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ISBN: 0-309-13877-9, 166 pages, 8 1/2 x 11, (1978)
This free PDF was downloaded from:http://www.nap.edu/catalog/12660.htmlThe Swine Flu Affair: Decision-Making on a SlipperyDisease
Richard E. Neustadt and Harvey V. Fineberg, M.D.
 
Copyright © National Academy of Sciences. All rights reserved.The Swine Flu Affair: Decision-Making on a Slippery Diseasehttp://www.nap.edu/catalog/12660.html
 
The
 
Swine Flu
 
Affair
 
Decision-Making on a
 
Slippery Disease
Richard E. NeustadtProfessor of GovernmentJohn F. Kennedy School of GovernmentHarvard UniversityHarvey V. Fineberg, M.D.Assistant Professor of Health ServicesSchool of Public HealthHarvard UniversityWith an introduction byJoseph A. Califano, Jr.,Secretary of Health, Education, and WelfarePublished by the U.S. Department of Health, Education, and Welfare1978
[Author’s Note, April 2009 (HVF): This electronic edition is dedicated to thememory of Richard E. Neustadt. This edition contains the text from the origi-nal report published by the U.S. Government Printing Office, reformatted for8.5x11-inch paper, and without the index that was paginated to the originalprinted edition. A few typographical errors in the original publication havebeen corrected. The Table of Contents has been renumbered to accord with thepagination in this document. So long as it is unaltered, this document may befreely reproduced and distributed.]
 
Copyright © National Academy of Sciences. All rights reserved.The Swine Flu Affair: Decision-Making on a Slippery Diseasehttp://www.nap.edu/catalog/12660.html
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 thevaccine was linked with the Guillain-Barré Syndrome—an often paralyzing and some-times killing side effect.In the fall of 1976, HEW had begun vaccinating millions of citizens in an un-precedented national influenza program—an attempt to vaccinate virtually the entireAmerican population against swine flu, and to vaccinate high-risk persons against bothswine flu and A/Victoria flu.Two main formulations of vaccine had been produced for this nationwide immu-nization drive: one, monovalent—the swine flu vaccine alone; the other, bivalent—theswine flu vaccine combined with A/Victoria vaccine. But over a two-month period in thefall of 1976, use of these vaccines on millions of people had turned up a hitherto unrec-ognized 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? Noone could be certain.But we had to make a decision. On January 29, 1977, A/Victoria flu had eruptedin a nursing home in Miami. There was the possibility that this flu could become wide-spread, endangering high risk groups such as the elderly and those with chronic lung dis-ease. 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 wasavailable 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 releasethe swine flu vaccine.In the end, after much debate and on the advice of the experts, I decided to releasethe bivalent vaccine. But in the course of making this decision, I was impressed by theenormous difficulty that a lay official has in fulfilling his responsibility to make sound,balanced judgments about complex scientifically-based public health issues. From brief-ing papers I had read before becoming Secretary and discussions of other issues I knew Iwas soon to be faced with other difficult public health questions—ranging from settingguidelines for recombinant DNA research to issues relating to psychosurgery and sterili-zation—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 orii
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