cannot be ruled out—indeed these factors are ever-present aspects of human decisionmaking, but that should not be confused with a finding that these factors have been shown to have had a determinate impact on the specific decisions analyzed.


FDA Letters of March 1983

On March 24, 1983, Joseph Petricciani, Director of the FDA Bureau of Biologics, issued three letters recommending steps to take to reduce the risk of transmission of AIDS through blood and blood products. These letters went to whole blood collection centers, plasma collection centers and plasma fractionators. Common to all these letters is a request that measures be taken to institute appropriate donor screening practices and procedures for individual donors and donor groups known to be at increased risk for transmitting AIDS (Petricciani, 1983a,b,c). (See also Chapter 3, Chapter 5, and Appendix D).

The letters sent by Dr. Petricciani (1983a,b,c) are interesting from three different perspectives. The letters recommend slightly different requirements. The requirements recognize the differing positions of whole blood collection centers, plasma collection centers and plasma fractionators in the collection and distribution of blood and blood products. The letter to plasma fractionators seems to have imposed a higher standard of donor education on source plasma collectors than for blood banks that collect blood for transfusion. For example, both blood banks and plasma collection centers were instructed to revise their standard operating procedures to include the quarantine and disposal of blood and/or plasma collected from a donor known or suspected to have AIDS (i.e., an individual with a history of night sweats, unexplained fevers, unexpected weight loss, or signs of lymphadenopathy or Kaposi's sarcoma). In addition to these requirements, plasma collection centers were required to label each unit of plasma if it was collected from a high-risk donor, to examine donors for lymphadenopathy, and to record the donor's weight prior to each donation. The American Blood Resources Association (ABRA) complained of this disparity and questioned its scientific and public health rationale (Reilly 1983). ABRA suggested that the plasma center protocol be applied to blood banks as well. Dr. Petricciani responded (on August 22, 1983) by saying only that there was concern that more demanding requirements might adversely affect the supply of whole blood.

The letters did not specify what was to be done about plasma or derivatives that had been collected from unscreened donors (i.e., individuals who had not been specifically questioned about early signs and symptoms of AIDS or whether

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