FDA Direct Ep. 5: What's the Deal with Talc? – Recapping FDA’s Expert Panel on Talc

It's good.

And we're doing this
and it's good to see you again.

So, Vinayak, good to see you, Sanjula.

Great to see you.

And today we're talking
about root causes of diseases.

And we are talking about
one potential root cause in particular.

And that is the roundtable
we just had on Talc.

And so we convened experts
from around the world,

and they came and educated us about talc.

And it was pretty eye opening.

I would say. It was!
I have, you know, my association of talc

was always baby powder. Right?

And even when a certain company
was in the news couple of years ago.

But I had not thought about it since then.

And now I'm reevaluating a lot of what I,
what I consume now.

Yeah, I learned a ton,
and I had not appreciated that,

it was used almost as
an industrial lubricant in the tablets

and pills of even commonly taken
prescription medications.

I hadn't appreciated that,

that was like case.
The number one, three, nine and ten,

most common medications in the United
States have talc. In the pill? In the pill or on the pill.

Presumably so that it doesn't get stuck
when it goes through the machines,

that machine, it or something. The machine,
or to keep the texture of the pill. I see.

And so million Americans
plus are taking talc,

probably on a daily basis,
on top of the talc that appears in food.

Yeah. Tell us about that.
It appears in like gum or something. Yeah.

So I mean it's crazy.

So, you know, I grew up,
my grandfather would always like

have gum in his pocket and have Pockets 
in his jacket. My dad would always have a certain.

And so I didn't know this.

I always thought, if you like open gum.
Do you Chew the gum, by the way?

Is that something you do?

I do, but now. It's okay. 
Maybe now I need to reevaluate this.

Its not smoking cigarettes.

It's like as a kid, right?

It was like this treat. And so it is.

I don't know if you can see it,
but like this, like dust, like dusting.

And I always thought it was sugar.

I thought was flavor.
Yeah, I thought it was sugar.

or flavor.

But I think in most cases, it's talc.

So it doesn't stick to the wrapper. Yeah,

to make it. Talc is definitely I don't know
how frequent, but it definitely

is used to prevent sticking
when it comes to gum and candy.

And it's been used ubiquitously.

Yeah. Throughout the food supply.

So lollipops with the wrappers.

They might have talc on, whenever
we see that white powder, sometimes

that is Talc. Well you know I
you know I'm try to look at the numbers.

And I was trying to quantify it.

But it's really hard because
usually it presents in trace amounts.

So sometimes you don't see it
on ingredient lists.

And it you know I think some places
you know, in the, in the medications,

generic versions may be less likely
to have it versus the branded versions.

But then, you know, it can be something
in like rice and in particular

like in international, you know, rice
like basmati rice, you know, probably

is more likely to have it, which is why
they kind of tell you to, to rinse it.

Or at least my mom told me that,

you know, when you cook the rice,
you rinse it and a lot of it.

Yeah, it could be the starch in the talc.

They put it in rice too? Prevent the rice grains
from sticking?

Not all, but it
but it helps prevent stickiness.
Interesting.

There's a study that is cited
in this recent review from Stanford

that showed that some of the rice,
I think it was in China was tested

and they found talc on the rice, 
you know, particles.

So it's again industrial lubricant.

It prevents, you know, jamming in the
machines and mass production of food.

Yeah.

And so talc is really kind of everywhere.

And makeup, I mean, it's
probably in my foundation or something.

And I mean, it's just everywhere.

And we've learned a lot about talc,

and the potential carcinogenic
risk over the last years or so.

And it was historic.

It was it was not well appreciated
just a few decades ago

that it could be linked
to potentially human cancer.

Well, that's what's nuts
is we thought it was just in baby powder.

There was a big effort
to get talc out of baby powder.

Yeah. But we're eating it. Yeah, yeah.

And so what I learned at this roundtable,
we're going to say something.

Oh, I was going to say,

I think, like,
initially people thought that, like, talc

was carcinogenic cause
it also had asbestos in it.

But then even when you look at talc
separate from the asbestos

containing talc,
it still had a concerning safety signal.

And you're going to say, so,

And then there's still residual amounts
we're ingesting

and inhaling
and inhaling and putting on our face.

And so yeah go ahead.

This all started in 
when the National Toxicology Program

did a report and they found, quote
unquote, clear evidence

of carcinogenic activity
in animal studies with talc.

