The Bleeding Edge Page #3

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And he went out in the hallway

and just screamed for someone to come,

and they all just came in.

They threw me on a gurney, and off I went,

stretcher down the hallway.

I was scared.

I was really thinking about...

"What's gonna happen to my kids

if I don't wake up?"

The old-time medicine man

would sell his snake oil

by positively guaranteeing

it would cure any and every disease

known to man and beast.

Fortunately,

this form of quackery in medicine

is gradually being eliminated

by our food and drug laws,

but there's still another form,

equally dangerous

and far more difficult to control.

Phony machines and devices,

which are supposed to diagnose

and treat disease.

Unlike new drugs,

therapeutic devices do not have to be

proved either safe or effective

before they are sold or used.

The history

of medical devices is odd.

There was an explosion in the 1920s

and '30s and '40s of fraudulent devices

that pretended to put sound waves

into the body to cure cancer

or any number of these weird devices.

Some were dangerous, such as ones

that had radioactive qualities.

There are some as phony

as a three dollar bill.

Like this Zerret Applicator, for example,

which has claimed to cure arthritis

with Z-rays.

There are no Z-rays.

Investigate before you invest

in health services or products.

Help stamp out quackery.

This has been

a public service announcement

from the Food and Drug Administration.

For many years,

devices just came onto the market

with the anecdotes

of doctors who used them,

who would say, "Well, I think it works."

It was only with

the Medical Device Amendments of 1976

that devices came under control of FDA.

At that point, industry argued,

"We don't want to have to test everything

we're already using,

pacemakers and other devices."

And the FDA said,

"Okay, you can grandfather in

anything that was on the market

prior to 1976.

The regulation of medical devices

has always been less than ideal.

Since 1976, the complexity of devices,

the number of devices,

the types of devices,

just rapidly expanded.

So we have the same framework

that was imposed, you know, 40 years ago

for a device world that is much more

complicated today.

Dr. Kessler,

please proceed when ready, sir.

Mr. Chairman, Americans rightfully expect

public health decisions...

to be made in their interest

and to be based on the best science

and medicine.

I was appointed as FDA commissioner

by the first President Bush

and asked to stay on by President Clinton.

FDA is the most important

consumer protection agency in the world.

It regulates virtually everything

that comes in contact with the body.

FDA is organized by centers.

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