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Therapeutic Nightmare: The Battle Over the World's Most Controversial Tranquillizer [Kietas viršelis]

  • Formatas: Hardback, 224 pages, aukštis x plotis: 235x155 mm, weight: 330 g, figures, tables
  • Išleidimo metai: 01-Oct-1999
  • Leidėjas: Earthscan Ltd
  • ISBN-10: 1853835528
  • ISBN-13: 9781853835520
Kitos knygos pagal šią temą:
  • Formatas: Hardback, 224 pages, aukštis x plotis: 235x155 mm, weight: 330 g, figures, tables
  • Išleidimo metai: 01-Oct-1999
  • Leidėjas: Earthscan Ltd
  • ISBN-10: 1853835528
  • ISBN-13: 9781853835520
Kitos knygos pagal šią temą:
Presents an account of how the psychotropic drug Halcion came onto the market in the UK and the US and how it was subsequently withdrawn in the UK after having serious effects on many patients - such as amnesia, suicidal behaviour and psychosis. The text is a study in the issues and difficulties of controlling the safety of new drugs, the interests at stake, the science involved and the problems confronted both by regulators and consumers.
Acronyms and Abbreviations vii
List of Tables
ix
Introduction xi
Acknowledgements xiii
The Nature of Tranquillizing Drugs
1(11)
Introduction
1(1)
The demand for a quiet life
2(2)
For a few profits more
4(2)
Beyond barbiturates
6(2)
Too much of a `good thing': benzodiazepine accumulation and dependence
8(2)
Conclusion
10(2)
The Political Control of Medicines
12(15)
Introduction
12(1)
Governments as drug safety watchdogs
13(2)
The Food and Drug Administration: American regulation gets serious
15(3)
The British Department of Health: Secrets and shoestrings
18(3)
Who is government's best friend: industry or consumers?
21(5)
Conclusion
26(1)
The Rise of Halcion: Getting Approval
27(16)
Introduction
27(1)
British acceptance of Halcion
27(3)
The Dutch crisis
30(5)
Mobilizing American approval
35(4)
Halcion is number one
39(2)
Conclusion
41(2)
Sounding the Retreat: The Accumulation of Post-Marketing Problems
43(25)
Introduction
43(1)
Not what the doctor ordered: amnesia, seizures and hallucinations
43(6)
Assessing the risks of Halcion: the Food and Drug Administration at war with itself
49(4)
Compromising medicine: safety in doses?
53(6)
Blinkering expert advice: the Food and Drug Administration reconsiders Halcion
59(7)
Conclusion
66(2)
Legal Challenge and Loss of Faith: British Medicines Control in Crisis
68(36)
Introduction
68(1)
The truth is out there: the Grundberg case
68(3)
The hottest data in town: Protocol 321
71(6)
Enough is enough: the British suspend Halcion
77(4)
Making up data and other irregularities: disqualified clinical investigators
81(7)
An allegation too far: BBC television Mangolds Upjohn
88(6)
Upjohn's appeal to the Committee on Safety of Medicines
94(4)
Upjohn's appeal to the Medicines Commission
98(1)
Upjohn's appeal to the panel of appointed persons
99(1)
The Medicines Control Agency decides
100(2)
Conclusion
102(2)
How the West was Won: Keep Taking the Tablets in the United States
104(32)
Introduction
104(3)
Watching the detectives: the Food and Drug Administration's inspection of Upjohn
107(3)
Return of the experts: Psychopharmacological Drugs Advisory Committee, 1992
110(15)
Conflicts of interest: more than meets the eye
125(2)
Justice and the Food and Drug Administration's conscience
127(1)
A task for the super scientists? The Institute of Medicine analysis
127(7)
Conclusion
134(2)
Prescription for Change: The Science and Politics of Medicines Control
136(11)
Methodological Appendix 147(4)
Notes 151(22)
Glossary of Tranquillizers 173(2)
Index 175