Slight Changes = Sleight of Hand @ FDA

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Misty L. Trepke

http://www..com

 

Slight changes = sleight of hand at the FDA

 

 

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March 28, 2005

 

Spawn of The Little Agency that Couldn't

 

I can't believe the government thinks we're this stupid.

 

After decades of unchecked botchery, ineptitude and corruption, the

U.S. Food and Drug Administration is trying to pull a fast one. In a

shameless attempt to sidestep the ocean of bad press - not to mention

dead bodies - resulting from its own gross negligence in reviewing

drugs (like Vioxx, Prozac, and about a zillion others), the

beleaguered agency is now forming an " independent " Drug Safety Board,

according to the AP and other sources.

 

The February 15th announcement follows a 3-day FDA summit ostensibly

convened to review the safety of the killer Cox-2 inhibitor class of

arthritis drugs. More likely, the meeting was called to figure out

some way to keep the public from going " Bastille " on the agency

(figuratively speaking, of course). The result - the formation of

this new Safety Board - is nothing but a shameless PR spin to shift

the focus away from the agency's abhorrent track record at

protecting us from the drug companies' poisonous products.

 

They're giving us a target, a focal point, a symbol of the agency's

changes. And they're giving themselves a new place to shift the blame

when people die.

 

How do I know this is all a bunch of bureaucratic legerdemain?

Because the FDA ALREADY HAS an Office of Drug Safety that's supposed

to be monitoring drugs after they're approved and released. But in

the last year or two, the utter inadequacy of this office has made

itself glaringly apparent - consumer groups and lawmakers have been

clamoring for changes, so the FDA cooks up this new band-aid-on-a-

bullet-wound.

 

Supposedly, this new, " independent " Safety Board will have broader

powers, a more representative governing body, and more money and

power to enforce safety-driven policies. They've got a long way to

go - because as of right now, the anemic FDA can't even force

dangerous drugs to wear a WARNING LABEL without endless haggling

with drug makers. This is exactly the kind of cart-before-the-horse

nonsense that enabled Vioxx to be on the market for so long without

anyone having an inkling of its dangers!

 

No one except Merck and the FDA, I mean. Naturally they knew long

before you did.

 

Listen, I'll believe in the benefits of this new Safety Board only

after I see that it's truly independent, powerful enough to force the

hand of drug makers, and well-funded enough to truly serve as a

watchdog to the prescription drug industry. Until then, I'm going to

think of it as nothing more than another meaningless extension of the

FDA. I hope I'm proven wrong, but I'd bet anything I'm right...

 

And anyone who takes a prescription drug is already betting on it -

with his life.

 

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A drop in the bucket

 

I don't know if this new Safety Board will amount to anything in the

REAL " war on drugs " (the one we're fighting against killer

prescription drugs every day), but I do know this: Something's got to

change, and fast.

 

According to a recent Associated Press article, the FDA received

nearly FOURTEEN PERCENT more reports of drug side effects in 2004

than just one year earlier. To put that in perspective:

 

If the number of negative reports continues to increase at this rate,

it will have nearly quadrupled in just 10 years.

 

As if this isn't scary enough, consider this: Last year's 422,500

adverse incidents were only those formally reported to the FDA. There

is no legal requirement for doctors, lawyers, hospitals or individual

patients to report these claims - these were only the ones that were

extreme enough to compel someone to report them voluntarily.

 

Can you imagine the TRUE number of adverse drug incidents that

happened in calendar year 2004? I'll bet it's 25 times that number -

10 million, easily.

 

But we've got no way of knowing, do we? And that's just the way they

want it.

 

Wanting to believe, not deceive,

 

William Campbell Douglass II, MD

 

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