Testing times: The emergence of the practolol disaster and its challenge to British drug regulation in the modern period

Social History of Medicine

Volumn 19, Issue 1, 2006, Pages 127-147

  Abraham, John ^a   Davis, Courtney ^a  

^a UNIVERSITY OF SUSSEX   (United Kingdom)

Author keywords

Drug safety; Medicines regulation; Pharmaceutical industry; Political culture; Practolol; Wonder drug

Indexed keywords

BETA ADRENERGIC RECEPTOR BLOCKING AGENT; PRACTOLOL;

DRUG INDUSTRY; DRUG LEGISLATION; HISTORY; HUMAN; REVIEW; UNITED KINGDOM;

ADRENERGIC BETA-ANTAGONISTS; DRUG INDUSTRY; GREAT BRITAIN; HISTORY, 20TH CENTURY; HUMANS; LEGISLATION, DRUG; PRACTOLOL;

EID: 33645558799     PISSN: 0951631X     EISSN: 14774666     Source Type: Journal    
DOI: 10.1093/shm/hkj005     Document Type: Review

References (99)

1. Department of Health Library (UK), Committee on Safety of Medicines 1975, 'Practolol and Ocular Damage', Adverse Reactions Series, January.
2. Food and Drug Administration (USA) 1971, Advisory Group on Drug-Related Carcinogenesis Meeting, Rockville, 7 October.
3. Food and Drug Administration (USA) Freedom of Information Office, Jackson I. 1971, Pharmacology Review of IND 5486 Amendments (Practolol), 31 March, Rockville, p. 2.
4. General Accounting Office 1973, Supervision of Investigational Use of Selected Drugs. Report to the Subcommittee on Reorganization, Research and International Organizations Committee on Government Operations, United States Senate.
5. Hansard Parliamentary Debates.
6. Imperial Chemical Industries 1974, Eraldin Data Sheet.
7. Imperial Chemical Industries 1977, 'In the Matter of Practolol (Eraldin)', Joint Legal Opinion by Mr C. M. Clothier and Mr Peter Crawford QC, (The Temple), 1.
8. Imperial Chemical Industries Pharmaceuticals Division 1974, 'Adverse reactions associated with long-term treatment with practolol', Dear Doctor/Pharmacist Letter, 12 July.
9. Imperial Chemical Industries Pharmaceuticals Division 1975a, 'Adverse reactions associated with practolol', Dear Doctor/Pharmacist Letter, 18 April.
10. Imperial Chemical Industries Pharmaceuticals Division 1975b, 'Restriction of Eraldin (Practolol) Sales to Hospitals Only', Dear Doctor/Pharmacist Letter, 30 July.
11. Observer.
12. Statement of Umberto Saffiotti before the Subcommittee on Executive Reorganisation and Government Research of the Senate Committee on Government Operations, 7 April 1971, p. 2.
13. Interview with expert scientist, who was a senior UK regulator during the 1970s, southern England, 19 July 2001.
14. Interview with former Head of Safety (practolol) at Imperial Chemical Industries Ltd. (hereafter ICI), 31 August 2000.
15. Interviews with former members of CSM in 1970s, southern England, 19 and 28 June 2001.
16. Interview with senior expert scientist, who was formerly member of CSM during 1980s, southern England, 19 June 2001.
17. Interview with senior UK regulator during 1970s, southern England, 19 July 2001.
18. Crout R. 1983, Head of the Bureau of Drugs, FDA, during practolol regulation, Statement in Channel 4 Television, Kill or Cure? Eraldin: The Forgotten Drug Disaster, 13 May.
19. Dimbleby D. 1977, 'Eraldin: Across the Safety Margin', BBC', Panorama, 23 May 1972.
20. Scowen E. 1977, 'Eraldin: Across the Safety Margin', BBC', Panorama, 23 May 1972.
21. Waycott J. 1977, 'Eraldin: Across the Safety Margin', BBC', Panorama, 23 May 1972.
