WEBVTT

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Good morning, everybody.

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Welcome to the show.

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Sorry I've been gone for the past couple days.

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So much happening in the background.

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A great interview finally happened between myself and Dan Cohen.

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I'm really hoping that you guys can share that far and wide.

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I think it's an interview that might be a good introduction for people who don't know me, for people on the left, et cetera, et cetera, et cetera.

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Arthur being the first person in the chat.

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Good to see everybody.

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Now, I know I'm not in uniform right now.

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That's because I'm going undercover.

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In light of all the recent false flag shootings, you might be wondering, how do I get in on the action, you know?

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What do I gotta do to be the lucky guy that gets recruited to do something crazy?

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How do I get in on that action?

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Lucky for you, citizen of the United States, and Biden's Build Back Better bill, because he loves you so much, absconded in the 10,000 pages federal false flag subsidization program.

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For example, if you're thinking, you know what, maybe I don't have the nerve to do something crazy.

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We'll give you all the SSRIs and fluoride you need.

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You're thinking, where do I get the money for these fancy guns?

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Where do you think these, like,

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mentally ill mcdonalds workers got the money from in this economy if you're wondering where you get money from just go on the internet and say that you're having violent thoughts all of our boys will swarm in there onto your venmo account to send you money our best discord groomers do your discord account to give you all the instruction manuals the quick rundowns and everything really

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If you think about it, you know, if we're defining vaccine really liberally, and these COVID vaccines are vaccines, the flu vaccine is vaccine, okay.

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But actually, they're kind of cheating when they're calling these things vaccines.

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And, you know, anything with really rapidly fading efficacy, such that you need shots within a year, you know, Canada's saying nine months, is as actually J.J.

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Cooey's insistence, and I think he's right, on calling them transfections rather than vaccines.

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Pass the time to our next honored guest.

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And yeah, I will keep fighting until the last minute.

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Last minute, for me, all for Chinese Communist Party.

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Thank you.

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Dr. Li Min Yang is not only a hero to the Chinese people, not only a hero to the American people, she's a hero to all mankind.

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The last thing I want to say, when Dr. Lee Min Yang left Hong Kong in the middle of the night because of the great work of the Rule of Law Foundation, the Rule of Law Society, the great heroes there and supporters, she defected and came out with tremendous danger to herself.

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When she first got here, I think we spent three, four, five days in due diligence with lawyers and scientists and all of that.

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And I have to say about her personal journey, she was

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very meek, very shy.

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The woman that was on the stage tonight was so shy and so demurred.

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I got to tell you, one year of breathing the fresh air of freedom has... We have to get her citizenship because we need her to run for the United States Senate.

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Thank you.

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Thank you, thank you everyone.

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Oh look, JC on the bike was timed out by Risa.

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Oh, time out JC on the bike.

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JC on the bike.

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It's JC on the bike.

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It's JC on the bike, yeah.

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Well I'm wise enough to know when a chump needs banning, and I know just the one.

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Look around, it's JC on the bike.

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Who says Vader didn't study music in college?

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The next thing that I want to say is our lack of biological knowledge and the general poor health of America, of the American people, is being used to create the crisis they need to divide and conquer us, to ruin maybe America, I don't know, crash the dollar, I don't know, steal the rest of what limited treasury value we have left, I don't know.

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But I know for sure

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that they are combining our lack of biological knowledge and our general society's lack of good health and access to health care to create a crisis to usher in all kinds of changes that would otherwise never be necessary and more importantly never be possible.

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The Matrix is a system, Neil.

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That system is our enemy.

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When you're inside, you look around, what do you see?

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Businessmen, teachers, lawyers, carpenters, the very minds of the people we are trying to save.

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But until we do, these people are still a part of that system, and that makes them our enemy.

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You have to understand, most of these people are not ready to be unplugged.

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And many of them are so inert, so hopelessly dependent on the system, that they will fight to protect it.

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Were you listening to me, Neo?

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Or were you looking at the woman in the red dress?

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I was... Look again.

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Freeze it.

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This... This isn't the Matrix.

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No.

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It's another training program designed to teach you one thing.

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If you are not one of us, you are one of them.

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the rules protect yourself at all times follow my instructions keep it clean touch gloves if you wish let's do it sweaty palms this is so crazy like goosebumps this is so crazy i feel so nervous like what in the world man

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Swimming in sevens slow, dancing in seconds Oh, and I'm the one that loves you Oh, and I'm the one that loves you I spend my down day dreaming Sure as the sea, it's just you and me Oh, and I'm the one that loves you

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Oh, and I'm the one that loves you.

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And if you had a bad week, just let me touch your cheek.

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Oh, and I'll be there waiting when you get frustrated.

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I know things are changing, but darling, I'm saying I'll be singing you in all of my songs.

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inside your mind for all of time singing we will be alright in the afterlife of all that is shifting and shaking my system i know your rhythm and i know i

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You had a bad week, let me sing you to sleep Oh and I'll be there waiting if you start to get jaded No things are changing, darling, I'm saying I've been here

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We'll still stay the same Inside your mind For all of time Singing, ooh We will be alright In the afterlife In the afterlife

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He's scheduled for 60 minutes next.

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He's going on French, British, Italian, Japanese television.

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People everywhere are starting to listen to him.

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It's embarrassing.

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you

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I forgot that this video makes me sound like a very bad sound engineer, but actually I couldn't get a good recording of this song without that clipping.

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At least that's the excuse that I'm going to offer you guys.

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Let me get over here to the desk.

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Good morning, everyone.

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Welcome to the show.

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This is GigaOM Biological, a high-resistance, low-noise information brief brought to you by a biologist.

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Please stop transfecting healthy humans.

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I really appreciate it.

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I'm going to start with a different slide deck today, just a real quick one.

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Again, very much my pleasure to be here this morning.

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It is not without any other means other than my followers, my supporters that I'm here, and it is my privilege to present to you this morning.

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I don't have a set of slides to talk about this in particular.

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I just have

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A couple videos that I recorded that I just want to watch and take notes.

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It's a bit what I used to call a study hall.

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As you can see I don't even have my front lights on so it looks a little dim here.

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I think it's really important.

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It's something that I think somebody like Mark Kulak could explain to you more.

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the frustration that can result from this phenomenon that I'm about to describe, which is that you think you know everything, or you understand the significance of something in a timeline, and it's only upon revisiting it, and then revisiting it again, and then asking if there's anything else there, that you finally stumble upon something that really hits home.

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the idea that you have had this in front of you all along and you just didn't know what it was good for.

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And in fact, if I think about it real critically, the few times that I've dared to discuss Jesse Gelsinger has been some of the times where in my gut I feel like I've gotten a lot of attention for other things.

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And it might be simply revealed in the C-Span videos that I've clipped.

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So you can see the whole video.

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I think I posted the video on my soapbox already.

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If I didn't, I will after the show.

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I'm just going to bring up my own folder over here.

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Sorry.

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And get the video up and play it directly rather than embedding it in a

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in a um let's see what would that be in then it would be in the clips thing right here and there and then let the hard drive chug for a minute and rearrange these in the right order and then yeah uh let's start with this one i guess is that the right one yeah so um i have so many things archived now there's been just this flood of discovery

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that results when you're finally so over the target that you can almost not miss.

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Mark and I have been joking, it's a bit like shooting fish in a barrel and then with no water in it, only fish.

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It is extraordinary.

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So this first video that I'm going to present to you or watch with you is a video, let me just check this quick.

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I gotta set this correctly and then I should be able to see that's not on.

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As I see.

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And I might take some notes.

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I might use my pad.

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I don't know if I'm going to use my pad or not.

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Let's see.

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My favorite pen needs to be refilled.

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And if you're familiar with fountain pens, usually that's not a very, you know, just do it in a few minutes.

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And certainly it can evolve into something that's much more than that.

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I've got a number of pens that probably need a little maintenance and a little ink.

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At some point I'll get there and so I'll just have to figure out which one of these is still running.

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Intramuscular injection of any kind is Frankensteinian.

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Frankensteinian.

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Okay, that's possible.

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This first video is taken from February 20... Sorry, no, it's the 2nd of February 2000.

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The year is 2000 and we're gonna watch a C-SPAN video from the year 2000.

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That's my...

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That's my task for today.

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I don't know why that's not working.

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I'll get it up there.

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Hold on one second.

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I'll get it up there.

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Hold on one second.

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I'll get it up there.

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Hold on one second.

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I'll get it up there.

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Hold on one second.

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I'll get it up there.

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Hold on one second.

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I'll get it up there.

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Hold on one second.

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Okay, so it should be noted already, right, that Frist is a guy who has a lot of connections to, what do you call it, stem cell therapy and all kinds of other, let's say, biotech and just be broad-brushed with it.

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The other guy that's sitting at the table there is a Kennedy.

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And so let me see, I probably should switch over here, but I bet I don't have that set up yet.

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Let me make a couple more mouse clicks over here if you don't mind.

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And I can get this second one set up quick.

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Yes, this one here.

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And that, and there, and oh, that's not focused yet.

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Hold on one second, I got to focus this camera.

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my green screen camera.

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Put my hand right in the mirror in there and... Does that look okay?

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I don't know why I gotta do this.

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Sorry.

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I gotta focus my camera.

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Otherwise I'll look funny.

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Let me see.

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There.

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Wow, why is that so hard to do?

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I don't know why that was... I couldn't barely see it.

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Okay.

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That should be set up correct now.

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This should be right.

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Right.

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Ding ding.

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And then if I turn that on and I put myself there.

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Okay, this should work.

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Thank you.

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Sorry for the delay.

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Oh, and then I have the wrong screen back here.

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Come on, man.

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Get your game on.

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Okay, here we go.

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OSIN with the link in the chat.

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Nice work, Jedi Master.

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This is the kind of wingman I need right there.

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Nice work, OSIN Page.

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That is fantastic.

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Good morning.

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I'm sure I'm saying your name wrong, but you know who you are.

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OP, baby.

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What are truly critical issues regarding

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the subject of patient safety in gene therapy clinical trials.

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The events of the past few months involving gene therapy research have given all of us, our government and our society, a reason to pause and have prompted the subcommittee today to undertake and initiate a thorough review of this revolutionary, truly revolutionary, research field

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and the systems which surround it.

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The revolutionary research field of gene therapy, and so what they are talking about here, let's just be very blunt, is the use of adenovirus to express proteins in people that are missing the proteins.

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In some cases, it may be to permanently edit people to produce the proteins or to change their protein in specific disease contexts, in imaginary or theoretical contexts even.

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And in the case of the boy that they're talking about, they're talking about using adenovirus to do that in the liver and delivering this directly to the liver.

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And so let's make no bones about it.

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There are some semantic things here that need to be discussed.

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The first one is, is that in general, as far as I understand it, and I'm happy to have someone correct me,

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When I was a neuroscientist, we talked about transformation and transfection as two different things.

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And transformation was the use of a viral particle carrier and the DNA being the vehicle by which the protein expression is changed.

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And so if you used an adenovirus to express an optogenetic protein in the brain of a mouse, you were transforming those neurons.

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If you used an mRNA to upregulate the number of glutamate subtypes in that or change the ratio of glutamate subunits in a neuron, then you were transfecting it.

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And that was just to keep those two things straight.

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What were you doing?

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Were you using a carrier, an mRNA, or were you using some form of what I understood as an adenovirus vector to carry a DNA in there to do the same thing?

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And so in this case what they are talking about doing is adenovirus transformation of his liver to fix his genetic deficiency.

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Now here's the trick and the part that I think is important as I hit play and then try to shut up.

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The J&J shot was

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For all practical purposes, no different than what they gave to him, except number one, the protein is different.

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Obviously, it wasn't an enzyme to digest starch.

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It was purported to be a fusion protein isolated from a novel coronavirus, with some alterations to make it permanently embedded in a membrane or something like that.

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And the second being that they rolled out mRNA with the same thing some months afterward.

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And if you hear the context, the history here, how are these people talking about it?

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Are they talking about it like, of course it's gonna work.

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We can give it to all the old people with these conditions.

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How are they talking about it?

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Are they respecting it as just because we don't know, but we expect it to work great, like what they were talking about at the beginning of the pandemic?

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Or are they talking about it with a bit more reverence?

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in a bit more respect, and start to listen carefully for that, because this language essentially belies the truth of what transformation and transfection is in healthy animals and mammals, which I've been saying for a while, would be criminal to claim that we know what we're doing, that we could use this methodology in general as a medicine.

