these companies are getting for their drug that they stand to profit and monetize significantly from. The NIH declined comment on this 2022 article, other than saying it takes research misconduct seriously.

[00:10:21] It doesn't appear that a lot of the co-researchers with Lesney were in on it. Karen Ash, who was with him at University of Minnesota, said that she felt misled and that she thought that that theory was going down the wrong road for a long time.

[00:10:38] She worked directly with Lesney for a while, and she does indicate that she still believes that there's good beta amyloid data and research out there, that it still is a possible therapeutic target and not to throw the baby out with the bathwater, so to speak, along with others stating similar things. But so many of his former co-authors came out on the ALS forum, which is an Alzheimer's kind of forum for people to comment.

[00:11:08] And it's one place where this article was put in a brief form. A lot of these researchers, Juergen Goetz in Queensland, Charles Glaib at UC Irvine, they responded to the allegations and, you know, acknowledged that, yeah, this does appear to be manipulated. But it makes me wonder, you know, is there collusion between the companies, the journals and the NIH?

[00:11:33] It sounds a little conspiratorial, but at the same time, we're seeing the same patterns play out over and over and over again. And as I've said, you will see where there is an entire paradigm shift where everybody abandons a certain mechanism. As I said, you know, metabasrophic glutamate-2, 3 receptors. Eli Lilly had a study that went bad. And as far as I know, that was the first one. And then the entire thing just got dropped.

[00:11:55] Or with phosphatidesters, where it does seem like whether it's collusion or just that everybody knows what everyone else is doing, where something happens and no one's going down that path anymore. And then as well as the idea, too, that, you know, things like how we do our peer reviews, you know, anonymous peer reviews and not falling prey to the idea that appealing to authority, like, well, this person's above reproach. So how, who am I to do a peer review of this person who's so far above me?

[00:12:21] And I like journals that have that anonymous peer review or even British Medical Journal, which their comments almost sometimes looks like a Facebook page because they will let anybody comment on there. And you can write in there, like, who you are or your credentials. But there's a very rapid response they allow that I think allows for a lot of, you know, that checking because they have a much more informal process for writing in and rapid reactions to articles and things. And I think that can be a good thing.

[00:12:47] Every now and then I like to read that journal just to see because people will flat out say if they think there's something not true or not. The funny or maybe the ironic thing is Matthew Schrag, he wasn't even investigating Leslie originally. He wasn't investigating the beta amyloid research. At first in early 2021, he got hired by an attorney who was hired by a couple of doctors that were questioning a company, Casava Sciences.

[00:13:15] So he got hired to investigate Casava Sciences drug, Simufilam, S-I-M-U-F-I-L-A-M, which is a filament A, something to do with protein folding, maybe an upstream target that if they could affect the protein folding process, then it could be a therapeutic drug target. He was investigating them for the same shit. And Casava, you know, denied, denied, denied.

[00:13:45] And since it has come out that they doctored images and doctored data, they tried to handle Schrag. They tried to discredit him. Journals denied any sort of manipulation, just as they did with Lesney's work. On both Casava and Dr. Hao Yan Wang, who is the co-developer of Simufilam at the City University of New York Medical School. This researcher, same thing.

[00:14:15] Image after image after image of things that were copy and pasted from one paper in, you know, for example, 1998. And then they show up again in a paper from 2012. Well, luckily, there are enough people out there that read enough of the papers and said, huh, this doesn't seem right.

[00:14:37] And so there's a website called PubPier, and it allows anybody in the world to review research articles and papers and put their critiques up there. Which is great, isn't it? Informal way of calling each other out. Yeah, exactly.

[00:14:55] So this Casava Sciences, fast forward to October 2024, they were fined $40 million, chump change, by the Securities and Exchange Commission, the SEC, for misleading investors with manipulated data. None of the parties associated admitted any guilt. And they had a new CEO take over for Wang, and they continued two of their stage three clinical trials.

