Introduction

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-Barré 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, monovalent—the 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-Barré Syndrome. Was Guillain-Barré 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-Barré. 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



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