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except in the rare cases where someone's gonna die anyway, where their system is so out of whack that maybe you have to try a last-ditch thing.

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And that's what you hear here.

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Today's hearing is a very important one.

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We'll be talking about death.

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I might have to speed it up.

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We'll be talking about promising new research, new research that couldn't have even possibly been imagined a year ago.

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Just a little bit faster.

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We'll talk about the tough ethical issues such as informed consent.

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What does it really mean about conflict of interest?

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Informed consent is what Brett Weinstein and the bioethicist Robert Malone says that this was all about all along.

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I mean,

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about the nature of experimentation in human beings.

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Inherently risky.

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Fundamentally profound.

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We'll talk about a preacher.

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What is gene therapy?

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How is it different from other therapy?

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What promise does it hold for each of us for our children?

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Gene therapy is an experimental procedure, one whose effectiveness has not yet been demonstrated, but it does offer

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real hope and real promise for those people who are suffering from genetic and non-genetic diseases.

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It holds great promise but because it is experimental there is an absolute need necessity that we in government and in the private sector provide appropriate and vigilant oversight.

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If we ask patients to participate in clinical trials in moving that promising science forward

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we must assure them that their patient safety is first and foremost.

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I hope that today's hearing will be a thoughtful discussion and provide a thorough review of the oversight mechanisms that are in place, both those that are in place and on paper, as well as giving us the opportunity to see whether or not what is on paper and in place is actually being carried out.

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Doctors and scientists do have what I regard as a truly noble journey to pass along the promising research, to explore that research in an appropriate way in this new scientific field.

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But in that journey, there is absolutely no room, no place for mistakes that compromise patient safety.

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The tragic death of Jesse Gelsinger, who is the first patient that we learned about

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that had died of gene therapy has sombered us all.

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Jesse, as all of you know, was 18 years old.

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He had a rare liver disease.

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He unselfishly, unselfishly volunteered for a gene therapy clinical trial, which was designed not to cure him, but instead to develop a treatment that others, other children, other babies could benefit from in the future.

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Mr. Pollack.

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Wow.

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He just said that, that, that treatment of Jesse Gelsinger wasn't even to treat Jesse.

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It was to develop something that could treat other people.

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That's an enormously interesting statement to make.

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Um, Oh, darn it.

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I don't have it up.

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Hold on one second again.

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Just let me make a couple of mouse clicks over here.

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I had, I, I told V to send out a notice, you know, at 1111 I'm going on.

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And then of course I wasn't quite ready to go at 1111.

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There we go.

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Bill Frist opened Stress on Bioethics, Promising Technology, New Scientific Field.

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We heard all about it, right?

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I mean, this is definitely, he's in, he's all in.

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But we have no room for mistakes, no room for patients, you know, getting hurt.

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And this is the first patient we learned about dying.

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Now, I don't know if he meant to say it like that, but it sounds like there are more people who died.

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maybe at other companies that were doing similar experiments at the same time.

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I wonder if there were any other companies doing similar experiments.

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My suggestion would be to, we should ask Housatonic Live if there are any other, were any other companies that might have also had experiments going on where

29:19.212 --> 29:22.295
patients may have died as a result of gene therapy.

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Anyway, I'll go back over here.

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Gelsinger, Jesse's father, has generously agreed to be with us here today.

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And at the outset, and you'll hear it many times, we offer our deepest condolences to the Gelsinger family.

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and our true gratitude that he comes before us in a painful time in his own life to share with us his experiences and to help us learn how we can make the big picture better, to make the system better.

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As we will hear Mr. Gelsinger graphically describe today, we absolutely must chart a new path that ensures that no family will have to endure what he and his family have had to endure over the last several months.

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Yet,

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Just this week, and I predict in the future, we're going to continue to learn more about adverse events that have occurred in gene therapy trials.

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Just this week we learned about unreported deaths.

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The National Institutes of Health, who is with us today, following Jesse Gelsinger's death, put out a call, a far-reaching call, for all investigators conducting gene therapy research to remind them that they must report serious adverse events to NIH and the FDA.

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The fact that NIH received 652 previously unreported serious adverse events in response to this request is really inexcusable.

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Wow.

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Clearly our oversight system is failing.

30:52.486 --> 31:08.415
Our hearing today is the first step in the congressional examination of the oversight procedures and the guidelines in place at the NIH and the FDA to determine whether or not we have adequate systems to approve and then to monitor these revolutionary new gene therapy trials.

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If we learn that the appropriate systems and guidelines are in place on paper, we must then ask, are they working in reality?

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I suspect they're not.

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The deaths of several patients reported over the last several days, the 652 previously unreported adverse events suggest the system is not working.

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All of these events trigger serious questions regarding federal oversight of these gene therapy trials as well as the adherence to the federal guidelines that are out there on the part of the individual investigators themselves, the research community.

31:40.836 --> 31:49.122
Serious ethical questions and so much of science today at the pace it's moving is introducing new ethical questions that we as policymakers have never had to address in the past.

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Ethical questions regarding the risk to patients in human experimentation in these trials.

31:55.902 --> 32:01.308
the high financial interest that are at stake as increasingly the private sector is funding such trials.

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We must examine our process of informing patients.

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Is it time for us to go back and look at what truly informed consent means in this new era of rapidly advancing science?

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Truthful and complete information to patients.

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We must ask if there is an atmosphere of unrealistic expectations with regard to gene therapy.

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We'll talk about that in our third panel.

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What does gene therapy truly hold as promise?

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How quickly can we realize those promises that are there?

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Are patients given full information regarding past adverse events as they enter participation in these clinical trials?

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Now an objective that I have is to keep the hearings as we go forward balanced,

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and make sure our discussion is careful nobody is on trial here not the government did not universities not research scientist and it is a clearly to everyone's advantage to put everything on the table

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in as quick a fashion as we can.

32:52.575 --> 33:01.120
It's tough because every day new information is coming out and I'm very hopeful that over the course of this morning that we can achieve that balanced and careful examination and discussion.

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We know that we can learn from previous mistakes.

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We do need to know what those mistakes are if we're going to learn from them, if we're going to improve the system, if we're going to move forward this field of gene therapy.

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The tragedy of Jesse Gelsinger

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basically, I believe, should not result in another tragedy.

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And that other tragedy, again, I hope that we talk about today would be to bring a halt to this promising research.

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And that's not the objective.

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In fact, I feel strongly that we need to develop a system where we allow this promising research to continue and to flourish.

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It does have the potential, I believe, of treating cancer and AIDS and cystic fibrosis and non-genetic diseases and genetic diseases alike.

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And so I think this is a... We must remain steadfast in our... This is a good place to stop because, you know, it's a new era of rapidly advancing science that's going to need some new kind of regulatory structures.

33:52.354 --> 33:58.196
And if we are going to move forward with this promising research, we're going to need this new regulatory structure.

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need new oversight yada yada yada bioethics informed consent it's kind of the same song and dance that that these these current posers in front of largely in front of the populist right in america um

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That's the same song and dance that they're performing right now.

34:20.833 --> 34:32.327
And so, by using these very broad strokes and these very general terms, they are able to seem as though they're genuinely concerned about this stuff, but he said it very clearly right there.

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The objective is to move forward.

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The objective is to find a way to have due process to move forward so that irrespective of the results that come and the sacrifices, or let's say the potholes in the road, irrespective of those potholes, we keep driving.

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because we are sure that the destination that we're moving toward this promising new research in gene therapy is really that destination where cancer will be cured and all diseases, genetic and non-diseases, will be cured.

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That's the push here.

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Commitment to ensure that patients are safe, that there are adequate human protections, and that the research is meaningful and substantial.

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With that as an overview, let me, before turning to Senator Kennedy, let me just tell people how I'd like the hearings to go forward.

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We will have opening statements.

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We will have brief opening remarks from our witnesses.

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And we'll have three panels today.

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Each of the witnesses are asked to keep their remarks to around five to six minutes in length so that we really can carry on a discussion as we go forward.

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Following the presentation, each of the members will be allowed to ask questions.

35:44.586 --> 35:51.287
The hearing record will remain open for individuals who would like to submit no more than 10 double-spaced pages of written testimony until February 9th.

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At that time, the hearing record will be closed.

35:54.468 --> 35:54.888
Senator Kennedy.

35:55.408 --> 35:58.709
Thank you, Senator Frist, and thank you very much for having these

35:59.910 --> 36:17.143
a hearing says you have mentioned the issue is of critical importance uh to the nation no other medical technology offers greater potential to provide needed is this uncle i think it's uncle right it's his uncle you have mentioned the issue is of critical importance to the nation

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No other medical technology offers greater potential to provide needed cure for so many diseases.

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And at the same time, no other medical technology has illustrated more clearly the need to protect patient safety and to provide the opportunity for informed consent.

36:32.403 --> 36:44.029
The tragic death of Jesse Gelsinger reminds us of the hope felt by those who look to gene therapy for a cure of their illnesses and the need for constant watchfulness in protecting the safety of patients involved in medical research.

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No other medical technology, please hear it.

36:49.131 --> 36:58.055
No other medical technology has the promise to achieve what gene therapy has the promise to achieve.

36:58.095 --> 37:01.017
These people have believed this for decades.

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And I would argue, in retrospect, the Human Genome Project was all about this.

37:08.209 --> 37:09.109
It was all about it.

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It was one contiguous project.

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to set up the technology, and then the infrastructure, and then the IT, and then the infrastructure for the data, and then all of the stuff that's being built now is all one continuous long-term plan.

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And to a large extent, they are meeting the computing goals, and the storage goals, and the ability to sample and test people.

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They're meeting all these goals.

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They have all the remnant streams set up.

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It's all ready.

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And it started all back here.

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Back here was when they were still speaking honestly.

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So listen to the honesty here.

37:52.002 --> 37:54.885
In many ways, Jesse Gelsinger was a typical teenager.

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Loved motorcycles and professional wrestling.

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Spent time with friends and worked at the local grocery store.

38:00.973 --> 38:03.214
Yet in one respect, he was very different from all his friends.

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Not because he had a rare genetic disorder, but because he had the courage to put himself at risk to test what he deeply believed to be the best hope of a cure for those with genetic disorders.

38:14.320 --> 38:16.762
Tragically, Jesse's courage led to his death.

38:17.662 --> 38:26.167
We must... So they're painting it as though Jesse knew he was risking himself for the future, which I'm...

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I'm skeptical of.

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I'm skeptical that his father would allow him to say, yeah, I'm all about it.

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I don't care.

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I'll risk my life to get a chance to save kids in the future.

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Maybe the next generation of this technology will work.

38:43.986 --> 38:45.968
Even if it screws me up, they'll learn a lot.

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So make sure you donate my liver and my body afterwards so that they can do a full autopsy and get all the data they need.

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Yeah, dad, that's what I want to do.

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I don't know, I think it's odd.

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Let's do all we can to see that his sacrifice was not in vain.

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His hope was that someday gene therapy will provide cures for tens of thousands of babies born with genetic disorders every year.

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Let's not forget that Robert Malone has been on several podcasts in 2021 and 22 where he explained that when he was a young grad student, it seemed pretty obvious to him at the time that within 10 years there would be a geneticist at every hospital curing genetic diseases with retroviruses.

39:31.886 --> 39:45.831
understand that these people and their mentors is a continuous chain of mentorship that extends directly back to these people who made gigantic assumptions about where we would be at this time and even earlier.

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Gigantic assumptions about how we would solve these problems.

39:52.621 --> 40:07.007
Many of these ideas go all the way back to Joshua Lederberg He's he's the guy who said that we would learn all about the first molecules of life from meteors in outer space He's the first guy to coin the term microbiome.

40:07.067 --> 40:20.832
He's the this guy and The people that were mentored under him and through him and followed him and who he was connected to and Who spoke at his funeral?

40:21.991 --> 40:30.734
These are important questions and really crucial, pivotal character in American history that nobody talks about.

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And here we are right now in 2000, the year 2000, talking about gene therapy with the utmost respect, the utmost reverence, and the utmost trepidation.

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And 20 years later, we would talk about it as a vaccine, as a foregone conclusion that not only would it work, but you would be a real selfish ass if you didn't take it.

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Interesting what you're about to hear.

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And for the millions more affected by cancer, heart disease, AIDS, and many other serious illnesses.

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The promise of gene therapy is shared by thousands of patients and is daily being brought closer to reality by talented researchers across the country.