[00:15:23] Fast forward a month later, and Simufilam's stage three clinical trials were discontinued. What? Huh. Huh. Interesting. It's almost like they fucking got caught. And then they said, oh, well, we're behind the eight ball now. And they kind of save face and do a little more quietly. And the story is straight out of the Merck, Bioxx. Yeah, that's what I was thinking of. Yep. I mean, it is the same story.

[00:15:50] And we'll see it play out again within the context of this conversation. But it's the same shit over and over again. You have a conscientious, well-meaning, patient-focused clinician, researcher who's trying to sound the alarm. And then they're just erroneously trying to say, you know, no, you are the one that is doing bad research. You're the one who manipulated data.

[00:16:15] And I always fall back on what are the potential motivations for different people? What is the motivation for you to call out an entire huge entity of a drug and drug maker and the researchers behind it if you don't actually believe that it's a bad drug and it's harming people? Just let's just have the truth out there wherever it goes, which is what science should be. Right.

[00:16:41] You can make the argument that people are trying to get some sort of recognition or national exposure. But it certainly is not as strong of an argument for the motivations for and against as when you count up all the ducats or dollar bills that are on the other side of that equation. And it's interesting where this is coming from. You mentioned the SEC. You mentioned individuals. But again, there should be a body that is evaluating the research. All right.

[00:17:09] If I if you're the FDA and I'm you know, my job is to give you my data and you review my data versus having your own set of data. If you're only relying upon what I do and you're just checking my work versus doing your own reporting. And again, would that look differently if we had a different way of gathering and evaluating study data, which you already kind of mentioned about? Would that role be different for the FDA if they were to pursue that?

[00:17:33] And I feel like historically, if one researcher proved something, the other researcher was actually going to try to disprove them, which is actually a really effective way to do research. Because if somebody is motivated to disprove your theory and they can't, well, then your theory is probably pretty valid. Right. What do you make of just the lack of journals, integrity and regulation?

[00:18:03] I mean, the general American public doesn't realize it, but I would say the vast majority of journals and the vast majority of the funding for each journal is it comes from the pharmaceutical industry. Right. And that goes back to the idea to be careful that we don't treat some of them as just glorified advertising. Like if you say, well, no, the ads on the other page, this page is data.

[00:18:26] If it's all we're using ghost writers and we're smoothing over the data and saying, okay, we've manipulated. Again, it is more of just an advertisement rather than, and especially if it doesn't actually apply, we're, you know, using the same 50,000 people that go in every trial. It's not a realistic population. It doesn't have any teeth. It doesn't apply to your actual patients. It's just another smiling face or we have put 50 happy people in the study. They did well in it. We approve it.

[00:18:52] But again, none of those are like my patients and we need study data that is replicable and that applies to our patients. It just seems like they don't want to face the music until they're absolutely caught red handed. You know, you lay out such a clear argument for how they're publishing things that are not valid. Otherwise they're never going to admit wrongdoing. And that drives me just up a wall. If I could just have an editor that comes out and says, oh yeah, we fucked that up.

[00:19:21] That would make me feel a lot. I think it would make the American public feel a lot better if there was just more transparency. I mean, you have seven different journals with Lesney's work alone. Only after Matthew Schrag and others went public. And only after Schrag went to them with the investigative report, then he got the corroboration of a lot of other top neuroscience researchers.

[00:19:47] Only once everything went public in science did those journals who had published Lesney's work and Wang's work agree to review them. With a lot of them since issuing retractions of that same work. But initially they're like, no, no, no, we didn't do that. No, there's nothing wrong. There's no manipulated data there. You know, you've got a situation now. This came up with Ken Gilman, PK Gilman, as you like to call him.

[00:20:14] When he sent me this article about how all of these journal editors are resigning, and I would imagine probably being replaced by figureheads. Recent. Yeah. Like in the last couple of years, just kind of an exodus of journal editors resigning because I guess because they're losing hold on their ability to determine what belongs in the journal and what doesn't.

