You
I
Don't want to lie, you know, I don't think I'm a liar. I try not to be a liar. I don't want to be a liar
I think it's like really important not to be a liar
Do we have a new person in the chat for the first time that actually knows why they're here? Well, welcome to the show. Well, great to see you
Tall trees catch a lot of wind get ready for some wind
It's about all I can say thanks. Thanks for showing up though, man. I'm really happy you're here 1313 Pam trying to hit it
Trying to hit it
That's a good question. I did not turn on YouTube. I'm sorry
I didn't that I won't be able to do it now. I would have to do too much
I'm just gonna leave it off a YouTube is not streaming right now. Sorry about that Schumer, but thanks for checking
I
Am very excited to be here today. I've got some actual work to do and this work allows me to also share it with you
And so I've got a little work to do on a consulting basis where one of the things that I need to do is take a look at a video
That is stored on the FDA website and so rather than just watch this video on my own
Without any fun help or commentary in the background. I thought I would share it with you
And yeah, let's let's see if this works
If you've been here for a while, then you know where you are if not
Welcome to the welcome to the show. We have at least one person here who may be a recovering skilled TV watch
You're finding us for the first time where we stay focused on the biology
We don't take debate on TV and we love our neighbors. Welcome
This is how it works people just keep sharing my work
So if you're here for the first time, please understand that if you enjoy it the best way that you think
You can help is not necessarily to send coin but to actually share it with people that you know haven't seen it
Because there's a lot of people out there that have not seen it and need to be exposed to this biology
But if you've been here a while and you think you can support please
I'm not I'm not telling you not to because there's a family of five that is trying very hard to support me
I mean, I'm part of that family of five
And so all of this is really a family effort
And it's not without the support of my family that would happen. And so you can support us at Giga on biological calm
You can also find all different ways to share us there and ways to connect with me, etc
I do play this list every morning and every afternoon although it's not complete right now
Some people don't want their name on it, but it is not as large as it needs to be
and so all
subscribers are welcome
That is about 120 people right now, so it's not a very big group of people that's that's coming together
And so each one of these people is a little tiny bit
Part of making this happen. I can't take credit for doing this on my own
The independent bright web is something that we're trying to start here a movement of citizen journalists
citizen archivists citizen historians
That are trying to take back the narrative take back our republic before they teach this mythology
Mythology to our children, and we can no longer get them back. That's really where we are
This illusion is sustained through our active participation and if we can't convince
college age kids and young adults young parents to
Extract themselves from participating in this illusion
We may we may lose what what we now call freedom and sovereignty forever for generations to come
And so the way we do that is united non-compliance
We don't participate
We may really need to do something as drastic as not send our kids to university for a few years
That wouldn't be an impossible movement
especially with people like myself and others who can provide the learning online and
provide the network of
activity and and and learning online the
Substitute for for that university system, which is right now just one giant grift where they pay
Where they pay
Deans and and and associate deans and and and assistant deans and
And football coaches and football staff more than they pay their faculty and their working postdocs
And it's a real it's real terrible
So I do think giggle and biological is one of the safest ways to get biology in your head. Hello Jeff if you're out there
Hello, good to see you
This is giggle and biological high-resistance low-noise information brief brought to you by a biologist
That biologist's name is Jonathan Cooey. That's me. I'm coming to you live from Pittsburgh, Pennsylvania
the back of my garage
and
Thank you very much for coming
Today we are still trying to penetrate this conscious and intelligent manipulation of our organized habits and opinions
The way that this has been accomplished is
over decades and
if you want to get a glimpse
into
how
ready
How the dominoes were all lined up from the beginning of the pandemic
I think it's really instructive to go back to the beginning and look at what people were saying how scared they were not scared
What concerns they really had what priorities they had what part of the train they wanted to grab onto and pretend they were stopping
What part of the train did they want to push on to say that they were helping
These people were orchestrating a theater and I think if you see
And if we take a look at some of these
Mashingations early in the pandemic we're going to see something that we never thought we would see
And so i'm excited to bring you this possible
insight
And so i'm just going to start with it right away because it is a little bit of a long video and I do want to complete the work
and so
I am going to watch the whole video
So and i'm not going to watch it at too much speed mostly because I don't think I can adjust that
because the player
That the hold on let me go down here
The player that the
Sorry that the
I don't think I can adjust it so you're just going to have to deal with it
And it's a weird recording. I couldn't download it. It's like broken up into two screens for a while
We're just going to have to cope
What this is and I think we'll get an exact
Read on what it is if I click play that i'm just going to try to preface it first a little bit
Um, if you wouldn't mind go check on on stream dot giga ohm dot bio and just see if everything is going okay
Um, and if you notice, um, if you leave a comment in
Oops not that one if you leave a comment on
Um
On the stream dot giga ohm dot bio
Chat then I can put it up here on the screen and we can we can answer questions that are in that chat
I'm trying to encourage people to use that because I want to see how much traffic it can handle
I wanted to see if for example, I was kicked off of twitch
And I primarily streamed on peer tube how many people can it handle that kind of thing
So I understand it's a little annoying to go over there or to click on that
But um, anybody that does have the bandwidth and wouldn't mind doing it. I would really appreciate it
So I'll go back over here to this thing
So I want to watch this video again. It's from the fda. I think it's from around february 2020 and what it is
Is it's a room full of people?
Who are going to get euas
Maybe even
Like robert melon and steve kirsch are sitting in the audience waiting to figure out how they can get an eua for from
Monoten from ota dean or selek oxib or whatever other things they were interested in
I find it very interesting that I think
I think steve kirsch was pushing something else other than ivermectin on brett wine steins podcast
and I think it was also a
substance that was identified by the domain server, although i'm going to have to go and check all these things
Mark has done a couple really great shows mark husatonic live
Mark hulak
If you're not familiar
Is a good friend of mine and somebody who through the course of the pandemic has become a very good friend of mine is also an independent
Archivist one of the best out there and he's been doing a lot of reporting lately brief reports on how
ditra and
and the domain and the domain program and all these things were really integral in in coordinating our perception of
the response and also
sort of seating a number of
What we can now see as narratives which which forward the idea of a novel virus which needs novel solutions
And the domain was this AI program that supposedly ditra ran with the help of robert melones team
Where they scanned all of the known pharmaceutical products on the fda register to see if they would interact with the three lc
three cl protease that robert melones team had made a virtual computer
3d crystallography model of it and then
I don't know he said at some point dontami's podcast that they also use laser scanning confocal microscopy
But I don't know how that interfaces with a 3d
virtual model of a crystal of a of an enzyme but anyway
He purports in three weeks or so to have helped ditra in this program domain or using this program
to have
Scanned all of these things and and predicted which ones would work and it's supposedly it spit out remdesivir
hypermectin cellococcib and
Fomotidine and then they all went to work testing them
And uh, so that's what we're supposed to believe but at the same time
Of course, you know that the fda was interested in giving out euas for testing
And that was one of the biggest, you know kind of the the number of euas that were giving out for testing might have been
More than 250 by the time we got to
2021 so that means roughly 200 give or take different
Methodologies different sets of proprietary variables that were involved in declaring covid or not covid
We're circulating and being spent money on in america
Nevermind the rest of the world and so it's a pretty extraordinary place to go right in front of I think this is in february
Right when they're starting to encourage everybody who has the entrepreneurial skills or resources to go into this and help
The response of the nation so i'm really curious as to how
Morbid this must be because it must have been a very scary time
When they thought they had to have an emergency meeting about emergency use
Authorizing all kinds of things that they otherwise wouldn't have needed if it wasn't such a crisis
I don't think we're going to switch to classic view because the last time I tried that I think it was screwed up and that's why I stopped watching it
There we go. Everybody can take their seats. We'll get started
Like I said, I'm not going to really try to speed it up or anything
You're just gonna have to follow
According to fda's website hhs has declared six emergencies that have authorized fda to issue emergency use authorizations
For unapproved and vitro diagnostic tests to diagnose. Wow. Did you know that?
