The Bleeding Edge Page #3

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regrettably, are regulated

under this framework.

This really can cause problems

when one medical device is approved

on the basis of being

substantially equivalent

to a previous medical device

that was approved

because it was substantially equivalent

to an earlier medical device than that.

You end up

with what we call a daisy chain.

And then, quite often what you found

is that some of these predicate devices,

as they call them...

have been recalled from the market

because they've been failing.

I called the FDA and asked them,

"How can you clear something

based on a predicate device

that's already been shown to be dangerous?

And they said,

"We don't judge what the prior device is."

So even if the device was recalled

because it was dangerous,

you can still use it as a predicate

and get your device cleared

'cause it's substantially equivalent.

So there's a lot of problems

with that 510 system.

And that's how metal-on-metal hips

got on the market.

A year and a half

after my operation,

I started having a slew

of health issues that I hadn't had before.

I developed a tremor

in my non-dominant hand.

His ears were ringing.

He was starting to repeat himself a lot

and explain things...

over and over.

As time went on,

those issues accelerated, and then,

I... I had a psychological decompensation.

He was attending a conference,

and I got a call.

He had trashed a hotel room.

He wrote all over the walls.

He took pens, Sharpies,

he wrote on the ceiling,

he wrote all over.

And when that was done, he took soap...

and he wrote on the mirrors.

It was a full-on breakdown.

You could see it in his eyes.

And just...

in turmoil...

knowing full well...

that he'd lost it.

All the while, he's still thinking.

He's still connecting the dots.

Eventually,

I started checking my blood and urine.

And my levels of cobalt

were 100 times what I should have.

I started calling up engineers at DePuy

and salespeople, saying,

"Is anyone else talking about this?"

The answer back was,

"No, we've never heard

of that being a problem."

But it was clear to me

that the hip would need to be redone.

So I chose a different model

with a plastic socket and a ceramic head.

When my doctor went in there

to revise my hip,

he found a virtual crankcase

of metal sludge.

And the critical ligaments, what we call

the hip capsule that holds a hip in place,

that had just kind of liquefied.

Within a month,

I had an incredible recovery

in terms of my psychologic symptoms

and my ability to think.

All the other symptoms

magically disappeared.

I got my husband back.

Come in.

Hey, Rodney.

Hello, Dr. Tower.

A long time, no see.

It's been a while.

How was your drive?

It was... The last 100 miles was snowy,

but it was a good drive before that.

Unless I'd personally

experienced this myself...

I wouldn't believe an orthopedic implant

could cause neurologic problems.

But with my experience,

I started to notice problems

in my own patients,

and it's not just metal-on-metal,

but metal-on-plastics, too.

I was going blind.

I was seeing stars,

constant stars in my eyes.

I couldn't remember words.

I'd start a sentence, then couldn't think

of the word that was supposed to go next

Problems with memory.

I was writing it off to, um, aging.

I thought I had Alzheimer's ordementia.

And that was really scary.

Just diagnosed me with Parkinson's.

My mind was... slowly slipping away.

I've seen so much of this

that now,

when a patient comes into the office,

if they have an artificial hip

and I know it has a chrome cobalt piece,

I routinely check

the level of cobalt in their urine.

I've just been progressively

getting better and better

since I had the hips both replaced.

It's very hard

to convince people this problem exists,

unless you show reversibility.

Get rid of the cobalt,

the problem goes away.

It's hard for people to argue with that.

The real breakthrough

in the last 18 months

has been the ability to actually image

the neurologic problem.

Dr. Tower came down

to the Imaging Center

to look at an MRI of the hip

and we got into a discussion

about the symptoms

of cobalt poisoning toxicity,

and he mentioned cognitive issues.

Dr. Bridges said, "Gee, yeah,

we ought to get an FDG PET brain scan

on a patient that you think

is having the neurologic problems,

because I bet we can see it.

We have a tool that can

actually detect dementias like Alzheimer's

years before they become clinically

evident on physical examination.

Basically, what I'm looking at

is the slice through the basal ganglia.

Blue is bad.

Blue is bad.Those are the areas

of the brain that are most affected.

By this scale, we're looking

at 2 to 3 standard deviation.

At least greater

than two standard deviations below normal.

The first patient came up very abnormal.

So then he suggested we do another patient

and then another patient,

and they all began to look the same.

You've got the typical findings

on the brain scan

that we're seeing

with the other 23 patients.

So you're number 24.

Doing a study on this

is something that I feel

I'm morally obligated to do.

But I don't think I should be the guy

who has to do that.

This work really needs to be reproduced

with hundreds,

if not thousands, of patients

to fully understand it.

I think the CDC should be doing it.

I think the FDA should be doing it.

And I've approached all those people,

and just not getting

a lot of support there.

I'm horrified because,

the more I'm looking at it,

I'm beginning to wonder,

is cobalt the new mercury poisoning?

Are these people being relegated

to the dustbin

because they have what somebody

misperceives as dementia?

How many people have been

misdiagnosed

with a permanent disease process

that actually have a reversible

disease process?

That's the horror right there.

Innovation lives here.

It's the foundation of our legacy

and the backbone of our DNA.

Our motto is never stop moving.

And some of the words that are behind that

are just this relentless pursuit...

of innovation that improves patient care.

Industry likes to use the term

innovation, innovation, innovation.

Innovation, to me,

means we've got something new,

but we've got good evidence to support it.

We've got good evidence about the benefits

and the harms.

You're developing medicine,

you're bringing it forward.

Without evidence, we don't know

whether it's really a development. It...

You know? Who knows? You don't know.

Surgeons and patients like the idea

that they're getting something new.

I tell my patients

new equates to unproven.

Companies can develop new products

that may not be safer and more effective

than other products already on the market,

but they will certainly

heavily promote them

to doctors, to hospitals,

to drive up their profits.

They wheel out patients and say,

"This person wouldn't be alive today

if they didn't have

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