April 6, 2023 • 53 mins
In this episode, Whitney is joined by Maddie Bannon to discuss FDA Commissioner Robert Califf and his role in removing regulatory obstacles for the "healthcare" related wearable, implantable devices and other emerging technologies seen as crucial to the advance of the 4th Industrial Revolution.
Follow Maddie: TLAVagabond Substack, Manufacturing Reality, @llspacejellyll
Originally published 04/03/23.
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Episode Transcript
Available transcripts are automatically generated. Complete accuracy is not guaranteed.
WW (00:19):
Hey and welcome to unlimited Hangout. I'm your host Whitney
Webb. For a little over a year,the American Food and Drug
Administration or FDA has beenled by a man named Robert
Califf. Very few people seem toknow much about Califf or his
background, and there is verylittle critical reporting on
this man despite the power hecurrently wields over
significant aspects of Americanpublic health policy. During his
(00:41):
confirmation hearings last year,there were a few stories here
and there noting Califf'sinvestments in the
pharmaceutical and biotechnologyindustries as well as his long
standing ties to Big Pharma andhow this might present a
conflict of interest. Yet thereis a deeper problem with Califf,
that goes far beyond theseconflicts of interest that more
often than not, are the normwithin the US federal government
and on Capitol Hill. This isCaliff second stint as FDA
(01:05):
commissioner, having previouslyheld the post toward the end of
Barack Obama's second term.After he left that position.
When Donald Trump took office inearly 2017. Califf joined Google
becoming the Silicon Valleygiants top strategist for its
forays into healthcarespecifically for Google's health
focus subsidiary, verily LifeSciences. Ever since then, Califf
(01:26):
has been at the vanguard of theeffort to kickstart the so
called Fourth IndustrialRevolution, or for IR in
healthcare, and this hasextended into the decisions he
has overseen over the past yearas head of the FDA. Perhaps
unsurprisingly, Califf himself isa major evangelist for the for
IR in healthcare and is onrecord stating that he shared
the four IR vision of WorldEconomic Forum Chairman Klaus
(01:48):
Schwab well before his notorietyduring the COVID era, her Schwab
and his allies, the four IR,particularly as it relates to
health care, is about themerging our physical, digital
and biological cells,essentially transhumanism by a
different name. troublingly asFDA commissioner Califf is
already creating regulatoryloopholes for devices that will
(02:08):
bring this dark vision tofruition, including brain
machine interfaces,neuromodulation devices and
surveillance wearables, amongothers. He is also doing the
same with other four IR healthfocus technologies, including
gene therapies and much more.For those Americans who are
concerned about the push toinject the four IR into the
American health care system andinto our bodies. Robert Califf
(02:31):
is the man to watch. Joining metoday to discuss Kayla from the
deeper problems here is MaddieBannon investigator Researcher
and Contributor to the lastAmerican Vagabond substack. Last
year, Maddie published a deepdive on K lift called Brave New
real world data on the tlapsubstack which focused on
Califf's time before he becameFDA commissioner and his love
affair with the World EconomicForum in the idea of the Fourth
(02:52):
Industrial Revolution. I highlyrecommend anyone interested in
Califf from the broader issues atplay here. Give Matt his piece
of read. With that being said,welcome to unlimited hangout.
Maddy, it's great to have youhere.
MB (03:03):
Oh, thanks for having me.
WW (03:04):
Absolutely. So, as I mentioned just a minute ago,
it's been acknowledged, rightthat Robert Califf has a
concerning conflict of interestwith Big Pharma, which is, as
you noted in your article, youknow, Bernie Sanders, among
others have challenged him onthis. So I guess before we get
into some of the other keyaspects about Califf here,
particularly about the four IRand things like that, let's talk
(03:27):
a little bit about his hisconnections to Big Pharma. Sure.
MB (03:31):
Well, first of all, is Gousto trial, which was a mega
trial, over 40,000 participantsin the study of cardio, mild
infarction, which is the heartattack was funded a lot by bear,
Sanofi GlaxoSmithKline on allthe big names. So he's been
(03:52):
receiving funding from the bigpharmaceutical industries for
the majority of his career, mostof his papers that he's issued,
and he he, a lot of people, whenthey're interviewing him, are
sure to make note of that he'sone of the most cited medical
writers in the field. They'resure to make note that for as
(04:18):
many papers, it's like, over1200 that is accomplished.
They're all punctuated by verylong conflict of interest
statements that lists, you know,dozens and dozens of
pharmaceutical companies. So hehas a very cozy relationship
with all of them.
WW (04:39):
Right. But I guess one of the things I want to talk about
today is that and what I'vetalked about in some of my work
over the past couple of years,is that big pharma and big tech
have essentially been comingtogether creating a lot of joint
ventures. And so what has beensort of emerging over the same
timeframe is you know, where Asthere was previously, this well
(05:01):
known revolving door between,you know, the FDA and Big Pharma
and other, you know, health carefocused agencies like HHS and
Big Pharma. Now, there's arevolving door between those
health agencies and big techfirms like Google. So Califf is
one of these guys, of course.But there's actually quite a
few. So if you go to the GoogleHealth About Us page, now that
(05:22):
Califf is, you know, more orless, not officially a big part
of it. But as you note in yourPC still is very much connected
to Google Health and itsinitiatives there. But their new
chief health officers, a ladynamed Karen DiSalvo, she was
formerly the NationalCoordinator for Health
Information Technology, andAssistant Secretary for Health
(05:42):
in the Obama administration. Andprior to that worked in HHS. And
then we have Dr. Michael Howell,who is at Google Health Chief
Clinical Officer and DeputyChief Health Officer. He's an
adviser to the Centers forDisease Control. And then one of
the newest hires at GoogleHealth as a man named Bakul
Patel, who's Senior Director ofglobal digital health strategy,
(06:06):
and I guess the relationshipwith regulatory agencies. And he
was, he'd been at the FDA fordecades before joining Google
most recently as the FDA isChief Digital Health Officer of
global strategy and innovation.So there's a lot of these guys,
but of course, probably the mostimportant one to point out would
be Califf. So as I mentioned inmy intro, Califf was, of course
(06:29):
at the FDA during the Obamaadministration, and then he
joined Google. So I guess maybeyou could tell us a little bit
about his time at Google and whythat's significant.
MB (06:39):
Sure. So he'll have served as the Commissioner for the FDA
between the years of 2016 and2017. And that was his first
stent under the Obamaadministration. During that
time, the 21st Century Cures Actwas passed, which is a very
(06:59):
important piece of legislationthat kind of allows for all the,
you know, very new breakthroughdevices and E ways and the
waiver of informed consent forminimal risk trials. So that was
passed during his time there.But he did leave in 2017. That's
when he went back to do for acouple of years. And he founded
(07:21):
Duke Forge. But in 2019, hejoined verily Life Sciences as
their their head of like healthstrategy and policy. During that
time, he headed projectbaseline, which that is
basically,
you know, huge mega trial. Alongthe lines of the things that
(07:47):
he's already very interested in
NS projects at Duke, includingthe Duke Clinical Research,
initiative, and clinical CTTI,which is clinical trials
Transformation Initiative, wherethey're aiming to use digital
infrastructure, passivelycollected patient data,
(08:09):
including electronic healthrecords. So project baseline at
fairly, was kind of areplication of that at a major
private company, who he said hasthe funding to do it, right,
which is what he is on, onrecord noting is very important.
(08:33):
He wants as much money as he canget to get these studies to be
what he actually wants. SoVerily, you know, they recruit
people to join these studies,they had a wearable, a
proprietary watch, that is byprescription only that sense,
(08:55):
you know, biometric data back toGoogle for to be studied. They
studied a number of things,including, you know, oral health
and how that relates to overallhealth. And you know, the
impacts of daylight savings timeon your restiveness and overall
(09:16):
well being based, they studied anumber of very trite things, you
know, that I don't think really,not a lot of these study
results, while they are postedon clinical trials.gov. The
results are not posted there. SoI'm not sure what the results
(09:36):
were. But they also study thingslike depression. So yeah, that's
basically their their wholething is to continuously monitor
and collect data, because on thepeople that are involved in
their studies, because theirgoal is to map human health.
They said, we already havemapped the earth and now it is
(09:57):
time to map human health andthat's kind of what they're out.
her.
WW (10:00):
Yikes. Yeah. So they've mapped human health and they
contract with like intelligenceagencies in the military. So
they can, you know, like dronebomb or find whoever they want.
Right. And so now we got themgot a map the human body to
Well, that's fun. Okay, so onething I really found interesting
as a major theme in your articleis this about clinical trials
(10:22):
specifically about bailiff. Soas you noted, you know, he made
a name for himself with this,um, I guess Gousto trial in the
in the mid 90s. But since then,he's essentially been trying to
revolutionize clinical trialsand how they're performed. And
so a lot of the stuff you'vetouched on, including project
baseline, I'd like to get ininto a little more detail of
those specific initiatives likethat. And other ones you
(10:43):
mentioned a little bit later inthis episode. But for now, I
just wanted to bring up that younoted in your piece that a lot
of key lifts career,specifically his time at Google
and this current stint as FDAcommissioner, he's been spending
it quote, tireless tirelesslydedicated to the task of
removing the obstacles facingthe four IR. So I think, you
(11:04):
know, since the four IR is areally key part of understanding
who Califf is why he wasnominated by the Biden
administration to be in thisparticular role, at this point
of time, it's all very importantto understanding those issues.
Right. So if it's cool with you,let's go over, you know, for
people who may not know what thefourth industrial revolution is,
what are qlf stated views aboutthe phenomenon? And what are
(11:27):
some of his roles in at the FDAand Google that he's played in
promoting these policies?
MB (11:32):
Sure. One of his greatest achievements, according to him,
is convincing them PresidentObama, that the Fourth
Industrial Revolution was realand happening and very
important. So he's very, he'svery much a fan. And he thinks
that it is important, he thinksthat that will be happening. And
(11:52):
basically what the whole conceptis, is that our bodies and then
eventually, our minds willeventually merge with
technology, and the internet byproxy. So this is the concept is
the brainchild of Klaus Schwabruns the World Economic Forum.
So, you know, the whole idea ofthe Fourth Industrial Revolution
(12:16):
is to gather as much datapassively generated by either
people or the environment, viawearable devices, electronic
health records, insuranceclaims, you know, the devices in
your car, your social media toget it to make you your digital
(12:36):
self. They'd like to merge yourphysical self with your digital
self into one thing, so totallyinseparable. But he, you know,
he cites Klaus Schwab and thefourth industrial revolution
book that he wrote in hispapers, academic papers. He
(12:57):
talks about it frequently ininterviews and things like that.
Yes, that's really hiscontribution as he I mean, he's
been, he's stated that he's goneto the World World Economic
Forum, and I'm sure he, youknow, Knievel's on the other
acolytes there.
