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How Clinical Depression Studies Are Fudged
Before we look at the specific tactics used in antidepressant
testing, let's step back and look at
the big picture of clinical depression and the attempts
to profit from it.
It takes several hundred million dollars (depending on
whom you believe) to bring a new
prescription drug to market. That's a major chunk of change for
anybody, or any company.
Researchers must answer to their supervisors, who must answer to
their supervisors, who must answer to their
superiors, who must answer to the company leaders, who must
answer to the stockholders.... (Who must answer to their
spouses!)
There's enormous pressure all the way up and down the line to
bring this new drug, whatever it is, to market. The company must
recoup the staggering investment of time and money that goes into
a drug's development.
Remember, a business exists to make a profit. No profit, - no
business, and thus more unemployed workers. Nobody wants that.
Beyond the drug companies own research, there are many additional
clinical studies performed on depression medicatons after they
have been approved and released into the marketplace.
Who funds these studies?
There aren't too many researchers who
are going to pull money out of their own pockets to pay for a
study on the long-term effects of paxil, for example. If you were
a scientist studying prescription drug efficacy, who would be
paying your bills?
Could you remain unbiased if your future funding depended upon a
favorable outcome for your present study? While most
researchers maintain impeccable standards and integrity (such as
my own father), I merely want to point out the
potential for abuse.
Always look to who is funding the study!
As I am writing this, I hear on the news about a clinical depression
study on antidepressants from
Duke Univeristy that concluded placebo produced better results
than either St. John's Wort or zoloft. Zoloft
maker Pfizer
called the results "confusing". (Yeah, I'd be confused, too...!)
Anyway, not much researcher bias
there, I suppose, unless they work for the makers of the placebo!
Given this context, it's important to look at the methodology
of clinical drug research. The procedures used are much more
important than the actual drug being studied - in terms of what
the results will be.
Far too many studies are not well designed, and admittedly use low
standards to 'prove' their results. (It's like if the Consumer
Reports car-testing division were all staffed by car salesmen!)
For example, severely depressed people are routinely
excluded from drug trials. This segment of the depressed
population, those who need help the most, presumably would not
realize any favorable improvement and would merely 'taint' the
results being sought.
Having even more impact is the technique of 'prescreening' all
potential drug study participants for placebo reactions.
It's common for all patients entering a drug study to be given a
placebo for one week. Those who show improvement are dismissed
from the study. Typically this amounts to anywhere from one
quarter up to one half of all participants!
Even after this weeding-out period, an average of about one third
of the remaining patients still respond to placebo just as
well as the drug under investigation.
(It's important to point out here that the response to placebo is
every bit as enthusiastic and 'miraculous' as the response to the
drug itself.
There is no difference in the quality of the response from
placebo as opposed to the drug in question.)
Another 'screening' occurs due to the fact that typically 15 to
20% of all drug study participants must drop out because the side
effects become unbearable. (Refered to as 'quitters' by the
clinical depression researchers!)
When you also consider the fact that some people
are taking other mood-altering drugs such as anxiolytics,
it's a wonder that the 'success' rate is a measly two thirds.
The bottom line in all this, is that potential drug study
participants are scrutinized, evaluated,
screened and perhaps even discarded not unlike
the potential jurors for a high-profile murder case.
Given these current standards, I believe even opium could be
'proven' to be as safe and effective as any other antidepressant.
I know I could do it with alcohol. (Just weed out the
alcoholics and serve the rest free beer!)
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Ahead to
3. The truth about dependency and withdrawal symptoms.

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