Roanoke Times
                 Copyright (c) 1995, Landmark Communications, Inc.

DATE: FRIDAY, July 14, 1995                   TAG: 9507150025
SECTION: NATIONAL/INTERNATIONAL                    PAGE: A-8   EDITION: METRO 
SOURCE: Associated Press
DATELINE: WASHINGTON                                 LENGTH: Medium

STUDY INVESTIGATES FAILURES THAT CAUSED HIV TAINTING OF BLOOD

Caution, fear of criticism and inadequate leadership led to the HIV contamination of the nation's blood supply in the 1980s, even after scientists knew that the virus causing AIDS was blood-borne, according to the National Institute of Medicine.

A 14-member committee appointed at the request of Health and Human Services Secretary Donna Shalala studied events and decisions affecting the blood supply from 1982 to 1986. It found mistakes or omissions at all levels.

``No person or agency was able to develop and implement a coordinated strategy, largely because there was no consensus about the magnitude of the threat and the costs, risks and benefits of proposed remedies,'' said Dr. Harold C. Sox Jr., committee chairman and head of the department of medicine at Dartmouth Medical School.

``As a whole, the blood safety system works effectively to supply essential blood and blood products and to check most threats,'' he said in a statement Thursday. ``But the events of the 1980s put the system under much stress and revealed an important weakness. The system was unable to deal with a threat characterized by great risk and uncertainty.''

The result was a pattern of responses which, ``while not in conflict with the available scientific information, were very cautious and exposed the decision-makers and their organizations to a minimum of criticism,'' the committee wrote.

Although evidence had emerged by January 1983 to suggest that AIDS was transmitted through blood and blood products, and could be sexually conveyed as well, no reliable test for HIV existed. The government recommended limited safety measures for dealing with the risk of AIDS transmission through blood, but these did not include asking donors questions about high-risk sexual practices, for example.

Hemophiliacs were hardest hit by these policies. During the early 1980s, more than half of the 16,000 hemophiliacs in the United States and more than 12,000 blood transfusion patients were infected with HIV through contaminated blood. Hemophiliacs' risk was compounded because the blood coagulation product called anti-hemophiliac factor (AHF) concentrate is made from the plasma of 1,000 to 20,000 or more donors.

Since the late 1940s some blood products have been treated with heat to destroy viruses, but such a process was not developed for AHF concentrate until 1983.

However, even after the process was developed, the Food and Drug Administration decided not to recall untreated AHF concentrate.

The FDA failed in several other instances to act decisively to protect the blood supply, according to the report. In March 1983, for example, it sent a letter to blood organizations that recommended, but did not require, several steps to improve screening and collection. In July 1983, it decided not to automatically recall plasma products whenever they were linked to donors who were suspected of having AIDS.

By January 1983, scientists had demonstrated that several groups - particularly gay men engaging in unprotected sex with multiple partners, intravenous drug users and Haitian immigrants - had a high risk of developing AIDS. Blood banks did institute some screening measures by early 1983, but only a few asked potential donors about homosexual activity.

The committee also singled out physicians for failing to tell their hemophiliac patients the risks of using AHF concentrate.