[00:20:38] Yeah, and again, a lot of these journals now are conglomerated into, you know, this is the El Salvador group, and this is under another group, and they're all falling under larger publishing umbrellas. And again, these journals themselves are maybe not as independent as they once were. You know, it's the same thing that exists in every industry is what we're facing now.

[00:20:59] We're being given the semblance of a free market when in reality we've got these huge corporations that have multiple different companies in the same market. So it gives the semblance of competition and free market, but it's not. It's run by the same people at the top. And you're right. I mean, these medical journals, which all used to be independent from each other, now they're finding themselves under the same umbrella.

[00:21:27] It's a dark road in some ways. Very, very dark. You know, the fact that right now is you have the insurance company that owns the PBM that owns the pharmacy. And so you literally, the entire thing is you have to use our pharmacy. We're going to control what we approve. Everybody is in the same boat. Do you ever watch Dr. Glockenflecken? Yes. He talks about that.

[00:21:56] He has a back and forth with, you know, Jimothy. Oh, Jimothy. And it's the administrator from United Health. And they're saying, yeah, Optum is owned by United. Yeah. And we're going to direct our patients to an Optum pharmacy. It's a disintegrating system. It really is. And it's sad. And hopefully now there's just, you cannot keep all this information under wraps. And more and more is coming out.

[00:22:22] I still think there's going to be elements of attempted, you know, mass control and manipulation. But there's just too many critical thinkers out there with access to a lot more information than they've ever had access to. And the ability to communicate with other people. One of the best articles I ever, 20 years ago, Wired wrote an article after the Guantanamo Bay incident. That they talked about, you know, we talk about Big Brother is watching you, but the counter of it is Little Brother.

[00:22:52] And Little Brother is every single person with their phones and their social media. And you have these big companies, but enough people reporting the truth. You know, eventually that provides a little bit of a counter. And I'll never forget that article because it comes out like the idea about Little Brother. And that's been the one advantage. One person can call them out, tweet it out, and eventually that gets magnified. And people have asked me, well, why don't you go into, you know, academia? And why don't you do research if you want to? I'm like, because it's not going to change anything, right?

[00:23:22] This might not change anything either, but this is my approach. Is to be a loud-ass motherfucker, a prick in the side of the people who are trying to hold our society back from advancing and be loud about it. Call people out. That might get me into a little bit of hot water, but we got to do something different. We're going to do the same insane, you know, form of trying to call this out like a nice scientific discussion.

[00:23:52] We're not allowed at the table for that. Yeah, that's why I like there was an article, I think I talked about it the other day, is a Jane Clinton psych just had an article out called Psychopharmacologic Laziness. Yeah. And I loved it because he flat out said it and he called out his fellow physicians and he said lithium, clozapine, LAIs. Not using these is because you're lazy. Like these will work. He's like, you know, I will die on the hill of clozapine and lithium and you're not using them because you're lazy.

[00:24:17] We've talked about this with lithium a lot, but clozapine too is some of the REMS program are some of the hoops that you have to jump through that you historically had to jump through that they're now lifting. Thank God. Yeah, I almost cried. I almost cried watching that. It's pretty amazing because you're going to see people doing so much better, you know, in the next couple of months when you get more people on clozapine that are really sick, they're going to get better.

[00:24:42] But it makes you wonder, is that by design, because clozapine is extremely cheap and you've got dozens upon dozens of new antipsychotics or newer profitable antipsychotics is all of that. Again, it gets to where it sounds conspiratorial. There's also a lot of very reputable and smart individuals who are noticing similar trends. Yeah.

[00:25:09] If you're saying the meme, there's a guy posing by like a grave marker like this, like a list of all the drugs that have gotten withdrawn from the market since lithium came out. There have been entire mechanisms that have died off or this has come out and that, but lithium is still around because it freaking works. There is nothing like it. It is not an old toxic drug. Yeah. This drug works. We're just trying to make sure we can get it in as many people as possible.

