Truth behind the discovery of mRNA vaccines - Robert Malone MD (Vejon Health)
YouTube video by Dr. Robert Malone (https://www.youtube.com/watch?v=U1pEtrEr2_s). Transcript is the auto-caption track — verbatim ASR, not a certified transcript.

[Music] hello and good evening to everyone and we're going to have an absolutely fascinating discussion because we're focused on mrna vaccines and critically we're focused on mrna vaccines in the context of someone who was the discoverer or the creator of it all the way back in 1988 that's rob malone and we're going to explore some of his ideas some of the history some of his experiences and i hope that you will find this as absolutely fascinating as i have so here we have with us rob how are you i'm good and and thank you dr mcmillan for dr uh for having me on your uh podcast and uh for the opportunity to discuss ideas and data and and science and everything else now listen let's get straight to the the crunch point that i want to understand you were a phd student when you first came up with the concept of mrna vaccination were you the first person i i can't say whether anybody else uh preceded me in thinking about it i'm not aware of documentation of others having done it in my experience when uh the time is right for a technology or discovery it tends to emerge kind of organically all across the world in this case strangely it doesn't seem to have done so in that time frame of the late 80s and uh so it it the the the record suggests that um i was the first to develop this idea but i can't say that nobody else had it um that's that'd be impossible and so when you think because you were studying you're you're doing your phd at the salk institute at that time and when you were working on your dissertation with mrna and just to clarify in case people don't fully understand even though we're talking about it in the context of covid a lot of people may not understand the simplistic perspective on mrna what really were you doing in a very simple way for somebody so you're kind of asking the question how did this all come about yes and i i can i can uh assure you that i did not start off thinking i'm going to have a phd on rna vaccines absolutely not the the genesis of this is that i was fascinated i i was fascinated with retroviruses um at i had kind of cut my teeth on mouse mammary tumor virus a breast cancer virus of mice and in a laboratory that played a key role in the initial discoveries having to do with the role of retroviruses and aids back at uc davis at the primate research center and so that was my background and i'd come out of that as uh entering into an md phd program uh absolutely fascinated with the idea of retroviral based gene therapy and i thought this was something that i could do with my fascination and knowledge of retroviruses um and uh that could be and it looked likely that this was really going to happen uh technically and it's something that could i could uh continue to pursue through my entire career and that that's at by this point in time there would be gene therapists everywhere in every hospital um that was my vision at the time um and so i went to this university uc san diego that had two of the absolute pioneers in retroviral gene therapy ender verma and ted friedman ted had been the one that really came up with the whole gene therapy idea now now where the rubber hits the road for the young graduate student is what are you actually going to do um what is the question you want to work on and for me i that one of the core questions was how does the rna of the retrovirus assemble into live virus particles and get produced as viruses this was essential to the fundamentals of making retroviral vectors work and there was enough known about the rna of the retrovirus in the specific packaging sequences that it was possible theoretically to examine that rna mutate that rna and ask questions about how those specific sequences were interacting with cellular proteins and viral proteins to assemble the retroviral particles before you go any further let me just clarify because i'm talking really basic stuff for people when you say rna usually the dna in our body is what makes all the proteins well it codes from dna dna makes rna and rna then makes the proteins yes and so when you talk about rna you are talking about going in the middle between the dna and the proteins to be able to change the way how a cell works is is that a boat right um so that that kind of jumps ahead in time uh to the idea of mrna is a drug and mrna is a vaccine at this point in time i just wanted to set the stage you know the truth of the matter is um retroviruses uh and it's a captured in the name retroviruses are very odd and david baltimore got the nobel for this in that they have a protein that will take from the rna and make dna which then gets put into the chromosome of the cell which then makes retroviral rna which then gets packaged and put out as new viral particles that's the life cycle of a retrovirus is it's got this backwards step but yes you're exactly right the central dogma biology is that dna makes rna rna makes protein so in this case i was trying to ask this question about how retroviruses package rna so that they can produce viable retroviruses and in order to build that as an experimental system i had to have a way to produce synthetic rna with mutations in it put it into a cell and ask whether it comes back out as virus particles and that's what got me going on this wasn't because i was gonna change the world or make an rna vaccine or any of that stuff that's where it started i was in a i was in an amazing hot house gene therapy environment um uh just to give an example the senior postdoc when he left the laboratory created uh the um leading adenoviral vector company that now has been sold to johnson and johnson and is that that technology is the basis for the j and j vaccine now so i you know i was in in this amazing pressure cooker doing these gene therapy experiments and uh surrounded by people grappling with the early days of gene therapy and what the problems were was there any specific moment when you thought oh my goodness this is a possibility to use this technology to make a vaccine all the way in the 1980s so it there was two kind of events um uh the first one was the aha moment about using gene therapy technology to produce vaccines and um that happened uh because i was collaborating i was working very closely with a kind of a post-doc mentor his name is dan st louis he still lives in san diego and uh dan was working on a system where he would use retrovirus vectors to put genes expressing a secreted protein into cells of a mouse and then collecting them in a little package in nodule we could say placing them as a transplant into the mouse and then the mouse would continue making the protein okay so this was putting you know putting things into engineered cells in cell culture and then implanting them back in the mouse that was the model using a retrovirus and dan ran into a problem it was a huge paradox in the laboratory the the cells would produce the protein in the mouse for about three weeks and then they would stop producing it and uh ender's lab where i was hinder verma um one of the top uh leaders at the time in uh regulatory regulation of gene expression um and the others who were supporting him in that mission uh thought that this must be a uh what was happening was some sort of a control event that the retroviruses were getting turned off in the cells and the aha moment for me as somebody trained in medicine for a couple of years and immunology and vaccines and all that was uh good heavens this is happening at three weeks which is exactly the timeline for a good robust cellular and immoral immune response may