And those were for america coronavirus and avian influenza in 2013
Abola in 2014
Evie d68 in 2015 and zika in 2016
Wow
Last week the secretary declared an emergency
Wait, wait, wait, wait, wait, wait, wait, wait. I gotta hear that. That's crazy
avian influenza
This website hhs has declared six emergencies that have authorized fda to issue emergency use authorizations
For unapproved and vitro diagnostic tests to diagnose the disease
And those were for america coronavirus and avian influenza in 2013
Abola in 2014
Evie d68 in 2015 and zika in 2016
And last week the secretary declared an emergency for the novel coronavirus some called the wuhan virus
Well, some of the tests authorized under the eua provisions have been cleared or approved by the fda
Many were never submitted to the agency for approval
Good morning. Okay. So
Just just so you're aware already what we just wrote down six emergencies in
2013 it was avian flu
And it was
mares in 2014 it was ebola in 2015 she said evd 68
And in 2016 it was zika so
Six emergencies who were declared where emergency use authorizations were given to things
Do you see what this means already is something that's never been on my radar before that this whole this whole
This whole circus has been fired up before
This whole
Drill has been done before complete with contracts and proposals and money exchanged and paid out
Do you see
Patents made products tested trials run six times since 2013
Why wasn't there why didn't she list sars in 2002
You know what I think that reveals I think that reveals that there was some kind of legislation between the original sars
And whatever happened in 2013 where they did it twice avian flu and mares
That's a pretty extraordinary first 25 seconds of a video. That's pretty badass is what that is
um
Okay, now i'm going to let it go again. Well, and welcome to the mvic fda workshop advancing euahibd products toward full marketing
status
Um, i'm tennel miller chair of the medical device innovation consortium. Okay. So look at that title already
it's advancing euahibd
I guess that's in vitro. I we'll we'll see what ibd is. I'm sure she's going to say it toward full marketing status
So we're talking about getting an euah product
full approval
February 3rd
2020
We're still a whole month away from 15 days to slow the spread and they are already talking about euas
being
a pathway to full marketing status ladies and gentlemen
If you rehearsed it six times in a row
2013
2013 2014
2015 and 2016 it's not really surprising that they fired it up like this now is it
They just did event 201 four months ago
I hope you're starting to see why this is a much more valuable video than I ever thought it would be already
clinical diagnostic steering committee and i'll be your
master of ceremonies for today's workshop
Although the timing is nearly perfect. We plan this workshop long before the wuhan coronavirus made headlines
And today is not specifically about the coronavirus and I wanted to be clear on that
Nonetheless to does today's discussions could color the path forward
This workshop explores the challenges in moving euah products to full marketing status through denogo
fighting k or pma
Or over the course of the day. We'll discuss the issues and consider potential solutions that could apply broadly
Many of which are likely much larger than fda
And require stakeholders of all different viewpoints and backgrounds to come together to collaborate
on finding reasonable solutions
Also, we don't have the experts around to engage in lengthy conversations about certain topics such as patent law
So we won't we're talking about those
Today we'll look forward to learning about lessons learned
And charting the next steps to the use of real world data and real world evidence to help support the advancement of euah ivd products
to full marketing status
But before we get started this workshop is the result of many many people working behind the scenes
And I'd like to thank our fda colleagues
doctors jennifer ross and kim sapsford and mike waters for their assistance
As well as the many other volunteers from various government agencies and the ivd industry
That work to make today's workshop possible to our speakers and panelists in advance who came from literally around the globe
Thank you for generously sharing your time your expertise your slides your information
Now i'd like to introduce our first speaker pamela goldberg
Pamela is just so you know that that overload is in me. It's overloading no matter how loud i put it background
On md. I see the medical device innovation consortium pamela
I agree the vocabulary is incredible. I mean this is shocking to me quite frankly
Thank you dinnell and welcome everyone look at the smile on her. We're really we've been
planning this for a few months and
What couldn't be more timely?
Those of you who don't know md. I see the medical device innovation consortium
We're a public-private partnership that got created a number of years ago
When there were frustrations about the regulatory science process
and um, but we bring together industry and
government
patient advocacy groups
nonprofits and
And academic they have been planning this for months
It's february third. I wonder how long months is
Is that since november or october?
event 201 happened in october
The first uh brat we Weinstein podcast was around that time
The eighth brat Weinstein podcast took place on december in december of 2019 where sam heris was allowed to say that when the next pandemic comes
We won't be able to tolerate any anti-vax views
And brat agreed
Do they not do these people actually believe the lie that they're telling themselves that it just happens to be
That we got told to plan a conference on euas
And it just happens to be arriving at february third
Who it won't be completely about the coronavirus, but it could be that this meeting just happens to determine all we do that
Are you kidding me? Could they possibly be that naive?
I'm afraid it's true
I'm afraid there are a lot of people inside of our bureaucracy that are exactly that naive
Exactly that naive because they have a salary
That makes them comfortable with being exactly that naive
They have a job security that makes them feel comfortable with being exactly that naive
Make no mistake about it ladies and gentlemen. She's smiling because she loves her job
She thinks honestly that she is part of an apparatus that saves lives and she's proud of it
She gets a good salary for it. She's got a great house. She's got she gets prestige and she gets
Reinforcement from her colleagues people look up to her
It's not much different than how a biology professor like myself can be trapped inside of academia and not understand exactly how trapped they are
Exactly how useless what they're doing is or potentially could be
And that's how deep this goes
We must wake people like this up to see that this is possible before they'll ever even believe it's true for them
It is extraordinary to see this. I mean, I need to get through this video. I don't know how I'm going to get through it
It's like an hour and 50 minutes
medical centers all to
Share the story about how do we get patients better products faster safe or cheaper and we do that through a number of pathways
Both in the diagnostics world
but
Throughout the medical device industry and so we're really excited to put today's event together
When we first started talking about this event with the diagnostic steering committee
It was a great idea and who should we bring to the table and
In part because this is such a timely topic today
We have
Over 150 people have signed up to be here in person
More than 90 people are joining us online. So
This is really important and we
Want and need all of your input to make today successful
So I don't want to take up too much of your time
And I don't want to interrupt all the time, but I just want you to know what's on my mind
One of the thing i'm thinking of right now is who's in that audience
And why are they in that audience?
I wasn't in that audience
If somebody at the University of Pittsburgh that was in the department of neurobiology
Was in their office at this time and I just casually walked by their office to ask them how their bike ride into work was
And they were watching this. I would be like, why the hell are you watching this?
And if somebody in the department of neurobiology
Smart enough to know what's going on said, oh, i'm watching this because I think i'm thinking about starting my own pcr testing
Facility in Pittsburgh how it had been like who the hell told you to do that?
Because I was still just going to work, right? We didn't even have a lockdown yet
So think about what it would take for you or your friend or a colleague of yours to have decided to attend this meeting
Why am I giving you this example?
I'm giving you this example because i'm being asked to watch this video as part of a consulting gig that I have
And that consulting gig is looking into
a
testing company or two on the west coast
And the crazy thing about this testing company is that they got a contract to test
uh
municipal employees
Somewhere on the west coast
And that contract was given to them of course very early because they had an EUA
For a pcr test for covid that they could offer to this municipality
The strangest shit though because the guy who started this company decided to buy four
incredibly over
Over budget pcr machines four of them in order to do this
Machines that are capable of doing all kinds of other things
They could have been machines that essentially served as a core facility for a university
But this guy already in I guess march of some time already decided it was time to order
Some pcr machines because it looks like that's going to be needed and I can get this contract and make a lot of money
Because they want to test municipal workers that don't take the vaccine every week
Well, how do you get told how do you get the clue to do that?
If you were a faculty member at a university like I was just explaining and you thought you were going to go into pcr testing
Had in february of 2020. I would have said who the hell called you
Why did you have that idea? I thought you were into your work
And
The guy who started the company that we're looking into was a porn movie producer
Now why in the hell would a porn
Movie producer decide to buy
$400,000 worth of pcr machines and apply for a contract with a new company that he's just starting
And get awarded the contract
It's very strange
And the cool thing is is that in this video somewhere is the person who actually approved the EUA of that company
And so I just want to see what the hell's going on
But I'm already asking this question because the person that I'm looking into it for is a person who had absolutely no business
Going in to the pcr testing business when they did and they had absolutely no business doing so
With the serendipitous chance that they would get a huge contract with a large municipality
Some very shady shit happened in 2020 ladies and gentlemen excuse my language
And we have a lot of work to do
I got a lot more of this video to watch so I got a I got to push play but I got to make sure you understand why we're watching this
And why i'm preserving it
Because we have some great speakers here today and some important issues to discuss
But thank you all for being here dinnell. Thank you for chairing our steering committee and for emceeing today
And uh, I'd like to uh recognize my colleagues from mdic
Um who really put this together?
carolyn hiller
Can you wave your hand in the back of the room for those who don't know carolyn?
She has uh
Has been remarkable in pulling this together and john hunt from mdic john
And uh, thank you all for being here and I look forward
I mean, it's extraordinary. This is really like
Love and and kumbaya and exciting. We're all going to make money
This is like a some kind of pre apple meeting or something like that. Look at the smile on her face
They're all excited. They're proud of the coffee and the donuts that they provided
They're so happy with the chairs they chose
I'm just so glad you guys were able to to get all the the emails out on time and everybody was able to get here and the web link is stable
It's just great. Isn't it?
