Red Cross Won't Release Information on Possibly Tainted Blood!

Submitted by SadInAmerica on Thu, 03/27/2008 - 11:11am.

The American Red Cross says it will not publicly release information about what happened to about 1,000 units of suspect blood that were subject to a recall and caused the organization to be fined more than $4 million by the Food and Drug Administration.

For weeks now, Cybercast News Service has attempted to ascertain the fate of the blood. On March 17, Cybercast News Service decided to ask the Red Cross in writing whether it had destroyed all 1,000 units of possibly contaminated blood products that it recalled between 2003 and 2006 or whether some of the blood got into the veins of patients.

Their reply came March 21.

"The Red Cross is not able to release that information," Red Cross spokeswoman Lesly Simmons told Cybercast News Service.

She said "the senior leadership" of the Red Cross had determined that because of "limited financial resources" - i.e., a budget shortfall affecting staffing, it would "take too much" to compile such a report.

The question had been a follow-up to an investigation conducted by Cybercast News Service into action taken by the Food and Drug Administration (FDA) in February against the blood provider.

Last month, the FDA fined the Red Cross $4.6 million for mishandling or inappropriately releasing possibly contaminated or suspect blood products.

The government agency also cited the Red Cross for failure to "defer" or exclude from its inventory units of blood taken from donors who it later learned had traveled in malaria risk areas, or in areas where there was known Creutzfeld-Jakob Disease (CJD), the human form of "mad cow disease"

Further, it fined the Red Cross for failing to properly screen out donors who had repeatedly tested positive for hepatitis or who had not disclosed whether they were HIV-positive.

On March 18, Cybercast News Service reported that the Red Cross either couldn't or wouldn't state whether potentially contaminated blood may have entered the blood supply. Officials would only say that "no adverse reactions" were reported.

At the same time, however, a senior Red Cross executive gave assurances that the organization had "complete traceability" of all its products.

"We know the disposition of all the units," said Eva Quinley, senior vice president for quality and regulatory affairs.

"We know whether the units were transfused, or whether they were destroyed, or whether they expired," she said.

But when asked if such a list was readily available, Quinley said it would have to be developed - and that it "might take awhile" to do so.

On March 20, Cybercast News Service formally asked the Red Cross to provide a disposition list or report however long it may take to develop.

Our request said, "We are not seeking the names of any individuals, or any information which might be covered by . . . privacy rules - simply whether the recalled products were destroyed or transfused."

The Red Cross response came late Friday.

'It shouldn't be this difficult'

The American National Red Cross is not alone in engaging in what appears to be stonewalling.

Last Monday, after two weeks of unsuccessful efforts going through normal channels to try to obtain an interview from the FDA, Cybercast News Service also posed questions directly to one of the government agency's top officials.

But when asked if the FDA knew the disposition of the blood in question, Julie Zawisza, assistant secretary for public affairs at the FDA, replied by e-mail, saying only that an FDA spokeswoman would be contacting Cybercast News Service. To date, that has not occurred.

Finding out whether potentially tainted blood has been transfused into people shouldn't be this difficult, according to Dr. Sidney Wolfe, director of the Health Research Group at Public Citizen, a consumer advocacy group.

When it comes to tracking blood, there are two questions that all blood providers ought to be able to answer, he said.

"One is, 'Did you ship out any blood that turns out to have been contaminated or laced with HIV or malaria or with hepatitis A, B, or C?'" Wolfe told Cybercast News Service. "The second, much more difficult question is: Did anyone get sick from that?"

The first question, he said, is one that all organizations that collect blood can - and should - be able to answer.

"The Red Cross ought to be able to tell you the disposition of blood - whether it was transfused or destroyed or is sitting on the shelves," Wolfe said.

The American National Red Cross, though a volunteer agency, is chartered by Congress and is legally regarded as a part of the federal government and required to carry out certain responsibilities delegated by the federal government.

Pete Winn - CNSNews -  Senior Staff Writer - March 26, 2008 - posted at

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Submitted by SadInAmerica on Thu, 03/27/2008 - 11:11am.


Anonymous | Fri, 03/28/2008 - 9:59am

Speaking anonymously on this subject but with some knowledge about how the blood system works I can state that the ARC knows exactly where all of the various blood components went. They are also able to tell exactly who and when the various components were transfused to. Before making a statement like "there were no adverse reactions" they absolutely would know the disposition of each of the units. I'm sure that many of the units were destroyed but I'm also sure that some of them were transfused into patients. Imagine if you received one of these units? The safeguards that are in place are there for a reason. Just becuase a unit should have been deferred doesn't mean that the use of that unit is going to cause HIV or any of the other blood bourne transmissible diseases. I can only conclude, and I don't have first-hand knowledge of this, that by tracing and providing a status for every unit the ARC would be opening themselves up to a huge litigation risk in the event that a name was matched to an effected blood unit. What's the best way to keep this under wraps? Subvert it with legal and PR mumbo jumbo. I think the people that may have been effected have the right to know, but sorting out the pieces and getting a straight answer would take months and years of legal wrangling. The ARC would need to step up to the plate on this becuase many of the people that received the blood products have no idea where they got the blood from. It could have been ARC provided blood or any number of other blood collection and manufacturing groups across the US.