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Today we'll hear about some of the ways in which gene researchers are making gene therapy safer and more effective than it's ever been before.

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Our challenge is to see that those who volunteer to participate in gene therapy trials are fully protected from unnecessary risks.

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Oversight of this field should be as comprehensive as possible.

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In particular, when tragic events do occur, they must be reported in a timely way to the appropriate oversight agencies.

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We must also see that those who volunteer to serve as research subjects are fully informed of the possible risks of the treatment they are about to receive so that the consent they give is well informed.

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I look forward to the testimony of our witnesses, to working with the members of the committee to assess the adequacy of the current rules governing this extraordinary area of medical research.

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And we are particularly indebted to Paul Gelsinger for being here today.

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We thank him for his own courage.

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It's never easy to talk about this kind of a extraordinary human tragedy.

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We're very, very grateful to him for being willing to appear before the committee.

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Thank you.

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Thank you, Senator Kennedy.

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Senator Hutchison.

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I think Senator Pritz, Senator Kennedy have outlined the issues very clearly and very well.

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I just want to say, Mr. Gelsinger, I was deeply moved as I read your testimony, and I look forward to hearing your testimony and your story.

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I noted in your written testimony that one of the leaders in the field called your son's death a pothole in the race to gene therapy, and that you observed that

42:43.857 --> 42:51.584
The concern should not be on getting to the finish line first, but on making sure no unnecessary risks are taken, no lives filled with potential or promise are lost forever.

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How true, and I want to join Senator Kennedy in saying that, in fact, your son's death was not in vain.

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And I think already it has called the nation's attention to some very great dangers.

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And I appreciate your courage and your willingness to come forward today.

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And I thank you for the hearing, Mr. Chairman.

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Mr. Chairman, you have you and Senator Kennedy and Senator Hutchinson have outlined the issues.

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I thank you for having the hearing.

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I thank Mr. Gelsinger for being here and the other witnesses, and I look forward to the testimony.

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Thank you.

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Thank you.

43:22.490 --> 43:26.152
The first of three panels, panel one will present and discuss the patient safety.

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So they called attention to the name of the nation.

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They called the attention of the nation to some great dangers.

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concerns and we'll talk about the informed consent issues in clinical research.

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Mr. Paul Gelsinger of Tucson, Arizona is the father of Jesse Gelsinger who tragically passed away last September during participation in a gene therapy trial at the University of Pennsylvania.

43:52.447 --> 43:54.890
Mr. Eric Kast of Norman, Oklahoma.

43:55.170 --> 43:55.971
Welcome, Mr. Kast.

43:57.409 --> 44:08.592
Eric is a cystic fibrosis patient who has participated in a number of clinical trials, including a gene therapy trial, in order to contribute to the search for a cure for cystic fibrosis.

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He currently works for Blue Cross Blue Shield of South Carolina, where he educates medical equipment suppliers about Medicare claims.

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He received his bachelor's and master's degree in journalism and public relations from the University of Oklahoma.

44:19.815 --> 44:22.236
He is testifying on behalf of the Cystic Fibrosis Foundation.

44:22.836 --> 44:31.662
Mr. Kast, again, thank you for being with us today and for your dedication in combating a disease that we're making tremendous progress on over the last 15 to 20 years.

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We'll begin with Mr. Gelsinger to be followed by Mr. Kast.

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Mr. Gelsinger.

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Let me just mention these microphones are very directional, so we may have to pull them up fairly close.

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Mr. Gelsinger.

44:43.391 --> 44:48.034
Thank you, Senator Frist, and thank you, members of this panel, for allowing me to contribute to this hearing today.

44:49.801 --> 44:55.064
I am addressing this committee in the hope of bringing to light some very serious concerns that I have as a result of my son's death.

44:56.125 --> 45:04.450
My son, Jesse Gelsinger, was participating in a first phase clinical trial conducted by the Institute for Human Gene Therapy at the University of Pennsylvania in Philadelphia.

45:05.531 --> 45:17.218
Jesse was recruited to participate in the trial after being told that his efforts would benefit newborns and other children with his specific disorder, Ornithine Transcarbamylase Deficiency Syndrome, and for a myriad of other liver disorders.

45:18.138 --> 45:18.839
Jesse did not

45:20.993 --> 45:23.355
Jesse did not need to participate in this clinical trial.

45:23.675 --> 45:26.377
Indeed, he was told that the trial would not benefit him in the least.

45:27.077 --> 45:33.121
At the time, Jesse was doing exceptionally well in his medications, and nothing should have prevented him from living a full and happy life.

45:34.342 --> 45:40.966
He believed, after discussions with the representatives from Penn, that the worst that could happen in the trial would be he would have flu-like symptoms for a week.

45:42.461 --> 45:52.484
He was also told that the most dangerous parts of the procedure were to be the catheterization procedure by which the gene therapy would be introduced to his liver, and the liver biopsy that was to be done a week later.

45:53.024 --> 45:56.125
And so, let's make no uncertain turn.

45:56.365 --> 46:09.910
Adenovirus was seen as a suitable carrier because adenovirus tends to end up in the liver and infect liver cells in many of its forms, as I understand it.

46:10.894 --> 46:22.282
If they thought that if they injected it right into the liver that it wouldn't go very many places and since those viruses don't tend to infect a lot of tissues in their understanding, then everything would be fine.

46:24.663 --> 46:29.447
Worst case scenario, he would have some flu-like symptoms, you know, because that's what viruses do.

46:33.206 --> 46:37.689
And the reason why he did it was because, you know, he thought he could help other kids in the future.

46:37.749 --> 46:44.875
He knew it wasn't going to help him, but he certainly didn't know that it could cause catastrophic autoimmunity.

46:47.837 --> 46:54.001
Which, of course, any of these scientists should have known and expected because, of course, Robert Malone knew that.

46:59.585 --> 47:00.286
It's remarkable.

47:01.365 --> 47:13.431
With the knowledge I had at that time, I was comfortable enough to send my son, just 18, on June 18th, 1999, to Philadelphia alone on September 9th to participate in this group of trial.

47:13.511 --> 47:19.194
I was scheduled to fly to Philadelphia on September 18th to be present with a liver biopsy and to bring Jesse home.

47:20.355 --> 47:27.218
Jesse put his personal life aside, took an unpaid leave of absence from his job, and accommodated everyone else's schedule to do what he did.

47:27.898 --> 47:28.759
He was excited to help.

47:29.597 --> 47:36.823
In addition, Jesse relied on my judgment in participating in this clinical trial, and I trusted this to be a well-controlled and purely ethical effort.

47:38.124 --> 47:46.370
Less than 24 hours after they injected Jesse with the vector in an amount only one other person had ever been given, Jesse's entire body began reacting adversely.

47:47.291 --> 47:51.694
He went into a coma before I could get to Philadelphia and see him, and died two days

47:52.483 --> 47:55.904
after my arrival directly as a result of that gene therapy experiment.

47:56.424 --> 48:01.666
While his death has been a devastating blow to us, his example has sustained us through it all.

48:04.327 --> 48:09.089
As you can imagine, my family and I have many concerns over what happened to Jesse.

48:10.290 --> 48:22.438
Jesse and I were told in late July 1999 that a prior patient, the patient before him, had shown a clinical improvement of 50% in her ability to eliminate ammonia from her system following gene therapy.

48:23.299 --> 48:29.463
At the Recombinant DNA Advisory Committee meeting in December, I discovered that no efficacy was achieved at all in this patient.

48:30.443 --> 48:35.767
We were also unaware of the severity of liver injury incurred by several of the patients prior to Jesse.

48:36.681 --> 48:45.006
I learned after Jesse's death that Penn had removed from it the information they gave Jesse and me any reference to deaths of monkeys which had previously appeared in their documents.

48:45.386 --> 48:45.706
Wow.

48:45.766 --> 48:53.311
At the RAC meeting in December, I also learned that at least one other monkey died in a related study using the same adenoviral vector used on Jesse.

48:54.531 --> 49:05.778
I learned that Penn neglected to follow its own and FDA protocols when it found that Jesse had ammonia levels above the permissible limits, a clear danger sign, and yet went forward with the procedure anyway.

49:06.934 --> 49:18.358
I learned that a pharmaceutical company had conducted experiments similar to the one Jesse was in and had obtained adverse results which, if disclosed, would have fully informed Jesse and me of the real risks in this procedure.

49:20.019 --> 49:26.681
I had very close contact with the doctors involved until December 10, 1999, immediately following the RAC meeting.

49:27.562 --> 49:30.983
Looking back, you can see that I was very naive to have been as trusting as I was.

49:32.324 --> 49:36.105
As serious as my concerns are with Penn's trial as Jesse's father,

49:37.193 --> 49:41.640
I have equally great concerns regarding the federal oversight of gene therapy as an American citizen.

49:42.601 --> 49:46.427
As a result of Jesse's death, many important issues regarding gene therapy have come to light.

49:47.486 --> 49:57.209
the number and lack of proper reporting of adverse events associated with gene therapy, the nature of gene therapy research, and the motivations behind the race for results.

49:57.609 --> 50:13.673
I wonder if you can imagine a scenario where this, this era in American history made them realize that there was no way through the normal regulatory means or the recombinant DNA committee or whatever the heck he's talking about, the RAC,

50:15.026 --> 50:25.896
that there was any way that this was going to become a mainstream medical practice, that there was going to become a mainstream medically accepted methodology.

50:25.936 --> 50:32.222
There's just no way it was going to get there through this means, and certainly not after this meeting.

50:34.524 --> 50:39.849
So what alternative would you have if you had a multi-decade plan

50:41.601 --> 50:57.293
to turn the American population into experimental animals and take their medical and genetic data and put it on a computer and apply machine learning algorithms to it and combine it with the data collected from other countries.

51:00.215 --> 51:03.537
And eventually to, you know, design

51:05.054 --> 51:17.539
transfections and transformations, probably just transfections, which are specific for individuals and thereby cannot be regulated by the FDA in its traditional way.

51:19.380 --> 51:19.980
What would you do?

51:20.661 --> 51:30.465
Maybe create a multi-decade emergency where the diagnostic stream could be used to establish the remnant stream that actually does all the sampling for you?

51:34.699 --> 51:46.292
and where the countermeasure to save us from the hypothetical biological threat is transfection called an investigational vaccine.

51:46.332 --> 51:49.716
I mean, that's kind of where your kids are right now.

51:50.536 --> 51:53.560
And as an adult, if you can't explain to them

51:56.345 --> 52:09.567
how this has been induced, how it has been created and maintained by the use of social media, by all of these naive adults around them, they will grow up not understanding the world they live in.

52:10.808 --> 52:23.730
Because in 2000, the use of adenovirus to transform a healthy human, a sick human, a sick human was considered to be very dangerous.

52:28.553 --> 52:29.453
what troubled me most.

52:30.714 --> 52:40.978
In my heart and soul search for the truth, I have learned that only six percent of nearly 700 adverse events were reported properly to the NIH.

52:42.259 --> 52:49.562
That some companies were reporting only to the FDA and labeling reports proprietary in direct conflict with NIH guidelines.

52:50.542 --> 52:54.544
And that the cooperative effort espoused by the NIH was virtually non-existent.

52:55.942 --> 53:07.018
I learned from a former RAC member and corroborated by another witness and from the actual minutes of the June 1995 RAC meeting that business interests had unduly influenced the FDA.

53:08.100 --> 53:12.166
At the December 1999 RAC meeting, I saw many things, some encouraging,

53:13.010 --> 53:13.610
some troubling.

53:14.090 --> 53:27.874
I saw a cooperative effort on December 9th, but on December 10th, I listened to the biotechnical lobby offer to voluntarily comply with the guidelines, and the pharmaceutical company stated everything is fine the way it is, that the FDA has everything under control.

53:28.855 --> 53:38.097
In private conversations with an FDA director, I was told that they would like to see legislative changes to untie their hands so they could be less secretive, that they could do the right thing.

53:39.478 --> 53:40.798
I have read that my son's death

53:41.508 --> 53:46.891
has been called by one of the leaders in this field as a pothole on the road to gene therapy.

53:47.451 --> 53:48.772
This death was no pothole.

53:49.673 --> 53:53.235
It was an avoidable tragedy from which I will never fully recover.

53:54.716 --> 53:58.718
My concern now is that Jesse's death not be in vain, not be just a pothole.

53:59.218 --> 54:00.799
I am not against gene therapy.

54:01.199 --> 54:04.021
I recognize it holds so much promise for so many people.

