FDA Direct – Understanding New World Screwworm with FDA's Vet Expert

Hey, folks.

We're here with Tim Schell, who runs our Center
for Veterinary Medicine, and Sanjula.

Good to see you as always.

So today, we're talking about something
very interesting.

Screwworm.

Except what is screwworm?
Because I had to learn a lot about it.

First of all,
it looks disgusting. Yeah. And, Yeah.

You have a couple photos there?

Yeah, there's a couple photos in here.

But, Tim, just in case anyone is finishing
their lunch as they're listening to this

and about to vomit here,
we're going to facilitate that.

That's the warning I was going to give.

You know,
make sure you have not eaten recently.

Oh there it is.

There's the screwworm,
it looks disgusting.

Like a lot of parasites.

But, Tim, tell us a little bit about it
because it's been in the news a bit,

but it's been something
that you've been thinking about

and working on and preparing for
and planning for a long time.

First, let me say I'm glad you didn't
show the true infestation pictures.

Oh, I've got those too.

That's the one you can't stomach.

But yeah, screwworm

is, new to the US in the sense
that we haven't had it since the s.

We had a small outbreak in the s,
but screwworm is a fly.

The fly will land on open
flesh wounds and will deposit its eggs.

And then the larvae hatch

and the larvae burrow into the flesh

and can cause, 
very serious damage to animals.

And if it's not treated,
it could be fatal for animals as well.

So the, screwworm has been pushed
to South America for many years.

We managed to control it, but, 
since I believe it's started to move

north and it's about, a few hundred miles
south of the U.S right now.

Our concern with it
is that it could infest animals

and come to the U.S
and cause serious economic damage

to our livestock production
here, specifically areas like in Texas

where they have a very large cattle
population, very susceptible,

we're concerned about wildlife
bringing it over.

And so our role at the FDA and CVM in
particular is to evaluate the products,

that could be used for treatment
or for prevention of screwworm.

And so we're busy trying to look at those
products and be prepared for that.

And we've looked at a lot of products,

with the declaration
of the emergency situation,

it'll allow us to evaluate products
and see if we need to issue any emergency

use authorization.

It'll allow us to speed up the process
to get the information we essentially need

to try to get products on the market
as soon as we can.

So maybe we should just to clarify
for everyone

why we're even talking about screwworm
today, right?

Because there've been some headlines
around it.

Well, this has been a problem
that's been brewing.

I've got some numbers here.

There are roughly cases

in animals over
the last three years in Central America.

Those are the numbers I have.

And in some areas of South America,
some have said it's endemic.

Now, a couple things
everybody should know,

what percent of cows in the world
are infected with a parasite?

Nearly all of them,
I mean, the vast majority.

And so we're talking

about a type of parasite
that appears to be entirely treatable.

And that treatment is,
there's a number of products out there

that probably don't want to say,
but ivermectin is one of them.

And in that family of drugs,

but we

are, we probably should preface this
by saying that there is no risk

that screwworm will cause a pandemic
or epidemic in humans.

No one is worried about that.

It's it's so there are so many steps
that need to take place, as you described

for us, the transmission
pathway. Yeah. The transmission.

But you may have to have an open wound.

You have to have exposure to flies

that are, you know, inspected, infected
with the larva that then can land.

Yeah.

You know, it would obviously start
with a small wound or infection

that would then continue to grow.

So if this were on a human
you'd quickly notice a wound or something.

But on an animal it can go unnoticed.

So, this is really about protecting, 
livestock.

And in a way that, makes sense
and in a way that follows protocols

so that people can know that, 
the system is working.

The USDA will inspect essentially
every single animal

that goes in, processing meat, poultry.

And so that screening procedure
would pick up an open wound,

especially when one of these gnarly wounds
with larva, infecting that.

Yeah.

And just to add to that,
I mean, obviously the, we’re

working with the USDA
and they're very aware of the situation.

So they're very alerted
to looking for these possibilities.

So when animals are processed,
they will look for those

and pull them aside if they are there.

So there's no concern
about eating these products. No, no.

And I think,

you know, to

go to your point about whether, you know,

there's a human issue in the countries
that have had this for years, right?

There's only a few hundred cases
in those countries altogether.

So it's not something
that rapidly transmits to humans.

That would be a big concern for you.

Put that in a scale.

It's about less than %
less than percent, I believe.

Right. Exactly.

That's crossed over to humans.

Yeah.

And, no,

there's never been a reported case
of somebody getting screwworm infection

from eating beef.
And so that's an important point.

Now, that's not saying that's impossible
for all of eternity, but it's

in the tens of thousands of cases.

Never been a single report.

Yeah.

I think at this point, as you mentioned,
products being available.

We currently don't have anything
approved for screwworm,

but we do have some remedies
that we think will work.

It's just a matter of us getting the data

and putting that information
out in the hands of veterinarians

and livestock producers,
so they use these effectively.

Obviously, one of our primary
concern is food safety, right?

So we want to make sure
the withdrawal periods are followed

and that the human food supplies
remain safe.

