December 2, 2025 • 24 mins
In this episode of Wellness Unmasked, Dr. Nicole Saphier opens up about her personal “December Reset,” sharing how she’s prioritizing both physical and mental health by ramping up her workouts and stepping back from social media. The episode then turns to a newly leaked FDA memo suggesting potential links between COVID-19 vaccines and pediatric deaths, sparking renewed debate over vaccine safety and data transparency. Dr. Saphier explains why rigorous, honest safety reviews are essential—especially when it comes to recommendations for children—and highlights what parents should know moving forward. Wellness Unmasked is part of the Clay Travis & Buck Sexton Podcast Network - new episodes debut every Tuesday & Friday.
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Episode Transcript
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Speaker 1 (00:04):
Hello everyone, Welcome to Wellness on Mass. I'm doctor mpul
Sapphire and I'm sitting down this morning doing this podcast
heading my morning cup of coffee because it is like
a wintry snowy mix outside, so it's like a delayed
opening for the kids' school, so it's a little bit
of a late start today. So let's have our coffee together,
shall we. Big news is now December second, and I
(00:25):
have decided to do a personal challenge for December. Well
I'm taking a sip big personal challenge for December. You know,
we all wait until January to come up with like
our New Year's resolutions. What are we going to do?
How are we going to get in shape? How are
we going to be a better version of ourselves in
the new year. I decided I want to do it
in December this year. So here's what I'm doing. So
(00:46):
for December, starting yesterday, I'm increasing the amount of workouts
I do. So my goal is to do twenty workouts
in December. Now, I know for people who work out
five six times a week, that doesn't sound like a
lot twenty workouts in a month, But when you have
holiday parties, you have Christmas and Hanukkah and all this
stuff at the kids' school. December can be very busy
(01:07):
and one of the first things to go are the workout.
So by having a little checklist making sure that I'm
getting twenty for the month, that's how I'm focusing on
my physical health. I'm also taking a bit of a
step back from social media. Ah, I know, how am
I going to do this? I'm not sure my voice
is going to come and go throughout this, but you
know it'll still be great. So I have decided I
(01:28):
want to get rid of social media from my phone
because it's so easy to just when you have a
couple minutes during the day, you just go on your
phone and you start scrolling, scrolling, scrolling. Well, do you
know that actually affects your brain chemistry. They do studies
looking at functional emerror and it shows activity in your
brain changes as you engage in social media. It also
(01:50):
elicits dopamine response, which is why if you do a
post and you get likes and comments and it's going
it's doing really well, that actually gives your brain reward
and that's why you feel good about it. But the
alternative is also true. If you do a post and
for whatever reason, people aren't seeing it, aren't liking it.
It causes negative emotions and feelings, which is why social
(02:13):
media use is linked to anxiety and depression and all
of these other things. So for my mental health heading
into the holiday season, I want to cut back. Now.
It's a little bit tricky to cut back on social
media when you have like a media presence. You know,
I go on TV, I'm doing this podcast, I have
a wellness company. All of these things I use social
(02:35):
media for so for business, but that doesn't mean that
it is still good for my mental health. So it's
not going to be black and white. I'm not completely
off of social media. In fact, you may be listening
to this podcast because I posted on social media, but
you're not going to see me as active on social
media as maybe I usually am. And that's just me
making a conscious effort to focus on more meaningful things
(02:57):
like real life personal in reactions, or you know, doing
more with my work because I actually find enjoyment in
my work, or focusing on other hobbies. I'm actually in
the process of writing a book right now. If I
have five minutes instead of doom scrolling on social media,
maybe I should be focusing on that book and so
some other things like that. So I'm heading into the
new year already focusing on my physical health, on my
(03:20):
mental health. So by the time New Year's resolution conversations
comes around, I don't have to be like, ah, crap,
what diet am I going to do this year? Nope,
because I'm already going to be feeling good mentally and physically.
So maybe for my twenty twenty six New Year's resolutions,
I can focus on bettering someone else, like what can
I do for other people? Because I've already spent December
(03:41):
focusing on myself, so that's my goal. I encourage everyone
to do it with me. Doesn't mean you have to
do the same things I'm doing, but maybe let's try
in December to get us to a good place so
that when we head into the holidays and we head
into our New Year's resolutions, we already are feeling pretty
good and so then we can focus on how can
we help others around us? So I know that sounded
(04:01):
like a lot of this topic, but that's not what
I want to get into today. On weilness unmass, if
you've been on social media, because that's where a lot
of this happens. You will see something pretty big happened
last Friday afternoon. Now, a lot of things get buried
in the news cycle when they occur on Friday afternoon,
but this one was pretty interesting and it's hit a
nerve with a lot of people, and to be honest,
(04:23):
it probably should. So there was a leaked FDA internal memo. Now,
whether or not it was actually leaked, I don't know.
I think it sounds like a pretty intentional leak. If
you send out a memo on a Friday afternoon, Friday
after Thanksgiving afternoon, you send it out to like over
one thousand people in an industry, do you really think
(04:47):
that that's going to stay internal Probably not. And if
you actually read this internal memo, it doesn't necessarily read
a something that was meant to stay internalized. So what
was this memo? Well, it was a memo from the
head of one of the interdepartmental agencies within the FDA
claiming that at least ten children deaths were likely linked
(05:11):
to the COVID vaccine through probably vaccine associated myocarditis. Although
they didn't necessarily come down by it, but what they
said was they looked at the ver's data, which VERS
is a public forum. It's an online thing that anyone
can go to. You can be a patient, you can
be a parent, you can be a doctor, you could
(05:31):
be a drug company. If you have a side effect
from a medication, a vaccine, you're able to input it
if you feel that the side effect is from that.
