Unfavorable Pharmaceutical Research Unrevealed
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
