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UBC Theses and Dissertations
Tainted blood, tainted knowledge : contesting scientific evidence at the Krever Inquiry 1999
|Title||Tainted blood, tainted knowledge : contesting scientific evidence at the Krever Inquiry|
Paterson, Timothy Murray
|Description||In this dissertation I provide an ethnographic account of the testimony of four expert witnesses who appeared before the Commission of Inquiry on the Blood System in Canada (the Krever Inquiry) as they described the production of scientific knowledge and the role that knowledge played in the struggle to protect the blood supply from being contaminated by AIDS during the early 1980's. In doing so, I bring together the experts' testimony with contemporary documents gathered by the Commission and interviews I conducted with participants in the proceedings. Using insights drawn from the disciplines of anthropology, sociology, and history, I explore what the witnesses' accounts reveal about their understandings of their professional world and its relationships with other worlds, especially that of public health policy making. The Krever Inquiry offered a valuable opportunity for carrying out such an investigation. It provided a site where science was not only used, it was talked about. The Inquiry invited those involved in the blood system in the early 1980's to reflect upon and explain the beliefs and actions which surrounded one of the worst public health disasters in Canadian history and it asked the witnesses how similar catastrophes could be avoided in the future. As a result, many of the issues addressed at the hearings reflect matters of current concern in public health and medicine. The Inquiry addressed difficult issues surrounding the nature of scientific knowledge and its application in health decision-making and policy formulation. This study, therefore, may be of interest to those dealing with the problems surrounding uncertainty and the management of public health crises. It may also be of interest to those dealing with conflicts rising out of the intersection of different worlds of experience and practice, as well as to those involved in the current initiatives to both make medical and public health institutions more proactive, and inclusive, and public health decision-making more transparent.|
Commission Of Inquiry On The Blood System In Canada.
Science -- Philosophy.
Science -- Social Aspects.
AIDS (Disease) -- Transmission.
Blood -- Collection And Preservation -- Standards -- Canada.
Blood Banks -- Risk Management -- Canada.
Blood Banks -- Canada -- Quality Control.
Blood -- Collection And Preservation -- Safety Measures.
Retrospective Theses and Dissertations, 1919-2007
|Series||UBC Retrospective Theses Digitization Project [http://www.library.ubc.ca/archives/retro_theses/]|
Doctor of Philosophy - PhD
Arts, Faculty of
|Degree Grantor||University of British Columbia|
|Aggregated Source Repository||DSpace|
|Digital Resource Original Record||https://open.library.ubc.ca/collections/831/items/1.0089863/source|
TAINTED BLOOD, TAINTED K N O W L E D G E : CONTESTING SCIENTIFIC EVIDENCE A T THE K R E V E R INQUIRY by TIMOTHY M U R R A Y PATERSON B.A. , Y O R K UNIVERSITY, 1988 M . A . , UNIVERSITY OF WESTERN ONTARIO, 1991 A THESIS SUBMITTED IN PARTIAL F U L F I L L M E N T OF THE REQUIREMENTS FOR THE DEGREE OF DOCTOR OF PHILOSOPHY in THE F A C U L T Y OF G R A D U A T E STUDIES (Department of Anthropology and Sociology) We accept this thesis as conforming to the required standard THE UNIVERSITY OF BRITISH C O L U M B I A August 1999 © Timothy Murray Paterson 1999 In presenting this thesis in partial fulfilment of the requirements for an advanced degree at the University of British Columbia, I agree that the Library shall make it freely available for reference and study. I further agree that permission for extensive copying of this thesis for scholarly purposes may be granted by the head of my department or by his or her representatives. It is understood that copying or publication of this thesis for financial gain shall not be allowed without my written permission. The University of British Columbia Vancouver, Canada Department DE-6 (2/88) 11 Abstract In this dissertation I provide an ethnographic account of the testimony of four expert witnesses who appeared before the Commission of Inquiry on the Blood System in Canada (the Krever Inquiry) as they described the production of scientific knowledge and the role that knowledge played in the struggle to protect the blood supply from being contaminated by AIDS during the early 1980's. In doing so, I bring together the experts' testimony with contemporary documents gathered by the Commission and interviews I conducted with participants in the proceedings. Using insights drawn from the disciplines of anthropology, sociology, and history, I explore what the witnesses' accounts reveal about their understandings of their professional world and its relationships with other worlds, especially that of public health policy making. The Krever Inquiry offered a valuable opportunity for carrying out such an investigation. It provided a site where science was not only used, it was talked about. The Inquiry invited those involved in the blood system in the early 1980's to reflect upon and explain the beliefs and actions which surrounded one of the worst public health disasters in Canadian history and it asked the witnesses how similar catastrophes could be avoided in the future. As a result, many of the issues addressed at the hearings reflect matters of current concern in public health and medicine. The Inquiry addressed difficult issues surrounding the nature of scientific knowledge and its application in health decision-making and policy formulation. This study, therefore, may be of interest to those dealing with the problems surrounding uncertainty and the management of public health crises. It may also be of interest to those dealing with conflicts rising out of the intersection of different worlds of experience and practice, as well as to those involved in the current initiatives to both make medical and public health institutions more proactive, and inclusive, and public health decision-making more transparent. Ill Table of Contents Abstract i i Table of Contents i i i Acknowledgment x SECTION ONE: SETTING THE STAGE P R E F A C E 1 First Inklings: The Emergence of AIDS 1 Research Background and Subject Matter of this Dissertation 4 INTRODUCTION 11 Unfulfilled Expectations, Growing Outrage 11 A n Investigation Into the Disaster is Called 14 The Role of Public Inquiries 17 Turner's Social Drama 19 The Tainted Blood Tragedy as Social Drama 22 Science Studies, Constructivism, Actor Network Theory 24 Science as Narrative: Understanding the World Through Stories 30 Accounting for the Stories Told at the Hearings 31 Chapter Outline 34 CHAPTER ONE: CONTEXTUALING THE ACCOUNTS 36 The Physical Setting 36 The Participants 37 The Rules of Procedure 40 The Hearing Room: A Day in the Life 43 The opening act 43 Curriculum vitae 45 Examination in-chief 46 Cross-examination 49 iv SECTION TWO; THE WITNESSES' ACCOUNTS PART ONE: AIDS A N D THE A M E R I C A N BLOOD SUPPLY CHAPTER TWO: DR. D O N A L D FRANCIS: THE CDC A N D THE E A R L Y Y E A R S OF THE O U T B R E A K 53 2.1 Confronting AIDS 53 Curriculum Vitae 53 The Centers for Disease Control and its Role in Public Health 55 Morbidity and Mortality Weekly Reports 56 Early Steps 58 Building information and research networks 59 Conflicting Hypothesis 61 A Clash of Opinions: The January 4th 1983 Joint Meeting 65 The Search for Meaning 67 Conflicting standards 68 Practical experience and its role in understanding 69 Thinking through models and analogies 70 The hepatitis analogy 71 Building Institutional Networks 72 Social Alliances 74 Measuring Risk: The "One in a Million" Calculation 76 2.2 Taking Action 78 January 13 th Joint Statement and the Matter of Public Education 78 Comment on the educational effort in Canada 82 Communication Breakdown: The Problem of Contradictory Advice 83 Withholding information .84 Clinical and Laboratory Response 86 Clinic: the debate over donor screening 86 Laboratory: the debate over surrogate testing 87 Recommendation Not Regulation 91 The Demand for Prudence: The Demand for Proof 95 Summary 98 C H A P T E R THREE: DR. THOMAS Z U C K A N D THE PERSPECTIVE OF THE A M E R I C A N BLOOD B A N K E R S 102 3.1 Confronting Aids 102 Introduction 102 Curriculum Vitae 103 The American Volunteer Blood System 105 AIDS and Institutional Relationships 108 Early Understandings of the Disease 109 V January 4th 1983, Meeting 116 3.2 Taking Action 118 January 13 th Joint Statement 118 Assessing the Evidence: Individual Judgement and its Determinants 124 Situated perspectives 125 Distinguishing between paid and volunteer donors 126 Constructing the public 128 Playing the Odds: Decision-Making and Risk 129 The Lessons of History 134 Svrrnmary 136 PART TWO: AIDS A N D THE C A N A D I A N BLOOD SUPPLY CHAPTER FOUR: DR. ROGER PERRAULT A N D DR. M A R T I N D A V E Y : SETTING THE CONTEXT OF THE DISASTER IN C A N A D A 139 4.1 Outline of the Examination of Dr. Perrault and Dr. Davey 139 Introduction 139 A Difference of Styles 141 Lawyers 141 Witnesses 142 Denying Responsibility 144 4.2 Establishing the Witnesses' Expertise 145 Curriculum Vitae 145 4.3 The Canadian Blood System: The 1940's to the 1970's 147 Origins and Financing of the System 147 Regulating the System 151 Structure and Organization of the Canadian Red Cross 152 The Revolution in Transfusion Medicine 153 The Growth of an Industry 155 Keeping Pace: Transforming Canada's Blood System in the 1970's 157 The Problem of Self Sufficiency 158 4.4 Into the 1980's and Disaster 160 Could Things Have Been Done Better? 160 Accounting for the Red Cross's Early Response 165 Supply issues 165 Expertise within the Red Cross 166 Access to information 167 Institutional alliances 168 Safeguarding the System: Donor Screening and Blood Testing 169 vi Summary 171 Into 1970's 171 Into the 1980's 172 CHAPTER FIVE: DR. PERRAULT A N D DR. D A V E Y : THE C A N A D I A N RED CROSS RESPONSE, J U L Y 1982 TO M A Y 1983 175 Introduction 175 Tentative First Steps 175 Early Research and Education Programs 177 Informing the medical community 177 Surveillance 178 Gathering and Evaluating Information 184 The Hepatitis Analogy 189 Donor Screening 191 A Lack of Conclusive Evidence 192 The Importance of Standards: Koch's Postulates 193 Safeguarding the Canadian System ; 194 Communicating risk and the notion of self exclusion 194 January 13th Joint Statement 196 Canadian Hemophilia Society recommendations 198 March 4th Public Health Service recommendations 199 The Canadian Red Cross Responds: March 10th Press Release 199 Reactions to the March 4 t h Press Release 201 Response of the gay community 201 Response of the Haitian community 203 Formulating Policy 206 C H A P T E R SIX: DR. P E R R A U L T A N D DR. D A V E Y : THE QUEST FOR SUPPORT, M A Y 1983 TO M A Y 1984 213 Introduction 213 Seeking Support 213 Playing Down the Risks: The One in a Million Calculation 216 Further Conflicts with the Gay Community 219 Continued Concerns Over Donor Education 222 Donor Screening: Navigating Turbulent Political Waters 223 Enlisting NACAIDS 225 Further Attempts to Discount the Risks 229 Growing Concerns Over Transfusion Associated AIDS 235 Steady Sailing: Holding True to Course 237 Summary 238 Vll SECTION THREE: ANALYSIS CHAPTER S E V E N : TRACING THE CONFLICTS IN THE TAINTED BLOOD T R A G E D Y Introduction 245 7.1 Confronting AIDS 246 Early Warning Signs 246 Early Investigations 247 Conflicting Interpretations 249 Communicating the Information 252 Education and Practical Experience and their Influence on Thought and Action 253 Standards and Methods and the Demand for Certainty 257 Models and Analogies 260 The hepatitis analogy 261 Sick blood: healthy blood 263 7.2 Institutional Priorities and Conflicting Perspectives 264 Introduction 264 Internal Conflicts and the Role of Institutional Memory 265 The Struggle for Institutional Power and Influence in the United States 267 Canadian Institutional Responses to AIDS and the Blood Supply 271 7.3 Science and Society: Constructing Difference 273 Introduction 273 The Lay Public 274 The Haitian Community 276 The Gay Community 277 Blood Donors 279 Dangerous Reifications 282 7.4 The Politics of Making Difference 284 Introduction 284 Distinguishing Science from Politics 285 Science as Politics 287 7.5 Constructing A Fact: the "One In A Million" Calculation 289 Introduction 289 Risk and Cost-Benefit Analysis 290 Characterizing the Calculation 291 A Deadly Silence 296 Effects of the Calculation 300 Vll l C H A P T E R EIGHT: ECHOS OF THE PAST: BLOOD S Y M B O L I S M A N D THE TAINTED BLOOD T R A G E D Y 303 Introduction 303 Blood Symbolism in the West 304 The Greeks: Blood, the Tie that Unites 306 The Judeo-Christian Legacy 309 Blood and Modern Science 312 Traditional Beliefs and the Problem of AIDS in the Blood supply 314 Blood, Disease and Morality 314 The Gift of Life 317 Nourishing Blood 318 Blood and the Social Body 319 Distinguishing Good Donors from Bad and its Impact on Policy 320 Purifying the Blood 322 Exclusion 322 Observation •. 323 Summary 324 CHAPTER NINE: CONCLUSION 327 Introduction : 327 The Tainted Blood Tragedy as "Social Drama" 328 Conflicting Views of Science and its Role In Public Health Decision-Making 331 Conflicting hierarchies of methods and evidence 333 Conflicting hierarchies of styles 334 Situated perspectives 335 Shifting interests: shifting perspectives 337 The diversity of perspectives within institutions 338 The Struggle for Institutional Power and Control 338 Science, Society and Politics 341 Tainted Science? 345 Heros and Villains 348 Towards a Resolution of the Problems Embodied in the Tainted Blood Tragedy 350 EPILOGUE 358 Abbreviations 361 Glossary 363 Technical Bibliography 367 Bibliography 369 ix Appendix 1: Chronology of Important Events, November 1980 to May 1984 383 Appendix 2: List of Names of Scientific Experts Cited 387 Appendix 3 List of Names of Legal Counsel Cited 389 Appendix 4: Index of Transcript Volumes Cited 390 - X - Acknowledgment I would not have been able to carry out my research without the assistance and support of a wide range of individuals and groups. I owe a special debt of gratitude to the Commissioner, Mr. Justice Horace Krever, who made me welcome at the Commission of Inquiry on the Blood System in Canada and who expended considerable time and effort helping me understand the public inquiry process in Canada as well as the specific structures and goals of his commission. I also owe a special thanks to the staff at the commission, particularly to Dr. Penny Chan, the Executive Coordinator and Scientific Advisor and Gregory Hamara, the Director of Communications, both of whom spent many hours helping me in my work. Likewise, I owe a debt to many of the participants at the inquiry, especially Kenneth Arenson, who was extremely generous in the time he devoted to helping me. Among the others who went out of their way to help me during my research at the inquiry were, Dr. Barbara Blake, Rebecca Bragg, Maureen Currie, R. Douglas Elliott, Jerry Friese, Dr. Roslyn Herst, Gabe and Lynn Kampf, the late Edward Kubin, Andre Picard, Kathryn Podrebarac, David Pollock, Dr. Alan Powell, Donna Ring, Alan West and Durhane Wong-Reiger. In addition to these individuals I extend my thanks to the many others at the hearings who shared their time, experiences, and understandings with me. I owe a number of debts to individuals outside of the commission, especially to my Research Supervisor, Dr. Martin Silverman and to the other members of my Research Committee, Prof. Brian Elliott, and Dr. Stephen Straker. I am fortunate, indeed, to have been the beneficiary of their insights, encouragement and guidance. I thank my colleagues in the Department of Anthropology at the University of British Columbia for their advice and support during my research. I also want to thank Murray Braithwaite and Harry Andrew, who, over the years, helped me develop a greater appreciation of the complexities of the legal process and legal reasoning. Without the unending encouragement and assistance of my family, especially that of my mother Nora Paterson, I would not have completed my research. I also owe a deep debt to my wife, Dr. Denise Nuttall. Her enduring support and keen insights were of incalculable value to my work and to my daily existence. Finally, I thank the Social Sciences and Humanities Research Council for the Doctoral Fellowship which helped finance the early years of my research, and I thank the University of British Columbia for the University Graduate Fellowship I received. In acknowledging the contribution of these individuals and institutions I do not intend to suggest that they are responsible for or endorse the views expressed in this document. Similarly, while those I have mentioned, along with many others, contributed greatly to my dissertation, I alone must take responsibility for its weaknesses and errors. 1 SECTION ONE: SETTING THE STAGE P R E F A C E First Inklings: The Emergence of AIDS By the spring of 1981 rumours were beginning to circulate in New York City that a number of gay men were in intensive care units at local hospitals being treated for a rare form of pneumonia. Following up on the rumours Dr. Lawrence Mass, a physician and part-time reporter with the fledgling gay tabloid, New York Native, contacted a doctor from the Centers for Disease Control (CDC) on loan to the New York City Health Department.1 The expert from the C D C assured Dr. Mass there was no strange new epidemic affecting the gay community. Accepting the assurance, Mass wrote an article for the New York Native discounting the rumours. The article, which appeared in the May 18th edition of the tabloid, was the first published reference to the disease which would later become known as Acquired Immunodeficiency Syndrome, AIDS (Kinsella 1989:25-28).2 1 Headquartered in Atlanta, Georgia, the Centers for Disease Control is the key federal agency responsible for disease surveillance in the United States (Grmek 1990:13). 2 Throughout this text I refer to AIDS as infecting, or contaminating the blood supply. Based on current understandings this usage is technically wrong. AIDS is the disease caused by the Human Immunodeficiency Virus, HIV. While first isolated in early 1983 the virus was not formally identified until the spring of 1984, the time my account of the early history of the contamination of the blood supply ends. I have, therefore, adopted the terminology most common during the period July 1982 to April 1984 which refers to AIDS in the blood supply. The term AIDS, initially an acronym for Acquired Immune Deficiency Syndrome (today generally interpreted as Acquired Immunodeficiency Syndrome), was developed at a CDC meeting in Atlanta and first officially used at a July 27 1982, Public Health Service Committee meeting on opportunistic infections. Its use thereafter in CDC reports led to its popularization. Prior to the introduction of the term AIDS, names such as Gay Related Immune Deficiency (GRID), the Gay Plague or Gay Cancer were commonly used to refer to the syndrome (Grmek 2 Meanwhile, infectious disease experts at CDC headquarters in Atlanta, Georgia were beginning to fear a strange new malady was indeed affecting young gay men in the major seaboard cities of the United States. In April "a technician responsible for non-routine drug orders" noted an ominous increase in requests for pentamidine, a drug distributed solely by the CDC, used to treat Pneumocystis carinii pneumonia (PCP), a rare opportunistic infection almost exclusively associated with individuals suffering from immune system impairment.3 Concerns at the CDC were further heightened by a report submitted by Dr. Michael Gottlieb, an immunology fellow at the University of California at Los Angeles Hospital. In late 1980 Gottlieb treated a previously healthy young man suffering from immune abnormalities and PCP. Two months later, he saw another male patient with similar symptoms. Believing the occurrences unusual enough to warrant further investigation, he began contacting colleagues and local health authorities. By May he had uncovered 3 more cases of the disease, at which point he informed CDC Atlanta, that since October of 1980, at least 5 young, gay men had been treated for PCP in Los Angeles area hospitals (Grmek 1990:4-6). On June 5th 1981, the Morbidity and Mortality Weekly Reports (MMWR), the CDC's weekly bulletin distributed to physicians and public health officials throughout the country, described the 5 Los Angeles cases. A month later, a second report of this strange outbreak appeared in the MMWR, under the title of "Kaposi's sarcoma and Pneumocystis carinii pneumonia among homosexual men — New York City and California." By early summer teams of CDC 1990:32). Several of the witnesses at the hearings stressed the fact that the name Acquired Immune Deficiency Syndrome underlined the confusion surrounding the nature of the malady and that initially it was not considered "a disease in itself but was marked by the presence of some other, relatively uncommon disease or infection..."(Epstein 1996:55). 3 Between 1967 and 1979 the CDC received only two requests for the drug where the patients were not receiving treatments known to suppress the immune response (Grmek 1990:6). 3 investigators were in the field gathering information on the disease and individuals it was affecting. The age of AIDS had arrived. I first became aware of the outbreak in the late fall of 1981. At the time I was working as a Clinic Assistant for the Canadian Red Cross Blood Transfusion Service, in Toronto. We had just set up a blood donor clinic in an auditorium of a church in the city's west-side.4 Thumbing through a newspaper as I waited for the clinic to open I happen upon a brief report of a mysterious and apparently deadly new illness affecting homosexuals in the United States. The report caught my attention. Perhaps it was because you did not hear about new diseases appearing everyday, perhaps it was the question of why it was affecting one particular segment of society, but something made that report stick in my mind. While it caught my attention, I certainly had no inkling that fourteen years later I would be sitting in a stuffy hearing room on the 20th floor of an office tower in downtown Toronto listening to legal and medical experts argue over how over 1,000 Canadians came to be infected with this deadly disease through the blood supply. As I sat in the hearing room it seemed hard to believe that strange new disease I had first read about so may years ago had led to one of the greatest public health disasters in Canadian history. 