Holy cow i'm never going to get done so productive day
Oh, I probably do have it a little lower than the video. Sorry
Thank you pamela
Next we'll transition into our opening session that provides an introduction to emergency outbreak
Situations and data collection our first
Is dr. Luciano borio
Dr. Borio is the vice president technical staff at ink utel an independent non-profit strategic investment firm that works to identify
Acutel
Solutions to support the missions of the united states intelligence community
She specializes in biodefense emerging infectious diseases
Medical product development and complex public health emergencies. Dr. Borio earned her MD from george Washington university
I swear I did not know this was in here
And critical care medicine at john's hopkins and the national institutes of health
Prior to joining ink utel. Dr. Borio served in senior positions at the at d. I can't believe it a council
Please welcome dr. Borio who will speak about national preparedness and response in the 21st century
I cannot believe it. I cannot believe it. I did not know this was going to ink utel. Oh my goodness. You don't
Thank you
Oh my gosh
Welcome
Great to have you nice
Is that lavender? Thank you for this kind introduction and good morning everyone
I very much appreciate the invitation to be here with you this morning
As some of you know, I spent almost 10 years working here at fda
and the teams at the commissioner's office
And in the office of in vitro diagnostic test she worked for 10 years for the fda before she went to ink utel
I mean come on. I can't even make this up. You got to be kidding me. I'm never going to finish this video
This is going to be a whole day's work
That organized this event with mdac are very special to me
I have fun memories of our collective work to
Come back many outbreaks and I'm extremely proud of their accomplishments
Which is why i'm deeply grateful for this opportunity to speak with you
today
As we gather here today, the world is experiencing a great threat from the novel coronavirus
That emerged in china at the end of last year. She's reading
Normally we have to remind people that we live in an era of epidemics
We talk about how infectious diseases emerge and re-emerge continuously
most often and predictably
That some can travel the globe quickly
while others devastate regionally
But either way these epidemics can cause havoc to their communities lead to lots of life
Make health care workers vulnerable disrupt economies
And in some instances lead to lots of confidence in our political leaders
We talk about how epidemics fray the she is telling us the story of giordano from another side
She just said sometimes the pandemics even cause
Epidemics even cause people to lose faith in their governments
It is extraordinary. This is the model of the world that they want everyone to assume
It's the model of the world. They always have to introduce to you in the beginning
So that you assume it it's it's the presuppositions of this model
That are going to enslave our children if we don't break it and you can hear her. It's incredible
And this is february 3rd when they're still not very good at it. They still haven't picked
the best
Enchanters
This is like audition days, you know, it's incredible in qtell, but I used to work for the fda
Fabric up society
And we remind folks that it is in our collective interest to contain these outbreaks as soon as possible
no matter where they occur
Today we live in the scenario that we have repeatedly worn one day would come
Look at how she's doing it here today
About 15,000 people mostly in china had been confirmed to be infected with this new virus
And sadly this number represents the very tip of the iceberg
As this virus continues to expand its footprint and spread around the world
And although we have learned from the past and we have made significant progress in combat and epidemics
The world is not prepared to respond to this latest threat. Wow a pandemic may be inevitable. Wow
Given what appears to be a highly transmissible respiratory virus
And much work remains ahead of us and we need to brace ourselves for
Some difficult weeks and months to come. Wow, she knows a lot
So as preceded my remarks this morning, I would like for you to keep in mind one theme
Which is the power of the we of the collective work for one thing I know
Unity's strength and when there's teamwork and collaboration unity is wonderful things can be achieved
These are now my words. These are the words of the child poet Maddie stephanak who died at a young age in my rare disease
And as my wonderful NIH mentor dr. Heron was or
Was one of the leading positions to combat the 8th epidemic in the early 80s
He likes to remind me to this day that yes, the path is difficult because
All of the easy things that could have been done by single individuals or institutions have been done already
So progress will require collective and hard work
In 2003 when the SARS coronavirus took the role by surprise
There were very few tools in place in the United States to rapidly combat emerging infectious diseases
The animal rule
Had been recently created in 2002 to help drug developers test countermeasures in diseases that could not be readily evaluated in people
And later in 2004 FDA was given the authority to issue
Emergency use authorizations or EUAs to authorize the use of unapproved countermeasures doing public health emergencies
And a prospect of benefit
Our way to risks and these were both very important useful and necessary authorities
The EU way in particular has proven to be crucial time and time again
It provided timely access to diagnostic tests during the 2009 H1 and 1 influenza pandemic
The 2014 West African Ebola pandemic the 2016 zik epidemic in the Americas just to name a few
Just to name a few of those of you the first robust reliance
On EU way for diagnostic tests. That's impressive
So we we were talking about this earlier, right?
We were when when we said that the first EUAs were given in 2013 after a declared emergency for MERS
And then also in 2013 for a declared emergency of avian flu
There were EUAs issued she just revealed that EUAs were established in 2004
So after the original SARS pandemic
So you could even imagine a scenario where the original SARS pandemic was made precisely for the establishment of the need for an EUA
And then six or five times six times
One two three four five six avian flu mares Ebola
Evd 68 which i'll look up after the stream and
Zika were all
Emergencies that were declared and EUAs were given out
So we're learning history here that we still really haven't learned at least I haven't in the last four years
So that really shows you how disingenuous the whole
mystery solving exercise has been I mean I
Why why hasn't any
Lawyer ever told me that EUAs were started in 2004 and I still don't know what law that is
And why didn't we talk about the EUAs that were given out in those years and that that precedent had already been established?
It's weird how the nuts and bolts of the cage that we're in are never discussed
We could just elect people that would get rid of the prep act we could just start
Filing suits in 50 different states with single people who are vaccine injured and try to claim
That it's a violation of our seventh amendment right to have to go through this CICP or the VICP
And eventually one federal judge
Sorry one state judge is all state judges have to say well
I can't see your trial because the prep act says that you can't sue
And then you can appeal to a circuit court in the circuit court
You will appeal to as that's a violation of my seventh amendment and one
Federal circuit court in America only one has to say holy shit
You're right the prep act is a violation of your seventh amendment right and
who
Case law
strikes the prep act
And the who has no ability to declare an emergency anymore that the human health and human services
division of the
uh
Of the executive branch can respond with there's no emergency to declare
There will be no EUAs there will be no legal
though will be no legal protection for countermeasure production
Or producers rather
It'll just be gone
That's as simple as it is. It's just one case that goes to one state court and gets denied trial and gets
appealed to a federal circuit and only one federal circuit judge has to say oh yeah, you're right seventh amendment violation doing
And it'll be over
But for some reason there isn't one organization in america that's taken that strategy
Not one organization not one lawyer not one legal fund
Not one nonprofit is taking that strategy, but that's the obvious strategy
It and any lawyer that i've ever talked to about it has had a real hard time explaining to me why it isn't the right strategy
The best response I heard from one time was I shit you not from erin siri who told me that it's not the right time
And there are people who heard him say that because that was in a zoom meeting
So i'm you can confirm it. It's not the right time. That was his that was his
That was his argument his answer
And so I have no answer for this other than to say that I think we are being led by our noses we are being
Trapped inside of a limited spectrum of debate that has no bounds in that sense that all parts of our reality are effectively controlled
Anywhere where there is a possibility of us escaping or a possibility where we could pass on
This freedom to our children and understanding of what really how it's defined
They have attempted to confuse us
And one of the things that you can see here is that this idea of an emergency and the idea of responding to it
Is already built into the the bureaucracy and in fact it almost
The bureaucracy feels better when they're called into action than they do when they're just waiting for it to happen
And that's why you see the smiles on their face
It's it's almost like a fire department that's been doing drills all the time
And now they finally get it to get into their trucks and turn on the sirens
You've got dang right they're going to drive through main street
You're gosh dang right they're going to use the hoses
And in cutel, I mean, I can't even I can't even believe it's in cutel. I don't even know why I stopped talking
I'm just going to keep watching. Sorry guys
In the 2009 flu pandemic was a paradigm shift
And I'm pleased to see that Sally Hui that is here with us today because she really led this effort back in the
2009
The agency worked alongside developers and in real time to get tests validated and authorized
FDA made clear that the data he needed to see
For these tests to be distributed for use
In a way that was responsible with public health
It provided guidance and support to dozens of developers
It showed that fda could serve the dual role as regulator and collaborator doing complex public health emergencies
That was a paradigm shift regulator and these processes are still in place today
This timely access reform regulator and collaborator
It was a major paradigm shift
She said in 2019 because of the flu or something like that of 2009. I don't know
But that's a pretty amazing revelation and also
actually an admission
That the fda sees themselves as a regulator and a collaborator so they're regulating themselves basically
They have a vested interest in things passing
It
Would be like teacher evaluations being filled out by the teacher, right?
That's essentially what we're talking about here. There's no
Advantage for them to evaluate their clients
In an honest way because they win either way
It's it's amazing
And this woman should have practiced her speech a little more because she reads terrible
By the eaway authorities is key since the agnostic tests
Are one of the most critical components of outbreak management and control?
I don't have to remind this audience, but I think I will
Diagnostics allow us to protect the healthy and treat the sick
They allow us identify and isolate the sick
They allow for the efficient allocation of scarce medical resources
They enable fundamental public health measures
They are necessary for the conduct of clinical trials to evaluate vaccines and therapeutics
And they are true
So if you didn't think it was a testing pandemic now you absolutely know it is because she's explaining to you now
the diagnostic testing is key
And in fact, it was very key to deciding between
Before we had diagnostic testing pere Corey says what we had was pulse ox
And so people who had low pulse ox were given supplementary oxygen because that makes sense
But supplementary
Oxygen at 10 liters a minute or 60 liters a minute
According to some crazy medical records that i've seen with my own eyes
That's pretty toxic
But if you use the diagnostics to tell doctors what to do if you tell
Doctors that these diagnostics tell you whether this is a particularly deadly disease or not
That's a pretty crazy rock and a hard place to be tweet be between
And professionally a lot of these were young kids
Residents that were told okay, you're taking over the er because we're sending the old attending physicians home and giving them
Early retirement and you might have to listen to this guy who just came in. He's from the national guard
This is February 3rd before all of that happened before any of that happened
And they have in cutel giving a presentation to fda and their associates
Please understand that this is as close to a smoking gun as we're going to get
To seeing how many of these dominoes were stacked perfectly
And how willingly they were kicked over
And how nobody did anything to stop it
And
That coupled with the fact that a certain number of these people are willing to read whatever is put in front of them or
More importantly willing to teach whatever they're told to teach even if it's just a mythology which gets everybody to conform
Comply
It's amazing. It's amazing. This is going to be one of the best long shows i've ever done
We are first a line of defense and can be read it sooner than any other countermeasure
I'm still stuck on it too. They've been planning this for months
2013 fda sought and was granted new authorities by congress to issue eways when there is potential for an emergency
even before it actually occurs
So that
You would not have to wait for an emergency threat to become an actual emergency
The thought being the diagnostic tests are important to detect outbreaks at the earliest possible timeline point when there is no time to waste
The novel coronavirus that is rapidly making its way around the globe serves as a stark reminder of the importance of diagnostic tests
Any vaccines and therapeutics that might be developed will take some time
Which may limit their impact on outbreak control
Whereas diagnostic tests are already making a difference. Wow and i'll come back to this later
So in addition to new authorities we have seen remarkable progress in what i like to call the response enterprise
So in terms of information sharing china publicly shared a viral sequence of the novel coronavirus early on
Allowing many researchers and developers to begin work and understanding and developing countermeasures for this virus
In terms of support for countermeasure development. There are new players in the mix
The coalition. I know you know, I know i'm stopping it a lot, but keep in mind what what what has she already
Now what part of that enchantment did you just get cast
The part of the enchantment that just got cast was that if they have the sequence
Then we can develop a whole bunch of new countermeasures for it because all we need is the sequence in order to do that
That's us. That's an assumption that is embedded in that's that little bit of the story. She just said
In every person in the room and every person that's online listening to it was already
Confirming their
They're
The narrative in their hand
Otherwise, they wouldn't be here. No, there's nobody in this they they say that this isn't about the coronavirus
They say they've been planning this for months and it's just lucky that we're having you know, so timely
But that's absolutely ridiculous
And
It's crazy. It is crazy what we have here
For epidemic preparedness innovations or sepi for short, which is led by my good friend, Richard hatchet
Is already working with multiple developers to facilitate vaccine development?
