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Gold/Mining/Energy : Vasogen-- VAS on TSE
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To: Pluvia who wrote (371)9/11/2006 12:16:52 PM
From: Clarksterh  Read Replies (1) of 377
 
Obviously damaged heart tissue seems to be key. Given VSGN's admission [buried in a publication, not via pr] they had done no dose ranging, these are pretty impressive results with a shot in the dark dose.

I understand the implicit putative MOA for their stat sig subgroup. But *you* need to explain why the damaged heart group was actively hurt by the treatment - my approx estimate of the p value for that group is better than p=0.05 that the excluded patients were HURT by treatment. Given that this makes little sense I would suggest that this is not a real result - meaning that both the benefitted subgroup isn't real, nor is the hurt subgroup.

Again, there is probably efficacy in some subgroup - but it almost certainly isn't in that large a subgroup.

Think of it another way:

a) do heart attack class IIs really have that much in common with non-heart attack class III/IV's?

b) I think you would make the same argument if the subgroup analysis said "Patients with QcT interval better than X" or "heart size less than Y" or ... . I could invent 100 categories of healthier patients and I GUARANTEE that I could find a permuted 'subgroup' combination that comprised greater thant 50% of 2400 patients that was significantly stat sig.

c) Whatever group was added to the 1305 subgroup to make it into 1747 subgroup was clearly nowhere near stat sig since the p value went up by more than a factor of 10 with the addition of only 442 patients. They are stretching to make the group look as large as possible.

Clark
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