4 1 joined the Canadian Red Cross Blood Transfusion Service in the late summer of 1981, about two months after the MMWR first reported that a mysterious illness was affecting gay men in the United States. By the time I left the in the late summer of 1986 the ELISA and Western Blot tests for AIDS had been in place almost a year. During those 5 years I worked on the mobile clinics, screening donors, asking i f they had read the health questionnaire and pamphlets carefully, making sure they had not had a cold or flu recently, they were not taking any medications, and had not suffered from any serious health problems in the past. I checked their iron level and did an A B O grouping. I assisted the nurses during the venipuncture, chatted with and looked after the donors while they were bleeding, and provided them with general information about blood and the blood program. 4 Research Background and Subject Matter of this Dissertation It was March 7 1995,1 was a Ph.D candidate in the Department of Anthropology at the University of British Columbia and for my field work I had returned to my old home town of Toronto to attend the national hearings of the Commission of Inquiry on the Blood System in Canada (The Krever Inquiry).5 This was the second of 4 visits I made to the inquiry over a three year period. I had spent two weeks at the commission while it was in Vancouver in April of 1994 during the provincial phase of the hearings.61 travelled to Toronto in March 1995 for the opening of the national phase of the inquiry. Between March and July I attended the hearings on a daily basis, taking notes, and making audio recordings of the testimony. Following the day's hearings I retired to the media room to read and take notes on the Exhibits7 and transcripts.8 On the days the commission was not sitting I would either work in the media room or interview some of the participants involved in the proceedings.9 5 During the provincial phase of the proceedings, February to December 1994, the commission travelled across Canada hearing evidence from local officials, those who had been affected by the contamination of the blood supply, and others who had information to contribute. After a short break, during which time the commission issued its Interim Report, the national phase of the hearings were opened and the authorities in charge of the blood system were asked to explain how the disaster came about. 6 While I was only able to attend the provincial hearings while they were in Vancouver I was able to video tape the proceedings as most were broadcast nationally on the Cable Parliamentary Access Channel (CPAC). 7 The commission received 175,000 separate documents totally between 800,000 and 1,000,000 pages (Commission of Inquiry on the Blood System in Canada, "Facts", December 1996). Of those approximately 100,000 pages of documentary evidence were selected and filed in the form of 1184 separate Exhibits. 8 The hearings generated some 49,932 pages of transcript (Commission of Inquiry on the Blood System in Canada, Facts, December 1996). 9 During the course of my interviews I spoke with the Commissioner, commission staff, witnesses, lawyers, and members of the intervenor groups. 5 I followed a similar pattern on my return in October of that year. After the close of the hearings in December 1995 I continued to work in the media room and interview those involved in the inquiry. I returned in November 1996 to hear the final submissions, again staying on several months after the close of the public proceedings in late December 1996. While I followed the inquiry from its opening to its closing days, I restrict my attention in this dissertation to a small but critical set of issues pertaining to the early years of the crisis in the blood system. A detailed accounting of the early history of the contamination of the blood supply was presented during the public hearings. While I draw on that material and explore many of the events of the early 1980's in some detail, I do not intend to provide a history of the tainted blood tragedy.10 I limit my attention to issues surrounding AIDS and the blood supply during the period between June 1981, when the disease was first officially reported, and April 1984, when the discovery of the virus responsible for causing AIDS was officially announced.11 Even then, my primary concern is not in reconstructing the history of the period. Rather my intention is to provide an ethnographic account of the ways in which the experts who appeared at the hearings reflected upon and represented science and its role in the events and decisions surrounding the I do not, for example, engage the complex and difficult issues surrounding the contamination of the blood supply with hepatitis C, a topic of considerable importance to the history of the disaster and a matter of much attention at the hearings. During the course of the inquiry it was revealed that at least 12,000 Canadians were infected with hepatitis C through the use of blood in the 1980's and that many of those will eventually succumb to complications arising from the disease. The contamination of the blood supply with hepatitis C has caused enormous personal suffering and has imposed staggering social and economic costs and has become matter of ongoing public controversy and debate. 1 1 While focussing on a limited time period and on only a small part of the story of the tainted blood tragedy, I believe that the issues I address represent fundamental patterns in the way information was generated, assessed, and applied in meeting the problems facing the blood supply in the 1980's. 6 contamination of the blood supply. I pay close attention to the experts' accounts in order to gain insight both into their understandings of their world and its interactions with other worlds. In doing so, I pay particular attention to the various ways in which the experts see outside social and political influences as impinging upon and, indeed, contaminating scientific practice and understanding. I focus on the testimony of just four of the almost 300 expert witnesses who appeared at the commission: Dr. Donald Francis, an infectious diseases expert at the Centers for Disease Control, Atlanta, during the early years of the epidemic; Dr. Thomas Zuck, blood banker, industry representative and former Director of the Blood Products Division of the Federal Drug Administration in the United States; Dr. Roger Perrault, former Director of the Canadian Red Cross Blood Transfusion Service (CRC BTS); and Dr. Martin Davey, former Assistant Director o f theCRCBTS. I single out the testimony of these witnesses, because of the positions they occupied and the roles they played in the early struggle against the disease, because of the breadth of expertise and experience they represented as a group, because collectively their accounts reflected and embodied the range of perspectives presented by the expert witnesses at the inquiry, and because of the highly articulate accounts they offered both of science and its relationship to public policy decision-making. During the early years of the AIDS epidemic the international community looked to the United States for information on AIDS and guidance on how to respond to it. The Centers for Disease Control (CDC) in the United States became the dominant authority on AIDS both nationally and internationally, while the standards and recommendations of its parent organization, the United States Public Health Service, became models for action throughout the 7 world. The contamination of the Canadian blood supply, the experts' understandings of the problem, the decisions they took, and the measures they instituted to protect the blood supply can not be adequately addressed without an understanding of the situation in the United States at the time. The importance of understanding the situation in the U . S. was underlined by the commission's inviting two American experts, Francis and Zuck, to be the first witnesses to appear at the national phase of the hearings. Through their testimony the commission was able to explore the state of knowledge concerning AIDS in the early 1980's while at the same time it was able to examine how that knowledge came to affect and be incorporated into policy decision-making both in the United States and elsewhere. In terms of their professional backgrounds, practical experiences, and differing perspectives Francis and Zuck were ideal witnesses to lead-off the national hearings.12 Francis was among the first researchers at the CDC involved in investigating AIDS. He was also among the first to address the problem of AIDS and the blood supply. During the early years of the epidemic he advocated a proactive response to AIDS, especially the institution of what some thought were radical interventions to protect the blood supply from contamination. While Francis's recommendations were criticized or ignored at the time, many now believe that had they been followed, the lives of a significant number of blood recipients could have been saved. Zuck's role in the early history of the disaster was less direct than that of Francis. He was, 1 2 In addition to being noted experts in their respective fields Zuck and Francis were both seasoned witnesses, each having appeared in numerous court cases, governmental investigations and institutional inquiries into the blood disaster. Both were also used to operating in the political sphere. Such experiences can be critical in determining the effectiveness of the expert witnesses' testimony. Those experts unfamiliar with acting in legal and political settings frequently prove to be poor representatives of science (Salter 1988:190). 8 nevertheless, an active and influential member of the blood banking community in the early 1980's and was soon to become Director of the Blood and Blood Products Division of the Federal Drug Administration (FDA). Zuck, therefore, provided the commission with important insights into the American blood banking system as well as the FDA, the agency responsible for regulating blood and blood products in the U.S. The occasionally provocative and often conflicting accounts offered by Zuck and Francis provided points of departure for the examination of the witnesses which were to follow. Of those witnesses, none received more attention than Perrault and Davey. There was good reason for this. Perrault and Davey were in charge of the Canadian Red Cross Blood Transfusion Service, the sole supplier of blood and blood products in Canada, and by default, the agency which was responsible for the regulation and safety of the Canadian blood supply in the early and mid 1980's. A wide range of institutions, agencies and individuals looked to the Canadian Red Cross for advice concerning AIDS and the blood supply during the early years of the epidemic. Perrault and Davey, therefore, had an enormous influence both on the ways in which the problem was understood and on the ways in which individuals and institutions throughout the country responded to the threat. Francis, Zuck, Perrault and Davey could be considered to be the key witnesses in the commission's investigation of the tainted blood tragedy. Not only did they provide a broad mapping of the understandings and decisions surrounding the contamination of the blood supply, they also presented an insightful and diverse series of perspectives on science and its relation to public policy making. They offered conflicting interpretations of the nature of scientific inquiry and disagreed widely over the role of science in the decision-making process. They debated what constitutes an adequate method, what constitutes proof and what sort of evidence provides 9 sufficient warrant for action. They offered conflicting assessments of the quality and meaning of the information available during the early years of the outbreak, they differed over the significance of the uncertainty which existed at the time, and they offered divergent interpretations of the role of science in the formulation of the early strategies to deal with the problem of AIDS in the blood supply. Unsurprisingly, they also disagreed over the value of those formulations. I recount some of that testimony as the witnesses describe their experiences and understandings of the events which led to the contamination of the blood system with AIDS. I look at the ways they depict science and explain its role in the management of public health problems such as the contamination of the blood system. I explore what these representations reveal about their understandings of science and its relation to society, and I examine what their accounts of doing science can tell us about the manufacture and application of scientific knowledge in situations such as the contaminated blood crisis. I pay close attention to their claims and counter claims and address some of the sources of their differences. I also look at the points of narrative overlap in their accounts and try to locate the sources of those shared beliefs. These points of consensus highlight the often unexamined shared assumptions ~ the matters of 'common sense' ~ which were woven into the witnesses' accounts and understandings. I conclude my examination by showing how insights drawn from the events and decisions surrounding the tragedy can serve as important lessons for those currently in charge of the blood system and can assist in understanding and reformulating the role of science in the broader sphere of public health policy and decision-making. The setting of the Krever Inquiry was particularly well suited to exploring these sorts of questions. The public inquiry form, as Liora Salter, Brian Wynne, and a number of others, have 10 pointed out, helps reveal the often undisclosed commitments and assumptions of the contesting parties involved.1 3 The Krever Inquiry was all the better suited to making such revelations because unlike many commissions of inquiry, science was not simply used as an instrument of investigation and evaluation, it was a central focus of the investigations. The hearings brought together a wide range of experts, representing a variety of disciplines, expertise and understandings and asked them, in a highly public forum, to discuss the role science played in the blood disaster and explain the place of science in public policy making. 1 3 According to Salter inquiries accomplish this by questioning the significance of the information under consideration while at the same time fostering public debate over it (Salter 1981:30). Wynne observes that the study of scientific controversy can be a fruitful site from which to study "science in the making." An adversarial setting pressures the contenders to make their conventions and premises explicit (Wynne 1989:33). Similarly Thomas Brante argues that during a controversy the contending experts scrutinize each others arguments and assumptions, and often violate taboos, to discuss connections between knowledge claims and interests. The observer in such situations, Brante suggests, is better able to explore the hidden norms and values within the scientific community (Brante 1993:186-187). INTRODUCTION 11 Unfulfilled Expectations, Growing Outrage The periodic 'visitation' of infectious diseases has been an important part of human history, inflicting enormous suffering and precipitating large scale social transformations. During the last century however, the development of sophisticated surveillance and reporting techniques, the increasing availability and use of vaccines, as well as advances in diagnosis and treatment, damped the frequency and scope of the outbreaks and lessened the severity of their effects. It became possible to think of a day when the greatest killers of humankind would be defeated. This optimism gained substance with the World Health Organization's announcement in the late 1970's of the eradication of smallpox from the natural environment. We seemed, and indeed we were, poised to enter a new world — but not the one envisioned in the hopeful conjectures of the research scientists and public heath officials. We were about to enter a world where modern medicines and techniques for managing disease not only appeared ineffective, they seemed to contribute to the dangers surrounding us.1 We were about to encounter what the historian of medicine Mirko Grmek refers to as the first of "post modern plagues," AIDS. 1 Keith Wailoo, for example, has pointed out that the spread of AIDS through the blood supply is a problem made possible by 20th century science and technology. AIDS could not have manifested itself in the same way in the 19th century prior to the existence of a blood transfusion network and the wide-spread use of the syringe (Wailoo 1997:14-5). Similarly the technological advances in the late 1960's and early 1970's which allowed for the large-scale production of anti- hemolytic clotting concentrates exposed hemophiliacs to a much greater risk of being infected by AIDS, and many other disease, than did earlier treatment practices based on the use of cryoprecipitate. Where the earlier product was manufactured from plasma collected from as few as 3 individuals clotting concentrates were manufactured in lots using plasma collected from 5,000 to 20,000 donors. 12 AIDS brought with it a set of challenges which changed our relationships with nature and with one another. Its effects were felt throughout society. The buoyant optimism of the 1970's, which saw the possible end to the scourge of infectious disease, gradually gave way to the sense that despite our sophisticated science and technology we remained vulnerable. Science was unable to protect us from this new and deadly threat, a threat which had been carried into our midst by groups of individuals accused of flouting the values and norms of society and the laws of nature. Homosexuals and drug addicts — those already marginalised because of their 'aberrant' behaviour -- were identified as the carriers of the contagion. Their transgressions presented a tangible threat to the entire society. The AIDS epidemic revealed the "stresses and vulnerabilities" of our society and exposed its "fault lines" (Treichler 1992:87). Fear, suspicion and intolerance marked the emergence of AIDS as they had marked so many other diseases in the past. The blood banking sphere was among the first areas where the transformations became apparent. The threat of AIDS was first generalized through the blood supply. The "gift of life" for decades a powerful symbolic expression of the bonds uniting individuals and communities ~ a powerful expression of social concern, belonging and sharing ~ suddenly became a focus of conflict and dissension. A conflict over blood signalled that a serious social disruption was under way: the world as we knew it was about to change but few heard the warning. Some of the effects of the contamination of the blood supply were almost immediately apparent — donors began to stay away from clinics, patients deferred treatment, demands for the exclusion of dangerous groups and individuals began to be voiced. Other effects, however, became apparent only with the passage of time. Not until the late 1980's and into the early 1990's, when those infected through the use of tainted blood products began to speak out and be heard, 13 did the extent of the devastation begin to be realized. In speaking out, those who were directly affected offered scathing criticisms of governmental agencies, social institutions and private corporations for their failure to ensure the safety of the blood supply. Experts and administrators who worked in the field during the time offered their own criticisms and explanations of the disaster. Public awareness of the criticisms grew, in part, because both the national and international media took up and championed the story. The French media in particular helped bring the story to the attention of the world. By late 1992 the story had become front page news as journalists chronicled the failure of the blood system and its officials to protect the blood supply or inform the broader public of the risk posed by the use of blood and blood products. Reports began to appear recounting the devastation experienced by the individuals and the families of those infected with HIV/AIDS through the blood supply.2 2 The story of the Canadian media's involvement in the tragedy is complex. While recognized as a central force in helping bring the disaster to light, the media has been criticized for being slow off the mark. Only after French reporters 'broke the story' did a serious interest within Canadian media emerge. As the journalist Andre Picard has noted, it was not until late 1992 that "tainted blood" became front page news in Canada. "[F]or almost a decade after the first victims started dying" the story went unnoticed (Picard 1995:1). The media's involvement in the story, however, did not begin in 1992. The media was an key instrument of communication from the early days of the outbreak and was thus an important actor in the tragedy. Blood banking officials have suggested the sensationalism surrounding early media reports of the disease contributed to the problems they faced in trying to manage the crisis. Others have accused it of playing the role of patsy, passing on whatever information blood officials provided, without questioning what was being said. The truth likely lies somewhere between. In many instances what blood bankers saw as sensationalism, now appear to have been more accurate than the reassurances they were issuing, while in other instances the extravagances of the media reports helped fan deeply held fears and biases. 