In addition, the department of defense has established an office of biotechnology
Led by anyone else finding an odd that she's funny that she has the sniffles
So she's really good friends with the head of sepi. That's great. That's great. Oh, wonderful
Good friend dr. met Hepburn to facilitate countermeasure development
And they're already working with other us government agencies to identify and support some of the most promising products
The
EUA however was never intended to be the end game
It was never intended to replace standard tried and true robust
scientifically and rigorously validated countermeasure development
There was tremendous pressure in 2014 to issue EUA's for investigation of vaccines and therapies
however from the experience that we had of issuing an EUA for permavirus a flu drug
In the 2009 flu pandemic
We knew that we wouldn't learn much about the drugs risks and benefits
We were challenged to do better when faced with Ebola in 2014
The idea that scientifically informative clinical studies were not feasible during public health emergencies
Were put to rest with several studies
Being conducted by the NIH in a series of efforts led by dr. Cliff Lane at NIAID
In collaboration with WHO, NGOs, and other international partners
The clinical studies were conducted under the most difficult conditions
The process was arduous and challenging. It required collaborations
Success was not obvious
Just be sure you understand that I am also very annoyed that she's reading a statement to us right now
I'm incredibly annoyed that she's reading a statement to us and I'm incredibly annoyed that she didn't practice it more
And I know that she probably did not write this
That's what we're dealing with here ladies and gentlemen. These people get paid good money. They have a very comfortable life
And so when they're told to read something they read something they think they are part of a governing apparatus
That's bigger than them and they have they just a part of it
They're happy to be here inside of it that lady is so happy
The lady before her was so happy and so proud that these months have been so productive and successful in organizing this extremely
timely conference
Sorry, I have to keep disappearing the efforts paid off
Today we have a licensed vaccine and clinical data on several several effective therapies for Ebola
That we hope will result in approved therapies
So where does that leave us with diagnostic tests?
Why have we struggled to achieve fd approval for diagnostic tests that are fielded under the eOA authorities
The good news is that the system for developing and validating diagnostic tests during emergencies
And the issuance of eOA's during the emergency is very well established
The bad news is that too few of these tests continue to be validated to the extent necessary to gain fd approval
As a result very few authorized tests are eventually approved
And we are here today to examine this issue and to develop solutions
It is most likely true that some tests when examined more regularly would not meet fd standard for approval
And some developers may choose not to pursue approval for fear of failure
I recognize that market forces play a very significant role here
There's little incentive. So she is more or less admitting that while an eOA exists
We could be using tests that actually aren't aren't good enough for fda approval
She just said that
And that lots of them might be that way
But it's still okay. It's still great. It's a great system. We need these tests in order to know who to treat
But the tests aren't good enough for fda approval. So we've got to fix that problem
So what are we going to do? We're probably going to lower the standards. We're probably going to enable
the
disingenuous data collection during its eOA application to
to
proxy for what would be a a proper
uh evaluation of of the diagnostic as a tool
That's that's what we're going to hear here. I can I can hear it already
But the the extraordinary thing is that she says the words
She read the words that she just read and I guess she must hear the contradiction in her hand
Or she's really just an orator and not really a thinker but just like a
Automaton or something. I mean it's it's absurdly obvious to me that this is
This is borderline criminal evidence of exactly what happened to us
For the commercialization of diagnostic tests for certain emerging infections, especially once the outbreak that drove the initiative development of the test is over
And we cannot ignore these market forces either
And aside from the commercial sector, it is fact that government
Has deprioritized the support for diagnostic tests as a countermeasure over and over again
When a decision is made to spend a dollar on a therapy or diagnostic tests
The therapy usually wins even though these drugs
Are incredibly important. They offer incremental benefit over standard support of medical care whereas diagnostics
Are the backbone of the response
I'm going to go so far as to say that this is her primary message and it's before I'm a I'm a levelate reason
And that malevolent reason is that this is part of the scottop to come of course that they're going to use PCR tests
They're going to sell PCR tests as being highly specific and very accurate so accurate
That they can pick up an asymptomatic infection to allow you to save your grandmother or stay away from her
And they're so accurate and so worth doing that we should line up
All the way around the block to drive through and submit to a swabby
I think that this is incredible because
She is making an absolute
B line hail mary pass
For the idea that diagnostics need to give getting more credit than they deserve and trying to tell a story about how you know
Therapeutics are often given given a lot more leeway than then diagnostics, but diagnostics are actually really important
And we were going to do tracking trace for more than a year to come
After this we were going to spend millions of dollars around the country
To follow up on positive tests by calling people and having them test
In cutel is telling the fda and an audience that's seeking potentially how to get an EUA
Up to full marketing status
The diagnostics are much more important and are going to be much more important in the future
Isn't that what she's saying?
I think she's saying that
And that's why collaboration and funding support by the US government
And other partners becomes important to promote the systematic collection of data from the real world use of these tests
These data could be used to support fda approval
And if that's done developers win because the
Requirements of the emergency create a path for utilization of real world evidence toward approval
This sets very nice precedence. It facilitates the approval pathway for many other diagnostic tests
And the public health and patients win
Because they have the confidence that the tools they're using have been subject to rigorous scientific scrutiny
Wow
But for this collaboration to take place we need to speak frankly about the obstacles to achieve this end goal
What's the option? And I would encourage you to do that today. Okay
We need to understand what capability is each has and we need to develop shared responsibility for making this a success
If we did this for vaccines and therapies, we can certainly do this for diagnostics if there is a will
And let's not stop here since we are
Together let's go further. Let's imagine a world where rapid diagnostic tests are available at the point of care
For every future emerging infectious disease epidemic
Or routine medical care wait, what a world with small handhelds that can one molecular base test what
I'm sorry. I have
Diagnostic tests are available at the point of care
For every future emerging infectious disease epidemic there you go
It's that there it is a world with small handhelds that can one molecular base tests in local complexity settings
See imagine how valuable that would be for responding to epidemics
And for caring for patients on a normal day
So to think about how amazing it would be if we could sequence your genome with a
Wow, I mean, wow
Hey, we come together with a tremendous sense of urgency
Innovative ideas and a renewed commitment to putting strategies into practice
Remember the world the words of Maddie step-a-neck
Unity's strength when there's teamwork and collaboration
Wonderful things can be achieved
In this era of order measures, quarantines
Social distancing, elbow bumps, I wish you a highly productive workshop and discussions. Thank you
Were we doing that already? Wow
This
This era this era she says
It's gonna be a new thank you dr. Borio
Wow
Diagnostics are the backbone of the response. I think that's that says it all. That's awesome. Thank you
Our keynote speaker today is dr. Neura Pollock. She said that was awesome
She is the associate medical director of the infectious diseases diagnostic laboratory at Boston Children's Hospital
As well as a faculty member of the division of infectious diseases at Beth Israel deaconess medical center in boston
She's an associate professor of pathology at harvard medical school with a joint appointment in medicine
And she completed her m d pht at the university of california, serencisco
Her medical residency at brigham and women's hospital in boston and her infectious diseases clinical microbiology fellowships at bid mc
Dr. Pollock has an active research program focused on the development and evaluation of novel diagnostics for infectious diseases and related applications
And she'll be speaking about evaluating novel diagnostics in an outbreak setting lessons learned from Ebola
Oh, man. So she's going to tell us how they
Tried to diagnose use in vitro diagnostics in the Ebola scenario and how well it worked or what come on you got to be kidding me
So
Just so you know, rober melon's not going to step up to the mic even though that wouldn't surprise me i'm pretty sure he doesn't
But steve kirsch could be in the audience at home i that that wouldn't surprise me
Uh oh
It problem all this conference has fallen apart fast
The coffee and donuts isn't going to make up for this
Can't find her slides
I need a head nod carolyn slides looking for my slides looking for slides
Yes remdesivir was used for Ebola as well, but i don't think it worked very well for Ebola
I
Think in today's world, it's a little bit of an assumption to assume that these are all women
But I think they are indeed female indeed. I do think that's true
Just want to be careful, you know, you don't want to make any
Holy shit, what's happening here? This is kind of funny
What wall I guess we're gonna have to call the it lady. She must be out getting more donuts
One thing you can never rely on
By telling you why I was invited i think and I appreciate that you really believe
um, I
My research program focuses as she said on the development of novel diagnostics
and I
I am here to tell you about the experience that we had
Evaluating novel diagnostics during the Ebola outbreak in West Africa in 2014-16
And this is something i'm sure that many of the people in the room were involved in
And my goal in the talk is actually to
a sense of what my experience was but as a generalizable
Topic so that we can pull from that okay
I'm actually thinking now it wouldn't be crazy if Robert Malone was in this audience as she says that
I think a lot of us were involved in that Ebola response
Well, he definitely was so it wouldn't be crazy if he was in in the room
Shit
It says it's running but it's not playing oh man did I screw it up please don't
What's happening
Shit
Darn it I might have to refresh it a little bit something why sorry
I'm still gonna try and keep it skipping forward and see if I can do that. I won't do it anymore. I'll just wait
So I think it is really interesting right we're talking about people again that have been through the
Been through it already now. I'll just start by by telling you why I was invited I think and I appreciate this invitation
I
My research program focuses as she said on the development of novel diagnostics
and I
Am here to tell you about the experience that we had
Evaluating novel diagnostics during the Ebola outbreak in West Africa in 2014-16
And this is something i'm sure that many of the people in the room were involved in
And my goal in the talk is actually to give you a sense of what my experience was but as a generalizable
Topic so that we can pull from that and take it to a larger level and apply it now
Um
I would just start talking there's a whiteboard behind you. I mean come on
I don't know. I I find this kind of funny
Um
Definitely the nqtell lady would have been screwed without her notes, right?