Now there's a huge caveat when you're looking at the
VERS data. So I can go on if I take
a medication and something happens to me in the next
couple of weeks or even a couple of months, and
I'm like, you know what it was? It was probably
(05:52):
that vaccine, I can go input that. Now other people
can read what I put down, and so they may
automatically think, oh my gosh, this person had this and
she said it was from this. But that's not necessarily true, right,
So just because I think it is doesn't mean it was.
Maybe I had an underlying viral infection that caused something.
The reality is this is just people inputting data, but
(06:14):
this is not verified data yet. So a couple of
months ago, people at the FDA said that they are
putting together a working group that they were actually going
to go through the ver's data. They are going to
actually look at those who said that they had side
effects from the COVID vaccine, and they wanted to look
at that and say were they really from the vaccine. Now,
the numbers that were in veirs, there were ninety six
(06:36):
supposed deaths from the COVID vaccine. That's how many were reported.
This internal memo says that they've gone through all of them,
and they say at least ten they believe are likely
linked to the COVID vaccine. So that's pretty big news.
And this memo, again, it comes from inside the FDA
(06:59):
Center for Biologics Evaluation and Research, which is essentially the
vaccine regulating arm of the agency. And so ten of
those deaths in children age seven to sixteen were considered
quote unquote likely or possibly related to mildcarditis after vaccination. Now,
on its face, that's obviously very serious, but I want
(07:21):
to take a pause before we jump to conclusions. This
memo itself is not pure reviewed. And while I think
it is incredibly important and excellent that they decided to
go through all of this bear's data, because there are
a lot of people out there who have been criticizing
COVID vaccines who have been saying that they have been
under reporting the safety data. And by the way, I'm
(07:41):
one of those people. I also think that they were
underreporting safety data when it came to the COVID vaccine.
So I was very happy to see that they were
doing a deep dive into the bear's data. But just
because they're now coming out saying, well, we looked at
it and we think at least ten of these deaths
are related, they did not, in this quote unquote leaked
to memo, they did not put forth any evidence as
(08:04):
to or any criterion as to why they believe those
ten deaths were linked to the vaccine. So what does
that do. Immediately, it's one opinion to another opinion. The
people who put the information into theirs, that's their opinion
that the death was related to the vaccine. Now we
have this internal memo where the FDA is saying, well,
(08:26):
we believe at least ten of these deaths are related.
That's another opinion. Because they didn't produce any data to
back up that opinion. So right now we have a statement,
but without the data needed to verify it, especially if
we want people to take it seriously. We already know
Trump Arrangement syndrome is a real entity in the sense
(08:47):
that anything that comes out of the current HHS, FDA
White House, anything that's associated with President Trump, Secretary Kennedy,
people are going to automatically reject just because of the
underlying bias that they whatever they do has to be wrong,
even if they're right. So if they're going to make
a statement like the vaccine, they're acknowledging that the vaccine
(09:09):
likely killed at least ten children, that's a heavy statement
to make without putting forth data, because immediately they're going
to be scrutinized by every academic, every media outlet. And
that's exactly what happened over the weekend. So this leaked
memo happened Friday afternoon. You had FDA Director Marty McCarey
(09:29):
was up right and early on Fox and Friends Saturday morning,
So that's again, memo came out Friday afternoon, media hit
Saturday morning, and it seemed very I mean, mcay does
a great job on TV, but he definitely had his
stocking points and so it did seem like some of
this was a little bit intentional, and he essentially said
something that he's been saying for the last year that
(09:50):
this new FDA is not going to be rubber stamping
vaccines just because it was approved in the past, just
because of the way things were done in the past,
They are not going to continue to to do this,
and they want rigorous safety data. I don't think anyone
can argue with that, although they're going to try. But
the problem that I have with the way that this
leaked memo rolled out was, again, it was a memo.
(10:13):
It's in the guise of it being now a leaked memo,
and there was no data to back it up. They
as far as we know, they're not. They haven't printed
it in a peer reviewed journal to show why they
believe that these deaths were linked, and so it's just
kind of out there, and when it's out there like that,
it kind of gets caught up in the weeds of
conspiracy theorists, even if they're right by the way. Again,
(10:34):
I personally believe that the Biden administration, the prior CDC,
the pharmaceutical companies were under representing safety signals when it
came to these COVID vackseats. Even Maderna in one of
their in their booster trial, a child died in that
booster trial. It took a while for them to actually
acknowledge it because they kept manipulating the data in such
(10:56):
that they didn't have to report that child's death. And
this is why pharmaceutical companies have a bad rap with
the American people, because they do such as this, but
goes both ways. You can't make a statement without having
data because if you just manipulate words to promulgate fear
and incite anger and other emotions without having the data,
(11:18):
you know, you're no better off. And that's where we're still.
