June 10, 2025 • 26 mins
In this conversation, Dr. Marty Makary discusses the evolving role of the FDA, particularly in relation to COVID vaccines, drug approvals, and public health messaging. He emphasizes the need for transparency, evidence-based approaches, and a focus on chronic illness prevention through nutrition. The dialogue also touches on the regulatory challenges faced by small businesses in the wellness industry and the importance of building trust between the FDA and the public. Wellness Unmasked is part of the Clay Travis & Buck Sexton Podcast Network - new episodes debut every Tuesday & Friday.
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Episode Transcript
Available transcripts are automatically generated. Complete accuracy is not guaranteed.
Speaker 1 (00:03):
Welcome to Wellness on Mass.
Speaker 2 (00:04):
I'm doctor Nicole Sapphire, where we peel back the headlines
and uncover what's really happening.
Speaker 1 (00:08):
In the world of health and medicine.
Speaker 2 (00:10):
I'm joined by someone today who needs little introduction, doctor
Marty McCarey, who's now serving as the Commissioner of the FDA.
We are going to talk about his vision for the agency,
what changes may be on the horizon, and how the
FDA plans to strike a better balance between innovation, safety
and transparency.
Speaker 1 (00:28):
And now we're not just going.
Speaker 2 (00:29):
To talk to him about the missteps that occurred during
COVID and how the vaccines and the COVID boosters were
continuously recommended into perpetuity without new data. We are also
going to talk about the expedited approvals of the GLP
ones where it comes to weight loss. Are too many
people using them? Do we even have safety data? And
what decisions the FDA are going to make about these medications.
(00:52):
I also want to ask him about American small businesses
who are being crushed under the FDA. We're specifically talking
about the hygiene, cosmetic, and wellness industries. Did you realize
that if you have a small business owner here in
the United States making an organic shampoo and conditioner, they're
subjected to costly testing, stringent guidelines, and also subject to
(01:14):
consistent inspections.
Speaker 1 (01:16):
Where if you look to China.
Speaker 2 (01:18):
The companies that are making cheap shampoo and conditioner are
able to sell it for cheap because they are not
under the same rules as the FDA. Why not Americans
are consuming those as well? Why is it not fair
to the American small business owner? This goes completely against
the America First agenda, So I want to ask doctor
McCarry about that as well. More coming up on Wellness
(01:40):
Unmasked with doctor Nicole Sapphire. All right, well, we're extremely
excited to have the new FDA commissioner, my friend and
former colleague, doctor Marty McCarey join us today on Wellness Unmasked. Marty,
let's talk about the FDA. In your view, how's it
been going the last four to five years.
Speaker 3 (02:00):
To evaluate how the FDA has done in its history.
I would say it is parallel to what the medical
establishment has done in its history, and that is, there
have been shining moments and there have been embarrassing moments
like OxyContin and yox and Mechina, And so the FDA
(02:23):
I think does best when we are incredibly transparent, when
we're humble, when we're open and honest about our mission
to safeguard the public and at the same time or
promote innovation. There are parts of the FDA that run really,
really well. There are parts of the FDA that are
very bureaucratic, and so we're trying to ask the big
(02:44):
questions that have never been asked before. Why does it
take ten years for a new drug to come to market?
Why do forty percent of our nation's children now have
a chronic disease and you don't see those numbers in
other countries.
Speaker 4 (02:58):
What can we do to create a great.
Speaker 3 (03:01):
Workplace environment, to make an attractive place to work? So
that's my focus as I walk into this role.
Speaker 4 (03:07):
Now. I think I've been here for about.
Speaker 3 (03:09):
Eight weeks or so, but those are some of the
questions that I'm exploring with the folks here.
Speaker 2 (03:16):
Well, something else that you've been doing that's made some
very recent headlines is that you're also demanding more data
when it comes to specifically COVID vaccines. The CDC can
remove the COVID vaccine from its routine immunization schedule for
healthy children. This came in a parallel time where you
were demanding that the pharmaceutical companies also provide more updated
(03:37):
data regarding healthy children and repeated COVID vaccines. But here's
my question, Marty, many parents physicians want to know. You know,
what was that decision based on. Was it compelling new
safety or efficacy data or was it just a tacit
admission that maybe the original data, you know, the justification
for putting it on the schedule in.
Speaker 1 (03:57):
The first place, was weak, flawed, or non existent.
Speaker 3 (04:00):
Yeah, so we don't have the data to support the
repeat booster strategy in perpetuity forever. That was a theory
that a young, healthy child should get a COVID booster
every year for their entire life, which would mean a
baby girl born today would get eighty COVID shots in
(04:20):
her average eighty year lifespan. And so that is a
theory that is unproven. We don't know if it's necessary.
We haven't fully assessed the harms of mRNA. We hear
of hundreds of thousands of individuals who have described injury
from the vaccine. There have been deaths from the vaccine,
and so people are wondering if the risk benefit ratio
(04:43):
favors a repeat booster in infinity. And so that's where
we have said, it's been about four years since we've
had randomized control trial data on the COVID shots and
the boosters, and it now is a different virus, it
behaves differently, and there's a large proportion of Americans that
(05:06):
have natural immunity or population immunity.
Speaker 4 (05:09):
So how do we answer that question?
Speaker 3 (05:10):
Honestly, for the twelve year old girl who comes in
and has already had five COVID shots, can we really
say that they need it? I mean, can we really
use that term in the absence of data? So I think, look,
we're taking an evidence based approach now on vaccines and
on the COVID shots, and so we published in the
(05:33):
New England Journal of Medicine and Evidence Based Strategy, which
brings us back to the gold standard of science where
we'll have clinical trial data to support. I just don't
think we should put on the blinders and blindly rubber
stamp COVID shots for young, healthy children in perpetuity. I
think we should get back to an evidence based approach.
Speaker 2 (05:54):
Well, you and I have been a lockstep with that
I think, you know, I was rage, texting and email
telling you you know, all throughout the COVID pandemic, specifically
when it started to be the universal recommendation was that
children get the vaccines, and then we saw the mandates
and then even the boosters came out.
Speaker 4 (06:10):
You know.
