NorthernGent -> RE: May be of interest...... (2/28/2008 2:43:47 AM)
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ORIGINAL: Alumbrado Ahhh yes... more evidence that you 'can't see'? You're still ploughing this furrow, Alumbrado? That was 2 days ago on a different thread. quote:
ORIGINAL: Alumbrado When it comes to matters I consider significant, I'll dig up as much information as I can, and make time to evaluate it....instead of using the media or the manufacturers as my sole source. The source is a study undertaken by researchers at a University. It's not a big issue for me, so I've had no past desire to spend my energy looking at the trials. As per the OP, I thought it may be of interest to some. Obviously, it's of little interest to you because you know all about this; this is fair enough. 'Hope this is all ok with you, Alumbrado. 'Wouldn't want to post anything that you find disagreeable........seeing as you're the enforcer 'round these parts. If it helps, I could send my posts to you in advance for a seal of approval? quote:
ORIGINAL: Alumbrado Psychology Today, Jul/Aug 94 Article ID: 1471 "After weeding out the most badly flawed studies, the FDA found only four that were adequate enough to consider. One of these showed that Prozac was no better than placebo. Three others supposedly showed Prozac to be somewhat superior to the sugar pill, but not as good as older antidepressants. However, due to adverse drug effects and lack of drug effectiveness, the dropout rates in most of these studies was very high. While the gross number of patients receiving Prozac in all the trials was more than 5,000, the actual number finishing the trials used for approval was very small. When I counted the actual number of patients who completed the four- to six-week trials used for the approval of Prozac, it turned out to be a grand total of 286. It bears restating--only 286 patients finished the four- to six-week trials used to determine Prozac's efficacy." Psychiatric News July 16, 2004 Volume 39 Number 14 © 2004 American Psychiatric Association "In April the British Medical Journal published a paper by Jon Jureidini, M.D., head of the department of psychological medicine at Women's and Children's Hospital in North Adelaide, Australia, and colleagues. The article reviewed the evidence base for efficacy and safety of antidepressants in children and adolescents. The authors included in their review published clinical trials, as well as some unpublished data .... ....Two weeks after the BMJ article, Lancet published a systematic review of SSRIs for childhood depression that also compared published and unpublished data from the same clinical trials that Jureidini analyzed." THE BOSTON GLOBE MEDICINE: No prescription for happiness By Thomas J. Moore, 10/17/99 "Lilly had conducted 10 such clinical trials for Prozac, according to FDA records. However, in six of these trials no measurable overall difference could be detected between those treated with Prozac and those who got the placebo. Prozac was usually ahead slightly, but within a margin that often could be explained by chance. One trial deemed successful was based on such a small group of participants that only eight patients taking Prozac completed it. The FDA discarded another ''successful'' trial because no one could explain why one investigator got so much better results than others giving the same drug to similar patients. " Robert Temple, M.D. Director, Office of Medical Policy Center for Drug Evaluation and Research U.S. Food and Drug Administration on Hearing: FDA's review of the safety and efficacy concerns in anti-depressant drugs for use in pediatric populations before the Subcommittee on Oversight and INvestigations Committee on Energy and Commerece House of Representatives September 23, 2004 "However, it is also important to consider the efficacy data for these drugs because a risk-benefit assessment is important to clearly understand the benefit side of this equation. Of the seven products studied in pediatric MDD (Prozac, Zoloft, Paxil, Celexa, Effexor, Serzone and Remeron), FDA's reviews of the effectiveness data resulted in only one approval (Prozac) for pediatric MDD. (In January 2003, FDA approved Prozac for the treatment of children and adolescents ages 7 to 17 for depression and obsessive-compulsive disorder.) Overall, the efficacy results from 15 studies in pediatric MDD do not support the effectiveness of these drugs in pediatric populations." Yeah, it appears to be old hat. Well done. Edited to add: I'm sure some people will go away from this thread with more knowledge than they had previously (myself included), so it may prove useful to some. There's no accounting for a spot of knowledge sharing between countries and continents!
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