THE VIRGINIAN-PILOT
Copyright (c) 1995, Landmark Communications, Inc.
DATE: Monday, December 11, 1995 TAG: 9512090005
SECTION: FRONT PAGE: A6 EDITION: FINAL
TYPE: Another View
SOURCE: By HAROLD C. SOX
LENGTH: Medium: 92 lines
In the early 1980s, a devastating epidemic struck the 16,000 Americans who had hemophilia. More than 10,000 of them were infected with HIV, the virus that causes AIDS, following transfusion of contaminated blood-clotting products. People without hemophilia also suffered: 12,000 recipients of contaminated blood transfusions contracted HIV. Some of these people unwittingly transmitted the virus to loved ones. The blood-supply system failed these people, and because everyone potentially benefits from that system, it failed us all.
Advances such as accurate tests for HIV and hepatitis now provide excellent protection against these known infections. But the system remains vulnerable to the next new blood-borne infection. With poorly characterized diseases continuing to appear throughout the world, we must learn from the tragic experience of the 1980s.
In retrospect, missed opportunities are easy to spot. There was enough evidence by January 1983 to be pretty sure that HIV could be transmitted through blood and blood products. But people responsible for manufacturing and regulating blood products had never encountered a problem like AIDS, which later proved to be almost universally fatal and could be transmitted by a seemingly healthy person. Faced with maintaining a blood supply that was barely adequate to meet national needs, officials took actions that were extremely cautious and, we now know, inadequate.
Industry had been working slowly in the 1970s to develop heat treatments to rid blood products of hepatitis virus. These treatments also were effective against HIV. But by 1984, when the heat-treated products became available, many people with hemophilia were already infected with HIV. No one had pressured industry to speed up this work - most people viewed hepatitis as an ``acceptable'' risk of hemophilia treatment.
In addition, when heat-treated blood products became available, the Food and Drug Administration did not insist that manufacturers get rid of the older products. No one insisted upon rigorous screening of blood donors when it became clear that certain groups were likely to transmit HIV through blood. No one insisted that blood banks seek out and inform those who had received blood from donors who later turned out to be infected.
The basic problem in the case of HIV and the blood supply was a failure of leadership. Responsibility for the safety of the blood supply is shared by a number of public and private organizations. No one compelled these organizations to take coordinated action and be accountable to the American people. Without a clear decision-making hierarchy, organizations fell back on bureaucratic standard operating procedures that proved inadequate.
Hindsight offers us the opportunity to do better next time. We must correct the flaws that led to previous breakdowns.
The Clinton administration recently took the first step in improving the system by having the assistant secretary for health be the government's blood-safety director, with responsibility for coordinating and overseeing blood-safety programs. A newly formed blood-safety committee and advisory council report to the blood-safety director, which should produce more effective responses to emerging threats and greater public accountability.
Additional steps are needed. When threats arise, the Food and Drug Administration needs to be more forceful. With the AIDS epidemic, the FDA sought consensus from leaders of the blood system before issuing regulations to govern the system - a strategy that led to an overcautious approach as the crisis unfolded.
The federal government must seek to mitigate the human suffering that can occur from an epidemic of contaminated blood and blood products. In the 1950s and 1960s, most states passed blood-shield laws that protected blood banks and manufacturers from lawsuits that could bankrupt them and leave our nation without a blood supply. As a result, victims of contaminated blood have little legal recourse to address the financial hardships caused by their illness. The federal government should consider establishing a compensation system for those who suffer if our blood supply again should become unsafe.
When the AIDS epidemic struck, physicians were reluctant to inform people with hemophilia about the risk of developing AIDS. These patients did not have the opportunity to make a truly informed decision about whether to continue treatment. Medical decision-making has changed.
Today we believe that patients and physicians should be equal partners in medical-care decisions - a partnership that requires full knowledge of risks as well as benefits.
The administration has made an auspicious start on the road to public accountability. But that road is long and perilous. The consequences of decisions made in the early 1980s haunt us still. We must learn from the mistakes made then and act so that history does not repeat itself. MEMO: Mr. Sox is chair of the department of medicine at Dartmouth Medical
School in Hanover, New Hampshire. He recently chaired the Institute of
Medicine's Committee to Study HIV Transmission Through Blood and Blood
Products.
by CNB