probably what's going on is not some epigenetic fancy chromosomal silencing thing but rather simply that the mouse is making an immune response against the foreign protein and lo and behold that was what happened now it seems like a very small thing in retrospect but it was heresy at the time uh gene therapy had not yet come to confront the fact that it has this fundamental logic flaw which is if you're putting the good gene into a patient the patient's immune system doesn't know that it's the good gene it only knows that it's a foreign gene and it will mount an immune response against it and it will also mount an immune response against the vector if it's an adenovirus or retrovirus or whatever okay so so this aha moment seems trivial in retrospect at the time it was a kind of heresy and uh not well received um as you might imagine uh but that that was one of the key ones was gene therapy can be used it it may not ever remember i come into this a true believer in gene therapy this is going to be my career okay i'm in i'm all in okay uh and suddenly the the epiphany oh this isn't going to work so good what are we going to do about it right because because if you've got an immune response there's no going back you know then you're into immune suppression land and and really complex science um and that doesn't work very well but the aha was oh um the one the way out of the woods is uh that we can use gene transfer technology to make vaccines and uh so that that was a key aha and i think dan st louis for helping me and mentoring me at that time when when i had that brainstorm the other one that was kind of pivotal was way downstream um and happened uh because of this serendipity that i was working with um a non-viral method for transferring rna into cells and then because i was working as a teaching assistant in an embryology course at uc san diego and i had extra xenopus embryos so these are basically early stage tadpoles and i took the material that i had been using for cell culture to test i was testing a whole large array of cell culture lines for the ability to put rna into them and i said well let's just see what happens with these frog embryos and those rna experiments worked to my great surprise astonishment really they work incredibly well and um then then we you know the next stage in the embryology course was some experiments involving chick embryos and so i i did this kind of same thing well if it works with frogs what about chicks um and lo and behold i got signal with chicks and uh so at that point um then things got serious and interesting um and uh disclosures were filed and people started wrestling over who got ownership and and all those kinds of things and it all went sideways so this is where you with this uh these embryos and how well this worked and and it was totally unexpected um but uh once there this was a simple two plus two you know it doesn't work that well i'm not going to cure um uh cystic fibrosis or muscular dystrophy but it might work well enough to to make an immune response um and that was kind of the synthesis so listen now this this race is an important phase because at this time you were also having difficulty as a phd in that environment and you did actually leave before you had finished was that a difficult time for you personally um so i ended up with a diagnosis of post-traumatic stress disorder from a university physician uh i i went through uh some experiences that i wouldn't wish on my worst enemy uh that that um you know with the with the perspective of time i would not be who i am now if i had not gone through those and i was absolutely an aggressive ambitious overconfident young graduate student um and uh um i if i you you mentioned before if i could speak to my younger self or to uh other graduate students um uh i i would tell my younger self uh a story about the importance of of humility and uh um being a little bit more low-key about things but that's who i was then it's not you know i it the experiences profoundly changed me um and probably and i'm sure for the better but they were extremely painful going through and so so let me ask you a hard question on that point because you left the salk institute and in a sense you left a lot of that work behind you do you think that you'd be in a completely different place if you had stayed and continued with that work there um okay so uh uh probably not the the uh um kind of uh seren cascade of serendipity continued um when i left salk and joined a little startup working for a scientist that i'd been collaborating with at the company syntax in palo alto that had been hired to this la jolla startup um uh called vical and um the the what happened was that i brought the protocols and reagents and know-how into vical and um there was capital and um uh willingness to support uh further animal research and to take it to the next step at vikal and that was what led to the science paper that was you know um considered to be analogous to cold fusion um that was the naked dna in rna paper um that wouldn't have happened had i remained at the salk absolutely uh so um uh would would it have been better for me in terms of my long-term career trajectory to stay at the salk um i don't know it was impossible for me to remain at the sulk psychologically it was not an option the the um i i had in in the context of all this recent churn about that those old days a colleague another postdoc from the lab wrote to me personally and empathized uh said that they hadn't realized all that i'd been going through but they shared what they'd gone through and what they had seen other people go through and um you may or may not be aware i don't think i'm sliding dr verma was uh asked to leave the salk institute where he was basically running the place after a an expose in science magazine about sexual harassment which this individual that wrote to me privately reminded me of some of the things that he'd observed so a duck and he spoke about dr verma's uh um practice of uh um being very casual with the intellectual contributions of others in the forms of manuscripts grants et cetera and the individual had the same exact experience that i had where inder would uh you know at one point ender gave me a stack of grants that he had to review and he said read these and get ideas i was shocked um and i went to uh the then president of the salk and said this isn't right is it and the response i got back was well maybe inder isn't the best role model for you um so there was kind of a tolerance there um for a number of things and um and i was an ambitious graduate student in a postdoc lab of i don't know 16 postdocs or something that were extremely competitive and and the practice was to assign multiple post docs to the same task and see which ones succeeded um so you can appreciate it's a just a pressure cooker and i i was warned uh not to go there um and yet i chose to do so because i was so passionate about um gene therapy and what i wanted to do in my career um so uh you know i i can't it i brought this upon myself in some ways maybe that's uh speaking you know a victim but regardless i i was not a a psychological option for me having been this starry-eyed naive ambitious young scientist to remain in that environment that i had walked into thinking it was the temple of knowledge with francis crick was there at the time there was a half a dozen nobel laureates it was kind of the center of uh the intellectual world of molecular biology um that and the white head and uh so um in retrospect can i say um i should have done it differently there's you know one makes many mistakes as a young person um uh but you know were they were they useful or not i think that has to do with what you do inside with those experiences and hopefully i've