WW (13:14):
He's openly said that lead he, you know, attended the WEF,
and was like, Wow, these guysare really on to something in a
video, I saw him where he'sdoing some Google interview
series. I mean, he talks veryglowingly about all of this
stuff. And in the web itself.And of course, as you note in
the piece, some of the stuffhe's overseen, as you know,
follows the web's favoritemodel, the public private
(13:36):
partnership, so he seems verymuch on board with a lot of this
stuff. And what's particularlyconcerning to me is that a lot
of these for IR technology, solike, you know, the way it's
described, it's something that'snot just going to revolutionize
healthcare, right? It's supposedto revolutionize every sector of
society, society itself changedthe meaning of what it is to be
human, and all other sorts ofstuff. But the way they seem to
(14:00):
be going to get sort of this,their foot in the door here is
is through healthcare. And youknow, as I wrote for tea lab a
few years ago, that particularpolicy has its ties with Google
going way back to the, you know,well, before COVID, with the
Eric Schmidt led nationalsecurity commission on
artificial intelligence, ofcourse, Eric Schmidt, being the
(14:22):
longtime head of Google. Andthat particular Commission said
that the best way to get AI massadopted by the American populace
was to have it sort ofshoehorned into health care
policy. And they essentiallyhave framed this as a national
security imperative. And so onthis commission, you know, you
have big tech, and you have thenational security state, you
(14:45):
know, mainly the military andintelligence communities and
this is their, their view, youknow, the most powerful actors
really in the United Statestoday that it's a national
security imperative to havebasically the the four IR types
of technologies implemented intoour healthcare system. First as
a way of having them spreadthroughout society, and they
frame this as, as you know,necessary to counter China's AI
(15:06):
supremacy and hegemony thatwill, you know, allegedly happen
if we don't surpass China interms of the mass adoption of
these types of technologies. Butoddly enough, you know, if you
really want to believe it takenational security agencies at
their word, you know, that thiswas about China, not about like
long standing agendas of theirsto mass surveillance, you know,
(15:27):
of mass surveillance and thingslike that, you know, obviously,
that's, that's up to you, andeveryone can have their own
opinion about that. But it seemslike Robert K lifts roll here
and more, you know, even biggerthan Califf, really is the role
of Google and all of this, it'sdefinitely something I think
more people should be payingattention to, at the very least.
So one interesting thing thatyou bring up in this article is
(15:51):
about Robert Califf, and youalready mentioned it a little
bit that He was the foundingdirector of the Duke Clinical
Research Institute, whichpredates his time working at the
FDA, but it sort of saw himpartner up with the FDA. While
he was at Duke, where I believehe's been for a decent amount of
his academic career. And this issort of a precursor to a lot of
(16:16):
the stuff that he's overseensince he got involved with the
FDA and overtly with Google aswell. So can you tell us a
little more, you know, maybe alittle more detail about this
Clinical Research Institute, hehelped create and the initiative
that you mentioned early,earlier, the clinical trials
Transformation Initiative? Yeah,sure. I
MB (16:33):
mean, they're, they both run along the same lines. And the
gold standard for clinicaltrials is a randomized control
trial. So they're looking foralternative fees. Because
though, to do a randomizedcontrol trial, it costs a lot of
money, you have to hire staff,you have to have, you have to
recruit participants, you haveto, you know, fly the
(16:54):
intervention, or the placebo,and make sure that you're
tracking all the informationthat's associated with that you
have to have people enter thatdata and then make sure it's
correct. And have like an actualtrial site and how people go to
and from and compensate them forthat. So it's, it takes a long
time and cost a lot of money. Sothe aim, as far as I can tell,
(17:16):
and from writings that he andothers have written about, you
know, real world evidencegeneration and real world data
in place of randomizedcontrolled trials, is that it
cuts down on cost significantly,maybe up to 30%. And you can
definitely get it done a littlebit faster. So if you already
have a pool of people whoseinformation that you already
(17:39):
have access to, for instance,like I mentioned, the cell phone
data, electronic health records,insurance claims, all that, you
don't need to bother recruitingthe participants, you don't need
to wait for that information tocome in, especially for the low
risk trials that you again, youdon't need informed consent for
(17:59):
those anymore, thanks to the21st Century Cures Act that was
passed in 2016. So you can get alot of things done faster and
more cheaply. If you useinformation. That's, like he
says siloed siloed, and notinteroperable. What do clinical
(18:22):
research institute and the ctciare aiming to do is advocate for
those those data to be on siloedso that they're free, they're
shareable. And also to advocatefor trials that use that kind of
data instead of the randomizedcontrol trial, right, the past
(18:44):
and that traditional sort oftrials.
WW (18:47):
So let's talk a little bit about what this means for you
know, the average person thatdoesn't necessarily like you
know, research these kinds ofworlds very much. So like ran
the way basically the way thatmedical and clinical trials have
been conducted. Pretty much inthe vast majority of the modern
era, right? This initiative wasabout essentially replacing
those trials with this realworld evidence paradigm, right?
(19:12):
And you have a really helpfulgraphic about what real world
data and real real worldevidence is in this piece, and
you know, that you wrote in someother descriptions of it that
you provide in the piece. Butthe graphics interesting because
it reminds me a lot of sort of,of the World Economic Forum's
policy paper, I think from 2018,about digital ID, where
(19:35):
essentially all these differentthings are interconnected. And
there's really like thiscentralized database for data
about you and so what's what'sreally crazy about it to me that
you know, it has, like, youknow, you're in the center,
right, and all these differenttypes of data that you generate,
are coming off, you know, fromyou and that this data is going
to be used to replace a clinicaltrial for to prove the
(19:58):
effectiveness of, of drugs. orwearables or, you know, brain
machine interfaces, you know,all this type of stuff. And it
has stuff like, you know,disease registries, things you'd
expect, right? Like electronichealth records, survey data,
pharmaceutical data, like whattypes of medicines you take, and
then the wearable stuff. But italso has stuff like consumer
(20:20):
data, which is your buyinghabits, what you buy online,
right, but also, social mediadata, you know, who what you're
interacting with, what you'resaying, online, what type of
information you're reading, andviewing, which is interesting in
the context of something I'dlike to talk about a bit later,
which is Robert K lifts missionto have the FDA play a major
(20:41):
role in pre empting anddebunking misinformation, which
is, which is interesting there.But the idea that all of this
data, this monitoring of stuffthat has never really been used
in existing randomized clinicaltrials and stuff like social
media data, and just sort ofdata, harvesting the stuff from
(21:01):
people without their consent,and using that, in lieu of
randomized clinical trials, isjust totally insane. And I just
in this, you know, the peoplethat wanted to put him in charge
of the FDA obviously knew thathe was in charge of these types
of initiatives, and that he was,you know, essentially there to
create the regulatory, I guess,I guess, you know, I'm calling
(21:24):
it a regulatory loophole, butreally, it's a complete
alteration of the existingregulatory paradigm, to totally
just replace it so that all ofthis fourth industrial
revolution, technology can befast tracked and mass, you know,
for mass implementation, massadoption by the masses, but it
doesn't necessarily have to usethe previous paradigm to prove
(21:47):
it any safety, any effectivenessunder past metrics, right? Um, I
don't know, your thoughts onthat. Maybe you disagree.
MB (21:56):
Um, I mean, it, the problem is, they can't really verify
whether or not the informationthat you're receiving is good or
bad. They're trying to come upwith ways to do that. But I
don't think that that's reallyfeasible. So, you know, one way
that Kailis has, you know, hegave a talk at Google was a
(22:18):
Google Talks, then it's onYouTube, he mentioned, the one
way, or at least one of the waysthat we'll find out if these
things go wrong is if theybecome catastrophic. So that's,
that's when we'll know how toregulate these kinds of trials
is if there's like, a massivesafety or efficacy, catastrophic
(22:40):
situation that occurs, as hesays, That's how things have
gone in the past. But, you know,when you're talking about mega
trials where, you know, over40,000 people, and he's already
done, that's, I don't know ifthe benefit, risk calculus
really makes sense there. So inand to be honest, I don't think
(23:00):
that these real world evidencebased trials are going to
supersede randomized controltrials entirely, I think that
they are using them to fasttrack certain sort of
medications and devices, atleast through phase one and
phase two trials. And they'redoing they're applying it to
(23:23):
post market studies as well. Soas far as actually, when the
when medical devices or drugsare, have some sort of risk to
them, I think they're stillapplying the randomized control
trial. But they're, you know,they're, they're huge, they're
implementing and using this asmuch as possible to cut down on
costs and getting those thingsto market as quickly as
(23:45):
possible. And another thing too,that I've been thinking about is
that I, he uses a lot oflanguage of these being
important and necessary so thatthose drugs and devices can be
made available to the public, asyou know, more quickly, and
that's kind of the the pill thathe gives you to swallow
(24:06):
alongside the current nearconstant surveillance that he
alleges will be occurring, andthat is occurring. Because
people need these life savingdevices. Now, they don't need
them in five to seven years. Butreally, you're asking the
consumer to adopt all the riskthere?
WW (24:24):
Well, we heard this with COVID, right? The same thing,
like a change of the regulatoryparadigm for the purpose of oh,
we need to get this out faster.So we have to produce a vaccine
on the timeline that'scompletely unprecedented. And we
have to change how trials areconducted. And you know, as I've
noted, in my work, and otherpeople have noted, you know, a
(24:46):
lot of these companies likeMadonna, for example, couldn't
get a product to market underthe previous regulatory
paradigm. And so the emergencyuse authorization and a lot of
these, you know, emergencymeasures we're used to sort of a
totally change how a lot ofthese trials for these vaccines
were conducted. And, you know,because of the, you know,
(25:07):
professed sense of urgency,that, you know, this idea that,
you know, the risk is beingtaken on by the person that
receives, you know, the vaccine,instead of having, you know, the
FDA saying, Yeah, we can say,Well, I mean, they did say it
was safe, right, but, you know,that wasn't necessarily
reflected by the trials, and itwas all justified by speed. And,
(25:29):
you know, what you're seeinghere is them using speed as as
the justification and also costreduction, but you know, it's
troubling stuff. And I may havemisspoken earlier, what I meant
is that um, so in your piece,you were talking about CTI this
transformation, clinical trialTransformation Initiative, and
you said it seeks to do is touse real world evidence in place
of evidence generated by RCTs.And so I sort of see what Robert
(25:55):
Califf is doing now at the FDAsort of as not necessarily
trying to replace, you know,eliminate randomized clinical
trials entirely. But when itcomes to a lot of these, more
like novel devices, notnecessarily things like
vaccines, and likepharmaceutical products that are
(26:15):
more traditional, like pillsand, and other types of
injections and stuff, it seemsto be some of these other
devices, whether they'rewearables or implantables,
really also are sort of beingtreated under this, this new
paradigm, this idea of like theremote clinical trial, it's not
(26:37):
necessary to physically monitorand observe patients and just
basically use the data that'scollected by their interaction
with these devices and theconnectivity. And all of that is
essentially replacingtraditional trials. And to me,
that seems sort of like a way ofsidestepping some of the
traditional metrics for theseparticular devices, which, of
(27:01):
course, those devices areobviously necessary to get the
for IR really rolling in thehealthcare space, right?
