Transnational industrial power, the medical profession and the regulatory state: Adverse drug reactions and the crisis over the safety of Halcion in the Netherlands and the UK

Social Science and Medicine

Volumn 55, Issue 9, 2002, Pages 1671-1690

  Abraham, John ^a  

^a UNIVERSITY OF SUSSEX   (United Kingdom)

Author keywords

Adverse drug reactions; Halcion (triazolam); Medicines regulation; Netherlands; Pharmaceutical industry; Post marketing surveillance; UK

Indexed keywords

DIAZEPAM; FLURAZEPAM; LORAZEPAM; NITRAZEPAM; TEMAZEPAM; TRIAZOLAM;

HEALTH SERVICES; PHARMACEUTICAL INDUSTRY; REGULATORY APPROACH;

AGGRESSION; AMNESIA; ANXIETY; ARTICLE; CATATONIA; DRUG EFFICACY; DRUG INDUSTRY; DRUG MARKETING; DRUG SAFETY; DRUG SURVEILLANCE PROGRAM; DYSPHAGIA; GOVERNMENT; HALLUCINATION; HAZARD ASSESSMENT; HUMAN; INSOMNIA; LICENSING; MALAISE; MEDICOLEGAL ASPECT; MUSCLE CRAMP; NETHERLANDS; NIGHTMARE; PAIN; PARALYSIS; PARESTHESIA; PERSONALITY DISORDER; PHYSICIAN; RESTLESSNESS; SIDE EFFECT; SKIN TINGLING; SUICIDAL BEHAVIOR; SWEATING; UNITED KINGDOM; VISUAL IMPAIRMENT; XEROSTOMIA;

ADVERSE DRUG REACTION REPORTING SYSTEMS; ANTI-ANXIETY AGENTS; DISCLOSURE; DRUG APPROVAL; DRUG INDUSTRY; GOVERNMENT AGENCIES; GREAT BRITAIN; HUMANS; INTERNATIONAL COOPERATION; NETHERLANDS; PHYSICIAN'S ROLE; POWER (PSYCHOLOGY); PRODUCT SURVEILLANCE, POSTMARKETING; PUBLIC HEALTH; TRIAZOLAM;

NETHERLANDS; UNITED KINGDOM;

EID: 0036842220     PISSN: 02779536     EISSN: None     Source Type: Journal    
DOI: 10.1016/S0277-9536(02)00160-0     Document Type: Article

References (73)