14 A n Investigation Into the Disaster Is Called With this coverage came growing outrage and increasing pressure for a public accounting of the events and decisions which had led to the contamination of the blood supply. A threat to the blood system represented a potential threat to all; anyone might require blood to save their lives. If public confidence in the system collapsed, the ability to ensure the availability of this essential life-giving liquor would be seriously compromised. In late 1992 and early 1993 The Standing Committee on Health and Welfare, Social Affairs, Seniors and the Status of Women, carried out an investigation of the tainted blood tragedy. In its report, Tragedy and Challenge: Canada's Blood System and HIV, May 1993, the Sub-Committee recommended that: "...a public inquiry be carried out into the Canadian Blood System, with the efficiency and safety of the system as the primary focus. The inquiry should include, but not be limited to, a full examination of the events of the 1980's when the Canadian blood supply became contaminated by the human immunodeficiency virus, the pathogen associated with AIDS." In its report the Sub-Committee noted that while it was mindful of the changes which had been made and were currently under way to make the blood system safer — and in no way wanted to interfere with these initiatives ~ it none-the-less felt a comprehensive review of the Canadian Blood System was necessary. It was necessary "in part to clarify the tragic events of the 1980's, in part to reaffirm confidence in the system, and in part to ensure that the Canadian Blood System will be able to deal with future challenges as well as the myriad [of] requirements of day-to-day operations" (Wilbee 1993:25). While the federal Minister of Health at the time, Lucien Bouchard, initially balked at the idea of such an investigation, by September he gave into mounting pressure, and announced that a joint federal and provincial commission of inquiry would go ahead. The Royal Commission on 15 the Blood System in Canada (the Krever Inquiry) was established by Order-in Council 1993- 1879 the following month. Mr. Justice Horace Krever - an eminent judge of the Ontario Court of Appeals with wide experience in the legal/medical field — was appointed to head the commission.3 He was to investigate the events surrounding the contamination of the blood system in the early 1980's, report on the current state and safety of the system, and to make recommendations for its future operation. In fulfilling its mandate the commission carried out an exacting examination of the current blood system, appointing expert committees and individuals to investigate and report on its current state and to offer advice on its future operations and goals. The commission also investigated the state of the relevant scientific knowledge and its role in the decisions taken to protect the Canadian blood supply from contamination by AIDS in the early 1980's. In carrying out this investigation the commission conducted a series of public hearings at which more than 400 expert and lay witnesses testified.4 3 The appointment of Justice Krever to head the commission was widely applauded. He was seen to bring considerable experience and expertise to his task. Justice Krever was appointed Justice of the Court of Appeal of Ontario in 1986 ~ for the previous 11 years having served as a Justice of the Supreme Court of Ontario. During his career he had been a member of several "medical and scientific panels and boards of investigation" including: "chair of a special committee on the Human Tissue Gift Act 1971 to 1975", "co-chair of the Royal Society of Canada Study on AIDS in 1988," and "Commissioner of the Royal Commission on the Confidentiality of Health Records in Ontario between 1977 and 1980 (Commission information package). In theory and practice Justice Krever personified what Martin Bulmer describes as the requirements of chair of a royal commission. He was "a person known to be effective in the conduct of committee business..." a person of "...drive, tact, patience, good temper, conciliatory skill, and the ability to provide leadership without dominance" (Bulmer 1983:441). 4 The hearings were divided into two main phases. The first, the provincial hearings, began in March 1994 and continued until late October. During the provincial phase the commission travelled across the country, hearing both from those affected by the contamination of the blood supply as well as local public health and blood officials. The second phase, the national hearings, were held in Toronto between March and December 1995. During this time the commission heard from national and international experts as they tried to explain the disaster and made 16 During the hearings the commission explored what was known, how it came to be known, who knew it, and how that knowledge was applied. It explored the communication networks which existed between research scientists, public health institutions, drug manufacturers, policy makers, hospitals, clinicians, the media and the public. It examined how, and to what extent, available information was made accessible to all of these levels of decision makers, and it examined the factors which restricted information sharing. Among the most difficult and controversial issues it grappled with was the extent to which the demand that action be based on scientifically valid knowledge, conflicted with and impeded the institution of prudent public health measures. The public hearings provided both those who had been injured by the system, and the experts who administered it, a chance to give voice to their own understandings, experiences and concerns, while providing the wider public audience an opportunity to gain insight into the enormous complexity of the issues, beliefs and practices which led to one of the greatest public health tragedies in Canadian history. The inquiry, therefore, served multiple purposes. It not only presented an instrument of investigation and reform, it provided those involved with the tragedy a vehicle to express their concerns and experiences, while at the same time it furnished a means of public education. The educative functions of the proceedings were particularly important. The inquiry gave many Canadians insight into the operation of the blood system while exposing the enormity of the tragedy which resulted from the contamination of the blood supply. It served to publicly acknowledge the failings of the system and the sufferings of individuals and groups by showing recommendations to avoid such a tragedy in the future. A series of unprecedented legal actions launched in early 1996, challenging the authority of the commission, delayed the hearing of final submissions for almost a year. As a result of the challenges Commissioner Krever's Final Report was not released until September 1997. 17 they had been taken into account. It also served to reassure the audience that the suffering would not be in vain and that the failings would not be repeated. Through this public accounting the commission sought to reestablish confidence in the system and put to rest the social dissension surrounding the disaster. In this sense the commission followed a familiar pattern. The persistence of the public inquiry process and its current popularity rests, in part, in its widely recognized value in dealing with controversial issues and the rehabilitation of institutions which have fallen into disrepute. The Role of Public Inquiries .,, Commissions of inquiry have become popular instruments of investigation and policy making and are widely used by governments to respond to matters of public controversy (Salter 1981:221 Wynne 1982:52-3).5 The more explosive the issue, the more likely it will be dealt with by a commission of inquiry (Salter 1981:204). Their popularity is due, in part, to their perceived ability to depoliticize the problem and get government officials out of the political hot-seat, in part, to their fluid form and wide applicability, and in part to their capacity to diffuse social conflict. In order to be effective, therefore, they must not only appear as objective, giving an equal voice to all parties concerned, they must do so in a timely manner. Speed is often a central issue in such investigations (Wraith and Lamb 1973; Salter 1981; Wynne 1982; Wynne & Smith 1989; Ashforth 1990). 5 Commissions of inquiry can be broadly divided into two types. They can be defined as either "investigatory commissions which look into allegations of wrong-doing by government officials" or "advisory commissions which advise governments on controversial policy matters". Both types may hold hearings, carry out research, gather information and present recommendations (Robbins 1982:3). The degree to which any inquiry fits into these analytic categories of course varies. The Krever Inquiry, for example, functioned both as an investigatory and advisory instrument. 18 While frequently employed, public inquiries have not been without their detractors and criticisms. Historically they have a strong association with despotism (Burton and Carlen 1979:4). As a number of studies have shown, the suspicion and dissatisfaction which often surrounds their use has not been out of place (Webb 1932; Wraith and Lamb 1973; Burton and Carlen 1979; Bulmer 1981; Wynne 1982; Ashforth 1990). In his influential study of the Windscale Inquiry and nuclear decision-making in Great Britain, for instance, Brian Wynne draws on the work of Mary Douglas, Edmund Leach, Steven Lukes, Max Gluckman and Victor Turner, to suggest that inquiries are elaborate rituals staged to distract attention away from contradictions between belief and experience (Wynne 1982:9, 181-2). Wynne joins many critics of the process, who have noted that while appearing collective and consensual, public inquiries are instruments of the state. They are governed by practices, conventions and ways of thinking determined by the authorities and used to promote the idea and the practice of expert control. While being powerful instruments of investigation their scope and methods are oftentimes strictly delimited. The scope of an inquiry, set out in its mandate, serves to establish and limit the focus of its investigations. The often limited mandate of an inquiry can serve to restrict investigations to a defined range of appropriate questions — questions which themselves are formulated with a predilection toward prevailing authoritative modes of fact gathering based on models provided by science and the law. It is not surprising, therefore, to find the inquiry process criticized for its tendency to reduce complex social problems to singular rational causes amenable to 'reasonable', engineering style, solutions. The inquiry provides a format in which both the public (albeit a public represented largely in the form of interest groups) and professional experts are invited to participate and often exchange ideas. One of the strengths of the public inquiry is it capacity to bring together a wide range of 19 groups and individuals representing of a variety of goals, viewpoints, and expertise and invite them to discuss the problem and offer possible solutions. While the range of participants and expertise varies widely between inquiries, its inclusiveness has led to some concern over its tendency to co-opt public dissent, drawing it "into a narrowly controlled process at the expense of political opposition on a broader front." Adding insult to the injury, the public's willing participation in the process can be, and often is used to legitimate predetermined decisions (Wynne 1982). While many critics of the public inquiry system draw attention to their shortcomings as instruments of 'rational' policy making, they are quick to acknowledge the significance of inquiries as social phenomena in themselves. Wynne, for example, describes public inquiries as important sites from which to explore value conflicts within a society: sites from which it is possible to get beyond crude stereotypes which explain conflict as the clash of specific social interests, and ask, "what, beneath public expression and institutional manipulation this conflict means". Alluding to Turner's notion of "social drama", he suggests that it is possible "to understand the 'deep structures' of power and social order by analyzing the implicit classification and metaphor transmitted in such rituals. The public inquiry, exposes, at least temporarily, the lasting but hidden structures and processes of social life" (Wynne 1982:9-11). Turner's Social Drama Wynne's use of Victor Turner's idea of "social drama" helps provide valuable insight into public inquiries and helps cast light on their functions in situations of social conflict (Wynne 1982:9-10). In Dramas Fields and Metaphors (1974) Turner describes how he developed the idea of 20 "social drama" as a means of accounting for particular types of social conflict and change while working among the Ndembu of Zambia.6 He recounts how one of the things which struck him most about Ndembu social life "was its propensity toward conflict" and that in watching their day-to-day interactions he began to perceive a form to the process, a form which he saw as being essentially dramatic. Turner called these "public episodes of tensional eruption... social dramas." These dramas seemed to constitute "isolable and minutely describable units of social process". They were "units of aharmonic or disharmonic process, arising in conflict situations" (Turner 1974:31-3). Turner came to see the pattern in a variety of settings and societies. He described the "social drama" as typically consisting of four main phases, the first of which arises with a breach or deliberate nonfulfillment of some crucial norm regulating relations between persons or groups within the same "perjuring system or set or field of social relations." The breach is a "symbolic trigger of confrontation or encounter." While it may be committed by an individual, he notes, it is always done with the belief that they are acting as a representative of others. Following the breach a period of "mounting crisis ensues" (Turner 1974:37-8). Unless quick action is taken and the breach is sealed off in an area of limited social interaction the 'crisis' will likely escalate. Eventually it will become "... coextensive with some dominant cleavage in the widest set of relevant social relations to which the conflicting... parties belong." The crisis phase exposes patterns of conflict and intrigue which hitherto had been covert. It represents a turning point, a moment of danger and suspense when "a true state of affairs is revealed" and it is no longer possible to pretend there is nothing "rotten" in the relations within 6 See also, Victor Turner, Schism and Continuity In an African Society (1957) in which he initially develops his idea of the "social drama". 21 the larger group or to ignore or wish the conflict away. It "dares the representatives of order to grapple with it" (Turner 1974:38-9). In the third phase of the drama, redressive action is undertaken. To limit the further spread of the crisis adjustive and redressive mechanisms are put into action. These are enacted by "leading or structurally representative members of the system in crisis." The mechanisms adopted will vary in type and complexity depending on the perceived significance of the breach, the extent of the crisis, the nature of the social group where the breach occurred, and the degree of the group's autonomy in terms of wider or external systems of social relations. These mechanisms range from informal mediation or arbitration to formal juridical and legal initiatives. In some circumstances the performance of public ritual may be called upon in an attempt to resolve the crisis (Turner 1974:39). During the redressive phase pragmatic techniques and symbolic action are most fully expressed. It is also during this phase that "a distanced replication and critique of the events leading up to and composing the 'crisis'" is carried out. This recapitulation, Turner suggests, may be presented in the rational idiom of a judicial process or it may find expression in the metaphors and symbols of a ritual process. A failure of the redressive measures usually precipitates a regression to crisis and the possible use of direct force. Generally, however, regression becomes a matter of smouldering factionalism without overt confrontations (Turner 1974:41). The final phase involves either the 'reintegration' of the "disturbed social group" or the "social recognition and legitimization or irreparable schism between the contesting parties." From the perspective of the observer the fourth phase presents "an opportunity for taking stock." Having already taken careful account of the temporal character of the drama the moment has arrived to address the situation synchronically. The political power relations which proceeded the 22 drama can be compared with the 'political field' that followed the redressive phase. "As likely as not... the scope and range of the field will have altered" but more importantly "the nature and intensity of the relation between parts and the structure of the total field will have changed (Turner 1974:42).Yet through all the change certain norms and relationships will be maintained. The explanation of both change and persistence Turner insists, "can only be found by systematic analysis of processural units and temporal structures, by looking at the phases as well as atemporal systems" (Turner 1974:43). The Tainted Blood Tragedy as Social Drama. Using Turner's model, public inquiries can be seen as an aspect of the third phase of a social drama. Following Turner, the Krever Inquiry might be described as a sophisticated instrument of social reflexivity aimed at reproducing, as exactly as possible, the chains of social events which led to social disruption and individual suffering. The stories presented at the hearings attempted to establish the facts and contextualize the events which led to and constituted the crisis. In doing so they revealed some of the hidden motives which impelled the actors to behave in the way they did. The stories, "frequently saturated with moral implications" allowed the earlier events and actions to be measured against the "ethical yardsticks of the group" (Turner 1988:39). The Commission's task was to provide a measure of what was done in the past as well as to offer advice on what ought to done in the future. Turner's model helps reveal that the tainted blood tragedy involved two separate, though related breaches. The first involved a breach of norms and values by 'miscreant' groups and individuals whose behaviour was not only seen as putting them at risk for the disease, it was actually believed in some way associated with the emergence of the contagion. A crisis erupted 23 when the errant few spread their impurity to the blood supply, thus generalizing the risk of the disease to the innocent citizenry. The crisis, which represented deep routed social-political conflicts over social values and norms, was effectively sealed off through the use of a technological fix in the form of a test to detect the virus believed to cause AIDS. The test, developed in the United States in the fall of 1984, and in general use at Canadian Red Cross blood centres by late 1985, served to minimize the threat the disease posed to the general population. The conflicts which lay behind the crisis, therefore, could once again be pushed out of sight or at least into the background. A second breach, however, occurred simultaneously with the first. It involved the failure of the experts and administrators in charge of the blood system to prevent the disaster or to adequately warn other health care workers and the lay public of the potential significance of the disease for the blood supply and its users. The crisis surrounding this breach, however, did not emerge until the early 1990's, when the media and those affected by the contamination of the blood supply began to publicly question the actions of the experts and administrators involved in disaster. Widely held expectations came to be undone. Those in charge of the system, it appeared, neither could be trusted nor could they be depended upon — realizations which were made all the more unsettling by the fact that these failures involved a cherished institution, the Red Cross and a potent symbol of community belonging and caring, volunteer blood donation. The second crisis brought with it many of the issues and problems which had been sealed off in 1985. The second crisis embodied a complex and interrelated network of scientific and social conflicts which threatened the blood system, public health and government agencies as well as the credibility of science and the scientific expert. 24 Science Studies, Constructivism, Actor Network Theory The question of the relationship between science and society and the existence of the boundaries between the two was a matter of considerable concern at the hearings; a concern shared by many theorists and researchers working in a programme broadly referred to as the social studies of science, a programme in which this dissertation might be said to be located. Researchers in the field of science studies have begun to investigate how communities of scientists, engineers, and physicians, as well as non-scientists, go about creating knowledge and the ways in which this knowledge is applied in the social world.7 These studies have done much to dispel the stereotypic distinction between science and society, the view that science somehow exists autonomously, free from the social and cultural worlds in which it is created and used. In the last twenty years, in particular, the field of science studies has expanded enormously and has become crowded with a diversity of theoretical and methodological orientations. Amidst all of this diversity, however, a couple of trends have become apparent. Attention has moved away from the products of science, turning instead towards its practices. In the late 1970's and early 1980's the laboratory bench became a site of ethnographic interest as concerns began to focus on what scientists actually do and say as they go about making science. "The field of resources" that scientists operate in and on became a matter of particular interest (Pickering 1992:2-3) as ethnographers followed science-in-the-making and found that much of it occurred outside of the laboratory and involved individuals, groups, and institutions not normally considered to be within the realm of science. In the late 1980's and into the 1990's these ethnographers of science have found themselves in boardrooms, courtrooms, hearing rooms and 7 In a recent essay Sharon Traweek catalogues some twenty academic disciplines which have been part of the "avalanche of research" in the field of science studies since World War II (Traweek 1993:4-6). 