Particularly with the, you know,the brain machine interface, or
some of these neuromodulationdevices sort of get the nervous
system of the human bodyconnected to the internet.
Right?
MB (27:20):
What what's funny about that is there the breakthrough
devices designation given by theFDA to medical devices is really
for devices that are or to treatlife threatening, or
irreversible diseases, which,when you think of a brain
(27:40):
computer interface, sure, youcan maybe make the claim that
our brain computer interface cantreat paralysis, or help the
blind see, or the, you know,stroke victims have more
functioning sides of their body.Yeah, that's fine, but they also
will be applied for many, manyother uses. So it just seems to
(28:02):
me that companies like BlackRock technologies, and Syncron
and neuralink, etcetera, areusing this, you know, this claim
that their brain computerinterface will be used to treat
life threatening and in orirreversible diseases as a way
to get get their stuff throughthe door and fret and prioritize
(28:24):
that at FDA so that it can bepushed through more quickly, you
know, disregarding all the otherapplications that Amin B is for
and it will most likely be usedfor and that's probably what
they're, what their primary aimis at the end of the day.
WW (28:37):
So even though you mentioned that, like the breakthrough
device designation, technicallyis sort of, like reserved for
these devices that are like for,you know, irreversible, you
know, diseases, terminalillnesses and conditions, stuff
like that. It's being given to alot of things that don't follow
under these metrics. So a recentFDA breakthrough device
designation was given to thiscompany called Suma, which is
(29:00):
very much you know, it'sbasically Soma but with a second
Oh, and it received thatdesignation for its innovative
at home depression treatmentdevice, which it describes
basically well in the picture inthe article anyway, it's
basically like a electrodes youwere on like a weird little
beanie thing over your head. Andlike a electroshock see you I
(29:25):
guess, certain parts of thebrain to like, make you not
depressed, right. But there's alot of other treatments for
depression, right? Andbreakthrough device designation
as opposed to be for conditionsthat don't have existing
treatments, you know? So, thisis one of those examples of sort
of the FDA sort of applying thisdesignation to places where it
(29:46):
doesn't really need to be givenright. And so you know, if you
look at this example, and a fewothers, it seems pretty clear
that the current FDA modusoperandi as it comes to this
brand, As it relates to thisparticular designation, it seems
to just sort of be giving it tocompanies that, you know, have
(30:07):
some of these four IR relateddevices or, you know,
neuromodulation stuffspecifically, and trying to get
them onto the market as quicklyas possible, allegedly for the
benefit of consumers. But, youknow, when you get these sort of
special designations, you'reallowed to sort of skip a lot of
the, you know, the regulationsand trials and other
(30:28):
requirements that, you know,competitors would have to
complete, you know, competitorsthat don't receive this
particular designation.
MB (30:38):
Yeah, right. I mean, what's the breakthrough device
designation also allows fornovel medical devices, they call
it de novo. So there's no youknow, to be a de novo device,
there's not any legally marketedpredicate device, so something
like it. As far as I know, Sumahas at least some competitors. I
(30:58):
saw other sort of beanieelectrode app applications and
devices a lot like it. So maybethey're competing for that
space. My My initial thoughtwhen I saw the, their device had
the head cap and the electrodes,I thought we had already kind of
tried electro thought shocktherapy for mental illness, and
(31:21):
that it didn't really work toowell, and also made people a
little bit weird. And not it wasnot good. So I think I mean, I
understand that it's a littlebit more low voltage. But it
doesn't seem to be too originalof an idea. But, yeah, as far as
(31:41):
I see, yes, they use a techniquecalled transcranial direct
current stimulation we reallyneuromodulation is well, there
are a few different definitionsthat I was able to find. But
they're mostly that theinternational neuromodulation
society defines it as thealteration of nerve activity
(32:02):
through the targeted directdelivery of a stimulus through
electric or chemical agents atcertain sites, so we have a lot
of companies that are looking atthe spleen. Let's just saying
what does that nerve called,there's a there's a certain
nerve that that originates atthe spleen. And it's part of the
(32:23):
autonomic nervous system. Andthey're looking at that for
Parkinson's to stop the handtremors. Yeah, so you have a lot
of people looking at that forthat. And they also are trying
to use it for rheumatoidarthritis, and things like
WW (32:38):
that. So one of the companies pursuing neuro modular
neuromodulation of thatparticular nerve, you mentioned,
I guess, the spleen at nerve isfor rheumatoid arthritis is
Galvani bioelectronics, which isan interesting company in the
context of Robert Califf,because it's a joint venture of
GlaxoSmithKline. And verily,which is Google's health
(33:00):
subsidiary that Robert Califfhas been involved with over the
years. And they're one of theones that sort of got this. I
think they've already startedimplanting it into people, but
they have a lot of ambitions forthese neuromodulation advices,
which is basically to alter howthe nervous system functions,
whether it's targeting specificnerves, or many nerves, or
(33:22):
groups of nerves, or the entirebrain. That's sort of the whole
ambition there. And of course,verily, is also the people
behind project baseline, whichis something that you mentioned
earlier. And I think not enoughpeople have paid attention to
this. And it's a really crazything when you think about it.
So, um, there's this one,there's a few things that have
(33:45):
been written on baseline, youknow, from mainstream sources.
So one summary offered here andwhich you sort of have touched
on already and what you'vetalked about, it says, The
verily baseline Health Studylaunched in 2017. So that's
around the same time that Califfwas at Google on being their top
health strategist, right. It waslaunched in 2017, with the goal
(34:05):
of mapping human health bycollecting data from a variety
of sources, including selfreported data, smartphone, or
wearable recorded data, orthrough electronic health
records. And as you mentionedearlier, because of the the
Cures Act, some of that recordeddata by smartphone or wearables
that data can be obtainedwithout informed consent.
Anyway, so it says essentially,a lot of this, this baseline
(34:30):
health study, and the broaderbaseline health platform is all
about changing. Again, howclinical trials function, right?
So I first heard about Projectbaseline during the COVID stuff
because they were using itspecifically for that. And a
bunch of weird stuff was goingon with verily and COVID tests,
(34:50):
including having people forcingpeople who took COVID-19 test
and the San Francisco area whichwere being managed I think the
government there, or hadcontracted Google or verily, to
do this, and they were requiringpeople that got COVID test to
basically link their testresults to their Google account.
And if they didn't have a Googleaccount, they had to make one in
(35:13):
order to participate, which ispretty insane. But essentially,
what it sounds like to me isthat project baseline is just
trying to gather an insaneamount of, of data on people for
all different types of purposes.And essentially, the goal they
say, is to collect comprehensivehealth information with the goal
(35:34):
of better understanding healthand the transition to disease.
And it's important to keep inmind that at the same time this
has been going on and when thiswas launched, is when the
Pentagon and Google teamed upfor this sort of predictive
health care thing. So basically,using all of this data, all of
these, this massive cachet thatmilitary holds from, like the
(35:56):
veteran and military healthsystems of X ray images, and
things like that, to train AI sothat the AI could offer
predictive cancer diagnoses. Sobasically, the AI is like, Oh,
well, we've decided that you'lldevelop cancer in five years,
but you don't actually havecancer, you know. So it's all of
this sort of, you know, whatI've, what me and people like
Ryan Christian are sort ofreferred to as the pre crime
(36:18):
paradigm applied to healthcare.So basically, you're going to be
told that you're going todevelop this disease by AI, or
some of these different devicesor by you know, this data
accumulation, and they're goingto decide, they're going to tell
you what you're likely todevelop before you develop it,
and then go and offer you allthese different weird
(36:39):
therapeutics, whether it's stufflike, you know, mRNA stuff, or
gene therapy, or, you know,these neuromodulation devices,
or wearables are stuff thatinteracts, you know, with your
nervous system, or changes howit functions and all sorts of
stuff, even though at thatparticular moment, you don't
actually need it, it's beingframed as preventative. Right.
(37:01):
And this is, again, Google withthe military doing this, and you
have them of course, doing it,and all other sorts of, of
different guises. Butultimately, you know, it's about
per them about health care.Right? But it seems to be a lot
more than that, if you asked me,but, you know,
MB (37:18):
yeah. And Kayla's. In an interview, he mentions that this
sort of, you know, influencesubtle influence over people in
regards to their health is, youknow, justifiable because it's
already happening. And it's beenhappening for a while through,
you know, private marketadvertisements, and cookies on
(37:39):
your computer and tracking whatyou buy, and figuring out what
you might be interested inbuying, and then presenting that
to you. So he's just in hethinks that doing that isn't
necessarily good. It's notgetting people, things that they
need, or make them have a happyor healthier life. So what he's
saying is, well, that's bad whenwe do it, it's good, because
(38:01):
we're trying to help people livelonger and be less ill. So we're
going to track you and just thesame way, we're going to nudge
you and influence you in justthe same way. But our ends are
delivering those drugs and thosemedical devices that you
actually you need, right, andyou'll be convinced that you
need them because we have allthe data, and we'll present you
(38:22):
evidence that we found and tellyou how this will help you and
your life before you are evenconsidering going to the doctor
about it. But like you said itis it is preemptive. And he
thinks that it's totally fine.There's there's good guys and
bad guys. And the bad guys arethe people who sell you clothes
(38:43):
and food and stuff like that.But they're good because they
sell you pharmaceutical, drugsand medical devices.
WW (38:52):
Yeah, crazy. So. So in your particular article in talking
about the Cures Act, you sort ofmentioned that Califf had a role
and getting that certain aspectsof that legislation, you know,
in place, you know, involved into an extent in the drafting and
lobbying process for thisparticular law. And so I found
(39:12):
it interesting, too, that rolledwithin that act, were things
like the BRAIN Initiative, andBiden's Cancer Moonshot
Initiative, which, you know, iswas basically the basis for
Biden's recent creation of ARPAH, which was previously shopped
around to the Trumpadministration under the name of
Harper. And we're basically ahealth focused DARPA equivalent
(39:35):
and I actually did a podcast afew months ago about one of the
guys behind the BRAIN Initiativeand how he has been very active
where I live down in SouthAmerica in Chile and getting
Chile to be the first country toestablish what he what are
called neuro writes. This ideaof trying to protect your
(39:58):
individuality and so Out of thisparadigm where brain machine
interfaces, and all of this are,are very common. And
essentially, you know what Isort of talked about this likely
being in that particularpodcast, instead of it being
framed as protecting you fromall the bad stuff these devices
could do to you. Making you loseyour sense of self, among other
(40:18):
things, is really about creatingthe necessary framework and
public justifications to getthese types of devices on the
market, not necessarily forhealthcare related purposes, but
also for commercial purposes.Because people like Elon Musk,
like neuro link and stuff, youknow, on one hand, they're
saying and I guess Syncron, toprobably in some of these other
(40:39):
firms doing the same thing, youknow, on one hand, they're
framing this as Oh, this is ahealth device to help people
that are paralyzed, walk, and,and all and blind people seeing
all of that, but at the sametime, you know, Elon Musk is
like, pretty open, that neurolink is intended to be like,
used for commercial purposes,people could use it to play
video games and stuff. And youknow, even some of the animal
trials, they promoted were likemonkeys with the neuro link
(41:02):
implant playing video games withtheir brain and stuff, not
paralyzed monkeys walking again,you know what I mean? So it just
seems, you know, a bit differentthan it's being done, it's being
sold.
