FDA's Role in the Off Label Use of Medical Devices Explained by Dr. Kanal, MD.

Show Notes

Watch on YouTube --> FDA's Role in the Off Label Use

In this episode of Zone 3 Podcast, we are lucky to have returning guest Emanuel Kanal, MD, FACR, FISMRM, MRMD, MRSE, AANG. Chief, Division of Emergency Radiology and Teleradiology. Director, Magnetic Resonance Services. Professor of Radiology and Neuroradiology. Department of Radiology University of Pittsburgh Medical Center,  here to discuss the FDA's role.
Specifically, how the FDA only governs who can market in the US, not how MD should practice medicine.

He also discusses how off-label use should be the standard if that is what is best for the patient regardless of FDA approval. Dr. Kanal helps to explain this by discussing an example about the neonate formula. 

He urges viewers to understand FDA’s approval regarding MRI safety is only to those companies who find it beneficial(profitable) to get FDA approval.  He also talks about the FDA approval process and how the safety guidelines are created. He takes us through many dates on how the FDA came to be, reminding us of the big picture of the FDA's role as a federal regulator. 

Toward the end, Dr. Kanal discusses his passion for flying. As a licensed pilot, Dr. Kanal tries to find the time in his busy schedule. It was fun to sit down with Dr. Kanal and see and hear that passion when spoke to him about something other than Diagnostic imaging. 

Thanks for Joining Us here in Zone 3. 

Timestamps below
00:00 intro
00:54 Dr. Kanal Intro
26:47 FDA's Role and Why they don't have oversight over how MD practice Medicine
51:00 -Liability when going off Label  
1:20:45 Message to Technologist
1:28:51 Community Questions
1:50:19 Outro with Sponsor  popup

About our Sponsor:  
Aegys is an innovative leader in the MRI safety industry and the Creator of The TechGate Automatic.
Aegys is committed to providing innovative product and process solutions that enhance overall magnet safety and improve efficiency.  TechGate Auto is a Zone 4 Barrier System that keeps patients and MRI technologists safe.  TechGate Auto allows technologists to focus on the care of patients and efficient room turnaround rather than worrying about anyone entering the MRI room behind them. Easy to use and designed for the MRI environment, TechGate Auto is deployed whenever the technologist enters or leaves the MR room or via push-button remote control, providing an immediate physical restriction of access to all unauthorized individuals.

The use of a “caution” barrier at the entrance to the MR room is now a recommendation of the American College of Radiology MR Safety Committee.


Links 
Aegys' Tech Gate Auto-  https://aegysgroup.com/
Questions Link- https://community.imagingqa.com/

Creators & Guests

Producer

Katie Lincoln

What is Zone 3 Podcast?

Zone 3 is a podcast that discusses everything MRI. Tune in to hear about the latest advances, optimization techniques, and more! Hosted by Robert and Reggie who are both MRI Technologists. They have an entertaining rapport as they tackle topics like MR safety, imaging protocols, upcoming technology, and so much more.

You can tune into Zone 3 Podcast on YouTube or listen to it on your Podcast RSS Feed! Thanks for Stopping by Zone 3.

On Zone three podcasts, I am Robert.

Yes, and I am Reggie.

And wow, we are joined today by an all
around nice guy as Dr.

Manny Canal. Dr.

Emanuel Canal.

Yes, thank you for joining us, Dr.

Canal.

It's my pleasure.

Yeah. Thanks for inviting me.

Of course. Yeah, it's an honor.

Trust me, it's I was telling everybody
today, introduce yourself for those living

under a rock.

My name is Manny Canal.

I'm at the University of Pittsburgh Medical
Center and have been there for a long time,

40 years now, and I do a lot of MRI.

I do a lot of work in neuroradiology,
emergency neuroradiology, and we do we do a

lot of work in MRI safety.

Thanks.

Well, you've got a passion in the industry
and it shows and you've got a name that's

recognizable because of it.

So that's the reason why we invited you.

Thank you for coming.

And so he just flew in from Pittsburgh, and
today's episode topic is FDA on label off

label scanning. And this is like a subject
that I imagine you're no stranger to.

You're actually the one that chose to choose
this as the topic today.

I don't know if you would just kind of talk
about the reason for today's topic is your

choice.

Sure.

The I guess I got a quick question kind of
open you up?

Absolutely. What was the first time that you
scanned off label or was it always on label?

And then you scan only

Started out in surgery.

Then I went to medicine that I went to to
radiology and off label is an integral part

of what we've done from med school.

It's it's there's no such thing as one was
the first time.

It's we're always off label where we're
always off.

If you're not doing things off label,
something's wrong.

Quite literally, something's wrong.

And that's part of what I want to get across
because I don't think people realize that and

the reason I actually brought this up.

Is.

You guys know, I do a lot of teaching about
my safety, and it's a passion of mine to try

to do things safely, but.

People have the impression that the reason I
give courses on MR safety is because I want

them to understand obviously what the issues
are, but also then they have to cancel

somebody. They know why they have to cancel
and it's true.

But that's not the real reason.

The the bigger reason.

Is because we can't sell a lot of people
that don't need to be cancelled.

And if you really do understand what's going
on, then it's actually easier to say yes,

really wise, man once said something to me
that just left such an impression, he says.

If you're in, if you're in a room and it's
all military, but nobody's wearing a uniform,

how do you know? Who's the highest ranking
officer there, right?

How do you know who's the highest ranking
officer if nobody's wearing uniforms?

The biggest or furthest man isn't.

That's ego.

Yeah, and you're right, you don't got to flex
if you are the man.

That's true.

It's the one who says yes.

Uh huh..

The person who has the authority.

Is the only one who's able to say yes
without having to worry about it?

Right? Everybody else says no, and that's
why I keep saying it's easy to say no, but it

takes knowledge and understanding and a
willingness to apply them to say yes, right?

So I think that what's ended up happening in
radiology is that there's there's a lot of

no. And a lot of those that really don't
have to be there are times that we really can

safely scan a patient, but we need to
understand that we can scan them safely and

what we can and can't do and how to go about
mitigating the risks.

So one of the things that we've run up
against one of the problems was that.

Even if people understand that they can do
it safely.

But the label doesn't let me.

And that's an issue.

The product label, the instructions for use,
the manual, the the prescription description,

whatever you want to call it.

People think that this is the labeling of
this drug.

The labeling of this device precludes my
being able to use it the way I would like to.

I can only use it this way.

And so there what is that?

What is that about? What is the product
label?

The package? Insert the instructions for
use.

What is it meant to teach us or what has it
meant to do?

Who is it meant for?

How do we use that?

Yeah, especially if that's holding us back.

Should it hold us back?

Or is it appropriate to hold us back?

Or no, we should ignore it entirely or
something in between.

I think there's a tremendous amount of
confusion in that, and that's what I was

hoping we could address today.

Oh yeah, for sure.

It's funny you said he left an impression on
you because actually, I remember something

you said when we met in Pittsburgh last year
that kind of resonated with me, pun intended.

You said basically, like we're always
concerned about like the like the safety

aspect of scanning the patient, but we never
really consider, you know, how detrimental it

is to not scan that patient as far as the
progression of their treatment.

Diagnosing what's going on and creating a
therapy plan, I guess so that kind of like

really left an impression with me.

I've never really thought of it from that
angle.

Right? It helps coming from a pure clinical
background because.

We feel in a sense, like heroes.

Oh, we canceled the study, we just saved
this patient from a fate worse than death,

and who knows that they could have had had
they gone in or whatever?

Right? But I think what we don't necessarily
see is that, well, now they may be going to

biopsy where they didn't have to before or
now they may be going to a conventional

angiogram, whereas before I could have done
it with an MRI angiogram or something less

invasive. So we're not evil, quite the
opposite.

We are literally motivated to help the
patient, but we may be.

We may be making a decision that results in
the patient being exposed to more risk

inadvertently, although we don't see that.

We just see that we're heroes because we
cancel the study and save them from something

that could have been a real safety issue,
didn't we?

After all, this is what I was afraid of.

Now that's not going to happen.

Yeah, but but now she's gone to the O.R.

or now she's had a milligram or something
that maybe it's not a big risk, but the risk

may be greater than it necessarily didn't
necessarily have to be.

What I'm concerned

About, one of the things that always made me
hesitant to always go by the guidelines is

because when you got to go to court, they're
going to ask you why you did this right?

They're going to ask, OK, so why did you
make the decision to scan this patient in a

certain way or whatever you did, right?

And if I can't say, oh, well, I just went
off the guidelines, then what am I going to

say, right? Like, that's one of my things.

What a fascinating word you use guideline
guideline.

We're going to talk about that guidance.

What are guidelines and who issues
guidelines?

And are these guidelines and what are we
supposed to do with what it says in the

instructions for use?

And then what are we not supposed to do?

So that's that's part of what we're going to
address directly.

And I love the fact that you use the word
that you did a very appropriate word

guidelines and them too.

Well, I think one thing that we did forget,
too, as far as I think, if you don't mind,

let's first have you define what it on label
off label sure is, right?

Sure. So what I'm going to discuss, we'll
talk about devices.

Implants, things of that nature, but it
applies to pharmaceuticals as well, it

applies to drugs or devices and and you'll
see it's all based on the FDA and what their

job is. And who are they speaking with?

They're going to govern drugs and
pharmaceuticals as well as devices.

Actually, food as well.

But that's not for for today.

So what is on label mean and what is off
label mean if you buy a drug, prescription

drug shows up or even non-prescription, if
you buy a drug and you open it up and has

this whole, you call it a package insert.

If it's a device, it may be instructions for
use what it actually is referred to as

labeling. Labeling simply means anything
that the manufacturer has accompanying this

device or this drug.

Anything is called labeling.

And so, for example, and magnetic resonance,
let's just jump right into the deep end of

the pool. We have a patient that has their
six foot four.

They have a they're diabetic and they have a
deep brain stimulator.

The deep brain stimulator has a label.

And it says it can be used on an MRI scanner
up to one point five Tesla and seven hundred

and twenty gauss per centimeter and normal
operating mode up to point for making this up

completely 0.4 watts per kilogram, 15
continuous minutes per series and two hundred

Tesla meter per second is the maximum
gradient that they want to use normal

operating mode. Mm hmm.

I just threw out a lot of terms.

I just threw out a lot of numbers, nailed
it, and I would like to scan his ankle.

Because he's a diabetic.

Or, as my granddaughter says, a diabetic and
they're looking for an abscess.

Now I made that up on purpose because I'm
not using ultrasound.

I'm not going to use nukes.

I'm not going to use CT, right?

The best test to evaluate.

Is there an abscess with the extent of the
Abscess?

How is it doing? Do I need to go in and
surgically or is this trainable?

Percutaneous? There's nothing to discuss.

We want an MRI.

My machine is a three Tesla.

My machine is a 1.5 Tesla.

Let's say it's labeled to five 40 gauss per
centimeter.

This is at seven 20 gauss per centimeter.

Or if it's labeled to seven 20, my machine
goes to a thousand eighty or whatever.

So the labeling means whatever is the label
of that, the package insert, right, if I am

about to scan that patient and every single
thing I said before, it's one point five

Tesla. It's less than seven 20 gauss per
centimeter.

It's less than 15 minutes in length.