25 a variety of other venues as they traced the networks of things and people tied together in the production of scientific knowledge. This has led to an expanded view of science and its place in decision-making as well as a reevaluation of the boundaries traditionally maintained between scientific knowledge, politics and so called popular belief. While the questions raised by these investigations and the perspectives brought to them have been diverse, many of those working in the field of the social studies of science have adopted a constructivist interpretation of the production of scientific knowledge. Constructivism is not so much a theory as it is a collection of related perspectives based on the premises that scientific knowledge is constructed rather than discovered and that the processes involved in that construction are socially and historically situated. The claim that scientific and medical knowledge is socially constructed is not intended to demean or belittle science. Rather, it aims at drawing attention to scientific knowledge as a product of creative social actors (Rapp 1991). The constructivist framework allows for an exploration of how humans give meaning to their experience through what they do and what they say — discourse and practice (Feldman 1995:13). The constructivists do not see the production of scientific and medical knowledge as something separate from other human activities. Science and medicine are treated as domains "of social practice and discourse, the limits and the contents of which are... set up by wider ~ but not separate ~ social practices." Science and medicine, however, are not seen as mere products and reflections of the social and cultural contexts in which they are produced. Science and medicine both express and contribute to the dominant social and cultural beliefs and practices of the time while maintaining their own identities (Wright & Treacher 1982:11). The constructivist frame offers an antidote to essentialist accounts of science and the 26 production of scientific knowledge while trying to avoid both idealist and social determinist interpretations. Its influences come from a variety of sources including the works of Dilthey, Mannheim, Ricouer, Fleck, Berger and Luckman, Kuhn, Foucault, and Geertz. Its roots are in the sociology of knowledge, interaction theory and interpretive anthropology (Treichler 1992:70-71). A major step in the development of the constructivist perspective, at least in terms of science studies, came with the publication of T.S. Kuhn's Structure of Scientific Revolutions (1962/1970). Kuhn's anthropologically sensitive approach, with its emphasis on the social situatedness of scientific theories and the centrality of communities of shared meaning and practice in the production of scientific knowledge, emboldened sociologists and others to claim the content of science to be a rightful subject of the social analyst. It was no longer simply mistaken scientific beliefs which required social explanation, all scientific theories needed to be understood in terms of their social and cultural underpinnings. While the impetus for an anthropologically oriented analysis of science was derived through the work of Kuhn, anthropology's influence in the field was most directly felt through the work of Clifford Geertz.8 Paula Treichler notes, for example, that it was Geertz who insisted the cultural be "inserted into the study of the sociology of knowledge" (Treichler 1992:72). Byron Good, argues that the greatest contribution anthropology has made to the sociology of knowledge, is its "insistence that human knowledge is culturally shaped and constituted in relation to distinctive forms of life and social organization" - a view, he notes, which has run 8 Geertz's interpretative approach assumes that: rather than being '"...an experimental science in search of law...'" anthropology is an interpretive science in search of meaning; that all interpretations whether they be the anthropologists' or the informants' are constructed not discovered; the whole truth of a matter is never attainable, cultural analysis is inherently incomplete; culture can be understood as '"an assemblage of texts'... 'as imaginative works built out of social materials'" that need to be understood as meaningful within a specified context (Geertz 1973 in Feldman 1995:11-12). 27 headlong into "the realist claims of modern biology" (Good 1994:21). Good suggests that the confidence that shines through in the work of Evans-Pritchard and Levi-Strauss is no longer available to the ethnographer and that this lack of confidence has affected our view of the natural sciences' ability to simply represent the empirical world (Good 1994:21). The constructivist frame has figured in the recent work of a wide range of anthropologists, historians, sociologists and others involved in the social studies of science (eg. Haraway, Latour, Law, Callon, Porter, Woolgar, Wailoo, Traweek, Feldman, Downey, Heath, Hess, Martin, Rabinow, Rapp, Lock, Treichler). While sharing a broad constructivist orientation the theoretical frameworks these scholars have adopted are far from uniform. Traweek, for example, pursues a Geertzian inspired interpretive approach which she describes as concerned with the "patterned interactions, such as oral and written discourse, or any other social 'text'... in which the form and the content reverberate to evoke significant strategic meaning to those who know the local patterns." In examining the world of high energy physics she explores how relations of power are created and enacted both locally and globally through discursive practice and through representations and other evocations (Traweek 1988; 1992; 1993). - Like Traweek, Latour, the French anthropologist turned sociologist, and leading exponent of "actor-network theory" (ANT), draws attention to the social and political factors involved in the construction and presentation of scientific knowledge. However, unlike Traweek and many of her colleagues, Latour and the actor-network theorists also insist that viruses and bacteria, as well as scientific instruments, be considered as actors in the construction of scientific knowledge. They insist on a symmetrical treatment of people and things. Rats, fleas, bacilli, viruses, scallops, flourescent dyes, electron microscopes, are all seen to be actants, all have to be negotiated with 28 and enlisted in the making of science. Latour and his colleagues draw attention to the discursive strategies scientists use to enlist and control allies and to the ways instruments function to convert local phenomenon into inscriptions, immutable mobiles; portable representations of the world which can be gathered together in "centres of calculation" and strategically deployed to promote particular points of view (Latour 1987:22-26; Woolgar 1988:69-71). For actor-network theorists the construction of a scientific fact is much like a military operation. It involves tying people and things together into networks of alliance while at the same trying to break apart competing alliances. Science, like culture or society, is never contacted directly. Instead what is seen is "a gamut of weaker and stronger associations" (Latour 1987:258). Part of the job of the anthropologist of science is to trace out these associations and enumerate the strategies employed in the building, stabilizing and deconstructing the networks of relationship whereby statements are made into facts or fiction (Latour 1987:25). Actor-network theorists (ANT) are critical of sociologists of scientific knowledge such as Barry Barnes, David Bloor, Harry Collins, and Steven Yearly. They take exception to sociologists' adoption of an ontology given to them by scientists, which divides the world into the poles of 'Nature' and 'Society'. For the actor-network theorists, 'Nature' and 'Society' are inextricably linked in scientific and technical practices: Nature and Society are the twin results of another activity, network building (Law 1986; Pickering 1992; Callon and Latour 1992). "Instead of providing the explanation, Nature and Society ... [must be] accounted for as the historical consequences of the movement of collective things" (Latour 1990:170).9 9 Latour argues that, "the major advantage for anthropology of this displacement is that it dissolves the great divide which Levi-Strauss, Horton, Goody and science students have struggled with for so long ... all collectives have to co-produce at once their societies and their 29 While arguing that science is social, perhaps the most social of all human activities, Latour boasts that the 'social' elements which populate his writing may not conform to the idea of the 'social' found in many of his colleagues work (Latour 1987:63). He is right. The influences of capitalism, the proletarian classes, and male dominance are all absent from his accounts, as are explanations of science based on the interests of multinational corporations, the military establishment, or those of professional elites. Latour warns that social interests cannot be used as explanatory devices because they are themselves reformulated in the process of making science. A n important aspect in enlisting allies is the job of translating their interests into your interests, he points out. Latour insists that in order to study "science in the making" it is necessary to be as undecided about what society is as we are about the nature of nature. The danger of not doing so, he warns, lies in ending up like the sociologists of scientific knowledge, being a social determinist when it comes to science and a realist when it comes to society (Latour 1987:143-4; 1992:345-8). Haraway, a primatologist and a leading exponent of the field of science studies, agrees with Latour that it is necessary to resist 'social' explanations of scientific practice, that by exploding the binary opposition between science and society we can gain insight into the ways scientific practice creates its own contexts. However, she, like many others, is critical of Latour and his actor-network colleagues for their impoverished view of the 'collective'. Haraway argues that while they correctly resist the opposition of science and society, actor-network theorists "draw a suspicious line around what gets to count as practice." Questions about how "the practices of masculine supremacy or many other systems of structured inequality" get built never get gods — Us as much as Them" (Latour 1990:170).In a recent series of lectures at the University of British Columbia (November 1998) Latour argued that what is needed is an approach which acknowledges a "multi-naturalism" as well as a "multi-culturalism". 30 addressed. This blind spot, she suggests, has led to a failure on the part of many of those working within A N T to take account of the last twenty years of feminist research (Haraway 1992:332-3). Neglecting to account for systems of structured inequality in the production and application of scientific knowledge is a serious omission. Anthropologists, especially those working in the field of medical anthropology, have drawn attention to the critical importance of understanding the power relationships involved in the production and use of scientific knowledge. Margaret Lock, Emily Martin, and Rayna Rapp, for instance, have built upon such ideas as Foucault's, "biopolitics", to explore the ways in which biomedicine has extracted patients from society to individualize and objectify their experiences and create docile bodies. Lock, Martin, and Rapp, have provided valuable insight into the ways scientific narrative naturalizes social hierarchical relationships and how, through these narratives, structures of domination are learned and internalized. Science as Narrative: Understanding the World Through Stories. Despite their many differences most constructivists acknowledge the importance of discursive practices in creating meaning in science and medicine. As in Foucault's system, entities are seen to be the "products of the discourse which embodies them" (Treichler 1992:73). Science might be described as an activity involving "the construction and sustenance of fictional accounts which are sometimes transformed into stabilized objects" (Latour & Woolgar 1979 quoted in Feldman 1995:15-16). In recent years Jamie Feldman, Emily Martin, Rayna Rapp, Sharon Traweek and others studying the production of science and medicine have come to treat scientific discourse as narrative, "as story telling within... contested narrative fields" (Haraway 1989:6). Like all stories 31 scientific stories can be temporarily stabilized, but they are never static. They rise out of social interaction and change over time. They are always capable of being challenged, reinterpreted and conflated with other stories, given new meanings and used for different purposes in different situations. This was something which became evidently clear at the Krever Inquiry hearings. Emphasizing that the stories are manufactured within contested fields draws attention to the constructed nature of science while avoiding the idea of sole authorship. It leaves open the possibility of multiple authors, both human and nonhuman. A scientific story must not only accommodate and represent the often changing goals, interests, beliefs, and practices of social actors it must also meet and express the demands of the nonhuman world. "The lens of storytelling defines a thin line between realism and nominalism" (Haraway 1989:8) Accounting for the Stories Told at the Inquiry The stories told in the course of a "social drama" are never self contained, independent inventions, while drawing on earlier stories they become incorporated into those which follow. The stories told at the Krever Inquiry were no exception. The accounts the witnesses provided were linked to a variety of earlier narratives, some specifically about the tragedy, others about the social and historical setting in which the disaster was enacted. The witnesses' accounts also became part of an enormous number of narratives which followed. Thousands of newspaper articles and media reports represented and commented on the testimony heard before the commission. At least three Canadian journalists have published books on the tainted blood tragedy in which they drew on stories of institutional failure, individual shortsightedness, political indifference and corporate greed which had been recounted before the commission. In the Gift of Death (1995), for example, Andre Picard, brings together a damning critique of the 32 Canadian Blood System during the 1980's with the personal stories of those whose lives were profoundly affected by the contamination of the blood supply.10 The most influential of the narratives to incorporate and comment on the stories told at the hearings, Justice Krever's Final Report on the Blood System in Canada, has been taken up in a wide range of settings by a variety of story tellers. Elements from the Report have become part of the personal commentaries of those affected by the contamination of the blood supply. They have become part of a myriad of media reports, embedded in the rhetoric of politicians, and incorporated into the stories told by scientists. They have appeared in other investigations into public health policy making and embodied in the policies of the newly formed Canadian Blood Services. The perspectives expressed and the issues addressed in the various accounts of the disaster have varied widely. Where many journalists explored the personal suffering of those affected, providing poignant reminders of the human costs involved, others, such as Justice Krever, provided a legal accounting of what was known, what was done and what should be done in the future. Despite their differences these accounts share a number of similarities. They have sought to uncover the conditions and failings which impeded the pursuit of scientific knowledge and thwarted its appropriate application. They have endeavoured to reveal what was truly known by the scientists at the time and enumerated the mistakes made. They have sought to disclose the social, political, institutional and economic interests and goals which led to those aberrations and offered a range of technical and social engineering-style solutions to those shortcomings. In 1 0 Picard, like many of the journalists I spoke to at the hearings, said he felt one of the most important things he could do in reporting on the tragedy is give a human face to the story. 33 doing so, they have accepted the ontology provided by the experts which divides the world into science and the rest. Outside of the sufferings of the individuals affected by the contamination of the blood supply, the social-cultural face of the story has appeared mainly as a means of accounting for the mistakes made. My approach is somewhat different. While sharing the underlying goal of most of the stories, that of helping insure the tragedy is not repeated in the future, I do not search for what was truly known or should have been known, nor do I suggest socio-technical solutions to the failings which plagued the blood system in the 1980's. Rather, I try to understand the beliefs and practices which made the understandings and actions of the experts possible at the time. I explore what the experts knew and what they needed to know as they carried out their various roles during the early years of the contaminated blood crisis. I try to understand what made those thoughts possible and reasonable to the people who held them and acted on them. I show that the disaster was the outcome of complex, historically and culturally located ways of knowing and behaving that are not readily remediable through social engineering-style solutions. In the chapters which follow, I present a close examination of the testimony of four of the almost three hundred expert witnesses who appeared at the Krever Inquiry. I analyze the witnesses' often divergent descriptions of science and its place in public health policy making and explore what their testimony reveals about the complex network of beliefs, practices, people and things involved in the construction and application of the scientific knowledge during the early years of the contaminated blood crisis. To accomplish this I draw on a variety of sources including the interviews I conducted, the Exhibits filed at the hearings and the transcripts of the proceedings. I bring together insights gathered from these sources with recent research in the fields of cultural, symbolic and medical 3 4 anthropology, as well as from the sociology, history, and philosophy of science. Drawing on those insights I show that the boundaries the witnesses described as existing between science and society not only misconstrued the relationship between the spheres, they contributed to the crisis in the early 1980's. Chapter Outline In Chapter 1,1 explore the context in which the testimony was presented. I begin with a brief description of the physical and social environment of the hearings and outline some of the rules of procedures and patterns of interaction which helped shape the inquiry as well as the witnesses' testimony. In Chapters 2 through 6,1 turn my attention to the testimony of my four main witnesses and use that testimony to provide a brief history of the tragedy. In Chapter 7,1 reconsider the testimony of the four witnesses and explore what their various accounts reveal about their understandings of the production and application of scientific knowledge. In Chapter 8,1 turn my attention to a notable silence in the witnesses accounts — the absence of any meaningful recognition or discussion of the symbols and beliefs surrounding blood in Western culture. In Chapter 9, the concluding chapter I review the insights derived from earlier chapters to show that the opposition between science and society depicted in the witnesses' testimony presents an inadequate account of the relationship between the spheres and that the related reliance on technical, engineering-style solutions is an insufficient strategy to avoid similar disasters in the blood system in the future. I suggest that a more profitable approach to 35 understanding science and its role in public policy making is to be found in promoting a dialogue between the dynamic and often contradictory systems of meanings, values and practices involved in and expressed in the witnesses' accounts at the hearings. 36 CHAPTER ONE: CONTEXTUALIZING THE ACCOUNTS In the following chapter I briefly review the history of my research at the commission and situate the day to day activities at the hearings within the context of the structures and procedures associated with the public inquiry process in Canada. The Physical Setting The national hearings were held on the 20th floor of the MacLean Hunter tower in downtown Toronto. The hearing room was a large, rectangular space, some 40 feet across. The windows which ran along the 85 foot length of the west wall lent a sense of openness to the room. At its north end, toward the window-side, sitting on a slight angle, was Justice Krever's desk. Located on a platform, about a foot in height, it stood above the rest of the room. Fifteen feet to its left, again sitting at an angle, was the witness stand. It too was perched on a platform, although not quite as high as the Commissioner's. (The angles of the desks provided a more direct line of sight between the witnesses and the Commissioner.) Slightly forward of the Commissioner's desk and a little closer to the window was the registrar's desk. Running down the centre of the room were five rows of heavy wooden tables. Each row was divided in the middle creating 10 seating sections with a corridor down the centre. Each section had four seats where the legal representatives and their invited, guests sat.1 Behind the lawyers' desks was a small open space and behind that was the public seating area which could accommodate about another 40 people. To the window-side of the public area stood 1 About 5 minutes before the proceedings began a folding table was set-up immediately behind the other desks, thus providing two additional seats. The Hepatitis C Survivors Society was assigned to these seats but not without some protest on their part. 37 a television camera. Immediately behind it sat the sound engineer with his mixing board which controlled the rows of microphones perched on the desks. Beside him was the translation booth. The room had three entrances. One, on the eastern side of the north wall, lead to the commission offices; the Commissioner entered and exited the room through this door. Commission counsel and other staff members also frequently used this door. The remaining two sets of doors were located on the east wall, one toward the north end and one towards the south. The north door was most often used by the witnesses, the southerly door functioned as the public entrance, used by commission staff, witnesses and the public spectators. The Participants Finding a good vantage point near one of the speaker cabinets in the public seating area, I settled in. It was about 9:30 A . M . , the proceedings were set to begin in 30 minutes.21 arrived early because I wanted to be sure I got a seat. As it turned out, I need not have worried. By the time the proceedings began, 16 of us were sitting the public area. While far from a capacity crowd this turned out to be one of the largest turn-outs at the national hearings. A typical morning would find perhaps two or three of us sitting in the public 'gallery' and two or three stalwart reporters in the media room. Having unpacked my tape recorder and set-up my microphone I began to sketch the lay-out of the room and make notes on the comings and goings. Things were relatively quiet for the first few minutes. A handful of people were in the room. A couple of lawyers had settled in at their desks, commission staff moved in and out of the room while the sound-engineer was busy 2 While in Toronto the commission generally sat Monday to Thursday between the hours of 10 A . M . to 1 P .M. and from 2:30 P .M. to 4:30 P .M. 38 thumping microphones making sure they were working. The pace picked up as ten o'clock drew closer. Legal counsel began to trundle in, dragging cartfuls of documents. Reporters, some with camera-persons in tow, scanned the area looking for likely candidates to interview, while others, who I could not identify, drifted in ~ sometimes by themselves, sometimes in groups — and found seats in the public area. Several of the commission staff hurriedly distributed documents to the participants, while the lawyers began to form small groups chatting, joking, and welcoming colleagues as they arrived. I recognized a number of the faces in the room, having become familiar with them over the previous year, but I still had a lot of sorting out to do. It was a difficult task just trying to keep track of the participants at the inquiry. Sixteen groups and individuals were granted standing during the organizational hearings held on November 22 and 23 1993.3 By the time the national hearings started the number had increased to 19.4 This included representatives of the federal and 3 The purpose of the introductory hearings was "to determine who should be granted standing and who should benefit from a recommendation to the government ...to obtain funding assistance" (Krever 1993:17). In most cases the two questions were linked. The cost of legal representation, made it virtually impossible for many of the organizations and individuals seeking standing to participate in a meaningful way without funding. The funding guidelines, as set by the federal government, therefore, played an important role in determining who would be granted standing. The guidelines stipulated that, to qualify for funding, the group or individual must have an identifiable and historically demonstrated interest in the issues that both requires representation and promised to contribute to the inquiry. Those requesting assistance were required to show that they did not have the resources to represent those interests. They were also required to have a funding proposal and an ability to account for the monies, i f received. 