| Description |
1 online resource (197 pages) |
| Contents |
Cover; Half Title; Title Page; Copyright Page; Original Half Title; Original Title Page; Original Copyright Page; Table of Contents; 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 |
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The British Department of Health: secrets and shoestringsWho 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? |
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Blinkering expert advice: the Food and Drug Administration reconsiders HalcionConclusion; 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 321; 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 |
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The Medicines Control Agency decidesConclusion; 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: Psychopharmacological 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 |
| Summary |
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 relea |
| Notes |
Glossary of TranquillizersIndex |
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Print version record |
| Subject |
Triazolam -- Toxicology
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Tranquilizing drugs -- Law and legislation
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Pharmaceutical policy -- United States
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Pharmaceutical policy -- Great Britain
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BUSINESS & ECONOMICS -- Infrastructure.
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SOCIAL SCIENCE -- General.
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Pharmaceutical policy
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Great Britain
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United States
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| Form |
Electronic book
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| Author |
Sheppard, Julie
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| ISBN |
9781134195749 |
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1134195745 |
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