Hey and welcome to unlimited
Webb. For a little over a year,
Administration or FDA has been
Califf. Very few people seem to
background, and there is very
this man despite the power he
significant aspects of American
confirmation hearings last year,
and there noting Califf's
pharmaceutical and biotechnology
standing ties to Big Pharma and
conflict of interest. Yet there
that goes far beyond these
often than not, are the norm
and on Capitol Hill. This is
commissioner, having previously
Barack Obama's second term.
When Donald Trump took office in
becoming the Silicon Valley
forays into healthcare
focus subsidiary, verily Life
has been at the vanguard of the
called Fourth Industrial
healthcare, and this has
has overseen over the past year
unsurprisingly, Califf himself is
IR in healthcare and is on
the four IR vision of World
Schwab well before his notoriety
and his allies, the four IR,
health care, is about the
and biological cells,
different name. troublingly as
already creating regulatory
bring this dark vision to
machine interfaces,
surveillance wearables, among
same with other four IR health
gene therapies and much more.
concerned about the push to
American health care system and
is the man to watch. Joining me
deeper problems here is Maddie
and Contributor to the last
year, Maddie published a deep
real world data on the tlap
Califf's time before he became
affair with the World Economic
Industrial Revolution. I highly
Califf from the broader issues at
of read. With that being said,
Maddy, it's great to have you
Oh, thanks for having me.
Absolutely. So, as I
it's been acknowledged, right
concerning conflict of interest
you noted in your article, you
others have challenged him on
into some of the other key
particularly about the four IR
a little bit about his his
Well, first of all, is
trial, over 40,000 participants
infarction, which is the heart
Sanofi GlaxoSmithKline on all
receiving funding from the big
the majority of his career, most
and he he, a lot of people, when
sure to make note of that he's
writers in the field. They're
many papers, it's like, over
They're all punctuated by very
statements that lists, you know,
pharmaceutical companies. So he
with all of them.
Right. But I guess one of
today is that and what I've
over the past couple of years,
have essentially been coming
ventures. And so what has been
timeframe is you know, where As
known revolving door between,
and other, you know, health care
Big Pharma. Now, there's a
health agencies and big tech
one of these guys, of course.
few. So if you go to the Google
Califf is, you know, more or
of it. But as you note in your
to Google Health and its
chief health officers, a lady
formerly the National
Information Technology, and
in the Obama administration. And
then we have Dr. Michael Howell,
Clinical Officer and Deputy
adviser to the Centers for
the newest hires at Google
Patel, who's Senior Director of
and I guess the relationship
was, he'd been at the FDA for
most recently as the FDA is
global strategy and innovation.
but of course, probably the most
be Califf. So as I mentioned in
at the FDA during the Obama
joined Google. So I guess maybe
about his time at Google and why
Sure. So he'll have served
between the years of 2016 and
stent under the Obama
time, the 21st Century Cures Act
important piece of legislation
you know, very new breakthrough
waiver of informed consent for
passed during his time there.
when he went back to do for a
Duke Forge. But in 2019, he
their their head of like health
time, he headed project
basically,
you know, huge mega trial. Along
he's already very interested in
NS projects at Duke, including
initiative, and clinical CTTI,
Transformation Initiative, where
infrastructure, passively
including electronic health
fairly, was kind of a
private company, who he said has
which is what he is on, on
He wants as much money as he can
what he actually wants. So
people to join these studies,
proprietary watch, that is by
you know, biometric data back to
studied a number of things,
and how that relates to overall
impacts of daylight savings time
well being based, they studied a
know, that I don't think really,
results, while they are posted
results are not posted there. So
were. But they also study things
basically their their whole
and collect data, because on the
their studies, because their
They said, we already have
time to map human health and
her.
Yikes. Yeah. So they've
contract with like intelligence
they can, you know, like drone
Right. And so now we got them
Well, that's fun. Okay, so one
as a major theme in your article
specifically about bailiff. So
a name for himself with this,
in the mid 90s. But since then,
revolutionize clinical trials
so a lot of the stuff you've
baseline, I'd like to get in
those specific initiatives like
mentioned a little bit later in
just wanted to bring up that you
of key lifts career,
and this current stint as FDA
it quote, tireless tirelessly
removing the obstacles facing
know, since the four IR is a
who Califf is why he was
administration to be in this
of time, it's all very important
Right. So if it's cool with you,
people who may not know what the
what are qlf stated views about
some of his roles in at the FDA
promoting these policies?