So I mean, it's not surprising I guess but maybe it's just you know, you want to do it right
And she knows she has her slides on that laptop somewhere
She's just gonna pull out her usb
Wow, I don't know what to say. I think this is uh
This is gonna be really gold
I'm gonna risk clicking this button again
Just gonna keep trying to go forward. Oh it guys here
Wow, they really had to pull the whole rip cord here after all this planning for months. I mean gee whiz
Just let the lady hook up her laptop
I
Oh now the rickin apologies. It appears we have the technology fixed hopefully the technology she calls it. There you go
Okay
All right, here we go. Thank you
No problem, masa
Okay, so as I said, we're going to be talking about lessons learned from ebola and with the goal of applying it to
Today, of course the bullet is still going on today. I know we are all focused on coronavirus, but
Okay, so as I mentioned my interest is in the development and evaluation of novel diagnostics
And there are a lot of as an academic coming to this with also a public health perspective
There are many opportunities and challenges in this area and lots of interesting things to do proof of principal demonstration with novel technologies
method comparison, which will definitely come up in this talk point of care used how good is the point of care testing to be
How good is a gold standard and what is clinical validation really involved?
What does that mean in a controlled setting but particularly in a field setting and particularly during an outbreak?
Okay
So the laboratory diagnosis of Ebola virus disease in the 2014 to 16 epidemic had many challenges that i'm sure many of you are available
But a main problem is that testing if if it was available
Was standard high complexity real-time PCR that was performed in biocontainment laboratories and biosafety was a very very big issue
There were specimen collection challenges
So there were resource limitations that meant that that actual supplies for doing the napuncher packaging
Transport were often not available and there was inadequate training for actually collecting these samples that compromise safety of the sample and safety of the operator
There were many logistic challenges that emerged as this rolled out including incomplete specimen submission forms lack of unique identifiers
Unfortunately, I see someone reading here as well
Um, I don't I don't know what else to say other than than than she's reading. She's much more rehearsed than the ink util lady
But this is definitely reading
It's fine, but i'm just letting you know transport delays results reporting delays
I'm certain that all of this is being felt right now in china
There was a big deal at that time. So the reality was it results could take a long time to return to clinical sites and there were many opportunities for error
So in 2014
At the beginning, um, the international mobile lab deployment to west africa was robust but there was still inadequate access in many many areas
And this led to an urgent clinical need for new tests and particularly rapid sample to answer point of care tests
That could be run by less experienced operators. So again here. She's defining a need
She's defining a need that wasn't met and so she's defining a new market and she's
It's really uh, it is a it is an amazing presentation
And this led to an explosion in test development that I certainly had never seen
And an acute need for evaluation of these tests
And so I was drawn in in the winter of 2014 when I was asked to help partners in health
Which is a Boston based nonprofit urgently developed some field studies and Sierra Leone to try to evaluate the most promising Ebola diagnostics
In the hopes that they could be used on those patients and we had some available funding from the abundance foundation
So what I knew before the Ebola outbreak from my experience was a fair amount consider all the variables think about everything sample handling
Who's the case? What's the reference method? What's the cutoff?
All of those things and I knew that we should expect the unexpected particularly in a field context
Lot to lot variability not assume that a fingerstick sample would be the same as a vena puncture sample
Which reference method gives the right answer? So I was familiar with these challenges up front
However, what I learned after being involved in this was much larger than that and that is that there are systemic and systematic
Challenges to evaluating novel diagnostics in an emergency setting in particular
And then if we don't collectively consider these challenges and find solutions together that development and evaluation of novel diagnostics and future outbreak settings
As we are in now would be handicapped
So this leads to the concept of a global emergency diagnostic framework and really a preparation that's diagnostic focused
To be prepared to act quickly and to succeed
Okay, so back to winter of 2014
So i'm i'm i'm immediately drawn to nick hudson statement, which is whenever they say they have a global problem that needs a global solution
You know that it's bullshit. She just said that we need a global solution to the evaluation of diagnostic tools
holy cow
That's pretty impressive
I mean, this is this is a major. Uh, this is this is impressive
It was a very confusing and chaotic time
Uh, there were multiple novel acids under development and it was a big question mark
Which one should be prioritized? Which of the tests are we going to test the video?
Should we go after a novel assay and a novel platform or only something that's well-known
What about platforms that have never been tested in the field before all sorts of developers were throwing their hats in the ring
There were technologies that had never seen
Anything outside of a laboratory. What about production capability?
Should we only go with companies that had the capacity to produce giant numbers of tests?
What about how do we plan?
um
The clinical studies in parallel with the development of the tests themselves. What what sample types are we going to do?
What should the study look like? How do we design it? It was pretty much chaos at that time
There were multiple RTPCR assays that were in use in the field
Which led to the question of which one of these should be choose is a reference method
Which is obviously extremely important for a test evaluation
But at the beginning of the outbreak there wasn't an Ebola virus diagnostic evd diagnostic with either fda or who approval
But there are a lot of laboratory tests out there ldt's lab develop test
CDC had one dod had one public health england had one there were home brews
And then it was so it was in the fall of 2014 that the first who
Emergency use authorization the listing was uh was was approved for a commercial assay
Which was the eltona real starfire of a file of iris screen?
And also in november 2014 came the first fda eua for a commercial assay also by
Interesting that she says the the who also gives out emergency use authorizations
That's an interesting thing that I didn't know so that's just take notes here
On a slightly different
But there were all these assays out there and there was very little sharing of data about how the ass is compared
So it was very difficult to understand which one of these we should choose as a reference method
Have which one was the best one to use for novel test comparison
On top of it. There were multiple people in charge and it was very difficult to understand who who was truly in charge
Who was there fda was there cdc dod phe department for international development
That was just the global groups and the us groups and and so on but in uk groups
But then you had the groups in country serially own what do they need who's in charge there?
So there were multiple bodies there as I've indicated here all of whom had to be in contact
And it was very unclear how to do that. There were formal processes for study approval
There were informal processes which you couldn't know unless you knew the right people to ask
And then there were unique biosafety considerations for collection and testing of samples
And then of course we were in an outbreak so speed was essential
So there were all of these barriers and sources of confusion upfront
So the first step for me was to learn something about diagnosis of Ebola
So as an ID clinician, I knew something as a microbiologist. I knew something but not what I needed to know
So these are the sort of traditional and historical background methods for how you test for Ebola
I won't spend much time on this other than to say Ebola is an RNA
I'm super annoyed because I thought that this would be up here, but it's not
I don't know why this is not working like that, but I can't
Just so you know, I can't download this video. It's like on only the FDA website. You can see the
The link up there. Maybe I can copy it for you if you want to
If you maybe you can figure out how to get this thing off of the internet and onto a hard drive
I don't know. I can't I'm gonna put this link in the chat
Maybe someone can try that. Yeah, you could screen record it, but it's really long
But yes, you could you could screen record it
Service in code separate viral proteins
The the stream that has caused the most damage is Ebola's eye ear, but it's not the only one
So traditionally it was cell culture, which is very slow
Then serologic tests came along where they didn't work very well because it took too much time to form an antibody
So it wasn't clinically useful then people realized you could detect proteins by ELISA and that those came up very quickly when someone was symptomatic
That became an area of use and then finally
reverse transcription PCR or real-time PCR, which was clearly
I'm pretty sure that ELISA is the
the antibody
Linking tests that is used in a lateral flow test
So when she says that they were testing for proteins using ELISA, that's
Would eventually become a lateral flow test. I guess they weren't producing mass producing lateral flow tests for Ebola
But that's what what an ELISA test would be as far as I know
I might have to go to the bathroom pretty soon, which is not what I intended, but
Maybe I'll take a break and and break the video into two. I don't know
Sensitive then the other methods and people also learn that the CT value
The psycho threshold could be useful for predicting outcome and then we could use those tests to look at other sample types
Not just blood but more saliva
Wow, that's interesting
So the psycho threshold of our tPCR is already being advocated for as being a useful indicator of infectiousness
Which we have already
It's already been shown that that's not really true unless you do a few
Reads, right? You got to do like three or four
PCR's and then you take an average of the CT
But if you just use one CT that will never work. That's an amazing thing to put in here
Wow, they were really on all of it
Fluid and so on so that was sort of a history
This was the figure that we ended up putting together during the work just to understand
How these different analytes came up over time?
When did someone have enough RNA in their blood and so on? So I won't dwell on this. This is
Published in a review that we did in 2016. Well, she did a review
But the point is that reducing the time to diagnosis is key and for pretty much any outbreak pathogen, that's true
For Ebola the clinical management and infection control issues were enormous
The clinical presentation was non-specific. They could have had malaria
They could have had many of of other things and so separating patients while you're waiting for the test results was a really big challenge
On top of it
It was very difficult for the patients themselves to go back to the community if they test until they tested negative
They needed a negative test to get out of that triage area
And to get healthcare elsewhere
There was the problem of testing of dead bodies
I'm sure you all know this that the that bodies needed to be tested in order to allow families to proceed with aerial practices
And then of course contact tracing, which is something that's very very
Important right now in our current outbreak
Okay, so that was step one to learn and then the second step was trying to design and execute as
Quickly as possible studies of the most promising diagnostics in the hope that they could actually be useful and be implemented
So in 2014 in the fall
What we as a community felt we needed were diagnostics that were safe and rapid and cost effective from the user perspective
But in particular that were usable at or near the point of care instead of having to go to a centralized laboratory hours over a dirt road
And they needed to be performable by local laboratory technicians or healthcare workers and ideally the latter
So it had to be easy
So the first study that we did was a evaluation of this particular test called the corgenics rebob antigen rapid tested
And i'm not going to focus so much on the details of this particular study, but just on the generalizable take home points
How do we pick this one we picked it as a community?