MB (41:14):
Sure. I think, you know, for the brain computer interfaces,
the only, there's a differencebetween imagination and reality.
And you can, you know, postulateand say that our BCI is going to
help people walk or see orwhatever, I don't see any
evidence of that, at least asfar as like the initial studies
(41:35):
and video footage and thingslike that, that there's no
evidence for that actuallyhappening. As far as what is
able to be accomplished is thatyou can control like, so if
you're a total, if you're 100%,paraplegic, and you have no way
to move your hands or interfacewith a computer, you can do so
(41:55):
they say, quote, unquote, simplyby thinking, and while that may
have medical application, youknow, if you're trying to help
people who are paralyzed, sure,but Why can't anybody else use
it for that? So it's just topass it under the guise and get
these sort of fast tracks tomarket seemingly to preempt your
(42:15):
competition and kind ofmonopolize that market as soon
as you can. Which is, I wouldsay, Syncron is definitely much
further ahead than than anybodyelse on that front. That seems
to be what it's actually for.Because I don't I don't, you
know, the brain computerinterfaces. There's, there's
just not enough evidence outthere to suggest that it's
(42:38):
actually going to help peoplewith with their claims of you
know, the ever irreversiblydebilitating diseases or the
life threatening diseases. Thereis one company it's called, see
things called like neuro neurolinks or neuro leaf, that's what
it is. They have this braincomputer interface that links
(43:02):
with an exoskeleton that helpspeople who have you know, have
had a stroke, move the hand,that's not working anymore. That
makes more sense. But yeah, itseems more just trying to get
these things on the market asquickly as possible under the
guise of helping people as
WW (43:20):
Yeah. And what I mentioned earlier, there's this whole, you
know, ulterior motive comingfrom the highest levels of the
national security state andpeople like Eric Schmidt, trying
to get the stuff out there onthe market as quickly as
possible because they see it aspart of this big tech war with
China. Right. Which is alsopretty crazy. And, you know, a
(43:41):
key point I want to make heretoo. So I'm sure people are
familiar with, you know, myanalysis and other people's
analysis of statements made byby people tied up with the World
Economic Forum and big you know,for IR evangelists, like Yuval,
Noah Harare, who basically saythat, like the whole wearable
paradigm, like getting wearableson everybody is the red line
that will, you know, result inthe ushering in of what he calls
(44:04):
digital dictatorships, you know,basically the surveillance of
what's going on not just insideyour body, but inside your mind.
And I think this is all kind ofinteresting when you're looking
at the big players here in thecontext of a lot of how this
mass surveillance is also, youknow, tied into this, this
effort to launch a war ondomestic terror and master bail
(44:25):
everybody and sort of usher inthe paradigm they tried to do
after 911 with things like DARPAis total information awareness
and stuff. So you know, you havegroups like Google and also
Palantir, which is basically youknow, as I've noted in my work,
essentially a CIA front that isbasically total information
awareness, privatized and soPalantir basically has access
(44:47):
and has been running a lot ofthe COVID-19 health data and
other health data held by HHSand also in the United Kingdom.
Basically, all NHS data is beingmanaged by Palantir is Well, and
then you have Google having thisthis big role. For example, they
host the FDA is my studiesprogram, and how on Google Cloud
(45:09):
and they have for some time, andyou have a lot of these, you
know, this revolving door, likewe talked about earlier, sort of
between the, the regulatoryagencies and Google and verily
is being used for a lot of thesenew remote trials to get some of
these, you know, more noveldevices, I guess, and like
neuromodulation devices on themarket more quickly, without,
(45:30):
you know, in person monitoringand, you know, completely
electronically conducted fullyremote clinical trials in
they're teamed up with thePentagon. I mean, there's all
sorts of crazy stuff going onhere. And I think some of that
overlap is interesting in thecontext of this whole, like, you
know, misinformation trying tostop people from spreading
(45:50):
what's deemed as misinformationabout about health and how that
also is, you know, one of themain objectives of the supposin
war on domestic terror, becauseRobert Califf has been very vocal,
since he came in to art it'scame into this position last
year about the need for the FDAas an agency to preempt and
debunk misinformation, which iskind of ironic, because some of
(46:13):
their efforts on that front haveactually involve the FDA
spreading the misinformation,for example, claiming that
ivermectin is not like, able tobe used in human beings that
it's like a horse and cowmedicine exclusively. And
regardless of what you thinkabout its validity as an early
(46:34):
treatment of COVID, or whatever,well, before the COVID era, it
was being used in people. So toframe it, as you know, a horse
to warmer exclusively, like hadbeen done on CNN is not
accurate. And the FDA obviouslyknows this. So it's just
interesting that you'd have youknow, Google Palantir, they're
big players in the healthcaresecure system getting more and
more tied up with the FDA. Andthey're a big part of this
(46:56):
misinformation, crackdown andprofiling of people spreading
misinformation as well. And Ithink people, you know, might be
might want to see that there'sthat degree of overlap there.
Because once you're surveillingpeople, whether it's under the
guise of healthcare, or underthe guise of stopping domestic
terrorism, I mean, ultimately, Ithink the end result is the same
(47:18):
essentially. And I've also kindof argued, and in some of my
work on, on the creation of ARPAH, under the Biden
administration, which sort ofgoes back to this Cures Act
stuff you were talking aboutduring the Obama administration,
I mean, essentially, that's alsoabout getting the mass use of
wearables for this, you know,predictive health paradigm and
(47:40):
precision health paradigm andall of this stuff. So, you know,
it may be it's being framed asyou know, a boon for public
health. But ultimately, it seemsto me like the four IR is just
about an insane paradigm of masssurveillance, and they're just
trying to see what sort ofjustifications they can make for
it, you know, what sticks andwhat people, you know, need to
believe and need to feel inorder to start using that type
(48:02):
of technology on and in theirbodies.
MB (48:04):
Yeah, I think that's the fourth industrial revolution,
you know, well, Klaus Schwab.And, you know, the people who
are as true believers, theydescribe it as the merging of
our personal and digital selves,right, or quantify cells. But
it's really about the lastfrontier, which is the mind,
right, and also, includinggenetics. So they're looking to
(48:27):
somehow be able to predict, andthey've been, you know, the US
government, at least for a longtime has been created, create a
artificial artificial models ofthe world and tried to use that
to predict how militaryconflicts would go, or certain
the certain release ofinformation would go, they
(48:48):
created a computer generatedmodels of the world and people
to the finest detail possible,hoping that they can predict the
future. And really, they need acomprehensive understanding of
how people think. And I thinkthat's really what it's about
the mind is really the lastfrontier, and genetics for
(49:09):
capitalism and in any ingovernments and surveillance and
control. So that seems to be tobe the primary target by merging
people's physical and digitalselves. And while you know, they
frame it as that's somethingthat will happen eventually. And
(49:29):
inevitably, the private marketand the public private market
are kind of already doing thatintentionally. So they're, you
know, whether or not that wouldhave happened otherwise, is
another question, but they'rekind of making that happen now.
And as far as, as far as thesurveillance stuff goes, this is
(49:49):
why I think artificialintelligence is so important is,
you know, considered to be anarms race at the moment between
the US you know, and They'recompetitors. Because it's a lot
of information, that's a lot ofdata, it's impossible to go
through all of that and assignpatterns with any sort of
efficiency. So you need to applyan algorithm machine learning
(50:13):
algorithm or an artificialintelligence to that, to find
what you're looking for, or toat least flag what it thinks it
might, you might be looking for.And as far as, you know, the
Patriot Act, and the NSA goesthere, their current release
their policies were to have ablack box where all this you
(50:35):
know, depersonalized informationlives until there's reason to go
and look through it. Because aperson can't go and just look
through the information to findwhat they think is a probable
cause to fill it further. Butyou can't legally have an
artificial intelligence do that,because it's not a person. So
essentially, what is what atleast to me, what seems to be
(50:58):
the probable outcome is thatthere will be many more false
positives, many more flags, andmany more issuances of probable
cause to look into people evenfurther. And, you know, to pull
up to the fullest extent, thenthere was before because there's
going to be many more patterns,or have a sense, you know,
(51:20):
patterns. What is that? Who'sWho's writing those artificial
intelligence, intelligenceprograms? And what did they
consider to be a pattern of, youknow, domestic terrorism or
anything that would warrantprobable cause. So that I mean,
and something that I readrecently from you is about
Gabriel and the artificialintelligence surveillance
(51:42):
software that's being appliedthrough things like cameras and,
and sound. So it's certainly inthe realm of technology,
something that is possible,especially if it's all in a
readable format, in text orENCODE.
WW (51:57):
Well, thanks for that really great summary about a lot of
really complex issues and how itall ties together. And you know,
a lot of what you know, we'refacing, I think people need to
pay a lot more attention to thehealthcare space, particularly
people who were opposed to stufflike the Fourth Industrial
Revolution, and its encroachmenton our lives and our government
and really society in general,because, you know, they're
(52:18):
trying to get a huge foot in thedoor through health care. And I
would argue, and I actually haveargued, I think, in some
interviews I've done over thepast year that Robert Califf is at
the FDA right now explicitly forthis purpose, like, as you note
in your piece, he's there toremove a lot of these obstacles
from this for IR paradigm forbeing ushered in, you know, sort
(52:38):
of in through the healthcaresystem first, you know, he's the
point man for that. So I thinkhe definitely deserves a lot
more scrutiny. And that's why Iwas so happy to find your piece
about him. And very happy tohave you on today to talk about
him. And these, you know, morebroad these broader issues on my
podcast. So thanks so much forcoming on Maddie. So where can
people follow your work, andsupport you.
MB (52:59):
So you can follow it on the last American Vagabond substack,
which is Te L Avagabond.substack.com. That's
where most stuff is. I also poston manufacturing reality.org,
which is James journeys blogthere, where he also
contributes, and stuff likethat. So those are really the
(53:21):
main two sources, you cansupport me by supporting tila.
And, and you can follow me onTwitter, and that space jelly.
If you just search she'll findme eventually.
WW (53:34):
All right, super. Well, thanks so much, Maddie, for
coming on. Really appreciateyour time looking into these
issues. And I'm looking forwardto following more of your work
here in the future. And thanksto everyone for listening to
this podcast, and hopefully somepeople listening will take the
time to look into some of thesedeeper issues as well, because
they really, you know, as Imentioned in the introduction,
there is a extreme lack ofreporting, not just on Robert K
(53:57):
lift, but a lot of the issues wetouched on today. And I think we
ignore this kind of stuff at ourown peril. So definitely,
there's a lot to dig into. Andyou know, we really just
scratched the surface about alot of these issues today. And
of course, as always, a bigshout out to unlimited hangout
supporters who make this podcastand pretty much all of my other
work possible as well couldn'tdo it without you guys. So
(54:20):
thanks so much. And thanks, ofcourse, to everyone who
regularly listens and sharesthis podcast around. Appreciate
you all as well. So thanks somuch everyone for listening and
catch you on the next episode.