processed them and um and and i take some comfort that i have had a long series of contributions since um and but but one of the things that comes out of that is is i am really religious about um ensuring that people get credit for their contributions um and i think it makes me a much better leader so that that raises a question before we move on in the discussion which is that when we see all the attention now on the success of mrna vaccines and so on how does it make you feel considering that you first i guess documented the idea it was your baby you were taking it forward and then you almost had to walk away from it and yet you are not giving any credit for it how does that make you feel okay let me frame it up a little bit um i i had no choice but to walk away from it because uh vical in my employment terms and agreement had had employment terms there that made it so that everything i did at vikal was owned by vical and furthermore i was not allowed to continue to develop that line of research it belonged to vical and they sold it to merck so uh for many years all of this data and information that i've recently and my wife has largely disclosed um uh was hidden away in a very large box in our closet and it wasn't an option now vikal recently went bankrupt and uh you know as an as a young academic i received cease and desist letters from vical so it really wasn't an option to carry on in the same way i had to do new things um so just to get that uh the feeling um so francis uh delia of heidi news was the one that first contacted me from the press about this whole situation and um and from the heart what i said to him was it feels like rape and i know that's a strong word um but uh what i was trying to express is it feels like something that i have created and um with you know my own passion and and uh effort i mean i worked tirelessly um is being taken from me uh completely without anything being taken by others um and uh that that's pretty rough um in academe there's rules about citing um citations you know that you're an academic and you publish also and um it's probably pretty important to you as it is to me um in this small strange world of academic research and publications that people acknowledge your intellectual contributions and i'm sure you like me are rigorous about uh acknowledging the uh you know the best metaphor is we all stand on the shoulders of giants and and i think it's important to acknowledge those that have contributed to this song that we all sing together um uh that have come before us and are our peers and um to have that kind of taken away uh and others uh seeking to advance their own agendas um without even acknowledgement is uh a little rough and uh so how does it feel it hurts a lot and uh you know uh um the uh quote i think it's from the outlander you know um it ain't right it ain't proper um and uh i think we all know that right um intuitively but uh science in academic science is a strangely competitive world that's very much a pyramid and um uh so it's a it's a personal commitment on my part to make sure that everybody that is in my world um gets credited for their contributions and i guess i kind of expect the same um from others regarding my contributions um it's it's the only thing it's it's part of the capital that we're all trading as ac you know as academics and intellects contributing to this common song that we sing in science and uh that we will all respect uh the contributions of each other does that mean absolutely absolutely and i i i feel honored that i'm in a position to be able to at least give you the opportunity to get some of that credit you know and i i i i feel honored about that so i'm going to take us on to a different part because we are in the middle of covid you are therefore one of the experts on mrna vaccination um and it has done a tremendous step with regards to reducing i'm shocked i mean i you know you know a in i am amazed i spent uh a couple of decades of my career trying to advance new gene delivery technologies um i was a founder of uh inobio the electroporation company and and uh mentored the the um norwegian young norwegian scientist that was behind that um i spent years and years developing and testing catanic lipids i know how hard this business is to get to get this level of transgene expression because that's really what it is this is really gene you know back to the original concept this is gene therapy applied to vaccines with rna wow i i thought uh given what had happened and all the pushback and and all the intervening time i thought that this would eventually come to pass but i would be long in the ground uh when it happened so to see it happen so suddenly in the context of this amazing public health crisis we're in um is mind-boggling and furthermore the the levels of activity of these lipoplexes that's the technical term for these small nano aggregates of rna and um and lipids that are formed which are what and allows the rna to go into cells and be produced into protein um the the level of efficient efficiency associated with those uh is mind-blowing to me um and uh i in particular i think the unsung hero in this song here is uh dr peter cullis and his team um who developed the core this advanced new uh um uh formulations of of lipids that are um directly being used by both the uh biointec pfizer product and the kirvak product the modernity product is a slight variation on the same the activity of those is mind-blowing so i never expected to see this in my lifetime um and uh it's uh i'm fascinated but with that high level of transfection activity of you know polynucleotide delivery ability um there comes uh consequences as you know in drug development nothing is free um and uh no drug is perfectly safe um and so uh with this uh amazing advance in efficiency uh come some potential issues uh which i think we need to be um sensitive to now this is a this is a sensitive topic because as i said we're in the middle of a pandemic there is a lot of pressure politically um to try and get out of it with regards to to vaccines and a major part of it especially with some of the other side effects that we're seeing from some of the other vaccine candidates it looks as though the mrna technology is leading the way so you've made a good point is that there is the opportunity to make a difference but as always with any technology there are risks or potential problems this is an important topic what have you come across recently that would make you think about um consideration of how we approach vaccination at this point so thanks for that and let me frame that up a little bit um during i was alerted uh from a colleague that worked for the government let's say u.s government that was in wuhan during the last month of uh 2019 i was alerted um in the first week of 2020 about the threat uh that the virus represented and uh i made a threat assessment i'm an experienced outbreak specialist uh that does a lot of biodefense work these days mostly with the us government and so i made a threat assessment and made a personal determination that the most efficient way to help provide protection was to focus on drug repurposing not on vaccine development now the government of the united states made a different assessment and different decision and i don't want to second guess that it's it's uh it's water under the bridge and i can tell you having been through too many of these outbreaks um when when it hits and the fog of war hits it becomes very difficult to process information and make decisions um this decision was made by the government to pursue uh vaccine technology um uh because there was uh apparently by these emails that have come out recently from the washington post under foia there was a sense that this was the best