Can you explain when the withdrawal period
is? Sure.

That'd be the time
they were treated with the drug

at the time that they're eligible
to go to market, or be eaten, so.

Well, that's it.

I mean, this is in the news
because there was a case of a human

who had recent travel to Central America,
right, who had, a case of screwworm.

And so, that didn't appear to be
any serious health concern,

but it is in the news.

We want people to know we're on top of it.

We've got this declaration
that enables us to move really fast

with the authorization of treatments
for animals with screwworm.

And, 
it is one of these slow moving, sort of,

you know, endemic things in cattle that 
we just have to keep an eye on and manage.

I think obviously the USDA plays
a really big role in this.

Especially we talk

Customs and Border Patrol
and keeping animals from coming across

the USDA inspections.

So there's a lot of us, a government
agencies involved in trying to protect us.

Yeah, it's
nice to see a coordinated public health

response
focus on preventing things. Right.

And it's
nice to be able to talk about it. Yep.

So I know, Tim,
you know, we've chatted a little bit

about kind of the broader CVM portfolio
and your passion about a lot of areas.

You had a fun analogy.

You know, you oversee pets and protein.

So I kind of think about that analog.

But what does, are there
any interesting trends

you're seeing the animal space,
like I think it's interesting

you mentioned some stat about pet owners
consume more, spend more money than.

Yeah. So, 
the the pet industry is booming.

People are very willing
to spend money on their pets.

I think if you go to the grocery store
or certainly if you go to a pet

supply store, the number of products
available for animals is just incredible.

We're talking mostly about feed,
but also there's drugs that,

consumers are interested in,

and they want to make sure
they're available for their animals.

They're spending a lot more on,
treatments for like, cancer, diabetes,

you know, mobility, long term things
that you wouldn't normally see in pets.

Consumers
are very willing to pay for those now.

So that's caused the increase
in those kind of products

for us to review
and to make sure they're safe for animals.

So we do see an influx of those now.

Are you seeing any kind of trends in terms

of, kind of the MAHA movement
as it relates to some of these products?

Yeah,
I think the concern would be things like,

you know, the GRAS issue,
whether these products,

there could be products in my animals
that have never been reviewed by the FDA.

And the answer is yes,
there could be, because,

you know, not
everything has to come to FDA right now.

Certainly.

We would like to see
that everything comes to the FDA

for some type of review

so that we can be sure they're safe
so that was one concern.

There are continually contaminants out
in the environment.

We talk a lot about the PFAS chemicals
that, are those forever chemicals

that end up in the water supply,
that end up in plants.

You know, we've done a lot of activities
around the PFAS to try to look at

where they're coming into animals,

and that would eventually
into the human food supply.

So there are a lot of MAHA type
things in the animal space as well. Wow.

Do you have any pets?

I was just gonna ask.
I do have pets. Yeah.

Yeah,
I have, two dogs and one, cat right now.

Okay.

What breeds?

So I have a Border
Collie and a Bernese Mountain Dog.

Okay. Wow. Okay. Commissioner,
do you have any pets?

I do not, my wife's allergic, so although
that's a little too much information,

she'll probably say,
keep me out of this. But,

Is pet

ownership increasing or decreasing,
it's increased, quite substantially.

So it's around, I think they said there's
around million pets in the U.S.

now, about % of households
have a pet in the house.

It's gone up in recent years.
And there's some really fun stats.

This is one of my favorite ones.

So % of pet owners
say that their dream job would offer

paternity or paternity leave.

And so they're they're looking.

That goes to my point
about them willing to spend money.

Right. Exactly.

And then to the money point,
a third of pet owners

spend more on their pets
than they do themselves.

And I think it was like or %
spend more than their significant other.

So no comment on that one.

Yeah. All depends how much you're spending
on your significant other.

Yeah it's it's all relative. It's
a moving benchmark. Yeah.

So you know it's been interesting
to learn a lot

about the animal health
versus human health.

Are there any other parallels.

You know, GRAS is a kind of common policy
area.

Healthier food for pets
seems to be a trend.

Yeah, yeah.

I think, one of the things to
to remind you of

is when, when we feed our pets,
we generally feed them a same diet.

They get the same diet all the time.

Usually if you get a brand
and you like the brand

and your animal forms well on the brand,
you keep buying it right?

So the animal has a very limited, intake.

And so if something's wrong with that,
it can be very problematic.

If it's deficient
in a particular nutrient,

the animal will suffer that consequence
because it'll be long term fed,

if it has a contaminant.

And same thing that it could potentiate
a problem much faster

because that's
the only thing they're getting.

So you have to be aware of the fact
that animals,

you know, are kind of bound
by what we feed them in a lot of ways.

So we have to be careful
what we're giving them is safe.

And is it fair to say on the human product

side, we've been talking a lot 
in these conversations

around the importance of, you know,

post-approval monitoring and real world
data and, domestic manufacturing.

Does that all kind of roll
over to the animal side, all this,

all the same scenarios? Right.