And then that spurred
this series of studies that was reviewed.

All the studies from to 
were reviewed.

And, 
specifically looking at ovarian cancer.

And they found that
there was a statistically significant

association between talc exposure
and ovarian cancer with an odds

ratio of so roughly
a % increase in ovarian cancer.

And in some cases,
when there was higher exposure,

there was believed to be an even greater
risk of ovarian cancer.

Now, ovarian cancer
I think affects like in women.

We now generally believe it comes,

the most common forms come from
the fallopian tube. Yeah and not the ovary itself.

And so, there was a pathologist
at this expert panel who actually said

I was looking at ovarian cancer cells
after resection

and could see talc in the ovarian cancer.
In the tissue. In the tissue.

Wow.

Then in

there was a review of 
studies have found a similar 

odds ratio and its causing cancer.

So it sort of affirmed the other review.

And then in Taiwan, they did a study

where oral talc consumption
was associated with stomach cancer.

And guess what

Cancers in the United States
are going up in young people?

It's the GI cancers with no known cause.

Now, I'm not suggesting I should be going
to be careful in this role.

We're not saying,

you know, this is driving our chronic
disease epidemic or this is driving

rates of cancer in young people to go up

when rates of cancer
and other groups are going down.

We, we don't know.

It's a scientific unknown,
but we have enough studies now,

that are pointing to the health concerns
of talc.

And I remember

as a surgical resident,
we would put talc in the chest tube

because it was known it would create this
intense inflammatory reaction

and that would create
such an inflammatory storm

in the pleural cavity
that it would create scar tissue.

And it did it very effectively.

That scar tissue would keep the lungs
suspended.

We should explain it.
So this is called pleural DCIS.

And so, unfortunately,
there's a subset of people

who have plural effusions
or fluid around the lung.

Often it's cancer related.

They have cancer there.

And that cancer sort of weeps fluid there.

And that kind of causes the inflatable
part of the lung to collapse

and the fluid to fill around it.

And you can have patients
who have shortness of breath

and they have to keep
coming into the doctor,

and we keep tapping them
and removing that fluid,

pleural synthesis and take it off.
Take it off.

But after a while that becomes so onerous.

We say, is there something we can do
to just keep the lung

inflated. We use to put talcum powder
in the cavity and get the, the,

the, the lung to stick to the outside
wall of the chest

so that it stays inflated in
the fluid has no place to go.

And when you say inflated like it's
basically to say inflamed?

It, well, there's an inflammatory reaction
on the edge and that creates fibrosis.

And it actually becomes kind of stitched
together like micro stitched.

I mean,
to let you know that there adherent

and this is called pleural DCIS.

And yeah, and the surgeons were
the ones who were doing it.

Surgeons like Marty. Guilty as discharged.

I did it.
And but that was the standard of care.

Oh yeah.

And I mean, it was the reason it was,
is because they at the time

did not recognize
the health concerns with talc

or at the time, even asbestos
contaminated talc that we do today.

And it was such a powerful driver
of inflammation.

And what, what strikes me as somebody
who's taking care of inflammatory bowel

disease, which has been going up
with no known cause, we have no idea why.

I mean, I, I have my hypotheses
that we're altering the microbiome

and ingesting so many pro-inflammatory
agents in the modern diet.

But here's something
that causes inflammation.

At the same time, we're seeing a rise
in inflammatory bowel disease,

inflammatory conditions,
ulcerative colitis, Crohn's disease,

all these inflammatory conditions
that drive chronic disease

coupled with insulin resistance,
that's kind of like the one two punch

general body inflammation
caused by that cumulative

effect of all these chemicals
that go down the GI tract.

And insulin resistance

probably explains a lot of disease
that we are trained to treat,

but not really, told what may be an underlying.
root cause. root cause.

So but one question for you and, 
are there alternatives?

You mentioned that there are
some other tablet two and four and seven.

They don't have it in them.

So what are the alternatives to machine
tablets that don't require talc?

That was pretty.

One of the amazing things I learned
yesterday is right,

despite having all this evidence.

There are alternatives that exist.

And it's
and there's a couple of them, right,

that are naturally occurring
that are already being used in production.

Magnesium stearate
was mentioned in the expert panel.

I think it was calcium stearate. Yeah.

It was.

The. I asked the expert on the panel,
everyone should go watch this panel.

