Posted by Alan on November 7, 2002, at 14:01:53
In reply to Re: Lexapro 'failed' trial?/bottom » dr. dave, posted by pharmrep on November 7, 2002, at 10:58:27
> > > > I too get a bit tired of the ad nauseum claims of Lex's lower incidence of SE 's and efficiacy over Celexa.
> > > >
> > > > We hear a lot about how 'the published studies' demonstrate both things clearly, even thou the data is contradictory at best.
> > > >
> > > > Know what I would like to see? The UNPUBLISHED studies that would have had to have been submitted to the FDA for the approval of Lexapro. They can be obtained thru the Freedom of Information Act for those brave enough to do so. I would NOT be surprised to see several studies that show NO greater effect than either placebo or Celexa for that matter.
> > > >
> > > > All we have so far are the studies done by paid Forrest consulants, which may not be all that objective.
> > > >
> > > > Perhaps I will take the time to learn how to submit a FOIA request for the unpublished studies submitted to FDA. I bet there are some real gems in there.
> > > >
> > > > Like Dr. Dave, I have yet to hear a remotely plausible explaination for the claims of less SE's with Lexapro.
> > > >
> > > >
> > > >
> > > ============================================
> > > Until the FDA has better oversight of the test results, the pharm. co.'s are allowed to cherry pick test results and throw out the undesired test results after having changed the test criteria until they get the result that they want - which the FDA never sees before adjudicating the drug's acceptance. Fox guarding the chicken coop.
> > >
> > > Alan
> > >
> >
> > ==================================================
> >
> > Maybe Pharmrep could help us out with this.
> >
> > To my knowledge, there have been four efficacy studies on escitalopram, two in the US and two in Europe and Canada.
> >
> > Both US studies compared Lexapro with Celexa. Study MD-02 has not been presented, but we know it was a 'failed' study in the sense that it showed no statistically significant difference between Lexapro, Celexa and placebo (see Cipralex product monograph at www.cipralex.com, page 22.)
> >
> > The other study (MD-01, published by Burke et al) showed no statistically significant difference between Celexa and Lexapro on the measure they had previously defined as the primary outcome measure.
> >
> > One of the European studies compared Lexapro with Celexa (study 99003, described in papers by Lepola et al, Montgomery et al and Reines et al. Note that these are not seperate trials but the same trial reported several times.) Again this showed no statistically significant difference between Lexapro and Celexa on the previously defined main outcome measure.
> >
> > If there have been other trials comparing the efficacy of Celexa and Lexapro I'm sure we'd all like to know about them.
>
> *** no failed trials...all are on the table...and all of the studies are LOCF (last observation carried forward)
======================================
And how is this distinguishable from the actual practice of the continual changing of critetia to finally get the desired results? LOCF? Last observation OR is it last *entire* test result carried forward including prior "side effects"? What happens to the old test results including side effects? Are they published? Or are they kept confidential?Most importantly, if they are internal documents, are the internal documents available to the FDA or other oversight for consideration of their methodology before the approval takes place?
Or does it take a court order as in Dr. Healy's case to view, at the last minute in a court case, to view evidence that Paxil representatives and lawyers covered up as to whether Paxil was addictive or not? (Which they still deny).
Just wondering if Forest is provably different from other companies about how they do tests in this regard?
Alan
poster:Alan
thread:109458
URL: http://www.dr-bob.org/babble/20021101/msgs/126845.html