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Biotech / Medical : Biotech Valuation
CRSP 53.85-4.5%Jan 9 9:30 AM EST

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To: zeta1961 who wrote (10208)1/30/2004 9:41:07 AM
From: NeuroInvestment  Read Replies (2) of 52153
 
<<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..>>

It does sound cavalier, and I agree that negative studies should be made public, rather than companies cherrypicking those that look the best. But, I'd be cautious about Katz's definition of "negative" study, since in his view, p=.06 would be "negative." Some of us might have a more flexible view of what constitutes an indication of efficacy.

<<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)...>>

I might have agreed with you--fifteen years ago. But I have seen too many instances where antidepressants provided tangible improvement to dismiss them as 'quick fixes.' For one thing, I am not convinced that endogenous depression, not a rare phenomenon in adults, is so rare in children, let alone adolescents. And while teenagers are a veritable maelstrom of biochemical turbulence, the fact that there is so much 'static' does not mean that one should not try to treat the depressive component. By the time they are adults, deciding that 'I guess he/she really was depressed, not just hormonal' is too late to avoid the deleterious consequences of depression at a time that a personal sense of competence, worth, and identity, is being consolidated.

There are times that medication is used in the context of depression that may be thought of as reactive--to stress, loss, etc. In a perfect world, each child/adolescent who needed services would have access to skilled individual therapy, their parents would have access to skilled couples therapy, and the whole family would be seen by a competent family therapist--with home visits and enough adolescent group homes and residential treatment facilities to handle those where the systemic chaos is irredeemable.

But given how far the system (and not just insurance 'coverage') falls short of perfection, sometimes the best that one can do is provide some psychotherapy and medication to help kids that are not inherently resilient become resilient enough to survive. And the 'message' a kid takes in from being given medication regarding being 'defective' is generally a red herring--they develop even more negative views of themselves from feeling chronically depressed, alienated, and incompetent (academically and socially).

I'm not defending the status quo as being desirable: just noting that in such a compromised system, the use of antidepressants is not merely a function of greed or laziness--often it is just the best that front-line clinicians can do at a time that the political landscape is dominated by a 'compassionate conservatism' that in fact is neither.

Harry
NeuroInvestment
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