While my expressed enthusiasm for the BPI molecule doesn't appear to meet the criteria established by the more zealous members of this board, I do nevertheless find BPI to be of interest. But the projected potential markets for this molecule seem to ignore the substantial financial considerations that are coupled with these types of pharmaceutical compounds. The abstract below (emphasis mine) addresses these issues:
Arch Intern Med 1994 Jun 13;154(11):1241-9
Projected impact of monoclonal anti-endotoxin antibody therapy.
Bates DW, Lee TH
Department of Medicine, Brigham and Women's Hospital, Boston, Mass.
BACKGROUND: The goals of this study were to evaluate the criteria for administration of HA-1A monoclonal antibody therapy from the HA-1A trial in
patients with suspected gram-negative bacteremia and to evaluate the accuracy with which Bone's criteria for sepsis syndrome identify patients with
gram-negative bacteremia. METHODS: This prospective cohort study included 1509 episodes in which hospitalized patients had blood cultures performed in
an urban tertiary-care hospital. The main outcome measures were gram-negative bacteremia and gram-negative sepsis. RESULTS: Of 1509 episodes, 115
(8%) represented bacteremia and 40 (3%) included gram-negative rods. Of these 40 patients, nine died in the hospital, including five patients who had
gram-negative sepsis; all five had another rapidly fatal disease. Using criteria for treatment and exclusions from the HA-1A trial, three of the patients with
gram-negative bacteremia would have been treated, while at least 52 patients without gram-negative bacteremia might have received HA-1A therapy (positive
predictive value of criteria, 5.5%). Of the 1509 episodes, sepsis syndrome as defined by Bone was present in 34 (2.3%). While 32 of the 34 patients had
suspected gram-negative bacteremia, only five had blood cultures positive for gram-negative bacteria. CONCLUSIONS: In this population, current criteria for
administration of monoclonal anti-endotoxin antibody therapy were not sensitive or specific for gram-negative bacteremia, and many patients with
gram-negative sepsis were too ill from other conditions to benefit. Indiscriminate use of these therapies could thus be costly yet yield few benefits. To identify
patients who should receive novel therapies, better risk-stratification methods and cost-effectiveness analysis are needed.
Comments:
Comment in: Arch Intern Med 1994 Jun 13;154(11):1183
PMID: 8203991, UI: 94263313
Hopefully BPI can help such patients but to think such treatments will be administered indiscriminately is IMO unlikely; especially so with HMOs influencing what therapeutic options can or can not be utilized. |
