Posted by football on April 22, 2007, at 2:52:56
www.socialaudit.org.uk/docs/Adweb.pdf
The most interesting part IMO...
"Much of the bedrock evidence put before the regulators appears suspect for
this reason. Publicly available data from the US Food & Drug
Administration (FDA) shows that fluoxetine (Prozac) was licensed in spite
of, rather than because of, clear-cut evidence of efficacy from controlled
trials:
• The FDA relied on four pivotal studies designated as “adequate and
well-controlled trials which provided evidence of efficacy” of
fluoxetine. (FDA, 1988)
• Of these four placebo-controlled trials, three permitted the use of “of
concurrent psychotropic medication”, and one-quarter of the enrolled
patients (135/540) took benzodiazepines (or chloral) as well as
fluoxetine.
• If these 135 patients are excluded from the analysis in these three trials,
fluoxetine does not show statistically significant efficacy over placebo
(Breggin & Breggin, 1994).
• The one study that did prohibit the use of other such medicines was also
the only one of the four to find no statistically significant difference
between fluoxetine and placebo."
How the hell did it ever get FDA approval?
poster:football
thread:752317
URL: http://www.dr-bob.org/babble/20070419/msgs/752317.html