Study Says FDA Allowed Risky Blood Tests

[OhioChick]

Source: AP

Tests Increase Risk Of Heart Attack, Death

POSTED: 2:47 pm EDT April 28, 2008
UPDATED: 4:48 pm EDT April 28, 2008

CHICAGO -- Experimental blood substitutes raised the risk of heart attack and death, yet U.S. regulators allowed human testing to continue despite warning signs, says a scathing new report.

The U.S. Food and Drug Administration fell short, the report contends, even as red flags popped up during studies by five biotech companies.

Rules barred the agency from releasing company trade secrets, and that kept some information hidden and may have led to unnecessary heart attacks and deaths, wrote the authors, who are government scientists and consumer advocates.

"There shouldn't be secret science," said the lead author of the report, Dr. Charles Natanson, of the National Institutes of Health Clinical Center. Safety data need "to be made public expeditiously so science can build on the mistakes" of previous research, he said.

The report, being published online Monday by the Journal of the American Medical Association, is the latest analysis of the risks of blood substitutes, which have been in testing for more than a decade.

Read more: http://www.newsnet5.com/health/16036037/detail.html

[undergroundpanther]

1. They don't care as long as it isn't their kid dying

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

[Warpy]

2. As I recall, what fatally flawed this study

was the insistence on using the artifical volume expander after the patient had reached the hospital instead of switching to blood ASAP.

The results might have been completely difference had the experimental blood substitute been used in the field with whole blood given as soon as it was available.

I would like to see the study redesigned to reflect this. Having an artificial substance capable of oxygen transport in the human body available in the field would likely save a lot of lives.