That's where we're at right now. We have this leak
memo that was full of what at this point opinion
without data backing it up. And I think, you know,
it's just as harmful as the pharmaceutical companies who are
hiding some of the data. So, you know, going back
to when these vaccines rolled out, I just want to
tell you my own personal opinion, I mean, Operation Warp
(11:40):
Speed was probably one of the most incredible things that
I had ever seen, the fact that President Trump was
able to harness his business mindset to really work with researchers, academics,
and pharmaceutical companies to get a vaccine available. You know,
within a year. That's a huge deal, especially when you
look at how long it cakes for drugs to be research, manufactured,
(12:02):
and brought to market. It's like anywhere from seven to
ten years on average. And no, that's not because we
do such rigorous safety data. It's more because we have
a lot of red tape and bureaucratic bloat that prolongs that.
So President Trump was able to cut through a lot
of that. So when it rolled out and all of
the initial data that showed that, guess it was able
(12:22):
to incite an immune response, which is the ultimate goal
of vaccines. So in theory, that should decrease severity and
hopefully should stop transmission of the virus or at least
decrease it. Obviously, I don't need to rehash what happened.
So a lot of people got the vaccines, whether you're
mandated to or not, and we did see dramatic decrease
in hospitalizations and deaths. The current FDA director, doctor McCarey,
(12:46):
just this Saturday reconfirmed that when you look at the data,
especially in the early days of COVID, the vaccines were
directly linked to remarkable decrease in severity of illness, especially
in older populations and vulnerable populations, that's undisputed. Now, fast
forward to when they started expanding the vaccines for kids, teenagers,
(13:07):
young adults, kids zero through I don't know thirty. That's
when I started to say pump the brakes a little
bit because I had three kids ranging from elementary school
to college, and I had already seen them all have
COVID at that point, probably a couple times, to be honest,
and the overwhelming data told us that they were the
lowest risk for severe illness. One thing that was concerned
(13:28):
and kids was the misc that multi inflammatory syndrome and children,
which was essentially an autoimmune and an inflammatory response that
the body did in reaction to the virus, and that
was pretty bad in kids. Now, those inflammatory type responses
can happen with a lot of viruses if it wasn't
specific to COVID, but we did see it with COVID
(13:50):
and kids. So my concern was, if we're concerned that
kids have this high inflammatory response to this virus, are
they going to have that same inflammatory respons to the vaccine.
And don't forget the vaccine we give tends to be
a higher anagen load to so is it going to
actually incite a higher likelihood of having this inflammatory response.
(14:11):
This was my biggest concern, and in fact, I wrote
about it many times on Fox Digital. I reached out
to my friend and colleague, doctor Marty McCarey, who is
now the FDA administrator. I mean, he's doing great things,
but he was one of the people I talked to
about my concerns, and funny enough, you know, he put
me in touch with a lot of people. So I've
met Memorial slan Kattererankee. He was at Johns Hopkins. Obviously
(14:33):
these are big name institutions. He put me in touch
with some people that he knew regarding pediatrics, so I
could ask my questions because I had huge concerns about
the vaccine causing an inflammatory reaction in kids. They all
kind of talked the line of you know, pediatrics and
fell in line with the American Academy Pediatrics of oh no, no, no,
(14:54):
it's much safer to have a inflammatory response to the
vaccine than the virus. The virus is predictable, blah blah blah. Listen,
I get it, that makes sense. But I was seeing
how little this virus was affecting school age and adolescent kids,
and I had a huge concern about introducing this vaccine
to them when I saw what little inflammatory response they
(15:17):
actually had to the virus. And as we knew, as
time was going on, the virus was weakening, so they
were having a less and less inflammatory response. So were
we really going to now give them this vaccine to
try and incite inflammation. It seemed concerning to me. McKay
and I actually wrote a piece in the Wall Street
Journal looking at that Pfizer data on kids, and the
(15:38):
star of the paper was very different than what it
actually turned out to be, and I'll be honest, I
was very disappointed with the end result of that paper.
My overarching theme was whether you let your child. We're
talking about healthy kids. Obviously at this point, I'm not
talking about the children with chronic illness that may put
them at higher risk. I'm talking about the the over
(16:00):
all healthy child. You know, when I was started writing
this Wall Street Journal piece, I wanted to essentially put
out there the risk of COVID to your child is
very low. When it comes to the vaccine, it's probably
also low risk to give your child the vaccine. But
the question is it actually necessary? Does the vaccine prove
a benefit over that low risk, and for me, it
(16:23):
hadn't yet. There hadn't been data to show that that
vaccine caused a benefit over the risk. After many many
iterations of that paper McCarey, myself, the editor Wall Street Journal,
it ended up just coming back saying, whether your kid
gets COVID or has the vaccine, it's low risk gets
up to you. So it kind of just stayed on
this line, this middle ground. I wanted to take a
(16:46):
little bit stronger of a stan saying I wasn't convinced
of the benefits of the vaccine, but you know, sometimes
you have to give a take, and I wasn't the
sole author, so I couldn't necessarily do that. So I've
always had concerns about the vaccine and kids hearing the
right now saying that they're looking at it again and
going back a little bit more. It's clear that milecarditis
(17:06):
in specifically adolescent boys, is a very real risk factor.
It absolutely is. It was well documented in Israel before
we even saw the safety signals here in the United States,
and here in our own data, it shows that there's
a much higher risk of milecarditis in adolescent boys than
any other age group or demographic. So for me, the
question is, should there be a black box warning about
(17:28):
this vaccine and it's specifically in that age in demographics. Probably,
I have a feeling one's going to come, especially after
some of the reviews right now. I think that's a
good idea. You're listening to Wellness and Mass We'll be
right back with more. I also like the fact that
the FDA, the CDC, the ASIP, they have said COVID
(17:49):
vaccines and the annual boosters probably are not necessary for everyone.