1. Abraham J. The science and politics of medicines regulation. Elston M.A. Sociology of health & illness special monograph on sociology of medical science. 1997;53-82 Blackwell, Oxford.
2. Abraham J. Regulating the cancer-inducing potential of non-steroidal anti-inflammatory drugs. Social Science & Medicine. 46:1998;39-51.
3. Abraham J., Lewis G. Harmonising and competing for medicines regulation. How healthy are the European union's systems of drug approval? Social Science & Medicine. 48:1999;1655-1667.
4. Abraham J., Lewis G. Regulating medicines in Europe. Competition, expertise and public health:2000;Routledge, London.
5. Abraham J., Sheppard J. Democracy, technocracy and the secret state of medicine. Expert and non-expert perspectives Science, Technology and Human Values. 22:1997;139-167.
6. Adam K., Oswald I. Can a rapidly eliminated hypnotic cause daytime anxiety? Pharmacopsychiatry. 22:1989;115-119.
7. Anon. (1985). Upjohn can resubmit Halcion in NL. Scrip, 1014, 1.
8. Anon. (1988). Top 50 branded products worldwide. Scrip, 20 (review issue for 1988).
9. Anon. (1990). Halcion re-approved in the Netherlands. Scrip, 1540, 22.
10. Anon. (1991a). Upjohn's Halcion data to be disclosed. Scrip, 1630, 14.
11. Anon. (1991b) Zantac leads in US. Scrip, 1669, 25.
12. Anon. (1993a). UK Halcion hearing set for February 1st. Scrip, 1788, 21.
13. Anon. (1993b). UK Panel recommends return of Halcion. Scrip, 1814, 25.
14. Anon. (1993c). Halcion - why UK authorities rejected panel advice. Scrip, 1830, 25-26.
15. Anon. (1999). European court of justice decision in Halcion case. Scrip, 2407, 2.
16. Asscher, W. (1987). The perception, measurement and management of therapeutic risk. Paper Presented on 11 June at Metropole Hotel, Brighton.
17. Asscher, W. (1991). 'Dear Doctor' Letter from W. Asscher. Chairman of Committee on the Safety of Medicines (CSM).
18. Ayd, F. (1992). Affidavit, Maryland, USA, 7 December.
19. Ayd F., Barday W.R., Callan J.P., Curran W.J., Gardner E.A., Greenblatt D.J., Ladimer I., Papierre Y., Lehmann H.E., O'Donnell T.J., van Praag H.M., Shader R.I. Behavioural reactions to triazolam. Lancet. II:1979;1018.
20. Bottomley, V. (1991). Secretary of state for health, psychotropic drugs. Hansard (Written Answers), 1568, 266-267.
21. British Broadcasting Corporation (BBC). (1991). The Halcion nightmare, Panorama, 14 October.
22. Burley D.M., Glynne A. Clinical trials. Burley D.M., Binns T.B. Pharmaceutical medicine. 1985;126-148 Edward Arnold, London.
23. Committee on Safety of Medicines (CSM). (1991). Report to EC Committee on Proprietary Medicinal Products (CPMP), 9 December.
24. Dement W.C. Rational basis for the use of sleeping pills. Pharmacology. 27(Suppl. 2):1983;3-38.
25. Dukes M.N.G. The strong, the weak and the wicked. Bowers J.Z., Velo G.P. Drug assessment criteria and methods. 1979;Elsevier, Amsterdam.
26. Dukes, M. N. J. (1994). Testimony quoted in Royal Courts of Justice Judgement between the Upjohn Company and Upjohn Ltd and Professor Ian Oswald and between Dr Royston Frederick Drucker and Professor Oswald and between the Upjohn Company and Upjohn Ltd and the BBC and Tom Mangold before Mr Justice May, Beverley F. Nunnery, London, 27 May.
27. Dukes M.N.G. Drug regulation and the tradition of secrecy. The International Journal of Risk and Safety in Medicine. 9:1996;143-150.
28. Food and Drug Administration (FDA). (1994). Establishment inspection report on Upjohn. Kalamazoo, MI, 15 April.
29. Hemminki E., Pesonen T. An inquiry into associations between leading physicians and the drug industry in Finland. Social Science & Medicine. 11:1977;501-506.
30. Idanpann-Heikkila J.E. Adverse reactions and post-marketing surveillance. Burley D.M., Binns T.B. Pharmaceutical medicine. 1985;126-148 Edward Arnold, London.
31. Inman W.H.W. Monitoring for drug safety. 1986;MTP Press, Lancaster.
32. Jones, K. (1992). Letter from Director and Chief Executive, MCA to Lee, Finance Director and Secretary, Upjohn, 17 July
33. Kagan (1979). Internal Upjohn memo to Struck, 14 September.
34. Kales A., Kales J., Bixler E.O., Scharf M.B., Russek E. Hypnotic efficacy of triazolam. Sleep laboratory evaluation of intermediate-term effectiveness Journal of Clinical Pharmacology. 16:1976;399.
35. Kratochvil. (1979). Internal Upjohn memo from the European Medical Affairs Director to Struck, 11 September.
36. Krzywicki, K. (1991). Safety of triazolam. Lancet, 338, 632.
37. Lasagna L. The Halcion story. Trial by media Lancet. I:1980;815-816.