It's less than two watts per kilogram.

It's less than its normal operating mode,
and it's less than 200 million tests of Tesla

per meter per second for the gradients.

If I do all that well, then you're just
following the instructions.

Right? Another term for product label is
instructions for use, in this case for a

device, and you're that's considered on
label.

If you do anything else, if you cross any of
those lines, if you're 16 minutes instead of

15 minutes, if instead of normal operating
mode, you say, I decided to go into first

level control mode.

If you do anything beyond not less than but
beyond what it describes, the only exception

meaning being radio frequency labels,
there's different energies we use in MRI.

There's a static field, there's a radio
frequency field and there's a gradient field.

And for the for the radio frequency field,
you can't be more and you can't be less.

You have to be on target, but for the
others, as long as you're less than you're in

great shape. So if you're exactly where
you're supposed to be, that's on label.

Anything else is off label.

So why would you do something off label?

I don't know. Maybe you don't have a one
point five test.

They only have a three Tesla scanner or
something like that.

Maybe for the benefit of diagnostics, you
need to use some parameters that would exceed

the labeled thresholds.

Now, if you do before you even discuss why
and should you or shouldn't you before you

even go there, the first thing is your off
label.

So the definition of off label means not.

I'm going to use an argumentative term on
purpose, not adhering to the product label.

A better way to say it is not following the
instructions for use.

Right?

In some way, going beyond or outside of the
defined labeling and defined instructions for

use that's considered off label.

Well, when they're making like when they
determine their label per say, are they?

Is it OK? This is what they tested it in and
it's safe for that.

So that's our label.

It's not like they're testing to see if it's
safe at this level or safe at that level or

safe at that level.

It's like they get approved and then that's
it.

That's what it is.

So the way it works, it's very insightful.

Seriously, the way it works is that some
company wants to get a product labeled.

Mm-hmm. This is an important question, and
it's a very simple one.

I'm asking the two of you.

Ok. I will say it again.

Why a company wants to get their device or
their drug.

They sell it as a more conditionally correct
answer.

If you have a device or a drug and you want
to sell it in the United States.

You cannot until it has a label, a label for
anything.

Yes, but it must have a label.

So in the United States, not having a label,
this is then experimental and it cannot be

sold. Not yet.

Now it's got all kinds of regulations on top
of it.

But the second this drug or device, I keep
having to add that.

But if I forget to just plug it in for me,
the second this drug or device is labeled for

any thing.

It's now legal to be sold in the United
States.

Does that make sense?

Yes. So getting a label is critical, right?

Getting a label is because the basis that
opens the door in a capitalist society for

the for profit corporation.

There's nothing. I find myself having to
defend that.

I don't want to defend that.

I'm not going to defend the United States.

It's who we are. We are a capitalist society
where for profit and we try to protect our

citizens in ways that make this a viable the
best.

In a sense, society, we can make it right.

So there's nothing we don't have to
apologize for being a for profit society.

But you should be aware that there are
limitations to this capitalist for profit

society. In fact, I should give you a two
bit piece of history here.

Like a background in 1906, I believe it was.

Teddy Roosevelt is the president who was
super superseding.

He was the one that was actually there
during what was referred to as the Pure Food

and Drugs Act that was the precursor for the
FDA.

In nineteen thirty eight, we had a real
issue.

In 1938, there was a legally marketed, let's
call it a drug.

Back then they called them elixirs.

Killed one hundred and seven people and
children.

Whoa. That was 1938.

That that I shouldn't say that happened
before 38 and that resulted in passing in the

1938 the federal Food Drug and Cosmetic Act.

Now that was critical.

The Federal Food Drug and Cosmetic Act of
1938, essentially, it revamped the whole

public health system.

Here we are selling something.

And one hundred and seven people died
because of directly because of this elixir

that was legally marketed and sold in the
United States.

That was.

You remember Michael columbini, the six year
old, and that tragic accident that changed

the face of MRI, right?

This event changed the face of the United
States.

And that's what caused the FDCA that act to
be passed.

And that is essentially you can trace it
back to that one event.

That's what gave the FDA the authority to
oversee drugs, devices, et cetera.

And I want to read this to you, if I may.

Forgive me for looking down for a moment.

The This act established that drugs and
devices that are approved to be marketed in

the United States quote may be labeled
promoted and advertised by the manufacturer

only for those uses, which the drug's safety
and effectiveness, for which the drug safety

and effectiveness have been established, and
which the FDA has approved.

Hmm. These are commonly referred to as
approved uses, unquote.

Does that make sense?

So now we've formed this concept that you
want to sell something in United States.

You're going to make some listen to the next
word claims, right?

You're going to claim this will cure cancer.

This will grow hair on bold people.

This will do something.

You're going to make a claim about this drug
device.

This act in nineteen thirty eight is the
source for which the FDA has their authority

to say you're not going to market sell,
claim anything in the U.S.

without having essentially an independent,
objective, knowledgeable group of people.

Let's call them the FDA review your claims.

The basis for those claims and say that
sounds perfectly reasonable to me.

You are here by. Listen to the next word
approved to make those claims, and you can

sell it and say this is going to lower your
blood pressure.

Absolutely. I've looked at your data.

It certainly seems reasonable.

Yes, we agree. This does have sound
scientific basis for the claims you're making

that this will lower your blood pressure if
taken in the following way, et cetera, et

cetera. Right. And that's the basis for
everything that we're about to discuss.

So the approval is necessary for you to
market.

Once it's marketed now, I get to use it.

Me being a health care practitioner and
specifically admittedly a physician licensed

to practice in that state.

The FDA's authority is federal.

It's over the entire country.

It's national. But the authority to license
medical practitioners resides with the

states, so you may be licensed in this
state, but not in that state, that would mean

it is technically and literally not legal
for me to act as a physician.

Whatever that means in the authority and
license granted to me in this state has not

been granted in that state if I didn't apply
for and was not granted a license there.

So it is different.

The FDA is national, whereas the physician's
license is granted state by state.

Does that make sense? Yeah.

Where is the authority for the Food and Drug
Administration coming from federal

government? Everybody with me?

Yep, cool down.

So but there is something that is as critical
as can be that I don't think people

understand there was some question before
that it was it was threatened a few times.

It was questioned a few times.

In nineteen ninety seven, there was the FDA
Modernization Act, the FDA modernization.

I'm falling asleep, just listening to
myself, talk history numbers.

It makes me fall asleep. No. But this is
really critical.

There they solidified and crystallize beyond
any question of a doubt the following, and

this is a direct quote I'm going to read
again.

Please pardon me.

November twenty one nineteen ninety seven
FDA Modernization Act.

Nothing in this act shall be construed to
limit or interfere with the authority of a

health care practitioner to prescribe or
administer any legally marketed device to a

patient for any condition or disease within
a legitimate health care practitioner patient

relationship. English.

Yeah, you got to convert that one for me.

The FDA has no authority over the practice of
medicine.

I'm going to say it again, because this is
the part that people don't understand.

That seems

They cannot

Discrepancy

There. It's the opposite of discrepancy and
that's what we're going to clarify.

That's the reason why I thought this was
necessary.

If you guys are confused, that's fantastic
because it means that everybody out there is

confused. How long have you been practicing?

You're supposed to be interviewing me.

I'm interviewing you. How long have

You been practicing EMDR tables?

Turn seven.

How long? I've been questioning nine or 10
now,

Nine or 10 years?

Yeah.

So you've got a decade plus between the two
of you pushing two decades, right?

And this is news to you.

Imagine somebody just starting out, right?

I should tell you this is news to most
physicians as well.

Look at what you're saying is that they they
can't control how you practice your medicine,

but in order for us to use something that is
off label, it has to get a label.

Or I mean, in order for us to use an implant
that's been created or whatever it has to be

has to get a label from the U.S.

FDA. And then then they can't judge you if
you use it or not.

I guess, I don't know. There's two different

Topics being discussed here.

One of them is I would like to use this
widget on my next patient.

I'd like to take.

I'd like to take this major and I want to use
it to for surgery.

This is nothing to do with the FDA now,
right, Manny Canal wants to take this and use

it during a surgical procedure on my patient
has nothing.

There is no labeling for it.

It's not even a medical device I would like
to take.

Let's get to a more serious and more a more
real example.

I would like to use peach pits to cure
cancer.

I would like to use an ingredient in peach
pits available in Mexico.

And I want to treat my patients with it.

The cyanide, for example, in peach pits.

I would like to take this peach pit, grind
it up, do stuff with it.

I'm going to give it to my patients.

There are laws that govern my ability to do
something that would be called experimental

medicine. We're not talking about the FDA
now.

We're talking about what I as a physician
can and cannot do in general.

But that's a different story, right?

So now what does it have to do with the FDA?

Manny, you just told me. That's the point we
have to clarify, right?

So now that you guys have understood this,
let me give you a let's go back to our

clinical case and see what we can, what we
can make heads or tails out of this.

Yeah, that six foot four guy is diabetic.

I think he may have an abscess in his left
ankle.

He has a deep brain stimulator.

And I want to scan his ankle, right?

I'm not going to take the time now to go
through, but I think you guys are certainly

able to understand that most of the fields
that I would be concerned about the radio

frequency field, the gradient fields, a six
foot four, I chose a large patient.

The exposure in his ankle if I center his
ankle put him in feet first.

I could use an extremity coil, maybe the RF
and the gradient exposure is let me

approximate zero.

It's not a safety concern for this guy's
deep brain stimulator in this theoretical

example. The static field, let's say, is
well within what is permitted by the labeling

has been shown to be safe.

Mm hmm. But unfortunately, it's off label
because the label does not allow me.

To scan with the energies I'm about to use,
we may not even allow me to use that coil.

Right now, I'm intentionally misleading you
by using words like it may not allow me.

But that's how you think about it.

Exactly how that

Is a mistake.

Now I need to make sure I clarify for you
some things we say are opinions.

Some things we say are clarifications, and
some things are just fact.

So I'd like to make sure you guys understand
these aren't opinions.

This is fact, right?

The concept of allow me, is an error.

It needs to be undone in our thinking.

Yeah. The FDA has no authority.

Over how I handle my patient care, not zero.

They are not licensed to practice medicine
in any of the states.

They certainly can't tell me how to practice
medicine or any other licensed practitioner.

So then what are they doing and and who are
they talking to?

I mean, it just sit there, it said.

One point five to who

Are they talking to?

Right? Yeah.

So let me ask you this. Do you think that
there should be like a different governing

body that oversees medical devices?

Yeah.

Not at all. I'm extremely happy with the
FDA's oversight.

I'm extremely happy with their oversight
over drugs and pharmaceuticals as well as

devices.

They've got so much.

They have oversight over the pharmaceuticals.

They have oversight over the devices.

Notice that what? They don't have oversight.

They don't have oversight over me.

And that's a misconception.

And that's what I'd like to explain.

All right. So this is I'm now reading you
from the FDA April nineteen eighty two, the

FDA's publication Vol.

12, no one referred to as the FDA drug
bulletin.

If you can capture this to me, I'll bring it
out for you.

So here we are. In April nineteen eighty
two, the FDA drug bulletin published by the

FDA, of course, and there's a section here
entitled Use of approved drugs for unlabeled

indications. And I know you can read, but
I'm just going to help you out here.

