RobertK, some of the comments and links you posted are of interest but I have only glanced over them and have not reviewed them in detail.
The market projections for BPI, if approved, as proclaimed on this thread are of a utopian nature. The large role that HMOs play in determining therapeutic options for a patient can greatly influence the utilization and success of any pharmaceutical agent. This factor can not be ignored and indiscriminate use of expensive treatments is unlikely:
Clin Pharm 1992 Mar;11(3):223-35
Gram-negative sepsis, the sepsis syndrome, and the role of antiendotoxin monoclonal antibodies.
Barriere SL, Guglielmo BJ
Department of Pharmaceutical Services, UCLA Center for the Health Sciences.
The incidence and mortality, pathogenesis, clinical manifestations, and management of sepsis and the sepsis syndrome are reviewed, and the use of antiendotoxin
monoclonal antibodies to treat patients with sepsis is discussed. The sepsis syndrome and septic shock are induced by the presence of endotoxin, a
lipopolysaccharide found in the outer membrane of gram-negative bacteria. Proper management of gram-negative sepsis includes appropriate antimicrobial therapy,
fluids and electrolytes, nutritional support, administration of vasopressors, and mechanical ventilation if necessary. To date, two antiendotoxin monoclonal antibodies
have been produced and subjected to extensive clinical testing. HA-1A, a human cell line-derived monoclonal immunoglobulin M (IgM) antibody that contains only
a small fragment of murine protein, was tested in one trial. HA-1A significantly reduced mortality in patients with sepsis and gram-negative bacteremia and
produced better resolution of major morbidities than placebo in those patients. E5, an IgM antibody produced entirely via murine monoclonal antibody technology,
was evaluated in two trials. Results from the first trial showed that E5 significantly reduced mortality in patients with gram-negative infection who were not in
refractory shock. In contrast, results from the second trial did not show any significant reduction in mortality among patients with gram-negative infection who
received E5. However, resolution of major morbidities occurred more frequently among E5 recipients in both trials. HA-1A and E5 were both well tolerated in the
trials. The cost of therapy is expected to be $3000-$4000 per treatment course. The antiendotoxin monoclonal antibodies represent the next step along the path
toward important reductions in morbidity and mortality from gram-negative infection. However, the financial implications of the use of HA-1A and E5 are
enormous, and stringent patient selection criteria for administration of these products will have to be developed.
Publication Types:
Review
Review, tutorial
Comments:
Comment in: Clin Pharm 1992 Mar;11(3):255-6
PMID: 1611812, UI: 92306494 |
