Acronyms and Abbreviations |
|
vii | |
|
|
ix | |
Introduction |
|
xi | |
Acknowledgements |
|
xiii | |
|
The Nature of Tranquillizing Drugs |
|
|
1 | (11) |
|
|
1 | (1) |
|
The demand for a quiet life |
|
|
2 | (2) |
|
|
4 | (2) |
|
|
6 | (2) |
|
Too much of a `good thing': benzodiazepine accumulation and dependence |
|
|
8 | (2) |
|
|
10 | (2) |
|
The Political Control of Medicines |
|
|
12 | (15) |
|
|
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) |
|
|
26 | (1) |
|
The Rise of Halcion: Getting Approval |
|
|
27 | (16) |
|
|
27 | (1) |
|
British acceptance of Halcion |
|
|
27 | (3) |
|
|
30 | (5) |
|
Mobilizing American approval |
|
|
35 | (4) |
|
|
39 | (2) |
|
|
41 | (2) |
|
Sounding the Retreat: The Accumulation of Post-Marketing Problems |
|
|
43 | (25) |
|
|
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) |
|
|
66 | (2) |
|
Legal Challenge and Loss of Faith: British Medicines Control in Crisis |
|
|
68 | (36) |
|
|
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) |
|
|
102 | (2) |
|
How the West was Won: Keep Taking the Tablets in the United States |
|
|
104 | (32) |
|
|
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) |
|
|
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 | |