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Biotech / Medical : Biotech Valuation -- Ignore unavailable to you. Want to Upgrade?

To: zeta1961 who wrote (10208)	1/30/2004 9:41:07 AM
From: NeuroInvestment	Read Replies (2) \| Respond to 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

To: zeta1961 who wrote (10208)	1/30/2004 10:37:20 AM
From: Biomaven	Read Replies (1) \| Respond to of 52153

Take a look at this very recent article showing brain changes in adolescents with depression: Hippocampal volume in early onset depression Frank P MacMaster and Vivek Kusumakar BMC Medicine 2004, 2:2 (published 29 January 2004) Abstract (provisional) Background Abnormalities in limbic structures have been implicated in major depressive disorder (MDD). Although MDD is as common in adolescence as in adulthood, few studies have examined youth near illness onset in order to determine the possible influence of atypical development on the pathophysiology of this disorder. Methods Hippocampal volumes were measured in 17 MDD subjects (age = 16.67 +/- 1.83 years [mean +/- SD]; range = 13 - 18 years) and 17 age- and sex-matched healthy controls (16.23 +/- 1.61 years [mean +/- SD]; 13 - 18 years) using magnetic resonance imaging (MRI). Results An analysis of covariance revealed a significant difference between MDD and control subjects (F = 8.66, df = 1, 29, P = 0.006). This was more strongly localized to the left hippocampus (P = 0.001) than the right hippocampus (P = 0.047). Conclusions Our findings provide new evidence of abnormalities in the hippocampus in early onset depression. However, our results should be considered preliminary given the small sample size studied. Free full text available at: biomedcentral.com My own guess is that undertreatment for adolescent depression is more of a problem than overtreatment. There's a fundamental problem with trials for conditions like depression and migraine prophylaxis. The problem is that different drugs work for different subsets of the population, and currently there is no predictive methodology for identifying which drug is likely to work in an individual patient. Thus you might have some drug that is extrordinarily effective in a small subset of the population - say 10%. Now if it's a condition like lung cancer then a drug like Iressa can get approval because you can demonstrate a few "miracle cures." But in a condition with a high placebo response it is much more difficult - you need huge trials and even then you will only demonstrate marginal statistical significance. The only good answer must come with better diagnostic methods and pharmacogenomics - so-called individualized medicine. But that has its own economic worries - only high prices can justify seeking approval for a drug that works for only a small subgroup. One interesting idea (which I don't hink I've ever seen discussed) is to restrict a Phase III trial to people for whom the drug showed efficacy in some sort of smaller pre-trial. You would then randomize amongst this pre-screened population. Not at all sure what the FDA reaction would be. Peter