Speaker 2 (06:11):
The concern that I had as a parent and as
a physician was that we started hearing from the Israeli
public Health that there were safety signals, specifically milcarditis or
heart inflammation in young men, young adolescents, and yet we
even started seeing rising cases in our vears or that
self reported database. Now, I know we don't necessarily do
(06:31):
policy over anecdotes, but how come they continued to be
you know, year after year, continued to get that rubber
stamp under the Emergency Use Authorization, and like clockwork ASIP,
you know, the CDC's Advisory committee continued to recommend them.
Speaker 1 (06:47):
Without new data, but there was clearly.
Speaker 2 (06:49):
Safety signals going on. What do you think led to
really the absence of data the last few years that
you are now finally starting to demand.
Speaker 3 (06:56):
You know, there has been a sort of strong culture
of pattern, and you've seen it in some of the
minutes of the past ASIP meetings on the COVID booster
for young healthy children. I wrote a piece titled why
Americans Don't trust the CDC and specifically cited the minutes
of some of those ACP meetings a couple of years ago,
(07:16):
where they were basically saying, we need a streamlined message.
People will be confused if we have a risk stratified approached.
That is a nuanced approach treating a sixty five year
old with a comorbidity different from a young, healthy, nineteen
year old boy. And the truth is that we've never
(07:38):
really gotten great data on the myocarditis risk. Some studies
have suggested that the risk is greater than one in
three thousand young boys after the second dose of one
of the vaccines.
Speaker 4 (07:52):
Now that means tens of thousands of boys.
Speaker 3 (07:55):
Have been affected by myocarditis, and some studies have shown
that a third those cases result in scarring, which may
be permanent, it's maybe a long term sequala.
Speaker 4 (08:06):
So you have to take things seriously. You got to
use good data.
Speaker 3 (08:10):
If you don't use good data and you're not capturing
complication rates with good methodology, you make the vaccine look
safer that it really is. And if you don't distinguish
incidental COVID hospitalizations from hospitalizations for COVID.
Speaker 2 (08:25):
We were dealing with, you know, we were not getting
the full picture when it came to the numbers. It
was not accurate whether someone was you know, we've said
many times admitted with COVID or for COVID. I think
in the updated application to the FDA from Maderna for
their updated booster though, they cited that by ninety days
those who had vaccine induced mildcarditis, when they looked at
(08:46):
the past data, there was still symptomatic. And so that's
concerning because the talking points when you were turning on
the TV, you would say, oh, it's just transient, everyone's
back to normal. But at no point should we just
wipe away the fact that heart and inflammation is transient
and it's fine, it's an acceptable risk factor.
Speaker 3 (09:04):
People have died from myocarditis and it's not just you know,
fairy tale or anecdote from somebody or who's a friend
of a friend. It was in the New England Journal
of Medicine elcardiitis from vaccine induced that is a death
from myocarditis from vaccine induced myocarditis eighty five percent of
(09:25):
healthcare workers said no thank you to the COVID booster
last season.
Speaker 4 (09:30):
When you go to the UK and look at.
Speaker 3 (09:32):
Their recommendations, it's recommended for people over age seventy five,
not just sixty five seventy five or high risk, and
in France it's eighty years of age or high risk.
So we're really catching up to the rest of the
world with our new vaccine framework.
Speaker 2 (09:48):
Well, I notice also that the new updated Maderna booster
is a fraction of the original dose, and on top
of that they have to have the warning about art inflammation.
So do you believe that they have lessen the dose
because of they were found to have more cases of
myocarditis and hard inflammation than Pfizer, which had a lower dose.
Speaker 4 (10:08):
I don't know the rationale.
Speaker 3 (10:10):
It is true that there were higher rates of myocarditis
reported in the past with the past Moderna versus Pfizer
COVID vaccines. The recent MODERNA vaccine approval was only for
high risk, it was a limited group and they agreed
to do a randomized control trial as a part of
(10:32):
that approval. And it is as you said, Nicole, it
is a so I don't want to say it's a
lightweight version, but it only includes some parts of the
protein of the spike protein, not the entire spike protein
or the majority of the spike protein as the current
MODERNA vaccine that's on the market. So it is very
(10:55):
similar but does not include the entire protein of the spike.
Speaker 2 (10:59):
It'll be interesting to see what happens that. I mean,
the most recent ACIP meeting by the CDC in April,
I believe it was, they did not vote on updated
recommendations for the COVID booster and they said maybe it'll
happen in June, even though it kind of, you know,
I think it was the lightweight version of just saying
this should be a decision between patients and doctors on
(11:21):
the CDC immunization recommendation. When you're talking about the Affordable
Care Act and what is really going to be recommended
and covered by insurance is going to be based on
what the ACIP votes on.
Speaker 1 (11:32):
And they could go either way.
Speaker 2 (11:33):
They could continue the path that they've been going down
for the last four to five years of universal recommendations,
or they're going to.
Speaker 1 (11:40):
Do it risk base.
Speaker 2 (11:41):
And I have a feeling with your leadership and if
the FDA obviously you do have some influence there at
the CDC looking at the data. It'll be interesting to
see what they do and hopefully they'll give some more
clarity on that. You know, and I know that big
pharma does tend to.
Speaker 1 (11:56):
Get a bad rap.
Speaker 2 (11:57):
We talk about profit mongering and everything, but we rely
heavily on them in innovation, especially in healthcare. I mean,
they are the reason that we're living longer. And so
how do you at the FDA plan to foster a
relationship with innovation in the pharmaceutical industry but also holding
firm on safety and efficacy standards.
Speaker 3 (12:17):
At the FDA, we would like to see more cures
and meaningful treatments for Americans.
Speaker 4 (12:22):
That is one of our top priorities.
Speaker 3 (12:24):
We also want to see a discussion of the root
causes of the rising rates of cancer and young people,
of the chronic disease apidemic in children.
Speaker 4 (12:34):
We can't keep.
Speaker 3 (12:35):
Medicating our population at scale. We have to look at
food as medicine and the microbiome, and look at snap programs,
and look at the food supply and the chemicals that
are banned in other countries but allowed in the United States.
