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November 14, 1994

Looking Back on HA-1A

Author Affiliations

Critical Care Medicine Department National Institutes of Health Bethesda, MD 20892

Arch Intern Med. 1994;154(21):2393. doi:10.1001/archinte.1994.00420210017002

IN THIS ISSUE of the Archives, The National Committee for the Evaluation of Centoxin1 reports data from a French national registry that monitored the outcome of 600 septic patients given a single 100-mg dose of HA-1A (Centoxin, Centocor, Malvern, Pa), a sepsis drug that was recently approved for, and then withdrawn from, clinical use in Europe. The authors show that patients treated with HA-1A had a higher mortality rate than would have been expected from their scores measured by means of the Acute Physiology and Chronic Health Evaluation II (APACHE II). The study was retrospective and compared HA-1A—associated mortality with APACHE II—predicted mortality, rather than a simultaneously treated control group. Although the P value of.06 for increased mortality did not reach statistical significance, P values less than.1 are more than adequate to suggest evidence of harm. Despite these potential limitations, the French findings should prompt a reexamination of the sequence