You still do not get it, the placebo enrollment goes under the same conditions, same 6 hours, same IV access problems, same transport
problems, same INFORMED CONSENT problems, and that is the BEAUTY AND THE SCIENCE of all of it, that it is REAL blinded, that the
same conditions are operating, and there is not room for EXCUSES, except to market types that ridiculously call for the children (no
bias here, but couple of xoma shares)and do not comprehend honest statistical science and the best evidence epidemiology can provide
the true RAMDOMIZED PLACEBO CONTROL TRIAL.
Cacaito,
The problem is that most of the kids probably received antibiotic treatment before arriving at one of the trial centers. Even the 60 or so that died and were not entered into the trial received antibiotics. (So if you want to compute an overall death rate for the normal treatment add those sixty on top of the placebo group.)
Furthermore, the kids arriving at the trial centers could basically be divided into two groups. One group that was improving with antibiotics and the other that was not improving with treatment. The 60 I mentioned above were in the latter group; therefore, most of the kids entering into the trial were probably already improving (or at least stabilizing.)
Essentially, what I think the results are showing is a comparison of Neuprex (plus antibiotics) to placebo (plus antibiotics) in children, most of whom, were already improving with normal treatment. |