The appropriateness or the legality of
prescribing approved drugs for use is not

included in their official labeling because
sometimes it cause of concern and confusion

amongst practitioners.

I would refer to this as a moment under the
FDA, the Food and drug and, excuse me, the

federal Food Drug and Cosmetic Act.

A drug approved for marketing may be
labeled, promoted and advertised by the

manufacturer, only for those uses for which
the drug safety and effectiveness have been

established and which FDA has approved.

These are commonly referred to as approved
use.

Remember that this means that adequate and
well controlled clinical trials have

documented these uses, and the results of
the trials have been reviewed and approved by

the FDA. So before we continue, what is
approved mean, and in case you want to know,

this is an open book test, the answer is on
slide

Well approved for what?

What I find interesting is that the
manufacturer is going with what the FDA is,

which is probably only so they can.

I don't know.

Exactly, take a look, what's highlighted
approved by definition means only one thing

It would make you look it off my paper
cheater, right?

But all kidding aside, what does it mean to
say something is FDA approved?

Guys, this blows people away because they
really, really don't understand this.

After four years of med school and going
through residency and fellowship, people

don't understand this.

It means it's been reviewed, tested and
guaranteed to be OK to you.

Be careful. There's no such word guarantee.

It means they reviewed it.

They find the claim defendable and
reasonable, and they approve marketing.

They allow the pharmaceutical firm, the
manufacturer of this device, to sell it with

those specified.

Here is the word claims.

I claim that if you use my drug or device in
the following fashion, this is what should

happen. That's what it means.

And the FDA remember they had this elixir
that they sold, marketed legally, and one

hundred and seven people died.

That's what they're trying to cure.

They're trying to prevent a claim that has
no basis.

An unscrupulous third party that's just
wants to in a for profit society, I would

like to make money. Well, you can't say it's
going to cure cancer because everybody on

their mother is going to buy it because you
don't need me to tell you what it's like when

somebody has cancer. God forbid what will
grasp at any straw to try to save our family

member. So the FDA says you're not going to
claim it cures cancer until I've seen it, and

I agree with that claim.

Any claim you make?

I need to see it before I allow you to claim
it.

The FDA.

Governs overseas.

Marketing. Not you, not me marketing.

It's their only authority.

As far as the discussion that we're having
today about MRI safety.

All right. When you see the word approved,
look at the bottom, what I've added here for

the rest of your life, when you see the word
approved, FDA approved in your mind, add the

words for marketing.

It's OK for you to mark it.

That's all it means.

It means marketing means to claim.

It means you are allowed to say that if you
use this drug in this way, the expectation is

that your blood pressure will go down.

And if the FDA is approved, reviewed your
data and says that looks well performed well

executed, I agree with those conclusions.

Yes, you may claim that is preventing the
public from being exposed to unsubstantiated

claims, right because now they've been
substantiated by an an independent, no

financial gain, an independent party.

The FDA? Yes.

Go ahead.

Well, do you have outside, of course, the
application fees.

Is there any other fee that you have to pay
to get something approved?

Oh, my goodness gracious.

Fees after fees, after fees.

We'll get there. We will get there.

So now take a look. The FDA and CE Act does
not, however, limit the manner in which a

physician may use an approved drug.

Once that product has been approved for
marketing, a physician may prescribe it for

uses or in treatment regimens or patient
populations that are not included in

approved. What is the word approved meaning
approved for marketing?

Labeling such unapproved or more precisely
unlabeled uses may be appropriate and

rational in certain circumstances, and may
in fact reflect approaches to drug therapy

that have been extensively reported in
medical literature.

And that's critical for you to understand.

And this is the FDA talking the term
unapproved uses is, to some extent,

misleading. It includes a variety of
situations.

It can be unapproved, and if you use it in
that fashion, you're going to kill this

patient, right? Or if you use it in this
fashion, it's the state of the art that is

the standard of care is to use it in that
fashion, even if it's not in the product

label. Do you understand that?

Yeah, there are many, many reasons why a
drug may be used for a certain off-label

indication, even though there's no labeling
for it.

An example that was published in JAMA in
1984.

For many years, status epilepticus disease
has predominantly a disease in children.

For many years, the drug of choice for
treating status epilepticus, which is a

seizure that essentially just doesn't stop
it continues to season, can't break it.

That could be extremely dangerous.

Could even be life threatening.

The drug of choice for that was intravenous
valium for many years, while the drug of

choice the standard of care was intravenous
valium.

The product label for intravenous valium
said We contraindicated in patients with

seizures. Oh, you can't use it in seizure
patients because you're thinking the word

can't has something to do with your ability
to practice medicine.

It means they can't make any claim because
no data was submitted to the FDA about

seizures, and therefore they're not approved
for marketing to claim.

But then you go to a meeting and in the
meeting they tell you this is the drug of

choice and all the physicians out there say
This is what we've done and we've done

research and we've found this is the best
drug in the world the product label hasn't.

It may take years for a product label to
include that indication if it ever does.

What would what would make?

What would motivate a company, a
pharmaceutical firm or a manufacturer of a

device? What would motivate them to add a
claim to a product label?

What do you think?

Sales were down. I'm sorry.

Like, if they were trying to like, you

Know, out of what to product?

Yeah, you have. You have a drug this drug is
approved for.

I use I love using minoxidil.

This drug is approved for antihypertensive.

After a few years, it was found essentially
fortuitously by accident.

Mm hmm.

That minoxidil grows hair.

It grows hair on this table.

Minoxidil? No kidding.

Really good hair grows hair.

Yeah. Now this is an antihypertensive.

And it was labeled as an antihypertensive
and it's used as an antihypertensive.

But then after a few years, they found now
this is no joke.

It actually literally grows hair.

You can imagine that that might be.

So is that like the main ingredient of
Rogaine or something?

Well, we'll get to.

Yes. It's not. It's not what I'd like to
focus on now because I don't want to have

anybody thinking that

Maybe I can maybe get a good beard fine.

So I'm

Just trying to make an observation

Here.

This is not a for profit discussion, but but
it actually gets me right to the point.

So now with that in mind, what might
motivate a company to add another indication

grows. Not only is it an antihypertensive,
it also can be used to grow hair.

Why would they want to put that in the
label?

Oh, because they can just reach a larger
market?

Thank you. In other words, it may be a
profitable thing to do, right?

It may. So what you're saying is correctly,
it's a business decision, right?

Do you understand it has nothing to do with
science?

That it is one hundred percent

That is completely against every business.

Ladies and gentlemen, this is critical for
you to understand what is or is not in a

product label. It's a business decision.

If you think otherwise.

You were trained incorrectly and you have
incorrect information that you're making

decisions based on, right?

I'm so programmed to think that way, though,
so you must just

It's it goes so much further than that.

Stay with me. Ok.

People think that this is approved up to
five 40 gauss per centimeter.

What's going to happen in seven 20 gauss per
centimeter is obvious.

Five 40 is safe.

What does that tell you?

About seven 20? Obviously, it's not safe.

The whole reason why 540 everything I just
said is incorrect, right?

Everything I just said is an error.

It's approved to 540.

Why you actually already gave the answer to
that.

And we started this discussion minutes and
minutes ago.

Why is it approved at five 40?

Because that is the data that the company
submitted to the FDA.

The FDA reviewed it and said This is a
reasonable conclusion and you are now

approved to make that claim.

Wouldn't it be in their best interest, more
marketable if they brought it to its limits?

Why not, say, seven 20 is asking.

Here's the five dollars I owed you to be my
straight man.

So now let's go with that, right?

What?

What does the company want?

They want for a brand new product, for a
brand new drug or brand new device.

What do they want? They want approval for
what anything?

They can't market it without a label, right?

They need approval.

What if it's seven 20?

They may be asking a few questions that it
looks good.

Yeah, but well, what if they had it on for a
little bit longer?

They may get sent back by the FDA says it
looks OK, but just to be sure, do some more

studies delays them eight months, maybe
another three point six million dollars of

another comparative study that they have to
execute the logistics issue?

It's not logistics. You're definitely
misunderstanding

The market, right?

This is a financial issue.

This is anything else means you're not
catching the point.

Ladies and gentlemen, this is a financial
discussion.

Whether a company can market a drug is not
logistics, it's not science.

What they put in there is based on the
finances of their their business plan for

this drug.

If they get the late eight months, how

Long does it take? How much does it cost to
get a drug approved?

Now I have a date, I have numbers that I was
quoted, and I'll quote that to you.

But then I'll show you in writing a
different number, the number that I was

quoted from the time that you have an idea,
I have this drug.

I'd like to get approved till you create the
drug.

You do all the tests. You submit the data to
the FDA.

The FDA approves it.

We name the drug. I'm so sorry.

Can we name it Zone three?

Can we name the

Drugs own through the drug?

Yeah, I'm not sure you guys a drug.

Or is it a downer as addictive as it may be?

Yeah.

Well, if it be addictive, it would be a
controlled substance and you don't want it to

be controlled. Do you want it out there?

Ballpark one hundred million dollars.

Wow, wow.

The number I'll show you in a moment quoting
from the AMA is over a billion dollars.

So somewhere in there is the go.

Somewhere in there is the truth.

So if let's say the company says the data
for five 40 is really solid, I mean, nobody

questioned that if I did seven 20, it maybe
people would like it better, but it may delay

me. Or I may have to do more studies, right?

I think I'll submit it with five 40.

Get it approved. It gets better than that.

We have a drug, we have a drug.

We have a device that Medtronic put out a
device.

A stimulator of deep brain stimulator was
approved at 0.1 once per kg.

Now, as you guys, I'm sure aware, scanning
is zero point one watts per kilogram is

essentially not not.

It's not possible. It's not clinically
feasible.

It's not practical.

You guys sitting right there relaxing,
taking it easy.

Resting your basal metabolic rate right now
is zero point four watts per kilogram.

This is one quarter of your basal metabolic
rate.

I must say that next time I work on what
sounds so smart

For a 70 kilogram person, zero point one
watts per kilogram, seven watts, that's how

much energy I can irradiate and have him
absorb seven watts.

So you understand it's not practical.

You're not going to get three slices out of
that study, right?

Why would anybody approve it at zero point
one?

So what ends up happening is approved at
zero point one.

What happens as soon as it's approved?

Oh, that's right. They can now market it,
sell it.

Now, they can market always.

And then, as one of the one of these
articles wrote Intrepid researchers, then

some people say. Zero point one is just it's
just not practical.

I'm going to go off label and I'm going to
try this at zero point to see what happens.

I have data to suggest that it shouldn't be
harmful and if I see anything, I'll stop

immediately. They try it at zero point two
or zero point three or zero point four.

Nothing happened. They write an article on
the peer review literature, hey, I went to

zero point, whatever.

Even though it was labeled a zero point one
and it was fine, three other people say,

that's fascinating. Let me try that.

They try it.

They write articles and then I'm making this
up from now on now it's a man he's made up.

It's no longer facts.

And now seven people write peer reviewed
articles in the next year and a half, two and

a half years. And everybody now uses it.

The state of the art.

The standard of care is now approved, not
approved.

Excuse me, it's now that people are clearly
routinely across the country using it at zero

point three watts per kilogram.

It's labeled at zero point one, but
everybody is using it as they've seen it

safe. They've got their own data.

