not dealing well with contemporaneous blood safety issues such as hepatitis, and was not prepared to deal with the far greater challenge of AIDS.

By January 1983, the Centers for Disease Control (CDC) had accumulated enough epidemiological evidence to conclude that the agent causing AIDS was almost certainly transmitted through blood and blood products and could be sexually transmitted to sexual partners. The conclusion that the AIDS agent was blood-borne rested on two findings. First, AIDS was occurring in transfusion recipients and individuals with hemophilia who had received AHF concentrate; these AIDS patients did not belong to any other known high-risk group for contracting AIDS. Second, the epidemiologic pattern of AIDS was similar to hepatitis B, another blood-borne disease. However, the magnitude and consequences of the risk for transfusion and blood product recipients was not known at this time. Furthermore, the epidemiological pattern of the new disease was difficult to interpret because, unlike most infectious diseases, there seemed to be several years between exposure leading to infection and the development of symptoms. As a result, physicians and public health officials underestimated the large number of infectious people who had no symptoms of AIDS but could transmit the disease to others and therefore substantially understated the risk of infection.

Compared to the pace of many regulatory and public health decision processes, the federal government responded relatively swiftly to the early warnings that AIDS might be transmitted through blood and blood products. Public and private sector officials considered a range of clinical and public health interventions for reducing the risk of AIDS transmission through blood and blood products. This period, however, was characterized by a great deal of scientific uncertainty about the risks of HIV infection through blood and blood products and about the costs and benefits of the available options. The result, the Committee found, was a pattern of responses which, while not in conflict with the available scientific information, was very cautious and exposed the decisionmakers and their organizations to a minimum of criticism. This limited response can be seen in the refusal of blood banks in 1983 and 1984 to screen for and defer homosexuals or use surrogate tests (Chapter 5), in the Food and Drug Administration's (FDA) cautious and inadequate regulatory approach to the recall of potentially contaminated AHF concentrate (Chapter 6), and in the failure of physicians and the National Hemophilia Foundation to disclose completely the risks of using AHF concentrate and the alternatives to its use (Chapter 7).

Blood safety is a shared responsibility of many diverse organizations. They include U.S. Public Health Service agencies such as the CDC, the FDA, and the National Institutes of Health (NIH), and private-sector organizations such as community blood banks and the American Red Cross, blood and plasma collection agencies, blood product manufacturers, groups such as the National Hemophilia Foundation (NHF), and others. The problems the Committee found



The National Academies | 500 Fifth St. N.W. | Washington, D.C. 20001
Copyright © National Academy of Sciences. All rights reserved.
Terms of Use and Privacy Statement