22. Zacharias F. J. 1972, 'Practolol and Skin Reactions', New Perspectives in Beta-Blockade, International Symposium, Denmark, 238.
23. ABPI 1977, ABPI Annual Report 7976-77, London.
24. Abraham J. 1995, Science, Politics and the Pharmaceutical Industry: Controversy and Bias in Drug Regulation, London: UCL Press.
25. Abraham J. 2002, 'The Political Economy of Medicines Regulation in Britain', in Lawton Smith H. (ed.), The Regulation of Science and Technology, Basingstoke: Palgrave Macmillan, 221-63.
26. Abraham J. and Lewis G. 2000, Regulating Medicines in Europe: Competition, Expertise and Public Health, London: Routledge.
27. Abraham J. and Sheppard J. 1999, The Therapeutic Nightmare: The Battle over the World's Most Controversial Sleeping Pill, London: Earthscan.
28. Alcock S. J. and Bond P. A. 1964, 'Observations on the Toxicity of Alderlin (Pronethalol) in "Laboratory Animals'", Proceedings of the European Society for the Study of Drug Toxicity, 4, 30-9.
29. Anon. 1959, 'Trade Association News', Pharmaceutical Journal, 182, 348-9.
30. Anon. 1963a, 'Safety of Drugs', Pharmaceutical Journal, 190, 317-21.
31. Anon. 1963b, 'Committee on Safety of Drugs: Members and Terms of Reference', Pharmaceutical Journal, 190, 534.
32. Anon. 1963c, 'Committee on Safety of Drugs: Assessment of Reports to Begin on Jan. 1st', Pharmaceutical Journal, 191, 313.
33. Anon. 1968, 'Industry, Safety, Sainsbury and the Bill', Pharmaceutical Journal, 200, 274-5.
34. Anon. 1970, 'Medicines Act Reassurance for Manufacturers', Pharmaceutical Journal, 204, 48.
35. Anon. 1974, 'US Trials on Practolol Suspended', Scrip, 5 December, 17.
36. Anon. 1976a, 'Adverse Reactions to Drugs', The Lancet, 2, 1312-13.
37. Anon. 1976b, 'CSM interested in Computerised Monitoring of Adverse Drug Effects', Scrip, 11 December, 2-3.
38. Anon. 1976c, 'Pharmaceutical Industry', British Medical Journal, 2, 1397.
39. Anon. 1976d, 'CSM asked to Speed up Procedures', Pharmaceutical Journal, 217, 46.
40. Anon. 1977a, 'US BuDrugs Report Explains FDA Position of Beta-Blockers', Scrip, 12 November, 20-1.
41. Anon. 1977b, 'London Meeting highlights the Problems of Post-Marketing Surveillance', Scrip, 17 December, 9.
42. Anon. 1977c, 'Expert Committee calls for Improvements to Drug Safety Testing', Scrip, 9 April, 6.
43. Anon. 1978a, 'UK CSM suggests Post-Marketing Surveillance System in Consultation Letter', Scrip, 11 March, 2.
44. Anon. 1978b, 'Range of Post-Marketing Surveillance Schemes revealed at WHO Symposium', Scrip, 9 December, 14-15.
45. Areskog N. H. 1971, 'Effects of Practolol in Acute Exercise Studies in Angina Pectoris', Postgraduate Medical Journal, 47Suppl. 2, 44-8.
46. Bendtzen K. and Soborg M. 1975, 'Sclerosing Peritonitis and Practolol', Lancet, 1, 629.
47. Bernecker C. and Roetscher I. 1970, 'The Beta-Blocking Effect of Practolol in Asthmatics', Lancet, 2, 662.
48. Brown P. 1974, 'Sclerosing Peritonitis, An Unusual Reaction to a Beta-adrenergic-blocking Drug (Practolol)', Lancet, 2, 1477-81.
49. Bud R. 1998, 'Penicillin and the New Elizabethans', British Journal for the History of Science, 31, 305-33.
50. Cantor D. 1992, 'Cortisone and the Politics of Drama, 1949-55', in Pickstone J. V. (ed.), Medical Innovations in Historical Perspective, Basingstoke: Macmillan, 165-84.
