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


To: IRWIN JAMES FRANKEL who wrote (23734)5/22/2007 9:04:20 AM
From: scaram(o)uche  Read Replies (2) | Respond to of 52153
 
Message 23560773

Six of the 48 trials did not report any myocardial infarctions or deaths from cardiovascular causes and therefore were not included in the analysis

(snip)

I think the FDA has to get serious about defining real risk - benefit ratios for drugs, especially ones that treat large populations.

Nissen is simply out of control. 28K patients, weighted to regimens that included rosiglitazone, and a difference of 14 MIs. "Risk-benefit"??

He has rock-star envy.



To: IRWIN JAMES FRANKEL who wrote (23734)5/22/2007 10:59:07 AM
From: CrazyPete  Read Replies (1) | Respond to of 52153
 
Cougar3's pooled analysis is not a valid method for combining data across experiments with different sample ascertainment. There are good reasons why the standard meta-analytic method is to combine the odds ratios rather than pooling the underlying counts.

You can easily construct situations where every study has an odds ratio > 1 but the combined counts give a value < 1, and Cougar3's analysis is really a demonstration of this flaw. NEJM is not stupid and the statistics in this paper would have been carefully vetted.



To: IRWIN JAMES FRANKEL who wrote (23734)5/22/2007 11:20:43 AM
From: Proud Deplorable  Respond to of 52153
 
Just remember Rezulin!



To: IRWIN JAMES FRANKEL who wrote (23734)5/23/2007 8:58:47 PM
From: georgiabiotech  Read Replies (1) | Respond to of 52153
 
Avandia trial analysis
IJ I reviewed your post on MI's between the avandia group 86 MI's .60% and 72 MI,s .62% in the control group so I also was not impressed with the data but then I went back and looked at the article and for Cardiovascular death there were 39 deaths .27% in the avandia group and 22 deaths .189% in the control group. I am not really dissagreeing with you on the MI data difference but there appears to be a difference in the cardiovascular death data between avandia and the control group.
Bob