The Swine Flu Affair

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The Swine Flu Affair Decision-Making on a Slippery Disease Richard E. Neustadt Professor of Government John F. Kennedy School of Government Harvard University Harvey V. Fineberg, M.D. Assistant Professor of Health Services School of Public Health Harvard University With an introduction by Joseph A. Califano, Jr., Secretary of Health, Education, and Welfare Published by the U.S. Department of Health, Education, and Welfare 1978 [Author’s Note, April 2009 (HVF): This electronic edition is dedicated to the memory of Richard E. Neustadt. This edition contains the text from the origi- nal report published by the U.S. Government Printing Office, reformatted for 8.5x11-inch paper, and without the index that was paginated to the original printed edition. A few typographical errors in the original publication have been corrected. The Table of Contents has been renumbered to accord with the pagination in this document. So long as it is unaltered, this document may be freely reproduced and distributed.]

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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 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 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 immu- nization 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 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? 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 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 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 brief- ing 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 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 or ii

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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 intel- ligent 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 impor- tant to learn what they were so we might not repeat them, either in immunization policy or in other, similar decision-making contexts. Indeed, the swine flu experience threw into sharp relief two questions that in- creasingly challenge officials at the high policy levels of government: • First, how shall top lay officials, who are not themselves expert, deal with fundamental policy questions that are based, in part, on highly technical and complex ex- pert knowledge—especially when that knowledge is speculative, or hotly debated, or when "the facts" are so uncertain? When such questions arise, with how much deference and how much skepticism should those whose business is doing things and making policy view those whose business is knowing things—the scientists and the experts? • How should policymakers—and their expert advisers—seek to involve and to educate the public and relevant parties on such complicated and technical issues? To what extent can there be informed and robust public debate before the decision is reached? Increasingly, the questions that Presidents, cabinet officers and other officials confront involve extraordinarily technical complexities and uncertainties: defense policy and disarmament choices involving sophisticated and expensive weapons systems, for example; health policy decisions involving subtle questions of scientific possibility and probability. With these questions in mind, I remembered an illuminating report I had read sev- eral years ago about another problem-laden episode, the Skybolt missile affair. President John F. Kennedy, in a difficult and controversial decision, had canceled the Skybolt missile—setting off a chain of diplomatic consequences which, to the dismay of the President and his advisers, none of them seemed to have foreseen. Somewhat sha- ken, President Kennedy invited Professor Richard E. Neustadt of Harvard, a renowned scholar of the Presidency and the decision-making process in government, to trace the Skybolt affair and prepare a report that might draw some lessons for future policymaking. As a newcomer to the staff of Defense Secretary McNamara in the early 1960’s, I read Neustadt’s report to President Kennedy. I found it a fascinating narrative—and a sober- ing, cautionary tale. iii

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Now Professor Neustadt and his able colleague, Dr. Harvey V. Fineberg, at my request, have anatomized the swine flu affair—in search of lessons for the future, not of fault in the past. I asked them to give me as objective and clinical report as they could write. This book is their report. The views and observations they express here, I should stress, are their own. I sought neither to direct nor to influence the report—only to learn from it. Their narrative will prove enormously valuable to policymakers in this Depart- ment facing difficult decisions in the future—and needing to steer by the light that a clear, objective history can shed upon their way. Indeed, this study can have great mean- ing for all citizens, within government and outside it, who are interested in the process by which large decisions are made—and who are eager to improve that process. JOSEPH A. CALIFANO, JR. Secretary, Department of Health, Education, and Welfare July 1978 iv

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Letter of Transmittal Honorable JOSEPH A. CALIFANO, JR. Secretary of Health, Education and Welfare Washington, D.C. 20201 Dear Mr. Secretary: We present to you our study, done at your request, of Federal decision-making on the swine flu program from March 1976 to March 1977. We include the program’s lega- cies of policy in the year after and our own retrospective reflections, along with a techni- cal afterword. The study’s coverage runs to March 1978. The study’s terms are indicated further in our foreword. We have sought details for the sake of lessons. The search was educational for us, but that is not the point. We hope it proves useful to you. Sincerely, RICHARD E. NEUSTADT HARVEY V. FINEBERG Harvard University June 1978 v

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Acknowledgements Four of the principal participants in the swine flu program came to Cambridge at our invitation to review the first draft of this study. They commented freely, we listened attentively, then made what seems to us a careful judgment on each point. Whether they will agree is not for us to say. But what we can say is that we appreciate their courtesy, applaud their candor, and consider ourselves fortunate to have had their counsel. Several Harvard colleagues and a few outside observers read and commented on chapters in draft. We are grateful to all, especially to those who offered criticism. We may not have taken it to their satisfaction, but we certainly thought about it, with benefit on almost every page. We are grateful also to the many HEW officials who cheerfully responded to re- quests for files, and to the GAO officials who let us review some of their workpapers on state plans. We are grateful to still larger numbers of present and former officials from many parts of government who made themselves available for interviews. Our gratitude extends no less to persons in the private sector, scientific advisers, drug company offi- cers, insurance executives and members of the press, both print and electronic, who let us interview them. To the Columbia Broadcasting System, which made TV transcripts avail- able, and to Vanderbilt University, which lent us tapes, we offer thanks as well. We have done this work part-time during the academic year 1977-78 and have been helped by two extraordinary research assistants, Thomas Kinsock of the Harvard Law School, class of 1979, and Michael Holt of the Harvard Medical School, class of 1980. Our files are extensive, our interviews many; these two know everything and can find anything. They also are severe at copy-editing, and in the realm of policy they make, we think, sophisticated judgments. We are grateful to them. And to our secretary, Sally Makacynas, goes our gratitude on behalf of our readers. H.V.F. R.E.N. vi

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Contents Page FOREWORD . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1 1. THE NEW FLU . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 4 2. SENCER DECIDES . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 8 3. COOPER ENDORSES . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 15 4. FORD ANNOUNCES . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 21 5. ORGANIZING . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 27 6. FIELD TRIALS . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 32 7. LIABILITY . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 41 8. LEGISLATION . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 49 9. STARTING AND STOPPING . . . . . . . . . . . . . . . . . . . . . . . . 54 10. CALIFANO COMES IN . . . . . . . . . . . . . . . . . . . . . . . . . . . 61 11. LEGACIES . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 65 12. REFLECTIONS . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 72 TECHNICAL AFTERWORD . . . . . . . . . . . . . . . . . . . . . . . . . . 87 APPENDICES A. "Cast of Characters" . . . . . . . . . . . . . . . . . . . . . . . . . . . 98 B. Terms and Organizations . . . . . . . . . . . . . . . . . . . . . . . 102 C. Detailed Chronology . . . . . . . . . . . . . . . . . . . . . . . . . . . 104 D. Selected Documents . . . . . . . . . . . . . . . . . . . . . . . . . . . 126 E. Useful Questions . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 147 READINGS . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 151 NOTES . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 153 AUTHORS . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 159 vii