and it’s about the covid-19 vaccine and
some of the harms due to the vaccine
it’s the largest observational analysis
of 99 million people and it’s entitled
covid-19 vaccines and Adverse Events of
special interest a Multinational Global
vaccine Data Network cohort study of 99
million individuals they like to put the
99 million in the title so they can try
to get accepted in a good journal and
they actually did this time and this
paper shows very concerning safety
signals across a number of domains
including myocarditis paric carditis ITP
gomar syndrome Bell’s paly ADM pulmonary
embolism fbal seizures and more I’m
going to talk about those concerning
safety signals seen in this paper but I
want to talk more broadly about what the
paper shows and why it is so unnerving
because I think it suggests rather
strongly that there were safety signals
that have been ignored and underexplored
and that in many populations
particularly young people particularly
people who had already had and recovered
of covid-19 and for many additional
doses Beyond dose 2 plus 3+ 4 plus 5
plus it is quite likely in some cases
you can easily show for instance young
men between the ages of 16 and 24 but in
other cases it’s probably quite likely
that the harms outweigh the benefits for
vaccination in that age group and that
means that the mandates in those age
groups are deeply morally problematic
they’re scientifically problematic and
they bankrupt trust in public health one
more bit of background before I get into
this page paper is that just in the last
2 weeks Astra zenica has announced that
they’re going to Cease the production of
their covid-19 vaccine the adenoviral
vector vaccine both the Johnson and
Johnson and astrazenica vaccine are
adenoviral vaccines with a very large
DNA payad and one of the problems that
these vaccines had was vaccine induced
thrombocytopenia and thrombosis or vit
which is a lot like Hein induced thomy
and thrombosis or hit this isn’t just
your typical blood cloth this was
Runaway
activation that cannot be easily turned
off leading to catastrophic thrombotic
events in places you don’t want them to
happen including the cerebral Venus
Sinus I remember when I heard about vid
I think it was in 2021 and I realized
that this complication was first
reported in women between the ages of 18
and 64 and it was occurring at a rate in
the initial reports of 1 in 200,000 I
think some subsequent reports have
brought it as frequent as 1 in 140,000
and I tweeted very early on you can go
check the rec that that was game over
for this vaccine that safety signal was
so catastrophic basically in some cases
leading to the death of the person or
brain herniation or neurological
Devastation that’s so horrific and
you’re debuting it in a population like
an 18-year-old woman that has a very
lowrisk of bad covid-19 outcomes that
even a modest harm like that is going to
be a huge setback for your vaccine
particularly when there was another
vaccine product that didn’t have that
complication which is the MRA vaccines
so I I called it game over back then it
took them a few years but finally
Johnson and Johnson has thrown in the
towel not only on that vaccine but on
the entire process of drug development
around the adov vector vaccines and more
broadly and Astro zenica is thrown in
the towel so that is an
admission that perhaps governments were
too zealous and didn’t Target this
intervention in the appropriate cohorts
of elderly people who had not previously
had covid-19 let’s talk about the new
paper and vaccine this is done by a
large multinational group and this
concerning safety signals so maybe let
me run through you some of those signals
there’s at least three tables I need to
make a note of this minute three three
tables I got to put the slide in later
in the postproduction three tables that
you need to look at okay one table looks
at the odds ratio so so basically what
are they doing in this they got 99
million people and they’ve got the
records of their vaccination and they’re
pretty good about when they were
vaccinated they also have electronic
health records for what happened to them
afterwards and you know whether or not
the electronic health record documents
one of several I think they looked at
about 30 or 40 different Adverse Events
of Interest things that they thought
might be implicated with the vaccine and
they looked at those 30 or 40 events and
what they’re doing is they’re comparing
the rate of those events prior to
vaccination to the rate immediately
after vaccination looking at if there’s
an increase in these Adverse Events
after vaccination in the electronic
health
record what they find is that for some
things there is for the cadx vaccine
which is an adro Vector vaccine they
find uh guon baret syndrome is increased
that’s noted in red anything in yellow
and red on the screen is going to be
something that is statistically
significant increase in an Adverse
Events uh transverse myelitis which is
basically a paralytic syndrome is also
increased Bell’s paly has increased for
a number of these including the fiser
and the Mna vaccine uh acute
disseminated encom mylitis ADM which is
a catastrophic side effect is increased
for these vaccines um fbal seizures are
increased uh in
different uh for different products you
can look at the table and you can see