54:04.842 --> 54:07.163
But we cannot allow what happened to Jesse to happen again.

54:08.314 --> 54:14.520
I am not a politically sophisticated man, but neither am I unintelligent when it comes to what motivates people.

54:15.521 --> 54:21.566
I understand how important competition is in the world of business, and I can understand the temptation to influence government.

54:22.347 --> 54:25.109
And I realize the desire of some to make a name for themselves.

54:25.990 --> 54:32.616
However, when lives are at stake, and my son's life was at stake, money and fame should take a back seat.

54:33.362 --> 54:39.824
The concern should not be on getting to the finish line first, but making sure no one's necessary risks are taken.

54:40.304 --> 54:43.325
No lives filled with potential and promise are lost forever.

54:44.185 --> 54:45.946
No more fathers lose their sons.

54:47.046 --> 54:51.607
Understand no more fathers losing their sons.

54:51.647 --> 54:53.968
How about no more daughters losing their fathers?

54:55.308 --> 55:01.190
How about no more sons losing their fathers and their mothers?

55:03.786 --> 55:14.713
Because the exact same concerns should have been applied to the use of adenovirus in our old people, even if we were going to intramuscularly inject it instead of into the liver.

55:19.937 --> 55:22.118
Jesse Gelsinger doesn't have to have died in vain.

55:22.298 --> 55:30.704
Jesse Gelsinger could also be part of the sort of ghosts of USA past.

55:33.513 --> 55:35.094
that could come to our rescue.

55:35.954 --> 55:39.977
The real story of Jesse Gelsinger is wanton neglect.

55:41.538 --> 55:47.981
It is avarice, this extreme arrogance.

55:52.344 --> 56:00.969
They were augmenting a kid that would have lived a long, healthy life, essentially qualifying as a healthy kid.

56:01.892 --> 56:06.113
And they were augmenting him by intra-liver.

56:06.894 --> 56:10.195
How would that intra-hepatital injection.

56:16.297 --> 56:20.238
I mean, we've got to get our heads around the big ideas here.

56:22.138 --> 56:26.700
And the big ideas go back really a hat tip to Brandy Vaughn.

56:29.560 --> 56:39.387
I am really starting to feel less and less concerned about the food that I eat, and so much more worried about what people are injecting.

56:41.489 --> 56:46.052
Because I trust my gut, I trust my liver, I trust those things.

56:46.112 --> 56:52.637
Now, you can have a leaky gut, you can have a leaky blood-brain barrier, and the causes of those things are many, I'm sure.

56:54.378 --> 56:56.080
But if these barriers are intact,

56:58.393 --> 57:01.834
And these barriers are maintained or even fortified, for example.

57:02.615 --> 57:06.096
Imagine the change in the health of humans.

57:08.177 --> 57:14.499
Now, it's independently, you know, I'm not saying we can just eat glyphosate and all that other stuff and, you know, nothing's going to happen.

57:14.539 --> 57:21.501
But what I am suggesting is that there is an order of operations and then there's a rank of severity and

57:23.735 --> 57:41.054
You know, injecting a well-blended Philly cheesesteak into your arm, even just a little milliliter of that, is very different than eating liters and liters of the same concoction in a shake.

57:43.547 --> 57:44.567
and just chugging it down.

57:45.307 --> 57:47.068
It's just different.

57:47.688 --> 58:06.413
Even if you sterilize the Philly cheesesteak emulsified injection and sterilized it and whatever, and then put it in, it's still ridiculous to think that that would be a way to give someone medicine.

58:08.106 --> 58:22.611
And yet that is the foundation of the childhood vaccine schedule, that there is a combination of substances that can be injected intramuscularly, which will result in a net positive for that child.

58:24.852 --> 58:35.135
The main net positive being that they will not exhibit the symptoms that we describe as measles, the symptoms that we describe as polio, I guess.

58:37.881 --> 59:04.216
And now, ladies and gentlemen, I'm not saying that I've got all the answers, but I am saying that this mythology, that they have all the answers, and that their understanding is of extremely high fidelity, that their mastery of these unseen domains of molecules and chemicals and the foundational principles of life is all within their toolbox.

59:04.256 --> 59:05.317
This is an illusion.

59:06.325 --> 59:12.107
And it is an illusion that goes all the way back to the announcement that the Human Genome Project has finally been achieved.

59:13.087 --> 59:16.689
An announcement made by Francis Collins and Mark Lander.

59:19.229 --> 59:24.911
And now we are under the spell of people who are essentially have been mentored by these people.

59:26.032 --> 59:29.513
People that have been mentored by Hilary Kaprowski and Stanley Plotkin.

59:29.553 --> 59:32.434
We are under the spell of people that have been mentored by

59:33.220 --> 59:39.102
by Mary Holland and Andrew Wakefield.

59:39.622 --> 59:41.683
We are put under the spell.

59:42.123 --> 59:57.948
Your family and friends that believe that in the Maha movement right now, they are all under the spell of some kind of non-real health freedom movement, which is just a fake populist right movement.

01:00:01.024 --> 01:00:04.606
It's terrible, but your family and friends are trapped.

01:00:05.087 --> 01:00:07.028
They are fooled by these people.

01:00:07.428 --> 01:00:11.871
And you can see that at some point in the United States, the truth was still available on TV.

01:00:12.331 --> 01:00:25.860
At some point in the United States, they still hadn't gotten so far down the road of just lying about it that this hearing actually occurred.

01:00:26.040 --> 01:00:27.761
I find this extraordinary.

01:00:29.175 --> 01:00:38.540
The confidence of all Americans in their government has been so weakened that the response I get most often from my story is, so what else is new, even from my other children?

01:00:39.781 --> 01:00:48.525
The answer for me in all this is to apply Jesse's intent to the oversight and application of gene therapy, not for profit or recognition.

01:00:49.266 --> 01:00:52.348
That will come naturally, but for the betterment of all people.

01:00:53.488 --> 01:00:58.731
Senators, please help me be able to tell my children that our government is all that it should be.

01:01:00.379 --> 01:01:01.500
Thank you.

01:01:02.741 --> 01:01:03.622
Thank you, Mr. Gelsker.

01:01:04.402 --> 01:01:04.903
Mr. Kast.

01:01:05.363 --> 01:01:06.904
Thank you, Mr. Chairman, members of the committee.

01:01:07.004 --> 01:01:08.906
I appreciate being invited here to talk with you today.

01:01:09.646 --> 01:01:15.771
My name is Eric Kast, and I was diagnosed when I was three months old with cystic fibrosis, so I've never known what it's like not to have CF.

01:01:16.331 --> 01:01:20.635
Over the past 10 years, I've participated in eight different clinical trials, including gene therapy.

01:01:21.584 --> 01:01:31.113
I'd like to offer our condolences to Mr. Gelsinger and for his personal loss, as well as from the perspective of somebody who's participating in gene therapy and somebody who may benefit one day from gene therapy.

01:01:31.493 --> 01:01:34.356
I truly appreciate what Jesse's went through and what he's done.

01:01:34.376 --> 01:01:35.177
So thank you.

01:01:36.917 --> 01:01:47.690
This morning, I'd like to also share with you some of the concerns that I have as a research participant, and some of those issues are the patient safety, informed consent, and also the reporting of these adverse medical events.

01:01:48.150 --> 01:01:55.659
I'd also like to share with you the Cystic Fibrosis Foundation's perspective on how the safety of patients and the urgent need to develop new therapies can best be met.

01:01:56.300 --> 01:01:59.481
First, we must maintain the FDA's authority over the gene therapy trials.

01:02:00.002 --> 01:02:01.462
Second, we should encourage the recovery.

01:02:01.522 --> 01:02:06.024
We should maintain the FDA's authority over the trials.

01:02:06.104 --> 01:02:09.706
Now, I have a picture somewhere that I'm not going to be able to find it right now.

01:02:09.726 --> 01:02:11.207
I think it's in the general biology book.

01:02:11.227 --> 01:02:11.527
Hold on.

01:02:17.569 --> 01:02:18.750
Yes, here we go.

01:02:18.910 --> 01:02:23.112
I have a picture of Mr. Mann, Mr. Francis Collins.

01:02:23.951 --> 01:02:29.675
Mr. Francis Collins is the guy who found the gene for cystic fibrosis.

01:02:29.775 --> 01:02:39.901
So, Francis Collins is really sitting right here, basically, because, you know, the whole idea of finding the gene for cystic fibrosis is so that you can, excuse the bump,

01:02:40.861 --> 01:02:41.941
Oh, that was loud.

01:02:41.961 --> 01:02:45.903
That you can, um, that you can, you know, identify the gene and fix it.

01:02:45.983 --> 01:02:56.726
So, Francis Collins is right here, and cystic fibrosis was meant to be one of these low-hanging fruits, you know, that would be cured because the Human Genome Project does that.

01:02:56.946 --> 01:03:04.528
And it hasn't been cured, um, at all, but this was one of the, let's say, this was one of the shit-talking points that they had.

01:03:04.588 --> 01:03:08.689
That this was, well, obviously, this was going to be one of the first things that was fixed.

01:03:09.520 --> 01:03:12.922
because they, you know, one of the first genes they were able to identify.

01:03:13.683 --> 01:03:19.767
from the DNA Advisory Committee to work closely with the FDA to examine the overall field and to educate the public.

01:03:20.327 --> 01:03:27.072
We urge you to identify the best balance between patient confidentiality and the disclosure which can ensure the patient's safety.

01:03:27.692 --> 01:03:33.236
Cystic fibrosis is a genetic disease that primarily destroys the lungs and it also affects the digestive system.

01:03:33.736 --> 01:03:37.719
Also, as a direct result of CF, I now have diabetes so I take insulin injections.

01:03:38.279 --> 01:03:43.143
Just taking care of myself and being able to breathe takes about two hours per day, something that most people take for granted.

01:03:43.723 --> 01:03:45.405
Despite my problems, I know I'm fortunate.

01:03:45.826 --> 01:03:46.727
I'm 33 years old.

01:03:47.307 --> 01:03:49.590
But after those two hours a day, he can do this?

01:03:50.231 --> 01:03:53.374
That's... I'm very skeptical now.

01:03:53.534 --> 01:03:53.895
Darn it.

01:03:53.915 --> 01:03:57.139
The average life expectancy of somebody with CF currently is only 32 years.

01:03:57.719 --> 01:04:01.884
When I was born, my life expectancy was only 11, thanks to the work of the CF Foundation.

01:04:02.972 --> 01:04:05.093
that life expectancy continues to increase every year.

01:04:06.034 --> 01:04:11.017
To me, my five-year-old niece who also has CF, and to the other 30,000 people in the U.S.

01:04:11.137 --> 01:04:15.420
who have CF, 32 years old is an average life expectancy is just unacceptable.

01:04:16.220 --> 01:04:23.365
One of the highlights of my life was when I was six years old is proclaimed Eric Casta in Indianapolis by then Mayor Richard Lugar, who's now one of your colleagues.

01:04:24.145 --> 01:04:32.211
Another highlight of my life, and one of the things that I am most proud of is the opportunity that I had to participate in gene therapy trials.

01:04:32.731 --> 01:04:36.934
To date, 180 people with cystic fibrosis have been able to participate in these trials.

01:04:37.295 --> 01:04:46.902
Of course, the Nunn-Lugar Act, I think, is the one that was cleaning up the nukes and established DITRA, and Robert Malone was working for DITRA at the beginning of the pandemic.

01:04:46.942 --> 01:04:48.023
Something like that, you know?

01:04:48.043 --> 01:04:48.443
I don't know.

01:04:49.417 --> 01:04:53.961
Right now, we are at the crossroads in the race to find a cure for myself and those with other life-threatening illnesses.

01:04:54.541 --> 01:05:00.806
We can continue with the appropriate oversight and the caution that we require, or we can let the fear paralyze us into inaction.

01:05:01.387 --> 01:05:08.032
One of my greatest fears is that if we delay greatly, that I may die just a year or two before a cure is found for CF.

01:05:08.672 --> 01:05:16.799
If that happens, my wife Sherry is going to have to live the rest of her life knowing that if I just survived or made it one more year, we may have lived happily together for the next 30, 40, even 50 years.

01:05:18.320 --> 01:05:34.132
wow that is a really am i wrong is that kind of a selfish statement like uh you know we should rush it with jesse because maybe jesse's experiments will will save me or um i don't know i i'm

01:05:36.243 --> 01:05:42.246
That's really almost like Kurtzweiler saying, you know, if you live to 2040, then you're probably going to live forever.