Hey and welcome to unlimited Hangout. I'm your host Whitney
Webb. For a little over a year,the American Food and Drug
Administration or FDA has beenled by a man named Robert
Califf. Very few people seem toknow much about Califf or his
background, and there is verylittle critical reporting on
this man despite the power hecurrently wields over
significant aspects of Americanpublic health policy. During his
(00:41):
confirmation hearings last year,there were a few stories here
and there noting Califf'sinvestments in the
pharmaceutical and biotechnologyindustries as well as his long
standing ties to Big Pharma andhow this might present a
conflict of interest. Yet thereis a deeper problem with Califf,
that goes far beyond theseconflicts of interest that more
often than not, are the normwithin the US federal government
and on Capitol Hill. This isCaliff second stint as FDA
(01:05):
commissioner, having previouslyheld the post toward the end of
Barack Obama's second term.After he left that position.
When Donald Trump took office inearly 2017. Califf joined Google
becoming the Silicon Valleygiants top strategist for its
forays into healthcarespecifically for Google's health
focus subsidiary, verily LifeSciences. Ever since then, Califf
(01:26):
has been at the vanguard of theeffort to kickstart the so
called Fourth IndustrialRevolution, or for IR in
healthcare, and this hasextended into the decisions he
has overseen over the past yearas head of the FDA. Perhaps
unsurprisingly, Califf himself isa major evangelist for the for
IR in healthcare and is onrecord stating that he shared
the four IR vision of WorldEconomic Forum Chairman Klaus
(01:48):
Schwab well before his notorietyduring the COVID era, her Schwab
and his allies, the four IR,particularly as it relates to
health care, is about themerging our physical, digital
and biological cells,essentially transhumanism by a
different name. troublingly asFDA commissioner Califf is
already creating regulatoryloopholes for devices that will
(02:08):
bring this dark vision tofruition, including brain
machine interfaces,neuromodulation devices and
surveillance wearables, amongothers. He is also doing the
same with other four IR healthfocus technologies, including
gene therapies and much more.For those Americans who are
concerned about the push toinject the four IR into the
American health care system andinto our bodies. Robert Califf
(02:31):
is the man to watch. Joining metoday to discuss Kayla from the
deeper problems here is MaddieBannon investigator Researcher
and Contributor to the lastAmerican Vagabond substack. Last
year, Maddie published a deepdive on K lift called Brave New
real world data on the tlapsubstack which focused on
Califf's time before he becameFDA commissioner and his love
affair with the World EconomicForum in the idea of the Fourth
(02:52):
Industrial Revolution. I highlyrecommend anyone interested in
Califf from the broader issues atplay here. Give Matt his piece
of read. With that being said,welcome to unlimited hangout.
Maddy, it's great to have youhere.
MB (03:03):
Oh, thanks for having me.
WW (03:04):
Absolutely. So, as I mentioned just a minute ago,
it's been acknowledged, rightthat Robert Califf has a
concerning conflict of interestwith Big Pharma, which is, as
you noted in your article, youknow, Bernie Sanders, among
others have challenged him onthis. So I guess before we get
into some of the other keyaspects about Califf here,
particularly about the four IRand things like that, let's talk
(03:27):
a little bit about his hisconnections to Big Pharma. Sure.
MB (03:31):
Well, first of all, is Gousto trial, which was a mega
trial, over 40,000 participantsin the study of cardio, mild
infarction, which is the heartattack was funded a lot by bear,
Sanofi GlaxoSmithKline on allthe big names. So he's been
(03:52):
receiving funding from the bigpharmaceutical industries for
the majority of his career, mostof his papers that he's issued,
and he he, a lot of people, whenthey're interviewing him, are
sure to make note of that he'sone of the most cited medical
writers in the field. They'resure to make note that for as
(04:18):
many papers, it's like, over1200 that is accomplished.
They're all punctuated by verylong conflict of interest
statements that lists, you know,dozens and dozens of
pharmaceutical companies. So hehas a very cozy relationship
with all of them.
WW (04:39):
Right. But I guess one of the things I want to talk about
today is that and what I'vetalked about in some of my work
over the past couple of years,is that big pharma and big tech
have essentially been comingtogether creating a lot of joint
ventures. And so what has beensort of emerging over the same
timeframe is you know, where Asthere was previously, this well
(05:01):
known revolving door between,you know, the FDA and Big Pharma
and other, you know, health carefocused agencies like HHS and
Big Pharma. Now, there's arevolving door between those
health agencies and big techfirms like Google. So Califf is
one of these guys, of course.But there's actually quite a
few. So if you go to the GoogleHealth About Us page, now that
(05:22):
Califf is, you know, more orless, not officially a big part
of it. But as you note in yourPC still is very much connected
to Google Health and itsinitiatives there. But their new
chief health officers, a ladynamed Karen DiSalvo, she was
formerly the NationalCoordinator for Health
Information Technology, andAssistant Secretary for Health
(05:42):
in the Obama administration. Andprior to that worked in HHS. And
then we have Dr. Michael Howell,who is at Google Health Chief
Clinical Officer and DeputyChief Health Officer. He's an
adviser to the Centers forDisease Control. And then one of
the newest hires at GoogleHealth as a man named Bakul
Patel, who's Senior Director ofglobal digital health strategy,
(06:06):
and I guess the relationshipwith regulatory agencies. And he
was, he'd been at the FDA fordecades before joining Google
most recently as the FDA isChief Digital Health Officer of
global strategy and innovation.So there's a lot of these guys,
but of course, probably the mostimportant one to point out would
be Califf. So as I mentioned inmy intro, Califf was, of course
(06:29):
at the FDA during the Obamaadministration, and then he
joined Google. So I guess maybeyou could tell us a little bit
about his time at Google and whythat's significant.
MB (06:39):
Sure. So he'll have served as the Commissioner for the FDA
between the years of 2016 and2017. And that was his first
stent under the Obamaadministration. During that
time, the 21st Century Cures Actwas passed, which is a very
(06:59):
important piece of legislationthat kind of allows for all the,
you know, very new breakthroughdevices and E ways and the
waiver of informed consent forminimal risk trials. So that was
passed during his time there.But he did leave in 2017. That's
when he went back to do for acouple of years. And he founded
(07:21):
Duke Forge. But in 2019, hejoined verily Life Sciences as
their their head of like healthstrategy and policy. During that
time, he headed projectbaseline, which that is
basically,
you know, huge mega trial. Alongthe lines of the things that
(07:47):
he's already very interested in
NS projects at Duke, includingthe Duke Clinical Research,
initiative, and clinical CTTI,which is clinical trials
Transformation Initiative, wherethey're aiming to use digital
infrastructure, passivelycollected patient data,
(08:09):
including electronic healthrecords. So project baseline at
fairly, was kind of areplication of that at a major
private company, who he said hasthe funding to do it, right,
which is what he is on, onrecord noting is very important.
(08:33):
He wants as much money as he canget to get these studies to be
what he actually wants. SoVerily, you know, they recruit
people to join these studies,they had a wearable, a
proprietary watch, that is byprescription only that sense,
(08:55):
you know, biometric data back toGoogle for to be studied. They
studied a number of things,including, you know, oral health
and how that relates to overallhealth. And you know, the
impacts of daylight savings timeon your restiveness and overall
(09:16):
well being based, they studied anumber of very trite things, you
know, that I don't think really,not a lot of these study
results, while they are postedon clinical trials.gov. The
results are not posted there. SoI'm not sure what the results
(09:36):
were. But they also study thingslike depression. So yeah, that's
basically their their wholething is to continuously monitor
and collect data, because on thepeople that are involved in
their studies, because theirgoal is to map human health.
They said, we already havemapped the earth and now it is
(09:57):
time to map human health andthat's kind of what they're out.
her.
WW (10:00):
Yikes. Yeah. So they've mapped human health and they
contract with like intelligenceagencies in the military. So
they can, you know, like dronebomb or find whoever they want.
Right. And so now we got themgot a map the human body to
Well, that's fun. Okay, so onething I really found interesting
as a major theme in your articleis this about clinical trials
(10:22):
specifically about bailiff. Soas you noted, you know, he made
a name for himself with this,um, I guess Gousto trial in the
in the mid 90s. But since then,he's essentially been trying to
revolutionize clinical trialsand how they're performed. And
so a lot of the stuff you'vetouched on, including project
baseline, I'd like to get ininto a little more detail of
those specific initiatives likethat. And other ones you
(10:43):
mentioned a little bit later inthis episode. But for now, I
just wanted to bring up that younoted in your piece that a lot
of key lifts career,specifically his time at Google
and this current stint as FDAcommissioner, he's been spending
it quote, tireless tirelesslydedicated to the task of
removing the obstacles facingthe four IR. So I think, you
(11:04):
know, since the four IR is areally key part of understanding
who Califf is why he wasnominated by the Biden
administration to be in thisparticular role, at this point
of time, it's all very importantto understanding those issues.
Right. So if it's cool with you,let's go over, you know, for
people who may not know what thefourth industrial revolution is,
what are qlf stated views aboutthe phenomenon? And what are
(11:27):
some of his roles in at the FDAand Google that he's played in
promoting these policies?
MB (11:32):
Sure. One of his greatest achievements, according to him,
is convincing them PresidentObama, that the Fourth
Industrial Revolution was realand happening and very
important. So he's very, he'svery much a fan. And he thinks
that it is important, he thinksthat that will be happening. And
(11:52):
basically what the whole conceptis, is that our bodies and then
eventually, our minds willeventually merge with
technology, and the internet byproxy. So this is the concept is
the brainchild of Klaus Schwabruns the World Economic Forum.
So, you know, the whole idea ofthe Fourth Industrial Revolution
(12:16):
is to gather as much datapassively generated by either
people or the environment, viawearable devices, electronic
health records, insuranceclaims, you know, the devices in
your car, your social media toget it to make you your digital
(12:36):
self. They'd like to merge yourphysical self with your digital
self into one thing, so totallyinseparable. But he, you know,
he cites Klaus Schwab and thefourth industrial revolution
book that he wrote in hispapers, academic papers. He
(12:57):
talks about it frequently ininterviews and things like that.
Yes, that's really hiscontribution as he I mean, he's
been, he's stated that he's goneto the World World Economic
Forum, and I'm sure he, youknow, Knievel's on the other
acolytes there.
