The Bleeding Edge Page #9

---

Major health concern over breast implants.

They could cause a rare form of cancer.

It may cause other illnesses too.

When she had hers taken out,

they found mold inside,

and she's not alone.

Two dead, 179 exposed

to a dangerous superbug.

A piece of medical equipment

may be to blame.

A device called a morcellator

as used to shred fibroid tumors.

so they could be easily removed.

The shredding ended up

inadvertently spreading the cancer.

A defibrillator was withdrawn

from the market

after 13 deaths

were linked to wiring problems.

The FDA approved this device,

but did not require testing in humans.

We can no longer rely

on the medical device companies

to do what's in the best interest

of the patient.

And we can no longer rely on the FDA

to properly regulate these devices.

I was at the Food and Drug

Administration from 2006 to 2009.

I was the lead gastroenterologist

of devices.

I think I cleared,

or was involved in the clearance,

of over 250-odd devices

I think the vast majority of doctors

and scientists at the FDA...

do their best.

They do it with integrity, honesty.

In mid-2009, a file came on my desk

to look at this CT scanner,

this device that affects

many millions of people in our country.

A CT scan takes the equivalent

of hundreds and hundreds of X-rays.

while a machine rotates around your body.

They're an incredibly good test

for diagnosing a range of diseases

that gives you

very sophisticated 3-D images.

But the doses of radiation

that we use day in and day out for C are in the range that we know

it will cause cancer in some people.

And yet, the use of CT scanning

has quadrupled in the last 15 years.

The elephant in the room

is it's a very profitable

part of the health care system.

It's a way a lot of radiologists,

emergency departments, hospitals

make money

There's a lot of excess use

of this device,

and so I simply said,

"We should have a warning on the FDA label

just to warn the doctor...

and therefore the patient,

that actually if you use this device...

and certainly if you use it repeatedly...

your risk of cancer

or developing

abdominal cancer will increase.

I couldn't believe the pushback I'd got

from managers with no medical experience.

There was a group of FDA physicians

who were very concerned about the way

products were being cleared and approved.

We took these concerns

up the chain of command to Jeffrey Shuren,

the director

of the Center for Medical Devices at FDA.

And what did he do?

He not only did nothing,

he took it one step further.

He retaliated against people.

Once we started complaining...

FDA put their spy software

in our computers.

And they were monitoring

all our activities.

The FDA installed

what's called Spector software

onto a number of physicians'

and scientists' computers,

and it allowed them to capture screenshots

every two seconds...

and keystrokes.

It's as if to say their own doctors

are somehow criminals for exposing...

a public health issue.

It left a tremendous chill

amongst the FDA scientists.

Listen, safety's as important to us

as it is to anybody else.

None of us want a product on the market

that's not safe, right?

That's why we rely on regulators

to help us get there.

I think the US regulatory system

works well.

It's robust, it's thorough,

and it's been very effective.

Ladies and gentlemen,

please welcome president and CEO

of AdvaMed, Scott Whitaker.

The device industry

is very well represented

by their main lobbying group, AdvaMed.

Good afternoon, everyone,

and welcome to the Global Summit

for Medical Technology.

This is a room full of disruptors.

We are risk-takers of the highest order.

Not enough Americans understand

the important role we play,

or frankly give us enough credit

for the innovation we bring.

Sure, we'll pay attention to Washington.

That's my job. That's what I do.

But we have more power in this room

than most governments around the world.

We have the ability

to create jobs and prosperity...

to open and expand markets

and unleash innovation.

Let's show the world that we are

what's next.

They have lobbied hard

to see the standards for approval

of devices watered down over the years.

Device companies

unleash armies of lobbyists

in order to influence politicians.

And these politicians are vulnerable.

They don't know science.

It's often very flowery

and impressive language

about how they put patients first

and they want only the best.

We want to make surethat new

medical innovations get to patients

and help save lives,

improve the human condition,

eliminate suffering,

and make this world a better place,

That's what we all agree on, right?

The medical device industry

has incredible levels of influence

in Washington, D.C.

They have provided dark money

contributions

that are used to secretly fund

political campaigns.

Medical device companies also fund

think tanks and patient advocacy groups

that can go to Congress

and make the case for them.

Perhaps an even worse problem

is the revolving door.

A number of FDA officials

have both come from industry

and then go back to industry

after they're at FDA.

When they go to work for the companies,

they can tell the companies all the tricks

of how to get around FDA regulations,

how to get what you want.

Almost all the heads at the FDA

went on to work for industry.

President Donald Trump

says he's picked a nominee

to run the Food and Drug Administration.

Dr. Scott Gottlieb is a popular choice

in the pharmaceutical industry.

"Thank God it's Gottlieb," said

an investment analyst at Robert Baird.

Why would they have that reaction?

They were breathing a sigh of relief.

He's a known entity in the industry.

I've known Scott

for a long time.

He took that job

because he wants to do what'sin the best

interest of the American people

and the agency, and notwhat's

in the best interest of anyone else.

Gottlieb has been a consultant

to a range of medical industries.

He's also worked

at a venture capital firm

that actually specializes in investing

in start-up medical device companies.

I'm proud of my relationship

with New Enterprise Associates.

It's been one of thepremier

venture capital firms in the country,

starting a lot of innovative ventures.

Over the time that I was there,

they invested about $14 billion

in 500 different companies.

You have spent

your life entrenched in the companies

that would benefit

from looser regulations.

But I think it raises

the very real question

of whether someone who seems to oppose

the FDA's basic safety mission

should be running the agency.

I can tell you he doesn't have any bias

as a result of that.

I've never seen it

and don't expect to see it,

knowing him the way I do.

The FDA is supposed to protect

the public interest.

Unfortunately, their behavior shows

that they have been captured by industry.

Scott, thank you for coming

Rate this script:0.0 / 0 votes