Sure. One of his greatest
is convincing them President
Industrial Revolution was real
important. So he's very, he's
that it is important, he thinks
basically what the whole concept
eventually, our minds will
technology, and the internet by
the brainchild of Klaus Schwab
So, you know, the whole idea of
is to gather as much data
people or the environment, via
health records, insurance
your car, your social media to
self. They'd like to merge your
self into one thing, so totally
he cites Klaus Schwab and the
book that he wrote in his
talks about it frequently in
Yes, that's really his
been, he's stated that he's gone
Forum, and I'm sure he, you
acolytes there.
He's openly said that lead
and was like, Wow, these guys
video, I saw him where he's
series. I mean, he talks very
stuff. And in the web itself.
the piece, some of the stuff
follows the web's favorite
partnership, so he seems very
stuff. And what's particularly
of these for IR technology, so
described, it's something that's
healthcare, right? It's supposed
society, society itself changed
human, and all other sorts of
be going to get sort of this,
is through healthcare. And you
few years ago, that particular
going way back to the, you know,
Eric Schmidt led national
artificial intelligence, of
longtime head of Google. And
that the best way to get AI mass
was to have it sort of
policy. And they essentially
security imperative. And so on
have big tech, and you have the
know, mainly the military and
this is their, their view, you
really in the United States
security imperative to have
of technologies implemented into
a way of having them spread
frame this as, as you know,
supremacy and hegemony that
if we don't surpass China in
these types of technologies. But
really want to believe it take
their word, you know, that this
long standing agendas of theirs
of mass surveillance and things
that's, that's up to you, and
opinion about that. But it seems
and more, you know, even bigger
of Google and all of this, it's
more people should be paying
So one interesting thing that
about Robert Califf, and you
bit that He was the founding
Research Institute, which
FDA, but it sort of saw him
he was at Duke, where I believe
his academic career. And this is
the stuff that he's overseen
FDA and overtly with Google as
little more, you know, maybe a
Clinical Research Institute, he
that you mentioned early,
Transformation Initiative? Yeah,
mean, they're, they both run
gold standard for clinical
trial. So they're looking for
though, to do a randomized
money, you have to hire staff,
recruit participants, you have
intervention, or the placebo,
tracking all the information
have to have people enter that
correct. And have like an actual
and from and compensate them for
time and cost a lot of money. So
and from writings that he and
know, real world evidence
in place of randomized
cuts down on cost significantly,
definitely get it done a little
have a pool of people whose
have access to, for instance,
data, electronic health records,
don't need to bother recruiting
to wait for that information to
risk trials that you again, you
those anymore, thanks to the
passed in 2016. So you can get a
more cheaply. If you use
says siloed siloed, and not
research institute and the ctci
those those data to be on siloed
shareable. And also to advocate
data instead of the randomized
and that traditional sort of
So let's talk a little bit
know, the average person that
know, research these kinds of
the way basically the way that
been conducted. Pretty much in
era, right? This initiative was
those trials with this real
And you have a really helpful
data and real real world
you know, that you wrote in some
you provide in the piece. But
it reminds me a lot of sort of,
policy paper, I think from 2018,
essentially all these different
there's really like this
about you and so what's what's
you know, it has, like, you
right, and all these different
are coming off, you know, from
to be used to replace a clinical
effectiveness of, of drugs. or
machine interfaces, you know,
has stuff like, you know,
expect, right? Like electronic
pharmaceutical data, like what
then the wearable stuff. But it
data, which is your buying
right, but also, social media
interacting with, what you're
information you're reading, and
the context of something I'd
which is Robert K lifts mission
role in pre empting and
is, which is interesting there.