[00:25:33] As Michael Nels points out on his substack, a German MD, PhD in molecular biology, lithium has been around and is used by the most primitive bacterium, the most primitive microorganisms that existed. And when our planet was just a primordial goop of tiny little amoebas, it's been in use forever.

[00:26:01] It is absolutely critical to so many different cellular processes, yet it's demonizes this thing that we can't tolerate. We've been tolerating it since we were amoebas in our evolutionary history. I've been trying to tell patients of like, you know, after reading an article by Dr. Gami, you know, like lithium stabilizes the cells of your body. Like you want to talk about a medication that treats things like this drug to make sure mitochondria work right. You should probably take it. You should probably take it, but you're not going to feel it.

[00:26:31] If you take a low enough dose, it may take two years to get to the max benefit. You might not feel anything for several months or you may never notice the shift. Others may notice it in you. Right. But if some people want to say, I want that tired feeling, I want to feel calmer. I want to feel doped up, you know, anastochotics are faster efficacy for mania, but lithium works. But then you get to the maintenance drug and that's when you're like, all right, lithium maintenance. Yeah. Yeah.

[00:26:57] Anyway, so we're about to go to an even, I don't know if I should say more egregious, but potentially even a more egregious example of how we have diverted billions of dollars away from advancing our understanding of the process of disease. That causes Alzheimer's or Parkinson's or other neurodegenerative conditions. Lesney's work on beta amyloid and Wang's cassava's semifilam.

[00:27:25] They're not the only historical examples of manipulation in neurodegenerative research. Two years after that 2022 article came out about Lesney's work that goes back into the 90s and is just scathing in terms of all the falsities that he put into his papers. Another article came out just a couple of months ago in science and it was about Elisir Maslia.

[00:27:53] So Elisir Maslia in 2016, this is a absolute veteran in the research field working out of California, San Diego, UCSD. Neuropathologist, a researcher has more than 800 papers on Alzheimer's and Parkinson's. He takes over as the director of the neuroscience department division of the U.S. National Institute on Aging or the NIA.

[00:28:21] And that neuroscience department gets $2.6 billion of NIA's budget, which absolutely dwarfs the rest of the NIA's budget. This is a guy who is rated in the top 10 of all world scientists in various fields of neurodegenerative research. It's ridiculous. Like the top 10 of anything in the world. I'll put the graphic up.

[00:28:46] They list off in graphical form like 10 different areas of research and he's top 10 in all of them. He's number one or two in a lot of them. So he's put a bunch of papers out. These papers have been cited tens of thousands of times, again, as evidence that his theories are legitimate.

[00:29:06] So in September of 2024, Journal of Science Investigation finds scores of lab studies riddled with falsified Western blots. Western blots are a type of image and research that allows the researcher to see proteins, which is really important when you're talking about beta amyloid, which is a protein. And you're talking about tau, which is a protein that accumulate and deposit.

[00:29:33] And we see those in people's brains after they die from those conditions. They said scores of lab studies riddled with falsified Western blots and micrographs of brain tissue regarding Maslia's extensive research history. And this all started in 2023 on PubPier when reviewers started to call out images.

[00:29:57] And actually, initially, they got a response from Maslia or some of his co-authors corrected some things. But a couple of months ago, science and 11 independent and unpaid neuro researchers, including Schrag and some others we'll touch on. They put out this 300 page dossier that revealed concerns between 1997 and 2023.

[00:30:26] And that's again, that's literally, you know, pervasive. It's like the entire beta amyloid. I would say probably 90% of the money that's been put into beta amyloid research has been in that time frame from 97 to now. Yeah, because I think one of them is like 91 is when the first paper ever came out. It's your almost the entire thing. Right. 132 published papers by Maslia.