way to move forward is to invest all capital and effort into vaccine development and um and the nih as well as biointec back in uh eu'd made a strategic assessment to uh invest in rna-based approaches which was quite bold um and uh that decision has been uh validated um and so i've watched with great interest as this has proceeded uh recently uh because of my background and i i'm a clinical development specialist i'm experienced in toxicology and regulatory affairs and other things this is what i do for a living these days um uh i was approached by some individuals uh to provide an assessment an independent assessment of some data that had been revealed through a freedom of information act submitted by a group of canadian scientists and physicians application which pfizer and biointec had submitted for their mrna vaccine to the regulatory authorities in japan and this is uh forgive me there's some technical words here um this was their uh initial new drug application or their common technical document these are regulatory terms what it means is it's the information package that a drug developer or sponsor in this case vaccine developer would submit to a government regulatory authority that's basically says here's the sum total of all of our data at this point in time supporting the use of this product in humans and uh so this normally these packages of information are closely held confidential um and are not discover above by freedom of information act they're usually protected from that and that's certainly the case in the united states but these canadian scientists and physicians who were very concerned about some of the safety signals that they were seeing in vaccine recipients canada decided to uh of their own initiative to seek more information and so they obtained this and within 24 hours i was asked by the editor-in-chief of an organization called trial site news in the united states to look at this document in another document that was publicly available from the european medicines agency that was their official summary of their assessment of the analogous initial new drug application and a common technical document that had been submitted to them can i stop you here a minute robert before you go any further because we're speaking we're going we're speaking live and this information is being shared publicly and you are walking in an area here that is not well taken where you are saying stuff that can be challenging to the political narrative with regards to vaccines are you sure you want to speak about this and you know yeah so thank you uh for giving me the opportunity to pause and reconsider um i'm i'm really committed to openness and transparency and part of that comes from the background of you know the crucible that i've had to go through but it also comes from the extensive training i've had in bioethics and um i'm personally as a physician scientist uh clinical development specialist i have a really bedrock commitment to fundamental principles of bioethics and among those is transparency and the importance of full disclosure to particularly um people uh receiving experimental products so i'm comfortable continuing to speak i'm i'm an experienced professional regulatory professional and um i'm i i hope that you don't in any the audience doesn't in any way infer that i am invested in um a contrary position regarding vaccines um i'm not an uh anti-vaxxer i've spent my whole life developing vaccines and trying to advance vaccines um but that that doesn't uh override my commitment to uh transparency and disclosure and good science i'm i'm of the belief that uh the public is the adult public is mature enough um to make their own informed decisions uh based on the information available and that it's the obligation of governments and public health organizations to in particular in the context of an experimental product like these vaccines all are right now it's the obligation of the public health community the official public health community to convince the public that they're safe and effective um and uh so i'm i'm totally okay with proceeding um and i'm i'm a grown up too and uh if i say something that's controversial and i start getting hate mail it's part of the price i have to pay uh but it doesn't i've i've been through situations before where i have gone public about major uh ethical issues that i've encountered in um uh in this kind of uh technology development space and drug development space and clinical research space and um i've i've had consequences in my career uh but um it doesn't that doesn't absolve me from the obligation that i think i have to uh be open and transparent about information which is relevant and in my opinion um should be made publicly available well well that is that is tremendous and we do appreciate that because we do need scientists like yourself who are studying and able to challenge and make sure that everything that we do is as safe as possible so yes please go ahead we are very appreciative of that so thank you for that support in those words um let me just kind of loop back just a little bit on that theme um in my experience and my strong opinion science requires uh that we challenge each other and if we don't do that we end up with group think and we end up making mistakes so continuing on the theme these documents were provided to me and i was asked to render an opinion about what i saw as a professional with the level of you know the type of experience and background that i have um this these documents that had been uncovered by my respected scientific and clinical colleagues in canada and so i made an independent assessment of those and then i was concerned that i may have over interpreted or misinterpreted uh and so i asked an even more senior regulatory specialist that i uh respect highly to look over the same documents and draw their own independent opinion to make sure that i wasn't um overreading things or overreacting to them um uh so so that happened um and um with those documents um we both observed that there were deficiencies that were highly unusual and uh not what we would anticipate seeing in a regulatory submission from uh an organization of the experience and capabilities of pfizer and uh that was i found that a little bit alarming so did my colleague um he was uh less sanguine about uh placing his name to his assessment um and so he remains anonymous uh but uh i was comfortable that the assessment that i made was true and accurate based on the documents that i had so the findings included that um there were data in in the ind package from japan data tables that uh examine the biodistribution of the vaccine product in a animal model in a in a rodent model with limited numbers of samples using two core technologies one was the one that i used way back in the day when i was pioneering rna delivery which is expression of proteins from an rna encoding the protein that makes the firefly tail glow okay so it has the perhaps unfortunate name uh here in the states where we have a strong religious community of being luciferase um that's uh luciferase is is just the name that the discovers that we're trying to understand how come fireflies glow at night um gave to the protein when they cloned it and it turns out to be a super duper uh we call it reporter protein way to detect whether or not a pro a polynucleotide an rna or a dna has gotten into a cell and been turned into protein because it will produce photons and those are easy to detect so a lot of technical there so the studies were done in non-good laboratory practice means uh and they involved uh use of the luciferase rna rather than the actual rna of the drug product encoding spike and um and they involve tritiated rna to so this is a radioactively tagged rna that