data, this monitoring of stuff
in existing randomized clinical
media data, and just sort of
people without their consent,
randomized clinical trials, is
in this, you know, the people
of the FDA obviously knew that
of initiatives, and that he was,
create the regulatory, I guess,
it a regulatory loophole, but
alteration of the existing
just replace it so that all of
revolution, technology can be
for mass implementation, mass
doesn't necessarily have to use
it any safety, any effectiveness
don't know, your thoughts on
Um, I mean, it, the problem
whether or not the information
bad. They're trying to come up
don't think that that's really
that Kailis has, you know, he
Google Talks, then it's on
way, or at least one of the ways
things go wrong is if they
that's when we'll know how to
is if there's like, a massive
situation that occurs, as he
gone in the past. But, you know,
trials where, you know, over
done, that's, I don't know if
really makes sense there. So in
that these real world evidence
supersede randomized control
they are using them to fast
medications and devices, at
phase two trials. And they're
post market studies as well. So
when medical devices or drugs
them, I think they're still
trial. But they're, you know,
implementing and using this as
costs and getting those things
possible. And another thing too,
that I, he uses a lot of
important and necessary so that
made available to the public, as
that's kind of the the pill that
alongside the current near
alleges will be occurring, and
people need these life saving
them in five to seven years. But
consumer to adopt all the risk
Well, we heard this with
like a change of the regulatory
we need to get this out faster.
on the timeline that's
have to change how trials are
noted, in my work, and other
lot of these companies like
get a product to market under
paradigm. And so the emergency
these, you know, emergency
totally change how a lot of
were conducted. And, you know,
professed sense of urgency,
you know, the risk is being
receives, you know, the vaccine,
FDA saying, Yeah, we can say,
was safe, right, but, you know,
reflected by the trials, and it
you know, what you're seeing
the justification and also cost
troubling stuff. And I may have
is that um, so in your piece,
transformation, clinical trial
you said it seeks to do is to
of evidence generated by RCTs.
Califf is doing now at the FDA
trying to replace, you know,
trials entirely. But when it
like novel devices, not
vaccines, and like
more traditional, like pills
injections and stuff, it seems
devices, whether they're
really also are sort of being
paradigm, this idea of like the
necessary to physically monitor
basically use the data that's
with these devices and the
essentially replacing
that seems sort of like a way of
traditional metrics for these
course, those devices are
for IR really rolling in the
Particularly with the, you know,
some of these neuromodulation
system of the human body
Right?
What what's funny about that
devices designation given by the
for devices that are or to treat
irreversible diseases, which,
computer interface, sure, you
our brain computer interface can
blind see, or the, you know,
functioning sides of their body.
will be applied for many, many
me that companies like Black
and neuralink, etcetera, are
that their brain computer
life threatening and in or
to get get their stuff through
that at FDA so that it can be
know, disregarding all the other
and it will most likely be used
they're, what their primary aim
So even though you mentioned
device designation, technically
these devices that are like for,
know, diseases, terminal
like that. It's being given to a
under these metrics. So a recent
designation was given to this
very much you know, it's
Oh, and it received that
at home depression treatment
basically well in the picture in
basically like a electrodes you
beanie thing over your head. And
guess, certain parts of the
depressed, right. But there's a
depression, right? And
as opposed to be for conditions
treatments, you know? So, this
of the FDA sort of applying this
doesn't really need to be given
look at this example, and a few
that the current FDA modus
brand, As it relates to this
to just sort of be giving it to
some of these four IR related
neuromodulation stuff
them onto the market as quickly
benefit of consumers. But, you
special designations, you're
the, you know, the regulations
requirements that, you know,
complete, you know, competitors
particular designation.
Yeah, right. I mean, what's
designation also allows for
it de novo. So there's no you
there's not any legally marketed
like it. As far as I know, Suma
saw other sort of beanie
devices a lot like it. So maybe
space. My My initial thought
the head cap and the electrodes,
tried electro thought shock
that it didn't really work too
little bit weird. And not it was
understand that it's a little
doesn't seem to be too original
I see, yes, they use a technique
current stimulation we really
are a few different definitions
they're mostly that the
society defines it as the
through the targeted direct
electric or chemical agents at
of companies that are looking at
what does that nerve called,
nerve that that originates at
autonomic nervous system. And
Parkinson's to stop the hand
of people looking at that for
to use it for rheumatoid
that. So one of the
neuromodulation of that
I guess, the spleen at nerve is
Galvani bioelectronics, which is
context of Robert Califf,
GlaxoSmithKline. And verily,
subsidiary that Robert Califf
years. And they're one of the
think they've already started
they have a lot of ambitions for
which is basically to alter how
whether it's targeting specific
groups of nerves, or the entire
ambition there. And of course,
behind project baseline, which
earlier. And I think not enough
this. And it's a really crazy
So, um, there's this one,
been written on baseline, you
So one summary offered here and
on already and what you've
verily baseline Health Study
around the same time that Califf
health strategist, right. It was
of mapping human health by
of sources, including self
wearable recorded data, or
records. And as you mentioned
Cures Act, some of that recorded
that data can be obtained
Anyway, so it says essentially,
health study, and the broader
about changing. Again, how
So I first heard about Project
because they were using it
bunch of weird stuff was going
including having people forcing
and the San Francisco area which
government there, or had
do this, and they were requiring
basically link their test
And if they didn't have a Google
order to participate, which is
what it sounds like to me is
trying to gather an insane
all different types of purposes.