01:05:42.266 --> 01:05:48.729
You're going to have a chance to upload your consciousness or there won't be any more disease or, you know, I don't know.

01:05:48.749 --> 01:05:50.110
I just, I don't like this.

01:05:50.170 --> 01:05:51.431
This guy's reading a script.

01:05:51.631 --> 01:05:53.912
It's a lot more of a placed kind of dude.

01:05:54.933 --> 01:05:56.874
And so I'm very skeptical of his story.

01:05:57.234 --> 01:05:59.195
We really are that close and we've really come that far.

01:06:00.475 --> 01:06:05.899
These advances, I believe, are a direct result of the CF Foundation acting as an advocate for those of us with CF.

01:06:06.559 --> 01:06:15.165
Over the past several years, the Foundation has worked closely with the FDA to speed the CF drug approval process and also to plan gene therapy research.

01:06:15.746 --> 01:06:21.250
That certainly helps those of us with CF and also those of us who battle every day with other life-threatening illnesses.

01:06:22.421 --> 01:06:24.061
Foundation does believe in the urgency.

01:06:24.161 --> 01:06:29.022
Those of us who battle every day with life-threatening illnesses.

01:06:29.102 --> 01:06:40.044
So again, he's lumping in himself with a lot of other people on this very scripted response that really does neutralize Paul Gelsinger's response.

01:06:40.144 --> 01:06:40.844
It's impressive.

01:06:41.064 --> 01:06:44.505
Of drug development, but absolutely not at the risk of patients' lives.

01:06:45.045 --> 01:06:50.166
People with CF do die every day, but the safety of all patients in clinical trials is the number one concern.

01:06:51.581 --> 01:06:55.702
patients must be fully informed of any previous problems and any potential risks.

01:06:56.603 --> 01:07:00.244
As precaution, the foundation has suspended their gene therapy trials using the adenovirus.

01:07:01.104 --> 01:07:09.047
These trials will not resume until the FDA or the RAC addresses the vector's safety and also if the FDA approves future clinical trials with that vector.

01:07:10.027 --> 01:07:14.529
Now remember, as far as I understand adenoviruses, there are several

01:07:18.991 --> 01:07:24.014
there are tens if not more than 20 serotypes.

01:07:25.214 --> 01:07:37.481
So in that context, I'm quite certain from a regulatory context, from an approval context, just like the lipid nanoparticle was supposedly proprietarily

01:07:38.613 --> 01:07:54.547
altered or improved in such a way that Robert Malone claims that he took it because Peter Cullis, the guy who made the lipid nanoparticle that was used by these companies, apparently told him that it stayed at the injection site when it didn't.

01:07:56.669 --> 01:08:05.236
And so this argument about whether something is new and proprietary and how you define it as new and proprietary, this is a little game they're playing right here.

01:08:06.368 --> 01:08:19.593
And that game would be way over the head of anybody that didn't know that there were so many different ways to classify serotypes of adenovirus and that by the year 2020, there were like 25 or 26 serotypes in use.

01:08:20.093 --> 01:08:22.855
And so which one did they use for the J&J vaccine?

01:08:23.315 --> 01:08:26.576
How many different ones did they use for the J&J vaccine?

01:08:26.596 --> 01:08:31.418
These are all fundamental biological questions that even in the context of accepting

01:08:32.768 --> 01:08:40.331
adenovirus biology as it stands in the books and is accepting that it could be used as a vector to transform our cells.

01:08:42.893 --> 01:08:52.837
This was deadly and dangerous and only worth risking if you would die at age 30 anyway, so why not risk it?

01:08:55.838 --> 01:08:59.540
That's what this hearing in 2000 should tell you.

01:08:59.660 --> 01:09:01.281
And what I want you to understand

01:09:02.432 --> 01:09:13.460
is that our ability to augment a healthy human or a sick human using these techniques has not increased even one iota.

01:09:15.021 --> 01:09:31.313
The only thing that has happened is that our ability to deliver genetic material to locations has seemed to diversify because we have tried so many different ways to do it with precision and failed.

01:09:33.638 --> 01:09:44.461
So it seems like we've got a lot of tools in the garage and there's drawers and drawers of ratchets and wrenches and things that click and ding.

01:09:45.682 --> 01:09:48.203
But most of those tools are useless.

01:09:48.283 --> 01:09:49.463
They don't do anything.

01:09:49.503 --> 01:09:52.704
We can't fix the car or the motorcycle that's in the garage.

01:09:54.369 --> 01:10:10.309
And so if they've tried a million different ways like electroporation or soap bubbles or gold particles to bring genetic material to a target, it hasn't worked.

01:10:11.641 --> 01:10:20.329
It still results in the same failure because you're trying to augment something with a very, very ridiculously simple augmentation.

01:10:20.389 --> 01:10:24.452
It's just not the way the biology of the body is organized.

01:10:27.615 --> 01:10:35.802
And if you don't take into account the way that the body is organized and the way that it functions and maintains homeostasis, then how in the world are you ever going to augment it?

01:10:39.332 --> 01:10:41.934
And so those arguments could be made right here.

01:10:41.995 --> 01:10:48.801
They could be made right here in this very hearing or in this next hearing that comes after this guy's done talking.

01:10:49.882 --> 01:10:52.564
I'm going to see if I can find that one.

01:10:52.584 --> 01:10:55.667
Go forward.

01:10:55.767 --> 01:10:56.388
Thank you very much.

01:10:56.969 --> 01:10:59.291
I'll ask the third panel to come forward.

01:11:09.420 --> 01:11:11.562
I'm excited about our third panel today.

01:11:12.302 --> 01:11:24.491
Apologize for the length of time it has taken to get to the third panel, but the third panel really does bring together, to me, the excitement of the science of gene therapy, cutting right

01:11:25.595 --> 01:11:41.971
to the heart of the excitement of the promising future of gene therapy, but also a discussion of what we didn't have to think very much about 30 years ago or 40 years ago, and that is the bioethical issues that are introduced by this new science.

01:11:42.391 --> 01:11:46.835
The competing interest of the various stakeholders in this type of biomedical research.

01:11:47.296 --> 01:11:49.778
Science was just different 40 years ago today.

01:11:50.919 --> 01:12:14.224
what we have with us uh three um individuals can you not can you not just love those light bulbs i think that is that your time is running out it's a yellow light i gotta keep talking very good type of biomedical research science was just different 40 years ago today what we have with us uh three um

01:12:14.664 --> 01:12:19.748
individuals, experts in their field, and I will introduce them, and then we will have them testify in this order.

01:12:20.228 --> 01:12:25.552
Dr. Ender Verma is a professor of molecular biology at the Salk Institute in La Jolla, California.

01:12:25.952 --> 01:12:35.019
Dr. Verma, the president-elect of the American Society for Gene Therapy, will explain the rationale and science behind gene therapy, as well as its potential uses and limitations.

01:12:35.382 --> 01:12:46.090
And don't forget that Inder Verma is somebody under whom Robert Malone trained and claims to have been given PTSD, whatever that means.

01:12:46.150 --> 01:12:50.152
I guess you can have post-traumatic stress disorder from a post-doc.

01:12:51.053 --> 01:13:00.600
But apparently this guy in the blue suit is such a jackass that he's also kind of a sexually harassing kind of dude, and that's why he lost his position at the Salk.

01:13:01.580 --> 01:13:10.289
But in this thing, he's at the head of the Salk, and he's also the president-elect of the Gene Therapy Association or something like that.

01:13:10.329 --> 01:13:12.431
So he's a pretty high roller right here.

01:13:14.841 --> 01:13:20.805
He received a master's degree in biochemistry in India, a PhD in biochemistry in Israel.

01:13:20.906 --> 01:13:22.867
He did his postdoctoral training at MIT.

01:13:23.527 --> 01:13:37.218
Dr. Leroy Walters is the director of the Kennedy Institute of Ethics at Georgetown University, where he also serves as a professor in the Department of Philosophy, as a former chairman of the Human Gene Therapy Subcommittee of RAC, Recombinant DNA Advisory Committee.

01:13:37.678 --> 01:13:43.683
Dr. Walters will explore the critical bioethical issues involved in patient participation in experimental clinical trials.

01:13:44.463 --> 01:13:46.404
including informed consent and conflicts of interest.

01:13:46.604 --> 01:13:48.105
Dr. Walters received his Ph.D.

01:13:48.125 --> 01:13:48.526
from Yale.

01:13:49.887 --> 01:13:50.167
Ms.

01:13:50.347 --> 01:13:56.031
H. Stewart Parker of Seattle, Washington, is the president and CEO of Targeted Genetics Corporation.

01:13:56.551 --> 01:13:56.711
Ms.

01:13:56.751 --> 01:14:10.960
Parker is the former chair of the board of the Washington State Biotechnology Association and currently serves on the board of the Biotechnology Industry Organization, on whose behalf... The Washington State Board of Genetic Technology is an interesting one.

01:14:11.000 --> 01:14:13.162
I don't know if that would have any ties to the

01:14:14.150 --> 01:14:22.671
the earliest COVID vaccine and the first COVID patient in the sense of if that was also Washington State University or not, I don't know.

01:14:23.590 --> 01:14:25.251
on whose behalf she's testifying today.

01:14:25.311 --> 01:14:26.291
Maybe that was just Washington State.

01:14:26.311 --> 01:14:26.351
Ms.

01:14:26.371 --> 01:14:31.313
Parker will present the views of the biotech industry companies regarding current proposed NIH and FDA guidelines.

01:14:31.993 --> 01:14:36.155
I ask all of the, she received her MBA in finance and international business from the University of Washington.

01:14:37.255 --> 01:14:40.156
I appreciate all three of you here today, appreciate your patience.

01:14:40.196 --> 01:14:47.259
Again, this is a tremendously, to me, exciting panel that will discuss the breadth of the issues involved in gene therapy research.

01:14:47.859 --> 01:14:48.219
Dr. Burman.

01:14:49.053 --> 01:14:49.673
Thank you, Senator.

01:14:50.373 --> 01:14:59.557
I'm both honored and pleased to testify in front of this committee to tell you the science of gene therapy, its potential benefits to society, safety issues that do relate to the practice in patients.

01:15:00.457 --> 01:15:04.558
Gene therapy is a form of molecular medicine which will have major impact on human health in the coming century.

01:15:05.319 --> 01:15:07.059
The basic concept of gene therapy is simple.

01:15:07.699 --> 01:15:08.420
Introduce the gene.

01:15:08.960 --> 01:15:14.522
Its product should have the ability to either cure the disease, ameliorate the disease, or perhaps slow down the progression of disease.

01:15:15.475 --> 01:15:18.337
The scope of gene therapy has considerably broadened in the last decade.

01:15:18.857 --> 01:15:24.960
Not only we can now consider correction of genetic defects, for which there are thousands, and with the Human Genome Project completing, we shall learn more about it.

01:15:25.761 --> 01:15:29.142
Not only the fact it can actually help in curing many cancers by- So you heard that, right?

01:15:29.162 --> 01:15:31.344
The Human Genome Project's not done in the year 2000.

01:15:33.345 --> 01:15:36.106
So I'm gonna go back a couple, just make sure you hear that.

01:15:36.647 --> 01:15:42.210
The science of gene therapy, its potential benefits to society, safety issues that relate to the practice in patients.

01:15:43.123 --> 01:15:47.226
Gene therapy is a form of molecular medicine which will have a major impact on human health in the coming century.

01:15:47.966 --> 01:15:49.707
The basic concept of gene therapy is simple.

01:15:50.347 --> 01:15:51.068
Introduce the gene.

01:15:51.568 --> 01:15:57.192
This product should have the ability to either cure the disease, ameliorate the disease, or perhaps slow down the progression of disease.

01:15:58.120 --> 01:16:00.981
The scope of gene therapy has considerably broadened in the last decade.

01:16:01.521 --> 01:16:07.624
Not only we can now consider correction of genetic defects, for which there are thousands, and with the Human Genome Project completing, we shall learn more about it.

01:16:08.424 --> 01:16:19.369
Not only the fact it can actually help in curing many cancers by completely destroying and killing them, it has influence in the cardiovascular disease, in a number of neurological diseases, and perhaps even in elimination of many of the pathogens.

01:16:20.365 --> 01:16:26.529
Rarely there has been a technology in the human health which can have such a pervasive effect on human health in the coming century.

