Dec. 31, 2024

178. The Surprising Truth About Librela and Solensia Nobody Tells You

Librela (for dogs) and Solensia (for cats) isn't the "miracle" drug that Zoetis has promised to veterinarians. Dr. Josie Beug has been warning us for nearly a year about this drug, which was declined in human use, and now the FDA has finally issued a warning letter. Find out more: https://petadvocare.com/ FDA warning letter: https://www.fda.gov/animal-veterinary/product-safety-information/dear-veterinarian-letter-notifying-veterinarians-about-adverse-events-reported-dogs-treated-librela ...

Librela (for dogs) and Solensia (for cats) isn't the "miracle" drug that Zoetis has promised to veterinarians.

Dr. Josie Beug has been warning us for nearly a year about this drug, which was declined in human use, and now the FDA has finally issued a warning letter.

Find out more: https://petadvocare.com/

FDA warning letter: https://www.fda.gov/animal-veterinary/product-safety-information/dear-veterinarian-letter-notifying-veterinarians-about-adverse-events-reported-dogs-treated-librela

Dr. Karen Becker's 12 minute video on the FDA warning letter: https://www.instagram.com/reel/DDz5zkkyn7b/?utm_source=ig_web_copy_link&igsh=MzRlODBiNWFlZA==

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Welcome back, pet parents.
I hope you and your family and

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your fur babies had a wonderful
holiday.

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I know we're in this weird place
where like time doesn't exist

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right after the holidays and
like going into the new year.

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And I just want to say thank you
so much for being here with us.

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Being a dedicated pet parent.
I have a very, very important

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episode today, and I have been
planning this for, gosh, a

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couple of months now just trying
to gather information and get it

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to you.
And I'm hopeful to have a

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particular veterinarian back on
the podcast to talk to you about

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it some more because we can't
get the word out quick enough or

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far enough.
And So what we're going to be

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talking about today is a
prescription medication for

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dogs, it's called Librella.
For cats, it's called Silencia,

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but it's basically the same
thing.

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So what I'm going to do is just
give you a rundown of everything

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I have learned about this and I
will and I'll give you some

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recommendations of where to go
to learn more about this.

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Because everything that I have
learned about it and has been

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from Doctor Josie Bug, who has
been on the podcast in the past.

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And hopefully I'll be able to
have her back on to talk a

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little bit more in detail about
specifically about what to do if

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your animal has had this
injection once or multiple times

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or there's so much unknown
around it.

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So really quickly, let me let me
do my little spiel.

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We'll jump into everything.
If you're new here, my name is

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Jessica.
I am a canine nutritionist, a

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feline nutritionist, a holistic
pet health coach, and a positive

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reinforcement dog trainer.
And of course, I'm also the host

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of this podcast that you're
listening to right now, the Pet

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Parenting Reset.
I'm so happy you're here.

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I'm so happy you have decided to
be the best pet parent you can

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be and continue to learn and
increase our pets health span.

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That's the goal here really
quickly.

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If you do want, I am still doing
one-on-one consultations.

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My packages are changing in the
new year.

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I'll have my existing package up
for a little while just to give

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people a little bit of time to
get used to the new packages.

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But you can find all of that at
jessicalfisher.com.

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Also LinkedIn the show notes.
So let's get into Librella and

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Silencia.
So right off the bat, I'll, I'll

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give this to you again at the
end, but pet pet.

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So Pet advocare.com is a website
you can go to learn more if you

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have more questions and I'm sure
you will because this is a very

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complex topic.
And again, all of this

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information I have been learning
over the past few months from

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Doctor Josie Bug.
So Librella is what it's called

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for dogs.
Silencia is what it is called

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for cats.
And it's it's considered by the

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FDA a biologic and a biologic is
considered the same thing as a

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vaccine.
This is a monoclonal antibody.

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It's the same class as
Cytopoint.

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So one of the biggest problems
here is that the pharmaceutical

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reps are promising that there
are absolutely no side effects.

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So veterinarians who don't have
the time, energy, whatever to do

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their own research, who trust
their pharmaceutical reps are

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believing that there are
absolutely no side effects and

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don't understand when patients
come back in with all of these,

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like, adverse reactions, they're
not connecting the dots because,

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Oh my gosh, the pharmaceutical
company says there's absolutely

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no side effects.
What it is, is a once a month

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injection for arthritis and it's
intended to be received

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indefinitely, which to me is the
biggest red flag, right?

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We should never ever, ever
unless outside of, you know, a

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type 1 diabetic who literally
cannot live without insulin.

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Like, and maybe a couple of
other cases that I just can't

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think of off the top of my head.
Like we should not be ever

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considering a pharmaceutical for
life.