[00:30:51] And they said it had to just be Maslia because he is the sole common author on all of these papers with 238 active drug patents concerning conditions that cited Maslia's work. So we've got 238 drugs that are out there using his work as the evidence that is then dictating how they do their research.

[00:31:18] Yeah, you know, we're talking an entire foundation now we're finding is just that stand is starting to just shift under it. And same things copy and pasting images within and across different papers, sometimes years apart in separate journals. And these papers, here's our next drug.

[00:31:38] They paved the way for a drug called Pracinezumab, which is made by a company, Prothena, that has some sort of financial connection with Hoffman LaRoche. But this Pracinezumab is a anti-Parkinson's drug.

[00:31:55] And in 2022, the FDA denied its approval based on a 316 patient study revealed in the New England Journal of Medicine, where the clinical trial showed no benefit compared to placebo, was not FDA approved. But importantly, this drug has been approved in several other countries. So, again, we'll give the FDA credit on that one at least. Got to give them credit where it's due. A couple of notable kind of comments on this one.

[00:32:24] One notable comment. Sorry, but it's kind of funny. I'm bracing myself. So, Samuel Gandy is a prominent neurologist at Mount Sinai Alzheimer's Disease Research Center. He says hundreds of images reveal ongoing manipulation for years, and the bus driver could see that they're identical in terms of the images that were just copy and pasted in several different articles.

[00:32:49] And he specifically references mitochondria in two different papers that were two years apart in two separate journals. And again, I'm hearing this for the first time. And my first thought, too, is when you're talking about those images, which we can at least with images, you can show that they're manipulated or static across different places. Because if somebody were to doctor numbers, it's much harder to prove that unless you have the raw data. So this is just something we can observe.

[00:33:19] Doctoring or malfeasance in other areas is almost unprovable. Yeah. It's almost like comparing two snowflakes. There's no two Western blots that are the same. They're called out on this, but who knows what other stuff not involving images may be manipulated or used for at an end that we don't know of. Exactly. Because this is the stuff that we can prove. Right. And that's the biggest concern. And there are so many other concerns with some of these clinical trials that I have.

[00:33:46] Like if I was the investigator that had the financials on the line, well, if I'm trying to compare an Alzheimer's drug to a placebo, I want my placebo to be not noticeably necessarily in the numbers sicker, but I want them to be further along in their progression. Because I want to see the placebo drop off more than my drug, regardless of what the effect of my drug is.

[00:34:13] Again, this is if I'm focused on, you know, advancing myself financially and monetarily. Providing raw data or providing, you know, again, some extent, you know, obviously you have to identify, but if you can show like these are the individual patients and this is their actual data sheets. Again, there's that transparency. We can disagree on what it means clinically, but you can at least say the data there is sound.

[00:34:37] 99% if not 100% of academic researchers of scientists. If you ask them in a public forum, and I don't care if they're Sylvan Lesney or if they're Elsevier Maslia, anybody with a semblance of scientific integrity.

[00:34:57] If any research should have all of the original data available for peer review in a public forum, every single person is going to say yes. Because everybody agrees that that's how research should be done. If you do a paper, if you do a study, then from the get go, that stuff should be available to anybody else that wants to review it. And you should not feel like you have anything to hide.

[00:35:25] Without dovetailing too much of a topic, we'll talk about later. But that's why clinicaltrials.gov should be that essential check mark. When somebody says, I'm going to write a study, here's my protocol. You can go back and compare the final result to the initial protocol and say, hey, it looks like you changed your outcomes so that something, your primary outcome is no longer the primary or you have too many secondary outcomes. Or in the case of a study 329, that's what they did. They said, look, you want to call us out.

[00:35:55] Here's the raw data we obtained. You can do the numbers now and you can crunch them and you can see if we're right or not. That transparency of, look, call us out. Show us where we're wrong. It's so important. I would encourage anybody who's watching, anybody who's listening, if you have a counter argument to that, why we shouldn't have raw data and methodology available to anybody who wants to review it, please reach out and let me know.