01:16:27.209 --> 01:16:28.450
And this is why there is excitement.

01:16:28.890 --> 01:16:33.433
This is why so many people are devoted to do research in gene therapy because it's potentially the normals.

01:16:34.234 --> 01:16:44.080
I do think it's important to listen to that again because he does already mention it as being able to be a treatment for pathogens.

01:16:44.966 --> 01:16:52.628
So this could already be a hint here that the idea of using it as vaccination or to augment the immune system is already on their radar.

01:16:52.668 --> 01:16:53.849
And that would make sense, right?

01:16:53.889 --> 01:16:56.849
Because this is one of the guys that Robert Malone trained with.

01:16:57.570 --> 01:16:58.450
And so, yeah.

01:16:58.470 --> 01:17:09.033
The fact that it can actually help in curing many cancers by completely destroying and killing them, it has influence in the cardiovascular disease, in a number of neurological diseases, and perhaps even in elimination of many of the pathogens.

01:17:10.023 --> 01:17:16.205
Rarely there has been a technology in the human health which can have such a pervasive effect on human health in the coming century.

01:17:16.866 --> 01:17:18.086
And this is why there is excitement.

01:17:18.546 --> 01:17:23.068
This is why so many people are devoted to do research in gene therapy, because it's potentially enormous.

01:17:23.508 --> 01:17:30.571
The public is excited, the patients are excited, and scientists are excited because this offers an opportunity to bring their work into the clinical practice.

01:17:30.911 --> 01:17:37.534
Now let's just stop here for a second so that we can talk about what he said, because I do think it's simple but important.

01:17:38.842 --> 01:17:49.767
He said the basic principle of gene therapy is that you introduce the gene and then its product should cure or ameliorate the disease.

01:17:51.208 --> 01:17:53.029
Now I apologize my writing isn't that great.

01:17:53.049 --> 01:17:55.930
This is a very sharp pen and so it makes it harder for me.

01:17:55.970 --> 01:17:58.771
I need a little bit more ink coming out here so I can flow better.

01:17:59.712 --> 01:18:06.695
But introduce the gene is already something that we could zero in on because it is

01:18:08.897 --> 01:18:14.918
It is so oversimplified to say that a gene codes for a protein.

01:18:14.978 --> 01:18:22.179
And so if we put the sequence of the gene that codes for the protein in, that we have put in a gene.

01:18:24.560 --> 01:18:28.500
Because of course, that protein sequence needs to be regulated.

01:18:29.481 --> 01:18:31.541
It needs to have on and off switches.

01:18:31.721 --> 01:18:33.521
It needs to have a volume knob.

01:18:34.021 --> 01:18:36.782
It probably needs to have a five-band equalizer.

01:18:40.154 --> 01:18:58.578
And so the idea that you've captured the gene, if you have the protein, is already a dumb, simple, biological principle that they beat into your head, even in these things where they're trying to summarize stuff.

01:18:58.978 --> 01:19:02.159
And what they end up doing is casting an enchantment.

01:19:02.819 --> 01:19:05.800
Because they don't know what a gene is.

01:19:07.839 --> 01:19:22.982
In this context, they mean very specifically a DNA sequence which, when transformed into a cell, will result in the expression of a protein that they can predict, and it's tied to the sequence of the DNA.

01:19:23.122 --> 01:19:26.743
In no way, shape, or form could that ever be the gene.

01:19:28.764 --> 01:19:35.465
The gene for collagen, for example, is not the protein sequence of collagen.

01:19:37.321 --> 01:19:50.290
That would mean you understand nothing about why collagen is here, why collagen is not there, why it's sometimes here, why it's expressed in this form there, in that form there.

01:19:50.330 --> 01:19:51.090
You know nothing.

01:19:53.072 --> 01:19:57.715
And yet gene, as a magic word, implies you know everything.

01:20:00.250 --> 01:20:05.693
And so it's very important from a biological 101 perspective to understand this idea.

01:20:06.334 --> 01:20:13.378
And they say these words, if you think you understand them in their way, then you are trapped in their enchantment.

01:20:14.158 --> 01:20:26.226
If they say gain a function virus and the image of a virus and a bat and Shang-Chi Lee and Ralph Baric shows up in your head, then you are enchanted.

01:20:26.386 --> 01:20:29.868
And if they say introduce the gene and you go, yeah, I get it.

01:20:32.045 --> 01:20:33.207
You don't get it then.

01:20:33.368 --> 01:20:35.893
You just, you don't get it then.

01:20:36.634 --> 01:20:36.915
Okay?

01:20:41.141 --> 01:20:44.742
The key to success of gene therapy really lies in how to deliver the genes.

01:20:45.582 --> 01:20:47.663
It's not the concept, it's how do you deliver the genes?

01:20:47.683 --> 01:20:49.163
And there are a number of ways.

01:20:49.243 --> 01:20:50.843
How do you deliver the genes?

01:20:51.043 --> 01:20:57.385
So here we are again, making an enchantment where the assumption is that we already know all the genes.

01:20:57.825 --> 01:21:06.907
We're about to sequence the human genome and have a whole catalog of genes, some of which we won't even know what they do, but at least we have all the genes.

01:21:08.547 --> 01:21:29.271
And so here he is, head of the Salk Institute, head of some kind of society that wants gene therapy to go bananas as fast as possible to save people like cystic fibrosis guy from the first meeting, because you can't save a guy like Jesse Gelsinger.

01:21:29.291 --> 01:21:33.372
You can only use him as an experimental animal to see if we can save other kids.

01:21:37.059 --> 01:21:48.485
How is Jesse Gelsinger an experimental animal to save other kids, yet the adenovirus could be used as an experimental vaccine in 2020 for old people specifically?

01:21:51.347 --> 01:21:55.790
How is that even remotely the real history of America?

01:21:55.830 --> 01:21:56.270
But it is.

01:21:59.451 --> 01:22:07.195
To do so, some people introduce the gene directly by DNA direct injections, which is safe, but unfortunately not as efficacious as you might want to see it.

01:22:08.016 --> 01:22:13.439
Majority of the people and of the 375 trials, 80% of them have really been using viral vectors.

01:22:14.039 --> 01:22:18.102
By viral vectors, we mean viruses which have the ability normally to cause a disease.

01:22:18.602 --> 01:22:21.664
So how would they just inject the DNA directly?

01:22:22.404 --> 01:22:24.085
That is 20 years ago.

01:22:24.605 --> 01:22:25.426
How would they do it?

01:22:25.786 --> 01:22:26.907
They would make a vector

01:22:28.132 --> 01:22:55.389
maybe even drive the replication of the vector with an SV40 promoter, grow it in a test tube or in a culture bottle, absolutely positively no different than when they grew the spike protein on that BBC episode where the big tall Irish brawn lady with the giant hands is talking about how they make the spike protein.

01:22:57.028 --> 01:22:57.548
What was that?

01:22:58.268 --> 01:22:59.789
I don't know what that accent was, sorry.

01:23:00.549 --> 01:23:01.229
So here we are.

01:23:02.730 --> 01:23:12.712
The history of this technology, the history of this bioethics discussion goes all the way back to Jesse Gelsinger.

01:23:12.892 --> 01:23:22.235
And incidentally, so does the mentorship, training, and public presence of Robert Wallace Malone.

01:23:23.679 --> 01:23:34.666
One of these guys who I think is instrumental in whispering in other people's ears a script which protects this biosecurity imperative.

01:23:35.946 --> 01:23:37.767
Where we are being shifted.

01:23:38.568 --> 01:23:41.690
Our sovereignty is going to be eliminated.

01:23:42.546 --> 01:23:51.793
Our children will be enslaved by this system as they demolish the dollar, as they demolish our economy, as they demolish our infrastructure and let it rot.

01:23:52.234 --> 01:23:53.415
This is all on purpose.

01:23:56.397 --> 01:24:07.766
And it is because in order to get this level of submission from our children, the system where, you know,

01:24:09.215 --> 01:24:11.256
Dukes of Hazzard and Magnum P.I.

01:24:11.356 --> 01:24:16.277
and the A-Team are what's on TV, that system's over, that's gone, that's gotta be eliminated.

01:24:16.337 --> 01:24:32.521
And all the adults that understand freedom from that perspective and understand responsibility from that perspective, understand common sense from that perspective, are still raising children who have the potential to understand it that way and can resist this.

01:24:34.189 --> 01:24:45.896
but there are lots of adults who are raising children who are not understanding the trap we are all being walked into and have been being walked into for a number, a number of decades.

01:24:46.416 --> 01:25:00.944
The only reason why Inder Verma is not in front of us right now is probably because he had sufficient scruples to need to be removed from this, you know, national security theater.

01:25:01.527 --> 01:25:06.054
but one can debilitate them by removing the disease-causing potential and substitute them with a therapeutic gene.

01:25:06.755 --> 01:25:13.604
So the virus is fooled into behaving like a virus, but in fact is now carrying the therapeutic gene rather than the pathogenic gene which it normally carries with it.

01:25:13.624 --> 01:25:16.208
And there have been three principal kinds of vectors.

01:25:16.809 --> 01:25:25.174
Retroviral vectors, which normally cause cancer in animals, not in humans we know of, but in animals, they are wonderful tools because they can introduce genes and have long-term expression.

01:25:25.695 --> 01:25:31.579
Unfortunately, they can't introduce genes in cells which are not dividing, which means we can't put them in the brain, liver, and lung, which are normally not dividing.

01:25:32.478 --> 01:25:34.461
a second kind of a vector of which we heard a lot today.

01:25:34.901 --> 01:25:35.662
Interesting.

01:25:35.762 --> 01:25:46.635
So the reason why you can't use retroviral vectors from the perspective of Mr. Inder Verma is because they need to infect dividing cells.

01:25:47.631 --> 01:25:49.092
So they're not useful in the brain.

01:25:49.653 --> 01:25:51.254
Can't alter brain cells with it.

01:25:51.294 --> 01:25:59.920
But they're nice because they transform the cells and they result in long-term differential protein expression, which is pretty kick-ass.

01:25:59.960 --> 01:26:13.371
So he's really gonna lead us down the path of understanding the state of the art at this time, which I think is really crucial to frame the fact that this technology hasn't advanced one iota.

01:26:13.411 --> 01:26:15.993
The only thing that's happened is that we have more carriers

01:26:16.957 --> 01:26:22.721
which won't change anything, can only add to the problem or compound the problem or maybe obfuscate.

01:26:24.102 --> 01:26:32.268
We have more carriers and we have the ability to make all of these DNA cheaper.

01:26:33.229 --> 01:26:38.653
So that's the other thing that, you know, we can sequence them, we can print them and then grow them in mass.

01:26:38.693 --> 01:26:43.557
So all of these technologies are better, but still essentially, we're still just baking bread.

01:26:46.445 --> 01:26:51.988
We're not, we haven't advanced any farther than being able to make DNA and put it places.

01:26:52.089 --> 01:26:59.853
And yeah, the protein shows up and we call that genetic technology, but we're not using genes and altering genes.

01:27:00.374 --> 01:27:06.057
When we put protein sequences encoded in DNA into cells, we are transforming them.

01:27:06.617 --> 01:27:10.800
If we put RNA into cells encoding proteins, we are transfecting them.

01:27:11.240 --> 01:27:15.283
We are not putting genes in places or using genes.

01:27:16.235 --> 01:27:17.716
or expressing genes.

01:27:18.477 --> 01:27:20.798
This is all slave speak.

01:27:22.319 --> 01:27:28.763
It is slave speak of this old biology that gets you to believe that everything is predetermined and out of your control.

01:27:28.783 --> 01:27:43.133
And you can think of yourself as just a member of a species instead of an individual with a sort of God-given sovereignty and responsibility to raise adults, you know, children.

01:27:44.454 --> 01:27:46.715
is the adenoviral vectors, which is a common cold virus.

01:27:47.315 --> 01:27:50.997
And the nice part of this virus is that you can make trillions of virus particles, so you can make a lot of it.

01:27:51.817 --> 01:28:00.100
Unfortunately, it has some side effects of A, making short-term production of the protein, and that's why Jesse Gelsinger was told it could not have produced protein more than 14, 15 days.

01:28:01.681 --> 01:28:05.203
Furthermore, it has serious immunological consequences because the virus is toxic.

01:28:05.243 --> 01:28:06.704
So think about that!

01:28:07.325 --> 01:28:10.527
They told Jesse Gelsinger that it would never help him.

01:28:10.627 --> 01:28:10.927
Why?