They're happy with it. At the national
societies, the international meetings, they

present these papers, people hear those
results, they try it at home and everybody's

happy. Not only that, a few years from now,
if they wanted to, Medtronic can take all of

those data, all of those published
literature,

That's free research, print it up.

They don't even have to print it up today.

It's just electrons.

Send the PDFs to the Food and Drug
Administration and say we would like to

change our labeling to zero point three.

Here is the data, and it doesn't even cost
them a penny.

As you said, it's free research.

Hey, if they ever submit it in the first
place, right?

Right, right.

So there's an example of where you may have
labeling that it doesn't tell you that at

zero point one is safe, but in zero point
two, they're going to die.

Right? It tells you that.

What does it ever mean when it's labeled to
five 40 gauss per centimeter?

What do you know about seven 20 gauss per
centimeter

To determine, right?

It's undetermined, right?

The only thing you can say that is one
hundred percent scientifically accurate about

seven 20 if it's labeled up to five gauss
per centimeter off label means.

Un claimed.

Well, no claims are being made, it does not
mean that what most of us think is that we've

tested until it was unsafe and we back off
to where we see it is safe, right?

And I always use the example of I'm going to
put you guys on the spot here driving.

So let's just say theoretically, Sign says
fifty five miles an hour.

All right.

No one's watching.

It's just the three of us.

I mean, the age of HIV.

Have you ever go above fifty five?

Never, never.

Yeah. Might be watching.

Uh-huh. I'm not afraid.

Yeah. Yes.

How much should you go? Did you did you do
Sicko?

Yes. Did you do 70?

Yes. Ok, I'm not even going to go further.

Did you do 60? What if I ask somebody to
say, well, I'll go to sixty five, I'll go to

seventy five, I'll never go, but somebody
else says, Are you kidding?

I've done ninety. And I go with the flow,
you understand.

I go the flow of traffic.

So do you understand that?

What is the right answer to that question?

The question is silly, right, the question
is silly.

What do you mean the right answer for you?

I'm happy at 72 for him, 70 for this person.

Eighty five for this person.

Fifty five. I'm not going above it.

If they said fifty five, I'm not.

So I always say, what if you get to a curve
in the road, it says forty five and you've

been humming along at eighty five because
that's what you feel like because it's

straight as an arrow and you're out west.

You can go for an hour and never move and
you're going in a straight line, right?

Then you see a sinuses curve.

Forty five, you're still going to do eighty
five.

Now, some people may say yes, but most
people will say no.

Why? Because we understand that labeling
physics.

Yeah, we understand labeling that if
somebody went out of their way to say, here

I'm dropping, that means something's
different, right?

Something is about to change. Yeah.

Fifty five doesn't mean that you're going to
die at fifty six.

It means that someone's done some, some
work, and we all know exactly what it means,

and they say that fifty five doesn't mean
you're safe, there's no guarantees, right?

You absolutely can get a flat.

Next thing you know, flip and you died at 55
and you were 55.

One hundred percent. They'll write on your
tombstone that it was 55 when you died, but

you're still dead, right?

It's not a guarantee.

It's that this was a reasonable conclusion.

Independent third parties have posted it.

That's what we're dealing with here.

What is safe?

There's no single answer to that question.

What we can tell you is what has been shown
to be a reasonable claim period.

Are they using like human models for what to
determine?

So the FDA, when they label, when they the
FDA doesn't label the manufacturer labels and

they hears the word negotiate the label
literally with the FDA, the manufacturer and

the or the pharmaceutical firm and the FDA
negotiate an acceptable label based on the

data submitted and based only on the data
submitted.

The FDA is under no obligation to tell them
how they should market their device.

They're under no up and the company is under
no obligation if they did studies at point

three once per kg.

But they think it's question they're under
no obligation to submit that to the FDA.

They choose what they're submitting

Well when they obtain this info.

Is it based on like scanning phantoms?

So there's different pre marketing that's
done premarket approvals.

There's all different formal testing that
has to be done based on drugs based on

devices. So there's phase one, phase two,
phase three pre-clinical trials that I'm sure

you've heard of. Right.

So there's basic lab work, then there's
animal work, then there's human research

phase one two three.

Eventually, you might even have it approved,
and the FDA may say you're approved on the

grounds that there is phase four post market
data I still want to see.

I may pull back that that label if I get
further data.

They may demand phase four after it's
approved, but I still want data and I'm going

to check it out. So there's always data done
laboratory, there is always data done animal,

there's always data done, almost always on
humans.

And on the basis of that, the FDA reviews it
and says approved or not approved, approved

or not approved for.

Marketing. Hmm.

So the only correct answer is if it says
it's up to five 40, what do you know about

seven 20? The one thing you know for sure is
that no claims are being made about seven 20.

Right? That's the critical aspect that we
need to get across.

But there might be a turn coming up.

It might be anything.

It might be it might be absolutely unsafe.

It might be deadly, right?

And it may be one hundred percent fine.

But since it wasn't tested there, they're
not permitted to claim anything beyond.

Oh, so if you pick up the phone and I would,
I would advise you to do this.

Whoever is listening into this podcast, if
you pick up the phone and you dial your

pharmaceutical firm or dial your device
manufacturer, get them on the phone and say,

Listen, your drug or your device is approved
in the following fashion it's at five 40.

Can I go to seven 20?

And what you're going to hear are the other
end of the phone is, well, our device is

approved up to one point five Tesla and up
to five.

They have to read what they're legally
permitted to claim, right?

And anything else?

Marketing and sales, it is literally not
legal for them to say anything else.

But I wait. But I just heard this seven
articles I saw about point three watts per

kilogram, not point one.

Is that true?

And if you do say that to the sales rep or
to the marketing guy, they're going to say to

you, Dr. Canal, do I understand that you're
asking me for information about zero point

three watts per kilogram and articles that
you may have seen?

Or are there articles like that?

And I say, Yeah, right?

And they're supposed to say, thank you very
much for your question.

I do not have the answer to that, and I'm
not able to give you an answer to that.

I will send this to the medical affairs
group in our department, our customer, our

company, right, and someone will get back to
you.

They then have to record.

The question was originated by Dr.

Canal, not the marketing or sales guy he's
not trying to get.

You could use it at zero point three.

That shut them down.

Compile. They have to

Document Dr.

Canal and such and such date and such and
such time initiated the question.

I then sent this to medical affairs, not
sales, not marketing medical affairs.

This is for our protection.

We don't want an elixir that kills one
hundred and seven people and children.

It's just not what we're interested in
medical affairs, says Dr.

Canal. Thank you for your inquiry on such
and such date.

About the following we are permitted to give
you here is some data that we have from the

peer reviewed literature or even our own
research.

They would be permitted in such a controlled
fashion, from medical affairs physician to

physician, to answer your question as best
as we can with FDA's blessing and oversight.

They can communicate what the societies have
been saying peer reviewed literature, but

it's extremely controlled and regulated so
that they're not trying to get away with

marketing to you, things that the FDA has
not approved.

I have to be the one to ask for it, et
cetera, et cetera.

Do you understand? Yes.

So they want us to be practicing state of
the art medicine everybody does.

Our patients do. The government does.

Everybody wants us to be practicing state of
the art.

But listen, and this is the hard part that
we're going to have such difficulty shaking

out of the trees.

Why are you looking in the product label?

For the standard of care.

Why are you looking in the instructions for
use as to what the most current medical

knowledge is about, how to appropriately and
properly use this drug or device?

That's not the place to start and finish
your search.

You absolutely should start there.

Absolutely. Let's see what they claim.

But if you have an off label indication and
your patient can benefit from it and there is

data to support your doing so, you're not
just making this up, right?

It's not that you're allowed.

Here's the hard part.

You're bound to do so, and it's your duty to
do so and listen carefully.

If you don't do so, you're legally exposed
because you have to provide.

The standard of care, what a similarly
reasonably trained professional would have

done in that circumstance, if everybody is
doing point three and you're doing point one

or you're or you're cancelling this study,
right, but everybody else would have done it

if something untoward were to result, as I
like to say in my courses.

The laws of the United States find us
equally liable for acts of commission or

omission, whether we did something we
shouldn't have done or didn't do, something

we should have done.

We're equally liable, right?

I really feel like that's the underlying
cause, right?

We live in a world where people call or sue
because their coffee's too hot.

So liability is really the number one
concern, I think here, right?

And so when people scan off label, they
assume that liability, whereas before the

liability they could.

But then the question you bring up is what is
the liability for scanning off label?

Let's go there before we can, if we can.

Are we able to capture the screen again or
is it super?

This is the in twenty eighteen.

This is not nineteen eighty two.

This is twenty eighteen is when the contents
were current as of I brought this down a

couple of days ago. Was it?

The FDA's website contains the following
FDA's role in regulating medical devices.

The FDA regulates the sale of medical device
products, including diagnostic tests in the

U.S., and monitors the safety of all
regulated medical products.

The FDA does not have the authority to
remember this is the FDA speaking regulate a

physicians or nurses practice.

The FDA does not tell providers what to do
when running their business or what they can

or cannot tell their patients.

The FDA does not have the authority to make
recommendations for individual doctors,

clinics or home care agencies.

So you're suggesting that there is no legal,
beneficial or benefit to staying in

compliance with FDA.

It's the other way around.

If a medical malpractice suit should arise
from real or alleged injury by a drug, the

plaintiff's lawyer would probably attempt to
strengthen his or her case if he or she could

point to the lack of recommendation in the
manufacturer's literature for the use

involved. You, you gave this at seven 20
gallons per centimeter.

This is a proof of the five.

Ladies and gentlemen of the jury, do you see
how he ignored the safe usage?

And look, what Dr. Canal did in justice
might result if the defense failed to point

out that the FDA does not regulate the
practice of medicine, the labeling might be

given some consideration and how well it
reflects proper practice, but it should not

be allowed to establish what is proper.

Other medical literature or expert testimony
can quite validly support the correct use of

a drug. The FDA isn't there to teach many
canal how to do his job.

Turning to the FDA to learn how to care for
my patients right is inappropriate.

It is not the intent.

They do not issue guidelines on the care of
my patients.

They're not allowed to practice medicine.

They're not allowed to interfere or advise
me how I should practice.

That's the misunderstanding that's so
rampant everywhere.

Physicians have a technologists have it.

Nurses have it. In the old days, the FDA had
it in nineteen ninety seven.

It was solidified and crystallized.

Nothing in this act shall be construed as to
interfere with the practice of medicine from

a physician to his patient.

It's still really hard for me to wrap my head
around only because it really just seems like

I'm swimming against the waves, right?

Like this goes against everything that I'm
kind of familiar with your program.

Yeah. To be in compliance

Like, you know, FDA, Big Brother, you know,
they want.

You've got to do this because that's what
they want you to do.

Type of thing like, let's open it.

Let's go to the

Next the next slide.

Well, let me ask you this if you don't.

Sure. Who do you think should be the
ultimate decision maker on whether or not you

go off label, should it?

There is only in the United States, it's
different in different countries.

In the United States, that's an easy one.

There is only one that can make the
decision.

The physician, the physician who's licensed
to practice is the one who's going to be

doing a risk benefit assessment and will be
held liable for that assessment.

