Robert S, Endotoxins are not the only trigger of the Systemic Inflammatory response syndrome and or the Multiple Organ Damage Syndrome. (notice only).
I post about one month ago several links to the non sepsis causes of the SIRS/MODS.
I have posted several times my doubts on the choice of the Hemorrheagic/Trauma trial due precisely to the problems of non sepsis causes. The phase II from Xoma had 400 plus patients, there was only a clear decrease in gram negative pneumonia and the face saving composite pneumonia/ARDS.
I would have like more a Phase III trial on abdominal infections (great phase II results)for a clearcut gram-negative indication. I do think they will go ahead with a phase III in due time.
Xoma has the clinical infraestructure in place for th Hem/trauma trial, it is probably not very expensive, and they have a chance of showing decrease pneumonia, on itself worthwhile. Even without FDA indication approval it will be used by clinicians for this, if Bpi is FDA approved ever (if....If....If...).
But the phase II Hem/trauma did not show decreases in mortality, nor hospital stay, neither costs. These is as clear as could be, Bpi could control infections and sepsis related SIRS/MODS. Bpi could not control other causes of problems. Do you expect it to decrease traffic violations in Manhattan?
The article on endotoxins and congestive heart failure show an association between these two, but also showed the disappearance of the endotoxins after successful diuresis treatment. Could Bpi bring improvement faster in this condition? decrease mortality? decrease costs?, speculations for the future, Bpi for sepsis is the present.
But, in my view, burn affected patients will be one of the major beneficiaries of bpi products, it is a huge market. Pseudomonas and other resistant organisms are one of the big problems in burn victims.,
Sepsis is the indication, the rest is speculation.
Finally, all (or close to all?)cases of SIRS/MODS will receive Bpi, clinical distinction between sepsis and non sepsis origin will be debate after the use of the medication, TIME (actually the lack of time) will make it so. |