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Like, that does not make sense.
It makes sense to their

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pocketbooks, but it doesn't make
sense to our health or to our

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pets health.
And then fortunately and one of

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the one of the both cool things,
but also really scary things

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that I learned is that different
countries are getting different

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package inserts.
Now, you probably, if you have

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been offered this for your pet,
maybe the first time they get

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it, you're like, Oh my gosh, is
a miracle, right?

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But hear me out because there's
so, so much going on.

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And at the end of this, the
while I was preparing for this,

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the FDA actually issued a
warning letter to veterinarians

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on this drug.
So there is hope that our

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veterinarians are going to learn
that this is not the miracle

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that they, they were sold
basically by the pharmaceutical

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companies.
So the reality is there are so

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many adverse events being
reported, but what is it first?

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So it is a genetically
engineered protein creating

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created using recombinant DNA
specific to different things in

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the body.
So right now what it is doing is

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attacking or it's binding,
excuse me, to nerve growth

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factor and creating biologically
inactive nerve growth factor.

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And by doing this, it is
reducing or eliminating the pain

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of arthritis.
Really interestingly, and I just

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want to throw this in, I was
listening to Doctor Karen Becker

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and Rodney Habib, who when the
FDA came out with their warning

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letter did like a quick, I don't
know like 12 minute video, which

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I wish I could publish for you
on here, but I, I don't know

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that I have the rights to do
that.

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So what I can do is put the link
in the description or in the

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show notes.
So if you want to go watch that

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you can on I'll put the link to
Instagram.

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Thank you.
But what I heard, one of the

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things I heard Doctor Karen
Becker say on this live that was

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so interesting to me, is that
she has had reports of

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veterinarians who, because they
did not do their research and

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they don't understand what this
actually is and how this

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actually works, have been using
it in place of NSAIDs.

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So for all kinds of pain, not
just arthritis.

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And that is one of the most
scary things I've heard because

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it is absolutely not a
replacement for NSAIDs in any

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situation.
It was only designed by the way

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this medication was originally
brought for humans and failed.

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So the FDA said, no, we're not,
we're not doing this, you can't

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do this.
And so they just relabeled it,

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rebranded it and are giving it
to pets now.

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So there are so many side
effects listed in the package

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insert, not necessarily in the
one in the United States.

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So I think that one, they have
continually been changing up.

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But if you go to like the ones
from Europe from According to

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Doctor Josie Bug, there are so
many side effects listed.

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Increased BUN, lethargy,
vomiting, anorexia, lameness,

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cough, bacterial skin
infections, injection site

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reaction, UTI's, dermatitis,
dermal masses, redness, cysts,

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pain on injection, urinary
incontinence, increased drinking

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and thirst, ataxia, lack of
coordination, seizures,

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anaphylaxis, diarrhea and death.
So in the body, this is a

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foreign protein.
So in the body, this is a

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foreign protein and it is a
large antibody that creates an

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antigen, creates a large
antibody antigen process say

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that five times fast.
It is making the nerve growth

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factor biologically inactive in
the body.

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And what?
But one of the scarier things

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again in all of these side
effects that are being seen is

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that the theory here is that the
only thing nerve growth factor

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is doing is pain and weakness.
That's all that it's

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controlling.
And so when it inactivates nerve

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growth factor, it's removing the
pain and weakness of arthritis.

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The reality is nerve growth
factor does so much more.

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It help, it regenerates
everything in the joints and so

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many things we actually don't
even know yet that nerve growth

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factor does.
We're constantly learning new

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things that it does.
And so it's inactivating

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everything else.
Especially hate to hear younger

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animals being given this because
you're inactivating nerve

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growth, you're you're
inactivating all of it in the

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body.
And we don't have long term

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studies on it to know if it's
reversible at this point.

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So many animals, so many dogs
and I'm sure cats, but I, I

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think it is more prevalent in
dogs right now.

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But I think by that, I mean I
think more dogs are receiving

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Librella and not as many cats
are receiving Silencia, though I

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don't know, that could be
changing.

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It could just be that people are
more aware and paying attention

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to what's going on with their
dogs.

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I think that often is a case
with our pets.

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And I've talked about that
before on the podcast as well.

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So again, according to Doctor
Josie, bug nerve growth factor

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is a peptide.
We actually know very little

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about it, but we do know that it
is involved in the maintenance

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repair and neuroplasticity and
joints and heart tissue and it

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does seem to cross the blood
brain barrier.