So in consultation with the WHO find Ebola diagnostics access collaboration
So it was sort of put up as a possible front runner that met criteria
We knew it had detected. It was a simple lateral flow immuno assay. It didn't require external instrumentation
It did require a cold chain, which is not good, but nonetheless, this is the one we did
And so the kind of study that we designed for this is not rocket science
But it was actually pretty hard to conceptualize this rapidly because we knew we wanted to test finger sick
Samples at point of care that in itself is a big deal with Ebola
Because that means that it needs to be done by someone in full ppe and i'll show you some pictures
But we that's the point so point of care testing finger sick sample
Edd suspects at partners and health sites test performed at the bedside
So done and read by ministry of health technicians in what we call the red zone so full ppe
But we also wanted to know whether testing in a reference lab would look the same. So we had our our collaborators at public health england
testing
consecutive venous whole blood samples as they came into the lab for testing for clinical purposes
We also tested with the rdt
So we had our two pongs of testing and then we compared all of the rapid diagnostic test results
The rdt results blinded to the clinical test results on those same patients from the blood that had been done at drawn at the same time
And for that our reference method was one called altona
Which is as I said the one that had emergency use authorization
We had our visible lines on our lateral flow red by two readers and if they disagreed we had a third reader
So we were looking at inter operator variability. So we were trying to it
So you're looking at inter operator availability of lateral flow tests
Do you agree that there are two lines here?
I don't know that second line. It looks pretty dim. I don't know what what what would you say? Are you pregnant or not?
That
That's her job
Do you see what's happening here? We are actually witnessing the
ongoing
bamboozlement of an entire bureaucracy over the
primacy of
Diagnostics the usefulness of lateral flow testing the relevance of a combination of antibodies turning a stripe a different color
In finding viral particles or viral proteins. This is all part of their worldview
Most of them are presuppositions which have to be assumed to be true in order for you to even understand what this woman is saying
If you have any skepticism at all about the danger of RNA spreading around the world in the form of a bleeding sickness
Then you won't be able to understand a word this woman is saying
Because you have to assume that Ebola exists that it spreads
And that it needs to be tested for and so why aren't why wouldn't we evaluate all of these hundreds of tests?
Why wouldn't we send blood from africa to the UK so that they can verify the tests
Even though the blood could have Ebola in it
It's
It's amazing man. I'm ladies and gentlemen. I'm just having a blast. This is crazy. That's all of these characteristics at the same time
So this is what the setting looked like you can see colleagues and floral PPE at the partners in health site
This is to demonstrate how we had to collect our data. So here's a generalizable point
So we have a highly highly contagious agent and you are not allowed to take your data forms out of the red zone
So how do you do that? How do you capture the data?
We ended up there was a triage moment where we could capture clinical data on paper before the person went into the red zone
Then in the red zone we collected our our assay data on paper
On forms and we did the test and then we had to document this by please make no mistake about it. This is worst case scenario
This is just a very simple recitation of what the worst case scenario is and how you handle a worst case scenario
Her personal experience with executing a plan for worst case scenario
And why would they have her speak on february 3rd of 2020?
To a group of people about getting EUAs to full marketing potential
Man oh man when the people finally wake up. It's going to be one the heck of a barbecue. Holy cow
I can't wait
The bourbon is just going to flow
Bring it up over a fence between the hot zone and the non-hot zone and taking a picture from the other side of our case
Form so that we can we could record this data
So just an example of the challenges of data recording and I can
Imagine what is happening right now in china trying to actually transform transform data from paper to an electronic database and so on
It's very challenging particularly with biosafety issues in play
This is the more calm but still brought setting in the public health england lab where they're in the flexible film isolator
So same idea
Okay, she's showing pictures of people working in high containment facilities, of course
You know like the sheng she Lee picture then and then and the picture that we have of of a young Steve Hatfield
Um when he was working on Ebola you see now
You see she probably knows Steve Hatfield
Over our study conclusions we concluded that art that the test actually performed quite well against the compared of the altona as our benchmark
100 sensitivity and 92 specificity against his benchmark
We did see that we needed two readers to be able to get that sensitivity because sometimes they disagreed and there were weak bands
We learned but it was feasible to do this in the red zone that someone could read that one of these things through their foggy mask
And that um despite patients being dehydrated and we could do finger six and do this
So we learned that kind of practical stuff inter operator greeting was high
We detected all the patients with low CT values meeting high amounts of virus in the blood so the most infectious people
However, and here's a generalizable point
We learned that the altona assay was an imperfect reference method
And how did we learn this?
It's because we tried to do discordant analysis because we had some samples that were positive by the rapid test and negative by the altona
So we said public health england
Any other assay we could use and say they had an assay called the trombley assay, which they still use that was their lab develop tests
And as it turned out
On one to one comparison the trombley was significantly more sensitive than the altona tests
And we surmised that the that was probably because when public health england had to implement the altona tests in the field
They used what they could as an amplification platform. They had a smart cycler
That's what they use probably not the ideal method for this particular altona assay
And so the altona assay was actually missing
Samples that had low amounts of virus in the sample and the trombley detected those
So I know that fda doesn't like as I understand the fda doesn't like discordant or discrepent
Analysis, but it was actually critical here for us to understand what was happening
And what we came away with was that the reference standard actually causes to overestimate the true sense
It doesn't like as I understand the fda doesn't like discordant or discrepent
Analysis, but it was actually critical here for us to understand
She ain't supposed to say that missing samples that had low amounts of virus in the sample and the trombley detected those
So
I know that fda doesn't like as I understand the fda doesn't like discordant or discrepent
Analysis, but it was actually critical here for us to understand what was happening
The update was at the reference standard
Actually causes to overestimate the true sensitivity of the rapid test and underestimate its true specificity
Because it was just not a perfect reference method
And so we in the end of the day, we didn't really know how the rdt would have performed in a set of samples with lower
Viral loads or what the significance of such samples and patients would be
So generalizable the reference method really matters and you can't always know this up front
Integration and I'll just mention this because it's also I think relevant
There was a lot of disagreement after our study about how to implement this test or if
There was concern about the use at point of care of an imperfect
Test which most point of care tests at this point are how do you do it? How do you implement it?
How do you teach people there was a lot of discrepancy between what we saw in the field?
Not a lot, but and unfortunately she's not going to say the simple fact is that these tests become a problem at point of care
depending on the prevalence of the disease
if you're doing a PCR test it has a specificity that fluctuates depending on the
prevalence of the disease
and
Thomas binder explained that in our interview about a week ago where he said if you use a PCR test
To test to see if men are pregnant you will get false positives and none of them will be pregnant
And that's the specificity if it's 98 percent specific then that that's what you're going to get 2 percent false positives
in a population who cannot be positive
And so if you are testing on a background of no Ebola then you're going to get a lot of false positives
So she's not really telling you the whole story
But she's trying to give you the impression that there's a job to be done and there's an ideal to be attained
The ideal would be a hundred percent a hundred percent
But of course that's not possible and so we need to do all this complicated work and complicated p values
To understand which one is the best of these imperfect things
And then we can only deploy it when it's you know needed or useful or appropriate
It's nothing but an elaborate setup of smoke and mirrors to make sure
That as the the deck chairs are rearranged and the shells are moved around
And you're trying to keep track of where the ball is that it's impossible
She's already telling you why you won't be able to know
She's already telling you why there will be a lot of false positives when we issue EUAs for testing for a new virus
That's the problem we had with Ebola
And in fact the FDA doesn't like you to do the kind of cross across evaluation that in order to show it
Think about what she just said
Holy moses creable
Some discrepancy and what was produced in it by the WHO in a laboratory setting with process and samples
What does that mean?
Okay, and then on top of it very importantly, you still need the approval of the in-country
authorities whether or not you oh man, so the you the
WHO does
Makes up their own tests based on frozen samples and then we have to get those tests past
Individual fda's and cdc's it's awesome. This is the most amazing video ever
FDA WHO anybody else CE mark the country the one who's decides about whether to use this and it's a whole other level
So this led to stalemate and a lot of confusion
Okay, so a moment on the ora quick test another rdt. This is the one that has proceeded to
Full regulatory approval. It's FDA approved as of october 2019
And I just put up this detail about what was done in the package insert
Just so you can see what what it took to get to full regulatory approval
Well, what ora quick was not able to do was to do a point of care study on real patients in real time because it just wasn't ready
Then the patients were gone. So the the type of data that we got for the other test
Is not in here, but they did studies on for example non-human primates in fingers six
Um, so but you can see what was done here. Um, and she's almost making the argument
We've got a hurry so that we can test more of these diagnostics
That's the argument that I hear
That if we wait too long the disease will be gone and then we won't be able to test any of these diagnostics out on the people who are sick
It's extraordinary, but I do hear it
Just there was it was just not ready in time to actually do things like
Operational inter-feeder variability and so on on this test in real time in a in a keen incentive see
Okay, it's exactly what so just shifting to the other study we did the gene expert Ebola
So this is also in use now in the drc outbreak and I meant to say the ora quick is as well
Um
So this one also had EUA by both FDA and WHO and was CE March all around the same time
This you are probably familiar with it's an automated sample to answer system where you in this case put the sample into a
Inactivating reagent for about 20 minutes and then you transfer it into the cartridge
And then it goes on to the same expert platform that people are using for lots of things right now
Has two genetic targets and so on so this is what we chose for our other study
And what we learned here
Was that the on both whole blood and buckleswap samples this assay had very very good performance. It's a hundred percent sensitive
on whole blooded buckleswap
When compared to the trombly assay I mentioned run by public health English and the specificity
Here's another point of why I think discordant analysis even though it's complicated is really important
So what we saw was that the specificity of the expert versus in whole blood was around 96 percent
Okay, but then we said wait a second some of the ones that are testing expert positive and negative by the trombly assay
they might be real and we went back and looked at them and
um like
Seven out of eight of them were from patients who already had been diagnosed with Ebola and this were being
Seerily tested just to watch their viral lows fall down
So they were real and so we feel very confident in converting our our sense of best our specificity to 99.5
But that was the screpid analysis. So you take relief
Okay
point out that um doctor swab order of MSF also did a study
An operational study had very similar results was doing testing by right in a lab right next to their patients and found extremely similar results
Okay
So collective accomplishments
Um in this outbreak the lab response the deployment of international labs was truly inspiring
Uh, there were 40 international labs. They were performing real time. RTPCR. They all had rigorous bio containment
It was truly truly impressive
And what's also impressive is the fact that at the start of the outbreak there were as I said no
No diagnostics that had regulatory approval, but by may of 2016
So a little more than two years later
Um, a lot of tests were approved and we managed to do a small number of field studies for novel test evaluation
Not many, but there were a few
So this is you can't read this, but this is all the tests that got EUA. This is one slide of two
So we have a bunch of of manual
Real-time PCR essays in pink
So non-automated and then the next page we have some some automated
PCR essays in blue and then we have some rd cheese and green and some compressive, right?