where it’s yellow statistically
significant increase and where it’s red
statistically significant increase and
the odds ratio is quite notable I forget
the cut off here something like two or
three they also look at hematologic
conditions and what they find is yes
it’s linked to thrombocytopenia low
platelets idiopathic thrombocytopenia
ITP um I think this confirms an
observation many people had anecdotally
made that our patients with ITP or our
patients developed ITP at slightly
higher rates after vaccination
than they would otherwise have this is
sort of confirming that that observation
that’s been made by many doctors
pulmonary embolism appears to be
increased Cal Venus sinus thrombosis
which is the vit the vaccine induced
thrombocytopenia thrombosis syndrome and
splenic vein thrombosis also appears
increased and then finally across the
board the MRNA vaccines are causing
heart damage seen in the form of
myocarditis you actually see concerning
safety signals even for the adenoviral
vector vaccines but for things like
fizer and Mna they’re off the charts bad
and this confirms what we had already
known all right what are my thoughts on
this paper this paper’s an underestimate
of the problem okay there a number of
ways it’s a deep underestimate and let
me give you a couple examples one is
they know very well who got vaccinated
but they may be missing people who
suffered these complications for a
number of reasons for instance a lot of
people might have had thrombocytopenia
at low platelets but they had no petii
no bruising no bleeding they had no
symptoms that would prompt them to seek
care for those low platelets so they
just had low platelets they were lucky
they didn’t you know get in a car
accident or something like that they
didn’t suffer a a problem from that but
they probably had it that’s not going to
be the electronic Healthcare record cuz
they never sought care another way it
may not be in the electronic healthc
care record is that a young person may
come in with abdominal pain and it might
be a blood clot in the abdominal uh
vessels but for the doctor to think
about that and to run a CT with contrast
or CT angiogram to catch that the doctor
has to have that thought in the back of
in mind the doctor’s preest probability
the doctor’s thinking is that this young
person with abdominal pain that tends
not to be a blood clot in one of these
arteries and so they may not be willing
to run those scans they may be missing a
lot of these events and the last reason
it’s underestimate is the electronic
health record is a piece of I mean
I think anyone who’s actually done EHR
research will acknowledge that this is
really an incomplete an incomplete set
of what actually exists in the chart
would actually happen to people for
these reasons I suspect that this is an
under estimate of the extent of the
problem and that if we were to have
complete case ascertainment we would
have a higher estimate for a number of
these a number of these things now it’s
also possible that some of these things
will are are actually not linked and
they would not survive more robust
analyses I think that’s possible too my
intuition my suspicion and the based on
my analysis of how biases exist in the
data set is that there’s probably going
to be a bigger problem the other
direction where some things are found to
be at higher rates than what is depicted
in this paper the next thing that’s a
problem in this paper that I think
they’re really kind of cheating on is
that we know that these Adverse Events
don’t affect all populations equally if
you look at all the people who got the
MRNA vaccines and you look at all the
people who had myocarditis you’ll find
the rates are actually quite low
myocarditis is not that common well
that’s because 80y olds and 60y olds
don’t get myocarditis after the MRNA
vaccines it happens to young men
typically between the ages of 16 and 24
it happens also at high rate from 12 to
40 but slightly less the core
demographic group of men at the end of
adolescence and in early adulthood this
has also been seen before when it comes
to myartis after you know respiratory
infections
Etc if your denominator is everybody
you’re not going to see the safety
signal in the group of people you want
to see it even though they’re using an
everybody denominator they’re still
finding odds ratios of 3.48 and 2.78
concerning safety signals imagine if
they just focused on young men you might
find not only is the problem tfold
higher it might be hundredfold higher
and I think we know very clearly from
the the Israeli study that myocarditis
in the first two doses from the fizer
product is something about 1 in 3,000 1
in 3500 and we know from Katy Sharp’s
paper from the Kaiser Permanente
experience that from dose 3 is one in
10,000 if you have a one in 10,000 risk
of myocarditis from dose three of this
vaccine then a young man was harmed by
getting dose three end of story they’
had already had two doses they may have
already had covid-19 their risk of bad
Co outcomes after having had two doses
was floored and the risk of myocarditis
is probably in order of itude greater
than the risk of a bad Co outcome after
the first two doses so by giving them
each additional dose you’re subjecting
them to net harm which was in fact
sanctioned by public health and