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And so by the way, just a
reminder Librella Salincia are

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in activating this.
So what happens when we

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introduce these really large
foreign proteins into the body

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while we because that's what a
monoclonal antibody does, it

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creates immune reactions.
And so there are four different

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types, type 1, type 2, type 3
and type 4 of immune mediated

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reactions and this one is
causing problems all over the

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body.
She also is very, very clear

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that comorbidities are not
studied.

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So any of the packaging inserts,
even the one in the United

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States, very clearly says that
it is only for animals that do

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not have any other like disease
processes going on.

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That's kind of scary because I
would imagine many of these

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animals actually do.
That's the world we live in,

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right?
Actually, and I was wrong about

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Europe having the most extensive
package insert.

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I wrote this down because it was
important to me.

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The most thorough package insert
is actually from Canada.

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The next one is in the UK.
And then according to Doctor

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Josie Bug in the United States,
it pretty much mostly says, we

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don't know, like they are
basically passing off, like

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they'd have no liability.
It hasn't been studied.

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We don't know kind of thing in
the packaging inserts.

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So what has happened over the
past almost year is that a group

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of people, including Doctor
Josie Buke, who I was just

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talking about and where I've
learned all of this information

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from, have been putting
together, gathering data from

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people who whose pets have been
on this medication, who have

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been given this injection.
And so the statisticians have

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gone through, come through all
of the data.

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These are the most reported side
effects.

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Increased thirst, increased
urination, lack of efficacy,

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meaning that it doesn't work.
Lethargy, incontinence, death by

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euthanasia, vomiting, ataxia,
seizures, anorexia, dogs dying

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within hours of receiving the
injection within hours or days,

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partial or complete paralysis,
progressing to incontinence,

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seizures and death, sudden
blindness, dementia, lupus and

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other autoimmune conditions.
So one of the things when I was

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listening to Doctor Buve on
Doctor Judy Morgan's, Judy

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Morgan's podcast, she was saying
our best hope right now is if

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your pet has received this
injection, best outcome, the

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best we can do right now is to
keep your pet alive for a month

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for it to wear off in the hopes
of going back to normal.

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If your pet has had more than
one injection, there's a half

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life calculator on the website,
which again is pet advocare.com.

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But it's not necessarily the
same for every pet.

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It may work once or twice and
then it may not work anymore.

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And there are so many serious,
very serious side effects that

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it for her.
And I think for me too, it's

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just not worth it.
I mean, of course for you, you

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have to make that decision for
your pet.

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But what I do want to do is say
that again, the FDA did issue a

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letter to veterinarians.
It was on, I want to say

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December 17th or 18th.
Actually let me pull it up here,

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I'm sorry, December 16th and it
says the this is on fda.gov

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website.
FDA notifies veterinarians about

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an adverse events reported for
Librella and here is the letter.

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Dear Veterinarian the US Food
and Drug Administration's Center

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for Veterinary Medicine has
completed an evaluation of

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adverse events reported in dogs
of various ages treated with

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Librella.
The adverse events identified

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and analyzed include ataxia,
seizures, other neurologic signs

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including but not limited to
paresis, recumbency, urinary

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incontinence, polyuria, and
polydipsia.

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In some cases, death, including
euthanasia, was reported as an

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outcome of these adverse events.
The FDA is making available

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reports containing summaries of
clinical signs reported for

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Librella in the CVMFOIA FOIA
electronic reading Room.

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Drug Information.
The FDA approved Librella, a

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monoclonal antibody drug used
for the control of pain

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associated with osteoarthritis
and dogs, on May 5th, 2023, and

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it was introduced to the
marketplace later that year.

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Prior to approval, the FDA
reviewed available studies and

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other data on Librella and
determine Librella to be safe

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and effective for its intended
use for control of pain

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associated with osteoarthritis
in dogs.

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Librella is dosed by weight and
labeled for subcutaneous

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injection once a month.
What should a veterinarian do if

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a patient treated with Librella
has an adverse event?

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If a dog under your care
experiences an adverse event

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while receiving Librella, the
FDA encourage you, encourages

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you to report it to Zoetis, the
drug sponsor, and gives the

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phone number.
Drug sponsors are required to

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submit reports of adverse drug
events to FDA.

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If you would prefer to report
directly to

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fdapleaseseefda.gov/report
Animal AE.

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When reporting adverse events to
the FDA and or Zoetis, please

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include, if available, a full
medical history, how many times

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the dog has received Labella,
and the lot number on the vial

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used.
Where can veterinarians get more

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information about the adverse
events that have been reported

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to the FDA?
The FDA is posting reports

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containing adverse drug event
information for Librella on a

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rolling basis in the FOIA
Reading room for CBM.