There's no data to actually show that a healthy child,
especially a healthy young male teenager, benefits from getting an
annual COVID booster. The COVID virus continues to mutate, it
continues to get Yes, it is more contagious, it's going
around and round and round, but it's also a much
(18:11):
more mild virus where the risks with the vaccines are real,
especially in healthy young kids. So they have not proven
a large benefit in my opinion, and it seems like
the current FDA is also coming to that same conclusions.
I really agree with a lot that the FDA is
doing when it comes to the COVID vaccines. They're still
saying they're available. They're specifically available to those who where
(18:32):
there is an absolute documented benefit, older adults, people who
have chronic illness putting them at an increased risk of
severe disease, and anyone else who wants it there is
still availability for it. So I think these are all
a good thing. What I don't like is what just
happened on Friday with this leaked memo. Ten children died.
(18:52):
It's like, whoa what, Hold on a second, this is
huge news. If the FDA is saying ten children died
from the COVID and the FDA and the pharmaceutical companies
have not current have not previously said this or admitted this,
that's a big deal and it shouldn't have been thrown
at the American public the day after Thanksgiving in a
(19:13):
quote unquote leaked memo. It's not the right way to
do it. You know, Delivery matters. I think I've said
that at NASAM with this administration right now. I support
a lot of what's going on there, but delivery matters
if you actually want people to support it, and if
you actually want it to last beyond this administration, because
that's the ultimate goal, right It's not just what can
(19:35):
we jam back in four years while President Trump is
in the White House, just for it all to be
upended and undone when someone else comes into the White House.
That can't happen. People deserve so much better, Public health
deserves so much better. We have such a waste to
go from what happened during COVID, And while we're doing
a lot of good things right now, how we are
(19:55):
communicating it, how we're delivering it matters. And so that's
the thing that I have to say is we have
to ignore some of these headlines people. Probably why I'm
getting off social media a little bit in December, because
it really does incite a lot of emotions that are
not good for us. At the end of the day,
it's great that the FDA is looking at bears. It's
great that they are considering more rigorous trials and looking
(20:19):
at the data when it comes to our annual vaccine recommendations,
whether it's the COVID vaccine, whether it's the flu vaccines.
I mean, the reason they're able to quote so many
people get the flu vaccine is because it's mandated amongst
a lot of schools and all hospitals. I mean you
have to get it in hospitals. What happened as soon
as you took away the COVID mandate from hospitals, healthcare
(20:41):
workers didn't get the COVID booster. The reason healthcare workers
still get the flu booster flu shot is because they
have to. What would happen if you took away that mandate.
I guarantee a lot of hospital workers would stop getting
it because there's already a huge question as to what
the efficacy is of the flu shot at reducing transmission.
Just like cod we know it reduces severe illness and hospitalization,
(21:04):
but the effects on whether it actually reduces significantly at
a population level transmission hasn't been proven. And these are
the questions that the FDA is bringing up, saying, should
the CDC be having these conversations, Should we make sure
that these vaccines are doing what we say that they do.
We do a lot of lab studies, we do a
lot of epidemiological studies looking at stuff, but we're not
(21:26):
actually proving it. We're just saying, well, these are estimates,
these are what we think happens. And because this is
what we think happens, therefore you have to do it.
And I think we're kind of moved past that. Unfortunately,
COVID has actually fortunately not unfortunately, but fortunately COVID has
woken a lot of people up saying just because you
say this is right doesn't necessarily mean it is. Now
that being said, we obviously can see the benefits of
(21:49):
certain vaccines. We had measles eradicated here in the United
States because we had such high level population vaccination rates
of measles. Now all of a sudden, we're at cheopardy
of losing the eradication state because we have so many
cases of measles now because of community spread and low
vaccination rates. So we know that there are some benefits
(22:11):
to vaccinations. We know that there's huge benefits to population
level vaccination rates, but not all vaccines are created equally,
and they don't all have the same benefits, and so
it is important that we break it up a little bit.
This week, the ACIP, that's the kind of the vaccine
Recommendation Group the CDC. They're meeting Thursday and Friday, and
it's gonna be a blockbuster week. I'll definitely talk to
(22:33):
you about it. On Friday's rundown, they're talking about the
whole vaccine schedule. President Trump has made some comments about
maybe breaking up the vaccine schedule instead of giving someone
an MMR like measles, momps and rebella, maybe breaking them
up so you just get measles one visit, maybe you
get a rebel the other visit. Personally, that sounds like
a logistical nightmare from a pediatrician and a parent's standpoint.
(22:56):
And I also don't know if the drug makers are
willing to go back to the drawing board and reformulate
all of these vaccines, so they're going to have to
talk about that, and I hope that they keep some
of these things in mind when they make these recommendations.
Just because you want something doesn't mean it's possible. Also,
All Day Friday is scheduled to talk about the hepatitis
B vaccine in newborns. They were supposed to vote on
(23:16):
that a couple of months ago, but it got scrapped,
so that's going to be a heated conversation. I will
definitely bring you everything on Friday's weekly rundown because you
know it's going to be interesting, and I'll be watching
it live because I won't be following it on social media,
even though I probably will tap into social media a
little bit just to see what people are saying. Like
I said, my December challenge is not black and white,
(23:37):
but I have to kind of stay active. I want
to know what people are saying. So that's it for today.