say, is to collect comprehensive
of better understanding health
And it's important to keep in
has been going on and when this
Pentagon and Google teamed up
health care thing. So basically,
these, this massive cachet that
veteran and military health
things like that, to train AI so
predictive cancer diagnoses. So
well, we've decided that you'll
but you don't actually have
this sort of, you know, what
Ryan Christian are sort of
paradigm applied to healthcare.
told that you're going to
some of these different devices
accumulation, and they're going
you what you're likely to
and then go and offer you all
therapeutics, whether it's stuff
gene therapy, or, you know,
or wearables are stuff that
nervous system, or changes how
stuff, even though at that
actually need it, it's being
And this is, again, Google with
have them of course, doing it,
different guises. But
per them about health care.
more than that, if you asked me,
yeah. And Kayla's. In an
sort of, you know, influence
regards to their health is, you
already happening. And it's been
you know, private market
your computer and tracking what
you might be interested in
to you. So he's just in he
necessarily good. It's not
need, or make them have a happy
saying is, well, that's bad when
we're trying to help people live
going to track you and just the
you and influence you in just
delivering those drugs and those
actually you need, right, and
need them because we have all
evidence that we found and tell
your life before you are even
about it. But like you said it
thinks that it's totally fine.
bad guys. And the bad guys are
and food and stuff like that.
sell you pharmaceutical, drugs
Yeah, crazy. So. So in your
about the Cures Act, you sort of
and getting that certain aspects
in place, you know, involved in
lobbying process for this
it interesting, too, that rolled
like the BRAIN Initiative, and
Initiative, which, you know, is
Biden's recent creation of ARPA
around to the Trump
Harper. And we're basically a
and I actually did a podcast a
guys behind the BRAIN Initiative
where I live down in South
Chile to be the first country to
called neuro writes. This idea
individuality and so Out of this
interfaces, and all of this are,
essentially, you know what I
being in that particular
framed as protecting you from
could do to you. Making you lose
things, is really about creating
public justifications to get
market, not necessarily for
also for commercial purposes.
like neuro link and stuff, you
saying and I guess Syncron, to
firms doing the same thing, you
framing this as Oh, this is a
that are paralyzed, walk, and,
all of that, but at the same
like, pretty open, that neuro
used for commercial purposes,
video games and stuff. And you
trials, they promoted were like
implant playing video games with
paralyzed monkeys walking again,
seems, you know, a bit different
sold.
Sure. I think, you know, for
the only, there's a difference
And you can, you know, postulate
help people walk or see or
evidence of that, at least as
and video footage and things
evidence for that actually
able to be accomplished is that
you're a total, if you're 100%,
to move your hands or interface
they say, quote, unquote, simply
have medical application, you
people who are paralyzed, sure,
it for that? So it's just to
these sort of fast tracks to
competition and kind of
as you can. Which is, I would
further ahead than than anybody
to be what it's actually for.