WW (13:14):
He's openly said that lead he, you know, attended the WEF,
and was like, Wow, these guysare really on to something in a
video, I saw him where he'sdoing some Google interview
series. I mean, he talks veryglowingly about all of this
stuff. And in the web itself.And of course, as you note in
the piece, some of the stuffhe's overseen, as you know,
follows the web's favoritemodel, the public private
(13:36):
partnership, so he seems verymuch on board with a lot of this
stuff. And what's particularlyconcerning to me is that a lot
of these for IR technology, solike, you know, the way it's
described, it's something that'snot just going to revolutionize
healthcare, right? It's supposedto revolutionize every sector of
society, society itself changedthe meaning of what it is to be
human, and all other sorts ofstuff. But the way they seem to
(14:00):
be going to get sort of this,their foot in the door here is
is through healthcare. And youknow, as I wrote for tea lab a
few years ago, that particularpolicy has its ties with Google
going way back to the, you know,well, before COVID, with the
Eric Schmidt led nationalsecurity commission on
artificial intelligence, ofcourse, Eric Schmidt, being the
(14:22):
longtime head of Google. Andthat particular Commission said
that the best way to get AI massadopted by the American populace
was to have it sort ofshoehorned into health care
policy. And they essentiallyhave framed this as a national
security imperative. And so onthis commission, you know, you
have big tech, and you have thenational security state, you
(14:45):
know, mainly the military andintelligence communities and
this is their, their view, youknow, the most powerful actors
really in the United Statestoday that it's a national
security imperative to havebasically the the four IR types
of technologies implemented intoour healthcare system. First as
a way of having them spreadthroughout society, and they
frame this as, as you know,necessary to counter China's AI
(15:06):
supremacy and hegemony thatwill, you know, allegedly happen
if we don't surpass China interms of the mass adoption of
these types of technologies. Butoddly enough, you know, if you
really want to believe it takenational security agencies at
their word, you know, that thiswas about China, not about like
long standing agendas of theirsto mass surveillance, you know,
(15:27):
of mass surveillance and thingslike that, you know, obviously,
that's, that's up to you, andeveryone can have their own
opinion about that. But it seemslike Robert K lifts roll here
and more, you know, even biggerthan Califf, really is the role
of Google and all of this, it'sdefinitely something I think
more people should be payingattention to, at the very least.
So one interesting thing thatyou bring up in this article is
(15:51):
about Robert Califf, and youalready mentioned it a little
bit that He was the foundingdirector of the Duke Clinical
Research Institute, whichpredates his time working at the
FDA, but it sort of saw himpartner up with the FDA. While
he was at Duke, where I believehe's been for a decent amount of
his academic career. And this issort of a precursor to a lot of
(16:16):
the stuff that he's overseensince he got involved with the
FDA and overtly with Google aswell. So can you tell us a
little more, you know, maybe alittle more detail about this
Clinical Research Institute, hehelped create and the initiative
that you mentioned early,earlier, the clinical trials
Transformation Initiative? Yeah,sure. I
MB (16:33):
mean, they're, they both run along the same lines. And the
gold standard for clinicaltrials is a randomized control
trial. So they're looking foralternative fees. Because
though, to do a randomizedcontrol trial, it costs a lot of
money, you have to hire staff,you have to have, you have to
recruit participants, you haveto, you know, fly the
(16:54):
intervention, or the placebo,and make sure that you're
tracking all the informationthat's associated with that you
have to have people enter thatdata and then make sure it's
correct. And have like an actualtrial site and how people go to
and from and compensate them forthat. So it's, it takes a long
time and cost a lot of money. Sothe aim, as far as I can tell,
(17:16):
and from writings that he andothers have written about, you
know, real world evidencegeneration and real world data
in place of randomizedcontrolled trials, is that it
cuts down on cost significantly,maybe up to 30%. And you can
definitely get it done a littlebit faster. So if you already
have a pool of people whoseinformation that you already
(17:39):
have access to, for instance,like I mentioned, the cell phone
data, electronic health records,insurance claims, all that, you
don't need to bother recruitingthe participants, you don't need
to wait for that information tocome in, especially for the low
risk trials that you again, youdon't need informed consent for
(17:59):
those anymore, thanks to the21st Century Cures Act that was
passed in 2016. So you can get alot of things done faster and
more cheaply. If you useinformation. That's, like he
says siloed siloed, and notinteroperable. What do clinical
(18:22):
research institute and the ctciare aiming to do is advocate for
those those data to be on siloedso that they're free, they're
shareable. And also to advocatefor trials that use that kind of
data instead of the randomizedcontrol trial, right, the past
(18:44):
and that traditional sort oftrials.
WW (18:47):
So let's talk a little bit about what this means for you
know, the average person thatdoesn't necessarily like you
know, research these kinds ofworlds very much. So like ran
the way basically the way thatmedical and clinical trials have
been conducted. Pretty much inthe vast majority of the modern
era, right? This initiative wasabout essentially replacing
those trials with this realworld evidence paradigm, right?
(19:12):
And you have a really helpfulgraphic about what real world
data and real real worldevidence is in this piece, and
you know, that you wrote in someother descriptions of it that
you provide in the piece. Butthe graphics interesting because
it reminds me a lot of sort of,of the World Economic Forum's
policy paper, I think from 2018,about digital ID, where
(19:35):
essentially all these differentthings are interconnected. And
there's really like thiscentralized database for data
about you and so what's what'sreally crazy about it to me that
you know, it has, like, youknow, you're in the center,
right, and all these differenttypes of data that you generate,
are coming off, you know, fromyou and that this data is going
to be used to replace a clinicaltrial for to prove the
(19:58):
effectiveness of, of drugs. orwearables or, you know, brain
machine interfaces, you know,all this type of stuff. And it
has stuff like, you know,disease registries, things you'd
expect, right? Like electronichealth records, survey data,
pharmaceutical data, like whattypes of medicines you take, and
then the wearable stuff. But italso has stuff like consumer
(20:20):
data, which is your buyinghabits, what you buy online,
right, but also, social mediadata, you know, who what you're
interacting with, what you'resaying, online, what type of
information you're reading, andviewing, which is interesting in
the context of something I'dlike to talk about a bit later,
which is Robert K lifts missionto have the FDA play a major
(20:41):
role in pre empting anddebunking misinformation, which
is, which is interesting there.But the idea that all of this
data, this monitoring of stuffthat has never really been used
in existing randomized clinicaltrials and stuff like social
media data, and just sort ofdata, harvesting the stuff from
(21:01):
people without their consent,and using that, in lieu of
randomized clinical trials, isjust totally insane. And I just
in this, you know, the peoplethat wanted to put him in charge
of the FDA obviously knew thathe was in charge of these types
of initiatives, and that he was,you know, essentially there to
create the regulatory, I guess,I guess, you know, I'm calling
(21:24):
it a regulatory loophole, butreally, it's a complete
alteration of the existingregulatory paradigm, to totally
just replace it so that all ofthis fourth industrial
revolution, technology can befast tracked and mass, you know,
for mass implementation, massadoption by the masses, but it
doesn't necessarily have to usethe previous paradigm to prove
(21:47):
it any safety, any effectivenessunder past metrics, right? Um, I
don't know, your thoughts onthat. Maybe you disagree.
MB (21:56):
Um, I mean, it, the problem is, they can't really verify
whether or not the informationthat you're receiving is good or
bad. They're trying to come upwith ways to do that. But I
don't think that that's reallyfeasible. So, you know, one way
that Kailis has, you know, hegave a talk at Google was a
(22:18):
Google Talks, then it's onYouTube, he mentioned, the one
way, or at least one of the waysthat we'll find out if these
things go wrong is if theybecome catastrophic. So that's,
that's when we'll know how toregulate these kinds of trials
is if there's like, a massivesafety or efficacy, catastrophic
(22:40):
situation that occurs, as hesays, That's how things have
gone in the past. But, you know,when you're talking about mega
trials where, you know, over40,000 people, and he's already
done, that's, I don't know ifthe benefit, risk calculus
really makes sense there. So inand to be honest, I don't think
(23:00):
that these real world evidencebased trials are going to
supersede randomized controltrials entirely, I think that
they are using them to fasttrack certain sort of
medications and devices, atleast through phase one and
phase two trials. And they'redoing they're applying it to
(23:23):
post market studies as well. Soas far as actually, when the
when medical devices or drugsare, have some sort of risk to
them, I think they're stillapplying the randomized control
trial. But they're, you know,they're, they're huge, they're
implementing and using this asmuch as possible to cut down on
costs and getting those thingsto market as quickly as
(23:45):
possible. And another thing too,that I've been thinking about is
that I, he uses a lot oflanguage of these being
important and necessary so thatthose drugs and devices can be
made available to the public, asyou know, more quickly, and
that's kind of the the pill thathe gives you to swallow
(24:06):
alongside the current nearconstant surveillance that he
alleges will be occurring, andthat is occurring. Because
people need these life savingdevices. Now, they don't need
them in five to seven years. Butreally, you're asking the
consumer to adopt all the riskthere?
WW (24:24):
Well, we heard this with COVID, right? The same thing,
like a change of the regulatoryparadigm for the purpose of oh,
we need to get this out faster.So we have to produce a vaccine
on the timeline that'scompletely unprecedented. And we
have to change how trials areconducted. And you know, as I've
noted, in my work, and otherpeople have noted, you know, a
(24:46):
lot of these companies likeMadonna, for example, couldn't
get a product to market underthe previous regulatory
paradigm. And so the emergencyuse authorization and a lot of
these, you know, emergencymeasures we're used to sort of a
totally change how a lot ofthese trials for these vaccines
were conducted. And, you know,because of the, you know,
(25:07):
professed sense of urgency,that, you know, this idea that,
you know, the risk is beingtaken on by the person that
receives, you know, the vaccine,instead of having, you know, the
FDA saying, Yeah, we can say,Well, I mean, they did say it
was safe, right, but, you know,that wasn't necessarily
reflected by the trials, and itwas all justified by speed. And,
(25:29):
you know, what you're seeinghere is them using speed as as
the justification and also costreduction, but you know, it's
troubling stuff. And I may havemisspoken earlier, what I meant
is that um, so in your piece,you were talking about CTI this
transformation, clinical trialTransformation Initiative, and
you said it seeks to do is touse real world evidence in place
of evidence generated by RCTs.And so I sort of see what Robert
(25:55):
Califf is doing now at the FDAsort of as not necessarily
trying to replace, you know,eliminate randomized clinical
trials entirely. But when itcomes to a lot of these, more
like novel devices, notnecessarily things like
vaccines, and likepharmaceutical products that are
(26:15):
more traditional, like pillsand, and other types of
injections and stuff, it seemsto be some of these other
devices, whether they'rewearables or implantables,
really also are sort of beingtreated under this, this new
paradigm, this idea of like theremote clinical trial, it's not
(26:37):
necessary to physically monitorand observe patients and just
basically use the data that'scollected by their interaction
with these devices and theconnectivity. And all of that is
essentially replacingtraditional trials. And to me,
that seems sort of like a way ofsidestepping some of the
traditional metrics for theseparticular devices, which, of
(27:01):
course, those devices areobviously necessary to get the
for IR really rolling in thehealthcare space, right?
Particularly with the, you know,the brain machine interface, or
some of these neuromodulationdevices sort of get the nervous
system of the human bodyconnected to the internet.
Right?
