Biopure hits back at WSJ Hemopure articles

The USA's Biopure Corp has hit out at recent articles in the Wall Street Journal referring to adverse events in trials of its blood substitute Hemopure (bovine hemoglobin glutamer-250) and their potential significance in relation to Biopure's UK marketing application and the Food and Drug Administration's upcoming Blood Products Advisory Committee meeting to discuss the US Navy's proposed RESUS clinical trial of Hemopure.

Biopure noted that, while it has avoided responding on the record to recent media inquiries to pre-empt discussion of issues that may arise at the BPAC meeting, it issued a statement to correct the WSJ's "imbalanced perspective."

It said that the newspaper did not include background information to explain the nature of clinical trials as opportunities to identify whether the "benefit of an investigational product (in this case, a potential first-in-class product) exceeds the risks, so that appropriate guidelines such as patient population, dosage, etc, can be applied to a product label and/or future study protocols." Biopure noted that, while safety is evaluated by counting adverse events, not all adverse events are test-agent related.