Anti-endotoxin antibodies as treatment for sepsis - lessons to be learnt

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Abstract
Overstimulation of inflammatory cells by lipopolysaccharide (endotoxin) causes septic syndrome and septic shock during infections by Gram-negative bacteria. Monoclonal antibodies against endotoxin have been proposed as a treatment of Gram-negative sepsis. One such antibody, HA-1A, was released onto the market in some European countries and its approval in the USA was recommended by a panel of experts in September 1991. However, doubts raised by the lack of reproducible preclinical data, and by an independent re-analysis of the results of the first clinical trials, led to a further clinical trial. This second trial revealed an increase in mortality in HA-1A-treated patients. The trial was stopped and the drug withdrawn from the market. To avoid such disappointments, the marketing of new-technology products should be based on critical scientific analysis, free from commercial pressures, of thorough, reproducible and consistent preclinical and clinical studies.

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