We have to look at chemicals, exposures that don't exist
in other countries. Ultra processed food was a theme in
(12:58):
the report. Percent of the kids of the food kids
consumer is ultra processed. And how about we talk about
light exposure in children and circadie and rhythms. We've never
really been talking about this. It's time to broaden that conversation.
So we want to see more cures and meaningful treatments.
We're doing a lot to cut the red tape, to
streamline the process and create new pathways for new treatments.
(13:23):
At the same time, we're spending a lot of time
on food, which is why you saw our action to
remove all petroleum based food dies from the market.
Speaker 1 (13:35):
So I mean you anticipated my next question.
Speaker 2 (13:38):
Because the FDA does historically focus more on drugs than
on prevention nutrition. With Secretary Kennedy as HHS secretary, obviously,
I imagine the food industry is taking more of a priority.
Speaker 1 (13:49):
We're already starting to see that. You know, what can
we expect?
Speaker 2 (13:52):
You know, from an FDA standpoint, you already mentioned petroleum
based food dies, but you also have like a spartane
and you know some of the seat oil and ultra
processed foods these are all linked to chronic illness, yet
still considered safe by the FDA.
Speaker 3 (14:06):
We work closely with NIH, and NIH is going to
be commissioning some really important studies looking at these root
causes and chemicals. We have to talk about the environmental
exposures and chemicals that cause cancer, not just the chemo
to treat it. And by and large, our entire medical
industrial research complex has been focused really on just the treatments.
(14:30):
And we're not winning playing whaca mole like this. We're
not winning or country gets sicker. We have the most obese,
the most insulin resistant, the most disabled, the most.
Speaker 4 (14:41):
Medicalized population in the history of the world. We've got
to stop.
Speaker 3 (14:45):
Well, you don't have the time or resources or energy
to just stop and put your head up and look
around and say, what's going on? Look at our population.
It has gotten sicker over the last fifty years. In
terms of cutting edge operations and chemo drugs and gene therapy,
modern medicine has been a fifty year success, but in
(15:08):
terms of the health of the population, it's been a
fifty year failure. And so we now want to talk
about food and that is a huge priority for this
FDA and this administration.
Speaker 1 (15:18):
You're listening to wellness and mass We'll be right back
with more.
Speaker 2 (15:24):
It always sounds good to say, well, we want to
make sure that we have the good research on it.
Speaker 1 (15:28):
We have the data.
Speaker 2 (15:28):
If we're talking about some specific foods, you know, no
one wants the government to come in and take away
something that they like.
Speaker 1 (15:35):
But the problem with that.
Speaker 2 (15:36):
Is that's going to be a lot of big population
based studies. You're going to have a lot of correlative
data confounding, and it might be really difficult to pinpoint.
I mean, a lot of the stuff we're talking about
already has animal and rodent studies that show cancer causing potential.
So how are you going to do that on larger
scale with humans.
Speaker 3 (15:55):
Well, you're right, we cannot expect to do ten year
randomized control trials. I mean, you know, people who wanted
us to hold off on our action on food dies,
we're saying, oh, we need more research, we need more resar.
When you have enough suspicion that we may be harming children,
why take the risk. And that's why we decided to
(16:15):
move ahead with the action on food dies. We're doing
it with other chemicals. You may have seen that the
company that makes Skittles just announced they're going to remove
titanium dioxide.
Speaker 1 (16:25):
Can you believe there was titanium dioxide and Skittles to
begin with?
Speaker 4 (16:30):
Well, that's the question A lot of people are asking.
Speaker 3 (16:32):
You know, it's not allowed in other countries, and so
I don't think our childhood obesity diabetes epidemic is a
will power problem. I don't think we should be blaming
the kids. This is something we are doing to kids,
and we have to look at everything.
Speaker 1 (16:47):
Well, the FDA has been speaking of olesity.
Speaker 2 (16:49):
The FDA has been fast tracking drug approval approvals kind
of at an unprecedented rate, it feels like, but post
market safety concerns tend to follow. I mean we see
things that get approved and then it gets taken back.
I have major concerns about the GLP one drugs like
ozempic and wigobi. I have gone on air publicly saying
I think there are incredible benefits to this. I think
(17:12):
they decrease systemic inflammation. Maybe you're getting more insulin sensitivity.
You're seeing lower cholesterol rates, lower rates of cardiovascular disease,
and everything that comes along with focusing on the metabolic
issues that people are having.
Speaker 1 (17:27):
But do you believe the FDA has been maybe.
Speaker 2 (17:29):
Too quick to kind of green light the broader indications
and use of these medications because we don't really have
long term safety debt.
Speaker 4 (17:36):
Yeah.
Speaker 3 (17:37):
Our job is to review applications that present clinical data
and to decide whether or not that data warrants us
to green light a drug for use by doctors. Now,
the key is doctors have to use their judgment and
wisdom on a prescription basis to properly select. So it
(17:58):
is a complex problem and so you know, what we
are trying to do is to empower people with information,
allow doctors to have access to treatments, and to cut
the red tape at the FDA while focusing on the
root causes. That's sort of our charge as a regulatory body. Now,
(18:19):
the work of all the health agencies and government have
a very comprehensive approach to health.
Speaker 4 (18:25):
We have been at the center for.
Speaker 3 (18:27):
Medicare and Medicaid throwing good money after bad into a
broken system. We have to not just talk about how
to fund our broken healthcare system, but how to fix
our broken healthcare system. And so Memonaz is a transformational
leader there. One of the smartest guys i've ever met.
Ja Bodicharia has taken a fresh new look on funding
studies on root causes.
Speaker 4 (18:47):
There's a root cause that's right in front of our eyes.
Speaker 3 (18:50):
And that has been relegated to sort of the fringe
of NIH research.
Speaker 4 (18:55):
And so now that legitimate science is going.
Speaker 3 (18:58):
To get the proper we're funding to be able to
do the proper studies. So we're taking a comprehensive approach,
and you know, we're doing our best. This is a
healthcare system that has been on the wrong track for
over fifty years, so we're going to do everything we can.
And at the FDA, I think one thing we can
do is partner with developers instead of just being a
(19:19):
receive only mode.