And so the physician is the only one that
has the authority to say I choose to go off

label and will be held liable for going off
label or going on label for the decision that

they made. Right.

Forgive me if this is a stupid question.

But when you say physician, are you talking
radiologists or are you talking about

businesses?

Any physician has a legal obligation to make
risk benefit assessments on their patient and

will be held liable for those decisions in
the case of MRI.

One would think, how do I practice MRI?

What drugs do I or do I not use, right?

The only one who's been trained in that and
the only one that in court is Child's Play to

show has formal training in the execution of
these sequences in the interpretive.

Haitian in the safe execution of the study
itself, what drugs to use or not use, what

are the benefits of the individual contrast
agents?

Are they the same or are they different?

Do you really think you're referring
physician?

Has ever undergone any training in that it's
child's play for them to defend, saying I

ordered it, but I ordered it up.

I ordered endoscopy.

It doesn't mean that I'm going to be held
responsible when you perforate the patient,

right? I ordered the endoscopy.

You're the gastroenterologist.

You did the listen to the words medical
imaging procedure, and you'll be held

responsible for the safe execution of that
procedure.

Here they did. Radiology consultation form.

Right? Right. Mri with and without.

Yeah, if you think it's unsafe to give
contrast.

Why did you permit contrast to be given to
your patient, right?

Ama Journal of Ethics, if you can bring that
up.

This is in 2016 prescribing off label, this
is to your question what should a physician

disclose? Once the drug is approved by the
FDA approved for a specific indication,

legally, it can be used for any indication.

Off-label prescribing is common.

It accounts for 10 to 20 percent of all
prescriptions written.

Children's Hospital of Pittsburgh wants the
in.

The pharmacist at Children's Hospital of
Pittsburgh, one of the largest children's

hospitals in the country, told me that 90
percent of the drugs in the formulary of

Children's Hospital of Pittsburgh are not
approved for usage in children.

Now, why do you think that would be?

Because how do you get a drug approved?

You submit data to the FDA.

They review it and they say, This looks
good.

I approve it, right? Well, the vast majority
of the drugs that are out there and the

devices that are out there, do you have any
idea how much more expensive it is to get

studies reviewed on humans in children?

And there's another category zero to two.

How difficult it is and how expensive it is
to try to recruit patients to try to recruit

parents, to allow their three year old,
their one year old, their newborn in a

research study that forget this.

So it's so hard to get the data.

90 percent of the drugs in the formulary of
Children's Hospital of Pittsburgh are not

approved for usage in children.

That's funny, but that means it's

Approved for marketing, right?

It's got nothing to do with what's medically
appropriate.

In fact, possibly even the standard of care.

I like that that really paints a picture
right there.

Do you want to market it, you're going to
have to get that, that that labeling, but if

you you can utilize it all day

Off label is an FDA regulatory term that
denotes nothing about clinical risks or

benefits. This is the AMA talking.

Okay.

Yeah, that's pretty definitive, I don't know.

Can I paint a picture for me?

Well, now I think what we should do is take a
look at some of the

Attorneys seating analogy really spoke to me,
by the way.

They really helped paint a picture.

This is now attorneys reporting from the
legal literature, yeah.

In this article from the Indiana Health Law
Review, it is the physician's duty.

Does it say he's allowed to do so?

This is the lawyer's talking.

It is the physician's obligation.

It's their responsibility.

It's their duty to adequately weigh the
risks and rewards of a particular course of

treatment when prescribing medication.

Whether the physician has met this duty
depends not only on the warnings provided by

the manufacturer, but also the prevailing
knowledge in the fields.

Just looking at a product label is not
sufficient.

There may be an awful lot more known than
marketing has approved another label.

This is again from the legal literature.

Fda off label use and informed consent
debunking myths and misconceptions The FDA

never has had authority to regulate the
practice of medicine.

Physicians may use legally marketed drugs or
devices in any way that they believe in.

Their professional judgment will best serve
their patients.

Unfortunately, terminology problems persist.

It is common parlance to say that a drug or
device is FDA approved for a given use.

If that use appears on the label, would,
that suggests is that it's not approved for

something that's not on the label, and
nothing could be further from the truth.

The marketing claim is approved for what's
on the label, anything not on the label.

They are not approved to market it to me for
anything that's not on the label, right?

This erroneous concept of unapproved use
takes on derogatory connotations.

If divorce from a regulatory context,
they're just regulating what can be marketed,

not how I use it on my patients.

Yeah. And it would be a derogatory
connotation, as would be the case in an

informed consent discussions.

Thus, it is not possible to draw any
conclusions about the safety or effectiveness

of a particular use of a drug or medical
device from the administrative or legal

status of that use as off-label.

In many or most cases, the FDA will have
made no determination, positive or negative

about any given off label use.

The only certain conclusion is that the FDA
considers the product generally safe enough

to be on the market.

For the labeled approved use.

So what was approved is to market it as it
was labeled and anything beyond that.

The FDA says, I don't know.

I haven't seen it off label thus only means
silent label.

No claims. This is the legal literature.

The term denotes nothing about health or
risks.

Off label could be deadly.

It could be state of the art standard of
care, how could you not have done it or

anything in between? It simply means no
claim.

I would say ninety nine percent of what we
deal with as far as on and off label is

devices, but give an example of what a drug
might be that we would use an MRI that would

be off label.

Of course, if somebody is using a drug and
they decide to give double dose, if they're

using that drug and using it for CT because
it shows up on CT, the patients in renal

failure, let's use a gadolinium based
contrast agent and inject 40 cc's and do CT

as our contrast because it's not going to
induce renal failure, they say, as opposed to

the iodine, they would be concerned about it
back then, right?

So that's an off label use.

It just not approved for usage in CT.

Right. It's approved for MRI.

It's approved because of relaxed tivity that
has nothing to do with why you're giving it.

It's you're giving it.

Because of its atomic number for CT to stop
an x ray to reflect, deflect or absorb an x

ray is a completely different usage.

It's not listen to the words approved for
marketing for that indication, right?

But it's off label.

Just like your minoxidil example, I've
actually personally had an experience with

him, and I'm not sure if I know they do it a
lot with the NGO angiography, but I'm not

sure with like

Neuroimaging, you just gave the perfect
example.

In nineteen ninety one, I actually had the
first person to present a humans contrast

bolus dynamic MRI NGO Oh, there's November
nineteen ninety one.

I presented it the Arseny.

You just gave me goose bumps in

14, I believe years later.

It got 14, I believe.

Years later, the first gadolinium based
contrast agent was approved for Emre NGO.

All right, for every NGO we did before, that
was off label.

It took 14 years of research for them

To know it's how long it took until they
decided it was financially worth getting a

label. Remember, you you're you're
continuing to fall back to.

But the science is there, why don't you get
it?

It costs millions of dollars, right?

Dozens of millions of dollars to get a

Label got a B business.

You have a label and you want to get
something else.

You're meeting with the FDA.

The FDA doesn't charge you millions of
dollars.

The research that they're going to ask you
to show me that you that you can support your

claim. Millions and millions of dollars.

Conceptually, it may or may not be
financially sound practice for them to pursue

that label. For many years, there is no
drug, no gadolinium based contrast agent was

approved at zero to two, then one drug came
out with an FDA label approved in usage zero

to two. Next thing you know, everybody's out
there trying to get their drugs approved zero

to two because once one did the financial
potential problems of mine not having it.

People may think they can't use mine.

Or maybe legally, why don't I just use
theirs?

It's less of a legal risk.

They might think theirs is approved because
they don't understand.

All right. So as soon as one got it, now
they all submit data to get theirs approved

zero to two. It's a financial decision.

It's it's so hard to get that across.

This is a for profit discussion and the only
ones that don't recognize that are the

customers. And that's us, right?

We keep looking there for science.

It's not where we're supposed to find the
most state of the art science about any drug

or any device.

That's a mistake.

And as you saw from the attorney, we have a
duty to go beyond that and know standard of

care. And what's appropriate, whether that's
on label or off label is absolutely

inconsequential as not the label is
regulatory, not for us, for a pharmaceutical

firm, for a manufacturer, what they can
claim, it regulates them.

They cannot regulate the practice of
medicine.

I mean, I knew thought was going to be
interesting, but I didn't know my mom was

going to be blown. But like, we

Try to really, really wanted it for a
physicist to be here tonight.

Oh man, it's crazy.

You know, one thing I do find interesting is
just off label use in general, but we do a

lot in our personal experience with mostly
devices like I said before.

And so it's a lot of times it's the non
conditional pacemakers and like that.

But we're lucky enough to work at a facility
that has a physics department.

And so we have a physicist that we can use
to consult at any given time, right?

And we see him pretty often.

So he's a good resource for sure.

That was who I was hoping it would be here
tonight.

So I know you're watching Dr.

Panda,

Not that we're going to call you up by name.

You call them out.

So this is what I wanted you to see.

As discussed above, the FDA does not
prohibit nor regulate a physician from

prescribing a drug off label.

The FDA is intended mission is to regulate
the pharmaceutical industry industry without

interfering with the practice of medicine
that you need to publish it in neon lights

and place it on top of every MRI scanner,
right?

The FDA's intended mission is to regulate
the drugs and devices industry.

Without interfering with the practice of
medicine as such, allowing physicians to

prescribe drugs for such off-label usage is
quote an accepted and necessary corollary of

the FDA's mission because their mission is
to not interfere with the practice of

medicine and can be the standard of care in
many fields.

It should be printed in every zone.

Three Right.

My brain at this point is literally coming
out of my ears.

Yeah, it's pretty crazy, and I imagine you
just beat your head against a wall sometimes

just had to get the techs to reassure people
of this.

Here's one for you Nineteen ninety five
percent of drugs used in neonatology are are

used off-label.

Oh all right.

Well, because like you said, they can't test
it on baby.

Right, exactly. It doesn't mean that they're
not safe.

It means they don't have data that the FDA
has had submitted to them and they've

reviewed. So how do you know you can?

Seriously, how do you know that you can use
it safely?

Well, then you have that's what you were
asking before.

So you turn to societies, you turn to the
peer review literature, govern yourself.

Make sure you know how to practice medicine.

And where do you go to learn how to practice
medicine?

Don't go to a to the physician's desk
reference to see what somebody's got legal

legally allowed to market.

To me, that's where you start.

Well, now you go to societies, you go to
other physicians, you go to the peer review,

you go to experts. That's how science
develops.

That's how medical care is practiced.

Couldn't the ninety five now get like a retro
approval with the data that they have?

I mean, if the company feels that it is
financially sound business, plan to submit it

and get it approved. Yes, if it costs more
than they think they will earn, then no.

And let's go back to the minoxidil.

I'm just I'm making this up.

What if more people are prescribing it for
hair growth than for antihypertensive?

What if everybody's using it already?

Why should they bother getting it labeled if
it's already being used right?

Because I was going to do is cost them more
money.

It's going to cost them more money.

But I feel like it's going to open up a

If people are using it, it doesn't open up
anything.

And if they're not, then it would open up.

So it's a business decision, right?

There's already a whole bunch competition in
the hair growing industry.

That's the part that people

Think of the money, and I am thinking about
the money because I'm thinking if you've got

a drug that's FDA approved and you want to
sell it to a pediatric hospital,

I'm going to I'm going to interrupt for a
second.