So it's two slides of of test that got you a approval
Now tests that got EUA approval for Ebola, so imagine she's got two slides full for that
It was more than 250 in the united states in the first year and a half
So we were just over flooded with
With things that we didn't know worked and nobody gave a shit
She says this is totally normal
It's interesting and relevant to this group is sort of what where do they go after that, right?
And this is again not my area, but just focus of this this group
And so what I understand is that the WHO once there is no longer a public health emergency of international concern
They still encourage manufacturers of these products that are listed through their EUAL to apply for full prequalification
But there aren't any any products that have been fully pre-qualified as I understand it by WHO
I asked friends couldn't find it. So I
FDA it's just or a quick as I mentioned that one RGT that is progressed
Okay, so we'll be talking about that
There and I will I will not be the one to explain this mechanism
But I want to meet the point that even if it's approved that doesn't mean that you can get it and there was a useful
Study that was done
Recently, it's in common to nature from january 2019 where they this is the group in I believe the UK
Where they said, you know, we are in international reference laboratory
Let's see if we can get any of these Ebola diagnostics within two weeks
And so they emailed all the manufacturers they called everybody they put in all of the requests for tests and
They found that of all the available tests there were only four of them that they could actually get within two weeks
Okay, so even if they're approved that doesn't mean a company can just sort of get them to you in the necessary timeframe
So I think that is a key barrier
Okay
All right, so now to the bigger problem and these are the general points that I want to make
Which is that throughout the outbreak there was just a real lack of clarity regarding the processes
Certainly the priorities, but also because it was such a strong biosafety consideration for sample testing and and collection
There were major delays in the diagnostic evaluation process and it just really felt like we couldn't work fast enough
To develop and evaluate and improve these tests and I do think that we can and should do better
So I'm going to close by focusing on the specific challenges and questions that I think are quite generalizable and relevant right now
Okay, so let's start with sample ownership. Okay, so who owns the clinical samples once they're tested
Um, this is a summary that Betsy Wonderly and I
Wrote up after our experience. She worked with fine throughout and spent a lot of time on the ground
We we experienced a lot of the same
Frustration so we decided to summarize our thoughts together
So who owns the samples if you're going to make the biobe for example
Is it the government of the country whose patients were tested or where they were tested?
So Sierra Leone for example, do they own the samples?
Does it matter if the patients were searing Sierra Leone?
Do they own the samples?
Who owns the samples? What does she really mean there?
Who owns the data? That's what she means
Who owns the data? That's what she means. Do you hear it? I hear it
I hear it plain as day
Is it the lab who's doing the testing which was public health England?
Is it the organization that keeps and holds the sample of public health England? Is it?
Who's the funder the WHO owns the samples and that's very important for biobanking
And then of course
Oh my gosh. It's all one big agenda
Then there's the question. So once you have samples, what can you do with them?
Can you ship them out of Sierra Leone to someone else or to a company?
And should who pays for that? Should the company have to pay for it?
Who decides who gets those samples? Right?
So they would especially when the outbreak disappeared and there there are no more positives
Who determines the research priorities?
Academics companies who she didn't mention the patient exact
And then when we get to data ownership, it looks busy
But it's all the same question. Data ownership. So who owns the data that you get from that clinical testing?
Can you transmit it out of the company? Nice. Who pays for it? Or should you have to pay for it?
Just to get a clinical data. Oh my gosh. It's brilliant. Laboratory data
Who pays for the transmission? Who's in who's a prioritized receiver and so on?
So a lot of questions around data ownership. Oh my gosh. Do you understand the subject?
So this is a sticky area. So this is essentially what we are investigating
Because why would a PCR testing company started by a porn producer
Decide to buy $400,000 worth of core facility level sequencing machines
That could do a hell of a lot more than amplify a small amplicon on a single flagged PCR test
That doesn't even use nested primers
Do you understand how absurd it is the little little tiny little tiny
Piece of the puzzle that I'm working on
Right now
How many other diagnostic testing companies were started by people that weren't even faculty members at a university
That were tipped off
weren't even biotech entrepreneurs that were tipped off
But were just people
That were too dumb to know what they were being tipped off to do that were too dumb to know what the samples were being done with
after they took the test
Too dumb to care about where the data would be sent or who would be
In charge of the samples after they returned the test data to the municipality that was requiring their employees to take the test
In the first place did they do a whole genome sequencing and send that digital data to some other country
Send it to ditra send it to nih send it to some company and in in china
We don't know
But they certainly had the equipment in the laboratory that would have been able to do it
And that equipment was extreme overkill for testing
Using an EUA approved test with a single amplicon not to
Just one
No nested primers
And the testing supplies
And the test kit reagents were supplied by a company called bji or bci
Bci I think
A major sequencing company in china
With year long connections years long connections already to the human genome project
Did you hear what I said?
There was a diagnostic testing company on the west coast
That decided to apply for an EUA
Using a test produced by a chinese company that has a decade long
Partnership with the human genome project one of the largest
Genomic companies in china decided to provide the testing materials that we're going to get an EUA approval
By somebody in this lecture series on this day on february 3rd 2020
A porn producer started a company using chinese
provided reagents chinese provided
Primer sets chinese up
provided but EUA approved
PCR testing
For a single amplicon one target
And they got a contract that resulted in millions of dollars in profit
From a municipality
A porn producer decided that that was what he was going to do
And as I explained at the beginning of this video
I would have been suspicious of someone that was my colleague at the university of pittsburgh
A tenured professor that would have decided to attend this seminar
And see how they could go about getting an EUA for a PCR test and start a PCR testing company in pittsburgh
I would have been like who the hell called you?
We should find out who was in this audience
We should find out every single person that signed up for this and then figure out why the hell were you there?
Because there were
Places and people that were participating in this charade taking millions of dollars
And likely stealing the genetic data of american college students american police officers american paramedics
american doctors american health care workers anybody that was forced to test
Because at least one of these testing companies that got a very lucrative contract that no longer exists anymore that had a
EUA too early to be explained
Was set up by a porn producer
That's simply unexplainable
The illusion is bending too far. It's brittle. It's breaking. It's cracking and this video is incredible
February 3rd 2020
In subject need to provide consent for their wreaths for research testing to be done on their excess clinical sample
And this is an uh, you know a big area of discussion even in a non-entric setting
But in this
I can't believe she's saying this human subject. So this is a sticky area
So does the human subject need to provide consent for their wreaths for research testing to be done on their excess clinical sample and this is an uh, you know
Does it do they see her and so on so they need a lot of questions around
Do they subject so this is a sticky area
So does the human subject need to provide consent for their wreaths for research testing to be done on their excess clinical sample?
Do you hear she's asking a question does
The patient need to provide consent because the the college students of america didn't need to provide consent and the university sold those remnants on
I guarantee you they did
They sold those remnants on to sequencing companies that probably sold those sequences to china or whoever wanted them the highest bidder
They might have even taken those sequences and tried to correlate back to the
To the epic database if any of those
Children or college students are in that database so they could correlate the genetic data to the epic database
So
That's how dark I think this operation was I think that's what she's basically hinting at right here when she says
Do do do patients need to give permission for their remnants to be used for other things
That's at the heart of what we're looking at in in on the west coast right now with this
Extremely shady. How do you explain this guy decided to buy
$400,000 worth of sequencing equipment that he didn't need in order to fulfill a contract
That he apparently already knew he could win
It's because of the remnants of the testing samples ladies and gentlemen the remnants of the testing samples have your dna in it
And
This is a you know a big area of discussion even in a non-out break setting
But in this context, how do you do this language barriers?
Patients on death's doors as if they actually
All the patients as if they can
And then which bodies in country need to sign off on a human subjects research protocol
And I think this is really critical. This was a complete black box
Who do you have to ask for approval who needs to give it how many people what order and so on?
So that so it's a real barrier to making good progress
Then there's regulatory authority, right, which is why we're here
So but in practice the question is even once you have these EUA, what does a country do with that?
Will they accept WHO emergency approval as justification to purchase and provide the tests in their country or not
Do you have to generate additional in-country data in order to get the country to approve a test for use?
