Posted by JLM on June 9, 2003, at 1:42:39
In reply to Re: Side Effects, posted by blkvettes on June 9, 2003, at 1:08:43
Quite awhile ago, I posed a rather specific question to Pharmrep. Namely: have the data from ALL the clinical trials submitted to FDA for the approval of Lexapro been disclosed. I seem to recall some type of assurance that they indeed had been made public. Or actually, I believe what was said was that all the PUBLISHED trials have so far been favorable. Then I found this interesting tidbit:
http://journals.apa.org/prevention/volume5/pre0050033r.html
"1An internal memorandum by the Director of the Division of Neuropharmacological Drug Products indicates FDA awareness of this situation:
The Clinical Efficacy Trials subsection within the Clinical Pharmacology section not only describes the clinical trials providing evidence of citalopram's antidepressant effects, but make mention of adequate and well controlled clinical studies that failed to do so. I am mindful, based on prior discussions of the issue, that the Office Director is inclined toward the view that the provision of such information is of no practical value to either the patient or prescriber. I disagree. I believe it is useful for the prescriber, patient, and 3rd-party payer to know, without having to gain access to official FDA review documents, that citalopram's antidepressants (sic) effects were not detected in every controlled clinical trial intended to demonstrate those effects. I am aware that clinical studies often fail to document the efficacy of effective drugs, but I doubt that the public, or even the majority of the medical community, is aware of this fact. I am persuaded that they not only have a right to know but that they should know. Moreover, I believe that labeling that selectively describes positive studies and excludes mention of negative ones can be viewed as potentially "false and misleading" (Leber, 1998, p. 11)."
Thusly, Dr. Leber freely admits in his own memo, that some of the trials submitted as the basis for approval showed no beneft from Celexa whatsoever. Also, as Kirsch and Saperstein have pointed out this is the case for 50 PERCENT of the trials for the current AD's that are presently on the market. In other words, for the drugs that were approved only about half the trials showed them to be superior to placebo.
Its very important to make a certain distinction here I think. What I am interested in, and couldn't seem to get a straight answer out of pharmrep is this: what do the sum total of the trials show. I am not talking about the ones that have been published for Lexapro. Those obviously show effect. I am talking about all the trials submitted to FDA for approval. Did any of them show lack of effectiveness for the drug? This would seem to be the case for all the SSRI's currently on the market, according to Kirsch and others.
We shouldn't have to submit a Freedom of Information Act request to have access to this data. Am I the only that finds this intolerable? We also shouldn't have to live with publication bias either.
poster:JLM
thread:109458
URL: http://www.dr-bob.org/babble/20030604/msgs/232538.html