4 Those with standing at the inquiry included: The Canadian Blood Agency (CBC); Canadian Red Cross Society (CRCS); Canadian Hemophilia Society (CHS); Canadian AIDS Society (CAS); Hemophilia Ontario, Toronto and Central Region Chapter; Miles Canada; Connaught Laboratories Ltd.; HIV-T Group, Blood Transfused; Hepatitis C Group; Gignac, Sutts Group; Jean-Daniel Couture and Jean-Henry Godin; Canadian Hemophiliacs Infected with HIV and Janet Conners; Canadian Hemophiliacs Infected with HIV; Hepatitis C Survivors Society; Committee of HIV Infected and Transmitted; Association of Hemophiliac Clinic Directors of Canada; the Provinces of British Columbia, Alberta, Saskatchewan, Manitoba, Ontario, New Brunswick, Newfoundland and Labrador, Prince Edward Island, Nova Scotia, the Northwest 39 provincial governments, the Red Cross, treating physicians, pharmaceutical manufacturers, as well as individuals and groups affected by the tainted blood tragedy. Together they embodied a wide variety of interests, goals, experiences and expectations. With the exception of the Hepatitis C Survivors Society all of the groups and individuals with standing at the commission were represented by legal counsel.5 Some had a single lawyer present at the hearings, others had as many as four legal representatives in attendance at any one time. Participation in the inquiry was not restricted to those granted standing. Justice Krever welcomed submissions from interested parties, and made it clear that anyone who was either directly or indirectly affected by the contamination of the blood supply was welcome to testify before the commission. Many of the individuals and groups affected, took the opportunity to tell their stories and share their experiences during the provincial phase of the inquiry. The day-to- day activities of the hearings, however, remained in the hands of the lawyers. If a question was to be asked, a clarification sought, a request made, it had to be posed through legal counsel. Territories and the Yukon; and the Government of Canada. The Province of Quebec did not seek standing at the inquiry although it participated in and was represented by counsel at the Quebec hearings and the national hearings (Krever 1995:1106-7). 5 The Hepatitis C Survivors Society was granted standing but not intervenor funding and thus could not afford legal representation, although on occasion, 'volunteer' legal counsel appeared on their behalf. For the most part, however, members of the Society sat at the hearings and conducted cross-examinations. Two other groups with standing lacked the financial means to adequately represent themselves and did not receive funding. They did, however, have legal representation. Mr. Kenneth Arenson acted without fee on the behalf of the Committee of HIV Infected and Transmitted (CHAT) and Mr. David Harvey acted similarly for Hemophilia Ontario, Toronto and Central Ontario Region. Until December 1994 both Mr. Arenson and Mr. Harvey represented the HIV-T Group, Blood Transfused. In early December 1994, the Group issued a press release suggesting that as co-chair of the Royal Society of Canada Study on AIDS (1988) Justice Krever had remained silent about the dangers posed by HIV in the blood supply. They argued, therefore, that his position as Commissioner of the current inquiry represented a conflict of interest. Mr. Harvey and Mr. Arenson made it clear they did not support the group's actions and immediately resigned. 40 Submissions from the floor were not entertained.6 The Rules of Procedure ' The form and power of a Federal inquiry is broadly defined in the Inquiries Act.7 The Act gives a commission the power to take evidence under oath, to subpoena witness and documentary evidence, and to make findings of wrong-doing or innocence. (These findings, however, are not considered legal determinations and in fact, may be contrary to what a law court might find.) The Act also grants the commission the right to engage legal counsel as well as accountants, engineers, or other experts (Robbins 1982:11). The specific nature of the problem and the information being sought play an important role in determining the form an inquiry will take. The "terms of reference", set out in the order-in- council establishing the commission, therefore, play a significant role in shaping the proceedings as does the choice of Commissioner (Wraith and Lamb 1971; Salter 1981; Bulmer 1983; Smith 6 This was a source of considerable frustration for some of those affected by the contamination of the blood supply, as I learned during my interviews and conversations with them. Many expressed resentment over having others speak for them while several told me they felt frustrated by their lawyers' unwillingness to pursue the issues and questions they wanted addressed. Some of the lawyers I spoke with also noted the tension, explaining to me that occasionally they found themselves faced with demands from their clients, which in their professional judgement were not in the best interests of those clients. 7 The modern form of the royal commission in Canada was set out in 1846 in An Act to Empower Commissioners Inquiring into Matters Concerned with the Public Business, to take Evidence on Oath. Later Parts were added in 1880, 1912 and 1934. There are another 40 federal statutes which confer powers to hold inquiries in addition to the Inquiries Act and another forty seven which refer to the Act. A number of the provinces also have their own Acts governing inquiries (Robbins 1982:11). Part I of the current federal Inquiries Act is very similar to the original 1846 Act (Robbins 1982:7). 41 and Wynne 1989).8 Historically, Commissioners have enjoyed a wide degree of discretion in establishing the specific rules of procedure which will be followed. They have, however, generally done so with an eye to previous undertakings. This sensitivity to precedents has led to some significant changes over the years, including the way in which the rules of procedure are themselves determined. In the late 1960's the Le Dain Inquiry opened the door to an increased public participation in the process while the Mackenzie Valley Pipeline Inquiry in the early 1970's set a precedent by providing funding for the participation of the lay public (Salter 1981a:343-4). A few years later The Thompson West Coast Oil Ports Inquiry gave participants a major role in developing the rules of procedure. Since that time, those with standing have assumed a greater role in determining the day to day structure and practice of a commission (Robbins 1982:18.) Justice Krever followed precedent at the organizational hearings, inviting the legal representatives of those granted standing to attend a meeting "to discuss both the issues and procedures that should be adopted that would make it possible to canvas all the important issues adequately and in a fair way" (Krever 1993:20). Out of that meeting a set of 39 Rules of Procedure and Practice were established. The Rules of Procedure set-out the general rules for examination and the process for requesting the appearance of particular witnesses. It outlined the forms of evidence which would be accepted; established the protocol to be followed to protect witness confidentiality; defined the times the commission would sit; and stipulated the witnesses' right to counsel. One of the most significant procedural determinations in any inquiry is the degree to which 8 The Cabinet, as a rule, is responsible for selecting and appointing a Commissioner to carry out the inquiry. 42 the hearing process will follow a formal legal model or will adopt a more relaxed informal practice. This choice can have a significant effect on the inclusiveness of the hearings and the degree of satisfaction the participants experience with the proceedings (Robbins 1982:14). The Krever Inquiry adopted a relatively formal set of practices and procedures modeled on those of the courtroom.9 This lent an adversarial character to the proceedings. While cross-examination occasionally livened things up and helped draw out and clarify the information presented (Salter 1981:187, 199) it also led to unhelpful confrontations between lawyers, between lawyers and witnesses and between the Commissioner and the lawyers. With some notable exceptions, those who had been affected by the disease were treated rather gently. In general the lawyers reserved their more aggressive tactics for the expert witnesses. Through-out the hearings the Commissioner had to remind lawyers for the intervenor groups that the inquiry was not a court of law, the process of examination was to be inquisitorial not adversarial, and the witnesses were to be treated with respect.10 While the adoption of court-like procedures, may have contributed to the polarization of individuals and issues (Salter 1981) it can hardly be seen as the sole source of the adversarial interactions. Several of the lawyers identified very strongly with the groups they represented and 9 While the commission followed a relatively formal legal model, the hearing room was far more relaxed than an actual courtroom. The registrar, for instance, did not call the hearing to order when the Commissioner entered the room, participants were allowed to bring coffee and other beverages with them, cellular telephones were constantly ringing, lawyers and spectators alike came and went as they pleased. On one occasion one of the witnesses on the National Advisory Committee on AIDS panel got up from the stand, left the room, and return, without any comment being made. The Commissioner explained to me that it was his intention to make the proceedings as comfortable as possible for those not familiar with the courtroom while at the same time making sure the significance of the process and the decorum of the hearings was maintained. 1 0 A l l inquiries in theory, at least, are inquisitorial. The Commissioner is generally expected to intervene when things become too adversarial (Gee 1990:44). 43 that occasionally spilled over into the proceedings. For the most part, the lawyers at the inquiry were skilled courtroom litigators. They were in the habit of conducting adversarial examinations and were well experienced in the art. Some skilful performances were rendered at the hearings. At times it was hard to tell a genuine emotive outburst from what was being played out for the benefit of the media. Everyone was conscious of the media's presence; witnesses, lawyers, Justice Krever, and the members of the intervenor groups all used the press to get their messages out. The reporters, however, were fickle, their attention was hard to hold, they needed the promise of a good story to coax them out. The Hearing Room: A Day in the Life The opening act The promise of a good story had lured the press out this March morning. A new phase in the inquiry was beginning. The stories of the injured and the local functionaries had been told; it was time for those who were in charge of the system to provide a public accounting for the disaster. The show was about to get under-way, and the opening act was a headliner. Reporters from as far away as San Francisco had come to hear him testify. Dr. Donald Pinkston Francis, internationally respected infectious diseases expert and outspoken public health advocate, was about to take the stand. Francis was a popular and controversial figure. He had been on the front-line in the Sudan when Ebola first stuck and he was part of the WHO team that claimed victory over small-pox. His vociferous stand against the apathy of public officials and the inaction of the blood bankers when AIDS first emerged into public consciousness in the early 1980's made him a hero of books, movies and television. 44 Despite the anticipation there was nothing exceptional about his time on the stand. He levelled some stinging criticisms at the blood officials in both Canada and the United States and there were some heated exchanges between himself and Earl Cherniak, counsel for the Canadian Red Cross Society but for the most part, opening day at the national hearings followed a pattern which had become familiar in the provincial phase. As Justice Krever entered the hearing room, everyone rose. He seated himself, gave a nod of acknowledgement, and we all sat down again. The Commissioner wished the participants a good morning. (Most days, it was Commission Counsel who wished the Commissioner good morning.) As usual the next step in the procedure was to take care of any business; the filing of exhibits, follow-ups to previous issues, addressing other matters which may have arisen. Mr. Cherniak, rose and presented an extended submission on the behalf of his clients. He outlined a number of concerns including the belief that the tentative hearing schedule, which had been distributed to counsel, devoted too much time to the events of the 1980's and not enough time to the present structure of the system, the changes which had been implemented and the Red Cross's vision for the future. After listening to the submission Justice Krever said that he had noted their concerns, but "...The inquiry cannot go on for ever" and ultimately he, as Commissioner, would decide what issues would be addressed, not the Canadian Red Cross Society or its representatives (21470).11 Following a couple of other matters of business, Ms. Marlys Edwardh, Senior Commission Counsel, introduced Francis who was then sworn-in and informed of his right to object to answer 1 1 Information cited from the commission transcripts appear in this text as page numbers eg. (21470). In instances where it is not self evident who made the comment the citation includes a reference to the speaker eg. (Krever 21470). For an index of the transcript volumes cited in this text see Appendix 3. 45 any questions under Section 5 of the Canada Evidence Act. (All witnesses were sworn in ~ although occasionally the procedure was overlooked until after the testimony was already under- way.) Francis did not avail himself of the protection of Section 5 of the Canada Evidence Act although many witnesses who appeared before the commission did. That many sought protection was not surprising given the plethora of outstanding and potential lawsuits arising from the contamination of the blood system. (The legal implications no doubt contributed to the circumspection displayed in the answers provided by a number of the witnesses.) One final piece of business, which had been overlooked, the filing of Exhibits ~ including 11 volumes of documents relating to the early history of HIV and the American institutional response to the disease ~ was dealt with before Edwardh turned her attention to Francis' Curriculum Vitae. Curriculum vitae A review of the expert witness's Curriculum Vitae generally followed their swearing-in. This ensured that the highlights of the C.V. were entered into the record while providing the audience ~ especially those watching the hearings at home on television ~ with an outline of the witness' education, practical experience, employment history, professional affiliations and memberships, publication record, etc.12 The review helped focus attention on those areas of the witness' training, experience and expertise which bore most directly on the issues of interest to the commission. 1 2 Copies of the witness's C.V. were distributed to the legal representatives of each of the intervenor groups and extra copies were frequently made available for the media and other observers in the hearing room. 46 The C.V. was an important element in negotiating the public identity of the witnesses.13 It was employed both by them and counsel to establish or challenge their expertise and authority to speak on particular matters. Examination in-chief The first part of the morning was taken up examining Francis's C.V. and exploring the history, structure, and functions of the Centers for Disease Control in the United States. At 11:30 A . M . the commission took its customary morning break, resuming about twenty minutes later. After the break Edwardh turned to the early history of the disease. Her examination ranged from a general review of institutional structures of the blood system in the United States in the early 1980's to the specific events and activities surrounding the emergence of AIDS and the efforts taken to protect the blood supply. She examined the evidence available at the time, the methods used to generate it and the meanings attached to it by the experts. In the process Francis was called on to enumerate facts as well as offer opinions on a range of technical and social issues. Among the areas addressed were clinical medicine, public health and public health education, epidemiology, virology, serology, transfusion medicine, and blood product manufacturing. The interaction between Edwardh and Francis was relaxed, assuming the form of a dialogue for the most part. She asked many open ended questions: his answers frequently took a narrative style, sometimes running two or three minutes in length. A typical exchange, however, included a 1 3 For a discussion of some of the strategies employed in the construction of expert identities in the public hearing process see Gary Downey, Structure and Practice in the Cultural Identities of Scientists: Negotiating Nuclear Wastes in New Mexico (1988). 47 question of one or two sentences and an answer of three or four.14 From time to time the Commissioner would interject, sometimes to clarify a point about the documents that were being referred to, sometimes to seek clarification, and other times to pursue an issue which had been overlooked or not fully addressed. The documentary evidence played an important role in Francis's testimony as it did with all the expert witnesses. The documents were used by the witnesses and examiners to affirm particular points of view as well as to challenge them. They were interpreted and reinterpreted; and at times, their meanings became a matter of considerable debate and controversy. Previous evidence also entered the dialogue through the questions of the examiners. It helped shape their examinations, providing a source of questions as well as a resource drawn upon to challenge the testimony of a witness. Witnesses too, drew upon and commented on previous testimony. Witnesses became familiar with previous testimony through a variety of sources. The expert witnesses were interviewed by Commission Counsel prior to their appearance and might become aware of the previous evidence in this manner. They might also be briefed by other counsel at the commission as to particular matters that required further comment or clarification. A number of the organizations represented at the inquiry sent 'observers' ~ scientific experts, communications specialists, bureaucrats ~ to the hearings. A witness associated with one of these groups, therefore, might be made aware, either formally or informally, of previous testimony or documentary evidence. Media reports and the live and taped broadcasts of the proceedings provided yet other sources, as did press releases issued by a variety of the organizations 1 4 It was not uncommon for Francis to use sentences containing as many as 35 to 50 words. Ms. Edwardh's sentences were somewhat more modest, extending on occasion to 25 or 30 words. 48 represented at the inquiry. Copies of the previous day's transcripts could be purchased on floppy disk from the transcription company contracted by the commission. A 'hard' copy of the transcripts also was available, to the witnesses, the media as well as the public, in the media room. Finally, it was not uncommon to see witnesses who had appeared at the commission or were scheduled to appear, watching the proceedings in the public area. As was custom, the proceedings adjourned at 1:00 P .M for lunch. The reporters converged on the hearing room, forming a scrum around Dr. Francis. Within a few minutes, however, virtually everyone had drifted from the room. Around 2:15 people began to drift back into the hearing room, with a final rush at 2:30, just as the proceedings got under-way. Far fewer of the seats in the public area were occupied in the afternoon session. Perhaps the greatest struggle at the hearings that afternoon took place amongst the members of the audience ~ the struggle to stay awake. It was a battle waged most afternoons ~ the heads of audience members gently tipping forward, jerking up suddenly only to sink slowly forward again. The recycled air in the office tower, the warmth of the afternoon sun coming through the window, and the relative inactivity of the observers, when combined with what at times could be a staggeringly dull exchange of questions and answers, acted as a potent soporific on many of the spectators. By the time 4:30 arrived, the usual time the proceedings adjourned for the day, everyone appeared ready for a change. 