[00:36:20] Because I just don't see if we're really trying to advance scientific understanding and make progress. I don't see how anybody with that goal in mind would say, no, let's restrict the data. Yeah, because again, if I've got that recipe of chocolate chip cookies and I want to prove that my recipe is the best, then somebody else should be able to say, yeah, I followed the directions and I got to the same results. Yeah, absolutely.

[00:36:47] Back to September of 24, when this science article came out, you know, for years, people were calling out Maslia and the NIH. And it was the same story. Deny, deny, deny, deny until we just absolutely can't anymore. Two weeks after this article, this investigation was brought to light, the NIH released a statement and they said,

[00:37:14] NIH has made findings of research misconduct and Maslia no longer serves as the neuroscience division director. They didn't comment on whether he was still employed in any capacity. And Maslia didn't comment, nor did he respond to requests for raw images or the original data. He also did not deny wrongdoing. You know, it's just like, we're going to pin you against the wall.

[00:37:42] You're absolutely caught. And then you're going to come out with a statement. The thing that pisses me off the most, the NIH had made findings of research misconduct. No, you didn't. Yes. Okay. It makes it sound that it was their decision. No, we found out this thing. It was new to us. We investigated it. We found it out on our own without any kind of prompting, if you will. Right. Or somebody comes to him and says, this is what I've found. And thus they say, well, we will investigate internally in all they're really doing.

[00:38:12] I mean, it's like any, you know, story that you want to spin a certain way. You're going to state that, yeah, we're going to investigate this matter. We're looking into it. And while you're doing that, you're going to behind closed doors, get all the information you can about what they know so that you can propagate your life and further. So one of the things that, you know, you said the FDA did, we had to give them credit because they declined to approve the drug.

[00:38:38] Despite knowing all of this, they still greenlit human clinical trials, despite having evidence that there were some suspect papers. These things are currently ongoing. It's approved in other countries. There's papers going back to Maslia's work with a researcher who's now deceased, Dale Shank. They co-authored, I think four was the number pointed out as being manipulated.

[00:39:05] Between 2005 and 2017, that were crucial to prasinezumab's development. That according to Dr. Tim Greenemeyer, the director of the Institute for Neurodegenerative Diseases at the University of Pittsburgh, a very reputable psychiatric program. Yeah. Dr. Greenemeyer said these papers showed an astonishing level of image manipulation.

[00:39:35] And at this same time, Prothena, the company that makes prasinezumab, claims that nothing was interpreted as relevant to Parkinson's disease monoclonal antibodies, ongoing clinical trials. So what was it relevant to? They say the doctored images and papers are not relevant to Parkinson's, to the prasinezumab. But Dr. Tim Greenemeyer, who's the director of the Institute for Neurodegenerative Disease

[00:40:02] at a highly reputable institution, says that these papers are crucial to prasinezumab's development. So who do I believe? Probably the guy who's had decades of schooling and research in neurodegenerative disease. One of the things that I think is very also telling, turns out there's a lot of money on the line with prasinezumab.

[00:40:29] And I didn't know that this happened, but I guess Hoffman LaRoche had- We talked about them before. Yeah, yeah. I think they created Librium. Yes, that's it. For Spenzo. They have this financial agreement with Prothena. And I don't understand the agreement in full, but to date, they paid $135 million of up to $620 million based on if prasinezumab passes a series of performance goals.

[00:40:57] So the only efficacy that was found, because I already told you that the original clinical trial and their primary outcome measure said it didn't work and didn't provide any benefit. It's not like the Canamabs in that it's extremely dangerous, but they did find efficacy on a post hoc analysis. Oh, I wish we could talk about post hoc analyses. I'm like, I mean, you're talking about hundreds of millions of dollars openly being on the table

[00:41:23] if they can pass a series of performance goals or measures. That's not science. Post hoc analyses are, because it's not established at the beginning, these are things you look at later on. And since it was not part of the original, it's hard to establish that you aren't just cherry picking. You know, so all right, we have a set number of darts. You're going to throw them. How many of them hit the target? But then later on, okay, I'm going to go back and only look at the one dart I already threw.