Speaker 2 (19:20):
I continue to have concerns about these GLP ones. I'm
starting to see the cases of blindness. I think potentially
we might start seeing those medullary cancer diagnoses. And the
fact that there's expanded use now in kids. It seems
like it's very much going in the wrong direction when
we are trying to get towards the Make America Healthy
(19:40):
Again agenda and going to those root causes you keep
talking about, But it seems our society and even our
medical institutions, and our medical people who are making recommendations
are saying for kids and adolescents and just about everyone
to start taking these medications. And it's not you at
the FDA, but it certainly has me concerned. And I
(20:01):
hope we don't look back in ten years like we
are doing at opioids and say we should have known that.
Speaker 4 (20:07):
And that's the benefit of being able to use big data.
Speaker 3 (20:10):
Now, we're setting up a system so that we'll have
eyes on drugs and devices as soon as they're approved,
so we don't learn nearly twenty years later that a
drug like OxyContin may have been involved in the deaths
of many, many, many thousands of Americans, or that byox
may have killed up to thirty eight thousand Americans. That
(20:32):
was kind of realized five years after it was approved.
Speaker 4 (20:35):
Why aren't we.
Speaker 3 (20:35):
Getting eyes on these data in real time as soon
as they're approved. So now with the power of big data,
that's one of our big charges. We're also trying to.
Speaker 4 (20:47):
Use AI to do our job better.
Speaker 3 (20:49):
This week we announced AI being used for scientific reviews
agency wide, and we had a goal of January of
June thirtieth. We are ahead of schedule. And under budget.
And now, as of today, all the reviewers that do
scientific reviews and inspectors and core staff at the FDA
(21:12):
have access to this AI review and one of them
told me the AI did in six minutes what would
normally take them two to three days to do. So
we're trying to modernize our agency so we can provide
real time information to guide people.
Speaker 2 (21:27):
Ahead of schedule and under budget. I think those would
be very proud of you guys there. I just want
to ask you about one more thing and then I'll
let you go. I know we're going over time.
Speaker 1 (21:35):
Now. I want to talk about small.
Speaker 2 (21:37):
Business owners, specifically American small business owners who are in
like the wellness and beauty industry, because they're pretty furious
with the FDA because the FDA is regulating products like
shampoo and conditioner, lotions and makeups kind of like this
with the same intensity as pharmaceutical drugs. Now, if you
you know, if you go back to like President Trump's
(21:58):
America First policy, it's all about protecting American workers and businesses,
Yet the FDA is kind of doing the opposite when
it comes to the hygiene and wellness industry here in
the United States. Specifically the small business owners, because they
are heavily regulated by the FDA.
Speaker 1 (22:14):
They are subjected to constant routine inspections.
Speaker 2 (22:17):
They're quite stressful, quite expensive, all the testing and everything
they have to do. But if anything is made in
China or some other country, it can just be sent
to the United States and then we buy it on
Amazon or wherever, and it is not subject to the
same scrutiny as the American small businesses that are producing
pretty much the same thing are.
Speaker 3 (22:38):
Yeah, we're looking at that nicole because there are a
lot of frustrations out there. And our goal at the
FDA is similar to the goal that Secretary Kennedy has
put forth, and that is we want to implement gold
standard science and common sense. And common sense is a
big theme and a lot of what we're doing. Sometimes
I look at processes at the FDA and I think,
(22:59):
this doesn't makes sense.
Speaker 4 (23:00):
Why do we do it this way?
Speaker 3 (23:02):
And some of it is from legacy traditions, some of
it is because of the sort of natural history of
the growth of a bureaucracy over time, and so we
have to re examine all of that.
Speaker 4 (23:13):
And one other frustration.
Speaker 3 (23:15):
I've heard people say is that they don't know what
the FDA is thinking. And so for investors, for small
businesses to come up with a new product, or to
invest in a business or product, you want predictability. You
just want to know what the rules are. You want
to level playing field. So we're doing a lot to
be out there. It's one of the reasons why I'm
(23:37):
talking to you now. It's one of the reasons why
we have been on video almost every day in some format,
being out there letting people know exactly what we are thinking.
Just like we put out in the New England Journal
of Medicine our framework for a new COVID vaccine regulation.
Speaker 4 (23:56):
And so we're going to keep doing that. We're going
to keep talking.
Speaker 3 (23:59):
We're going to try to buy predictability to businesses and investors.
Speaker 2 (24:03):
Well, the trust gap between the American public and the
FBA has never FDA has never been wider. Being on
camera and being transparent forthcoming is certainly the step in
the right direction.
Speaker 1 (24:13):
Final thoughts, what do you say to the people who
feels the agency protects industry more than the people.
Speaker 3 (24:20):
Yeah, so we have to both partner with developers and
work with them and at the same time ensure that
the scientific Review is impeccably independent, and so that's one
of the reasons why I announced that we're going to
do a lot in partnership with the industry. We're we're
starting this week a national listening tour with pharmaceutical executives.
(24:43):
But one of my first actions was to remove pharma
and industry members from all FDA advisory committees where statutorily possible.
And so that was basically addressing this concern that the
public has that the industry he has had points, the
agency has had points in its history where it may
(25:05):
have had pockets of capture by the industry that it's
supposed to regulate.
Speaker 4 (25:09):
So we're going to do our best.
Speaker 3 (25:10):
I don't think anyone has any question what our motives are.
Speaker 4 (25:15):
Our motives are to serve the American people.
Speaker 2 (25:18):
And you've also said that you will not be jumping
right to a pharmaceutical company as one of their lead
advisors as soon as you step away from the FDA.
Speaker 4 (25:28):
You know me, and you know that's not me.
Speaker 2 (25:30):
Know, Martin McCarey, thank you so much for joining us today.
I really appreciate you taking the time.
Speaker 1 (25:35):
I know Hope as you are.
Speaker 4 (25:36):
Great to see Nicole.
Speaker 2 (25:37):
I want to thank doctor Martin McCarey for joining us
and offering a candid look at where the FDA is headed.
Whether it's increasing public trust, streamlining approvals, or embracing new innovations,
it's clear we're entering a pivotal time and health policy.