We're going to post it on

all these social media platforms
starting at the beginning.

Not with the elevator music first.

I know that was a pet peeve of ours. Yes.

Yeah. It needs to start
with the starting of speech.

Yeah. Welcome.

Yeah, yeah.

So, people are going to see,
this incredible discussion

where, this expert who talked about these
low cost, these alternatives.

I asked him what the cost was, and he said
they're comparable and they're a low

cost. And widely available
as far as availability.

Yeah, it's just amazing to me.

We don't talk about that.

How many oncology conferences
have I gone to where

we're talking about cancer
in every dimension.

We're talking about the sort of the
soul of the person we treat with cancer.

We're talking about the cost.

We're talking about, 
the latest discoveries.

We're talking about chemo and radiation
and proton beam

and Car-T therapy and immunotherapy
and sophisticated technical operations.

We talk about every aspect of cancer
care at our oncology

meetings,
except that what might be causing cancer.

Yeah, right.

And to me,
that is just mind boggling. Modifiable exposure

over the course of a lifetime that can be
mitigated is something

that is woefully under discussed in
every oncology conference I've ever been to.

But it makes sense, right?

The system is working
the way it was designed

from an economic incentive
point of view. Right?

I mean, we incentivize physicians
to treat I'm not saying,

you know, physicians
don't care about the root causes,

but in their data practice,
you're thinking about

what are the treatments.
You have people coming in the door

who has cancer already,
and you have to take care of them.

And that's what you're thinking about.
And also the science of root cause

it's it's tough.

I mean, we're exposed to lots of things

in the course of our lives,
and we are all very different people.

And trying to separate these things
is a very difficult scientific task.

So I guess the question so we, you know,
we had this roundtable discussion right,

to open our eyes
to all of this evidence, a lot

that's been around
for a couple of decades now.

And there's more evidence coming out.

And there is a viable alternative,
some of which is being used,

some that's not so much.

So, Marty,
why is it that we think as an industry

just the implementation of a substitute
would just be too hard to bear?

And maybe that's why

we haven't acted on this yet, or like,
why have we been ignoring this?

The few people
I've talked to on the manufacturing side

are generally unaware
of this body of literature.

That, and expertise that it has been,

you know, waving a flag to say, whoa, hey,

you know, this may be a carcinogen,
and it may be no coincidence

that the orally ingested talc
in the Taiwan study caused stomach cancer.

And it may be no coincidence
that the, talc

powder that was used in women in the,

study of ovarian cancer, the proximity

and the finding of talc in ovarian
tissue in patients with cancer.

They're saying, look,
this is no coincidence.

You're right Vinay, sometimes

the root causes
are hard to study or impossible this time.

Right? Right.

The impact of red dye
number on on cancer rates.

We know
sometimes these are causing inflammation.

Sometimes we have animal studies.

But in this case,

actually there's a ton of data
that we've just not been talking about.

It's just I don't want to say ignoring it
because that implies some, some malice.

And I don't think there is any malice.

I think the scientific community
has caught up,

with the studying
this molecule, and we just have not been

we're disconnected from that community.

I mean, the scientists that were in at at
the top roundtable were impressive.

I've never heard of them.

They don't come to our oncology meetings.

Yeah. And it's like front and center.

These are the root causes
that get me excited

because we can actually take a hard
look at this with an evidence

based approach and use common sense,
because I don't think anyone would want to

say, yeah, there's a lot of evidence
to suggest it causes cancer.

But you know what?

Let's just wing it.

The kids will probably be fine.

Yeah,
the rates of cancer are going up in kids.

Yes. The rates of, inflammatory
conditions are going up in kids.

But, you know, it's
probably not from that.

You know who thinks like that? Yeah.

I just wanna make
one point, which is that,

one of the things you've

taken on is mitigating
potentially harmful substances,

that we're Americans are just ingesting
millions of Americans and includes

your petroleum based dye initiative
that's touching on this talc issue.

And on other issues,
we've talked about the importance

of randomized controlled trials.

So sometimes people say to me,
how come you don't need

randomized controlled trials to take out,
the petroleum based dyes?

And I say that, you know,
this is just a simple teaching point.

The evidence to take a medical product
that's supposed to make you better

is different than the evidence to mitigate
a potentially harmful substance

you're ingesting,
for which there are substitutes,

for which
there are no real clear benefits.