If you've got a drug who's marketing is FDA
approved for a single indication, go ahead.

Yeah, it's way more marketable, so it's way
more competitive.

So way more people are going to buy your
product.

The real truth is that because the contents
of this podcast are so misunderstood.

You're absolutely right.

People go out of their way.

They will say to you. And their ads now
indicated for the use in zero to two

indicated for MRI angiography.

I've been using it for MRI angiography for a
decade.

But we live in that world, so people don't
are not doing

It, so it may be cost effective and they may
think it's not cost effective and they may be

wrong. It's just humans make.

It's a business.

All I want you to recognize is it's a
business decision, right?

I mean, because FDA literally said in the
last slide that we just showed standard of

care is to go off label.

There's one care is to provide the best care
for your patients.

That's care for the patient period, right?

And whether that is or isn't off-label has
nothing to do with the standard of care.

Nothing. It's a mistake to think that on or
off label defines standard of care that

sentence has to get across in this podcast,
right?

It is a mistake to think that whether it is
or isn't labeled for a certain indication or

whether I am on or off label defines
standard of care in any way, in any way,

ever. It is not the intent.

Their job, as we saw in that slide a few
slides ago, is to regulate the company's

industry. The FDA regulates industry.

They do not regulate the practice of
medicine.

Their job is to regulate industry, to
prevent unsafe things from being sold in the

first place or unapproved inappropriate
claims, right?

They therefore regulate marketing what they
can claim.

It's my job to go way beyond just a claim
and to know how to use a drug or device best

for my patients individually.

Every single one of them, that's my as you
saw the legal publications, it's my legal

duty, which means obligation.

And if I don't provide my obligation, that's
defined as negligence, not providing the

standard of care as a synonym for
negligence.

So that's one thing I really appreciate about
where we work is that we work at a facility

that just today they scan and off label
device.

And so they're not looking for reasons not
to do that.

They're looking about how can we do it
right?

So a lot of places, I don't know, it seems
like if they have it out, they take it well.

It may be that they're taking it, perhaps
because they misunderstood.

They may think that they have to take it
right.

Well, it's nice to work for a place that's
educated on that then.

Yeah, for sure.

Well, I'm glad to see that at least it took
the two of you off guard and by surprise,

because there may be, maybe it'll also be
useful for the people listening in your

podcast.

Well, I'm glad we covered this topic for
sure.

I think it's got a lot of merit to it, for
sure.

Yeah, it's just yes, it's so interesting.

I can't wait to go do my own due diligence
'cause I'm definitely going do some fact

checking.

Well, the truth is that you would be
tremendously helpful to your physicians in

general if you were able to find information
and provide it to them.

A physician can't be expert in everything in
the universe.

They're human is just not possible, and
intelligent physicians obviously would like

to surround themselves with the most capable
technologists they can.

Those who have this knowledge and do some of
the footwork and and say, This is what I was

able to find out. You make the decision, but
at least this is what I was able to find out

how others have used it and where it.

Here's my references that would be.

It's worth its weight in gold.

Well, and honestly, not where I'm working
now, but places I've worked in the past.

I do find that a lot of radiologists lean on
the techs to make that decision.

As far as safety goes, should we should we
not like I've had many radiologists go, Yeah,

I don't know. What do you think?

I think that if if a radiologist is not
expert in that area will be held liable and

they turn to a technologist that is more
expert and ask for advice and guidance.

I think that's exactly how the system should
work.

That's what we're looking for.

Surround yourself with people that have
expertise in that area.

Guys, I say it all the time.

You're the ones that say, Don't call me a
technician.

I'm not a technician. I'm a technologist.

The difference between a technician and a
technologist, a technician knows what to do.

A technologist understands the knowledge
behind it.

And if you're technologists, it would be in
my selfish best interests to ask you for your

advice and then make the decision, and I'll
be held liable for the decision.

I make the best president surround
themselves with brilliant advisers.

They could be. I use Reagan as an example.

Whatever you thought about him, he was an
actor.

He was a Hollywood actor.

Those were his qualifications.

But he had. Everybody agrees.

He had some tremendous advisors.

You could be president of the United States.

If you have excellent advisors, you
certainly can be a better radiologist if you

lean on expertise from wherever you can find
it.

And if you can find it from your own
technologist, that's fantastic.

And that's how the system is designed to
work.

I do find when I'm in those situations where
I'm asked for my opinion, I do caution on the

side of error and I am more likely to say I
don't think we should do this because I've

had several patients where gsw, they've got
a bullet in them somewhere.

And I would say, I don't know.

I mean, I've seen a lot of radiologists say
no to this based on my experience and the

consultations I've had prior to this
particular patient.

I think maybe we shouldn't scan.

And then it turns out we scanned it and it
was fine.

So like and we've had patients with gunshot
wounds that were scanned that have permanent

injury afterwards.

So this is now you understand this is the
art and science of medicine because you may

be a 57 mile per hour kind of guy.

And what's wrong with that in certain things
you might say, I don't have the data to

support it. That's not even a 57.

That's a 45 turn.

I'm going to I'm going to slow down.

That's perfectly fine. It's cured.

There is no right or wrong unless you're so
egregiously aggressive or egregiously, I'm

never going to go beyond the product label,
either.

Those two extremes, OK, there.

Perhaps you might say it's too far.

There are many facilities that are that way,
though.

Oh yes.

The first starts with questioning this
process that we've been talking about with

the FDA and how we kind of understand that
concept, because how do you not question

after this, right?

Like, you have to kind of think about it
like that, like, OK, well, obviously, we can

kind of discuss a conversation about doing
this now because they're saying that we can't

go past five hundred twenty, but that
doesn't mean it hasn't been tested at seven.

Right, right.

Well, it sounds like is your you're
referencing the canal method?

Yes, exactly. All right.

So now we can figure we can end using the
example we started with because now you

understand this six foot four diabetic.

Right? It's completely off label, but you
have personal knowledge of your own machine.

You know where the fields are distributed.

You are comfortable that you're not exposing
this device to any field or fields, static

time varying gradient time varying RF that
will be harmful or technically off label for

what it's already been approved for.

For labeling for marketing, you're
comfortable that it's so far out that it's

not going to be exposed to harmful levels of
any of the three energies.

So off label, but you do your patient to a
service, a benefit.

Instead of sending them to the O.R., you can
perhaps answer it with a noninvasive study

and maybe allow percutaneous drainage and
guide where they need to go.

And that's exactly what we're looking for.

I told you at the beginning and I'll say it
at the end.

Nobody wants a Yahoo.

Nobody wants an aggressive cowboy out.

They're saying yes to everything, right?

It's easy to say no.

It takes knowledge and understanding and a
willingness to apply them to say yes and not

letting marketing limitations limit your
practice of medicine and the care of what's

best for your patient.

That's the whole point you are trying to
make all along,

Very well said.

And what we don't see a lot of times is just
the behind the scenes like these patients are

coming to us with stories and history and
experiences and their anxiety.

And when they're being turned away at other
facilities and you work at a facility that

can think outside the box.

It's I keep going back to.

I feel like we're really grateful.

I'm really grateful to work out where I do.

And to see the look on that patient's face
when we're done with the exam and I bring

them out of the board and they say, we're
done and I say we're done and they that

weight of anxiety releases from them.

They know they've got a good study.

They know that they're going to get whatever
answers that they're looking for.

It's just it's a very rewarding and very
satisfying feeling,

Especially after they've got so many no's
before that

I've seen them overcome their just
claustrophobia.

But I love seeing us overcome this, these
moments of adversity where we're supposed to

just somehow make it work right?

I have a special message to the
technologists.

The the message is don't be afraid to think.

Don't be afraid to take the knowledge that
you have and share it.

You know your relationships with your
physicians.

Nobody else is going to explain that to you.

And you know that some of you will have
difficulty doing it, but many of you will

not. And you'll be able to say, Dr.

Canal, Dr. Smith, Dr.

Jones, I got to tell you, I'm not
comfortable doing this because of the

following or I just want you to know, you
know, you have to make the decision.

But I got to tell you that I think we can do
this safely because I think this is far

enough removed or I can make sure that I can
drop the if you're worried about the heating,

I can take care of that.

I can do single slice.

If you need me to, I can drop the essay or I
can go way down.

I can. I can put pauses.

I can decrease the duration if you feel
comfortable.

Don't be afraid to think, and don't be
afraid to explain and to share what the

knowledge you've worked so hard to get right
you had.

There are 7000 people that by now have taken
my courses in MRI safety and I've told them

the same thing. I'm telling you, I'm not
knowledge and understanding is not my

problem. I don't have the slightest concern
that you're not going to be able to

understand it or know what we're trying to
teach.

You all got to where you are because you
have skills and you have talents, right?

The part that I'm worried about is the
willingness to apply it knowledge and

understanding, but the willingness to apply.

It is what you've got to work on.

If you think you can do it safely, say so.

Maybe the radiologist really will appreciate
your knowledge and will appreciate and say,

Well, tell me more. Why do you think so?

And what can you do to reassure me?

And do you have any references or is there
someone I can call that might be able to back

you up? Don't take that as an insult.

That's how it works in science.

You want somebody to back you up and you
love being the one that afterwards, if you

suggested it and you did it safely and you
got that feeling afterwards, they were about

to cancel a study that you were confident
you could safely do.

That is what makes you a technologist for
real, not just what you understand.

I don't care what you understand if it stays
locked up in there.

As far as I'm concerned, you're a technician
if you share it.

That's what makes you a technologist.

Nice. If I could just say one as a
technologist, my personal experience one, I

think critical aspect, though.

And again, I keep plodding the place that I
work, but I applaud any place that allows you

a big enough time slot because you said time
is money, right?

And it's all about money. We live in a
capitalistic world, right?

But at the end of the day, if you're given
the enough adequate time to say, Hey, I can

do the one slice I can do, the 15 minutes
can wait 30 minutes, I can do all these

different things. It's nice to have because
I worked at places that it's just kind of in

and out, in and out, in and out.

And if you are going to take more than a 30
minute time slot, then you're not FDA

approved. Sorry. And we move on to the next.

So it's nice to work at a place that well.

I've heard a saying an interesting slogan.

A Democrat, a liberal, is a Democrat that
hasn't yet been mugged.

Well, from that from that point of view,
warped as it may be.

There is also the point of view of somebody
who's aggressive, somebody who hasn't yet

been sued. Oh, somebody who hasn't yet hurt
somebody and I mean hurt somebody because

they're after the almighty buck.

And listen, if I keep saying, if if you
never hurt anyone, you get away with it.

It's fantastic, right?

Right? The only time it ever is an issue is
if somebody gets hurt.

And at that point, the legal system finds a
way to make sure someone's there to pay.

So I agree with you, if you're working in a
place that's you're very fortunate.

If you work in a place that says, get me an
answer, if it takes an extra 15 minutes, it

takes an extra 15 minutes.

But I need this answer. I need to know if
this cord compression, that's a perfect

example for a cord compression.

You're worried about heating up this this
abandoned lead.

You're doing three slices, you're doing a
central five mm thick for all.

I care. You just want to see if there's cord
compression, a gradient echo, you just do it.

In fact, you could probably get away with
doing nothing more than your localized and

you have an answer.