01:28:11.007 --> 01:28:15.310
Because they could only express the protein in his liver for 14 days.

01:28:18.932 --> 01:28:21.074
And then the immune system would prevent it.

01:28:22.901 --> 01:28:32.767
Now the only thing they didn't realize was if we inject a bunch of adenovirus and we keep going, maybe the autoimmunity will cause a catastrophic liver failure.

01:28:32.907 --> 01:28:34.288
Oh wow, that's surprising.

01:28:37.490 --> 01:28:40.512
So catastrophic autoimmunity is the problem.

01:28:40.612 --> 01:28:46.696
Catastrophic autoimmunity was the reason why he was told you're only gonna get 14 days, it's only a test, it's never gonna help you.

01:28:49.118 --> 01:28:50.439
And they didn't know?

01:28:51.314 --> 01:28:54.076
They didn't know that autoimmunity was a possibility.

01:28:54.176 --> 01:28:55.957
It's impossible that they didn't know.

01:28:58.939 --> 01:28:59.799
Of course they knew.

01:28:59.879 --> 01:29:03.221
They hoped it wouldn't be, but they knew.

01:29:03.241 --> 01:29:11.066
And of course, if they were honest, then the results would be catastrophic.

01:29:11.146 --> 01:29:12.287
It's your liver.

01:29:15.929 --> 01:29:17.410
At high doses, the virus is toxic.

01:29:17.470 --> 01:29:18.391
It has liver toxicity.

01:29:19.232 --> 01:29:27.502
Nevertheless, it has serious risk of A, making short-term production of the protein, and that's why Jesse Gelsinger was told it could not have been produced protein more than 14-15 days.

01:29:28.383 --> 01:29:32.027
Furthermore, it has serious immunological consequences because the virus is toxic.

01:29:32.928 --> 01:29:34.409
At high doses, the virus is toxic.

01:29:34.489 --> 01:29:35.350
It has liver toxicity.

01:29:36.226 --> 01:29:43.311
Nevertheless, this virus has been used much more in the case of cancer, where the cell needs to be killed anyway, so the toxicity was less of a concern.

01:29:43.771 --> 01:29:50.936
The third vector is an AAV vector, which is a relatively new one, and that's now being considered as a very interesting vector for which their trials are being conducted.

01:29:51.716 --> 01:29:54.619
Another vector, which I'm personally interested in, is a vector based on AIDS virus.

01:29:55.360 --> 01:30:02.767
We have been able to debilitate the AIDS virus to introduce genes, and now they are able to introduce genes directly into a wide variety of cells, both dividing and non-dividing.

01:30:03.147 --> 01:30:11.015
Now, interestingly, for this purpose of discussion, the pseudo-virus, the pseudo-AIDS virus, has been

01:30:12.336 --> 01:30:18.217
the way that a lot of these viral vectors are tested and a lot of these spike proteins are expressed.

01:30:18.337 --> 01:30:31.339
So, that Ralph Baric paper from 2015, for example, where everybody's saying he's doing gain-of-function, is really what they describe in the methodologies as a pseudovirus made from HIV.

01:30:31.839 --> 01:30:41.481
A virus that's no longer replication competent, that they put in the genes of interest so that they can see what those genes of interest do for receptor binding or whatever.

01:30:42.824 --> 01:30:54.152
And so here he is talking about that in the year 2000, 15 years before Ralph Baric's paper comes out and everybody starts claiming that this was an AIDS vaccine that got loose.

01:30:57.074 --> 01:31:01.377
And so I am aware that they've been trying to say it's an AIDS vaccine since the very beginning.

01:31:01.437 --> 01:31:06.260
Dan Surotkin is one of the first people to have said that, but he's not the only one.

01:31:06.681 --> 01:31:07.301
And now that,

01:31:07.955 --> 01:31:29.220
that rung of the hamster wheel is coming back again on X and other places where they're saying that this was a a self-spreading vaccine candidate that was released in China and it had all kinds of bad it's just a joke because again if you pay attention and listen carefully you can hear the the pre-pandemic

01:31:31.766 --> 01:31:33.369
you know, crumbs of this narrative.

01:31:33.409 --> 01:31:34.050
You can hear it.

01:31:34.551 --> 01:31:46.410
All of the raw materials for a narrative about a gain-of-function virus or a narrative about a self-spreading vaccine or a narrative about pandemics is all brewing right here.

01:31:48.208 --> 01:31:59.932
Nobody's worried about the adenovirus or the pseudo-AIDS virus or any of these things escaping or acquiring the genes necessary to pandemic.

01:31:59.952 --> 01:32:07.075
We're not talking about that at all right now because here, we're just trying to cover up for the fact that we just killed a kid for nothing.

01:32:08.756 --> 01:32:16.959
Because we were so stupid and so naive, we actually thought we could augment a healthy human

01:32:18.004 --> 01:32:24.251
by injecting some, you know, it's extraordinary.

01:32:24.691 --> 01:32:31.218
Policy conference, discussion of it, more is being done, safety vectors are being made, but nevertheless, that is a very exciting venue of introducing genes.

01:32:32.559 --> 01:32:37.845
If the concept of gene therapy is so simple, but critics have often asked, why has it not been more successful?

01:32:38.366 --> 01:32:40.508
Why are there not resounding successes of gene therapy?

01:32:41.852 --> 01:32:44.375
The field of gene therapy is young, as you mentioned in your introduction, sir.

01:32:45.155 --> 01:32:47.438
It's only been 10 years that the first ADA patients were tried.

01:32:48.159 --> 01:32:53.284
It was accompanied by enormous excitement, but unfortunately a lot of hype and unrealistic expectations.

01:32:53.644 --> 01:32:55.446
We have now learned these vectors are not so easy.

01:32:55.906 --> 01:32:57.768
They don't make the protein as long as we wish them to make.

01:32:58.369 --> 01:33:01.793
They are not as immunologically less competent as we wish them to be.

01:33:02.734 --> 01:33:03.654
And we are learning about them.

01:33:04.554 --> 01:33:07.958
The interesting part to mention here is that there's a tremendous progress in the last many years.

01:33:08.339 --> 01:33:09.260
Better vectors are coming.

01:33:09.600 --> 01:33:11.202
Long-term production of the protein is being made.

01:33:11.643 --> 01:33:21.435
And just to add to that, there was a marvelous talk at a recent meeting of gene therapy where two patients treated with a deficiency much like ADA in Paris have now shown for one year complete cure.

01:33:22.296 --> 01:33:24.298
This is a fantastic promise of gene therapy.

01:33:24.318 --> 01:33:25.899
These children will live a normal life.

01:33:26.580 --> 01:33:28.261
They're anecdotal examples for hemophilias.

01:33:28.601 --> 01:33:30.063
They're anecdotal examples for cancer.

01:33:30.583 --> 01:33:39.611
The reason I say they're all anecdotal is because until they are not published in peer-reviewed journals, one really cannot comment on that because all we can tell you is that this is what we learn at meetings when people give a talk.

01:33:39.951 --> 01:33:41.993
And that really is a very exciting venture of it.

01:33:44.946 --> 01:33:50.949
The field of gene therapy has also undergone enormous amount of scrutiny, both from NIH and from public.

01:33:51.209 --> 01:33:54.871
There were special reports at NIH to ask the question, is gene therapy efficacious?

01:33:55.291 --> 01:34:02.555
And suggestions were made, and people were asked to actually work more on basic sciences, and that time not so much on the clinical sciences, because that's what was required for its success.

01:34:03.836 --> 01:34:06.958
The patient safety in clinical research is always paramount concern.

01:34:07.718 --> 01:34:08.919
It is true that new modalities

01:34:09.798 --> 01:34:12.099
both risks, known ones and unknown ones.

01:34:12.559 --> 01:34:17.561
But that almost all the more reason for us to be more vigilant than in any other technology because we don't know what this might do.

01:34:18.682 --> 01:34:22.083
There are, as you heard, RAC, FDA, IRC, IRBs.

01:34:22.103 --> 01:34:25.225
There are many, many ways in which their gene therapy acts are being controlled.

01:34:26.085 --> 01:34:32.128
After saying all that, one would like to know, if all that was in place, what failed the brave Jesse?

01:34:33.049 --> 01:34:35.771
How did we fail, brave Jesse, that this did not work?

01:34:36.592 --> 01:34:44.259
You heard many suggestions today, and I'm actually quite encouraged to see how a close harmony between FDA and RAC will allow perhaps a better monitoring of it.

01:34:44.639 --> 01:34:47.882
And we are hoping that this is a young science.

01:34:48.683 --> 01:34:50.704
We are just beginning to get the fruits of this science.

01:34:51.769 --> 01:34:55.691
Tragic incidences of the unexpected deaths of Jesse Gelsinger make us pause.

01:34:56.471 --> 01:34:58.272
We think back what we could have done different.

01:34:59.032 --> 01:35:00.433
What we could do differently next time.

01:35:00.893 --> 01:35:02.614
And that is what this meeting is about to help us.

01:35:03.494 --> 01:35:09.957
I was deeply saddened to hear from Mr. Gelsinger the sad comment of a colleague who might have said the potholes in the road to gene therapy is the death.

01:35:10.137 --> 01:35:10.938
That is not how we feel.

01:35:11.678 --> 01:35:13.359
We feel terrible about it, and we're very sad.

01:35:13.960 --> 01:35:15.261
This is not how our community feel.

01:35:15.801 --> 01:35:18.263
We feel this is a very serious event.

01:35:18.703 --> 01:35:19.764
We take it very seriously.

01:35:20.044 --> 01:35:22.426
But at the same time, we believe that we have to move forward.

01:35:22.846 --> 01:35:24.147
We've got to learn from this technology.

01:35:24.527 --> 01:35:34.214
And what we'd like to do is to be able to do a better job, learn more from this, and move this field to what I will consider a major challenge and a major benefit into the human disease as we go to the next century.

01:35:34.915 --> 01:35:36.075
Thank you very much for inviting me.

01:35:36.316 --> 01:35:37.416
I'll be happy to ask questions.

01:35:37.797 --> 01:35:38.577
Thank you, Dr. Burma.

01:35:39.118 --> 01:35:39.618
Dr. Walters.

01:35:40.814 --> 01:35:45.996
Mr. Chairman, thank you for inviting me to discuss ethical issues in gene therapy research.

01:35:47.837 --> 01:35:53.540
In my written statement, I review the 25-year history of the recombinant DNA advisory committee.

01:35:54.784 --> 01:36:03.329
Recombinant DNA Advisory Committee is called the RAC.

01:36:03.569 --> 01:36:10.674
So if you hear someone calling the RAC, it's the Recombinant DNA Advisory Committee, and that is an FDA thing.

01:36:12.393 --> 01:36:22.355
It's interesting because I guess the RAC would have been completely bypassed once the PREP Act was enacted, or not enacted, but evoked, and the emergency was evoked.

01:36:22.415 --> 01:36:29.717
Then they could roll this out as an investigational vaccine without having to go through the RAC, for example.

01:36:30.457 --> 01:36:32.358
The first two gene therapy studies.

01:36:33.118 --> 01:36:42.900
And in September of that year, Ashanti Da Silva received gene therapy at NIH in the first clinical study undertaken after that approval.

01:36:44.640 --> 01:36:50.781
We had so much hope in those days that this field would be successful and soon and with many diseases.

01:36:52.781 --> 01:37:02.103
By the mid-1990s, we began to see that the situation would not be quite so simple and that success would not come quite so soon.

01:37:03.905 --> 01:37:11.927
One of the best moments in the entire history of the Recombinant DNA Advisory Committee, in my view, occurred in June of 1995.

01:37:13.387 --> 01:37:25.230
At that meeting, and after six months of intensive work by the staff, RAC members presented a comprehensive overview of the field of gene therapy to date.

01:37:26.471 --> 01:37:32.292
That overview detailed adverse events as well as the minimal success to date.

01:37:34.517 --> 01:37:45.510
The results of that overview were published in 1996 in the journal Human Gene Therapy, and I'd like to ask that a copy of that overview be included in the record.

01:37:45.550 --> 01:37:46.832
That objection will be made part of the record.

01:37:49.710 --> 01:37:57.255
We knew already in 1995 that we were reaching the limits of manual systems for tracking what was happening in gene therapy.

01:37:58.276 --> 01:38:07.782
In fact, some staff members at NIH told me they almost died during that six months of reviewing and gathering information for the June meeting.