implemented and forced in the form of
mandates so what I think is this is a
deeply problematic look at the safety
literature because it doesn’t take much
harm to realize that the public health
apparatus actually coerced and forced
people under penalty of being fired or
thrown out of school to receive dose
after dose even if that dose was at net
harm to them
I think the same thing is true for ITP
I’d love to see that broken up by age
I’d love to see um you know Ser venosus
thrombosis obviously broken up by age
because if an 18-year-old is getting
cereal Venus sinus thrombosis even at a
rate of 1 in 200,000 that’s enough to
tank any potential benefit of the
vaccine in that age group because their
risk of hospitalization or death was
already very very low particularly if
they’re a healthy 18-year-old you know
so these papers in my mind are always
dishonest because they don’t break apart
the risk benefit calculus in each age
group one more Point sometimes people
say that no matter what Adverse Events
you find from vaccination the covid-19
is always worse that’s a pretty stupid
thing to say and here’s why it’s a
stupid thing to say if you look at the
papers that make that claim here’s what
they look at they look at among people
who went to the doctor and had a
covid-19 positive test how many of them
had myocarditis how many of them had
severe disease how many of them got sick
so the rate of myartis is among those
people we’ve documented covid-19 in X
number of people had myocarditis and you
compare that among the people who got
the shot X number of people had
myocarditis but the problem is the
denominator for the shot is the real
denominator you know who got it but the
denominator of people who came to you
and tested positive for covid-19 is not
the real denominator the real
denominators all the people who had
covid-19 the vast majority of which one
didn’t even know they had it two they
felt a little tickle in their throat
they didn’t even test themselves three
they felt sick at home with a cold and
they did nothing about it four they
tested themselves at home but they
didn’t tell you the test result and then
five got so sick so concerned that they
sought medical care and that’s the
denominator you’re focusing on you’re
looking at Adverse Events in a subgroup
of people probably the sickest and
probably those at most at risk of these
Adverse Events and then you’re comparing
that against vaccination absolutely
brain dead epidemiology you need to do a
Sero prevalence study to actually survey
the population see how many people
actually had Co and use that as your
real denominator if you actually cared
about doing honest science which I have
not yet seen we’re doing an empirical
analysis on this that’s a spoiler don’t
steal my idea anyone listening to this
we’re going to publish a paper on this
I’ve not seen anyone do it right yet I’m
going to look at every single paper and
I’ll tell you how many did it right but
I don’t think many of them are going to
do it right they’re not doing it right
the next problem with that argument is
that the vaccine doesn’t stop you from
getting covid-19 anyway so if there is a
harm of myocarditis from getting
covid-19 you don’t avoid getting
covid-19 even if you get nine doses
you’re still going to get co9 it might
be less of a harm of getting covid-19 if
you’ve had two doses than no doses at
all so we could Quant ify that but it’s
certainly not vaccine or infection it’s
as many vaccines as you want and then
infection okay so infection always comes
always comes those are two of the big
reasons why I think that there’s some
dishonesty in this literature and then
the other reason when we talk about
young populations we talk about
six-month-old babies 2-year-olds 5-year
olds 11 year olds we have to acknowledge
there’s no evidence of efficacy that’s
worth its salt we’ve got very flawed
case control studies where the controls
are fundamentally sampled from a
different population than the cases and
That’s a classic problem in case control
literature we also have observational
studies that are plagued with numerous
biases that on my substack I’m going to
cover more in in the next few weeks
because I think it’s really good to
teach epidemiology with I read a really
great article by Peter Doshi he talks
about some of those biases I’m going to
talk about that more in my substack
that’s what you should go subscribe to
because that’s where I talked about this
initially so putting it all together we
see concerning safety signals for ITP
and thrombocytopenia meaning that this
vaccine can lower your platelet so that
establish that I think as a biological
fact I think that goes hand inand with a
lot of evidence we see febal seizures
that’s a problem myartis pericarditis
racing heart super ventricular teoc
cardia Bell’s paly PE ADM and more does
it mean that every age group derive net
harm I think that’s that’s not the case
I I don’t believe that’s the case I
think there’s a lot of reasons why
that’s probably not the case elderly
2021 or in the Delta wave of 2020 were
so bad that they probably still derived
net benefit for instance a nursing home
resident but does it mean that a young
man derived net harm absolutely I think
that’s been shown over and over we first
showed that in an article that I wrote
in Med page we urge the CDC to do