So the standard to remove a petroleum
based dye that, if anything, just makes

cereal more, 
visually appealing to children

and has no real purpose,
that standard is going to be different

than injecting yourself
with a yearly booster.

And so naturally, for for medical
therapies, we ask for randomized data,

but we don't ask it for risk
factor mitigation.

We don't ask it to tell people

to stop smoking, or to remove petroleum
based dyes, or to take action on talc.

And that's a fundamental difference
between public health,

which is one hat

you wear, and being a doctor,
which is another hat you wear

and you're doing
both in the commissioner role.

So I think it's good
to explain that to people.

And I mean, you make a good point.

We talked about this
last time around that meeting

I had with a couple of the scientists

talking about another different food
chemical that I can't name just yet.

And we were reviewing the literature
and announced the names. Right?

I mean, I'm still learning all these names,
but it's that different

standard of what type of studies
in correlation and causation.

But with food,

it is so hard to isolate every single one
and then do this year long study.

And to me it's intuitive
that I mean. It's common sense.

It's common sense.

Like, you know, I need to be,

I don't want to ingest, dyes
that may potentially be harmful.

I have a much lower threshold to

to try to eat healthy, you know, than I do
to, like, get medical products.

And what was powerful, sorry Marty,
what was powerful about the roundtable

discussion was that you had experts
from all different segments, right?

You had NIH,
you had, you know, Stanford and Brigham.

You had, someone from university out
in Australia.

You had industry, right?

And everybody had a different
lens on the evidence

and focusing on different methods
and types of data.

And they all said, we're never going
to have %, kind of knowledge.

Here right.

If it's like a puzzle,
you're gonna have a couple of

pieces missing, but we have enough pieces
to kind of see the puzzle.

Right.

And that's enough to to say that
if there is an alternative

and there's enough compelling data,
we should probably do something, right.

And they were all consistent in that.

And then the other thing
we think about it, FDA, is

what is the evidence for the alternative?

Is the alternative safe?

What do you know about the alternatives.

And so that you know that
that's part of this discussion too.

And part of this thinking.

Yeah.

When there's a low cost alternative
that changes the whole calculus.

Why are we taking this risk? Right.

If we're taking the risk for a potential
big benefit, that's one thing.

Taking it when there's a low cost alternative.

Don't you want
colorful breakfast cereal? Marty doesn't

do it, right.

Yeah, but, you know, all these issues,
it's it's all the same.

And you've approved a bunch of food dyes
that are from natural products, right?

Yeah, yeah, two dyes from natural colors.
We love them.

Yeah, we love them.

And, so we've approved a bunch more.

So with three, just,
about a week and a half ago. Yep.

But on the on the talc.

And by the way, your point
about the vaccines, it's interesting

because our job, 
as we are commissioned by Congress

is to review evidence and then

greenlight chemicals
based on what is safe and effective.

Generally, we're talking about drugs
and devices, right? So

in the vaccine world,
in the vaccine booster world, we have new

vaccine boosters that are creating
a new protein in the body.

If you think about that camp that
we talked about last time, that is the,

blindly approved boosters

every year in perpetuity
with no clinical trials.

I forget what you called
it. BBP.

BBP. without a clinical trial.

Yeah, yeah. Yeah.

Right. Awesome.

Yeah.

Which is alive and well
and vocal inside. It's a minority group.

They're really telling us to suspend

our responsibility to determine
what's safe and effective

and to greenlight new things based on,
you know, an assumption.

Yeah. So, I think the talc thing.

Sorry to go back.

No, no, no,

no, no, no, I think it's

I think it's interesting
to draw the distinctions between the

to kind of fundamental roles
you have as FDA commissioner,

but, and it ties what you've been saying
all along about common sense

and gold centered science. Right?

These are all different types
of studies and methods and evidence.

But you have to think about it
a little bit nuanced

and differently based off the application.
And the use case.

Evidence is always contingent
on the specific question you face.

And that question is different
in these two use cases.

And it's,

you know, it's something

that comes up in your world of cancer
drug approvals all the time.

Do you know,
do you look at surrogate endpoints,

or do you look at clinical endpoints
that are meaningful to patients.

That is overall survival.

So this is another terrific point,

which is that our regulatory
framework acknowledges that the evidence

to give a blind booster in perpetuity
to a seven year old healthy girl,

we're going to want to see evidence
that makes us confident

the benefits outweigh the risks.