[00:41:52] So you can zero in on something and make it a significant when it may not have been. Since you're not establishing and designing a study to test that thing, again, the idea that you've got a type two error is certainly there. There's a couple examples here. We could say the example of the cake, right? The merit of the most delicious cake should be held with the hundred people who try your cake and my cake and they get to decide. But then when they decide that Michael's cake is better than my cake. Because it is. Well, it's debatable.

[00:42:22] But at that point, then I say, well, let's go to a secondary outcome measure of how many chocolate chips does it have on it? And mine has more chocolate chips. Therefore, mine is effective, aka mine's tastier. But don't worry about the primary outcome data. That doesn't matter. Yeah. Maybe we're only looking at the ones that liked your cake out of the sample. The other example I thought of was you're on the playground and you're playing basketball, playing against the bully in the class, right? And they're bigger than you, but you play a great game. We're using flashbacks here.

[00:42:50] You're playing a great game and you beat the bully, right? You beat them 10 to nine. And then what does the bully do? He says, no, we were actually playing for who could get the least number of points. That's who wins golf rules. Yes. It's like, what are you talking about? But I mean, that's, it's the same idea here. The discussionary point here, and I'm asking you this question. I know the answer.

[00:43:15] Should performance measures dictate financial transactions between pharmaceutical companies? And again, if everything is simply based upon the incentivized and the financials, that will push us towards getting the research done as quickly. And as you know, people can get fired if I don't show this drug works. And so whether you want to or not, you're incentivized to get the product out there. There's so much money changing hands.

[00:43:43] There's so much financial pressure. Sometimes I kind of feel a little bit bad for some of these executives who maybe do have a moral bone in their body. And they just feel, I'm sure they deal with an excruciating amount of pressure to meet these performance measures. Yeah. And there's organizations too big to fail where it's like, you know, there's something wrong, but it's like, if I call it out, I'm bringing down a lot of good people.

[00:44:08] And again, that's a tough spot to be at, but that's where we need to be able to check ourselves and make sure that as a society, we're not propping up people with ill intentions. The more years that I do this, one thing that I recognize about myself is I hate more than most things, just being told what somebody thinks that I want to hear, because that is so often disgenuine.

[00:44:37] And that's, that's what we're talking about. It's, you know, in these small circles, I don't think everybody is like, Hey, we're manipulating this. We're doing this. No, I think it's just something that you don't talk about. And you don't bring up and you just tell each other what you want to hear that is consistent with the deal getting done. Yeah. And that's why even in research, there's things like funnel plots where the whole goal was to show that if all your data is perfect, that's the best indicator that it's not perfect.

[00:45:07] Yeah. Like there is, should be expected to be a reasonable amount of pro and con or positive and negative. And if there's not, then it means that something's gone on that we're share picking certain things. Yeah. And that's why you need to have that. But you said that there has to be the balance there to make sure we're doing it right. Yeah. The guy who wrote both of these articles in science, his last name's pillar. But according to him, I stumbled across his social media.

[00:45:32] And remember, this is all happening in real time in terms of it being in 2024. But according to him, Prothena, after this article came out and there were these 11 prominent neuroscience researchers who said, yeah, this is absolutely manipulated images. There's no doubt about it. We all agree. And we have stock in the beta amyloid theory.

[00:45:59] Even he said that Prothena scrubbed references on its website to the suspect studies by Maslia that the company previously had described as vital to the development of its experimental Parkinson's drug, prasinezumab. So it goes back to you. You said that, right? That stuff wasn't vital. But it turns out is. And that's the thing, though. You know, it's vital. It's not vital. Whatever sounds best and whatever we need people to hear. That's what it is.