is able to be detected very sensitively uh because it's radioactive in various tissues of the animal in which it's been injected and so uh the data that i was able to review had to do with the distribution of injected rna lipoplex complexes we talked about that earlier this is the actual material only it wasn't the actual material um which is what usually one has to do these studies with um it was a surrogate the rna for luciferase instead of the rna encoding the uh vaccine which is encoding spike uh so what the data showed was that um the inject in these rodent models and it was small numbers of rodents that the injected material um uh a lot of it stays near the injected ejection site but a lot of it doesn't and it goes uh throughout the bodies of these mice or rats and um and um it appears that it may have remained biologically active in some of those distal sites and it certainly um the data suggested and it's the tables are a little difficult to follow for me because they analyze both the lipid distribution and the tritiated signal distribution they showed a high concentration in and relative concentration into for instance ovarian tissue spleen and liver but in particular the ovarian tissue was surprising um and particularly it was surprising because there was not that concentration in the in the testis that were sampled from the male rodents okay so we had concentration of the lipids in particular in ovaries and we had some relative concentration of the tritiated signal suggesting the rna in the ovaries compared to some other tissues but strikingly we had distribution of all of this kind of systemically throughout these animal models is that is that what we would expect to a certain extent with regards to injecting a vaccine isn't there some degree of spread or do we expect it to remain local to where it was injected um good question and um uh entirely appropriate uh and um uh the i had no way to assess because we didn't have the controls of alternatives but yes one would expect um to some degree uh uh spread of the injected material the core thesis that had been advanced in the scientific literature uh before um me my you know i can only speak my personal experience my encountering um these uh data in this ind package i ended up being the abbreviation for initial drug application um my expectation from the literature was that the injected material and the encoded spike protein would remain membrane bound and regional i was aware that these complexes had been engineered as a formulation historically specifically so that they would be uh transmitted along lymphatic system and uh i'm trained in pathology i used to teach university pathology and i know darn well that the uh lymphatic system drains into the blood and circulates and passes through the liver and all that good stuff this is you know fundamental uh biology and human physiology and mammals um so uh the prior publications and information had suggested that these complexes would remain at the site of the formulations were specifically engineered to to preferentially go through lymphatics to the draining nodes lymph nodes which is where the immune system processes antigens and teaches b cells and t cells these are the things that attack other cells or produce antibodies um teaches them uh educates them so that they make the proper immune response against the antigen just for the uh for the viewership um so uh that was the logic spike was engineered with the tether um it uh transmembrane region it was supposed to stay in the cells that it was uh that were in the region and uh it was not uh previously disclosed let's say um in the literature that it would move systemically in any kind of a systematic ways uh in a significant way so can i can i ask me as a surprise and the relative concentration in certain organs was a bit of a surprise you'd expect it to concentrate in spleen because and in liver yeah the ovarian signal was a little surprising um more than a little surprising a bit concerning particularly since now we get into this intersection between um these many reports that patients that are out there the patients have made and we have to be really careful because there's a selection bias when somebody makes a spectacular claim um you know i i lost my baby or i had um you know my parents died or you know right after vaccination whatever um these things uh quickly catch fire in social media these days um and uh the truth is that all of these events would be expected to occur at some normal frequency and for instance there are those who say oh we have x number of vaccine-associated deaths well and then there's others that i've heard public health officials saying no there's no vaccine associated deaths okay well i know that's false because by random chance a certain number of people will die within the two weeks after they receive a vaccine the question is is there any causative relationship between those and is there more people dying at for example just to take the extreme are there more people dying than would normally happen by random chance in x period of time after they received a vaccine those are the key issues um and uh so so there's various claims that are made uh um and people are there there are those that are very upset and understandably so about risks including this group of canadians um and uh i hear about it all the time as you might imagine with my background you know people on the street uh the house cleaner you know should i take a vaccine i have these problems this background um and i'm acts to opine uh so i get hit with this um in this case some of these reports about dysmenorrhea um or other ovarian related events that may or may not have been under reported by public health authorities or may have been readily discarded as not vaccine related because this is all subjective that's the one thing about this we can talk as if this is hard science and we're all dealing with numbers and statistics and machine learning and all that wonderful stuff but the truth is it comes down to somebody making a subjective decision this is related to vaccines or it isn't related to vaccines because you know and and that triggering uh an investigation so um that you know if the person making that decision that call has any intrinsic bias this can cause problems and we're very aware of that type of problem in clinical research i want to pause here a minute i want to take you back to something that you'd said which was in relation to the spike protein spreading systemically that's mean throughout the body i remember seeing a very interesting study in in israel where they were looking at patients with hematological malignancies and they realized that they can't do pet scans within a certain time frame because if they did they were starting to get false positives because nodes were lighting up all over the body and they couldn't differentiate post-vaccination does this fit with spike protein going and spreading into nodes and and spleen throughout the body okay so so we have to allow me to dissect that a little bit and it's a fascinating observation and insight that you're sharing and thank you for sharing it um it's it's adding value in and this is a great example of how science good science happens is a lot of the folks you know it takes a lot of minds the expression it takes a village it takes a lot of people thinking really hard in looking for associations to pick signal from noise and you've just given a great example of of that so let's pull apart a little bit what you said you were speaking about spike protein so the the data that kind of lit me up a little bit um uh with looking at the pfizer ind package uh was relating to the distribution of the transfection complexes transfection being a fancy scientific word for