As always, thank you for listening to Wellness and Mass.
I'm doctor Nicole Sapphire on America's number one podcast network, iHeart.
(25:58):
Follow Wellness un Mass with doctor Nichol's Sapphire and start
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your podcasts, and we'll catch you next time
Welcome to Wellness on Mass.
Speaker 2 (00:04):
I'm doctor Nicole Sapphire, where we peel back the headlines
and uncover what's really happening.
Speaker 1 (00:08):
In the world of health and medicine.
Speaker 2 (00:10):
I'm joined by someone today who needs little introduction, doctor
Marty McCarey, who's now serving as the Commissioner of the FDA.
We are going to talk about his vision for the agency,
what changes may be on the horizon, and how the
FDA plans to strike a better balance between innovation, safety
and transparency.
Speaker 1 (00:28):
And now we're not just going.
Speaker 2 (00:29):
To talk to him about the missteps that occurred during
COVID and how the vaccines and the COVID boosters were
continuously recommended into perpetuity without new data. We are also
going to talk about the expedited approvals of the GLP
ones where it comes to weight loss. Are too many
people using them? Do we even have safety data? And
what decisions the FDA are going to make about these medications.
(00:52):
I also want to ask him about American small businesses
who are being crushed under the FDA. We're specifically talking
about the hygiene, cosmetic, and wellness industries. Did you realize
that if you have a small business owner here in
the United States making an organic shampoo and conditioner, they're
subjected to costly testing, stringent guidelines, and also subject to
(01:14):
consistent inspections.
Speaker 1 (01:16):
Where if you look to China.
Speaker 2 (01:18):
The companies that are making cheap shampoo and conditioner are
able to sell it for cheap because they are not
under the same rules as the FDA. Why not Americans
are consuming those as well? Why is it not fair
to the American small business owner? This goes completely against
the America First agenda, So I want to ask doctor
McCarry about that as well. More coming up on Wellness
(01:40):
Unmasked with doctor Nicole Sapphire. All right, well, we're extremely
excited to have the new FDA commissioner, my friend and
former colleague, doctor Marty McCarey join us today on Wellness Unmasked. Marty,
let's talk about the FDA. In your view, how's it
been going the last four to five years.
Speaker 3 (02:00):
To evaluate how the FDA has done in its history.
I would say it is parallel to what the medical
establishment has done in its history, and that is, there
have been shining moments and there have been embarrassing moments
like OxyContin and yox and Mechina, And so the FDA
(02:23):
I think does best when we are incredibly transparent, when
we're humble, when we're open and honest about our mission
to safeguard the public and at the same time or
promote innovation. There are parts of the FDA that run really,
really well. There are parts of the FDA that are
very bureaucratic, and so we're trying to ask the big
(02:44):
questions that have never been asked before. Why does it
take ten years for a new drug to come to market?
Why do forty percent of our nation's children now have
a chronic disease and you don't see those numbers in
other countries.
Speaker 4 (02:58):
What can we do to create a great.
Speaker 3 (03:01):
Workplace environment, to make an attractive place to work? So
that's my focus as I walk into this role.
Speaker 4 (03:07):
Now. I think I've been here for about.
Speaker 3 (03:09):
Eight weeks or so, but those are some of the
questions that I'm exploring with the folks here.
Speaker 2 (03:16):
Well, something else that you've been doing that's made some
very recent headlines is that you're also demanding more data
when it comes to specifically COVID vaccines. The CDC can
remove the COVID vaccine from its routine immunization schedule for
healthy children. This came in a parallel time where you
were demanding that the pharmaceutical companies also provide more updated
(03:37):
data regarding healthy children and repeated COVID vaccines. But here's
my question, Marty, many parents physicians want to know. You know,
what was that decision based on. Was it compelling new
safety or efficacy data or was it just a tacit
admission that maybe the original data, you know, the justification
for putting it on the schedule in.
Speaker 1 (03:57):
The first place, was weak, flawed, or non existent.
Speaker 3 (04:00):
Yeah, so we don't have the data to support the
repeat booster strategy in perpetuity forever. That was a theory
that a young, healthy child should get a COVID booster
every year for their entire life, which would mean a
baby girl born today would get eighty COVID shots in
(04:20):
her average eighty year lifespan. And so that is a
theory that is unproven. We don't know if it's necessary.
We haven't fully assessed the harms of mRNA. We hear
of hundreds of thousands of individuals who have described injury
from the vaccine. There have been deaths from the vaccine,
and so people are wondering if the risk benefit ratio
(04:43):
favors a repeat booster in infinity. And so that's where
we have said, it's been about four years since we've
had randomized control trial data on the COVID shots and
the boosters, and it now is a different virus, it
behaves differently, and there's a large proportion of Americans that
(05:06):
have natural immunity or population immunity.
Speaker 4 (05:09):
So how do we answer that question?
Speaker 3 (05:10):
Honestly, for the twelve year old girl who comes in
and has already had five COVID shots, can we really
say that they need it? I mean, can we really
use that term in the absence of data? So I think, look,
we're taking an evidence based approach now on vaccines and
on the COVID shots, and so we published in the
(05:33):
New England Journal of Medicine and Evidence Based Strategy, which
brings us back to the gold standard of science where
we'll have clinical trial data to support. I just don't
think we should put on the blinders and blindly rubber
stamp COVID shots for young, healthy children in perpetuity. I
think we should get back to an evidence based approach.
Speaker 2 (05:54):
Well, you and I have been a lockstep with that
I think, you know, I was rage, texting and email
telling you you know, all throughout the COVID pandemic, specifically
when it started to be the universal recommendation was that
children get the vaccines, and then we saw the mandates
and then even the boosters came out.
Speaker 4 (06:10):
You know.
Speaker 2 (06:11):
The concern that I had as a parent and as
a physician was that we started hearing from the Israeli
public Health that there were safety signals, specifically milcarditis or
heart inflammation in young men, young adolescents, and yet we
even started seeing rising cases in our vears or that
self reported database. Now, I know we don't necessarily do
(06:31):
policy over anecdotes, but how come they continued to be
you know, year after year, continued to get that rubber
stamp under the Emergency Use Authorization, and like clockwork ASIP,
you know, the CDC's Advisory committee continued to recommend them.
