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'Devastating' Trial Results for Controversial Artificial Blood Product
December 20, 2006 2:58 PM
A controversial drug experiment, involving artificial blood given to accident victims without their consent, resulted in a 40 percent higher death rate than the standard treatment given to a control group.
Preliminary trial results released yesterday revealed that 46 subjects died after receiving the experimental blood substitute, Polyheme. There were 35 deaths among patients in the control group who received the standard care of saline solution in the field and real blood in the hospital.
An ABC News investigation this year raised questions about the propriety of administering the experimental product to subjects without their consent.
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The results were termed "devastating" by Dr. Peter Laurie of the watchdog group Public Citizen, which criticized the ethics of giving an experimental drug to patients without their consent. He said Polyheme itself is now on "life support, and needs a transfusion of real blood."
Shares in the company that makes Polyheme, Northfield Labs of Evanston, Ill., have fallen more than 50 percent since the test results were made public late yesterday.
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Northfield said it will re-analyze the results because of what it termed "discrepancies" in the data.
Dr. Stephen Gould, Northfield's Chairman and CEO, said the company will push ahead with its efforts to get Polyheme approved by the FDA for public use. According to Dr. Gould, "We continue to move forward to submission of a Biologics License Application, and will review the data and submit to the FDA once we receive the final results."
December 20, 2006 | Permalink | User Comments (12)
If i don't know what it is no way is it going in me!!!
Posted by: Brandy | Dec 20, 2006 10:25:09 PM
If it's still an experiment....and is artificial it has to have something missing.It's never like the original!
Posted by: Brandy | Dec 20, 2006 10:27:44 PM
The point is it was given to probably unconscious people in an ambulance rushing to the hospital. Ambulances carry no blood, so they figured this would be a lifesaver. The earlier stage testing was promising enough to move to this kind of test.
Posted by: Warren | Dec 21, 2006 1:55:07 PM
My city is one of the lucky few to be testing this new product. I now am thankful that Inever needed it.My city is also comprised mainly of minorities and I wonder if that played a hand in its being chosen.
Posted by: Christpher | Dec 21, 2006 2:42:13 PM
To have one's personal body invaded without one's knowledge or consent should be, and often is, criminal. Unwanted and nonconsensual insertion is RAPE--whether chemical, medicinal or penal. Why are some entities allowed to poison the public for private profit? I myself have had pesticide exposures from ILLEGAL applications--and I have simply been abandonned to my PINS (pesticide-induced neuropathy). Most shocking to me is that there seem to be no protocols for dealing with injured victims when there are misuses, accidents or abuses.
Posted by: Lee | Dec 26, 2006 1:12:52 PM
Perhaps they should study the use of Polyheme vs. Saline in the field
but still administer blood in the E.R. To continue Polyheme in the E.C. in light of these numbers would seem to border on the criminal side, especially with no consent from family members.
Posted by: John B. | Dec 27, 2006 5:53:02 PM
It is clearly unethical to experiment on people without their consent. As a white person, I am sure that they purposely chose areas that were mostly made up of minorities. That is disgusting.
Posted by: B Holt | Dec 28, 2006 8:54:19 PM
I live in Kentucky and I know a nurse that was involved with the testing here in the state. She was very impressed with the product and thinks that it will be on the market soon.
Posted by: Walker | Jan 8, 2007 1:31:13 PM
B Holt, is your white guilt so bad that you automatically assume that the big bad company is out to get the black race? Belive me I know the history and I have been to Tuskegee, but to jump to a conclusion that a (supposed) group of white men got together and decided to once again hurt the black man is ignorant. I don't know all of the locations of the company's test but as I posted before, I line in Kentucky and the population is more white than black. Does that mean that the company was trying to kill poor white people?
Posted by: Walker | Jan 8, 2007 1:40:52 PM
Walker, You've been to Tuskegee? Well, now, that certainly makes you an expert. There are numerous examples of drug companies experimenting on minorities, females, disabled, and so forth. Living in KY is no excuse for denying that there's a factual basis for racism, and that racism may extend to drug experimentation.
Posted by: ~Chip :) | Jan 9, 2007 1:00:55 AM
Several points need to made here: The first is that the only people who were given the Polyheme were people who were likely to die regardless (it wasn't given to someone on their way to the hospital with a broken leg) and as such, were not likely to even be conscious to give consent (and as such, its not like the paramedics "withheld" asking the patient). Secondly, people given polyheme were less likely to receive blood upon arrival to the ER, so it is likely that the true cause of death is the lack of follow-up blood given, rather than the actual polyheme itself. And third, the majority of people involved in violent crime are black people...that's called selection bias, not racism. Racism is not the reason the top three leading causes of death in young black men is homicide, suicide, and accidents. Everyone needs to stop playing the race conspiracy card and grow up...crying wolf about racism in everyday life only detracts from the circumstances under which it actually occurs. And for the record, I am a physician in KY.
Posted by: Marc J | Jan 10, 2007 5:17:33 AM
I am interested to know what some of those "numerous" examples of drug testing done on females/minorities/disabled etc are...my guess is you made that one up
Posted by: Marc J | Jan 10, 2007 5:21:24 AM
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