The Swine Flu Affair: Decision-Making on a Slippery Disease
In early February 1977, less than two weeks after taking office as Secretary of Health, Education and Welfare, I was faced with a difficult health policy decision : Whether to release stocks of influenza vaccine that had been withheld after use of the vaccine was linked with the Guillain-Barre Syndrome-an often paralyzing and sometimes killing side effect.
In the fall of 1976, HEW had begun vaccinating millions of citizens in an unprecedented national influenza program-an attempt to vaccinate virtually the entire American population against swine flu, and to vaccinate high-risk persons against both swine flu and A/Victoria flu. Two main formulations of vaccine had been produced for this nationwide immunization drive: one, monovalentthe swine flu vaccine alone; the other, bivalent-the swine flu vaccine combined with A/Victoria vaccine. But over a two-month period in the fall of 1976, use of these vaccines on millions of people had turned up a hitherto unrecognized association between flu vaccine and Guillain-Barre Syndrome . Was Guillain-Barre the result of the swine flu vaccine, the A/Victoria vaccine, or all flu vaccines? No one could be certain.
But we had to make a decision. On January 29, 1977, A/Victoria flu had erupted in a nursing home in Miami. There was the possibility that this flu could become widespread, endangering high risk groups such as the elderly and those with chronic lung disease . If it did spread, the risks of influenza would far outweigh the risk of Guillain-Barre. But there was no way to gauge the extent of the danger; and the A/Victoria vaccine was available only in the bivalent formulation : in combination with the swine-flu vaccine. Thus, a decision to release the A/Victoria vaccine was necessarily a decision to release the swine flu vaccine.
In the end, after much debate and on the advice of the experts, I decided to release the bivalent vaccine . But in the course of making this decision, I was impressed by the enormous difficulty that a lay official has in fulfilling his responsibility to make sound, balanced judgments about complex scientifically-based public health issues . From briefing papers I had read before becoming Secretary and discussions of other issues, I knew I was soon to be faced with other difficult public health questions-ranging from setting guidelines for recombinant DNA research to issues relating to psychosurgery and sterilization-that would require a careful weighing of scientific fact, some of it speculative, with ethical and policy considerations.
As a lawyer and former special assistant to former Secretary of Defense Robert S. McNamara and President Lyndon Johnson, I had frequently faced situations with little or no initial knowledge of the complex substance of the events or subject matter involved . This swine flu situation surprised and bedeviled me, however, because I knew so little that it was difficult even to determine the questions to ask in an attempt to reach an intelligent decision.
During this experience - and the review of the swine flu program it occasioned - I was struck that those who might find themselves facing sensitive health policy decisions could benefit greatly from a careful study of that program.
If the swine flu experience had any lessons to teach, it was important that we learn them . If there- had been mistakes or missteps - however well-intentioned - it was important to learn what they were so we might not repeat them, either in immunization policy or in other, similar decision-making contexts.
The Swine Flu Affair: Decision-Making on a Slippery Disease
