Posted by JLM on November 5, 2002, at 16:19:03
In reply to Re: Lexapro 'failed' trial, posted by dr. dave on November 5, 2002, at 5:04:21
> > > 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 The UNPUBLISHED studies that would have had to have been submitted to the FDA for the approval of Lexapro.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 Perhaps I will take the time to learn how to submit a FOIA request for the unpublished studies submitted to FDA.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.Dr. Dave,
Its my understanding that companies must submit all trials for a given indication to the FDA as a part of the approval process, including failed trials. These typically would NOT be published anywhere in the public domain, but ARE available thru the Freedom of Information Act.
Thus, there may be quite a few trials that were conducted that we are not aware about. I'd be curious to see these unpublished results, but the only way to get them is to submit a FOIA request to the FDA. This is what was done in the Kirsch metaanalysis of AD's that was published in the Journal of Prevention and Treatment this July. They got ALL the trial resuls available thru FOIA.
Also, its my understanidng that there is NO requirement to list the negative trials, if there are any, in the PDR product labeling. In fact, you almost never see any mention of studies that do not demonstrate drug benefits in the PDR. That doesn't mean they aren't out there lurking.
poster:JLM
thread:109458
URL: http://www.dr-bob.org/babble/20021101/msgs/126557.html