So if you if you're that tech, they get
called in at 2:00 in the morning for cord

compression. I've been this tech and you
said, can your patient go by wheelchair or

stretcher? Oh yeah, he's actually just
walked to the bathroom right now.

He walked to the bathroom and he walked here
and he could do all these different things.

But I'm running a thirty minute, 35 minute
scan in the middle of the night to see if he

has cord compression.

All right. I'm not here to judge whether or
not that person should or shouldn't have been

there.

Come on, I got a neuro radiologist.

Neuro radiologist says he doesn't tell
somebody how to practice medicine.

Aha. A great answer, Steve.

We were testing you away.

Well, you know this.

I think one way that I explain and MRI
safety to patients is that I because a lot of

times they'll say, Well, why is it that I
have, you know, this hip replacement and

that's not OK, but or that is OK, but this
isn't, you know, and I say, well, when it

comes to MRI safety, it's not black and
white.

It's great. And it's really great.

Fifty Shades of Grey,

I don't say that. What do you say?

Ooh, I tell them that the is presupposing
that it's a simple black and white, but

there's an awful lot more there that you
have to know and understand, and we won't be

able to cover that in the space of a few
minute conversation between us.

So just trust me that like they like to say,
don't confuse your Google search with my

medical degree, right?

They're going to ROI give me something.

No, I mean, seriously, the point is that it's
not that it's great because you guys do

understand MRI safety and you can learn it
in.

So many people have said afterwards, I never
understood it before, but now I understand so

much more. You definitely can master this
field and it's a lot more complex and

involved. And that's all it is and somebody
saying.

But this is not safe and this is it doesn't
make any sense.

You're right. It doesn't, because it's a lot
more complex than you're thinking.

Not that it's voodoo magic is that it takes
a lot more.

And that's why I'm a technologist.

Right?

Levels do it.

That's why eventually I see us all get into
an Marso position.

And for the record, I'm not so, but

One of the biggest parts of the job, right?

That's a goal, for sure. You got to have
that knowledge.

I think more than just looks good on a resume
right on us, but it honestly is just great.

Just Vance,

If you were the patient.

Who would you want taking care of

You, right? And honestly, I treat every
patient like that way, but.

I don't know. Yeah. Do you have any
conferences or any educational things you're

doing? Coming up, you want to give a shout
out to?

We just finished, of course, last week in
Orlando.

That was really nice.

And it's nice to see that we.

It was nice to be in Florida, I have to say,
and it was nice to see a turnout that I was

actually very shocked because actually the
majority of hospitals are still still have a

no travel policy, right?

But we still had about one hundred and fifty
show up, and that was amazing to me that that

many people would show up in a in the middle
of still being on top of us.

It just goes to show that there's still
tremendous interest in doing our job better

and better.

Yeah. Well, we're hoping for a good turnout
at Arseny.

We're going to see you in a couple of weeks,
I hear.

So God willing, be there.

Yeah, yeah. Hopefully we can have dinner one
of those nights.

I'm looking forward to it the whole week.

I hate to say this, but yes.

Why do you hate to say it's my first year?

Do you know something I don't?

I'm sure you know a lot that I don't.

And we're

Out. This is my thirty fifth to 40th year.

Oh, wow. And it's a very it's a busy week.

It's a busy time.

Nonstop layovers in Chicago.

So I'm excited, actually.

You're going to have a blast. It's the
greatest radiologic show on Earth, although I

think this year will be much, much slower.

But right, it is truly a circus.

It's it's huge.

Well, I do have some questions from some
coworkers and whatnot, and so I do want to

ask you those, if you don't mind.

Absolutely. Fire away.

Katie, thank you,

By the way. Yeah, because I told Katie,

You know who you are? Hmm.

All right. So word for word it says so I
know this scanning off label is how implants

become FDA approved.

I want to understand that process.

Who can you take the off label data to the
FDA to get something approved?

For example, there is an active implant that
is one point fifty head in extremity only

scanning permitted, per the product
labeling.

But we have been off label scanning prostate
exams even in a three team with low SAR and

physicists supervision, et cetera.

How many times would this have to be done to
take the data to the FDA should it be

multiple patients same patient with multiple
scans?

I think we kind of covered that right?

Well, the answer to the question that we
didn't actually answer that question.

The only one, the only one who can take it
to the FDA is the manufacturer or the

pharmaceutical firm. Ok, industry, the I
cannot take it.

Hey, do you approve this?

We can merely hand them the data if they
don't take it.

It's proprietary.

It's owned by this company.

They determine its labeling, not you many.

They determine the labeling with the FDA.

They negotiate the label right based on the
data that they choose to submit.

It's for profit business and they will
decide what will and will not be labeled so

they'll gather data.

If they want that indication that this
questioner is asking and they may go to their

site and say, Can I have your data?

They may go to other sites. They say, Did
you publish it?

And then they may take that data, turn
around and submit it to the FDA.

But the fact that you did it means nothing
to the FDA.

They want to see prospective controls.

Show me what you did, show me what you
monitored, showed you show me the adverse

events. Show me that you were prospectively
monitoring for adverse events.

How do you know there wasn't an internal
thermal injury that you're not aware of?

This is it's science.

They're not interested that you did it and
nobody seemed to die, right?

That's not science, right?

I find this an interesting question, and I
think that this would actually, I don't know,

be almost like a shield of protection for a
lot.

But should the patient sign a consent for
off label scans?

The idea of consent is informed consent is
another lecture entirely.

It's a completely separate discussion,
informed consent.

I'm not an attorney, I don't play one on TV.

Informed consent is essentially best
determined if a reasonable patient would have

heard. The potential risks.

Would have said, Oh, if that's the case, I'm
not doing this.

Then you should have gotten informed consent
for that.

If there's a realistic chance that a
reasonable patient would have said, Wait, you

mean I, I could get a burn.

And if the chance of a burner one in three
million.

No way am I going to.

If that would be what a reasonable patient
would likely say, then a court may find.

And why didn't you get informed consent as
the again, we didn't go to the point of my

showing you this exact slides, but informed
consent because and only because it's off

label does not seem warranted.

So you've been an expert witness in
litigation, right?

I've been involved in over 350 legal cases in
my career.

Surprise that you wouldn't just definitively
say absolutely get informed consent because

every, you know,

Every little, we don't get informed consent
for everything, for many reasons.

For example. I don't want to scare my
patients on the grounds four.

Please forgive me protecting me.

I actually do care about my patients and if
I think a patient needs a test and if the

only reason I'm telling them about something
so that I'm covered, yeah, that's a conflict

of interest. Yeah, if the patient is going
to get scared off from a test that I think

they really do need, and I think it's in
their best interest and any reasonable person

would say, of course I want this.

Do you tell every patient that you give
penicillin to that there's a one in 100000

chance that they may get anaphylactic and
die?

No, I don't understand.

But is it one in 100000 chance that they may
die?

How could you not have told them, right,
because she has pneumonia and she will die if

she doesn't take an antibiotic?

Right? This is one of the safest antibiotics
there is.

There is a chance she could die and there's
no way I'm going to get informed consent for

a one in 100000.

Chance of anaphylaxis is not going to happen
because I'm going to scare my patient from

doing the right thing and that's the
practice of medicine.

So luckily, I have the rest of society and
the medical society with me.

Nobody gets informed consent for giving
antibiotics for fear, giving penicillin.

Now what if there's an antibiotic with the
chances of death?

There's one in 500.

Ok, that's a different story entirely.

All right, so what a reasonable person
considers.

I would certainly have said no if I would
have.

Ok, then maybe you should have gotten
informed consent, Manny and something like

one in 100000.

I don't believe that's what a reasonable
person would say.

I'm not in that case. I'm going to stay
unprotected and allow this this pneumonia to

run its course and hope it doesn't kill me.

All right. Well, I wonder if maybe that
answers the next question, because I do find

this in my experience a lot.

If a patient cannot will not remove body
jewellery, should they sign a consent for

burns?

It depends. Many body jewelry, I would like
to have off for multiple reasons.

Frankly, for most of them, I wanted off
because of artifact potential.

Now there are potentials for thermal injury
there.

I will admit that, but I think there are few
and far between.

Most earrings or something of that nature,
it's small.

It's completely conductive.

There's no reason to suggest that it'll heat
up.

And I, frankly, I'm not worried about the
thermal injury.

Concern is much. And plus you can mitigate
that risk by putting a heat sink on it and

just put a saline bag, a cold saline in a
towel on top of it.

And it'll absorb any energy that that you'd
be concerned would otherwise be a thermal

injury. So the informed consent is there
when I think the patient has a realistic

chance of getting injured.

I'll tell you where I get informed consent.

I tell the patient, you need hearing
protection for this study because it can

cause hearing loss.

You can actually expect temporary hearing
loss and without hearing protection, it can

be permanent hearing loss.

So you should have hearing protection if the
patient refuses hearing protection.

I want that in writing informed consent.

I might choose to cancel the study, or I
might choose to say, you don't want to

protect your own hearing.

And you need the study.

I might be willing to execute the study, and
you sign to confirm consent that you may have

permanent hearing loss.

I might proceed with that.

We'll see. It depends on what they indicate.

If it's for headaches, I'm not doing the
study.

If it's record compression, I might.

Ok. And the FDA is the one who says we need
to wear hearing protection, right?

Not a matter of need to wear hearing
protection.

I mean, you have the FDA is the one that
said that you have to have the hearing, the

sound pressure level decrease below ninety
nine decibels in the scale.

Right. And that's based on OSHA,
Occupational Safety and Health Administration

guidelines as to what they've considered,
what they've found is harmful and for what

duration of exposure.

It's not just an absolute level, but also a
duration and level that combined to form.

I'm hearing loss and beyond a certain level
instantaneous hearing loss for explosions and

what have you. Right?

One thing I do find I do, I think maybe it
does.

I don't know. I think maybe it creates a
culture where the patient starts to question

the necessity of some of these safety
precautions.

We take that if we say, Hey, you have to
remove the earring.

And they say, I can't take it out and we
say, all right, never mind.

Now they say, well, what else would they
say, never mind about, maybe I shouldn't

mention it. Right?

And so I do think that there's multiple
consequences.

I don't ask our technologists to say, never
mind.

We say we want them off seat wmra.

Want them off. And what if they can't?

Then we say you can degrade the examination.

Oh yes. If you think there's something
that's a safety issue, then we would say it

may be a safety issue.

Yeah. And with respect,

If they're wearing electrically conductive
clothing, I say that has to come off.

Well, no, I don't want it to come off, then
I don't tell them it's an artifact potential.

I tell them I'm worried about potential
thermal injury, a burn and to use the

English, don't say thermal injury to a
patient.

You say, we're afraid that you may suffer a
burn.

Do you understand blisters or worse?

The answer that I get very often is they let
me wear it last time.

Oh yeah, super.

I mean that when we come, we hit that
question all the time.

And so we answer them is, isn't it wonderful
that we're living in a society where our

knowledge and our ability to decrease and
mitigate risks continues to advance because

now we've learned ways to do it more safer
than we used to.

Oh, you're a doctor, you are a sweet talker.

But it is the truth, isn't it?

I want you to be my wingman, by the way.

Forget it. You could be mine.

You know what I tell patients and not as
articulate as used.

I just say just because you drove one
hundred and twenty miles per hour and got

here safely doesn't mean you should always.

