Biotech Values

[DewDiligence]

FDA Mulling Changes to Blood-Donor Rules

[These kinds of problems are only going to get worse, IMHO. And that’s good news for GTCB, whose transgenically-derived proteins do not expose users to the risks of pathogens from human plasma. (See #msg-3587713.)]

http://online.wsj.com/article/0,,SB109838813643752248,00.html?mod=yahoo_hs&ru=yahoo

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By JENNIFER CORBETT DOOREN
DOW JONES NEWSWIRES
October 21, 2004

WASHINGTON -- The Food and Drug Administration is considering changes to its blood-donor guidelines including increasing the time that people suspected of having or diagnosed with West Nile virus should be prohibited from giving blood.

The FDA convened an outside panel of medical experts Thursday for a two-day meeting to consider the proposals and make recommendations to the FDA.

Under current guidelines, people who state on blood-donor questionnaire that they had a fever and headache in the past week are asked to defer their blood donation for 28 days as a protection against the possibility of West Nile virus getting into the blood supply. Those who test positive for the mosquito-borne illness are also deferred for 28 days.

Now the FDA is considering extending the deferral period to 56 days because new studies involving West Nile suggest the virus can be active for 49 days, according to background materials the agency prepared for the meeting. Many people who contract West Nile suffer from flu-like symptoms including headache, fever and other body aches. In some cases the virus can cause brain swelling and infection.

The panel will vote Friday on recommendations about the proposed West Nile virus changes, including whether it is even necessary to defer people who said they had a headache and fever because there are now tests that can screen blood for West Nile virus. The FDA guidelines for West Nile were developed prior to the development of tests that can screen blood for West Nile.

The FDA hasn't approved those tests, but all blood clinics screen blood for West Nile as part of ongoing studies that FDA will eventually use to formally approve them.

Blood clinics routinely screen blood for a host of other viruses like HIV, Hepatitis B and C.

The FDA is also considering ways to allow some people who have been permanently banned from donating blood because screening tests suggested they might have Hepatitis B. Some of the tests can come up with a false positive, meaning that people don't actually have the disease. Hepatitis B is a serious liver infection and is transmitted through contact with blood and bodily fluids. More than one million people world-wide die annually from the infection.

There are now specific tests that have been submitted to the FDA for review that can use DNA to directly test for Hepatitis B and other viruses. Some of those tests include one jointly developed by Chiron Corp. and Gen-Probe and one made by a unit of Roche Holding AG.

The FDA panel didn't specifically vote on the matter, but were generally supportive of FDA efforts to eventually allow those who tested positive for Hepatitis B and never came down the virus to be retested once the newer tests are on the market. If those tests are negative, people would then be allowed to donate blood.

According to a presentation by the American Red Cross -- which runs many blood-donation clinics -- an estimated 500,000 to one million people have been banned from donating blood based on false-positive Hepatitis B tests.
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