[00:46:28] That's the beauty about it. You can cache websites. You know, you can check for changes on these. You can check for changes on an FDA labeling. If you're suspect about something, I encourage you to take a screenshot of it. Thanks for listening to me rant on this topic. It really is kind of mind-blowing to me the level of corruption that exists in the field of neurodegenerative research. Is the beta amyloid theory of Alzheimer's dead? I'm not exactly sure.

[00:46:55] But whether it's the beta amyloid theory of Alzheimer's or misfolded protein theories of Parkinson's or any other related theory, there are a lot of good scientists that have followed and worked on these theories in the pursuit of truth for decades.

[00:47:12] And now we're realizing that these theories are, at best, incomplete, and at worst, totally off base in a waste of tens, if not hundreds, of billions of dollars of taxpayers' money and private investment, as well as ailing families' health and financial stability over the last three to four decades.

[00:47:38] It really is saddening to me that those pursuing truth in science, which I would argue are the vast majority of scientists, are overshadowed by assholes seeking to be recognized and empowered based on false findings. And I'd love to be able to say it is only isolated to this one area of neurodegenerative disease research.

[00:48:03] Based on the flagrant, blatant, and pervasive examples throughout recent and remote medical history, I would guess the problem is just as widespread in other research avenues as it is in the fields of Alzheimer's, Parkinson's, and neurodegenerative diseases. These are conditions that, even if you're able to capture only a couple percentage points of the population with these diseases, that's a lot of people.

[00:48:29] And companies stand to profit generously from the sale of these drugs. I think oftentimes people like Sylvan Lesney and Elisir Maslia are able to peddle their nonsense and bullshit pseudoscience because so many other entities stand to profit as well and back them up. Then, when they're caught, those other entities find a way to stay out of the general public spotlight. They tend to deny wrongdoing and avoid direct confrontation or debate,

[00:49:00] instead relying on press releases and nonspecific statements alleging it's all just a big misunderstanding and they're just being mistreated. One trend I've noticed in my own training program and up to the highest ranks of Kentucky and national medical establishments is that those in power typically fall into two categories. Yes men and women and narcissists.

[00:49:26] The former make it known that they're willing to be controlled for the perks that come with the job. But the latter are the bigger problem. They don't care about the pursuit of truth, but they do know how to manipulate others to believe that they do. They are only concerned with climbing the ranks of some imaginary corporate power ladder, constantly striving to achieve enough control and influence

[00:49:54] that it will appease their sad inner sense of insignificance and irrelevance. But little do they know, they will always feel unfulfilled, especially seeking fulfillment from the outside world or from positive appraisals from those people who are in power, as they will always ultimately feel lesser than. And when they're discovered for just what they are, con men and crooks,

[00:50:23] they'll not only disappear from scientific significance with a huge and smelly stain on their reputation forever. They will live on in infamy, only remembered for setting society back for decades. While it's sad, don't fall into the trap of believing that there are not a lot of good people out there doing important research. We just have to demand that

[00:50:50] those put into regulatory positions of power are conscientious and trustworthy and establish better systems so we can remove calculating thieves and con artists from derailing our quests for truth. Thanks for listening. Thanks for watching. Don't forget, there are good providers. There are good scientists out there that we need to build up and thank for being driven by that pursuit of truth. Remember,

[00:51:20] progress over profit. Thanks again for watching and or listening. If you're passionate about the subjects that I discuss on the channel, do me a favor and like, comment, subscribe, do whatever you can to make your voice heard that these are problems that must be addressed in our society. If you have any questions, comments, or concerns, I want to hear them.

[00:51:50] Feel free to reach out on social media or email us at renegadesyke at gmail.com and if you'd like to be a guest of the show or you have a connection to somebody that you think would be a good guest, let us know. Thanks again for listening. Thanks again. Thanks again. Thanks again.