49 Cross-examination Francis was on the stand for about 18 hours over a 4 day period. Edwardh's examination in- chief took about 10 1/2 hours, the cross examination lasted approximately 7 1/2 hours. During that 7 1/2 hours he was examined by 12 lawyers.15 On average 30 to 50 percent of an expert witness's time on the stand was dedicated to cross- examination. As most witnesses appeared for a pre-determined period — generally 2 to 4 days ~ there were real time constraints when it came to cross-examination. Those wishing to question the witness were asked to let the commission know how much time they would require. Commission Counsel then determined the amount of time each would be given to carry out their cross-examination. The time restrictions helped shape the style of examination and the interactions between the witnesses and the lawyers, and this affected the quality of the evidence presented. Cross- examination was much faster paced, something which became apparent to me as I tried to keep up taking notes. Less time was spend pondering the minutiae in the documentary evidence. Strategies were also employed to limit the witness's answers, especially the use of restrictive yes/no style questions. More open-ended why questions, inviting narrative exposition, were generally avoided. This depended, in part, on whether the examiner considered the witness an ally or not. The lawyer was more likely to relinquish some control and give 'freer rein' to those they perceived as having allied interests. This pattern appeared to be typical of that found in 1 5 Most of the intervenor groups were allotted thirty minutes for their cross examination. Some ~ such as counsel for the federal government ~ took less than 10 minutes others such as Cherniak questioned Francis on the behalf of the CRCS for 3 1/2 hours. 50 courtroom practice 1 6 . During cross-examination the lawyers often tried to keep the witnesses focused on a very narrow range of issues. As one lawyer at the inquiry explained to me, the object is to convince the witnesses that you know the material better than they do. You do this by keeping them locked into a very narrow channel which you have researched thoroughly. You try not to let them out of it. You make them think that your knowledge of the field is "a mile wide and a mile deep, when in fact it is a mile deep but only an inch wide". This sort of strategy led to some interesting interactions, as the witnesses in many cases were equally well-skilled in handling themselves in difficult public situations. Struggles between the witnesses and counsel would occasionally break out, especially when overly restrictive tactics were employed by the lawyers or evasive answers were proffered by the experts.17 Justice Krever would intervene on occasion to ensure that the witnesses had an adequate opportunity to answer fully the questions posed. Ensuring that the witnesses had an adequate opportunity to present their views was a critical issue not only in terms of gathering information but also in terms of the concern over natural justice.18 This was particularly pertinent to the Krever Inquiry given the 1 6 For a discussion and analysis of examination techniques employed in the courtroom see William M . O'Barr Linguistic Evidence: Language Power and Strategy in the Courtroom (1982), and Susan Urmston Philips, The Social Organization of Questions and Answers in Courtroom Discourse (1987). For a discussion of issues the expert medical witnesses may face in the courtroom and the public inquiry see D.J. Gee The Courts and the Doctor (1990). Gee suggests that among the various venues to which a doctor may be called to testify the public inquiry is perhaps the most stressful. Even veteran witnesses can find themselves shaken by the experience (Gee 1990). 1 7 These sorts of struggles were not restricted to the cross-examination, but they were far more common during this phase than during the examination-in-chief. 1 8 For a discussion of natural justice in the public inquiry process see John J. Roger, Natural justice and the big public inquiry: a sociological perspective (1987). 51 legal challenges which were launched following the commission's issuance of Section 13 notices in late December 1995. Section 13 of the Canada Inquiries Act stipulates that: "no report shall be made against any person until reasonable notice has been given to the person of the charge of misconduct alleged against him and the person has been allowed full opportunity to be heard in person or by counsel." 1 9 The specific and often divergent interests and concerns represented by the various intervenor groups, helped limit the duplication of the areas covered in their cross-examinations, enabling the A central responsibility in investigatory inquiries is the protection of individual rights, including the right to be heard. The question of whether some of the witnesses had been given an adequate chance to present their views became an important issue in the legal challenges which were launched against the Krever Inquiry following the commission's issuing of Section 13 notices to 95 persons, corporations and governments. The notices informed the recipients of the possibility the commission might make findings of 'misconduct' against them. The Canadian Red Cross and five pharmaceutical companies, together with the federal government, a half dozen provincial governments and various ex-officials of the Canadian Blood System immediately launched a series of unprecedented court challenges over the scope of the inquiry and its ability to make specific findings of misconduct. Several of the litigants fell out after the Federal Court ruled in Justice Krever's favour but a number of them including the Red Cross, 13 of its ex or current officials, several pharmaceutical companies as well as a number of ex- bureaucrats and government ministers appealed the ruling. Justice Richard of the Federal Court of Appeal ruled in Justice Krever's favour upholding his right to make findings of individual misconduct. Justice Richard stated that the Blood inquiry "does not carry the same weight as a trial," Justice Krever's findings of wrong-doing only reflect his own "opinions." The Court did, however, restrict the number of individuals Justice Krever could name. Following this decision the Red Cross, 2 of the drug companies and 12 individuals applied for and were granted leave to appeal the case to the Supreme Court of Canada. The matter came to an end in the late Summer of 1997 when the Supreme Court unanimously upheld the lower court ruling that Justice Krever had the authority to make findings of fault. The legal challenges, which delayed the release of the Final Report by more than a year, were considered by many to be extremely significant for the future of public inquiries in Canada. In pursuing the matter to the Supreme Court the Red Cross argued that given the current widespread use of commissions of inquiry, establishing what powers they were to have and what legal "safeguards" the "targets" of such proceedings were to enjoy, was a matter of "national importance" and a matter "urgently" requiring the guidance of the Supreme Court. Concern was expressed in many quarters that if the Supreme Court found in favour of the litigants it would spell the end of the ability of pubic inquiries to carry out thorough-going investigations. 52 individual lawyers to focus their expertise and energy on the particular areas of concern to them and the groups they represented. Some of the legal representatives carried the strategy further, forming alliances with one lawyer taking responsibility for issues surrounding risk estimates, for example, another perhaps focussing on educational efforts, and another dealing with the acquisition and distribution of manufactured plasma products. While there appeared to be no strict adherence to this strategy it occasionally provided intervenor counsel with the opportunity to pursue key issues in greater depth than would have been possible had they not worked co-operatively. The co-operative interaction amongst the various groups also extended their sharing of information and informants.20 Access to information and expert advice was an issue of considerable concern. A number of representatives from the intervenor groups complained to me about not having adequate access to experts. They felt at a disadvantage compared to some of the groups represented at the inquiry who had their own scientists on staff.21 While the strategies employed by the intervenor counsel helped reduce overlap among themselves, their examinations often travelled the same path already covered by the Commission Counsel. As a result there were many repetitious moments in the cross-examination, although on occasion it drew out some important issues. 2 0 Liora Salter (1981) and Brian Wynne (1982) have drawn attention to ways in which public inquiries can stimulate and facilitate the formation of information gathering networks amongst intervenor groups. 2 1 Counsel for some of the groups also spoke about the difficulties they had experienced in finding scientists who were willing to go on the record with their criticisms of the Blood System and the decisions which were made surrounding AIDS and the blood supply in the early 1980's. 53 SECTION TWO: THE WITNESSES' ACCOUNTS PART ONE: AIDS A N D THE A M E R I C A N BLOOD SUPPLY C H A P T E R TWO: DR. D O N A L D FRANCIS: THE CDC A N D THE E A R L Y Y E A R S OF THE O U T B R E A K 2.1 Confronting AIDS Curriculum Vitae Ms. Edwardh, senior counsel for the commission, began her examination in-chief with a brief overview of Dr. Francis's Curriculum Vitae (CV). She pointed out that from 1975 to 1977, he held a Fellowship in infectious diseases in Channing Laboratory, Harvard University Medical School in Boston and in 1979, he received his Doctor of Science in Microbiology and Virology at Harvard School of Public Health (21482-3). Francis pointed out that he had combined clinical work in infectious disease with laboratory research while at the School of Public Health. He recalled that it was during this period he first learned that a viral infection, years after its acute phase, could lead to a variety of chronic manifestations, including cancer. This insight, he suggested, gave him an abiding interest in the late manifestations of viral infections (21487-8).1 Turning to his practical experience Edwardh noted that he joined the CDC in 1971 and for the next 20 years remained with the organization. After retiring from the service, she said, Francis 1 One of the most interesting models of this phenomenon at the time was feline leukaemia virus, a disease which initially produced only a mild clinical state in the animal but could later cause marked immunosuppression, the occurrence of opportunistic infections, immunocomplex diseases and cancer (Francis 21488). 54 joined a private pharmaceutical company, where he was involved in research on the development of an AIDS vaccine (21484). She pointed out that in 1978 he assumed the position of Assistant Director for Medical Science, Hepatitis and Viral Enteritis Division, Centers for Disease Control, Phoenix Arizona (21488).2 Francis told the commission that he was initially in charge of the epidemiology side of the activities at Arizona, monitoring hepatitis, studying its occurrences, designing and implementing programs for its control. An important part of his work there involved the investigation of the newly developed hepatitis vaccine (21489-90).3 This research necessitated carrying out in-depth interviews, which, he suggested, led him to develop some "very close relationships" with a several of the participants in the study (21490-1). Edwardh noted that in May 1983 he became coordinator, AIDS Laboratory Activities, Division of Viral Diseases at the CDC Atlanta serving also as Assistant Director, Division of Viral Diseases Centers for Disease Control, Atlanta. Discussing his involvement with research on the emerging epidemic Francis explained that given his "background in a disease of cats that looked very similar to the disease we were seeing in humans at that time" and his "experience working with the gay community where this new disease, AIDS, was prevalent," it was impossible for him to stay out of the "melee" (21491-2). 2 This section of the CDC was primarily assigned to monitor and control hepatitis in the United States but it was also a World Health Organization collaborating centre for hepatitis which involved a considerable amount of international work (Francis 21488-9). 3 This was one of the two studies which led to the licensure of the hepatitis B vaccine. The study centred on five cities in the United States and involved 2,000 gay men, all of whom were considered to be free of hepatitis-at the time of their enrolment. Half of the group was given the vaccine and half received a placebo. Both sub-groups were tracked for almost 24 months to compare their respective rates of infection (21490-1). 55 Francis related how, toward the end of his assignment in Atlanta, the Director of the Centers for Infectious Diseases at the CDC, asked him to bring together existing laboratory and epidemiological field studies in the form of a Prevention Program. He drafted a national program for the prevention of AIDS in the United States which was then sent on to Washington for approval and funding. The problem, according to Francis, was the Administration "was not interested in aggressively pursuing the prevention of AIDS". The proposal was summarily rejected (21493). Francis recalled that his dismay at the attitude of the federal government caused him to contact officials in California who had earlier expressed interest in setting-up a prevention program. Finding his ideas well received, he requested a transfer which was granted. He became a CDC consultant to the State of California, a position which he held until 1992 when he retired from the Public Health Service (PHS) (21494). After establishing Francis' educational, practical and research experience Edwardh briefly touched on his publication record recounting that he had written on feline leukaemia virus and on infectious disease outbreaks; particularly on methods or strategies for their prevention and control. She also noted that in 1979 he had written an article for the Lancet on Hepatitis B infections in commercially prepared plasma products in India and that since the early 1980's he had written extensively on the epidemiology of AIDS, its spread and its control (21494-7). The Centers for Disease Control and Its Role in Public Health The review of Francis's C.V. provided Commission Counsel an opportunity to explore the history of the CDC. Francis explained that while originally established to deal with malaria, the CDC went through a number of changes over the years, eventually becoming the key Public 56 Health Service agency involved in disease surveillance (21527-8).4 Francis took this opportunity to point out one of the strengths of the CDC; its ability to bring young people into the Public Health Service. He recounted, how, in the early 1970's he had planned to move to Canada to avoid serving in Vietnam but changed his mind after learning that the C D C was a "uniformed agency" and he could fulfil his military service with them. He down- played the militaristic aspects of the CDC, however, saying that little emphasis was placed on hierarchy within the agency. Instead, he stressed the nonconformist ethos of the agency, its ability to attract youthful people willing "to question the system". This, he suggested, was one of the reasons why the CDC was so successful. Francis felt it essential that an activist spirit permeate the sphere of public health; the status quo was antithetical to good public health (21525).5 Morbidity and Mortality Weekly Reports Noting that everyone at the inquiry had occasion to read the Morbidity and Mortality Weekly Reports (MMRW), the CDC's official instrument of communication, Edwardh asked Francis i f he 4 Originally the acronym CDC stood for Communicable Disease Center. It was later renamed the N C D C , the National Communicable Disease Center. In 1980 the acronym CDC was again adopted, this time, however, it stood for the Centers for Disease Control and Prevention, a change prompted by "the victory thought to have been won over infectious diseases." The new name reflected an enlargement of the organization's original mandate to include a commitment to "the institution of research surveillance, and prevention of all causes of morbidity and mortality (Grmek 1990:14). Francis explained that the CDC originally focused on infectious diseases but over the years came "to include both occupational and chronic non-infectious disease situations" within its purview. He also pointed-out that at the same time it was expanding its scope in the early 1980's funding for the institution was beginning dwindle; annual budget cuts of 10 to 12 percent were common (21509). , 5 Francis returned to this point later arguing that "on the whole we are too conservative in public health", that despite the costs, "overreaction is probably a wise thing ..." (21727). He was adamant, however, that his view of the public health expert's role as advocate was not a moral, ethical stance, it was simply a matter of doing the job (22015-6). 57 might describe how it is created and say a bit about its history (21518). Francis confessed to being vinfamiliar with its founding history but he suspected it dated back to the earliest days of the CDC. 6 Basically, he said, the MMWR provides an epidemiological accounting — a "reporting of the given occurrence of diseases by geographical area" and that this is frequently broken down on an annual basis by age and sex (21518). He explained that "the simplest way to understand epidemiology is it is the who, what, when and why of disease occurrence and much of that can be described statistically" (21518). He estimated the weekly circulation of the MMWR in the early 1980's to have been somewhere between 100,000 and 200,000 copies. While distributed internationally, he said, it was designed primarily to keep public health practitioners and physicians in the United States apprised of current public health problems and trends. He described it as a particularly effective instrument in this respect because of its rapid reporting ability: Where it might take six months to publish an article in a journal, the MMWR can get the information out within a week (21519-20).7 Francis related how the MMWR's review process changed as the AIDS problem began to grow and how the publication became subject to political interference. In the past, he said, the MMWR was "extremely independent", today all the articles are reviewed in Washington at the Center Director's level; the Center Director ultimately decides what is going to appear in the publication. He also noted, the MMWR has changed from being an exclusively internal publication to one which includes a number of jointly authored articles (21520-2). 6 According to the medical historian Mirko Grmek the MMWR first appeared in 1961 (Grmek 1990:14). 7 According to Francis it is generally the person carrying out the particular investigation who gets "stuck" with the job of writing the article, although in the past, it was hard to tell who the author was because the items were anonymous. These days you tend to see more attribution, he said (21520). 58 Early Steps Turning her attention to the early history of the outbreak Edwardh asked Francis how he had "become involved with the AIDS issue" (21537). Francis said that, as far as memory served, his involvement began with a phone call just prior to the publication of the report of Pneumocystis carinii pneumonia (PCP) amongst young gay men in Los Angeles, June 1981. He recalled that Jim Curran, a associate at the C D C , 8 had phoned him as one colleague to another to see i f he could "lure" him into joining the effort to uncover "the epidemiology, the transmission and the cause of this new disease". According to Francis the call was a typical attempt to interest and recruit people to investigate a new disease (21537-40).9 The Commissioner interjected, asking Francis whether Pneumocystis carinii pneumonia was indeed a new disease? Francis said that neither PCP nor Kaposi's sarcoma (KS) were new diseases, "but they were certainly new diseases in healthy and young people." These were not the typical sort of individuals affected by the diseases. PCP, for instance, was a disease generally seen amongst cancer patients and those suffering from immunosuppressive disorders "so it was a very unusual phenomenon" (21540).10 8 Curran was head of the Venereal Disease Branch of the CDC and had wide experience working with the transmission of infectious diseases within the gay community. Curran headed the CDC effort to track the new outbreak. 9 Francis, in fact, had already pointed-out that the CDC "will tap into any person who will cooperate with them to search out the cause of a new disease" and that in the case of AIDS, laboratories around the world were working with the agency (21492). 1 0 Kaposi's sarcoma generally affected older men, usually of Mediterranean or Jewish ancestry (Grmek 1990:113). 59 Building information and research networks Edwardh drew his attention to the first two reports of the diseases in the MMWR in June and July of 198111 and asked him to discuss the CDC's initial response, especially its formation of a Task Force in July of 1981 to investigate the reports of PCP and Kaposi's coming out of New York and Los Angeles (21541). 1 1 The June 5 1981, MMWR, outlined the 5 cases of PCP in California. A l l had been treated in Los Angeles between October 1980 and May 1981. In addition to the rare pneumonia all 5 had a current or previous history of cytomegalovirus (CMV) infection as well as candidal mucosal infection. Four of the men had serologic evidence of past hepatitis B infection although none appeared to be currently infected. "The patients did not know each other and had no known contacts or knowledge of sexual partners who had similar illnesses." Two of them "reported having frequent homosexual contacts with various partners." A l l 5 used inhalant drugs such as amyl nitrite and one reported "parenteral drug abuse" (MMWR 1981:250-l). The Editorial Note following the report stated that "the fact that these patients were all homosexual suggests an association between some aspect of a homosexual lifestyle or disease acquired through sexual contact and Pneumocystis pneumonia in this population." It was speculated that the PCP and candidiasis infections might be related to a common exposure that predisposes individuals to opportunistic infections. Cytomegalovirus (CMV), it was pointed out, had been known "to induce transient abnormalities of in-vitro cellular-immune function..." The authors of the Note, however, cautioned that it was not possible to establish the role of C M V in the recent series of illnesses given the "lack of published data on cellular-immunity among healthy homosexual males..." (MMWR 1981:251-2). A month later the first scientific report of a rare cancer affecting gay men appeared. The July 3 1981, MMWR, reported that in past the 30 months Kaposi's sarcoma (KS), had been diagnosed in 26 homosexual men (20 in New York City and 6 in California.) Like the PCP outbreak in Los Angeles the rare form of sarcoma seemed to be affecting relatively young, previously healthy, homosexual men. A number of the KS patients also suffered from opportunistic infections including PCP, C M V , candidiasis, and herpes simplex. Past infections with hepatitis were also common. It was also noted that since that previous report of the 5 PCP cases in Los Angeles an additional 10 cases (4 in Los Angeles and 6 in the San Francisco Bay area) had been identified in homosexual men. Two of the 10 new cases also had KS (MMWR 1981:305-6). The Editorial Note following this report indicated that it was "not clear i f or how the clustering of KS , Pneumocystis, and other serious diseases in homosexual men is related." It also observed, earlier studies of patients with KS demonstrated a specific serologic association between KS and C M V and researchers had previously hypothesized "that the activation of oncogenic virus during periods of immunosuppression may result in the development of K S . " The author cautioned, however, that while immunosuppression often results in C M V , "it is not yet clear whether C M V infection precedes or follows the above-mentioned disorders" (MMWR 1981:306-7). 