Biopure's Safety Claims Leave Some Doctors in Doubt

Biotech firm Biopure's (BPUR Quote) statement Aug. 27 that its highly anticipated blood substitute met safety requirements hasn't closed the book on the product -- it's provoked a whole new series of questions from medical professionals.

Shares of Biopure have risen nearly 13% since the company announced that an analysis of testing data showed its blood substitute Hemopure was essentially no more dangerous for patients in surgery than blood transfusions, an assertion reinforced by the comments of CEO Carl Rausch.

But a closer examination of Rausch's comments and Biopure's explanation of how the safety analysis was conducted tells a different story. Expert physicians doubt statements made by CEO Rausch about the relative safety of blood transfusion. One physician even calls the admitted rate of kidney problems found in Hemopure patients "alarmingly high" and "unacceptable." In addition, reviewers conducting Hemopure's safety analysis were not given access to patient data crucial to making judgments on Hemopure's safety -- information that the company has not made public. ...