MB (27:20):
What what's funny about that is there the breakthrough
devices designation given by theFDA to medical devices is really
for devices that are or to treatlife threatening, or
irreversible diseases, which,when you think of a brain
(27:40):
computer interface, sure, youcan maybe make the claim that
our brain computer interface cantreat paralysis, or help the
blind see, or the, you know,stroke victims have more
functioning sides of their body.Yeah, that's fine, but they also
will be applied for many, manyother uses. So it just seems to
(28:02):
me that companies like BlackRock technologies, and Syncron
and neuralink, etcetera, areusing this, you know, this claim
that their brain computerinterface will be used to treat
life threatening and in orirreversible diseases as a way
to get get their stuff throughthe door and fret and prioritize
(28:24):
that at FDA so that it can bepushed through more quickly, you
know, disregarding all the otherapplications that Amin B is for
and it will most likely be usedfor and that's probably what
they're, what their primary aimis at the end of the day.
WW (28:37):
So even though you mentioned that, like the breakthrough
device designation, technicallyis sort of, like reserved for
these devices that are like for,you know, irreversible, you
know, diseases, terminalillnesses and conditions, stuff
like that. It's being given to alot of things that don't follow
under these metrics. So a recentFDA breakthrough device
designation was given to thiscompany called Suma, which is
(29:00):
very much you know, it'sbasically Soma but with a second
Oh, and it received thatdesignation for its innovative
at home depression treatmentdevice, which it describes
basically well in the picture inthe article anyway, it's
basically like a electrodes youwere on like a weird little
beanie thing over your head. Andlike a electroshock see you I
(29:25):
guess, certain parts of thebrain to like, make you not
depressed, right. But there's alot of other treatments for
depression, right? Andbreakthrough device designation
as opposed to be for conditionsthat don't have existing
treatments, you know? So, thisis one of those examples of sort
of the FDA sort of applying thisdesignation to places where it
(29:46):
doesn't really need to be givenright. And so you know, if you
look at this example, and a fewothers, it seems pretty clear
that the current FDA modusoperandi as it comes to this
brand, As it relates to thisparticular designation, it seems
to just sort of be giving it tocompanies that, you know, have
(30:07):
some of these four IR relateddevices or, you know,
neuromodulation stuffspecifically, and trying to get
them onto the market as quicklyas possible, allegedly for the
benefit of consumers. But, youknow, when you get these sort of
special designations, you'reallowed to sort of skip a lot of
the, you know, the regulationsand trials and other
(30:28):
requirements that, you know,competitors would have to
complete, you know, competitorsthat don't receive this
particular designation.
MB (30:38):
Yeah, right. I mean, what's the breakthrough device
designation also allows fornovel medical devices, they call
it de novo. So there's no youknow, to be a de novo device,
there's not any legally marketedpredicate device, so something
like it. As far as I know, Sumahas at least some competitors. I
(30:58):
saw other sort of beanieelectrode app applications and
devices a lot like it. So maybethey're competing for that
space. My My initial thoughtwhen I saw the, their device had
the head cap and the electrodes,I thought we had already kind of
tried electro thought shocktherapy for mental illness, and
(31:21):
that it didn't really work toowell, and also made people a
little bit weird. And not it wasnot good. So I think I mean, I
understand that it's a littlebit more low voltage. But it
doesn't seem to be too originalof an idea. But, yeah, as far as
(31:41):
I see, yes, they use a techniquecalled transcranial direct
current stimulation we reallyneuromodulation is well, there
are a few different definitionsthat I was able to find. But
they're mostly that theinternational neuromodulation
society defines it as thealteration of nerve activity
(32:02):
through the targeted directdelivery of a stimulus through
electric or chemical agents atcertain sites, so we have a lot
of companies that are looking atthe spleen. Let's just saying
what does that nerve called,there's a there's a certain
nerve that that originates atthe spleen. And it's part of the
(32:23):
autonomic nervous system. Andthey're looking at that for
Parkinson's to stop the handtremors. Yeah, so you have a lot
of people looking at that forthat. And they also are trying
to use it for rheumatoidarthritis, and things like
WW (32:38):
that. So one of the companies pursuing neuro modular
neuromodulation of thatparticular nerve, you mentioned,
I guess, the spleen at nerve isfor rheumatoid arthritis is
Galvani bioelectronics, which isan interesting company in the
context of Robert Califf,because it's a joint venture of
GlaxoSmithKline. And verily,which is Google's health
(33:00):
subsidiary that Robert Califfhas been involved with over the
years. And they're one of theones that sort of got this. I
think they've already startedimplanting it into people, but
they have a lot of ambitions forthese neuromodulation advices,
which is basically to alter howthe nervous system functions,
whether it's targeting specificnerves, or many nerves, or
(33:22):
groups of nerves, or the entirebrain. That's sort of the whole
ambition there. And of course,verily, is also the people
behind project baseline, whichis something that you mentioned
earlier. And I think not enoughpeople have paid attention to
this. And it's a really crazything when you think about it.
So, um, there's this one,there's a few things that have
(33:45):
been written on baseline, youknow, from mainstream sources.
So one summary offered here andwhich you sort of have touched
on already and what you'vetalked about, it says, The
verily baseline Health Studylaunched in 2017. So that's
around the same time that Califfwas at Google on being their top
health strategist, right. It waslaunched in 2017, with the goal
(34:05):
of mapping human health bycollecting data from a variety
of sources, including selfreported data, smartphone, or
wearable recorded data, orthrough electronic health
records. And as you mentionedearlier, because of the the
Cures Act, some of that recordeddata by smartphone or wearables
that data can be obtainedwithout informed consent.
Anyway, so it says essentially,a lot of this, this baseline
(34:30):
health study, and the broaderbaseline health platform is all
about changing. Again, howclinical trials function, right?
So I first heard about Projectbaseline during the COVID stuff
because they were using itspecifically for that. And a
bunch of weird stuff was goingon with verily and COVID tests,
(34:50):
including having people forcingpeople who took COVID-19 test
and the San Francisco area whichwere being managed I think the
government there, or hadcontracted Google or verily, to
do this, and they were requiringpeople that got COVID test to
basically link their testresults to their Google account.
And if they didn't have a Googleaccount, they had to make one in
(35:13):
order to participate, which ispretty insane. But essentially,
what it sounds like to me isthat project baseline is just
trying to gather an insaneamount of, of data on people for
all different types of purposes.And essentially, the goal they
say, is to collect comprehensivehealth information with the goal
(35:34):
of better understanding healthand the transition to disease.
And it's important to keep inmind that at the same time this
has been going on and when thiswas launched, is when the
Pentagon and Google teamed upfor this sort of predictive
health care thing. So basically,using all of this data, all of
these, this massive cachet thatmilitary holds from, like the
(35:56):
veteran and military healthsystems of X ray images, and
things like that, to train AI sothat the AI could offer
predictive cancer diagnoses. Sobasically, the AI is like, Oh,
well, we've decided that you'lldevelop cancer in five years,
but you don't actually havecancer, you know. So it's all of
this sort of, you know, whatI've, what me and people like
Ryan Christian are sort ofreferred to as the pre crime
(36:18):
paradigm applied to healthcare.So basically, you're going to be
told that you're going todevelop this disease by AI, or
some of these different devicesor by you know, this data
accumulation, and they're goingto decide, they're going to tell
you what you're likely todevelop before you develop it,
and then go and offer you allthese different weird
(36:39):
therapeutics, whether it's stufflike, you know, mRNA stuff, or
gene therapy, or, you know,these neuromodulation devices,
or wearables are stuff thatinteracts, you know, with your
nervous system, or changes howit functions and all sorts of
stuff, even though at thatparticular moment, you don't
actually need it, it's beingframed as preventative. Right.
(37:01):
And this is, again, Google withthe military doing this, and you
have them of course, doing it,and all other sorts of, of
different guises. Butultimately, you know, it's about
per them about health care.Right? But it seems to be a lot
more than that, if you asked me,but, you know,
MB (37:18):
yeah. And Kayla's. In an interview, he mentions that this
sort of, you know, influencesubtle influence over people in
regards to their health is, youknow, justifiable because it's
already happening. And it's beenhappening for a while through,
you know, private marketadvertisements, and cookies on
(37:39):
your computer and tracking whatyou buy, and figuring out what
you might be interested inbuying, and then presenting that
to you. So he's just in hethinks that doing that isn't
necessarily good. It's notgetting people, things that they
need, or make them have a happyor healthier life. So what he's
saying is, well, that's bad whenwe do it, it's good, because
(38:01):
we're trying to help people livelonger and be less ill. So we're
going to track you and just thesame way, we're going to nudge
you and influence you in justthe same way. But our ends are
delivering those drugs and thosemedical devices that you
actually you need, right, andyou'll be convinced that you
need them because we have allthe data, and we'll present you
(38:22):
evidence that we found and tellyou how this will help you and
your life before you are evenconsidering going to the doctor
about it. But like you said itis it is preemptive. And he
thinks that it's totally fine.There's there's good guys and
bad guys. And the bad guys arethe people who sell you clothes
(38:43):
and food and stuff like that.But they're good because they
sell you pharmaceutical, drugsand medical devices.
WW (38:52):
Yeah, crazy. So. So in your particular article in talking
about the Cures Act, you sort ofmentioned that Califf had a role
and getting that certain aspectsof that legislation, you know,
in place, you know, involved into an extent in the drafting and
lobbying process for thisparticular law. And so I found
(39:12):
it interesting, too, that rolledwithin that act, were things
like the BRAIN Initiative, andBiden's Cancer Moonshot
Initiative, which, you know, iswas basically the basis for
Biden's recent creation of ARPAH, which was previously shopped
around to the Trumpadministration under the name of
Harper. And we're basically ahealth focused DARPA equivalent
(39:35):
and I actually did a podcast afew months ago about one of the
guys behind the BRAIN Initiativeand how he has been very active
where I live down in SouthAmerica in Chile and getting
Chile to be the first country toestablish what he what are
called neuro writes. This ideaof trying to protect your
(39:58):
individuality and so Out of thisparadigm where brain machine
interfaces, and all of this are,are very common. And
essentially, you know what Isort of talked about this likely
being in that particularpodcast, instead of it being
framed as protecting you fromall the bad stuff these devices
could do to you. Making you loseyour sense of self, among other
(40:18):
things, is really about creatingthe necessary framework and
public justifications to getthese types of devices on the
market, not necessarily forhealthcare related purposes, but
also for commercial purposes.Because people like Elon Musk,
like neuro link and stuff, youknow, on one hand, they're
saying and I guess Syncron, toprobably in some of these other
(40:39):
firms doing the same thing, youknow, on one hand, they're
framing this as Oh, this is ahealth device to help people
that are paralyzed, walk, and,and all and blind people seeing
all of that, but at the sametime, you know, Elon Musk is
like, pretty open, that neurolink is intended to be like,
used for commercial purposes,people could use it to play
video games and stuff. And youknow, even some of the animal
trials, they promoted were likemonkeys with the neuro link
(41:02):
implant playing video games withtheir brain and stuff, not
paralyzed monkeys walking again,you know what I mean? So it just
seems, you know, a bit differentthan it's being done, it's being
sold.