But if somebody has a life threatening
terminal disease, it's a rare condition.

They're not that many people out there.

That person should have tremendous
regulatory flexibility to choose

to take products, based on surrogate
or intermediary markers,

while we continue to follow up survival
in real world data sets.

So our it's it's not one size
fits all across all of these questions. Amen.

and not even rare conditions.

Yeah, not even right.

Common cancers.

Surrogate endpoints are powerful.

But we should also be looking
at these overall survival endpoints

after the approval.

And we'll be able to do that
with our big data team,

which is actually right next door
working like crazy.

And so they're going to help consolidate
the adverse event databases.

They're working on this big,

post-approval monitoring, data
set that's going to be powerful.

So back to kind of talc and food
then, right?

You're not going to have survival
endpoints in that context necessarily.

Right? It's
a little bit of a different mechanism.

So where do we go from here.

We had this great discussion,
great evidence presented.

What happens now?

So to me for years we've known
Talc causes cancer in animal studies.

And then we have
all of these other studies in humans.

We have enough suspicion.

You can see where I'm going with this,
but I'm not going to make

any announcements right now.

But this is a conversation with 

Petroleum based food dyes.

We looked at the heavy hand.

The heavy hand of regulation, the hammer.

And we looked at,

the civil courtesy
of working with industry

to get them to voluntarily
remove these products.

So, we're going to have an internal set of
meetings to talk about, talc.

But it's amazing to

me to think that million plus
Americans are taking

this daily in their medications,
assuming they're compliant.

And, on top of that,
kids are eating it in

candy, all the time.

And yet we had this big pile on
to make sure we get out of,

you know, the business that people stop

exposing women
to talc, on powder on their surface.

So to me, there is a there's some
there's something potentially big here.

It's a little tragic.

It's taken over years
for us to have an FDA panel

where we bring in experts
to talk about this, but, it was good.

I, I encourage
everybody to go and watch it.

I got a ton out of it.
It was really eye opening.

We're going to post it.

So, I think it's one of those

great opportunities
we have at the FDA to look at not just

medications and therapeutics,
but also root causes

because of the jurisdiction
we have over food.

And that's just the first of many
that you have planned, right?

You're planning to convene
a couple of other

expert panels on a few other
topics. Hormone replacement therapy and menopause.

Menopause has just not gotten
the attention it deserves.

And unfortunately, there's
a lot of misinformation on menopause.

I mean, I remember a

woman came into clinic

once with all of these symptoms,
this whole constellation of symptoms.

And, you know, everyone got
went to the back room where we, you know,

code and bill and chart the document.

I call it the coding room.
It's called the clinical room.

Spend all our time there.

You know what code for those. So,

we got went back there
and everyone came up with these elaborate

theories
of what could connect all these symptoms.

And then it was like a female
medical student that said, hey, guys.

It was because mostly men she has
just,

She's going through menopause.

Yeah.

It just hit me like we are not

we still don't
that are not properly teaching menopause.

There was a general feeling
that hormone replacement therapy,

which can not only alleviate the symptoms
but have started before age can

have incredible long term health benefits
to bone, heart, all kinds of things.

And because of the dogma
that it causes breast cancer,

I should say that it, increases

the risk of dying of breast cancer,
which has never been found to be true.

The increased risk of breast cancer
mortality, never been proven

because of that dogma, people
have felt like, well, there's nothing

you can treat menopause with. So why

educate students
on menopause or residents on that?

If it's nothing you can do for it.

So just

women just kind of need to tough it out
unless they want to take some cancer risk.

That was generally the dogma.

And so we're going to be bringing
in experts

to address the latest state
of the art science on that topic.

And some others. Yeah. I'm excited.

That'll be fun to unpack it.

Exciting times here. Great.

Well, 
so Vinay is dying to get back to his office

getting you how to get back
to a giant stack of meetings.

That's true.

Very true.

Hesitate to say that
because what's it say about me, man?

You got a lot to do.

You're probably late for a meeting.

Yeah, a bunch of meetings today,
and it's been.

It's been great.
We got just some exciting.

I wish I could sort of share every meeting
I have this afternoon with the world,

because it's.

This is a great opportunity.

It's a great time.

It's a great FDA and so great to see you Vinay.

Great to see you Sanjula.

Yeah okay,
guys. We'll see you again soon.