know, the brain computer
just not enough evidence out
actually going to help people
know, the ever irreversibly
life threatening diseases. There
things called like neuro neuro
it is. They have this brain
with an exoskeleton that helps
had a stroke, move the hand,
makes more sense. But yeah, it
these things on the market as
guise of helping people as
Yeah. And what I mentioned
know, ulterior motive coming
national security state and
to get the stuff out there on
possible because they see it as
China. Right. Which is also
key point I want to make here
familiar with, you know, my
analysis of statements made by
Economic Forum and big you know,
Noah Harare, who basically say
paradigm, like getting wearables
that will, you know, result in
digital dictatorships, you know,
what's going on not just inside
And I think this is all kind of
at the big players here in the
mass surveillance is also, you
effort to launch a war on
everybody and sort of usher in
after 911 with things like DARPA
and stuff. So you know, you have
Palantir, which is basically you
essentially a CIA front that is
awareness, privatized and so
and has been running a lot of
other health data held by HHS
Basically, all NHS data is being
then you have Google having this
host the FDA is my studies
and they have for some time, and
know, this revolving door, like
between the, the regulatory
is being used for a lot of these
these, you know, more novel
neuromodulation devices on the
you know, in person monitoring
electronically conducted fully
they're teamed up with the
sorts of crazy stuff going on
overlap is interesting in the
know, misinformation trying to
what's deemed as misinformation
also is, you know, one of the
war on domestic terror, because
since he came in to art it's
year about the need for the FDA
debunk misinformation, which is
their efforts on that front have
spreading the misinformation,
ivermectin is not like, able to
it's like a horse and cow
regardless of what you think
treatment of COVID, or whatever,
was being used in people. So to
to warmer exclusively, like had
accurate. And the FDA obviously
interesting that you'd have you
big players in the healthcare
more tied up with the FDA. And
misinformation, crackdown and
misinformation as well. And I
might want to see that there's
Because once you're surveilling
guise of healthcare, or under
terrorism, I mean, ultimately, I
essentially. And I've also kind
work on, on the creation of ARPA
administration, which sort of
stuff you were talking about
I mean, essentially, that's also
wearables for this, you know,
precision health paradigm and
it may be it's being framed as
health. But ultimately, it seems
about an insane paradigm of mass
trying to see what sort of
it, you know, what sticks and
believe and need to feel in
of technology on and in their
Yeah, I think that's the
you know, well, Klaus Schwab.
are as true believers, they
our personal and digital selves,
it's really about the last
right, and also, including
somehow be able to predict, and
government, at least for a long
artificial artificial models of
to predict how military
the certain release of
created a computer generated
to the finest detail possible,
future. And really, they need a
how people think. And I think
the mind is really the last
capitalism and in any in
control. So that seems to be to
people's physical and digital
frame it as that's something
inevitably, the private market
are kind of already doing that
know, whether or not that would
another question, but they're
And as far as, as far as the
why I think artificial
you know, considered to be an
the US you know, and They're
of information, that's a lot of
through all of that and assign
efficiency. So you need to apply
algorithm or an artificial
what you're looking for, or to
might, you might be looking for.
Patriot Act, and the NSA goes
their policies were to have a
know, depersonalized information
and look through it. Because a
through the information to find
cause to fill it further. But
artificial intelligence do that,
essentially, what is what at
the probable outcome is that
positives, many more flags, and
cause to look into people even
up to the fullest extent, then
going to be many more patterns,
patterns. What is that? Who's
intelligence, intelligence
consider to be a pattern of, you
anything that would warrant
and something that I read
Gabriel and the artificial
software that's being applied
and sound. So it's certainly in
something that is possible,
readable format, in text or
Well, thanks for that really
really complex issues and how it
a lot of what you know, we're
pay a lot more attention to the
people who were opposed to stuff
Revolution, and its encroachment
and really society in general,
trying to get a huge foot in the
would argue, and I actually have
interviews I've done over the
the FDA right now explicitly for
in your piece, he's there to
from this for IR paradigm for
of in through the healthcare
point man for that. So I think
more scrutiny. And that's why I
about him. And very happy to
him. And these, you know, more
podcast. So thanks so much for
people follow your work, and
So you can follow it on the
which is Te L A
where most stuff is. I also post
which is James journeys blog
contributes, and stuff like
main two sources, you can
And, and you can follow me on
If you just search she'll find
All right, super. Well,
coming on. Really appreciate
issues. And I'm looking forward
here in the future. And thanks
this podcast, and hopefully some
time to look into some of these
they really, you know, as I
there is a extreme lack of
lift, but a lot of the issues we
ignore this kind of stuff at our
there's a lot to dig into. And
scratched the surface about a
of course, as always, a big
supporters who make this podcast
work possible as well couldn't
thanks so much. And thanks, of
regularly listens and shares
you all as well. So thanks so
catch you on the next episode.