We we have a lot of
our industry is abroad in the drug side.

And we depend on those products
coming into the U.S.

and it's a little scary
sometimes when we have problems.

And the supply chain, doesn't allow us
to have the products that we need.

So we're a little aware of that.

What was the other part of
you were mentioned?

I forgot, 
you mentioned in kind of aligning the data

submission pathways with kind of reframe
when you modernize a lot of.

Yeah, we're spending a lot of time,

one of the things that we've done at CVM
in the last year

is we've solicited ourselves
for a lot of feedback,

and so we're on the precipice of being
able to say, we got all this feedback.

What are we going to do with it?

So we're in the position right now

where we're evaluating all that input
that we have and figuring out

how we're going to use it, and
what does that look like to move forward.

I think it's fair
for us to challenge ourselves

and get the feedback to say, okay, how
can we get better if we don't ask for it?

We're not going to know
and we're going to,

you know, complacency
is one of my big concerns, right?

If we

if we sit there and think we're doing fine
and everything doesn't need to change

while the world around us does change,
then we have a problem.

So we've solicited a lot of input.

Now it's up to us to implement those
changes that can benefit our industries.

And your background is in, you have a PhD,
I understand.

And is it sort of animal health.

So I have a PhD in pigs. So I'm a pig guy.

PhD in pigs? Yeah. That's right.

And you're asking yourself ...
That's what your diploma says?

No specifically. It's in swine nutrition.

So I got a master's
and PhD in swine nutrition.

And, it's a long story
how I end up there.

I'm not really sure how I ended up there,

but I did like pigs somewhere
along the way.

Okay. Wasn't like, birth or anything?

You know, I could only study pigs. My.

Well, you know,
when you're in, you’re in high school

and you say you like animals,
what's the first thing they tell you?

Well,
you got to go to vet school, right? So.

But but you just don't know
what the world looks like.

And as I got into the animal world,
I realized my interest was in, teaching

and research, and you didn't really need
to go to vet school for that, right?

So I focused on teaching and research
and moved in that direction.

Did you grew up around pigs
or anything like that. Wow.

It is a fascinating animal.

Yeah, they’re smart,
they can essentially eat trash.

And right,

I mean, I don't know if I call that
a plus, but, yes they can, so, yeah.

Right.

My major professor actually did
a lot of work on feeding trash to pigs.

That was one of the things he did.

I know in some very poor
parts of the world, they, you know, they,

pigs are an important, 
form of sustenance because,

you don't, you know, where they don't
have enough food for humans, right?

Sometimes the the pigs can survive.

And so it is a fascinating animal.

And of course, now
there's a lot of research into, organs

that come from pigs, pig farms
that are, genetically modified,

lines of pigs that are used for, 
experimental organ transplants.

And, I think one of those pig farms
is in Blacksburg, Virginia.

It is. It's not where you did
your PhD. Yes.

They have a nice facility down there.

It's funny that one of the reasons

I was interested in pigs is because
of their similarity humans. Right?

So you could go into human nutrition,
you could go into human medicine,

you could stay in animal medicine.

So that's kind of one of the reasons
I was attracted to pigs.

And it's it's worked out very well.

Is it true that pigs have been sort of,
in one experiment, taught certain tricks,

frozen for an extended period of time

and when they thaw out,
can remember those tricks?

Now, I have never heard
what I've never heard that

that did not come from me.

Okay, so many factoids there.

So I know you were recently traveling
in, was it Iceland?

Was there any unique wildlife there
that you saw?

I don't know much about Iceland. Well,

so it turns out there's
not much wildlife in Iceland.

But what they do have is a lot of horses
and they have a lot of sheep.

And the interesting thing
about the sheep that we found

was that in the US, you drive along,
you see sheep and they're together,

and the reason they're together
is for protection, right?

Because they fend off any kind of,
predator.

Well, in Iceland
they don't have any predators.

So you will see sheep scattered all across
the mountainside just by themselves.

In two and threes.

And we were just fascinated that they were
just everywhere, all by themselves.

So because they had no predators.

So kind of like buffalo out in Montana
or something.

They're just kind of doing their
thing. Wow. So yeah. Oh.

Well, Tim,
we're so thankful you're here at the FDA.

You have a big, distinguished career,
and you're using your wisdom to help

get products for animals across the finish
line and get and get decisions out.

So, thanks for being here. It's
been great working with you.

And I hope you enjoy these fancy
new microphones that Bigfoot

got us, or Michael, in conjunction
with a bunch of folks.

I think it's pretty, pretty good.

We're starting to get,
some people were saying

the audio quality was not that great.

So, thanks.

Thanks for Bigfoot for setting this up.
Should we vote on the couch? Do you?

What do you think of the couch? You’re
the first one to try it. Yeah, yeah, yeah.

Okay. Yeah.

All right, folks, there you have it.

Screwworm, pigs, veterinary medicine
and getting to know Tim in a deeper way.

I hope you’re
enjoying your household pets,

if you've got some right now
watching this and, more to come.