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and 38.5% in older adults). Though older
adults are the main market for these drugs,
they tend to be more susceptible to side
effects. Individuals receiving commonly
prescribed medications were excluded in
54.1% of trials.5 Based on such selection
criteria these drugs should not be used
with any other medication, yet they are.
Gender was grounds for exclusion in 39.2%
of trials. In a study of all exclusion criteria,
less than half the criteria was graded
as strongly justified in the context of a
specific study. Exclusion criteria were
not reported in 12% of trials; industry
sponsored trials were more likely to
exclude individuals due to concomitant
medication use, medical comorbidities
and age.6 So much for the reliability of
"random" trials. Based on such exclusions,
these drugs should be used only on young
males who have no health conditions and
who are not on any other medications.
This becomes a major issue when one
considers that these studies are also used
to determine the rates of side effects.
Excluding older people, women and those
not on other medications, cuts out 70%
or more of the drug users and severely
underestimates potential negative side
Even if the experiments did not have
these biases, many drugs are approved for
use on the basis of a surrogate outcome.7
For instance, a drug may be approved for
use to fight cardiovascular disease because
it lowers cholesterol. While the link
between cholesterol and CVD is now
unclear, it is also not clear that we
understand all the associated issues with
reducing cholesterol through pharma-
ceutical intervention. Consequently, drugs
are approved to combat CVD by lowering
cholesterol despite the fact that these
drugs have never been shown to have
even a 1% benefit of reducing the risk of a
The follow-up studies that are
After the clinical trial process is complete
and appropriate approvals have been
given, it is often a requirement for drug
companies to continue with trials or
monitoring, or both, so that more data
may be gathered regarding a drug's
efficacy and safety. Unfortunately, this does
not always happen. The Food and Drug
Administration (FDA) in the US reported
that in 2007 only 29% of the required post-
marketing studies had been commenced.
Knowing that occasionally drugs are
removed from the market because safety
issues become apparent after marketing
begins, it is disturbing that more than two-
thirds of drugs are not being adequately
monitored to detect potentially harmful
effects at the earliest possible moment.
These companies have a responsibility
to conduct the tests. They rush the early
tests through to get the products onto
the market, then delay tests that show
whether the drugs really work.
continued page 38
'In a review of 74
registered FDA studies of
12 antidepressant agents
involving 12,564 patients,37
31% (accounting for 3,449
study participants) were not
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