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Biotech / Medical : Biotech Valuation
CRSP 53.85-4.5%Jan 9 3:59 PM EST

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To: Biomaven who wrote (10206)1/30/2004 2:15:06 AM
From: zeta1961  Read Replies (2) of 52153
 
<<The issue of negative trials that never get published is troubling>>>

Indeed it is...what I find more troubling is <<"If the companies wanted to publish negative studies they could, but companies don't like to publish negative studies," said Russell Katz, director of the neuropharmacology division at the FDA , which has access to all the data. "It's amusing so many people are making pronouncements about the data -- scientists and physicians -- . . . without seeing the data.">>>

Katz finds it "amuzing"?...pretty flip comment by someone we pay to ensure our safety..

IMO...the whole notion of using antidepressants with children except for that rare child that has true endogenous depression is questionable...kids are resilient beings both physically and emotionally...Professionally and personally, I've never met a child(have worked with them my entire career)...who is not "sad" or agitated, for very real reasons...family, environment at the top of the list...but too often, a "quick fix" is insisted by the families, insurance companies(probably more the latter's pressure)...

From what I gather from this article, most of the negative is that they don't work...by not publishing these, the physicians don't have the data leading to these conclusions...is it because the child did go to therapy, support groups etc in conjunction with medication?...how old are these children?...my guess is that pubescent and adolescent kids are the most likely to be in these studies...with metabolic/endocrine systems pumping growth hormones, reproductive hormones at full throttle, natural behavioral changes even in the best of circumstances...imo, adding a neurochemical to this mix is not prudent...even emotionally not prudent...confers to the kid that he/she is mentally defective...

To end my little rant...it seems obvious that they don't want to publish this data because physians will be hesitant
to use these for kids under 18, decreasing revenue stream for co....but...it does not mean the end of antidepressant use, huge revenue stream...In the late 80's after many years of being vexed regarding the cause of often fatal Reye's Syndrome in children, a pediatrician in Boston discovered a very simple reason...aspirin...for some reason, young children with a viral infection when given aspirin for fever control, developed this multisystem reaction...Reye's has now been eradicated....but aspirin is here to stay...adults did not stop taking it...and they're taking more for their hearts!

Thanks Peter for sharing this information...this deserves a letter to the FDA...
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