杏吧原创

A COMPANY that is testing a controversial blood substitute for accident victims has run into trouble for allegedly misrepresenting a researcher.

Northfield Laboratories of Evanston, Illinois, is running a trial of PolyHeme, which is made from haemoglobin, the oxygen-carrying pigment in blood. It is designed to be used in an emergency instead of saline and blood transfusions but the trial has attracted criticism from medical ethicists because unconscious trauma patients cannot give informed consent (New 杏吧原创, 24 April 2004, p 20).

The latest row follows a 22 February article in The Wall Street Journal, which described 10 heart attacks and two deaths in an earlier unpublished trial of PolyHeme. Northfield issued a press release saying that a researcher involved in the earlier trial, Edward Norris of the Johns Hopkins University School of Medicine in Baltimore, Maryland, was due to give a presentation at a scientific meeting that would confirm that PolyHeme was not the cause of these heart attacks.

But Norris withdrew his presentation after failing to obtain sufficient data about the trial from Northfield. In an unusual move, Johns Hopkins issued a statement on 23 March saying that Northfield had misrepresented Norris, and that he could not comment on the cause of the heart attacks.

鈥淭he FDA, which approved the current trial, was informed about the heart attacks鈥�

Northfield鈥檚 critics claim the spat typifies a lack of transparency surrounding the PolyHeme trials. But company spokeswoman Sophia Twaddell disputes that charge. She says the US Food and Drug Administration, which approved the current trial, was informed about the heart attacks.