NCPA - National Center for Policy Analysis

FDA Blood Ban Relies On Poor Risk Assessment

August 25, 1999

Last week, the Food and Drug Administration announced its intention to ban blood donations from anyone who has spent a cumulative six months or more in the United Kingdom since 1980. The agency fears that blood recipients in America might contract the deadly brain infection known as Creutzfeldt-Jacob disease (CJD) -- a new variant of which has been associated with Britain's mad-cow disease, or spongiform encephalitis.

Medical experts charge the FDA did a poor job of risk assessment in adopting the policy.

  • The annual incidence of CJD is one in a million -- half the risk of being struck by lightning.
  • U.S. blood banks are already dangerously low on supplies, and demand for blood could outpace supply as early as next year.
  • The FDA admits that there is no evidence the new variant of CJD has been transmitted by blood transfusions.
  • The chief medical officer of the American Red Cross -- which collects half the U.S. blood supply -- says the FDA decision was based on "very scanty scientific data" and confirms that there has "never been a case world-wide of this disease or any related disease being transmitted by blood transfusion."

While it is estimated that the agency's ban would only result in a 2.2 percent reduction in the nation's blood supply, that loss could have a substantial impact on the number of people who need transfusions. That, in itself, is a safety issue, experts warn.

Source: Editorial, "Mad Regulatory Disease," Wall Street Journal, August 25, 1999.


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