Speaker 1 (06:47):
Without new data, but there was clearly.
Speaker 2 (06:49):
Safety signals going on. What do you think led to
really the absence of data the last few years that
you are now finally starting to demand.
Speaker 3 (06:56):
You know, there has been a sort of strong culture
of pattern, and you've seen it in some of the
minutes of the past ASIP meetings on the COVID booster
for young healthy children. I wrote a piece titled why
Americans Don't trust the CDC and specifically cited the minutes
of some of those ACP meetings a couple of years ago,
(07:16):
where they were basically saying, we need a streamlined message.
People will be confused if we have a risk stratified approached.
That is a nuanced approach treating a sixty five year
old with a comorbidity different from a young, healthy, nineteen
year old boy. And the truth is that we've never
(07:38):
really gotten great data on the myocarditis risk. Some studies
have suggested that the risk is greater than one in
three thousand young boys after the second dose of one
of the vaccines.
Speaker 4 (07:52):
Now that means tens of thousands of boys.
Speaker 3 (07:55):
Have been affected by myocarditis, and some studies have shown
that a third those cases result in scarring, which may
be permanent, it's maybe a long term sequala.
Speaker 4 (08:06):
So you have to take things seriously. You got to
use good data.
Speaker 3 (08:10):
If you don't use good data and you're not capturing
complication rates with good methodology, you make the vaccine look
safer that it really is. And if you don't distinguish
incidental COVID hospitalizations from hospitalizations for COVID.
Speaker 2 (08:25):
We were dealing with, you know, we were not getting
the full picture when it came to the numbers. It
was not accurate whether someone was you know, we've said
many times admitted with COVID or for COVID. I think
in the updated application to the FDA from Maderna for
their updated booster though, they cited that by ninety days
those who had vaccine induced mildcarditis, when they looked at
(08:46):
the past data, there was still symptomatic. And so that's
concerning because the talking points when you were turning on
the TV, you would say, oh, it's just transient, everyone's
back to normal. But at no point should we just
wipe away the fact that heart and inflammation is transient
and it's fine, it's an acceptable risk factor.
Speaker 3 (09:04):
People have died from myocarditis and it's not just you know,
fairy tale or anecdote from somebody or who's a friend
of a friend. It was in the New England Journal
of Medicine elcardiitis from vaccine induced that is a death
from myocarditis from vaccine induced myocarditis eighty five percent of
(09:25):
healthcare workers said no thank you to the COVID booster
last season.
Speaker 4 (09:30):
When you go to the UK and look at.
Speaker 3 (09:32):
Their recommendations, it's recommended for people over age seventy five,
not just sixty five seventy five or high risk, and
in France it's eighty years of age or high risk.
So we're really catching up to the rest of the
world with our new vaccine framework.
Speaker 2 (09:48):
Well, I notice also that the new updated Maderna booster
is a fraction of the original dose, and on top
of that they have to have the warning about art inflammation.
So do you believe that they have lessen the dose
because of they were found to have more cases of
myocarditis and hard inflammation than Pfizer, which had a lower dose.
Speaker 4 (10:08):
I don't know the rationale.
Speaker 3 (10:10):
It is true that there were higher rates of myocarditis
reported in the past with the past Moderna versus Pfizer
COVID vaccines. The recent MODERNA vaccine approval was only for
high risk, it was a limited group and they agreed
to do a randomized control trial as a part of
(10:32):
that approval. And it is as you said, Nicole, it
is a so I don't want to say it's a
lightweight version, but it only includes some parts of the
protein of the spike protein, not the entire spike protein
or the majority of the spike protein as the current
MODERNA vaccine that's on the market. So it is very
(10:55):
similar but does not include the entire protein of the spike.
Speaker 2 (10:59):
It'll be interesting to see what happens that. I mean,
the most recent ACIP meeting by the CDC in April,
I believe it was, they did not vote on updated
recommendations for the COVID booster and they said maybe it'll
happen in June, even though it kind of, you know,
I think it was the lightweight version of just saying
this should be a decision between patients and doctors on
(11:21):
the CDC immunization recommendation. When you're talking about the Affordable
Care Act and what is really going to be recommended
and covered by insurance is going to be based on
what the ACIP votes on.
Speaker 1 (11:32):
And they could go either way.
Speaker 2 (11:33):
They could continue the path that they've been going down
for the last four to five years of universal recommendations,
or they're going to.
Speaker 1 (11:40):
Do it risk base.
Speaker 2 (11:41):
And I have a feeling with your leadership and if
the FDA obviously you do have some influence there at
the CDC looking at the data. It'll be interesting to
see what they do and hopefully they'll give some more
clarity on that. You know, and I know that big
pharma does tend to.
Speaker 1 (11:56):
Get a bad rap.
Speaker 2 (11:57):
We talk about profit mongering and everything, but we rely
heavily on them in innovation, especially in healthcare. I mean,
they are the reason that we're living longer. And so
how do you at the FDA plan to foster a
relationship with innovation in the pharmaceutical industry but also holding
firm on safety and efficacy standards.
Speaker 3 (12:17):
At the FDA, we would like to see more cures
and meaningful treatments for Americans.
Speaker 4 (12:22):
That is one of our top priorities.
Speaker 3 (12:24):
We also want to see a discussion of the root
causes of the rising rates of cancer and young people,
of the chronic disease apidemic in children.
Speaker 4 (12:34):
We can't keep.
Speaker 3 (12:35):
Medicating our population at scale. We have to look at
food as medicine and the microbiome, and look at snap programs,
and look at the food supply and the chemicals that
are banned in other countries but allowed in the United States.
We have to look at chemicals, exposures that don't exist
in other countries. Ultra processed food was a theme in
(12:58):
the report. Percent of the kids of the food kids
consumer is ultra processed. And how about we talk about
light exposure in children and circadie and rhythms. We've never
really been talking about this. It's time to broaden that conversation.
So we want to see more cures and meaningful treatments.