I hope you have a wonderful week. I hope you
join me in our December challenge for physical and mental fitness.
I need to take my kids to school, I need
to do some work, and I have to get my
butt on the peloton because I have to get that
workout in today. Thank you so much for listening to
Wellness on mass I'm not going to be full saffire.
(23:58):
Make sure you tune into iHeart Radio or wherever you
get your podcasts, and I'll see you next time.
Hello everyone, Welcome to Wellness on Mass. I'm doctor mpul
Sapphire and I'm sitting down this morning doing this podcast
heading my morning cup of coffee because it is like
a wintry snowy mix outside, so it's like a delayed
opening for the kids' school, so it's a little bit
of a late start today. So let's have our coffee together,
shall we. Big news is now December second, and I
(00:25):
have decided to do a personal challenge for December. Well
I'm taking a sip big personal challenge for December. You know,
we all wait until January to come up with like
our New Year's resolutions. What are we going to do?
How are we going to get in shape? How are
we going to be a better version of ourselves in
the new year. I decided I want to do it
in December this year. So here's what I'm doing. So
(00:46):
for December, starting yesterday, I'm increasing the amount of workouts
I do. So my goal is to do twenty workouts
in December. Now, I know for people who work out
five six times a week, that doesn't sound like a
lot twenty workouts in a month, But when you have
holiday parties, you have Christmas and Hanukkah and all this
stuff at the kids' school. December can be very busy
(01:07):
and one of the first things to go are the workout.
So by having a little checklist making sure that I'm
getting twenty for the month, that's how I'm focusing on
my physical health. I'm also taking a bit of a
step back from social media. Ah, I know, how am
I going to do this? I'm not sure my voice
is going to come and go throughout this, but you
know it'll still be great. So I have decided I
(01:28):
want to get rid of social media from my phone
because it's so easy to just when you have a
couple minutes during the day, you just go on your
phone and you start scrolling, scrolling, scrolling. Well, do you
know that actually affects your brain chemistry. They do studies
looking at functional emerror and it shows activity in your
brain changes as you engage in social media. It also
(01:50):
elicits dopamine response, which is why if you do a
post and you get likes and comments and it's going
it's doing really well, that actually gives your brain reward
and that's why you feel good about it. But the
alternative is also true. If you do a post and
for whatever reason, people aren't seeing it, aren't liking it.
It causes negative emotions and feelings, which is why social
(02:13):
media use is linked to anxiety and depression and all
of these other things. So for my mental health heading
into the holiday season, I want to cut back. Now.
It's a little bit tricky to cut back on social
media when you have like a media presence. You know,
I go on TV, I'm doing this podcast, I have
a wellness company. All of these things I use social
(02:35):
media for so for business, but that doesn't mean that
it is still good for my mental health. So it's
not going to be black and white. I'm not completely
off of social media. In fact, you may be listening
to this podcast because I posted on social media, but
you're not going to see me as active on social
media as maybe I usually am. And that's just me
making a conscious effort to focus on more meaningful things
(02:57):
like real life personal in reactions, or you know, doing
more with my work because I actually find enjoyment in
my work, or focusing on other hobbies. I'm actually in
the process of writing a book right now. If I
have five minutes instead of doom scrolling on social media,
maybe I should be focusing on that book and so
some other things like that. So I'm heading into the
new year already focusing on my physical health, on my
(03:20):
mental health. So by the time New Year's resolution conversations
comes around, I don't have to be like, ah, crap,
what diet am I going to do this year? Nope,
because I'm already going to be feeling good mentally and physically.
So maybe for my twenty twenty six New Year's resolutions,
I can focus on bettering someone else, like what can
I do for other people? Because I've already spent December
(03:41):
focusing on myself, so that's my goal. I encourage everyone
to do it with me. Doesn't mean you have to
do the same things I'm doing, but maybe let's try
in December to get us to a good place so
that when we head into the holidays and we head
into our New Year's resolutions, we already are feeling pretty
good and so then we can focus on how can
we help others around us? So I know that sounded
(04:01):
like a lot of this topic, but that's not what
I want to get into today. On weilness unmass, if
you've been on social media, because that's where a lot
of this happens. You will see something pretty big happened
last Friday afternoon. Now, a lot of things get buried
in the news cycle when they occur on Friday afternoon,
but this one was pretty interesting and it's hit a
nerve with a lot of people, and to be honest,
(04:23):
it probably should. So there was a leaked FDA internal memo. Now,
whether or not it was actually leaked, I don't know.
I think it sounds like a pretty intentional leak. If
you send out a memo on a Friday afternoon, Friday
after Thanksgiving afternoon, you send it out to like over
one thousand people in an industry, do you really think
(04:47):
that that's going to stay internal Probably not. And if
you actually read this internal memo, it doesn't necessarily read
a something that was meant to stay internalized. So what
was this memo? Well, it was a memo from the
head of one of the interdepartmental agencies within the FDA
claiming that at least ten children deaths were likely linked
(05:11):
to the COVID vaccine through probably vaccine associated myocarditis. Although
they didn't necessarily come down by it, but what they
said was they looked at the ver's data, which VERS
is a public forum. It's an online thing that anyone
can go to. You can be a patient, you can
be a parent, you can be a doctor, you could
(05:31):
be a drug company. If you have a side effect
from a medication, a vaccine, you're able to input it
if you feel that the side effect is from that.
