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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