Well, yes, but remember that I'm the one that
last time told them to go 120 miles an hour.

So I don't want to draw attention to the
fact that last time we didn't get them in,

this time we found them.

We tell them we don't

Put me in a tough spot, but are

You? We just tell them we've learned new
information and and therefore we're now doing

it. We're safely.

Ooh, yeah, I know, right?

You heard that so well, I'm at the point.

It's really true. It's wonderful that we are
able to learn about it and do things more

safely than we did in the past.

It's just people don't think about it
because you're trying to defend what you used

to do. I'm not here to defend what I used to
do.

I'm always trying to do the best I can and
the fact that we're doing, you know, in the

old days, I also used to use leeches, but
now we use antibiotics, right?

So it's just progress.

It's wonderful. I wouldn't say that to a
patient.

That sounds insulting, but I'm saying to us,
we recognize we used to use leeches, right?

Today we we can we don't have to use a
leech.

We can do other things to make it even
better.

And you know, it's progress.

Literally, it's all it is.

It's my first course was 2014, literally.

And and I am glad to say that I think things
have substantially changed in the industry

since these were introduced.

It's just progress is nothing to be
embarrassed of what we used to be like.

It's the opposite since we think we can do
better.

We teach each other how to improve and then
we tell our patients, Look what we learned.

Yeah, OK. I like that.

That's great.

Yeah, we get a lot of these.

It's a lot of these consent questions.

So here's another one.

Should a patient, a patient sign a consent
when undergoing an MRI under anesthesia, the

risk of burn is higher for the simple fact
that the patient cannot feel a burn or able

to communicate with us, even if we pad the
patient's everywhere.

The following S.R.

or SaaS B B one or REMS levels, the patient
could still potentially experience a burn so

under anesthesia should they sign an
additional consent or consent, acknowledging

the fact that in RF burn could

Happen by now, you know me well enough to
know that I never tell anybody else how to

practice medicine. I can simply tell you
that no, I do not in my institution.

I had the answer Yes.

Ok, it looks like this one's a case study
herbal here.

So you've got an eighty seven year old
patient with pacemakers scheduled for C-spine

T spine and L spine.

It is discovered with prior imaging that the
patient clearly has an omna phase, penile

implant or implant penile implant patient
claims to have had implant for 30 years.

Patient has been scanned eight times since
having the implant, all on a one point five.

Brain full spine angiogenic neck have all
been scanned.

No anesthesia implant is considered.

M.r. Unsafe patient is not consistently
disclosed.

The implant on screening in the past most
screenings patient has admitted it seems this

patient has been scanned off label for years
now.

At what point can this be considered a
conditional device?

I guess we don't define it.

You're right, it's never considered
conditional, but they meant from a practice

point of view. When are you happy that it's
safe?

You answered it yourself.

Having, I like to say, just because I cross
the street with my eyes closed doesn't mean

it's going to be safe the next time, right?

And there may be different circumstances,
right?

Right. Maybe next time it won't be five
a.m., Maybe it'll be five p.m.

and I'll have a different outcome.

Maybe the rate at which they move through
the field, the angle in which they're with

the field, the the previous ones were non
shielded and this one is shielded, and

therefore it's a greater attraction as they.

Go through the shield, there's so many
variables that this is what this person is

asking is a person has had it done without
any significant or untoward event.

Does that mean I can rely on it being so in
the future?

And the answer is a very definitive
objective.

Mathematically verifiable.

Of course not

A question, but it does play devil's advocate
because I mean, they this person would argue

that mathematically we're eight four eight,
as far as, say, no safety issues.

So mathematically and therefore worse, say
that it

Is six eight four eight.

Now we'll go back to what we said before.

Remember, we said that can we submit the
data somebody asked to the FDA and get

something labeled or we said no, the company
has to submit.

No, what that I had after that, I said,
that's not data.

Did you prospectively evaluate it?

Right. Otherwise, it's a bunch of anecdotes
and listen to the next sentence.

A collection of anecdotes and anecdotes does
not constitute data.

It's still anecdotes.

Nothing more. You know, nothing about how
they went through what speed they went

through with orientation, what field?

What were the spatial feel, gradient
distribution.

You know, nothing period, about that person
other than they entered into a scanner and

left, and they're here to talk about it.

And so I'll be glad to show them patients
that have entered into scanners and walked

out and they have ferromagnetic aneurysm
clips.

Would you put them in again?

No, I can show you a hundred percent.

I'll show you images scanned.

And then with massive artifacts, nothing
happened.

Not a thing. They asked afterwards is, are
we done?

Yeah, it's an anecdote.

If they go in seven times, Manny, come on.

At some point.

Yeah, at some point you hit the eighth time.

Right, right. I see where you go with this.

Yeah, I got it.

Well, all right. With the whole

Idea, I'm so sorry. One last thing.

Oh yeah, go ahead. What do you tell the
family on the eighth time?

But they went through seven times and
nothing happened.

And the family sits there and says, You're
pointing to the times.

Nothing happened.

My concern is not about the times.

Nothing happened. My concern is the time
something did happen.

And why did you rely on anecdotes as opposed
to science in making your decision?

I don't know, I don't want to

I feel like if I'm still playing devil's
advocate, those eight exams would be the

scientific method

Roi. So that is science.

Science is not. Eight.

Eight is not. It's not.

They had different circumstances each time.

Oh, yeah. They're not controlled

Studies. That's true, it's not controlled.

You're too smart to argue with a man is too
smart.

Now if if you dropped pennies on the table
eight of them and they all came up heads,

would you put your life savings at the next
time they're going to do it again if?

Eight. Listen to this.

I know it can't happen.

It can't happen an

Awful lot of money in roulette because of
this

Fame.

But if I dropped it eight times, if I dropped
eight pennies and they were all heads and I

dropped it again and all eight were heads a
second time, would you put your life savings

on the third time? Do you know what the
chances are of it happening twice?

That's why it's called statistics, because
the chance isn't zero, man.

It's just statistics, right?

Right? That's what you're gambling with.

Is my patient. Is that the luck of the draw?

What if every time you cross the street, it
ended up being nighttime and hardly anybody

was on the road? And the next time it's
daytime and it's rush hour

Day, you should have been a lawyer man.

Oh, that hurts. Oh man.

Very, very complimentary way.

You got it. You got your power persuasion.

I think that question brings up a good
concept or at least a good, I don't know a

good question for me to ask about unsafe
claims.

So if we're with this whole new idea of FDA
and Big Brother marketing, like, we'll let

you in the market. Why would anyone ever
submit like how did things become unsafe,

right?

Wow, that's it. You've opened a complete new
bag of worms here.

This is not a joke.

I don't think you understand what you just
entered into.

More unsafe means that the company has
today.

The FDA claims that with one exception,
we're about to get to, that's the bag of

worms. Mm hmm. They're not allowed to submit
a claim.

They said to me nowadays of mere unsafe
unless it has been shown to be unsafe.

I just don't want to do any research.

It's too expensive.

Let's just label it as more unsafe.

That interferes with patient care because
people look at that and they start to think

that that's telling me how to practice and I
see are unsafe.

That's a listen to the words claim you're
claiming this has been shown to be unsafe,

and in the past there's a lot of M.R.

unsafe that was simply, I don't want to test
it.

I will be satisfied with a label of unsafe.

You understand. So the FDA people at the FDA
have fed back to me that nowadays they will

no longer permit that, that if you're saying
it's more unsafe, they will want to see data

to support unsafe.

Not just that. You're in a sense, right?

Don't wish to spend the money to prove that,
yes, it is actually going to be attracted or

heat or what have you, except for orthopedic
devices.

Oh, and for reasons that are beyond the
scope of this podcast for the foreseeable

future, orthopedic devices apparently will
still be allowed to claim him or unsafe, even

without formal testing showing that it is
unsafe.

Now, there is some reason to support that.

Imagine, for example, for now, imagine some
orthopedic devices.

How do you use them?

Well, it's it's woodworking with humans.

It's human working right and it's tinker
toys.

And you're going to screw this to that, this
to that and to this, so what configuration

would you like me to test?

How are you going to test every possible
configuration?

How are you going to be able to predict what
it's going to look like in that patient?

Did you ever do any to fix any two external
fixations that were identical?

They can't be. Everybody's different in the
size, the dimensions and right.

And if this one didn't heat, does that mean
that one won't heat?

After all, we've had eight of them that
we've done.

It's a that's a study by now, isn't it?

Eight different X fixes?

They all had the Label X fixed.

They all. Nobody died, right?

So of course, the next one will be safe to.

Conceptually. Devices that are meant to be
implanted with other devices in orientation

that just can't be predicted necessarily.

They do present a problem.

So with that potential exception about
safety?

Right? Supposedly my understanding.

I could be wrong, but the understanding that
in a discussion with an FDA employee at the

time is that nowadays we will not, with the
exception of orthopedic devices, perhaps we

will no longer accept new devices claiming
unsafe without data to support the claim that

it is indeed unsafe.

I just don't understand why why a company
would want to do that.

They don't want to, but they have no choice
if it's unsafe.

They don't want to hurt anybody and they
don't want somebody to be hurt by their

device. It's not good for the patient, of
course.

It's also not good for them.

It's not good for anyone to injure anyone.

So it's in everyone's best interest if it is
indeed overtly unsafe to be absolutely

certain that you tell people this is unsafe,
even if you think it may be.

There are many devices that we don't know
for sure that it's unsafe or that it will

always be unsafe, right?

But if it may be better safe than sorry is
their approach.

And there is some logic behind that

That makes sense because it's still bad
marketing if something happens, right?

Yeah, it's bad for everyone. If a patient
gets injured, right, even for their bottom

line, for it, not just for the patient, but
for everyone.

It's a bad business, right to injure anyone,
and nobody wants to do so, obviously, right?

All right.

Thanks. Great question.

But do you feel like there's anything we
haven't covered yet before we wrap up this

episode? That's a big enough wrap.

You don't know that I'm trying to get him to
do a wrap, but

That's up to you. I can't.

I can't really tell you what is it you
wanted to cover, but no.

But seriously, as far as as far as this
topic is concerned, I just wanted to make

sure that people understood the role or lack
thereof of the FDA in my obligation to do

what's best for my patient.

It's a good takeaway for sure.

It's a good take away. Well, we'll wrap it
up, Reggie.

Do you have anything you think of?

Yeah, of course. Big shout out to ages or
sponsor.

You know, they always take care of us.

So if we want to show those guys some love
and then gave last day this last recording

with us, man,

And they get in front of the camera equipment
up to your

Face, it's been, I don't even know, 20 plus
episodes with this guy.

I don't know what we're going to do without

Him since day one.

David's been with us. He's our producer.

He is our Jamie.

For those of you that watch Joe Rogan.

Yeah, and we're losing

Our Jamie r.o.

So thank you, Dave, for all that you've done
so far.

And we're going to miss you.

We truly appreciate you. And we appreciate
you.

Yes. So thank you.

My pleasure. Thank you, Dr.

Caldicott.

My pleasure. Thank you for bringing me out to
86 degree weather.

Next time, we're going to try to get you to
fly your own plane out to.

Yeah, it's not good.

If you want, you got a date night.

So Zone three podcasts.

We're out.

Thank you. Good.