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Fri, 26 Mar 2004 01:33:00 -0500

WC Douglass

The depressing truth

 

Daily Dose

 

March 26, 2004

 

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Burden of proof

 

Be glad our court system isn't run by the same standards

that the FDA requires of the drug industry.

 

Here's what I mean: Unlike in court, where everyone involved

is entitled to ALL the evidence (theoretically, anyway) in

any given case - and that evidence becomes part of the

public record after a case is settled - the pharmaceuticals

industry isn't legally required to show doctors, patients,

or the public at large ANY unfavorable findings research may

reveal about their patented poisons.

 

Yes, you read that right: Even though a medication may

strike out time and again in clinical trials, we typically

only hear about the ones in which the drug produced a

clearly favorable result. And in no segment of the drug

market do these types of statistical shenanigans happen more

frequently (or egregiously) than in the antidepressant

realm. I've written about this before (Daily Dose,

4/4/2003), but if you haven't been with me that long, here's

what I said back then:

 

" Before a drug can be approved by the FDA, its maker is

required to submit two trials that show clearly positive

effects... the manufacturers of Prozac needed five separate

trials to collect a pair with positive clinical results. And

for the makers of Paxil and Zoloft, it took EVEN MORE. "

 

Think about this absurdity for a minute. Given a large

enough pool of double blind, placebo-controlled drug trials,

the law of averages dictates that at least a few are likely

to yield findings that support the use of the study's

medication. But even if the VAST MAJORITY of these trials

are inconclusive - or find that the placebo group is the

more effective - the only ones you (or the FDA) may ever

find out about are the few flattering ones used as the basis

for the drug's approval.

 

What's worse, the only studies on these drugs most doctors

are likely to see are the ones published in the medical

journal articles - some of which are ghostwritten by

professional " spin doctors " posing as real MDs (Daily Dose,

9/19/2003). And guess which studies are likely to make the

news in these venues...

 

You guessed it: The dramatic, drug-friendly ones.

 

Why is this so important that it needs to be reiterated now?

Because this kind of shameless deception on the part of the

drug manufacturers isn't just robbing people of their hope

for cures (and their money), it's actually KILLING THEM.

Keep reading...

 

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FDA-sanctioned manslaughter?

 

Again, you've heard me talk at great length about the

antidepressant/suicide link (Daily Dose, 12/26 and

12/30/2003) in the past, but there's a more ominous

component to this correlation that I've never mentioned

before - and it relates directly to the " selective

reporting " topic I discussed above...

 

According to a recent Washington Post online article, makers

of several of the most popular " happy pills " have refused to

divulge any details about the bulk of the antidepressant

trials they've conducted on children. As I've already

explained, hiding negative study results is par for the

course in the drug biz. But in this case, such conduct

clearly denies doctors and parents the facts they need to

make informed decisions about children's mental health. Why

is this so important all of a sudden?

 

Because of the abundance of evidence suggesting that taking

antidepressant drugs might cause kids to KILL THEMSELVES.

Not break out in a rash, gain a few pounds or develop

sleeping problems - but take their own lives. This tragic

correlation has been speculated about before, as several

instances of seemingly antidepressant-related suicide have

occurred in recent years.

 

In one 2004 trial for the antidepressant duloxetine, a 19-

year-old female test subject hanged herself in the drug

company's research lab at Indiana University. And here's the

kicker: She WASN'T EVEN DEPRESSED; she was just a perfectly

healthy, random participant in the trial. Not surprisingly,

the incident prompted 19 participants and study volunteers

to quit the test in fear for their own lives.

 

The bottom line is this: As long as drug companies are free

to submit for review and publication only that research

which is flattering to their patented medications, we'll

never really know the truth about what these chemicals are

doing to us - or NOT doing to us (like healing us). By

looking the other way and allowing pharmaceuticals makers to

keep negative findings about drugs under wraps, the FDA

becomes complicit in every adverse occurrence that happens

because of these drugs - including deaths. This is

manslaughter, in my eyes.

 

I say it's high time the FDA changed its rules to require

drug companies to submit ALL research related to ANY drug,

and to make these studies a matter of public record...

 

Then maybe we'd know what we're really risking every time we

pop a prescription pill.

 

 

Leading you AWAY from the slaughter,

 

William Campbell Douglass II, MD

 

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The Daily Dose may not be posted on commercial sites without

written permission.

 

 

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