At 4:34 AM -0500 12/13/06, Allen Esterson wrote:
On 12 December Paul Brandon wrote, quoting a letter in the NYT on a
cholesterol drug [snip]:
On the general topic of proving drug safety and effectiveness,
this letter to the editor in the NYT a couple of days ago might be
interesting:
You refer to "me too" drugs as offering "a merely incremental
advance over some existing therapy," but there is no reason to
think that they offer any advance at all.
In the clinical trials required for approval by the Food and Drug
Administration, manufacturers do not have to compare "me too"
drugs with old drugs in the same class, only with placebos.
For all we know, then, each new "me too" drug may be worse
than existing ones.
In the case of psychiatric disorders, it is widely recognized (and much
written about) that the older tricyclics are generally at least as
effective as the newer SSRIs (though the specific disorder must also be
taken into account). The reason that SSRIs are usually preferred is that
they have fewer, and more easily tolerated, side effects.
The problem is that without head-to-head trials we cannot adequately
compare either the safety (side-effects) or the effectiveness of two
drugs.
The assumption of fewer side effects from SSRI's is based on rates
measured in separate trials, and side-effects reported by users, not
by a direct comparison based on the same population sample.
--
The best argument against Intelligent Design is that fact that
people believe in it.
* PAUL K. BRANDON [EMAIL PROTECTED] *
* Psychology Dept Minnesota State University *
* 23 Armstrong Hall, Mankato, MN 56001 ph 507-389-6217 *
* http://krypton.mnsu.edu/~pkbrando/ *
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