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To the Editor: From 1997 to early 1998, we were members of the data and safety monitoring board (DSMB) for Baxter Healthcare's US study of diaspirin cross-linked hemoglobin (DCLHb) in adult trauma patients experiencing hemorrhagic shock.^1-2 Thus, we read with interest the study by Dr Natanson and colleagues³ describing the cumulative experience and adverse outcomes associated with the use of hemoglobin-based blood substitutes (HBBSs).³ While the cumulative adverse outcome data for HBBSs speak for themselves, the authors imply there has been a consistent pattern of delay in the release and publication of negative trial results with HBBSs.

In the case for which we have direct personal knowledge, the US trauma trial conducted by Baxter Healthcare,² the sponsor responded immediately to safety concerns and the recommendation of the DSMB to suspend subject enrollment, disseminated raw mortality data 24 days after the DSMB recommendation to formally terminate the trial and 10 days . . . [Full Text of this Article]

Roger J. Lewis, MD, PhD
roger@emedharbor.edu
Department of Emergency Medicine
Harbor-UCLA Medical Center
Torrance, California

Norman Fost, MD, MPH
Department of Pediatrics
University of Wisconsin School of Medicine and Public Health
Madison

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