紹介
'Brilliantly documents how the flawed drug industry/government axis allows Halcion and other dangerous, but real, nightmares to be approved and widely used. The book's lessons, if learned and acted upon, can prevent further disasters of this kind from occurring ' - Sidney M Wolfe, MD, Director, Public Citizen's Health Research Group. 'Provides a rigorous but accessible analysis of the story behind Halcion. It shows how the supposedly technical evaluation of the drug has in fact been captured by wider socio-political interests. The authors make a compelling argument for greater transparency in drug regulation' - Andrew Webster, Professor of Sociology of Science and Technology, University of York, and author of "Science, Technology and Society". 'A detailed and comprehensive report of a major drug debacle, and an important contribution to the drug safety literature' - Thomas I Moore, author of "Prescription for Disaster: the Hidden Dangers in Your Medicine Cabinet". How do drugs get to the market? What controls are there and what procedures for monitoring their effects? And how adequate are the regulators in protecting public health when new drugs have serious side effects?
"The Therapeutic Nightmare" tells the story of the sleeping pill Halcion - a story which is far from over. First marketed in the 1970s, Halcion has been taken by millions of patients around the world. For many years it has been associated with serious adverse effects such as amnesia, hallucinations, aggression and, in extreme cases, homicide. Thirteen years after its first release, it was banned by the British government. It remains on sale in the United States and many other countries. This book explains why patients have come to be exposed to Halcion's risks and examines the corporate interests of the manufacturers, the professional interests of the scientists and medical researchers and the interests of patients in safe and effective medication. It reveals how these contending forces shape the regulatory decision-making process about drug safety. As the number of new drugs and health products grows, a major challenge facing regulators and the medical profession is how to put the interests of public health decisively and consistently above the commercial interests of the drugs industry, while becoming more accountable to patient and consumer organizations.
John Abraham is Professor of Sociology and Co-director of the Centre for Research in Health and Medicine at the University of Sussex. He is author of "Science, Politics and the Pharmaceutical Industry". Julie Sheppard is Head of Communications at University College London Hospitals. It was originally published in 1999.
目次
Acronyms and Abbreviations List of Tables Introduction Acknowledgements 1. The Nature of Tranquillizing Drugs Introduction The Demand for a Quiet Life For a Few Profits More Beyond Barbiturates Too Much of a 'Good Thing': Benzodiazepine Accumulation and Dependence Conclusion 2. The Political Control of Medicines Introduction Governments as Drug Safety Watchdogs The Food and Drug Administration: American Regulation Gets Serious The British Department of Health: Secrets and Shoestrings Who is Government's Best Friend: Industry or Consumers? Conclusion 3. The Rise of Halcion: Getting Approval Introduction British Acceptance of Halcion The Dutch Crisis Mobilizing American Approval Halcion is Number One Conclusion 4. Sounding the Retreat: The Accumulation of Post-Marketing Problems Introduction Not what the Doctor Ordered: Amnesia, Seizures and Hallucinations Assessing the Risks of Halcion: the Food and Drug Administration at War with Itself Compromising Medicine: Safety in Doses? Blinkering Expert Advice: the Food and Drug Administration Reconsiders Halcion Conclusion 5. Legal Challenge and Loss of Faith: British Medicines Control in Crisis Introduction The Truth is out there: the Grundberg Case The Hottest Data in Town: Protocol 32 1 Enough is Enough: the British Suspend Halcion Making up Data and Other Irregularities: Disqualified Clinical Investigators An Allegation too far: BBC Television Mangolds Upjohn Upjohn's Appeal to the Committee on Safety of Medicines Upjohn's Appeal to the Medicines Commission Upjohn's Appeal to the Panel of Appointed Persons The Medicines Control Agency Decides Conclusion 6. How the West was Won: Keep Taking the Tablets in the United States Introduction Watching the Detectives: the Food and Drug Administration's Inspection of Upjohn Return of the experts: Psychopharmacologica1 Drugs Advisory Committee, 1992 Conflicts of Interest: More than Meets the Eye Justice and the Food and Drug Administration's Conscience A Task for the Super Scientists? The Institute of Medicine Analysis Conclusion 7. Prescription for Change: The Science and Politics of Medicines Control Methodological Appendix Notes Glossary of Tranquillizers Index