And if so, who's in charge of that process who's saying yes, and this has been very slow
I think in all the countries that were affected in terms of actual in-country
Independent approval of specific tests for use
According to the organizers which spoke at the beginning of the video
You can roll it back and listen to or say it that they have been planning this
This meeting for months, and they're just really excited that it's going off without a hitch
List of the large scale of the WHO and FDA
UAs
So then regulatory continued how do manufacturers actually validate their system when they have trouble getting access to samples
And biosafety concerns are big and complicate testing and who should be responsible for organizing test validation
Should it be the manufacturers themselves or should there be some umbrella group the WHO the CDC because remember
How would anybody in this audience validate their EUA?
How would anyone in this audience evaluate their potential EUA test unless they had a sample that they could use?
It's extraordinary ladies and gentlemen what you're hearing here
How could anybody these of these people develop a test unless again we talked already
Half an hour ago an hour ago. She said that the sequence was available so people could already start making shit excuse my language
So it's it's this is amazing. I'm I am having such a good time with this
Fine
And then who decides which tests are prioritized? This was a big deal during Ebola
There was a lot of discussion about this is your test and this is your test and and who's you know
My tests and so that kind of stuff just shouldn't be happening
Then there's what I mentioned about approval. So aside from what what what tests can be done in country
What sample types are approved?
So in us labs we take this very seriously in terms of going off label requires a whole validation, right?
So what if WHO says you can test being this whole blood
But CE marks is you can do finger stick blood or what if WHO says you can do plasma and
FDA says you can do finger stick like what's approved?
What can you do and can you do something else that makes more sense for you and this validated or not?
Okay
Then there's this gold standard. So this is what I referred to when I mentioned the altona not being a
optimal benchmark in our study
What do you do when a lab develop test?
Looks like it might be best, right?
Should a lab develop test even be considered as a reference method for everybody and if so, what do you do?
What kind of valuations must be done in order to make it the method, right?
Should efforts be made to take the best looking lab develop tests and give it to everybody and if so, who's paying for that?
And then one thing we found throughout was was that the you know, even what you test how you call the test positive
Not consistent from test to test. What's the CT cutoff? These are things that are, you know, very deliberately selected
But to say a test is positive doesn't have a lot of meaning unless you really know how that test performs against
other benchmarks and so on
Communication, how do we communicate findings to clinicians in the field if there are if there isn't good infrastructure?
They need to know what the results are so that they use the test properly. How do you do that?
Especially if their decision Wi-Fi everywhere?
So the vision that we we had was this idea of a global emergency diagnostic framework where this stuff could just be figured out in advance
frameworks and standards for specifically for diagnostic evaluation or ideally development and evaluation in an outbreak setting
With ideally the major players and experts developing these standards with international input
And the goals for this would be to have a system systematic framework for diagnostic evaluation so that in advance you would have prepared templates
For a diagnostic evaluation and you could give them to a field lab. You could give them to a test developer. Give them to the clinical site
And you could develop guidelines that would summarize for example, what's the IRB process in this country?
How do you do it? What does it look like? Have a template know what you need to do know what it needs to say?
So planning in advance who needs to approve it and so on could be an extreme benefit in these situations
And we already know how that we need to accommodate lots of different types of evaluations. We need point of care
We need in lab. We need different sample types all of it. We should we can easily prepare that in advance
Then we need to optimize collaboration between the global leaders WHO and CDC FDA in particular
There was a lot of redundancy and lack of synergy during Ebola
There were controversies about which tests to include in multi-test evaluations tests that were left out of
Multi-test evaluations just because the form wasn't filled out properly and and things that we can avoid
So we should be doing collaborative bio banking. We should be synergizing together for test evaluations
You have a set of samples. Let's test all of these different products together
So we can really see how they compare no standardized samples for she just said that the FDA doesn't like that earlier
That's pretty funny that she's advocating for that now. Hey
And then of course communication and we definitely need increased transparency as much transparency as possible for data sharing
For EUA
Valuations we found, you know, sometimes there would be an EUA document and it just didn't have still the information that we needed
In order to compare between tests. We couldn't do that with the documentation that was there
So there were some interesting
Points just from the industry perspective and I know there are many industry people here
This was sapphire who did the gene expert and the point was made companies need funding to do this
And what do you do about the fact that if if a test is only going to be used intermittently during an outbreak?
What do you do the rest of the time?
Can you just divert sapphire's production line suddenly to Ebola away from MRSA and flu, right?
So these they need to think about this
And it's particularly important that the testing is to use in a resource limited setting because then you need to keep the test costs low
um, so
Funding is is key can't easily maintain large stocks on the shelf
And so there's this concept growing I can see of surveillance testing and the utility of that for all the reasons
You can imagine for catching outbreaks early, but also to keep products in motion and to keep them developed so that nothing is dormant on a shelf
Um, uh, biomareu
Marc Miller they developed the biofire for Ebola and had some feedback as well the importance of the biome and the
biofire
I think was also is still um one of these large
Panel diagnostics is also a biofire test now with like 17 different targets
So that company's been around for a while if i'm not mistaken
The the video is frozen, but I don't think it's it's it's actually recorded frozen
So i'm just going to leave it frozen. I'm not going to try and fix it questions around who can access the biobank
Can anybody or do you have to meet some basic standard of performance before you get those those sa samples?
What are the requirements for ua? Um, how you know, how do you?
Uh, what what what rules are specific to a given country as opposed to
Here and so on and and a plug for common procurement systems to make it easier to actually bring tests into different countries
Okay, so i'm going to finish up status of biobank. So, um, this this is a actually a 2016 review
but there are
Ebola biobanks
As of 2016, um, this WHO review found 162,000 sample stored 15,000 in which were positive
But there were concerns about how they were stored 116,000 samples. That's a lot of genomes
um the you know the
Tenuous freezer conditions and so on so higher lab capacity needed
Um, but one biobank i learned about preparing for this talk was a biobank is a collaboration between ministry of health this year
Early own and public health england and this is the Ebola biobank and so they have there's they wrote a paper and uh welcome open research
About it so you can read about it there, but it's it's an interesting general concept. It's a shared biobank 57
41 i'm just going to try and see if i can fix this. Sorry
I'm just going to 5741 if this doesn't work. I'm going to go to basketball pretty soon anyway
So i'm going to try and reload the recording
And then see if we can go forward
I know this is probably not going to work, but hopefully it will 57 right there
Open research about it and you can read about it there, but it's it's an interesting general concept
It's a shared biobank Sierra Leone actually owns the samples if anyone wants to have access to it
They put in an application. They have to get IRB approval in Sierra Leone
They have to have an mta. There are some ip issues
But it's a process that they have worked out and there's access to these samples
So I find this an impressive biobank that emerged from this
And finally so progress so there is an R&D blueprint that came out after this
Called action to prevent epidemics planet of action
So it came in May 2016 and was updated in 2017 and 2018 and their goal was to create a road map
To accelerate the development and evaluation of therapeutic vaccines and diagnostics for pathogens without break potential
So a very laudable goal
Had the list of priority diseases
But just as as the the previous speaker said, it's really focused on therapeutics and vaccines and diagnostics are kind of the the lower lower end
The 2020 website for this does mention biobanking, but it is just really not that focused on diagnostics
Um, so but we can assume that any elements that are focused on funding data sharing biobanking regulatory approval will have
You know, so diagnostics and biobanking is what she thinks is most important
And also what the cue and acute intel person thinks is most important boss relevance, but it's not
But what it does say is something that I agree with which is that everybody will benefit if if the development effort during outbreaks are
facilitated by adoption of
Principles that are fair and transparent and have been negotiated in advance
And I really strongly think that anything we can do together to develop these principles and in a framework
For actual development and evaluation and diagnostics in an outbreak setting will be very you a very worth it
So I'll stop there. Thank you very much
It's quite a few people
Thank you very much Dr. Pollock very um thought pervert thing
Okay, we're going to shift gears just a little bit and
Here from the fda on the perspective on the ua situations
So join me in welcoming the following representatives from fda and fda representatives if you would come up
I can go ahead and and sit down in your
seats up here. You can see their name tags there
I have real admiral denise hinton fda chief scientist
Tim stencil
Md phd director of o ht seven an office of in vitro diagnostics and radiological health for cdr
Uve sharp phd director division of microbiology devices for o ht seven
oir
Michael waters phd shield team leads cdr h rwe tactical team. Oh, I are representative fda
Um, I understand some of you may have slides
So mike if you want to come help me at least pull up the slides. That would be great. Okay. It's 313
Um, I'm going to my excuses. I'm only one handed and it's my left
I'm going to call and take a break here. Um, I think it's a good place for me to
To try and cut it in half
Um, the fda portion of this presentation will be just as good as the in cutel and uh, n i h portion or n i i d
Persian
Um, but I I need to get some ducks in a row and get my stuff together and then i'll be back after dinner
And i'll try and do this thing
After dinner around seven thirty or eight o'clock when the boys go to bed
Um, and then we'll do the last half of this. Um, and I think it's going to be a really good
Um, I mean it's already been very good. We've learned a lot of things
We learned the most that I've ever learned in eight minutes of video was the the first eight minutes of this video
The link is in the chat here
So you can watch it yourself if you want to or try to download it using the instructions that where I think provided by suit spider
Had giga ohm dot bio. Um our soapbox over there. So a lot of fun things are happening. Um, uh, we're we're making progress
I do uh really feel as though we are still
Um in this state where we are being consciously and intelligently manipulated
And so we need to start really being um, highly highly aware
Of the fact that um, there are people who believe that we that it's okay to govern us like this
There are people who believe that because of the nature of human population and coming generations
And the imperative to collect this data in order for us to get anywhere before this population is gone
Um, I think we are being actively bamboozled and so
Ladies and gentlemen, please stop all transfections and humans because they are trying to eliminate the control group by any means necessary
and uh
We will see each other, uh in a few hours. I think if all goes well
Um, I'll post something on soapbox if i'm gonna cancel on you, but I don't think I will. I'll see you after dinner
So
You