01:38:09.183 --> 01:38:18.329
From my perspective, federal oversight during the early years of gene therapy worked reasonably well with some minor tensions between NIH and FDA.

01:38:19.980 --> 01:38:27.991
However, I think we've seen, especially since September of last year, that the oversight system is failing us, and that serious problems have arisen.

01:38:28.011 --> 01:38:28.952
Okay, I'm going to cut it short.

01:38:28.972 --> 01:38:31.436
There's a lot of reasons for that, and we can go into them.

01:38:31.536 --> 01:38:34.961
I'm going to cut it short here, because I think I can summarize this better by just...

01:38:36.923 --> 01:39:01.954
by just cutting over here and saying that I think these two videos really reveal that in the year 2000 when Jesse Gelsinger had just died that the current state of affairs was that that gene therapy was being regulated by a committee called the RAC and the FDA and that there was an ongoing debate about what was going on and how to move forward with this technology.

01:39:01.994 --> 01:39:05.256
They all agree in the room that they have to move forward, but how to move forward?

01:39:06.493 --> 01:39:08.575
Because the FDA is essentially in the way.

01:39:08.635 --> 01:39:09.856
The RAC is in the way.

01:39:09.916 --> 01:39:11.517
These dead kids are in the way.

01:39:15.480 --> 01:39:28.930
Because all of these, they're used, that umbrella term, gene therapy, but they can be talking about a plethora of things, depending on whether it's DNA or RNA, how the DNA or RNA is made, and what carries it there.

01:39:30.936 --> 01:39:33.960
And so they know that they're going to try everything.

01:39:34.040 --> 01:39:37.744
They know they're going to throw everything at the wall and see what sticks.

01:39:37.924 --> 01:39:44.131
And Jesse Gelsinger is absolutely just a pothole in the road.

01:39:46.414 --> 01:39:47.135
And they mean it.

01:39:47.775 --> 01:39:49.217
This is for all the marbles.

01:39:49.277 --> 01:39:51.460
And that's why the pandemic was, was

01:39:52.972 --> 01:39:54.333
as a theater was executed.

01:39:54.373 --> 01:40:00.136
That's why we have been subject to this because they needed to find a way to bypass this.

01:40:00.196 --> 01:40:11.321
And now the trick is, is to keep control of the FDA and the CDC so that this, this bait and switch is not caught, this bait and switch is not regulated.

01:40:11.501 --> 01:40:12.922
And so it may be

01:40:14.451 --> 01:40:16.471
And I'm just going to throw this out there.

01:40:16.752 --> 01:40:22.713
I'm going to switch over again to this one, and that one, and this one.

01:40:22.733 --> 01:40:34.376
I think it's really important to realize and keep it steady in your head.

01:40:34.456 --> 01:40:35.556
Sorry, this dried out a little bit.

01:40:37.146 --> 01:40:42.331
that there are certain issues at play and this is just a little summary and then I'll let you go.

01:40:42.351 --> 01:40:45.054
I might even put on a little music for this summary.

01:40:47.637 --> 01:40:49.318
Did you like Maggie Rogers?

01:40:49.378 --> 01:40:50.620
She's got a really nice voice.

01:40:50.680 --> 01:40:55.024
It's not music you can listen to all the time, but sometimes when you're in the mood for it, it's very, very nice.

01:40:55.725 --> 01:40:56.526
I'm going to look for

01:40:58.286 --> 01:41:01.507
Some... I know exactly what I want.

01:41:01.567 --> 01:41:02.707
I'm just going to find it.

01:41:02.787 --> 01:41:04.328
So you're just going to have to wait.

01:41:10.889 --> 01:41:11.770
No, I don't see it.

01:41:12.170 --> 01:41:12.550
Darn it.

01:41:12.730 --> 01:41:13.190
Oh, there it is.

01:41:18.091 --> 01:41:25.433
So, I think it's really important as we close this stream to kind of summarize what we have here.

01:41:26.234 --> 01:41:26.634
In the year 2000,

01:41:29.143 --> 01:41:34.286
gene therapy was considered dangerous.

01:41:37.348 --> 01:41:44.213
Actually one of these guys said that it was a danger that the nation had now been alerted to that they weren't alerted to before.

01:41:49.197 --> 01:41:57.643
And now we of course have several different varieties of gene therapy that we use regularly because mRNA has been

01:41:59.150 --> 01:42:02.493
sort of become generally accepted.

01:42:02.573 --> 01:42:03.574
So this is the trick.

01:42:07.678 --> 01:42:13.363
General acceptance is actually crazy powerful, right?

01:42:13.544 --> 01:42:14.544
And so they have

01:42:15.475 --> 01:42:20.756
They have pushed hard on the fact that PCR works.

01:42:21.957 --> 01:42:31.079
And there is no one in Trump's camp, or in the Democratic camp, or in any place in America that's going to question the fact that PCR works.

01:42:31.579 --> 01:42:33.860
And that's really weird because it doesn't.

01:42:34.720 --> 01:42:40.482
And certainly not in the high-fidelity, flawless, errorless way that they portray it.

01:42:41.730 --> 01:42:57.007
Um, and what's interesting and what I would predict is coming now is this general acceptance is going to be, um, it's going to be reinforced by another theater and the theater that they're going to do is that they're going to tell you that the recombinant.

01:43:00.994 --> 01:43:09.422
mRNA and the recombinant AAVs, you know, that's what they were using here, were contaminated.

01:43:09.483 --> 01:43:10.564
These are just bad, right?

01:43:10.604 --> 01:43:16.810
They pulled those off the market and that was part of the theater, but now they have this recombinant DNA that everybody from

01:43:17.470 --> 01:43:37.418
Kevin McKernan to Kevin McCairn to to John Campbell to all these people, you know, Brett Weinstein and and Robert F Kennedy jr Our Health and Human Services secretary are gonna tell us that there's recombinant DNA Contamination in our RNA that contaminant DNA

01:43:39.753 --> 01:43:47.696
is also endotoxins from the, that's just like bacterial proteins and stuff that weren't adequately cleaned out.

01:43:48.136 --> 01:43:56.419
And so they're gonna admit that the first round of mRNA was very flawed and it probably hurt a lot of people.

01:43:56.939 --> 01:44:05.482
But what they're also gonna be able to ride in on a white horse with, and maybe even Robert Malone will ride in on this white horse, is that they can print mRNA.

01:44:06.445 --> 01:44:10.167
They have lots of different means by which they can chemically print RNA.

01:44:10.627 --> 01:44:16.069
Now, number one, these are still very expensive means of making RNA.

01:44:16.090 --> 01:44:19.551
You can't make batches for billions of people by printing RNA.

01:44:19.851 --> 01:44:24.934
It's very expensive, but they can print mRNA.

01:44:24.974 --> 01:44:27.375
And so they can make a very pure quantity.

01:44:28.123 --> 01:44:34.166
with less impurities in the RNA and less impurities from the manufacturing process by just printing it.

01:44:34.227 --> 01:44:35.707
And they have that technology.

01:44:36.168 --> 01:44:38.449
They had that technology before the pandemic.

01:44:41.711 --> 01:44:48.955
And so they've known that this is the direction that they're going to go in because this is the direction that the evolution of the technology can go.

01:44:50.188 --> 01:45:05.645
just like the evolution of collecting your medical data and collecting your genome, it would have been silly to evolve to this stage in 2010 when the technology to sequence and store the data wasn't available and wasn't cheap enough and it wasn't ubiquitous enough.

01:45:07.207 --> 01:45:11.712
Now that that technology has been adequately developed and farmed out and

01:45:12.857 --> 01:45:17.444
and optimized by the expense of the Human Genome Project over the last 20 years.

01:45:17.885 --> 01:45:22.653
They've now moved on to create the infrastructure by which machine learning can be applied to these data.

01:45:23.567 --> 01:45:34.350
data like the EPIC database, that even if it's de-identified, machine learning algorithms can be used to tie this genetic data back to those database.

01:45:34.450 --> 01:45:52.414
That is the fundamental task that would be the next incremental step in achieving what these people since Joshua Lederberg have dreamed of achieving, which is a database with as many genomes as possible, harvested over the entire lifetime of

01:45:52.794 --> 01:45:53.615
the human.

01:45:54.776 --> 01:46:10.912
Data about the microbiome, data about exosomal signaling inside the plasma and elsewhere would all be great and I think that in the end these are all things that will likely come to fruition in the form of various biometric devices and things that everybody will think is cool.

01:46:11.809 --> 01:46:18.131
Of course, maybe they'll allow you to put a chip in your hand that will have all kinds of magic properties in combination with your Apple phone.

01:46:18.611 --> 01:46:25.053
But little do you know that that chip in your hand will also be sending biological data, sampling things, whatever.

01:46:25.973 --> 01:46:27.953
These are all in their imagination.

01:46:28.013 --> 01:46:31.074
This is all how they see the progress into the future.

01:46:31.134 --> 01:46:40.717
And what I need you to understand or try to ponder is that they've had this rough idea in mind since back when Jesse Gelsinger's dad was in tears

01:46:41.457 --> 01:46:43.439
in that meeting that we just watched today.

01:46:43.879 --> 01:46:45.340
Thank you very much for joining me.

01:46:45.901 --> 01:46:49.884
I really appreciate everybody who's here and having the patience.

01:46:49.964 --> 01:46:51.105
Why are you not rolling?

01:46:52.166 --> 01:46:54.428
Having the patience to wait for me to get going.

01:46:54.768 --> 01:46:55.149
We are

01:46:56.186 --> 01:47:00.708
We're going to have daily shows coming up, maybe even already starting today.

01:47:01.988 --> 01:47:08.731
The wood pile of work to do has now just amassed and it's time for a little bit of a landslide here.

01:47:09.731 --> 01:47:12.192
So we're going to try and hammer as often as we can.

01:47:12.212 --> 01:47:14.673
I won't be on later today, but I'll definitely be on tomorrow.

01:47:15.153 --> 01:47:19.955
And you can expect regular updates from the Gigaohm Biological HQ.

01:47:20.936 --> 01:47:24.903
Email, which you can email from the website, et cetera.

01:47:25.244 --> 01:47:28.169
Thank you very much for being here, and I definitely will see you tomorrow.

01:47:29.452 --> 01:47:30.453
And that should be up.

01:47:36.331 --> 01:47:59.968
So they're using clinical trials for Cystic Fibrosis, Haemophilia B, Arthritis, Hereditary Emphysema, Leber's Congenital Armorosis, Age-related Macular Degeneration, Duchenne Molecular Dystrophy, Parkinson's Disease, Caravan Disease, Batten Disease, Alzheimer's Disease, Spinal Muscular Atrophy... How can they be making a AAV-based

01:48:02.765 --> 01:48:08.188
vector treatment for Alzheimer's disease when they don't even know what causes Alzheimer's.

01:48:08.248 --> 01:48:10.509
They don't even know the mechanism of Alzheimer's.

01:48:11.410 --> 01:48:12.410
This is the problem.

01:48:16.926 --> 01:48:17.966
Thanks for being here, everybody.

01:48:18.026 --> 01:48:20.467
I'm really excited to see you tomorrow again.

01:48:20.907 --> 01:48:25.689
Trying to get into the habit and build the momentum again like we had about a half a year ago.

01:48:26.809 --> 01:48:27.569
Especially now.

01:48:27.709 --> 01:48:32.211
I hope next week we're going to get Marty confirmed and we're going to get JB confirmed.

01:48:33.891 --> 01:48:51.123
Please, every once in a while, if you want to take the extra step to go on social media, when you tag me, tag me as Dr. J. They're going to try and give Jay Bhattacharya that nickname, but of course, that nickname belongs to the

01:48:51.683 --> 01:48:57.210
basketball-playing biologist from Team USA, Jonathan J. Cooey.

01:48:58.091 --> 01:49:03.877
So if you don't mind, tweet out Dr. J and tweet out GigaOM Biological.

01:49:05.038 --> 01:49:06.180
I'm going to see you very soon.

01:49:08.832 --> 01:49:11.055
I'm so excited about this spring.

01:49:11.516 --> 01:49:12.698
Thank you very much for joining me.

01:49:13.238 --> 01:49:15.602
Brandy Vaughn's birthday is coming up.

01:49:15.842 --> 01:49:19.447
See if you can figure it out for yourself before I announce it.

01:49:19.507 --> 01:49:20.669
Thanks very much for being here.

01:49:20.709 --> 01:49:21.330
See you again tomorrow.