51. Chang L. C. T. 1971, 'Use of Practolol in Asthmatics: A Plea for Caution', Lancet, 2, 321.
52. Claessens H. et al. 1972, 'Practolol in the Treatment of Acute Cardiac Dysrhythmias', Acta Cardiologica, Suppl. 16, 59-70.
53. Daemmrich A. A. 2002, 'A Tale of Two Experts: Thalidomide and Political Engagement in the US and West Germany', Social History of Medicine, 15, 137-58.
54. Daemmrich A. A. 2004, ', Pharmacopolitics: Drug Regulation in the United States and Germany, Chapel Hill: University of North Carolina Press.
55. Dollery C. T. and Rawlins D. 1977, 'Monitoring Adverse Reactions to Drugs', British Medical Journal, 1, 96-7.
56. Dunlop D. 1971, 'The Problem of Modern Medicines and their Control', Twelfth Maurice Bloch Lecture, University of Glasgow.
57. Dunstone G. H. and Ive F. A. 1975, 'Sclerosing Peritonitis and Practolol', Lancet, 1, 275.
58. Eltringham W. K. 1977, 'Sclerosing Peritonitis due to Practolol: A Report on 9 Cases and their Surgical Management', British Journal of Surgery, 64, 229-35.
59. Felix R. and Ive F. A. 1974, 'Skin Reactions to Practolol', British Medical Journal, 1, 333.
60. Fitzgerald J. D. 1972, 'The Pharmacology of Practolol: A Cardio-selective Beta Adrenergic Blocking Drug', Acta Cardiologica, Suppl. 16, 1-18.
61. Fletcher P. 1989, 'What can be Learnt by Examining the Data in the Files of Regulatory Authorities? The Clinician's Viewpoint', in Lumley C. E. and Walker S. R. (eds), Animal Toxicity Studies: Their Relevance to Man, Lancaster: Quay Publishing, 41-6.
62. Gillespie B. Eva D. and Johnston R. 1979, 'Carcinogenic Risk Assessment in the US and Great Britain: The Case of Aldrin/Dieldrin', Social Studies of Science, 9, 265-301.
63. Halley W. and Goodman J. D. S. 1975, 'Practolol and Sclerosing Peritonitis', British Medical Journal, 2, 337-8.
64. Hodges M. 1987, 'Control of the Safety of Drugs, 1868-1968', Pharmaceutical Journal, 240, 119-22.
65. Inman W. H. W. 1977, 'Recorded Release', in Gross F. H. and Inman W. H. W. (eds), Drug Monitoring: Proceedings of an International Workshop held in Honolulu 24-28 January 1977, Lancaster: MTP Press, 65-78.
66. Inman W. H. W. 1999, Don't Tell the Patient: Behind the Drug Safety Net, Los Angeles: Highland Park Productions.
67. Jasanoff S. 1990, The Fifth Branch: Science Advisers as Policymakers, Cambridge, MA: Harvard University Press.
68. Kristensen K., Kristensen J. S. and Thorborg J. 1975, 'Practolol and Sclerosing Peritonitis', Lancet, 1, 741-2.
69. Liebenau J. 1987, Medical Science and Medical Industry: The Formation of the American Pharmaceutical Industry, Basingstoke: Macmillan.
70. Lumley C. E. et al. 1986, 'The Under-reporting of Adverse Drug Reactions seen in General Practice', Pharmaceutical Medicine, 1, 205-12.
71. McLean A. 1989, 'What can be Learnt from Case Studies? A Collaborative Approach', in Lumley C. E. and Walker S. R. (eds), Animal Toxicity Studies: Their Relevance in Man, Lancaster: Quay Publishing, 79-84.
72. Mann R. D. 1984, Modern Drug Use: An Enquiry on Historical Principles, Lancaster: MTP Press.
73. Marks H. M. 1997, The Progress of Experiment: Science and Therapeutic Reform in the United States, 1900-1990, Cambridge: Cambridge University Press.
74. Medawar C. and Hardon A. 2004, Medicines out of Control? Antidepressants and the Conspiracy of Goodwill, The Netherlands: Askant Academic Publishers.
75. Meyboom R. H. B. 1975, 'Practolol and Sclerosing Peritonitis', Lancet, 1, 334-5.
