500lbguerilla
07-11-2006, 12:25 AM
Several years ago a clinical trial of a blood substitute called PolyHeme finished with worrisome results. Ten of 81 patients who received the fake blood suffered a heart attack within seven days, and two of those died. None of the 71 patients in the trial who received real blood were found to have had a heart attack.
PolyHeme's maker, Northfield Laboratories Inc., quietly shut down the trial and didn't publicly disclose the results, which are described in internal documents viewed by The Wall Street Journal. It decided the heart attacks might have been due to doctor inexperience in using PolyHeme, not a problem with the product itself.
Now Northfield is in the middle of a new trial. A Food and Drug Administration official, Jay Epstein, calls the earlier data " alarming " but not sufficient to stop Northfield from trying out its product on hundreds of trauma patients.
The FDA is allowing Northfield to test its blood substitute without the consent of the trauma patients, who often are unconscious. In lieu of patient consent, the 31 medical centers testing the product are required to carry out community-awareness campaigns about the trials. Several hospitals have told community meetings that previous trials showed PolyHeme to be safe, failing to mention the 10 heart attacks in their printed materials.
Some veteran doctors are concerned about the push by Northfield, of Evanston, Ill., to test its product without publicly disclosing earlier results. Ronald M. Fairman, chief of vascular surgery at the Hospital of the University of Pennsylvania, says he repeatedly urged the company to publish the data but got nowhere. "Even now, it remains frustrating the multicenter results were not disclosed,"; he says.
Northfield's chief executive, Steven A. Gould, argues the heart attacks could well have been caused by doctors pumping too much total fluid -- PolyHeme plus real blood -- into patients. He says PolyHeme could help many people, such as those in an ambulance who don't have access to human blood. " Our experience suggests the risk- benefit balance is in the patient's favor, " Dr. Gould says.
In a statement, Northfield denies it " resisted publication " but says: " We did not allocate resources to publication. In retrospect, reporting the full study results earlier would have been better. "
Northfield says any American who doesn't wish to participate in the current PolyHeme trial should ask the company for a blue plastic wristband that would alert paramedics. Those who fail to get a wristband and find themselves in a hospital trauma unit " can withdraw from the study, without prejudice, at any time, " the company says.
http://www.defrance.org/artman/publish/article_1531.shtml
For a full list of hospitals go here:
http://abcnews.go.com/WNT/story?id=2166058&page=1
Also notice that ABC didn't even report on the earlier study...
PolyHeme's maker, Northfield Laboratories Inc., quietly shut down the trial and didn't publicly disclose the results, which are described in internal documents viewed by The Wall Street Journal. It decided the heart attacks might have been due to doctor inexperience in using PolyHeme, not a problem with the product itself.
Now Northfield is in the middle of a new trial. A Food and Drug Administration official, Jay Epstein, calls the earlier data " alarming " but not sufficient to stop Northfield from trying out its product on hundreds of trauma patients.
The FDA is allowing Northfield to test its blood substitute without the consent of the trauma patients, who often are unconscious. In lieu of patient consent, the 31 medical centers testing the product are required to carry out community-awareness campaigns about the trials. Several hospitals have told community meetings that previous trials showed PolyHeme to be safe, failing to mention the 10 heart attacks in their printed materials.
Some veteran doctors are concerned about the push by Northfield, of Evanston, Ill., to test its product without publicly disclosing earlier results. Ronald M. Fairman, chief of vascular surgery at the Hospital of the University of Pennsylvania, says he repeatedly urged the company to publish the data but got nowhere. "Even now, it remains frustrating the multicenter results were not disclosed,"; he says.
Northfield's chief executive, Steven A. Gould, argues the heart attacks could well have been caused by doctors pumping too much total fluid -- PolyHeme plus real blood -- into patients. He says PolyHeme could help many people, such as those in an ambulance who don't have access to human blood. " Our experience suggests the risk- benefit balance is in the patient's favor, " Dr. Gould says.
In a statement, Northfield denies it " resisted publication " but says: " We did not allocate resources to publication. In retrospect, reporting the full study results earlier would have been better. "
Northfield says any American who doesn't wish to participate in the current PolyHeme trial should ask the company for a blue plastic wristband that would alert paramedics. Those who fail to get a wristband and find themselves in a hospital trauma unit " can withdraw from the study, without prejudice, at any time, " the company says.
http://www.defrance.org/artman/publish/article_1531.shtml
For a full list of hospitals go here:
http://abcnews.go.com/WNT/story?id=2166058&page=1
Also notice that ABC didn't even report on the earlier study...