60 Francis described it as "a common response to an unusual event". It was a serious situation. "This was not just a disease that made you feel sick and the whites of your eyes turned yellow like hepatitis; this was a disease that when that happened you went on to die." It was typical in such situations, for the CDC to establish a group to look into and evaluate reported occurrences, he said (21542-3). Francis suggested that the first thing you do when investigating a new disease is find some way of reporting it. This, requires several things including a clear definition of the disease, the cooperation of medical personnel in the field who are in contact with infected patients and the development of a network of investigators to follow up reports when they are received. In the case of this mysterious new outbreak, one of the first problems that had to be dealt with was that both PCP and Kaposi's sarcoma existed previous to the outbreak; a means had to be devised to separate the new disease from the older ones. Francis recalled that while the definition changed over time it was initially decided that because Kaposi's sarcoma was a disease of older individuals, only biopsy-confirmed cases, reported in those under sixty years of age, were to be considered as an occurrence of the new disease. Similarly, only those cases of PCP where the individual was free of the underlying conditions traditionally associated with the infection, would be considered as an instance of the new disease (21543-5). With a working definition established reporting forms were drawn-up and distributed to those in the field. Francis explained that the success of the approach depended on gaining the cooperation of local health officials and practitioners for whom the form represented extra work and few rewards. They were certainly not compelled to help: At the time the disease was not reportable under law. Nonetheless, he said, in the case of this new disease, as with other diseases, when the CDC asked for assistance there was high compliance on the part of those in the field. 61 Reports began to flow in. Once received an investigator was dispatched to follow them up. Initially these follow-ups were carried out by CDC representatives but as the number of cases increased they came to depend on local individuals to carry out the investigations (21544-5). Francis recounted how in tracking the outbreak, the CDC also drew on existing resources. One of the most valuable of these turned out to be the dispensing records for pentamidine, an unlicensed drug distributed by the CDC and used almost exclusively for the treatment of PCP. The CDC had been the sole distributor of the drug in the United States since 1967. Dispensing records provided an overview of the historical incidence of PCP infections while in-coming requests for the drug helped identify new cases as they emerged. Cancer registries throughout the United States were also examined in an attempt to establish the incidence of Kaposi's sarcoma prior to 1980 and to track current incidence rates (21549-50). With an information gathering and research network in place, the CDC rapidly began to compile an enormous amount of information. By November 10, as Edwardh pointed-out, they had documented 159 cases of the disease in the United States. Francis added that in 40 percent of those cases, the individuals had already died (21552). Conflicting Hypotheses Francis told the inquiry that the early information emerging from epidemiological, clinical and laboratory research reinforced the belief, at least amongst CDC experts, that they were looking at a new disease, caused by a viral agent with a pattern of transmission similar to hepatitis B. He also noted that almost from the beginning a link was made between the behaviours of those 62 affected and the disease.12 He did allow, however, that a number of competing hypothesis were entertained during the early months and years, especially by those outside of the CDC (21574). Some, for example, felt that amyl or butyl nitrite might cause the illnesses by altering the immune systems of its users while others speculated a toxic contaminant in the nitrites might be causing the outbreak (21576). Francis told the commission that personally, he did not see support for the nitrite hypotheses in the epidemiological data. First, the outbreak seemed to be concentrated in a few major cities, whereas "poppers" (a term commonly used to refer to the nitrites), were used across the country. If nitrites, or some contaminant in them, was causing the immune suppression, why was the disease not being seen throughout the United States? Second, not all the gay men with AIDS used poppers. The involvement of nitrites became even more problematic, with the identification of the syndrome amongst I.V. drug users in December 1981.13 Intravenous drug users were not known to take poppers. The nitrite hypotheses did not provide a link between the groups. With the reports of Haitian and hemophiliac cases in July 1982, the nitrite hypothesis grew even less plausible (21593-94).14 Laboratory tests also revealed 1 2 A short while later Francis pointed to a June 18 1982, edition of the MMWR saying it provided important support for the early suppositions. The MMWR reported on a cluster of KS and PCP infections amongst male homosexuals in Los Angeles and Orange Counties California. He explained that investigators established a pattern of sexual contact amongst various members of the group and some time later linked them with another group of patients in New York. Ultimately, he said, all of them were linked to the Canadian airline steward, referred to as "patient zero" (21590-3). 1 3 The association of the disease with I.V. drug-users was first reported by Henry Mazur et. al in the December 10 1981, New England Journal of Medicine (Exhibit 549:tab 6). 1 4 The disease was first reported amongst Haitians in the United States in the July 9 1982, MMWR (Exhibit 549:tab 28.) The following week the MMWR announced that PCP had been reported in the cases of three hemophiliacs (Exhibit 549:tab 29). The emergence of a variety of groups at risk for the disease had important implications for research both the terms of the 63 no causal link between nitrites and the new syndrome. Francis described how they had exposed "some poor rats to nitrites for several months and probably gave them terrible headaches, but nothing else". Other than the association between the gay "lifestyle" and the use of poppers, the nitrite hypothesis lacked any strong supporting evidence. Despite this, he said, the hypothesis persisted until it was finally laid to rest in a September 9 1983, article in the MMWR (21589).15 Another popular explanation at the time was the "immunologic overload" hypothesis, based on the notion that repeated exposures to foreign proteins in clotting factors, the "garbage" in street drugs or the introduction of semen into the blood stream during anal intercourse, might eventually cause the immune system to "burn-out". The major problem with this theory, according to Francis, was the apparently recent appearance of the disease. Homosexual behaviour has existed for thousands of years yet this devastating form of immune suppression appeared to have arisen only recently. Similarly, he said, the intravenous injection of contaminated street drugs has gone on for decades yet there was no indication in the historical and medical literature of the previous existence of the disease among drug users. Another problem, he pointed out, was the theory's inability to explain why the transmission of the disease and its incidence. Where gay and IV drug using populations were diverse, and in many instances anonymous, hemophiliacs presented a relatively circumscribed and easily observed group. With the hemophiliacs "you have an entire group to study." Within months of the disease being reported in the hemophiliac population studies were beginning to report the extent of the disease markers within the population (Francis:21649). Hemophiliacs, however, were frequent users of blood products. It was not until the emergence of transfusion associated cases, which were more likely to be one time treatments, that the moment of infection could be identified and specific suspect donors identified and traced. 1 5 When the early hypotheses began fall apart some researchers speculated that nitrites were acting in conjunction with a genetic predisposition to produce the new disease. Most of the investigators at the CDC, however, felt that nitrites use "was really a secondary phenomenon due to sexual contact. That... individuals who had lots of sexual activity would be more likely to use stimulants" (Francis 21589). 64 outbreak among gay men and intravenous drug users was restricted to specific geographic locales when the behaviours were evident throughout the country. He characterized the theory as "...a new and yet to be described phenomenon..." one which remains undocumented "to this day" (21575) . Some explanations enjoyed wider support than others.When Edwardh asked about Cytomegalovirus (CMV), for example, Francis acknowledged that many, both inside and outside of the CDC, initially thought C M V was involved in the outbreak. He pointed out that from the first published report of the disease in June 1981, C M V was "mentioned as a possible etiology" (21576) . (Early studies indicated that close to 90 percent of those affected by the syndrome were either currently infected with, or had a history of, CMV.) Francis, however, made it clear that the C M V hypothesis had its sticking points. It had been known for some time ~ in fact long before AIDS appeared ~ that C M V infection was widespread amongst sexually active individuals, both gay and heterosexual. It remained to be explained, then, why only some of those infected with C M V developed immune suppression. There was also the puzzle of why ~ given the history of C M V ~ this new disease was appearing only now. Francis suggested that some of those working in the field speculated that either the cytomegalovirus had changed or that it was working in combination with some other agent (21575-6). Even i f this was true, he said, it still did not explain why approximately 10 per cent of those with AIDS showed no indication of C M V infection at all (21579). By the summer of 1982, as he recalled, the C M V hypothesis had lost much of its force (21586). As information continued to. accumulate throughout 1982 and 1983 many of the early conjectures grew less plausible. The ever increasing number of medical and scientific experts working in the field of AIDS research, however, were far from agreeing as to what was causing 65 the disease or what methods might be effective in its prevention. This uncertainty helped fuel resistance within the blood banking sector to the imposition of any new protocols aimed at protecting the blood supply. A Clash of Opinions: The January 4th 1983, Joint Meeting This resistance became particularly apparent at the January 4th 1983, meeting in Atlanta. The meeting represented a critical juncture in the early history of AIDS and the blood supply. The meeting had been called by United States Assistant Health Secretary, Edward Brandt with the purpose of formulating recommendations for the prevention of AIDS; the emphasis was on the possible transmission of the disease through blood and blood products (Francis 21783-4). Invitees included representatives from the volunteer and commercial blood banking sectors, pharmaceutical manufactures, the hemophilia and gay communities, hemophilia treaters, the CDC, the F D A and the media. Francis told the commission that he and his colleagues at the CDC had been somewhat naive going into the meeting; they expected that the information would be presented, a series of preventative methods would be proffered and that the various groups would simply fall in line behind the CDC recommendations. In practice, he said, they found things to be quite different. Francis recalled there being a big square table at the meeting, with about 40 invitees located around it. At its head sat the CDC representatives. Behind them stood a large screen onto which various slides were projected depicting the history of AIDS, the epidemiology of transfusion and hemophilia associated AIDS, and the benefits of surrogate testing (21823-4).16 Following the 1 6 Surrogate testing involved the use of indirect laboratory tests as an indicator of possible risk. For example, the early association between Hepatitis B and AIDS suggested that tests which detected individuals with a history of hepatitis B might be effective in identifying those at risk of 66 various presentations, a series of what Francis described as "relatively obvious" methodologies for dealing for the problem of AIDS in the blood supply, were tabled. As he explained, the methodologies, "were out on the table for discussion and the meeting was supposed to come to some recommendations. It was quite obvious what the CDC recommendations were going to be, but it's typical that you want to bring the parties at hand along with you before you make the final recommendations of the group. And... after the meeting, we naively presumed that we would have a summary of what the group recommended along these avenues" (21824). According to Francis, what followed, was "an absolutely horrible" discussion in which the blood bankers from the volunteer sector resisted the CDC's proposals. The blood bankers simply claimed that "they did not believe that transfusion associated AIDS from blood itself ~ from non- plasma containing material ~ had been documented well enough to make such radical recommendations" (21825). The CDC, in fact, found itself stymied almost at every turn. Francis described the gay community representatives as being resistant to the institution of any measures which would further stigmatize "a group who had already been, in many segments of the population, despised in the first place." They were against the use of any sort of questioning regarding sexual preference although they did support the use of surrogate tests, a strategy which also had some support within the commercial plasma collection sector. The volunteer blood bankers, however, were steadfast in their opposition to the use of surrogate testing (21824-5). Francis said that he became so frustrated at the "remarkable resistance to action", that towards the end of the meeting he began to pound the table asking '"How many deaths will it take? If you don't believe five cases, will you believe 10; will you believe 20; will you believe 30?"' carrying the new disease. (21829). 67 The Search for Meaning Initially, at least, the disagreements amongst the various players in the blood system could be explained as due to the lack of information. With the increasing amount of data which came available in 1982 and 1983, debate began to centre on the significance and meaning of what was being revealed. At the commission hearings, Mr. Sandy Graham, counsel for the Government of Canada, drew attention to the uncertainty surrounding the meaning of the information emerging in 1982 and 1983. Graham was attempting to deflect Francis' criticism of governmental inaction during the early years of the epidemic. In doing so, he contrasted the views presented in two prestigious medical journals in early 1983 (22076). He pointed to an "Editorial" in the January 13th edition of the New England Journal of Medicine which noted the current hemophilia treatment program had been very successful and would be abandoned only with the "greatest reluctance" on the part of physicians and patients alike. The author nevertheless goes on to say that even i f the evidence to demand such a radical action is lacking, the time has arrived to consider such a move (22077- 8). Graham then pointed to an article in the April 2, 1983, Lancet which argued the inverse. While advocating the maintenance of current surveillance levels it stressed that the link between clotting concentrate and AIDS "must be regarded as not proven" and that the available data did "not constitute a strong argument for a change in treatment policy" (22078-9). 1 7 While this helped insure his place in the history of the struggle to protect the blood supply it effectively marked the end of Francis' official involvement in the blood problem. He had become "persona non grata" with the blood bankers. 68 Francis agreed, there was considerable discussion and debate over the meaning and significance of the rapidly accumulating information and there were a variety of approaches employed in trying to establish what the evidence was saying. Conflicting standards Some, like the volunteer blood bankers, met the uncertainty by refusing to accept any hypothesis which had not been generated through the appropriate application of scientific methods and which had not satisfied the standards of scientific proof. Until those demands had been met any significant change to standard practice was simply unwarranted on scientific grounds. They argued there was simply no proof that AIDS was caused by an infectious agent, let alone a virus, never mind it being transmitted through the blood supply. Early research had failed to fulfil Koch's postulates.18 No specific causal agent had been isolated and identified, nor had any researchers successfully transferred the disease from one host to another. During his testimony Francis acknowledged that efforts to isolate the virus from infected individuals and transfer it into chimpanzees had been unsuccessful (21723). He denied, however, that this failure was sufficient to warrant inaction on the part of those in charge of the blood system. According to Francis it was common within public health to take action without having 1 8 Great advances in bacteriology were made in the latter decades of the 19th century but there were also numerous failures for which there were no shortage of fanciful explanations. To stem the tide of this uncritical work, physician/bacteriologist, Robert Koch (1843-1910), set out his now famous postulates which maintained "that to prove that an infectious agent is the cause of an illness, it is necessary to establish that: 1) The parasite is present in every case of the disease under appropriate circumstances; 2) The parasite should occur in no other disease as a fortuitous and non-pathogenic parasite; 3) The parasite must be isolated from those infected subjects, cultivated in vitro (in pure culture), and induce the disease when introduced into health subjects" (Fujimura and Chou 1994). 69 satisfied Koch's postulates. He illustrated his point noting that preventative action had been initiated in the cases of legionaries disease and toxic shock syndrome long before any causal agent had been identified (21730-31). Besides, Francis felt that the California baby case, reported in the December 1982 M M W R , had satisfied the postulates, "... [H]ere you had a clear case of an at-risk individual, a gay male donating blood, or in this case a portion of the blood, platelets, to a baby who then developed AIDS..." The laboratory experiments may have been unsuccessful but here you had the terms of Koch's postulates satisfied "in a real life setting" (21762).1 9 Many, however, did not accept the California baby case as being a case of AIDS. As Francis pointed out, sceptics argued that an infant's immune system was immature and this made it difficult to tell whether the observed immune suppression was the result of an infectious disease or the result of congenital defects (21711).20 Critics of the imputed link between blood, blood products and AIDS could simply ignore the implications of AIDS in children. Practical experience and its role in understanding There was a general refusal within the volunteer blood banking sector to accept the interpretations and recommendations of the CDC experts. As far as they were concerned they simply lacked adequate scientific warrant. Many of the insights, however, were later verified and the recommended strategies shown to be effective. The question arose as to how it was that the CDC experts got things right when so many others did not. 1 9 The California baby case, also known as the Allman case (after the physician treating the infant) became the first published report of transfusion associated AIDS. 2 0 The problems surrounding the immature immune systems of infants, in fact, led the CDC to exclude such cases from the official definition of AIDS. 70 According to Francis, experience was key to his and his colleagues early insights. For example, when the Commissioner asked him about his early belief that AIDS was caused by a virus Francis explained that it was not a matter of brilliance that brought him and his associates at the CDC to fix upon a virus as the cause, to deduce its patterns of transmission and to develop a series of effective preventative strategies. Rather, he explained, it was their past experience working with infectious diseases amongst gay men which provided them with a uniquely placed "light pole". Other investigators with different backgrounds were looking for the "keys" under different light poles. As a result there were "multiple hypotheses working in parallel." It just happened to turn out the "keys" were under the CDC's light pole, he said (21559-61). The following day the Commissioner returned to the question of the divergent points of view which existed at the time. He asked Francis whether it was "... unreasonable for other people to have a different view ~ was it not possible that you were far-sighted and they were normal, i f I can put it that way, as opposed to your being right and them being backwards" (21728)? Francis again emphasized the importance of experience saying, "...it is true that we were far- sighted and they were not, and I would not put good and evil, or even right or wrong on this in any way. The difference is, we were experienced and they were not" (21728). He said that the senior level of the CDC group working on AIDS, "had probably seen 200 outbreaks of a variety of different diseases in different countries and different agents, that sort of expertise is what you need to apply to a new disease syndrome, and there should be a great deal of weight given to the expertise" (21729). Thinking through models and analogies Throughout his testimony Francis explained that this sort of experience is central to the 71 investigation of any new disease; "you are always trying to look at [the] occurrence of the disease and fit it into some pattern so at least you get some idea of where to search. And you take all the older diseases and say 'Is there a pattern of this epidemiology that looks the same?'" (21559-60). He argued that it was experience which first brought the CDC experts to view the outbreak as significant and serious and that this led them, almost immediately, to see the disease as being caused by a virus. Experience was also central to developing an understanding of the transmission patterns and therefore the identification of those at risk, and it was fundamental to the development of preventive strategies. The key to all of this, according to Francis was the CDC experts' experience with hepatitis in the gay community. Francis suggested that those working in the field of infectious diseases, saw gay men as a "bellwether" of new epidemics to come. Experience had taught them that "once diseases got into the gay community they spread very, very effectively, usually from coastal cities into the interior of the United States, and then out. Therefore, the occurrence of any new disease in the gay population was something that we all considered something to watch very carefully" (21551- 52).21 The hepatitis analogy Those at the CDC with experience in the epidemiology of hepatitis B in the homosexual community had been struck by the similarities between it and the new outbreak. Like hepatitis B those at greatest risk of contracting the disease appeared to be homosexuals, "blood sharers", 2 1 It had been widely known from the mid 1970's onward that hepatitis was widespread within the gay community, that up to 90 per cent of gay men tested positive for hepatitis B antibodies. Unlike antigen tests which indicated whether a patient was currently infected with the disease antibody tests also recognized people who had recovered from the disease (Francis:21801). 