76. Millar J. S. 2001, 'Consultations owing to Adverse Drug Reactions in a Single Practice', British Journal of General Practice, 51, 130-1.
77. Penn R. G. 1982, 'The Development of the Regulatory Control of the Safety, Quality and Supply of Medicines', unpublished MD thesis, University of Cardiff.
78. Pentecost B. L. George C. F. and Nagle R. E. 1971, 'Assessment of Drugs in Angina Pectoris', Postgraduate Medical Journal, 47 Suppl. 2, 49.
79. Pfeifer H. J., Greenblatt D. J. and Koch-Weser J. 1977, 'Adverse Reactions to Practolol in Hospitalized Patients: A Report from the Boston Collaborative Drug Surveillance Program', European Journal of Clinical Pharmacology, 12, 167-70.
80. Pieters T. 2004, 'Hailing a Miracle Drug: The Interferon', in de Blecourt W. and Usborne C. (eds), Cultural Approaches to the History of Medicine, Basingstoke: Palgrave Macmillan, 212-32.
81. Raftery E. B. and Denman A. M. 1973, 'Systemic Lupus Erythematosus induced by Practolol', British Medical Journal, 2, 452-5.
82. Robinson B. F. 1971, 'The Mode of Action of Beta-Antagonists in Angina Pectoris', Postgraduate Medical Journal, 47 Suppl. 2, 41-3.
83. Rowland M. G. M. and Stevenson C. J. 1972, 'Exfoliative Dermatitis and Practolol', Lancet, 1, 1130.
84. Scowen E. 1977, 'Monitoring Adverse Reactions to Drugs', British Medical Journal, 1, 975.
85. Skegg D. C. G. and Doll R. 1977a, 'Frequency of Eye Complaints and Rashes among Patients receiving Practolol and Propranolol', Lancet, 2, 475-8.
86. Skegg D. C. G. and Doll R. 1977b, 'The Case for Recording Events in Clinical Trials', British Medical Journal, 2, 1523.
87. Smart R. D. 1981, 'Foreword', ABPI Annual Report 1979-80, London: ABPI, 3.
88. Stieb E. W. 1966, Drug Adulteration: Detection and Control in Nineteenth-Century Britain, Madison: University of Wisconsin.
89. Temin P. 1980, Taking Your Medicine: Drug Regulation in the US, Cambridge, MA: Harvard University Press.
90. Thompson G. 1984, 'Rolling Back the State? Economic Intervention 1975-82', in McLennan G., Held D. and Hall S. (eds), State and Society in Contemporary Britain, Cambridge: Polity Press, 279-98.
91. Vos R. 1991, Drugs looking for Diseases: Innovative Drug Research and the Development of the Beta Blockers, Dordrecht: Kluwer Academic Publishers.
92. Walker S. R. and Lumley C. E. 1987, 'Reporting and Under-reporting', in Mann R. D. (ed.), Adverse Drug Reactions: The Scale and Nature of the Problem and the Way Forward, Carnforth: Parthenon, 124-35.
93. WHO 1969, Principles for the Testing and Evaluation of Drugs for Carcinogenicity, Technical Report Series No. 426, Geneva.
94. Wilson A. B. 1977, 'Post-Marketing Surveillance of Adverse Reactions to New Medicines', British Medical Journal, 2, 1002.
95. Wiseman R. A. 1971, 'Practolol - Accumulated Data on Unwanted Effects', Postgraduate Medical Journal, 47Suppl. 2, 68-74.
96. Wiseman R. A. 1972, 'Practolol - An Analysis of Clinical Trials in Cardiac Dysrhythmias', Acta Cardiologica, Suppl. 16, 20-8.
97. Wright P. 1974, 'Skin Reactions to Practolol', British Medical Journal, 2, 560.
98. Wright P. 1975, 'Untoward Effects associated with Practolol Administration: Oculomucocutaneous Syndrome', British Medical Journal, 1, 595.
99. Young J. H. 1989, Pure Food: Securing the Federal Food and Drugs Act of 1906, Princeton: Princeton University Press.