Now there's a huge caveat when you're looking at the
VERS data. So I can go on if I take
a medication and something happens to me in the next
couple of weeks or even a couple of months, and
I'm like, you know what it was? It was probably
(05:52):
that vaccine, I can go input that. Now other people
can read what I put down, and so they may
automatically think, oh my gosh, this person had this and
she said it was from this. But that's not necessarily true, right,
So just because I think it is doesn't mean it was.
Maybe I had an underlying viral infection that caused something.
The reality is this is just people inputting data, but
(06:14):
this is not verified data yet. So a couple of
months ago, people at the FDA said that they are
putting together a working group that they were actually going
to go through the ver's data. They are going to
actually look at those who said that they had side
effects from the COVID vaccine, and they wanted to look
at that and say were they really from the vaccine. Now,
the numbers that were in veirs, there were ninety six
(06:36):
supposed deaths from the COVID vaccine. That's how many were reported.
This internal memo says that they've gone through all of them,
and they say at least ten they believe are likely
linked to the COVID vaccine. So that's pretty big news.
And this memo, again, it comes from inside the FDA
(06:59):
Center for Biologics Evaluation and Research, which is essentially the
vaccine regulating arm of the agency. And so ten of
those deaths in children age seven to sixteen were considered
quote unquote likely or possibly related to mildcarditis after vaccination. Now,
on its face, that's obviously very serious, but I want
(07:21):
to take a pause before we jump to conclusions. This
memo itself is not pure reviewed. And while I think
it is incredibly important and excellent that they decided to
go through all of this bear's data, because there are
a lot of people out there who have been criticizing
COVID vaccines who have been saying that they have been
under reporting the safety data. And by the way, I'm
(07:41):
one of those people. I also think that they were
underreporting safety data when it came to the COVID vaccine.
So I was very happy to see that they were
doing a deep dive into the bear's data. But just
because they're now coming out saying, well, we looked at
it and we think at least ten of these deaths
are related, they did not, in this quote unquote leaked
to memo, they did not put forth any evidence as
(08:04):
to or any criterion as to why they believe those
ten deaths were linked to the vaccine. So what does
that do. Immediately, it's one opinion to another opinion. The
people who put the information into theirs, that's their opinion
that the death was related to the vaccine. Now we
have this internal memo where the FDA is saying, well,
(08:26):
we believe at least ten of these deaths are related.
That's another opinion. Because they didn't produce any data to
back up that opinion. So right now we have a statement,
but without the data needed to verify it, especially if
we want people to take it seriously. We already know
Trump Arrangement syndrome is a real entity in the sense
(08:47):
that anything that comes out of the current HHS, FDA
White House, anything that's associated with President Trump, Secretary Kennedy,
people are going to automatically reject just because of the
underlying bias that they whatever they do has to be wrong,
even if they're right. So if they're going to make
a statement like the vaccine, they're acknowledging that the vaccine
(09:09):
likely killed at least ten children, that's a heavy statement
to make without putting forth data, because immediately they're going
to be scrutinized by every academic, every media outlet. And
that's exactly what happened over the weekend. So this leaked
memo happened Friday afternoon. You had FDA Director Marty McCarey
(09:29):
was up right and early on Fox and Friends Saturday morning,
So that's again, memo came out Friday afternoon, media hit
Saturday morning, and it seemed very I mean, mcay does
a great job on TV, but he definitely had his
stocking points and so it did seem like some of
this was a little bit intentional, and he essentially said
something that he's been saying for the last year that
(09:50):
this new FDA is not going to be rubber stamping
vaccines just because it was approved in the past, just
because of the way things were done in the past,
They are not going to continue to to do this,
and they want rigorous safety data. I don't think anyone
can argue with that, although they're going to try. But
the problem that I have with the way that this
leaked memo rolled out was, again, it was a memo.
(10:13):
It's in the guise of it being now a leaked memo,
and there was no data to back it up. They
as far as we know, they're not. They haven't printed
it in a peer reviewed journal to show why they
believe that these deaths were linked, and so it's just
kind of out there, and when it's out there like that,
it kind of gets caught up in the weeds of
conspiracy theorists, even if they're right by the way. Again,
(10:34):
I personally believe that the Biden administration, the prior CDC,
the pharmaceutical companies were under representing safety signals when it
came to these COVID vackseats. Even Maderna in one of
their in their booster trial, a child died in that
booster trial. It took a while for them to actually
acknowledge it because they kept manipulating the data in such
(10:56):
that they didn't have to report that child's death. And
this is why pharmaceutical companies have a bad rap with
the American people, because they do such as this, but
goes both ways. You can't make a statement without having
data because if you just manipulate words to promulgate fear
and incite anger and other emotions without having the data,
(11:18):
you know, you're no better off. And that's where we're still.
That's where we're at right now. We have this leak
memo that was full of what at this point opinion
without data backing it up. And I think, you know,
it's just as harmful as the pharmaceutical companies who are
hiding some of the data. So, you know, going back
to when these vaccines rolled out, I just want to
tell you my own personal opinion, I mean, Operation Warp
(11:40):
Speed was probably one of the most incredible things that
I had ever seen, the fact that President Trump was
able to harness his business mindset to really work with researchers, academics,
and pharmaceutical companies to get a vaccine available. You know,
within a year. That's a huge deal, especially when you
look at how long it cakes for drugs to be research, manufactured,
(12:02):
and brought to market. It's like anywhere from seven to
ten years on average. And no, that's not because we
do such rigorous safety data. It's more because we have
a lot of red tape and bureaucratic bloat that prolongs that.
