Fwd: In the FDA we trust?

[Guest guest]

Tue, 30 Dec 2003 12:11:05 -0500

WC Douglass

In the FDA we trust?

 

Daily Dose

 

December 30, 2003

 

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The suicide squeeze (Part 2)

 

Last Daily Dose, I spilled a story that many in the medical

mainstream (and the drug companies they're slaves to) would no

doubt love to keep under wraps: A possible link between

antidepressant drugs and suicide in depressed juveniles.

 

But the ironic part of the story was that the red flag on this

potential link is being hoisted not by a marquis medical

journal, some big-name investigative reporter, or even a law

firm representing a class action suit on the matter - but rather

by the ponderous U.S. Food and Drug Administration, normally the

willing handmaiden of the prescription drug industry.

 

Which should lead you to ask: Why?

 

To understand the answer to this question, you need to know how

the FDA finds out about a drug's side effects. It might surprise

you to learn (but probably not) that after the approval process

- during which a drug's side effects are disclosed by the

selfless and honorable drug makers themselves - the only way the

FDA EVER DISCOVERS the side effects of any particular drug is if

individual doctors take the time to document and report them

from the field.

 

That's right. If sufficient numbers of doctors don't squawk

about the unknown (or undisclosed) side effects of an approved

drug, the FDA won't find out about them. And even once they do

know about these downsides, how likely do you think it is that

they'll sound the alarm about a drug's dangers, knowing full

well that the egg will be on their face - along with a bunch of

lawsuits?

 

The way I see it, such a disclosure would ONLY HAPPEN if the

public danger were significant enough for the FDA to feel the

need to control their own liability by preventing additional

cases from occurring. It's a simple dollars and cents equation.

If it'll cost them less to stay quiet than to sound the alarm,

then mum's the word. If not, they notify doctors and the

Associated Press.

 

But the scariest part of it all is this: The FDA has no real

idea of the scope of the antidepressant/suicide link. In fact,

it's a wonder they learned of it at all. After all, how many

doctors do you think are likely to willingly volunteer the fact

that one or more of their patients killed themselves after

taking antidepressants they prescribed - especially if it's a

medication other than the one drug currently approved for

juvenile depression?

 

This tells me that the risks are very real, and much greater

than they appear.

 

Thank God there are a few honest doctors out there who still

believe in their oath and their duty to their fellow man enough

to speak out about it. I tip my hat to them...

 

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Drive-by eye surgery?

 

I can't believe I'm really feeling the need to issue this

warning, but in light of some recent news stories, here goes:

 

Don't let people who drive up in a truck operate on you.

 

Sound like common sense? It does to me, too. But the siren song

of discounted prices and no-appointment convenience has got many

people boarding mobile surgery clinics to undergo delicate eye

operations.

 

Yep, you read that right. There are growing numbers of

road-going surgeons (fully licensed and totally reputable,

though, I'm sure) on our nation's highways, cruising around from

city to city in giant trucks or trailers to ply their wares:

Cut-rate laser vision correction surgery. Never mind that this

type of vision surgery sometimes requires a significant degree

of follow-up care. Forget about the fact that post-procedure

complications sometimes occur. And don't sweat the small

details, like the chance of blindness or permanent vision

impairment.

 

The handy little liability waiver takes care of all that!

 

Even though this sounds like something out of a bad science

fiction novel, believe it or not, this is really happening. But

what's next, I wonder? As the technology advances to make other

kinds of procedures easier, faster, and cheaper, will we soon

see drive-up vasectomies, breast augmentations, hair

transplantation, and liposuction? Where's it end?

 

Look, I'm all for free-market capitalism as the primary driving

force behind medicine, but parking-lot surgery of any type

crosses the line.

 

Much as I hate to say it, I think some regulation on the state

level may be needed on this. Now.

 

 

Running the " health " gypsies out of town,

 

William Campbell Douglass II, MD

 

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