Documents Raise Questions About the Safety of Nation?s Blood Supply; Public Citizen Calls for Congressional Inquiry

Jan. 24, 2002

Documents Raise Questions About the Safety of Nation?s Blood Supply; Public Citizen Calls for Congressional Inquiry

FDA Officials Made Declarations About Red Cross in Court Filings

WASHINGTON, D.C. — Public Citizen is calling on Congress to launch an inquiry after obtaining court documents raising serious questions about the safety of the nation?s blood supply, most of which is collected and distributed by the American Red Cross.

In a letter sent today to Senate Majority Leader Tom Daschle (D-S.D.) and Sen. Ted Kennedy (D-Mass.), Public Citizen asks lawmakers to force the Red Cross to improve its “public health-threatening record.”

In one document, the director of blood and blood products for the U.S. Food and Drug Administration (FDA) said that the Red Cross has operated with “an attitude of disregard for the public?s interest.” The official also was critical of the Red Cross? assertion that because there has been no documentation of transfusion-associated infections from tainted blood, the blood supply is safe. Calling this a “notoriously dangerous assumption,” he noted that transfusion-transmitted infections may not always be recognized and attributed to unsuitable blood. This is because some infections can remain dormant for long periods of time and because doctors aren?t required to report such incidents.

Another court document showed a dramatic increase in the number of unsuitable blood products released by the Red Cross over the years. There were 36 recalls of unsuitable blood products in fiscal year 1988 and 641 in fiscal year 2000, an 18-fold increase.

The documents were filed in December 2001 as part of an ongoing court case. In December, the FDA asked that the Red Cross be held in contempt of court for violating a 1993 consent decree because of longstanding and dangerous practices.

Read the letter.

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