We're doing a lot to cut the red tape, to
streamline the process and create new pathways for new treatments.
(13:23):
At the same time, we're spending a lot of time
on food, which is why you saw our action to
remove all petroleum based food dies from the market.
Speaker 1 (13:35):
So I mean you anticipated my next question.
Speaker 2 (13:38):
Because the FDA does historically focus more on drugs than
on prevention nutrition. With Secretary Kennedy as HHS secretary, obviously,
I imagine the food industry is taking more of a priority.
Speaker 1 (13:49):
We're already starting to see that. You know, what can
we expect?
Speaker 2 (13:52):
You know, from an FDA standpoint, you already mentioned petroleum
based food dies, but you also have like a spartane
and you know some of the seat oil and ultra
processed foods these are all linked to chronic illness, yet
still considered safe by the FDA.
Speaker 3 (14:06):
We work closely with NIH, and NIH is going to
be commissioning some really important studies looking at these root
causes and chemicals. We have to talk about the environmental
exposures and chemicals that cause cancer, not just the chemo
to treat it. And by and large, our entire medical
industrial research complex has been focused really on just the treatments.
(14:30):
And we're not winning playing whaca mole like this. We're
not winning or country gets sicker. We have the most obese,
the most insulin resistant, the most disabled, the most.
Speaker 4 (14:41):
Medicalized population in the history of the world. We've got
to stop.
Speaker 3 (14:45):
Well, you don't have the time or resources or energy
to just stop and put your head up and look
around and say, what's going on? Look at our population.
It has gotten sicker over the last fifty years. In
terms of cutting edge operations and chemo drugs and gene therapy,
modern medicine has been a fifty year success, but in
(15:08):
terms of the health of the population, it's been a
fifty year failure. And so we now want to talk
about food and that is a huge priority for this
FDA and this administration.
Speaker 1 (15:18):
You're listening to wellness and mass We'll be right back
with more.
Speaker 2 (15:24):
It always sounds good to say, well, we want to
make sure that we have the good research on it.
Speaker 1 (15:28):
We have the data.
Speaker 2 (15:28):
If we're talking about some specific foods, you know, no
one wants the government to come in and take away
something that they like.
Speaker 1 (15:35):
But the problem with that.
Speaker 2 (15:36):
Is that's going to be a lot of big population
based studies. You're going to have a lot of correlative
data confounding, and it might be really difficult to pinpoint.
I mean, a lot of the stuff we're talking about
already has animal and rodent studies that show cancer causing potential.
So how are you going to do that on larger
scale with humans.
Speaker 3 (15:55):
Well, you're right, we cannot expect to do ten year
randomized control trials. I mean, you know, people who wanted
us to hold off on our action on food dies,
we're saying, oh, we need more research, we need more resar.
When you have enough suspicion that we may be harming children,
why take the risk. And that's why we decided to
(16:15):
move ahead with the action on food dies. We're doing
it with other chemicals. You may have seen that the
company that makes Skittles just announced they're going to remove
titanium dioxide.
Speaker 1 (16:25):
Can you believe there was titanium dioxide and Skittles to
begin with?
Speaker 4 (16:30):
Well, that's the question A lot of people are asking.
Speaker 3 (16:32):
You know, it's not allowed in other countries, and so
I don't think our childhood obesity diabetes epidemic is a
will power problem. I don't think we should be blaming
the kids. This is something we are doing to kids,
and we have to look at everything.
Speaker 1 (16:47):
Well, the FDA has been speaking of olesity.
Speaker 2 (16:49):
The FDA has been fast tracking drug approval approvals kind
of at an unprecedented rate, it feels like, but post
market safety concerns tend to follow. I mean we see
things that get approved and then it gets taken back.
I have major concerns about the GLP one drugs like
ozempic and wigobi. I have gone on air publicly saying
I think there are incredible benefits to this. I think
(17:12):
they decrease systemic inflammation. Maybe you're getting more insulin sensitivity.
You're seeing lower cholesterol rates, lower rates of cardiovascular disease,
and everything that comes along with focusing on the metabolic
issues that people are having.
Speaker 1 (17:27):
But do you believe the FDA has been maybe.
Speaker 2 (17:29):
Too quick to kind of green light the broader indications
and use of these medications because we don't really have
long term safety debt.
Speaker 4 (17:36):
Yeah.
Speaker 3 (17:37):
Our job is to review applications that present clinical data
and to decide whether or not that data warrants us
to green light a drug for use by doctors. Now,
the key is doctors have to use their judgment and
wisdom on a prescription basis to properly select. So it
(17:58):
is a complex problem and so you know, what we
are trying to do is to empower people with information,
allow doctors to have access to treatments, and to cut
the red tape at the FDA while focusing on the
root causes. That's sort of our charge as a regulatory body. Now,
(18:19):
the work of all the health agencies and government have
a very comprehensive approach to health.
Speaker 4 (18:25):
We have been at the center for.
Speaker 3 (18:27):
Medicare and Medicaid throwing good money after bad into a
broken system. We have to not just talk about how
to fund our broken healthcare system, but how to fix
our broken healthcare system. And so Memonaz is a transformational
leader there. One of the smartest guys i've ever met.
Ja Bodicharia has taken a fresh new look on funding
studies on root causes.
Speaker 4 (18:47):
There's a root cause that's right in front of our eyes.
Speaker 3 (18:50):
And that has been relegated to sort of the fringe
of NIH research.
Speaker 4 (18:55):
And so now that legitimate science is going.
Speaker 3 (18:58):
To get the proper we're funding to be able to
do the proper studies. So we're taking a comprehensive approach,
and you know, we're doing our best. This is a
healthcare system that has been on the wrong track for
over fifty years, so we're going to do everything we can.
And at the FDA, I think one thing we can
do is partner with developers instead of just being a
(19:19):
receive only mode.