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If the agency has additional
information to share, it will be

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made available additional
information.

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00:15:37,880 --> 00:15:40,960
The FDA monitors the safety
profile of all animal drugs

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after they reach the market, as
widespread use of a drug in a

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large number of patients may
uncover adverse events not

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observed prior to approval.
Meaning your pet is the

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experiment, and I'm not saying
that they're saying that

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pharmaceutical companies.
Drug sponsors are required to

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report all cases of adverse
events they receive from the

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public, including pet owners and
veterinarians, to the FDA.

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The agency evaluates adverse
events and other safety

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information when it becomes
available and it goes on just a

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little bit, not much.
Now, of course, Zoatis has their

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own response and it says we
continue to have the utmost

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confidence in the safety and
efficacy of Librella.

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Go figure.
So basically, again, Doctor

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Josie Bug is the one that I have
been getting so much of this

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information from and following
on this issue believe Silencia

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is the exact same thing for
cats.

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I am hoping the FDA also issues
a warning for Silencia.

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You can go to petadvocare.com,
PET advocare.com if you would

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like to learn more.
And you know, this is just this

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is an ongoing thing.
It's really of course sad to me

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that our pets are the experiment
most often because this in my

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opinion, especially knowing that
it was disapproved for humans,

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it should never have been
approved for our pets.

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The adverse events being listed
in packaging in other countries

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and not in the United States is
terrifying.

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I think we're seeing so many
people are waking up to the fact

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that other countries definitely
have their citizens best

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interest at heart, more so maybe
not completely more so than

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agencies in the United States
do.

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And we have to be constantly
looking and researching and

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doing our own research and
figuring things out and doing

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what we feel is best for our
pets and for ourselves.

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So with that, I just, you know,
again, I, I hope to get Doctor

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Josie Beau back on to talk about
this some more.

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As she said, the best we can
hope for right now.

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If your pet has received an
injection of Librella or

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Silencia, keep them alive for
the month so that it has time to

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wear off.
And we cross all of our fingers

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and toes and hope that the pet
does get back to normal.

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Unfortunately, that's not what
she and other people in the

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field are seeing with this
particular pharmaceutical.

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So yeah, there's that.
There's so many other things

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that we can do in relation to
arthritis and osteoarthritis,

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namely some of the things that I
would start with.

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Of course, when I work with a
client one-on-one, I am always

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looking for, you know, I'm
looking at that individual's

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symptoms and needs.
And so it can vary, but I'm

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always looking to create an
anti-inflammatory diet.

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I am using very strategic
supplementation, high doses of

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Omega threes again for
anti-inflammatory properties,

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potentially like to mark
curcumin.

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Full spectrum hemp extracts are
amazing for helping manage pain,

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medicinal mushrooms for both for
inflammation and for overall

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immune support.
Because what we really need to

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do is support the body and not
attack the symptoms.

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And I, I know I say this all the
time and maybe I sound like a

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broken record, but that is
always the case.

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Supporting the body, supporting
the immune system, providing an

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anti-inflammatory body, creating
an environment that is

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anti-inflammatory, creating a
diet that is anti-inflammatory.

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That is going to be some of the
best things we can do.

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And then we can also look at
other modalities like pulsed

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electromagnetic frequency,
acupressure, acupuncture, There

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are lots of other modalities
that we can look at that are

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very beneficial for pain.
So with that, now if you do have

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any questions, please feel free
to reach out to me.

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And Instagram is usually the
best place to do that.

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00:19:58,680 --> 00:20:03,000
And I sincerely want to give
like my deepest sympathy to

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00:20:03,080 --> 00:20:06,880
anyone who trusted their
veterinarian to give this

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pharmaceutical to their pet and
their pet has suffered because

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of it.
It breaks my heart.

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So with that, I will talk to you
guys next week.

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I have a guest next week.
It's a very, very fun and

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00:20:17,840 --> 00:20:21,160
exciting episode.
I I please please, please don't

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00:20:21,160 --> 00:20:22,720
miss it.
You're going to want to catch it

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00:20:22,800 --> 00:20:27,360
right away as soon as it airs.
It is very time, like very much

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00:20:27,360 --> 00:20:30,160
the day it airs.
It is about that day.

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00:20:30,480 --> 00:20:34,280
So please set your reminders for
January 7th.

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00:20:34,280 --> 00:20:38,680
And that episode is with Amanda
Wilborn of The Nautical Dog, and

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00:20:38,680 --> 00:20:40,840
I cannot wait for you to hear
it.

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00:20:41,080 --> 00:20:44,640
So with that, I hope you and
your fur babies had a wonderful

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holiday and I will talk to you
next.