the process of the rna getting into cells so i was talking about the data relating to the distribution of the lipoplexes which cause the rna to get into cells and turn into spike protein you're talking about spike protein and um so there's another key paper that i'll remind you of i'm sure you're aware of uh that recently it's in press it's past peer review and it's impressed from harvard and brigham so generally you know this is like publication in ejm if it comes out of harvard and brigham we all say oh yes that must be true um but in any case it was a bunch of nurses a group of nurses about 14 or 15 that received vaccine and agreed to our um modernity in that case and agreed to have blood draws after vaccination over a period of time and uh some very sophisticated sensitive technology was used to detect the presence of free spike protein or subunit in their blood so the so the in that data set they're looking at the actual protein which is what you're referring to in your example um and of course the the production of the protein is a little time shifted it's a little delayed compared to the distribution of the rna and the the engineering that had been done uh at at the vaccine research center uh for the moderna product and um at biointec for the pfizer product had engineered the spike so that it would stay put where it was expressed and yet these nurses had significant levels of non-trivial levels of circulating free spike protein in their blood for a prolonged period of time now for me as a gene delivery guy this is kind of wow i'm shocked it's amazing i can't believe it well not really i mean i believe the data but it's it's profound i mean i guess perform in a good way or a bad way um in in terms of the underlying technology so both uh like we said at the beginning uh there's a yin and a yang to these things um so from as a technologist who had worked for decades trying to develop more efficient systems for non-viral gene transfer this was shockingly good as a trained pathologist uh you know clinical research specialist physician scientist this was a uh-oh um uh you know houston we've got a problem uh right um because this isn't supposed to be happening because spike protein is biologically active it's not an inert antigen it's not just an antigen the virus has evolved to do a whole host of amazing things um and and these little rna viruses are just evolutionary pressure cookers and uh there are all kinds of overlapping activities that exist in all of the express proteins for these little um uh rna viruses um like the cyrus kobe 2. um so spike spike is not just an antigen spike has its own intrinsic activity um and as you note uh among those things is that it binds to a particular receptor present widely in humans particularly in vascular endothelial cells that's a fancy word for the cells that line the inside of your blood vessels and they display they express and display uh this h2 receptor and um binding of ace2 ace2 is crucial for regulation of a whole bunch of things including blood pressure and uh so if you have something in the blood that can bind to ace two it can cause all kinds of issues many of which we don't we're only beginning to understand um and uh so what that also means is that the free protein detected in the blood of these nurses is a tiny subset of the total amount of free protein because most of it is probably sticking to ace2 on vascular endothelial cells among other things now this is a very important point because my research is focused on the autoimmune response in covet 19 and the fact that what i have been predicting is happening is that the serum or the free floating ace2 binds to the viral sphing protein and that combination then triggers an autoimmune response and from a clinical perspective what i've noticed is that many patients have symptoms about two weeks after the vaccination which would which would fit with an igg production time as opposed to necessarily being directly related to the spike protein so are we triggering an autoimmune response as well as an immune response to the viral spike protein is that possible ah thank you for for that last caveat is it possible absolutely um we're we're in so this is science right this is science the intersection of science and medicine and um i'm a big fan as a very young undergraduate i was taken into the wing of an experienced pathologist at davis and uh it was a little bit of a brutal uh experience i got a lot of things drummed into my head one of them was this ancient paper from the 1880s published in science called the method of multiple working hypotheses and it's how i've approached science ever since so the core idea is don't get invested in just one hypothesis recognize that when you encounter something scientifically some phenomena which is what we're talking about um then uh it's really good to come up with as many possible explanations as pos as you can think of you and all your buddies and then design experiments to reject those so that you get down to um a core of hypotheses that you haven't been able to reject and there's a good chance one of those is the true thing um now that's different some people have a tendency to say aha i know what the problem is it's this and they'll go and spend a lot of time focused on that but i i think there's a lot of merit to this idea that you are pursuing of autoimmune uh and absolutely i'm a fairly knowledgeable immunologist and i've i've spent time in computational immunology and and cellular immunology etc more cellular than uh these um antigen complexes which is what you're talking about forming whether they're membrane associated or free represent um again it gets back to the fundamentals the immune system doesn't know that it's you or not you they just know whether or not it's different from what it's seen before and anytime you do something like this where you have a foreign protein complex with a self protein then as far as your immune system is concerned that's something different and it needs to respond to it and we have uh you know that our our knowledge of the immune system is still evolving and um these days we have t regulatory cells and all kinds of complex regulatory networks um but is it is it conceivable that um that we are that much of the delayed pathology observed in cava disease recognize that kava disease is not the same as sars covi2 infection a lot of people get infected and they don't develop clinical disease only a subset do and often that more severe disease the part that puts you in the hospital and kills you if you are unlucky or put you on a respirator with a lot of oxygen that often is delayed as you say by to it's hard to measure because we don't we're not subjecting humans to challenge studies right now so we don't really know what the timeline is here but it looks like as you say it's two to three weeks now i would say one thing to your uh hypothesis about the rise of the igg just forgive me but you know i i've been tracking this really carefully and i and i completely agreed that the autoimmune hypothesis is one of the leading hypotheses for uh um here just a minute somebody's trying to call me and i'm going to hang up on them um so uh one of the leading hypotheses for both the genus pathogenesis of kaabid the disease that's often delayed um severe disease inflammatory disease and uh what the community calls long covered you know the thing that i experienced this this prolonged uh syndrome uh that is has a lot of symptoms that are a little bit inexplicable um that that there are many different uh systemic diseases that are consistent with that pots is one of them um but uh much of the myalgia arthralgia um in other in in potential coagulopathy that's observed um is consistent with uh autoimmune functions um another