CORPORATE CRIME AND THE REGULATORY STATE: THE CASE OF PURDUE PHARMA AND OXYCONTIN® By O. HAYDEN GRIFFIN, III A DISSERTATION PRESENTED TO THE GRADUATE SCHOOL OF THE UNIVERSITY OF FLORIDA IN PARTIAL FULFILLMENT OF THE REQUIREMENTS FOR THE DEGREE OF DOCTOR OF PHILOSOPHY UNIVERSITY OF FLORIDA 2011 1 © 2011 O. HAYDEN GRIFFIN, III 2 To my mother and father, thanks for all the love and support through the odyssey that was my education. You both mean the world to me and none of this would have been possible without the two of you. 3 ACKNOWLEDGMENTS I would first like to thank Joe Spillane for being my mentor for the full five years I was a graduate student at the University of Florida. From the advice he provided on seminar papers, to suggesting books and articles I should read, to critiquing my ideas, to shaping my research agenda, to the endless work he did with me on my dissertation – no other person will likely have the same impact on my career. I have not always made things easy for myself and unfortunately, this has often provided him with more than a few headaches along the way. Thus, I would like to thank him for seeing me through; I will always be grateful. I would like to thank Lonn Lanza-Kaduce for all the help he has provided me as both an advisor, a teacher and a committee member. I would also like to thank him for providing me with the opportunity to teach and all the advice he provided, especially early in my tenure in graduate school. I imagine I had more questions than any five graduate students, and he was always thoughtful and patient with me. I always enjoyed having him as a professor, both as a fellow “cult of law school” survivor and for the point of view he provided. I was always in awe of someone who had such an amazing intellect, but could so easily communicate it. I would like to thank Richard Hollinger, both as a teacher and committee member. I enjoyed having him as a professor, not only for the knowledge he provided, but for always challenging me as well. I have not met another professor who could so effortlessly make me laugh and learn simultaneously. Thank you for the input on this project, I know much of the literature I addressed is very important to you. Hopefully I did the literature justice. 4 I would like to thank Brian Mayer for serving on my committee. I know this project was not among his traditional interests, but I believe his perspective made it a much better project. I would like to thank Trysh Travis for serving on my committee, especially on such short notice, and thank her again for her comments. I would like to thank Elizabeth Dale for her previous service on the committee. Although her name does not appear on the final project, I appreciate the service and suggestions she provided. I would like to thank Bryan Lee Miller and Jeffrey Ward for their help in the very early stages of this project, as well as all other graduate students at the University of Florida who helped me throughout the last five years. 5 TABLE OF CONTENTS page ACKNOWLEDGMENTS .................................................................................................. 4 LIST OF ABBREVIATIONS ............................................................................................. 8 ABSTRACT ..................................................................................................................... 9 CHAPTER 1 INTRODUCT ION .................................................................................................... 10 2 CORPORA TE CRIME ............................................................................................. 17 Corporate Crime from Sutherland to Today: Understanding the Corporate Actor ... 18 State-Corporate Crime ............................................................................................32 States,Corporations, and Crime: Social and Institutional Environments ................. 36 3 THE PHARMACEUTICAL INDUSTRY AND STATE REGULATORY RESPONSE ............................................................................................................ 40 State Regulatory Response .................................................................................... 41 Abuse Liability Assessment .................................................................................... 51 Pharmaceutical Advertising .................................................................................... 61 4 OXYCONTIN® AND THE PROBLEM OF PAIN ..................................................... 65 Origins and Efficacy ................................................................................................ 65 A Developing Problem? .......................................................................................... 75 The Settlement ....................................................................................................... 78 The OxyContin® Narratives: Corporate Greed or Moral Panic? ............................. 80 5 METHODOL OGY ................................................................................................... 86 Research Questions ............................................................................................... 86 Constructing a Case Study ..................................................................................... 89 Expert Interviews ................................................................................................. 92 Postmarketing Surveillance ................................................................................. 94 Congressional Hearings ...................................................................................... 96 6 RESULT S ............................................................................................................. 104 Assessing the Abuse Liability Assessment System .............................................. 104 Predictive Assessments: Animal Studies ...........................................................104 Predictive Assessments: Human Studies .......................................................... 106 Predictive Assessments: Using Analogies to Learning from Past Failures ........ 110 6 Postmarketing Surveillance ............................................................................... 112 General Observations of the Abuse Liability Assessment System .................... 115 OxyContin®: Development, Approval and Marketing ............................................ 117 OxyContin®: Abuse, Diversion and Harm .............................................................127 DAWN Data ....................................................................................................... 129 NSDUH Data ..................................................................................................... 131 Monitoring the Future Data ................................................................................ 133 Postmarketing Response: A Chronological Narrative ........................................... 137 7 DISCUSSI ON ....................................................................................................... 159 Did the Abuse Liability System Actually Fail in the Case of OxyContin®? ............ 159 Developmental and Approval ............................................................................. 160 Postmarketing Surveillance and Policy Response .............................................167 Were Corporate Crimes Committed? ....................................................................171 State-Corporate Crime .......................................................................................... 180 Third Parties ......................................................................................................... 188 Conclusion ............................................................................................................ 192 LIST OF REFERENCES ............................................................................................. 197 BIOGRAPHICAL SKETCH .......................................................................................... 216 7 LIST OF ABBREVIATIONS AEA American Economic Association AIDS Acquired Immune Deficiency Syndrome ARC Addiction Research Center CNS Central Nervous System CSA Controlled Substances Act of 1970 DAWN Drug Abuse Warning Network DEA Drug Enforcement Administration FAA Federal Aviation Administration FBI Federal Bureau of Investigation FDA U.S. Food and Drug Administration GAO United States Government Accountability Office GHB Gamma-hy droxybutyrate MDMA Methylene-dioxy-methamphetamine NASA National Aeronautics & Space Administration NDA New Drug Application NHSDA National Household Survey on Drug Abuse NIDA National Institute of Drug Abuse ONCDP Office of National Drug Control Policy OSHA Occupational Safety and Health Program SAMHSA Substance Abuse and Mental Health Services Administration WHO World Health Organization 8 Abstract of Dissertation Presented to the Graduate School of the University of Florida in Partial Fulfillment of the Requirements for the Degree of Doctor of Philosophy CORPORATE CRIME AND THE REGULATORY STATE: THE CASE OF PURDUE PHARMA AND OXYCONTIN® By O. Hayden Griffin, III May 2011 Chair: Joseph F. Spillane Major: Criminology, Law and Society On May 10, 2007 three executives of the pharmaceutical company Purdue Pharma pleaded guilty in federal court to misleading doctors and patients about the risk of addiction and potential for abuse of the drug OxyContin®. It has been argued that the marketing of OxyContin®,