something about it we later published
that a paper by Kevin bardos where we
show that for boosters Public Health has
to be careful it’s not good enough to
sometimes do good and then sometimes
harm people using the Brute Force Power
of mandates you have to never harm
people using the Brute Force Power of
mandates you can never make that error
that’s an unforgivable error and it’s
unforgivable to use the Brute Force
Power of mandates when you don’t and you
haven’t proven benefit to third parties
that’s Contra that’s contrary to I think
traditional medical ethics and that’s
contrary to basic principles of of
Medical Science and so I think that
that’s a big problem putting this all
together I think this is concerning
safety signals this is a big population
study if anything I think for many of
them there’s an underestimate for the
reasons I’ve described I think comparing
it V virus vers vaccine is a flawed
comparison because they’re doing a
dishonest job they’re not doing Sero
prevalence denominator for the virus it
is almost certainly it is 100% the case
that young men were harmed in that age
group from dose two and Beyond easily
that’s easy to show uh it’s very likely
the case that many other demographics
particularly young healthy people were
harmed and suffered net harm from
aggressive vaccination campaigns the
lesson of the story is they could have
done a much better job if you want to
know how you should listen to my
forthcoming interview on econ talk with
Russ Roberts uh where I get into the
sorts of randomized control trials that
they ought to have done instead that
would have risk stratified by age and
had more appropriate and harder end
points and longer followup in younger
age groups those are some strategies
I’ll describe there they could have done
a better job Public Health getting this
wrong is a catastrophic error I think
that people in public health are
unwilling to admit they did it they did
wrong they’re unwilling to admit that
they used propaganda and other
bruteforce tactics including pressuring
places like YouTube and Twitter and
Facebook to remove content they’re
unwilling to admit they did all this and
they got it wrong and until they admit a
full admission of the errors that they
have made I think that the loss of trust
is just going to continue to grow we
already see signs of it I mean we
absolutely plummeting um trust ratings
and experts and we actually see
plummeting routine childhood
immunization rates as a CDC uh gets even
more bold and Reckless adding and I told
him not to you can read my article in
the Free Press run by Barry Weiss I told
told them not to add the covid-19
vaccine to routine childhood
immunization that’s going to result in
all of the childhood vaccines being uh
pushed aside and that’s in fact what
we’re seeing right now so those are my
thoughts it’s a very interesting paper
in vaccine I think it underestimates the
the problem here one more point the
author of this paper turned to Twitter
to say that my substack post had one
inaccuracy and this person or a couple
inaccuracies she thinks one of the
inaccuracies she said was that it has
been well shown that covid-19 vaccines
have an improvement in outcomes for
children that’s been well shown and then
she cites a metanalysis of a pile of
garbage which is a bunch of case control
studies and observational studies and
zero randomized control trials that are
powered for severe end points that to me
is a problem when the authors of the
safety signal Studies have their own
bias that they’re unwilling to concede
that the evidence is quite poor for AE
low age groups and that there is very
little risk in low age groups if they’re
unwilling to concede that I worry that
they’re easily able to lump age group
groups and do other things to distort
safety signals and minimize these clear
and concerning problems and then the
last thing I’d say is there’s a strong
political pressure in the scientific
Community not to investigate these
safety signals I think many people think
it’s career suicide or taboo and that is
also stifling to science and so I think
if anything the problem is worse than
what’s Stone in this paper which appears
in the journal vaccine a good journal
and is an interesting paper well done in
many respects despite the limitations
all right if you like this video you
know what to do I like to talk about all
sorts of evidence-based medicine across
all domains from Cardiology I did a
couple of randomized Trials there
including um for the impella oncology
which is of course my favorite thing to
look into the evidence of of course the
the most randomized control trials the
most interesting design features and
observational studies which mostly are
garbage and occasionally can be useful
but mostly are garbage and hyped here
there are some kernels of usefulness
here despite the the biases here so if
you like this video you know what to do
if you like this kind of analysis you
know what to do subscribe to this
Channel follow me at V prasad’s
observations and thoughts which is
drveni pad.com uh on substack I also am
a writer for sensible medicine I have my
podcast called plenary session and we’re
back the vpz show we’re putting those
episodes out and I hope to put out some
more and um that’s it for now until next
time
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