one that's worrisome is the thrombocytopenia that pops up yes my colleagues within the fda that i'm not gonna share their names uh tell me is a known complication of any oligonucleotide based uh therapy in a small subset of patients thrombocytopenia so it's uh so the formation of these complexes is absolutely um uh could yield a autoimmune response in a subset of patients and let me amplify that a little bit because it gets back to the safety there's a fact but i want yes this is a bit that i want to try and get close to administration of of market authorization that's the technical term for licensure um for a product for a vaccine product um until one to two years after at least three thousand subjects that's people have been exposed to the product why is that because of autoimmune disease largely um and the autoimmune disease risk uh because these are often fairly rare events um now we cannot you know it's i i i'd have i can't venture an opinion right now it's not my job to examine the data about whether or not these are rare events or relatively common events that we're seeing um but the the agent the regulatory agencies throughout the world generally agree that you want to be able to detect a severe adverse event which autoimmune is one an example at a frequency of about 1 000 okay when you power your clinical studies and the statistics just work out that if you want to make sure that you detect something that happens one in a thousand patients that receive the product you have to expose 3 000 people and then on average you would see three people that had that event so it would it would come across as a very rare thing um but if it's guillain-barre syndrome paralysis of the face that was observed with the swine flu vaccine and is part of the safety signal associated with flu vaccines in general um it occurs at a higher rate than that um and uh so so usually because autoimmune diseases manifest over a longer time course uh regulatory dossiers you know regulatory agencies require that we have two years of safety follow-up data after administration to at least three thousand subjects so in in this context so i'm where these things have not been deployed for two years yeah we don't have those data the uh safety data are emerging but we also have uh i like to say the wolf is at the door people are dying they're filling up our hospitals fortunately not at the same rate that they used to um i'm watching the uk carefully to see the impact of some of these new variants on disease attack rates and incidents in the uk um they don't seem to have come stateside in quite the same way yet um i work with closely with colleagues in india um that are developing vaccines more traditional ones and um and uh that is not a that is uh a very unpleasant situation right now so here's here's a question i hope that the uk doesn't experience something similar and that we don't see that in the states but time will tell so rob i'm going to have to ask you here based on what you have seen so far do you think it's appropriate for us to continue with mass vaccination when we have these questions um arising especially in groups who are at low risk for severe disease okay i'm i'm going to not give you an answer okay um and it and it has to do with me as a professional respecting my professional colleagues whose job it and just to provide context i did speak with insider colleagues that are very senior at the fda that i've known for many years and trust and they trust me about these potential safety signals and concerns about widespread distribution of the gene expression and the high levels of spike protein free in the blood um and the pfizer data package issues that i had observed and they had recommended to me that i speak to the director of the center for biologics evaluation research at the fda and uh he kindly granted me a meeting resume about a day ago and we discussed these various issues um uh he asked he basically uh presented to me what he could because he's constrained by his ability to disclose information associated with the pfizer package that was fully submitted to the us fda about two and uh and i respect he he has a excellent reputation within the fda as a person of intelligence and integrity um and so i trust that what he tells me uh reflects that that background of intelligence and integrity um and uh he assured me that the gaps that i had identified in the what are now really historic documents they're from a different time frame that were obtained by the canadian group um and uh may or may not reflect the current documents that have been submitted to the fda i i understand all of that but we are at certainly in different parts of the world there is a significant amount of pressure especially now that there has been some um it's certainly more they're aiming for the 12 to 15 year olds so children who are at low risk of severe disease and what i'm saying is i do understand that there is due process but this is in the context that if this is relevant for long-term impact on the young people this is a pretty important point that has to be raised to the public very quickly they should know about these issues you and i are aligned and this gets back to the bedrock bioethics uh fundamental principles of bioethics are for an experimental product which is what these are currently in certainly in the united states um they're under emergency use authorization they have not been approved yet in the united states i can't speak it's a little unclear to me about the status in the uk um but i i firmly believe that uh the i'm of the school as a physician that your patients have the right to understand uh their disease and understand potential interventions and participate in decision making it's their body your body doesn't belong to the state and i'm of the opinion as you suggest that full and open disclosure of risks is something that um not only can adults process and manage um and should be able to uh but i think we're obligated to have that full and open disclosure so you speak now about adolescence and um that's a special case bioethically um if if the product is not yet licensed and proven safe in an adolescent or child population they by definition they are not able to provide full informed consent they're not of the age of consent this is fundamental um uh and in the in this specific case um there are there are now known disclosed risks in the adolescent population particularly cardiomyopathy well not so long ago there was strong denial that there were any risks in this population and that was kind of the group consensus and the and the party line forgive me um put out by many public health professionals but among other things the fda has a absolutely super-duper biostatistician i'm one of the world leaders he actually is employed by oracle and he examined a lot of those data he discovered that there was a safety signal associated with cardiomyopathy in these mrna vaccine recipients that was then confirmed by the cdc the cdc issued a press announcement um and uh an announcement on their website i received a document from the maryland board of physicians which is my licensing board that specifically warned about cardiomyopathy in adolescence um and uh and then we have an editorial in science magazine revealing that you know everybody's kind of been relying on the israeli database as the most comprehensive and much reassurance was taken from the israelis not having reported anything having to do with the adolescent population and then they confirmed that in fact it doesn't inspire a whole lot of and it's in this particular population that we've all agreed deserves a particular caution and care um now if i can speak just a moment about cardiomyopathy because that's us as you know um among other