FDA Allowed Testing of Artificial Blood Despite Risk of Death

[babylonsister]

FDA Allowed Testing of Artificial Blood Despite Risk of Death

By Rob Stein
Washington Post Staff Writer
Monday, April 28, 2008; 2:02 PM



A new analysis concludes that the Food and Drug Administration approved experiments with artificial blood substitutes even after studies showed that the controversial products posed a clear risk of causing heart attacks and death.

The review of combined data from more than 3,711 patients who participated in 16 studies testing five different types of artificial blood, released today, found the products nearly tripled the risk for heart attacks and boosted the chances of dying by 30 percent.

Based on the findings, the researchers questioned why the FDA allowed additional testing of the products to go forward and why the agency is considering letting yet another study proceed.

"It's hard to understand," said Charles Natanson, a senior investigator at the National Institutes of Health who led the analysis, which was released early by the Journal of the American Medical Association so the data could be presented at an FDA meeting on the subject. "They already had data that these products could cause heart attacks and evidence that they could kill."

more...

http://www.washingtonpost.com/wp-dyn/content/article/2008/04/28/AR2008042801025.html

[Clear Blue Sky]

1. No surprise.

Once upon a time they said that HIV couldn't be spread via blood transfusions. Perhaps they prefer being reactive rather than proactive.

[Fredda Weinberg]

2. There's a reasonable response, but the details aren't in the article

This is an emergency product, to be used when regular blood isn't available. Under the right circumstances, additional risk is acceptable ... there was nothing specific but the implication is there that the test subjects were similarly vulnerable.

[undergroundpanther]

3. they tried testing it without consent, too

Chicago Sun-Times Feb. 9, 2004

Excerpt: In a rare exception to the way clinical trials are conducted, Loyola University Health System plans to test an experimental blood substitute on patients without their permission...

http://www.unknownnews.org/060710a-Panther.html
Somebody knew how risky those tests were,and didn't give a shit,as long as it was tested in the POOR neighborhoods...

http://www.democraticunderground.com/discuss/duboard.php?az=view_all&address=389x1093759

A little-known federal agency charged with protecting patients in medical research has expressed ethical concerns about a study of a Northfield Laboratories Inc. blood substitute being given to hundreds of trauma patients without their consent.
http://www.mindfully.org/Health/2006/PolyHeme-OHRP-Criticized10mar06.htm


Questions about PolyHeme arose after an article last month in The Wall Street Journal said 10 of 81 patients who received the product had a heart attack within a week -- and two died -- while none of the 71 patients who received real blood suffered one.

The results were described in internal documents obtained by the newspaper. The article also said Northfield Laboratories "didn't publicly disclose the results" -- a point Bernard disputes.
http://www.kctcs.edu/todaysnews/index.cfm?tn_date=2006-03-15

And it still goes on..
http://64.233.169.104/search?q=cache:2TC8HYLUXeQJ:www.defrance.org/artman/publish/article_1531.shtml+polyheme&hl=en&ct=clnk&cd=4&gl=us&client=firefox-a
http://blog.bioethics.net/2006/03/polyheme.html