72 individuals from developing countries, and the sexual partners of those at risk. And like hepatitis B the new disease appeared to be transmitted through contact with bodily fluids. According to Francis, by July 1982, it was clear that the new outbreak almost mimicked hepatitis B to a T ' (21609). It was not just that the patterns of transmission and the populations at risk were similar, "...they were identical... they were mirror images of each other" (Francis 21751). The analogy drawn between hepatitis B and AIDS helped give form to and directed much of the early research at the CDC. It also provided the foundation for many of the recommendations and guidelines which were developed in the coming months and years.22 Building Institutional Networks One of the things that became clear during Francis's testimony was the enormous number of different realms and areas of expertise involved in the early response to AIDS. The scientists at the CDC knew they had to gain the support and assistance of a wide variety of individuals and institutions i f they were going to be able to carry out their research programme and get their recommendations enacted. Francis recalled how the CDC struggled to enlist the support of a variety of agencies, institutions, groups and individuals world wide while at the same time maintain its scientific integrity and control. He stressed that despite its efforts to enlist a wide range of allies, the CDC tried to remain primarily scientific and for the most part stayed out of politics ~ at least formal politics (21523). He explained that as a result, the CDC had sometimes been relatively weak politically (21523) 2 2 The Guidelines for Health Care Workers which appeared in the November 5, 1982 M M W R (Exhibit 549, tab 41) for example, were virtually identical to those recommended for health workers dealing with hepatitis B patients and their specimens. 73 and that this led to difficulty gaining adequate funding. While Francis expressed the view that a "clear insulation" between science and politics was appropriate and necessary, he was unable to answer how you get the required public health funding without having political support (21529). During cross-examination, counsel for the Gignac Sutts Group, asked Francis' about the problem of elected officials interfering in the scientific independence of the Public Health Service. He wanted to know how to ensure that when public health recommendations are made by scientific agencies such as the CDC they are followed (21961). Francis began by making it clear that prior to AIDS, he had not really felt any conflict with elected officials. In the pre-AIDS era "we would make recommendations on a scientific basis and it caused very little ire from the politicians." The situation was very different with AIDS, he said, particularly after 1985, when the CDC "ended up with clear political conflicts on what messages needed to come out". He suggested that perhaps what was needed was a body like a "National Board of Health" which could serve as both a director of recommendations and an "insulator from the politicians above." He acknowledged, however, that this would not overcome the problems involved in budget setting which requires political support (21961-63). The problems the CDC faced trying to maintain support and control were not restricted to its relations with funding agencies and elected officials. They extended to the CDC's interactions with the other agencies and institutions involved in the investigation, as well as with social and consumer groups. On occasion these relations were far from collegial. For example, during cross-examination by Earl Cherniak, counsel for the Red Cross, Francis recalled that there had been "... active resistance to CDC; there was actually efforts to move responsibilities away from CDC to NIH and FDA in order to defuse the spark that CDC was trying to put to this" (22259-60). 74 Social Alliances Francis suggested, however, that a more positive relationship existed between the CDC and the gay community. He agreed with Mr. Elliott, counsel for the Canadian AIDS Society (CAS), that during the early days of the outbreak it was important to have input from gays, as well as the trust and support of the gay community leadership (21924). He said that those, like himself, who were familiar with the gay community, knew that there would be political statements and public objections to the exclusion of gay donors, but they remained confident about gaining the cooperation of the gay leadership (21924-25). He recalled that while the gay community representatives at the January 4th 1983 meeting had voiced strong opposition to the use of screening by direct questioning of donors, he remained convinced that their concerns could be met. He explained that while it was the job of the representatives "to express their political views" they were also "very reasonable" individuals. They were, after all, scientists, he pointed out; one a M.D., the other a Ph.D biologist. (21825- 26). The answer to the dilemma, Francis suggested, rested in avoiding a blanket exclusion of all gay donors and thus not raising a civil rights issue. He believed that allowing gay men who did not have sex with other men to donate would "... get rid of any feeling that you're discriminating against a specific group. But i f they've had sex, that takes them out of the ~ out of the system" (21826). Francis, also agreed with counsel for the HIV-T group about the importance of involving lay actors in the development of public health policies and initiatives (21976). He pointed out that the CDC had in fact tried to shift some of the responsibility for safeguarding the blood system to consumer groups as well as to the fractionators and blood bankers. The handful of experts at the 75 CDC, he explained, were already "overwhelmed" by all the different sides of the "mammoth epidemic". It was felt that these groups had more resources and were thus better able to deal with the problems (21978). Francis cautioned, however, that the inclusion of lay representatives sometimes impeded CDC attempts to gain broad support for its recommendations. He recalled the CDC representatives having "the wind taken out of their sails" at the July 1982 meeting of the FDA's Blood Products Advisory Committee when, Mr. Carman, a hemophiliac and representative of the National Hemophilia Foundation (NHF), pleaded with the assembled scientists, '"Don't take this [factor concentrate] away from us.'" Francis also expressed concern about involving individuals like Carman, who were in the employ of organizations such as the NHF. The NHF, he said, no doubt "received some money from manufactures" which left "all sorts of potentials for conflict of interest" (21978). Francis maintained that while it is important to bring lay representatives into the decision- making process it is essential that they not be allowed to "undermine proper public health practices"(21977). The experts have to be very clear in asserting their expertise and be willing to go against the wishes of the consumer groups when necessary. In terms of "statistics and words", it is essential "to stay at a scientific level and bring the consumer groups to that level..." (21979). The participation of consumer groups, manufactures and blood bankers was welcome, even necessary, but they had to 'toe-the-line' and not hinder the work of the experts. Francis saw them as being there in an educative and enabling capacity: they were to assist and inform CDC scientists. They were welcome to make their concerns known in scientific terms but ~ as in the case of the politicians and the blood bankers ~ they should have no ability to exert pressure on public health experts (21972). The decisions had to be left to the qualified experts. 76 Measuring Risk: The 'One in a Mill ion' Calculation In his testimony Francis argued that having to make decisions in the face of limited data and uncertainty was not a new phenomenon. Decision-making in public health is never straightforward. It was common in public health and medicine to take action without having all the information at hand. "We are always taking cutting edge data and making recommendations using that cutting edge information knowing that there are huge pieces of the puzzle that are missing" (21699). Even in cases where there is a fair degree of certainty in terms of the data and a consensus as to its meaning, decision-making is far from straight forward. There are always potentially negative consequences to any action, there are always the costs as well as the benefits to be considered. Francis explained that public health specialists are always "balancing the costs", comparing the cost of taking action with that of doing nothing ~ all the while keeping in mind that "the earlier you get water on the fire the easier it is down the road" (21724-25). During cross-examination, Cherniak attempted to show that the blood bankers and others, who refused to be goaded into what they believed were precipitous actions behaved reasonably given what was known at the time. They were doing exactly what Francis described as essential; they were trying to balance the costs and benefits. They were trying to balance the theoretical risk of contracting AIDS against "the risk of not using blood products which were necessary for their [patients'] survival or their treatment". Like many at the time, he said, the blood bankers were relying oh the current risk estimations of contracting AIDS through the use of blood and blood products and this was driving their strategies (22241). Francis agreed. The problem, he said, was that the risk estimates were faulty: in fact they were downright misleading. In early 1983 estimates began to circulate suggesting that the risk of contracting AIDS from a blood transfusion was in the order of "one in a million." Francis 77 suggested to the commission that while the "information, per se, was always correct" the supposed risk calculations represented the rate of infection not the risk of being infected. There were 10 million transfusions and 10 cases of AIDS. That was correct, but the denominator did not represent the number of recipients, it represented the number of transfusions. It, therefore, represented the incidence not the risk of contracting the disease. (Transfusion recipients receive an average of three to 4 units of blood). He also pointed out that the calculation took no account of the incubation period which was known to extend for a long period, although how long was unclear. Only those cases which had appeared were measured; the many which were suspected to lie "underneath the surface" were ignored (22241-2). Cherniak retorted that "it was the best information available at the time and it was widely accepted" (22242). Francis snapped back, "Wrong. It was the worst information at the time and it was widely accepted." Those using the figure, "had to know it was wrong... unless they were idiots." Francis did not believe they were idiots. As far as he was concerned, they knew the figure was wrong, yet they persisted in using it. They intentionally misled the public (22242-44). Cherniak challenged Francis' characterization, asking him to show the commission one publication from 1983, 1984 or 1985 suggesting the "one in a million" calculation was wrong (22243). The figure, he argued, had been presented at conferences by eminent scientists, and had appeared in industry newsletters and prestigious peer reviewed journals. It even appeared in Public Health Service publications (22243-4).23 Francis reiterated that while the figures were accurate they represented the incidence, not the 2 3 A PHS public information document dated April 1984, for example, stated that "...The chance of contracting AIDS through a blood transfusion has been estimated at less than one in a million" (22245). 78 risk, and using them as a risk estimate was misleading. The figure was intended to reassure people that everything was fine and not to worry about it. As far as the Public Health Service's role in spreading the misinformation, that too was the fault of the blood bankers. The estimate referred to in the April 1984, PHS document, he explained, had been provided by the American Red Cross. (The offices of the A R C were conveniently located just across the street from the PHS office which produced the pamphlet) (22246). The blood bankers' estimates which minimized the risks became part of the cost/benefit analyses and helped fuel resistance to the imposition of what many saw as "costly" and "unproven" safeguards (Francis 21827). Francis suggested, for instance, that Carman was "balancing the benefits without necessarily understanding the risks" when he pleaded that the clotting concentrates not be taken away (21645). 2.2 Taking Action January 13th Joint Statement and the Matter of Public Education On January 13, 1983 the American Association of Blood Banks, the American Red Cross, and the Council of Community Blood Centers released its "Joint Statement on Acquired Immune Deficiency Syndrome Related To Transfusion."24 The statement noted that the possibility of the 2 4 The Statement presented 7 recommendations for reducing the risk of AIDS transmission through the blood supply including the need for blood banks to: further extend educational campaigns to physicians to reduce the use of blood; prepare for increased cryoprecipitate use; give greater consideration to autologous transfusion; include specific questions to detect possible AIDS or exposure to patients with AIDS in their donor screening; avoid targeting individuals from high risk groups when recruiting donors; increase efforts to limit voluntary blood donation by individuals from groups with a high prevalence of AIDS; evaluate the use of surrogate tests for detecting donations at risk for carrying AIDS. The communique made it clear that direct or indirect questions regarding donor's sexual preference were inappropriate, that such an invasion of privacy could not be justified without evidence of clear cut benefits. It also made clear that no recommendation was being made for the 79 transmission of AIDS through blood, while unproven, has been raised and that this "impression" is reinforced by the 8 confirmed cases of hemophiliacs treated with factor concentrate, by a case of an infant, "and by the fewer than 10 unconfirmed case reports of other transfusion recipients" (Exhibit 554:tab 18). While acknowledging the possibility of transfusion associated AIDS the January 13th Joint Statement made clear the volunteer sector's reluctance to put forward aggressive and costly safeguards and its intention to rely on more passive strategies. Rather than trying to apply a blanket exclusion of all high risk donors, or asking invasive personal questions or instituting "unproven" laboratory tests, the volunteer blood sector opted for a program of communication and public education. Francis described the initiative as operating on two levels. The first was largely a public health undertaking involving community outreach programs and mass communication in the media. It was designed to inform the public about the disease, particularly the behaviours associated with its transmission, as well as to provide them with strategies to avoid infection. One of its central aims was to keep high risk donors away from the blood clinics (Francis 21835). The second level of the program was to take place within the blood clinics themselves. Here pamphlets and questions were to be used to inform donors of the risk groups and behaviours associated with AIDS. The hope was that any individuals at risk for the disease who made it through the clinic door would voluntarily exclude themselves (Francis 21835). routine implementation of any laboratory screening program for AIDS, although it indicated that various laboratory tests were being evaluated in areas of the country where AIDS was prevalent. It was felt, however, that the implementation of a laboratory screening program for AIDS by the voluntary sector would be inappropriate at this time. In closing, the authors noted: "...that the cause of AIDS is unknown and that evidence for its transmission by blood is still inconclusive... Until more information is available, we believe the measures outlined ... are prudent and appropriate" (Exhibit 554:tab 18). 80 Francis suggested that from a public health standpoint, these strategies — the provision of basic information on what the disease was and how to prevent it ~ were quite appropriate (21932). When you have "...an epidemic that is transmitted by behaviours such as intravenous drug use and sexual activity, education becomes paramount" (21972). He also noted the importance of educating physicians to reduce the unnecessary use of blood (21862). The specifics of the January 13th Joint Statement, however, were another matter. While reviewing the document with Edwardh, Francis referred to it as "incredibly confusing, a nightmarish form of public health education..." (21871). He took particular umbrage with a statement in item 6(b), which claimed that direct questions about their sexual behaviour '"no matter how well intentioned, are ineffective in eliminating those [high risk] donors'" (21871). He pointed out that direct questioning had been adopted by some collectors within the commercial sector and that their experience had shown it to be a very effective strategy for reducing the number of at risk donors.25 He also pointed to his own experience using such questions while working on hepatitis within the gay community. He said that as long as the interviews were conducted in private and carried out in a non-judgmental manner he encountered few problems with their use. In fact, he told the commission, the use of such questions, "was standard practice in public health ... not to mention medicine, where that information was necessary" (21772). Francis allowed that the practice of questioning donors about their general state of health was important. He argued, however, that such procedures were insufficient to safeguard the blood supply: they were "frosting compared to the ultimate questions which are dealing with risk 2 5 For example, Alpha Therapeutics, one of the more aggressive members of the commercial sector, announced at the January 4th, meeting that it had initiated a program (mid-December 1982) to educate its donors and ask them directly if they fell into any of the high risk groups. Francis noted information quickly came forward indicating that during the first few weeks of the program 305 donors had identified themselves and been deferred (21782). 81 behaviour"(21869). General health questions, he suggested, were of no value in picking up asymptomatic individuals and were extremely difficult to apply effectively in the fast moving and highly public setting of a blood donor clinic (21870). A few minutes later Edwardh asked about the value of the pamphlets used within the blood clinics. He again agreed with the idea in principle, but added that while pamphlets might be useful as a reference, he "would not rely on such a passive approach" (21892). Ms. Currie, counsel for the CRC, interrupted at this point saying she would like it noted for the record that while Francis is an expert in infectious diseases and epidemiology he has no expertise in blood banking. She argued that in litigation cases, both in Canada and the United States, his qualifications in blood banking had not been accepted (21892-93). The Commissioner replied that he was not sure why Currie wanted this noted and that he "would like to hear [Francis] on anything he has an opinion on." He then reminded her and the other participants, "for the fifteenth time," that this was not litigation. Francis's qualifications, he said, did not restrict the kind of evidence the commission would like to hear from him (21893). Currie responded that she was not objecting to the questioning but that she "wanted it noted that we will be hearing from people who are indeed experts in blood banking" (21893). Following the exchange both Edwardh and Francis worked together to reinforce his authority to speak on the matter at hand. Edwardh rephrased her question asking whether, based on his "public health background," he believed that the donor education program should have rested solely on the provision of an information pamphlet distributed within the blood donor clinics (21894). Francis replied that "from my experience in public health education, which is part of the process here regardless of whether it is a blood bank or not, this is ~ these kinds of documents are useful but they are passive-pamphlets to read are not the finest form of health education" (21894). 82 Comment on the educational effort in Canada Several times during his appearance Francis was asked to comment specifically on Canadian efforts to inform and educate both blood donors and the wider public of the risks associated with AIDS. After drawing attention to a March 10, 1983 Canadian Red Cross press