Speaker 2 (19:20):
I continue to have concerns about these GLP ones. I'm
starting to see the cases of blindness. I think potentially
we might start seeing those medullary cancer diagnoses. And the
fact that there's expanded use now in kids. It seems
like it's very much going in the wrong direction when
we are trying to get towards the Make America Healthy
(19:40):
Again agenda and going to those root causes you keep
talking about, But it seems our society and even our
medical institutions, and our medical people who are making recommendations
are saying for kids and adolescents and just about everyone
to start taking these medications. And it's not you at
the FDA, but it certainly has me concerned. And I
(20:01):
hope we don't look back in ten years like we
are doing at opioids and say we should have known that.
Speaker 4 (20:07):
And that's the benefit of being able to use big data.
Speaker 3 (20:10):
Now, we're setting up a system so that we'll have
eyes on drugs and devices as soon as they're approved,
so we don't learn nearly twenty years later that a
drug like OxyContin may have been involved in the deaths
of many, many, many thousands of Americans, or that byox
may have killed up to thirty eight thousand Americans. That
(20:32):
was kind of realized five years after it was approved.
Speaker 4 (20:35):
Why aren't we.
Speaker 3 (20:35):
Getting eyes on these data in real time as soon
as they're approved. So now with the power of big data,
that's one of our big charges. We're also trying to.
Speaker 4 (20:47):
Use AI to do our job better.
Speaker 3 (20:49):
This week we announced AI being used for scientific reviews
agency wide, and we had a goal of January of
June thirtieth. We are ahead of schedule. And under budget.
And now, as of today, all the reviewers that do
scientific reviews and inspectors and core staff at the FDA
(21:12):
have access to this AI review and one of them
told me the AI did in six minutes what would
normally take them two to three days to do. So
we're trying to modernize our agency so we can provide
real time information to guide people.
Speaker 2 (21:27):
Ahead of schedule and under budget. I think those would
be very proud of you guys there. I just want
to ask you about one more thing and then I'll
let you go. I know we're going over time.
Speaker 1 (21:35):
Now. I want to talk about small.
Speaker 2 (21:37):
Business owners, specifically American small business owners who are in
like the wellness and beauty industry, because they're pretty furious
with the FDA because the FDA is regulating products like
shampoo and conditioner, lotions and makeups kind of like this
with the same intensity as pharmaceutical drugs. Now, if you
you know, if you go back to like President Trump's
(21:58):
America First policy, it's all about protecting American workers and businesses,
Yet the FDA is kind of doing the opposite when
it comes to the hygiene and wellness industry here in
the United States. Specifically the small business owners, because they
are heavily regulated by the FDA.
Speaker 1 (22:14):
They are subjected to constant routine inspections.
Speaker 2 (22:17):
They're quite stressful, quite expensive, all the testing and everything
they have to do. But if anything is made in
China or some other country, it can just be sent
to the United States and then we buy it on
Amazon or wherever, and it is not subject to the
same scrutiny as the American small businesses that are producing
pretty much the same thing are.
Speaker 3 (22:38):
Yeah, we're looking at that nicole because there are a
lot of frustrations out there. And our goal at the
FDA is similar to the goal that Secretary Kennedy has
put forth, and that is we want to implement gold
standard science and common sense. And common sense is a
big theme and a lot of what we're doing. Sometimes
I look at processes at the FDA and I think,
(22:59):
this doesn't makes sense.
Speaker 4 (23:00):
Why do we do it this way?
Speaker 3 (23:02):
And some of it is from legacy traditions, some of
it is because of the sort of natural history of
the growth of a bureaucracy over time, and so we
have to re examine all of that.
Speaker 4 (23:13):
And one other frustration.
Speaker 3 (23:15):
I've heard people say is that they don't know what
the FDA is thinking. And so for investors, for small
businesses to come up with a new product, or to
invest in a business or product, you want predictability. You
just want to know what the rules are. You want
to level playing field. So we're doing a lot to
be out there. It's one of the reasons why I'm
(23:37):
talking to you now. It's one of the reasons why
we have been on video almost every day in some format,
being out there letting people know exactly what we are thinking.
Just like we put out in the New England Journal
of Medicine our framework for a new COVID vaccine regulation.
Speaker 4 (23:56):
And so we're going to keep doing that. We're going
to keep talking.
Speaker 3 (23:59):
We're going to try to buy predictability to businesses and investors.
Speaker 2 (24:03):
Well, the trust gap between the American public and the
FBA has never FDA has never been wider. Being on
camera and being transparent forthcoming is certainly the step in
the right direction.
Speaker 1 (24:13):
Final thoughts, what do you say to the people who
feels the agency protects industry more than the people.
Speaker 3 (24:20):
Yeah, so we have to both partner with developers and
work with them and at the same time ensure that
the scientific Review is impeccably independent, and so that's one
of the reasons why I announced that we're going to
do a lot in partnership with the industry. We're we're
starting this week a national listening tour with pharmaceutical executives.
(24:43):
But one of my first actions was to remove pharma
and industry members from all FDA advisory committees where statutorily possible.
And so that was basically addressing this concern that the
public has that the industry he has had points, the
agency has had points in its history where it may
(25:05):
have had pockets of capture by the industry that it's
supposed to regulate.
Speaker 4 (25:09):
So we're going to do our best.
Speaker 3 (25:10):
I don't think anyone has any question what our motives are.
Speaker 4 (25:15):
Our motives are to serve the American people.
Speaker 2 (25:18):
And you've also said that you will not be jumping
right to a pharmaceutical company as one of their lead
advisors as soon as you step away from the FDA.
Speaker 4 (25:28):
You know me, and you know that's not me.
Speaker 2 (25:30):
Know, Martin McCarey, thank you so much for joining us today.
I really appreciate you taking the time.
Speaker 1 (25:35):
I know Hope as you are.
Speaker 4 (25:36):
Great to see Nicole.
Speaker 2 (25:37):
I want to thank doctor Martin McCarey for joining us
and offering a candid look at where the FDA is headed.
Whether it's increasing public trust, streamlining approvals, or embracing new innovations,
it's clear we're entering a pivotal time and health policy.
As always, thank you for listening to Wellness and Mass.
I'm doctor Nicole Sapphire on America's number one podcast network, iHeart.
(25:58):
Follow Wellness un Mass with doctor Nichol's Sapphire and start
listening on the free iHeartRadio app for wherever you get
your podcasts, and we'll catch you next time
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