38. Lazarou J., Pomeranz B.H., Corey P.N. Incidence of adverse drug reactions in hospitalised patients. A meta-analysis of prospective studies Journal of the American Medical Association. 279:1998;1200-1205.
39. Mann R.D. Modern drug use. An enquiry on historical principles:1984;MTP Press, Lancaster.
40. Mann, R. D. (1987). (Ed.). Adverse drug reactions: The scale and nature of the problem and the way forward (pp. 115-126). Carnforth, Lancashire: Parthenon Publishing.
41. Medawar C. Secrecy and medicines. The International Journal of Risk and Safety in Medicine. 9:1996;133-142.
42. Medicines Commission. (1992). Report on Halcion.
43. Meyboom R.H.B. The triazolam experience in 1979 in the Netherlands. A problem of signal generation and verification Strom B.L., Velo G. Drug epidemiology and post-marketing surveillance. 1992;Plenum Press, New York.
44. Morgan K., Oswald I. Anxiety caused by a short-life hypnotic. British Medical Journal. 284:1982;942.
45. Oswald I. Triazolam syndrome 10 years on'. Lancet. II:1989;451-452.
46. Personal Communication. (1994a). Interview with Professor Sir William Asscher. at St. George's Hospital Medical School, University of London, 6 October, at pp. 9-10 of transcript.
47. Personal Communication. (1994c). Interview with Professor Ian Hindmarsh, University of Surrey, 10 October.
48. Personal Communication. (1994d). Interview with Professor Ian Oswald, Edinburgh, 15 November.
49. Personal Communication. (1994e). Interview with Professor Sir Michael Rawlins, University of Newcastle, 14 November.
50. Personal Communication. (1994f). Interview with former member of the CSM.
51. Personal Communication. (1995a). Letter to Dr Assenzo, Director of Pharmaceutical Regulatory Affairs, Upjohn, Kalamazoo, MI, 13 September.
52. Personal Communication. (1995b). Letter to Edward Greissing Junior, Vice-President, Upjohn, Washington, DC, 3 October.
53. Purpura, R. (1979). Internal Upjohn memo, 17 September.
54. Rickels K., Gingrich R.L., Morris R.J., Rosenfeld H., Perloff M.M., Clark E.L., Schilling A. Triazolam in insomniac family practice patients. Clinical Pharmacology and Therapeutics. 18:1975;315.
55. Royal Courts of Justice. (1994). Judgement between the Upjohn Company and Upjohn Ltd and Professor Ian Oswald and between Dr Royston Frederick Drucker and Professor Oswald and between the Upjohn Company and Upjohn Ltd and the BBC and Tom Mangold before Mr Justice May, Beverley F. Nunnery, London, 27 May.
56. Sigelman, D.W. (1989). Halcion: Waking up to the dangers of a sleeping pill. Trial, November, 40.
57. Silverman M. Prescriptions for death. The drugging of the third world:1982;University of California Press, Berkeley.
58. Silverman M., Lydecker M., Lee P.R. Bad medicine. The prescription drug industry in the third world:1992;Stanford University Press, Stanford.
59. Upjohn Ltd. (1979). Halcion data sheet.
60. Upjohn Ltd. (1982). Halcion package insert.
61. Upjohn Ltd. (1987). Halcion package insert.
62. UK Department of Health. (1993a). Letter in 'Current Problems', 9 June.
63. UK Department of Health. (1993b). Withdrawal of Halcion, Press Release, 9 June.
64. Van der Kroef, K. (1979). Reactions to triazolam. Lancet, 526.
65. Veldkamp, W., Rudzik, A. D., Metzler, C. M. (1973). Upjohn Pharmaceutical Research and Development Technical Report, U-33,030: Six-Week Tolerance Study, SPSM Protocol No. 321, Phase II Study, 27 August.
66. Vogel G., Thurmond A., Gibbons P., Edwards K., Sloan K.B., Sexton K. The effect of triazolam on the sleep of insomniacs. Psychopharmacologia. 41:1975;65.
67. Vos R. Drugs looking for diseases. Innovative drug research and the development of the beta blockers and the calcium antagonists:1991;Kluwer, Dordrecht.
68. Waller, P. (1994). Testimony of Dr. Patrick Waller. In Proceedings between the Upjohn Company and Upjohn Ltd. and Professor Ian Oswald and between Dr. Royston Frederick Drucker and Professor Oswald and between the Upjohn Company and Upjohn Ltd. and the BBC and Tom Mangold before Mr Justice May, Beverley F. Nunnery, London, 25 April, Day 54.
69. Walker S.R., Lumley C.E. Reporting and under-reporting. Mann R.D. Adverse drug reactions: The scale and nature of the problem and the way forward. 1987;115-126 Parthenon Publishing, Carnforth, Lancashire.
70. Wheatley D. Prescribing short-acting hypnosedatives. Drug Safety. 7:1992;106-115.
71. Wieringa N.F., Meijer A.H.R., de Schutjens M.D.B., Vos R. The gap between legal rules and practice in advertising non-registered pharmaceutical products. Social Science & Medicine. 35:1992;1497-1504.
72. Wood, S.M. (1991). MCA Report from Triazolam's Medical Assessor to CPMP, 9 December.