Bad Blood.

MayorBob.

Posted to SciTech on Thu May 31, 2007 at 06:54:41 AM EST (promoted by port1080). RSS.

Back in 2004 plastic.com had a brief discussion about PolyHeme.  At that time, a study of the temporary blood substitute manufactured from hemoglobin was just beginning.  While many, even some on Plastic, had concerns about PolyHeme and the manner in which the study might be run, a green light was given for the study.  Well, now the study is complete and the news isn't particularly good for PolyHeme or for Northfield Labs, the company which manufactures it.

Ethical questions about the study were issued early and loud, primarily over the fact that patients were to be randomly selected for use of PolyHeme vice standard saline and blood transfusion.  The US Food and Drug Administration (FDA) had given Northfield Labs authorization to conduct a no-consent study on PolyHeme, one of 15 such studies the FDA has approved since 1996.  Along the way, reports that Northfield Labs had suppressed the fact that PolyHeme had caused heart attacks in patients generated a number of class action lawsuits.  Meanwhile, clinical test results were pronounced troubling, at the least.  The last foot dropped as Northfield Labs announced the results of the study.

The study showed that PolyHeme was not as effective in preventing death as the standard treatment.  The blood substitute was randomly given to trauma patients at 21 medical centers around the nation.  46 of 349 subjects receiving PolyHeme died compared to only 35 of 363 patients who received blood and saline.  Dr. Gerard Fulda, head of surgical critical care at Christiana Hospital in Delaware, had expressed optimism four years ago that PolyHeme because the substitute could be given to patients regardless of their blood type.  Now Fulda, who isn't sure he knew about the heart attack controversy says he will hold final judgment on PolyHeme until Northfield releases actual study data.  Dr. Fulda may be willing to wait, but the investment community is less patient as share prices for Northfield Labs plummeted 55 percent with the news of the study results.

The overarching question of whether trauma patients should be the subject of a random, no-consent study on blood substitutes is raised by Dr. Arthur Caplan, bioethicist from the University of Pennsylvania.  Caplan feels that Northfield attempted to suppress the heart attack results "was a signal of serious problems" and "every hospital that was in the study definitely needed to reconsider their participation after that."  He believes the study presents ethical questions because patients - the persons whose lives hung in the balance - were not given the option to choose between the unproven effectiveness of PolyHeme and the demonstrated effectiveness of blood and saline.  Fulda says no-consent studies such as PolyHeme are not quite black and white, ethically:

"It's a very complicated issue," he said. "How do you do research on people having life-threatening problems? I appreciate the controversy that exists with the ethics involved."