things associated with autoimmune disease we don't know that that's the cause we're not taking the small number of children adolescents that have experienced cardiomyopathy and doing cardiac biopsies which is the kind of thing that's necessary because we generally don't do that it has a lot of risks associated with it also i just want to share one thing um because i work in this biodefense space at the time when the u.s government it's an anecdote okay so forgive me has to do with smallpox vaccine um and it illustrates kind of the situation i think quite well um there was a time when the u.s government was concerned about the risk of smallpox being released stateside as a bio agent a threat and they started vaccinating first responders and other health caregivers and they saw what they believed was an intolerable signal of cardiac cardiomyopathy in the vaccine vaccinee population and i was tasked i was working as under contract with the dod at the time department of defense of the us i was tasked with uh looking into whether this type of a problem had existed historically during the prior major smallpox eradication campaigns that had occurred historically and in fact the signal was there um soldiers and and others young people in particular receiving small back vaccine had an incidence of cardiomyopathy that was compromising their function and it was considered an acceptable risk because of the risk benefit ratio and that's crucial in understanding the perspective of the public health community about these signals the thing about the risk benefit ratio is it's subjective it's in the eye of the beholder um and uh so there's no you know there's no computer algorithm or machine learning whiz-bang to say ah you've crossed a line now you're over the risk benefit ratio it's very much a subjective call and it's very much a function of what is the risk of the pathogen in the population so if you were to do a risk benefit analysis for say an rna vaccine and um you were doing it from the perspective of the indian regulatory authorities currently um you would be probably you know responsibly very inclined to tolerate quite a bit of risk in the product because of the risk of death and long-term consequences associated with this variant that's spreading in infecting people in india if you were doing the same analysis from the united states currently as opposed to say six months ago the risk benefit ratio would change can you appreciate this yes i understand so with this adolescent population um it's it is not my job or pay grade to second guess national public health authorities what i will say is that i i i am confident in my position in bioethics and uh that position is while these remain experimental products not yet licensed or fully evaluated in terms of their safety there is an obligation to fully disclose risks ensure that those which receive the product are comprehending those risks and um that they have consented in some way to accept those risks which have been fully disclosed in which they have comprehended this is bedrock bioethics and um in the case of an adolescent we have all agreed that adolescents and young people down to people are talking about two-year-olds um are not able to provide that informed consent it can only be provided by their uh um uh by a responsible adult that's been designated whether it's their parents or or um whatever you know the the designation has to do with the people that have accepted responsibility for decision making on behalf of those adolescents or children and i'm i don't think while these are still experimental vaccines i i caution that governments and um health and public health professionals um that are are making these decisions about vaccination of adolescents in an environment where the safety database is evolving um in and as we've seen um i i think they are treading on very thin ice uh ethically and um i i really counsel that it's time past time for us as a world community and as a public health community to to take a good hard look at what we're doing here um you know in crisis it's easy to convince yourself of the need for extraordinary measures and history is full of examples um where we have decided to intern ethnic populations or whatever because of perceived risk or allow certain types of experimentation on populations the tuskegee experience in the united states is notorious african americans in the united states are still wary of participating in clinical research as a consequence for good reason um and i kind of feel like we're we're in that same kind of uh ethical um environment where we have to be very careful and cognizant of the decisions we're making because in retrospect we may regret having done so um particularly because it's i can say for me it's self-evident that the safety database is evolving um i look forward to um disclosures from our colleagues in the scandinavian countries and in the uk that have a well developed national health service with more rigorous methodical reporting unfortunately in the states um all of our safety databases are based on self-reporting and the consequence is we have neither a reliable i'm sorry i got to say it numerator nor denominator you know we don't know what the event rate is for these adverse events the true event rate of among all people vaccinated and we don't really know um the number of vaccine recipients in any kind of a rigorous way and these adverse events are self-reported so i i'm i'm i don't want to second-guess national health authorities and their policy it's not my job it's not my um purview but i do i do feel comfortable raising a concern about the underlying bioethics and reiterating that we in the west at least we all can agree on these fundamental principles for an unlicensed product that remains experimental there has to be full and open disclosure promptly of risks to the patients in the broadest sense you know when you know when you're running a clinical trial that list of risks that are disclosed is goes way down into the weeds just like it does in a package insert yeah and uh and so i we have to disclose i think we're obligated to we have to ensure that the public comprehends that disclosure we have to put it in plain words that they can comprehend and not obfuscate it and we have to have a process in which um they are consenting we i believe firmly the state in the west at least does not have the authorization to compel uh vaccination or administration of an experimental product full stop and i'm not shy about saying that absolutely listen robert we could talk for hours about these things i think this has been a truly enthralling discussion and i'm looking forward to having more of them but this is in truth probably one of the most important discussions in terms of its timing and in terms of the relevance to what people may choose to do and what governments and public health officials may need to do in order for us to have a truly safe and good practice going forward for health so i want to thank you again robert and i really appreciate the time i look forward to speaking to you again and i hope everyone watching has enjoyed this as much as i have thank you very much robert bye bye and thank you for the opportunity and for your interest and i look forward to learning from your [Music] bye [Music] you

Summary: [Music] hello and good evening to everyone and we're going to have an absolutely fascinating discussion because we're focused on mrna vaccines and critically we're focused on mrna vaccines in the context of someone who was the discoverer or the creator of it all the way back in 1988 that's rob malone and we're going to explore some of his ideas some of the history some of his experiences and i hope that you will find this as absolutely fascinating as i hav…