So President Trump was able to cut through a lot
of that. So when it rolled out and all of
the initial data that showed that, guess it was able
(12:22):
to incite an immune response, which is the ultimate goal
of vaccines. So in theory, that should decrease severity and
hopefully should stop transmission of the virus or at least
decrease it. Obviously, I don't need to rehash what happened.
So a lot of people got the vaccines, whether you're
mandated to or not, and we did see dramatic decrease
in hospitalizations and deaths. The current FDA director, doctor McCarey,
(12:46):
just this Saturday reconfirmed that when you look at the data,
especially in the early days of COVID, the vaccines were
directly linked to remarkable decrease in severity of illness, especially
in older populations and vulnerable populations, that's undisputed. Now, fast
forward to when they started expanding the vaccines for kids, teenagers,
(13:07):
young adults, kids zero through I don't know thirty. That's
when I started to say pump the brakes a little
bit because I had three kids ranging from elementary school
to college, and I had already seen them all have
COVID at that point, probably a couple times, to be honest,
and the overwhelming data told us that they were the
lowest risk for severe illness. One thing that was concerned
(13:28):
and kids was the misc that multi inflammatory syndrome and children,
which was essentially an autoimmune and an inflammatory response that
the body did in reaction to the virus, and that
was pretty bad in kids. Now, those inflammatory type responses
can happen with a lot of viruses if it wasn't
specific to COVID, but we did see it with COVID
(13:50):
and kids. So my concern was, if we're concerned that
kids have this high inflammatory response to this virus, are
they going to have that same inflammatory respons to the vaccine.
And don't forget the vaccine we give tends to be
a higher anagen load to so is it going to
actually incite a higher likelihood of having this inflammatory response.
(14:11):
This was my biggest concern, and in fact, I wrote
about it many times on Fox Digital. I reached out
to my friend and colleague, doctor Marty McCarey, who is
now the FDA administrator. I mean, he's doing great things,
but he was one of the people I talked to
about my concerns, and funny enough, you know, he put
me in touch with a lot of people. So I've
met Memorial slan Kattererankee. He was at Johns Hopkins. Obviously
(14:33):
these are big name institutions. He put me in touch
with some people that he knew regarding pediatrics, so I
could ask my questions because I had huge concerns about
the vaccine causing an inflammatory reaction in kids. They all
kind of talked the line of you know, pediatrics and
fell in line with the American Academy Pediatrics of oh no, no, no,
(14:54):
it's much safer to have a inflammatory response to the
vaccine than the virus. The virus is predictable, blah blah blah. Listen,
I get it, that makes sense. But I was seeing
how little this virus was affecting school age and adolescent kids,
and I had a huge concern about introducing this vaccine
to them when I saw what little inflammatory response they
(15:17):
actually had to the virus. And as we knew, as
time was going on, the virus was weakening, so they
were having a less and less inflammatory response. So were
we really going to now give them this vaccine to
try and incite inflammation. It seemed concerning to me. McKay
and I actually wrote a piece in the Wall Street
Journal looking at that Pfizer data on kids, and the
(15:38):
star of the paper was very different than what it
actually turned out to be, and I'll be honest, I
was very disappointed with the end result of that paper.
My overarching theme was whether you let your child. We're
talking about healthy kids. Obviously at this point, I'm not
talking about the children with chronic illness that may put
them at higher risk. I'm talking about the the over
(16:00):
all healthy child. You know, when I was started writing
this Wall Street Journal piece, I wanted to essentially put
out there the risk of COVID to your child is
very low. When it comes to the vaccine, it's probably
also low risk to give your child the vaccine. But
the question is it actually necessary? Does the vaccine prove
a benefit over that low risk, and for me, it
(16:23):
hadn't yet. There hadn't been data to show that that
vaccine caused a benefit over the risk. After many many
iterations of that paper McCarey, myself, the editor Wall Street Journal,
it ended up just coming back saying, whether your kid
gets COVID or has the vaccine, it's low risk gets
up to you. So it kind of just stayed on
this line, this middle ground. I wanted to take a
(16:46):
little bit stronger of a stan saying I wasn't convinced
of the benefits of the vaccine, but you know, sometimes
you have to give a take, and I wasn't the
sole author, so I couldn't necessarily do that. So I've
always had concerns about the vaccine and kids hearing the
right now saying that they're looking at it again and
going back a little bit more. It's clear that milecarditis
(17:06):
in specifically adolescent boys, is a very real risk factor.
It absolutely is. It was well documented in Israel before
we even saw the safety signals here in the United States,
and here in our own data, it shows that there's
a much higher risk of milecarditis in adolescent boys than
any other age group or demographic. So for me, the
question is, should there be a black box warning about
(17:28):
this vaccine and it's specifically in that age in demographics. Probably,
I have a feeling one's going to come, especially after
some of the reviews right now. I think that's a
good idea. You're listening to Wellness and Mass We'll be
right back with more. I also like the fact that
the FDA, the CDC, the ASIP, they have said COVID
(17:49):
vaccines and the annual boosters probably are not necessary for everyone.
There's no data to actually show that a healthy child,
especially a healthy young male teenager, benefits from getting an
annual COVID booster. The COVID virus continues to mutate, it
continues to get Yes, it is more contagious, it's going
around and round and round, but it's also a much
(18:11):
more mild virus where the risks with the vaccines are real,
especially in healthy young kids. So they have not proven
a large benefit in my opinion, and it seems like
the current FDA is also coming to that same conclusions.
