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Copyright and Use of This Thesis This Thesis Must Be Used in Accordance with the Provisions of the Copyright Act 1968 COPYRIGHT AND USE OF THIS THESIS This thesis must be used in accordance with the provisions of the Copyright Act 1968. Reproduction of material protected by copyright may be an infringement of copyright and copyright owners may be entitled to take legal action against persons who infringe their copyright. Section 51 (2) of the Copyright Act permits an authorized officer of a university library or archives to provide a copy (by communication or otherwise) of an unpublished thesis kept in the library or archives, to a person who satisfies the authorized officer that he or she requires the reproduction for the purposes of research or study. The Copyright Act grants the creator of a work a number of moral rights, specifically the right of attribution, the right against false attribution and the right of integrity. You may infringe the author’s moral rights if you: - fail to acknowledge the author of this thesis if you quote sections from the work - attribute this thesis to another author - subject this thesis to derogatory treatment which may prejudice the author’s reputation For further information contact the University’s Director of Copyright Services sydney.edu.au/copyright The Trials of Psychedelic Medicine LSD Psychotherapy, Clinical Science, and Pharmaceutical Regulation in the United States, 1949-1976 Matthew Oram A thesis submitted in fulfilment of the requirements for the degree of Doctor of Philosophy Department of History School of Philosophical and Historical Inquiry University of Sydney 2014 ii Declaration of Originality This thesis contains no material that has been accepted for the award of any other degree or diploma in any university or institute of higher learning. I affirm that the intellectual content of this thesis is the product of my own work. I certify to the best of my knowledge that all sources of reference have been acknowledged. Word count: 85,682. ……………………………………. ……………………………………. Matthew Oram Date iii Abstract Over the 1950s lysergic acid diethylamide (LSD) became the subject of widespread psychiatric research in the United States. Early research reported impressive results using the drug as a tool in psychotherapy, in a variety of ways and in a number of conditions. However, over the 1960s LSD psychotherapy research declined, before coming to a complete halt in the 1970s. The demise of LSD psychotherapy has commonly been linked to the growing controversy over the drug’s recreational use in the 1960s. With the drug’s image shifting from medical tool to dangerous public menace, medical opinion turned against it and the US federal government hampered research through strict regulation. This argument, however, often overlooks the broad changes in the regulation of pharmaceutical research and development that occurred during the period, as a result of the Drug Amendments of 1962. This thesis contextualises LSD psychotherapy research within these changes, providing an alternative analysis of its demise. Closely examining the regulation of LSD research through Food and Drug Administration files reveals that, in fact, the government not only did not deliberately hamper research, but also worked to ensure its survival in the mid- 1960s. However, the amendments formalized pharmaceutical research and development in a way that frustrated the progress of LSD research. Most significantly, the amendments’ requirement for proof of drug efficacy through controlled clinical trials made mandatory a method of drug evaluation that struggled to accommodate LSD psychotherapy’s complex method of using drug iv effects to catalyse a psychological treatment. As explored through researchers’ publications and personal papers, the difficulties in balancing scientific standards in evaluation with the clinical requirements of treatment left them unable to establish a consensus on treatment efficacy. Research subsequently dwindled. In making this argument, this thesis explores how the Drug Amendments of 1962 widened the division between psychiatry’s biological and psychological treatments, and explores the complex interplay between clinical science, regulation, and therapeutics in twentieth century American medicine. v Table of Contents ABSTRACT ........................................................................................................................................... III ACKNOWLEDGEMENTS..................................................................................................................VI ABBREVIATIONS............................................................................................................................ VIII INTRODUCTION .................................................................................................................................. 1 1. POST WAR PSYCHIATRY AND THE BIRTH OF LSD PSYCHOTHERAPY ...............38 2. REGULATING RESEARCH: ACCESS TO LSD AFTER 1962...........................................93 3. PROOF OF EFFICACY: CLINICAL TRIAL METHODOLOGY AND LSD UNDER THE DRUG AMENDMENTS OF 1962..........................................................................................142 4. RESEARCH AMIDST THE CONTROVERSY: THE SPRING GROVE EXPERIMENT .............................................................................................................................196 5. ELUSIVE EFFICACY: THE UNDERMINING OF THE SPRING GROVE PSYCHEDELIC RESEARCH ...................................................................................................261 6. THE QUIET DEATH OF RESEARCH ...................................................................................324 CONCLUSION...................................................................................................................................355 BIBLIOGRAPHY ..............................................................................................................................365 vi Acknowledgements Sincere thanks go to my supervisors Alison Bashford and Stephen Robertson. Both have acted as primary and associate supervisors, have taught me a great deal about researching and writing history, and have significantly influenced the shape of this thesis. Stephen’s close revision of drafts taught me a lot about writing, and his strict dismissal of rambling context helped me hone my arguments. Alison helped me to see above the minute detail and look at the big picture of my topic and candidature. Her hard work and responsiveness in the final months of my candidature has been particularly appreciated. After relocating from Sydney to Christchurch, in February 2011 a significant earthquake destroyed my office, along with much of my research material. My recovery from this event was significantly helped by the generous provision of a new laptop by the School of Philosophical and Historical Inquiry. For the last two years I have worked from the postgraduate study rooms of the Department of History of the University of Canterbury. Special thanks go to Jane Buckingham for inviting me to engage with the department and offering me access to the workspace. Thanks also to Judy Robertson for facilitating my continued access to a desk, and Peter Field for making me feel welcome. The department was in no way obliged to offer me a place to work. I am enormously grateful for their generous hospitality, and cannot overemphasize the impact it has had on the progress of my work. vii Many other people have helped me in my research and writing. Special thanks go to Stephanie Schmitz, archivist for the Psychoactive Substances Collection at Purdue University Libraries, for her generous help facilitating my research and trips to the archive. Thanks also to Kristin Leaman and Emma Meyer for quickly redacting materials prior to my arrival. Thanks to William Richards for taking an interest in my work and sharing some enlightening memories with me. Daniel Carpenter and John Swann took time to advise me on possible research collections to consult. Reviews of my work by Warwick Anderson and the anonymous reviewers for the Journal of the History of Medicine and Allied Sciences pushed me to clarify and better justify my arguments. This improved my thesis and I am grateful to them. Sincere thanks also to the numerous others who discussed my work with me in writing groups, at conferences, and elsewhere. Thank you to Judith Keene for offering me guidance during a difficult time in my candidature. Micaela Pattison and Dave Earl helped to keep me feeling connected to the Sydney postgrad community on my trips back. Their hospitality and friendship has meant a lot. Deep thanks go to my family, particularly Anne, Richard, Theresa, Rob, Margaret, Bob, Bill and Cher, who have helped and supported me in many ways, and without whom completing this thesis would not have been possible. Anne and Theresa generously proofread my thesis in the final weeks. My wife Amy’s endless patience and support has sustained me over the last few years; my words cannot adequately express my gratitude. viii Abbreviations AA Alcoholics Anonymous APA American Psychiatric Association CIA Central Intelligence Agency DPT Dipropyltryptamine ECT Electro-Convulsive Therapy FDA Food and Drug Administration IND Notice of Claimed Investigational Exemption for a New Drug (Form FD 1571) LSD Lysergic Acid Diethylamide Mcg Micrograms Mcg/kg Micrograms per kilogram of body weight MDA Methylenedioxyamphetamine MMPI Minnesota Multiphasic Personality Inventory MPRC Maryland Psychiatric Research Center NIMH National Institute of Mental Health NDA New Drug Application PHS Public Health
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