"Evanston, Ill.-based Northfield drew fire following a recent Wall Street Journal story that suggested the company tried to hide key details about the study on the blood substitute PolyHeme in elective surgery patients."


http://www.belleville.com/mld/bellev...s/14172223.htm

Thu, Mar. 23, 2006
Researcher withdraws presentation on blood substitute

CARLA K. JOHNSON

Associated Press

CHICAGO - A Johns Hopkins researcher says the maker of an experimental blood substitute did not release to him all the data from a 2000 study on the product, so he has withdrawn his presentation about the study from the program of a medical meeting next month.

"Northfield (Laboratories) was not able to provide me with the full data from the study and it's not possible to put a presentation together of any kind without access to the entire study database," Dr. Edward Norris of Johns Hopkins said Thursday.

Evanston, Ill.-based Northfield drew fire following a recent Wall Street Journal story that suggested the company tried to hide key details about the study on the blood substitute PolyHeme in elective surgery patients.

The Journal reported that 10 heart surgery patients in the study had heart attacks, while other patients given real blood did not. There were two deaths among the patients who suffered heart attacks.

Northfield now is the target of several lawsuits seeking class-action status for investors who believe the company failed to disclose facts that would have hurt the company's stock price.

Norris said Thursday a press release issued last month by Northfield inaccurately said he would "present the full study" at an April meeting on blood transfusion alternatives.

The company issued a corrected press release Monday after hearing complaints from the medical school, Norris said.

The original press release said Norris' presentation at the meeting would support the company's belief that PolyHeme did not cause the heart attacks.

"I personally think they overstated that and, without my having all the data from that trial, I think that was a big leap of faith," he said. He added it would be impossible to determine what caused the heart attacks because of the study's design.

The press release used "the language of Wall Street" more than the language of science, Norris said.

He has access only to patient data that came from Johns Hopkins participants, and no data from patients at other research sites. There were no deaths or heart attacks at his facility, Norris said.

He also had not seen himself described as the study's lead investigator before he read the press release, he said.

The company is testing PolyHeme in a new study that has been criticized by ethicists because it is injected into trauma patients without their prior consent. Finding a viable blood substitute would revolutionize emergency medicine and could potentially save millions of lives.

Northfield has denied covering up deaths and heart attacks. The company has said no safety issues have arisen with the ongoing study of trauma patients.

Company spokeswoman Sophia Twaddell said Thursday the company