Manfred, I am sure xoma will love to have the drug given the way you suggest, It was not allowed to do it, it is very real, informed consent was mean and a must to be obtained in the trial BEFORE the drug admninistration. One could argue long and that is the fact.
I met Dr Giroir, he was a moderator of a Pediatric critical care sepsis seminar in New Orleans meeting of the Amer Acad of Pediatrics/Society for Pediatric Research, and He is very good on the clinical science part, and I am sure He must be red hot with the REAL world constrains. Sometimes I feel like Bluegreen and his FDA concerns(but I try not to invest with my emotions).
The amputation side of the trial from 7.5% to 3.2% is a very strong trend, just increase in N will probably be enough.
Many drugs and procedures are approve and highly praise with this type of difference in outcome, like aspirin, heparin, streptokinase, tpa, betablockers,ACE inhibitors, stents in heart attack/angina. The huge number of subjects in the studies, some as high as 10,000 provides the "Power" and later the "p" to be accepted.
I do not blame the scientists and clinicians at all. My Point. |
