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Test of Controversial Artificial Blood Product a Failure

May 23, 2007 5:29 PM

Joseph Rhee Reports:

Test_of_controv_mn Results released today show a controversial experimental artificial blood product given to accident victims without their consent resulted in higher rates of mortality and side effects than among control patients who received standard treatment.

According to the results released by Northfield Labs, the maker of Polyheme, 11.1 percent of patients given Polyheme died, compared to 9.1 percent of patients who received the standard treatment of saline solution in the field and real blood in the hospital. In addition, 40 percent of Polyheme patients suffered serious adverse events, including shock, pneumonia, and respiratory failure, versus 35 percent in the control group.

The Northfield trial had been highly criticized by doctors and medical ethicists because Polyheme was given to seriously injured accident victims in 27 cities across the U.S. without their knowledge. The only way out of the experiment was to wear a blue bracelet provided by the company.

Pastor Paul Burleson of a Denver church alliance said the experiment turned test subjects into human guinea pigs.

"If I'm in an accident and I just don't happen to have this particular wristband, that I'd be a guinea pig is unconscionable," he said.

Northfield has maintained the unusual trial design was the only way to test such a product and that a viable blood substitute product would have revolutionary benefits for emergency medical care.

Northfield CEO Steven Gould said, "We continue to believe there is a potential benefit to using Polyheme in patients with delayed access to blood."

Past efforts to develop a viable blood substitute have met with failure because such products have been shown to cause a greater incidence of heart attacks. The Northfield results released today showed that seven percent of Polyheme patients suffered cardiac serious adverse events versus four percent of control patients.

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May 23, 2007 | Permalink | User Comments (9)

User Comments

I'm confused as to why this is news without mentioning that a YEAR ago Northfield refused to disclose disasterous results from polyheme trials that led to a class-action lawsuit filed THEN. Maybe a better hook would've been that the FDA knowingly -allowed- this new bizarre ethically-bankrupt experiment to go forward this long.

Posted by: J Vengac | May 23, 2007 11:53:36 PM

blood is a fascinating thing. i would love to listen to an evolutionist explain it's construction over hundreds of millions of years. only God could create such an amazing and simple and life sustaining fluid. the same blood which Jesus shed for the sins of all mankind. And He's coming back soon. Sooner than later. Best be ready. Rapture Ready.

Posted by: MIKE | May 24, 2007 12:13:59 AM

A serious efforts and monitoring controlling system should be taken all over the world immediately to keep our patients and donitars of blood save free of sickness, clean and keep a righ path to inspect for a clean blood.

Thanks & keep going

Posted by: Edward Elivis Keniddy | May 24, 2007 2:05:20 AM

The FDA pandering to drug companies needs to stop. They were put in place to regulate them, not help them make money off the deaths of Americans.

Posted by: skidog | May 24, 2007 1:35:10 PM

It doesn't sound like the results are too bad until you get to the last statistic: "seven percent of Polyheme patients suffered cardiac serious adverse events versus four percent of control patients." That means the substitute is 75% worse for patients. I suspect this study should never have been allowed.

And by the way, just who is Northfield? They seem to be hiding the true ownership of the company.

Posted by: Mark | May 24, 2007 4:09:26 PM

CEO Gould should explain how he got the mandatory permission for human trials from the FDA, if it was known by the FDA that testing would be carried out using unknowing citizens as test subjects without their permission.
Something seriously wrong with this picture...
And to the creationist, fine you have your opinion, but this is about human victims of unscrupulous drug companies, with all due respect, please share your religion on the religious blogs...

Posted by: brian | May 27, 2007 2:02:48 AM

I would wax rapturous if the weasels behind this Mengele-esque experiment were to be tried for murder, terrorism & crimes against humanity. Sadly, because they repersent the grossly over-moneyed pharmaceutical interests, nothing will happen. As a simple matter of note Another of these without consent frankenstein experiments has been authorised, this time 27 hospitals across the USA will be participating & there is no "opt-out" bracelet available. Write you congressional represtatives & any other governmental agent that you can, let them know that the populace of the USA will not stand for being made unwilling laboratory rats.

Posted by: not ethnocentric | May 28, 2007 9:43:39 PM

Life imitates bad thriller novels (Mount Dragon I think).

Setting aside the serious ethical and moral problems illustrated by this story, I'm also concerned the "ultra blind" study will become a common practice.

*Northfield has maintained the unusual trial design was the only way to test such a product*

Yes. Of course. Just like purposely with holding treatment from patients with syphillis is the only way to find out how the disease works [you over]!

Posted by: aje | May 29, 2007 7:25:45 PM

I can't believe that such an unethical experiment was legally performed w/ human test-subjects. This company and any participants in this "experiment" should be thrown in jail and their license to practice in their respective feilds should be revoked.

Posted by: Cynthia | May 31, 2007 4:05:25 AM

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