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Government Reorganizes How it Safeguards Blood Supply

October 12, 1995

WASHINGTON (AP) _ Responsibility for a safe blood supply is being given to the government’s highest-level doctors, a response to criticism that bureaucratic red tape allowed thousands of Americans to get AIDS-tainted blood in the 1980s.

A first step of the new Blood Safety Council, announced Thursday before Congress, will be to decide whether thousands should be notified that they may have caught the liver disease hepatitis from transfusions before 1990.

``There are an estimated 100,000 to 200,000 people infected with the hepatitis C virus (from transfusions) and are unaware of their infection,″ said Rep. Christopher Shays, R-Conn. ``Can I put that first on your list?″

Yes, responded the nation’s new blood director, Assistant Health Secretary Philip Lee. But he wouldn’t say whether the government was leaning toward notifying these patients.

Until now, blood safety has fallen to a government mishmash. The Food and Drug Administration regulates blood banks, the Centers for Disease Control and Prevention sounds the alarm when new diseases are found in blood and the National Institutes of Health performs blood research.

The Institute of Medicine last summer declared that fear and confusion among these agencies left Americans unprotected when HIV, the AIDS virus, emerged in the 1980s. Some 10,000 hemophiliacs, who need frequent plasma donations, and thousands of other blood recipients got HIV while the government debated what to do.

To prevent that from happening again, Health and Human Services Secretary Donna Shalala said Thursday she is elevating responsibility for blood safety to the government’s highest levels. She will designate her top assistant as blood director and establish the Blood Safety Council of top experts to keep transfusions free of emerging diseases.

``Blood safety must never again be handled as a secondary issue,″ she said. ``We will transform a system that had sometimes been plodding into one that can reach decisions and implement them quickly.″

But the U.S. blood supply, which provides 12 million units of blood to 4 million patients a year, is the world’s safest, she said.

Shalala’s plan is a good start, said Corey Dubin, a hemophiliac who caught HIV from transfusions. ``For the first time in many, many years ... we have got the highest levels of the United States government engaged on blood safety issues,″ he said.

But the council’s first test, he and others said, will be how it handles hepatitis.

Between 100,000 and 200,000 Americans may have caught hepatitis C from transfusions they received before 1990, when blood banks first began testing for the liver virus. This bloodborne type of hepatitis causes symptoms in about half of infected patients, and 25 percent eventually develop liver cancer or other serious complications. There is no good treatment.

Since 1990, the government has decided seven times not to track down these transfusion recipients and tell them to get tested for hepatitis, Shays said.

The problem is that 3.5 million Americans have hepatitis C _ and only a small fraction got it from blood transfusions, said FDA’s Dr. Jay Epstein. One group shouldn’t be singled out for testing, he said.

Patients disagree.

``The government must be responsible for informing the general public about the risks of receiving blood and products that may be contaminated,″ said Patricia DeFilippi of Arlington, Va., whose hemophiliac son caught hepatitis C from transfusions. ``I no longer trust the blood pool.″

The government will include more consumer input in evaluating blood safety, Shalala said. And, to counter criticism that a profit-hungry blood industry influences FDA decisions on which blood tests to use, that agency’s advisory panel will oust voting members with industry ties, she added.

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