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FDA Vetoes Tighter 'Mad Cow' Blood Restrictions


WebMD Health News

June 1, 2000 (Washington) -- After weighing the pros and cons of further tightening U.S. blood donation restrictions to combat the spread of new variant Creutzfeldt-Jakob disease (CJD), the human version of "mad cow disease," an advisory panel to the FDA voted overwhelmingly to keep things as they are.

CJD is a disorder that attacks the brain, literally punching tiny holes in vital nerve tissue. It is believed that CJD is caused by a prion, a protein that goes awry causing profound damage in the process. The disease strikes about one in a million people, and eventually leads to dementia and death. There is no cure. Scientists believe that prions from animals infected with mad cow disease are the source of CJD in humans, although the link has not been conclusively proven.

FDA experts met Thursday to decide whether an existing ban, which prevents some people who have lived in the U.K. from donating blood in the U.S., should be extended to France and other European countries that have reported cases of CJD.

A number of European public health specialists told the panel that it appears the CJD outbreak is still spreading, albeit very slowly, to countries beyond Great Britain, where the disease has claimed at least 57 lives. For instance, Ireland has had 12 cases of CJD since 1996, and in France, there have been three CJD deaths in the last 2 years.

The experts, however, recommended no further donor restrictions, voting instead to keep the blood supply flowing.

In August of last year, the FDA took steps to protect the U.S. blood supply from the threat of CJD. Based on a recommendation by this advisory committee, the agency decided to ban blood donations from people who had spent at least 6 months in the U.K. from 1980-1996. The theory was that they might have eaten British beef contaminated with mad cow disease.

It's estimated that the "deferral" on donors who'd been to the U.K. reduced the risk of catching CJD from transfusion by almost 90%. However, the action also diminished the amount of donated blood by an estimated 2.2%.

Based on the incidence of CJD in France, as compared to the U.K., 10 years would be the deferral policy for France. "There are so few people in the U.S. that have stayed in France for 10 years or more during the period 1980 to 1996, that I don't think it's even worth asking the question," Paul Brown, MD, panel chairman, tells WebMD.

"A recommendation for deferral of donors [from countries that have even lower rates of CJD] will necessarily further shrink a marginal blood supply," said Kay Gregory, director of regulatory affairs for the American Association of Blood Banks, in a statement for the committee. Apparently, the FDA policy hasn't had a measurable negative effect on the blood supply to date.

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