MB (41:14):
Sure. I think, you know, for the brain computer interfaces,
the only, there's a differencebetween imagination and reality.
And you can, you know, postulateand say that our BCI is going to
help people walk or see orwhatever, I don't see any
evidence of that, at least asfar as like the initial studies
(41:35):
and video footage and thingslike that, that there's no
evidence for that actuallyhappening. As far as what is
able to be accomplished is thatyou can control like, so if
you're a total, if you're 100%,paraplegic, and you have no way
to move your hands or interfacewith a computer, you can do so
(41:55):
they say, quote, unquote, simplyby thinking, and while that may
have medical application, youknow, if you're trying to help
people who are paralyzed, sure,but Why can't anybody else use
it for that? So it's just topass it under the guise and get
these sort of fast tracks tomarket seemingly to preempt your
(42:15):
competition and kind ofmonopolize that market as soon
as you can. Which is, I wouldsay, Syncron is definitely much
further ahead than than anybodyelse on that front. That seems
to be what it's actually for.Because I don't I don't, you
know, the brain computerinterfaces. There's, there's
just not enough evidence outthere to suggest that it's
(42:38):
actually going to help peoplewith with their claims of you
know, the ever irreversiblydebilitating diseases or the
life threatening diseases. Thereis one company it's called, see
things called like neuro neurolinks or neuro leaf, that's what
it is. They have this braincomputer interface that links
(43:02):
with an exoskeleton that helpspeople who have you know, have
had a stroke, move the hand,that's not working anymore. That
makes more sense. But yeah, itseems more just trying to get
these things on the market asquickly as possible under the
guise of helping people as
WW (43:20):
Yeah. And what I mentioned earlier, there's this whole, you
know, ulterior motive comingfrom the highest levels of the
national security state andpeople like Eric Schmidt, trying
to get the stuff out there onthe market as quickly as
possible because they see it aspart of this big tech war with
China. Right. Which is alsopretty crazy. And, you know, a
(43:41):
key point I want to make heretoo. So I'm sure people are
familiar with, you know, myanalysis and other people's
analysis of statements made byby people tied up with the World
Economic Forum and big you know,for IR evangelists, like Yuval,
Noah Harare, who basically saythat, like the whole wearable
paradigm, like getting wearableson everybody is the red line
that will, you know, result inthe ushering in of what he calls
(44:04):
digital dictatorships, you know,basically the surveillance of
what's going on not just insideyour body, but inside your mind.
And I think this is all kind ofinteresting when you're looking
at the big players here in thecontext of a lot of how this
mass surveillance is also, youknow, tied into this, this
effort to launch a war ondomestic terror and master bail
(44:25):
everybody and sort of usher inthe paradigm they tried to do
after 911 with things like DARPAis total information awareness
and stuff. So you know, you havegroups like Google and also
Palantir, which is basically youknow, as I've noted in my work,
essentially a CIA front that isbasically total information
awareness, privatized and soPalantir basically has access
(44:47):
and has been running a lot ofthe COVID-19 health data and
other health data held by HHSand also in the United Kingdom.
Basically, all NHS data is beingmanaged by Palantir is Well, and
then you have Google having thisthis big role. For example, they
host the FDA is my studiesprogram, and how on Google Cloud
(45:09):
and they have for some time, andyou have a lot of these, you
know, this revolving door, likewe talked about earlier, sort of
between the, the regulatoryagencies and Google and verily
is being used for a lot of thesenew remote trials to get some of
these, you know, more noveldevices, I guess, and like
neuromodulation devices on themarket more quickly, without,
(45:30):
you know, in person monitoringand, you know, completely
electronically conducted fullyremote clinical trials in
they're teamed up with thePentagon. I mean, there's all
sorts of crazy stuff going onhere. And I think some of that
overlap is interesting in thecontext of this whole, like, you
know, misinformation trying tostop people from spreading
(45:50):
what's deemed as misinformationabout about health and how that
also is, you know, one of themain objectives of the supposin
war on domestic terror, becauseRobert Califf has been very vocal,
since he came in to art it'scame into this position last
year about the need for the FDAas an agency to preempt and
debunk misinformation, which iskind of ironic, because some of
(46:13):
their efforts on that front haveactually involve the FDA
spreading the misinformation,for example, claiming that
ivermectin is not like, able tobe used in human beings that
it's like a horse and cowmedicine exclusively. And
regardless of what you thinkabout its validity as an early
(46:34):
treatment of COVID, or whatever,well, before the COVID era, it
was being used in people. So toframe it, as you know, a horse
to warmer exclusively, like hadbeen done on CNN is not
accurate. And the FDA obviouslyknows this. So it's just
interesting that you'd have youknow, Google Palantir, they're
big players in the healthcaresecure system getting more and
more tied up with the FDA. Andthey're a big part of this
(46:56):
misinformation, crackdown andprofiling of people spreading
misinformation as well. And Ithink people, you know, might be
might want to see that there'sthat degree of overlap there.
Because once you're surveillingpeople, whether it's under the
guise of healthcare, or underthe guise of stopping domestic
terrorism, I mean, ultimately, Ithink the end result is the same
(47:18):
essentially. And I've also kindof argued, and in some of my
work on, on the creation of ARPAH, under the Biden
administration, which sort ofgoes back to this Cures Act
stuff you were talking aboutduring the Obama administration,
I mean, essentially, that's alsoabout getting the mass use of
wearables for this, you know,predictive health paradigm and
(47:40):
precision health paradigm andall of this stuff. So, you know,
it may be it's being framed asyou know, a boon for public
health. But ultimately, it seemsto me like the four IR is just
about an insane paradigm of masssurveillance, and they're just
trying to see what sort ofjustifications they can make for
it, you know, what sticks andwhat people, you know, need to
believe and need to feel inorder to start using that type
(48:02):
of technology on and in theirbodies.
MB (48:04):
Yeah, I think that's the fourth industrial revolution,
you know, well, Klaus Schwab.And, you know, the people who
are as true believers, theydescribe it as the merging of
our personal and digital selves,right, or quantify cells. But
it's really about the lastfrontier, which is the mind,
right, and also, includinggenetics. So they're looking to
(48:27):
somehow be able to predict, andthey've been, you know, the US
government, at least for a longtime has been created, create a
artificial artificial models ofthe world and tried to use that
to predict how militaryconflicts would go, or certain
the certain release ofinformation would go, they
(48:48):
created a computer generatedmodels of the world and people
to the finest detail possible,hoping that they can predict the
future. And really, they need acomprehensive understanding of
how people think. And I thinkthat's really what it's about
the mind is really the lastfrontier, and genetics for
(49:09):
capitalism and in any ingovernments and surveillance and
control. So that seems to be tobe the primary target by merging
people's physical and digitalselves. And while you know, they
frame it as that's somethingthat will happen eventually. And
(49:29):
inevitably, the private marketand the public private market
are kind of already doing thatintentionally. So they're, you
know, whether or not that wouldhave happened otherwise, is
another question, but they'rekind of making that happen now.
And as far as, as far as thesurveillance stuff goes, this is
(49:49):
why I think artificialintelligence is so important is,
you know, considered to be anarms race at the moment between
the US you know, and They'recompetitors. Because it's a lot
of information, that's a lot ofdata, it's impossible to go
through all of that and assignpatterns with any sort of
efficiency. So you need to applyan algorithm machine learning
(50:13):
algorithm or an artificialintelligence to that, to find
what you're looking for, or toat least flag what it thinks it
might, you might be looking for.And as far as, you know, the
Patriot Act, and the NSA goesthere, their current release
their policies were to have ablack box where all this you
(50:35):
know, depersonalized informationlives until there's reason to go
and look through it. Because aperson can't go and just look
through the information to findwhat they think is a probable
cause to fill it further. Butyou can't legally have an
artificial intelligence do that,because it's not a person. So
essentially, what is what atleast to me, what seems to be
(50:58):
the probable outcome is thatthere will be many more false
positives, many more flags, andmany more issuances of probable
cause to look into people evenfurther. And, you know, to pull
up to the fullest extent, thenthere was before because there's
going to be many more patterns,or have a sense, you know,
(51:20):
patterns. What is that? Who'sWho's writing those artificial
intelligence, intelligenceprograms? And what did they
consider to be a pattern of, youknow, domestic terrorism or
anything that would warrantprobable cause. So that I mean,
and something that I readrecently from you is about
Gabriel and the artificialintelligence surveillance
(51:42):
software that's being appliedthrough things like cameras and,
and sound. So it's certainly inthe realm of technology,
something that is possible,especially if it's all in a
readable format, in text orENCODE.
WW (51:57):
Well, thanks for that really great summary about a lot of
really complex issues and how itall ties together. And you know,
a lot of what you know, we'refacing, I think people need to
pay a lot more attention to thehealthcare space, particularly
people who were opposed to stufflike the Fourth Industrial
Revolution, and its encroachmenton our lives and our government
and really society in general,because, you know, they're
(52:18):
trying to get a huge foot in thedoor through health care. And I
would argue, and I actually haveargued, I think, in some
interviews I've done over thepast year that Robert Califf is at
the FDA right now explicitly forthis purpose, like, as you note
in your piece, he's there toremove a lot of these obstacles
from this for IR paradigm forbeing ushered in, you know, sort
(52:38):
of in through the healthcaresystem first, you know, he's the
point man for that. So I thinkhe definitely deserves a lot
more scrutiny. And that's why Iwas so happy to find your piece
about him. And very happy tohave you on today to talk about
him. And these, you know, morebroad these broader issues on my
podcast. So thanks so much forcoming on Maddie. So where can
people follow your work, andsupport you.
MB (52:59):
So you can follow it on the last American Vagabond substack,
which is Te L Avagabond.substack.com. That's
where most stuff is. I also poston manufacturing reality.org,
which is James journeys blogthere, where he also
contributes, and stuff likethat. So those are really the
(53:21):
main two sources, you cansupport me by supporting tila.
And, and you can follow me onTwitter, and that space jelly.
If you just search she'll findme eventually.
WW (53:34):
All right, super. Well, thanks so much, Maddie, for
coming on. Really appreciateyour time looking into these
issues. And I'm looking forwardto following more of your work
here in the future. And thanksto everyone for listening to
this podcast, and hopefully somepeople listening will take the
time to look into some of thesedeeper issues as well, because
they really, you know, as Imentioned in the introduction,
there is a extreme lack ofreporting, not just on Robert K
(53:57):
lift, but a lot of the issues wetouched on today. And I think we
ignore this kind of stuff at ourown peril. So definitely,
there's a lot to dig into. Andyou know, we really just
scratched the surface about alot of these issues today. And
of course, as always, a bigshout out to unlimited hangout
supporters who make this podcastand pretty much all of my other
work possible as well couldn'tdo it without you guys. So
(54:20):
thanks so much. And thanks, ofcourse, to everyone who
regularly listens and sharesthis podcast around. Appreciate
you all as well. So thanks somuch everyone for listening and
catch you on the next episode.
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