I really agree with a lot that the FDA is
doing when it comes to the COVID vaccines. They're still
saying they're available. They're specifically available to those who where
(18:32):
there is an absolute documented benefit, older adults, people who
have chronic illness putting them at an increased risk of
severe disease, and anyone else who wants it there is
still availability for it. So I think these are all
a good thing. What I don't like is what just
happened on Friday with this leaked memo. Ten children died.
(18:52):
It's like, whoa what, Hold on a second, this is
huge news. If the FDA is saying ten children died
from the COVID and the FDA and the pharmaceutical companies
have not current have not previously said this or admitted this,
that's a big deal and it shouldn't have been thrown
at the American public the day after Thanksgiving in a
(19:13):
quote unquote leaked memo. It's not the right way to
do it. You know, Delivery matters. I think I've said
that at NASAM with this administration right now. I support
a lot of what's going on there, but delivery matters
if you actually want people to support it, and if
you actually want it to last beyond this administration, because
that's the ultimate goal, right It's not just what can
(19:35):
we jam back in four years while President Trump is
in the White House, just for it all to be
upended and undone when someone else comes into the White House.
That can't happen. People deserve so much better, Public health
deserves so much better. We have such a waste to
go from what happened during COVID, And while we're doing
a lot of good things right now, how we are
(19:55):
communicating it, how we're delivering it matters. And so that's
the thing that I have to say is we have
to ignore some of these headlines people. Probably why I'm
getting off social media a little bit in December, because
it really does incite a lot of emotions that are
not good for us. At the end of the day,
it's great that the FDA is looking at bears. It's
great that they are considering more rigorous trials and looking
(20:19):
at the data when it comes to our annual vaccine recommendations,
whether it's the COVID vaccine, whether it's the flu vaccines.
I mean, the reason they're able to quote so many
people get the flu vaccine is because it's mandated amongst
a lot of schools and all hospitals. I mean you
have to get it in hospitals. What happened as soon
as you took away the COVID mandate from hospitals, healthcare
(20:41):
workers didn't get the COVID booster. The reason healthcare workers
still get the flu booster flu shot is because they
have to. What would happen if you took away that mandate.
I guarantee a lot of hospital workers would stop getting
it because there's already a huge question as to what
the efficacy is of the flu shot at reducing transmission.
Just like cod we know it reduces severe illness and hospitalization,
(21:04):
but the effects on whether it actually reduces significantly at
a population level transmission hasn't been proven. And these are
the questions that the FDA is bringing up, saying, should
the CDC be having these conversations, Should we make sure
that these vaccines are doing what we say that they do.
We do a lot of lab studies, we do a
lot of epidemiological studies looking at stuff, but we're not
(21:26):
actually proving it. We're just saying, well, these are estimates,
these are what we think happens. And because this is
what we think happens, therefore you have to do it.
And I think we're kind of moved past that. Unfortunately,
COVID has actually fortunately not unfortunately, but fortunately COVID has
woken a lot of people up saying just because you
say this is right doesn't necessarily mean it is. Now
that being said, we obviously can see the benefits of
(21:49):
certain vaccines. We had measles eradicated here in the United
States because we had such high level population vaccination rates
of measles. Now all of a sudden, we're at cheopardy
of losing the eradication state because we have so many
cases of measles now because of community spread and low
vaccination rates. So we know that there are some benefits
(22:11):
to vaccinations. We know that there's huge benefits to population
level vaccination rates, but not all vaccines are created equally,
and they don't all have the same benefits, and so
it is important that we break it up a little bit.
This week, the ACIP, that's the kind of the vaccine
Recommendation Group the CDC. They're meeting Thursday and Friday, and
it's gonna be a blockbuster week. I'll definitely talk to
(22:33):
you about it. On Friday's rundown, they're talking about the
whole vaccine schedule. President Trump has made some comments about
maybe breaking up the vaccine schedule instead of giving someone
an MMR like measles, momps and rebella, maybe breaking them
up so you just get measles one visit, maybe you
get a rebel the other visit. Personally, that sounds like
a logistical nightmare from a pediatrician and a parent's standpoint.
(22:56):
And I also don't know if the drug makers are
willing to go back to the drawing board and reformulate
all of these vaccines, so they're going to have to
talk about that, and I hope that they keep some
of these things in mind when they make these recommendations.
Just because you want something doesn't mean it's possible. Also,
All Day Friday is scheduled to talk about the hepatitis
B vaccine in newborns. They were supposed to vote on
(23:16):
that a couple of months ago, but it got scrapped,
so that's going to be a heated conversation. I will
definitely bring you everything on Friday's weekly rundown because you
know it's going to be interesting, and I'll be watching
it live because I won't be following it on social media,
even though I probably will tap into social media a
little bit just to see what people are saying. Like
I said, my December challenge is not black and white,
(23:37):
but I have to kind of stay active. I want
to know what people are saying. So that's it for today.
I hope you have a wonderful week. I hope you
join me in our December challenge for physical and mental fitness.
I need to take my kids to school, I need
to do some work, and I have to get my
butt on the peloton because I have to get that
workout in today. Thank you so much for listening to
Wellness on mass I'm not going to be full saffire.
(23:58):
Make sure you tune into iHeart Radio or wherever you
get your podcasts, and I'll see you next time.
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