The science and politics of medicines control

Drug Safety

Volumn 26, Issue 3, 2003, Pages 135-143

  Abraham, John ^a  

^a UNIVERSITY OF SUSSEX   (United Kingdom)

Author keywords

[No Author keywords available]

Indexed keywords

CANCER RISK; CARCINOGENICITY; CONTROL SYSTEM; DRUG SAFETY; DRUG SCREENING; DRUG SURVEILLANCE PROGRAM; POLICY; POLITICS; PRIORITY JOURNAL; PUBLIC HEALTH; REGULATORY MECHANISM; REVIEW; RISK BENEFIT ANALYSIS; STANDARD;

ANIMALS; CARCINOGENICITY TESTS; CLINICAL TRIALS; CONFLICT OF INTEREST; DRUG AND NARCOTIC CONTROL; DRUG INDUSTRY; GOVERNMENT AGENCIES; GREAT BRITAIN; HUMANS; PHARMACEUTICAL PREPARATIONS; POLITICS; PUBLIC POLICY; RISK ASSESSMENT;

EID: 0037220149     PISSN: 01145916     EISSN: None     Source Type: Journal    
DOI: 10.2165/00002018-200326030-00001     Document Type: Review

References (33)

1. Merton RK. Science and the social order. In: Storer NW, editor. The sociology of science: theoretical and empirical investigations. Chicago (IL): University of Chicago Press, 1938
2. Popper KR. The logic of scientific discovery. London: Harper, 1965
3. Abraham J, Lewis G. Secrecy and transparency of medicines licensing in the EU. Lancet 1998; II: 480-2
4. Bardelay D. An ISDB survey to assess the degree of transparency of drug regulatory agencies. Int J Risk Saf Med 1996; 9: 151-5
5. Abraham J, Sheppard J, Reed T. Rethinking transparency and accountability in medicines regulation in the UK. BMJ 1999; 318: 46-7
6. Abraham J, Lewis G. Regulating medicines in Europe: competition, expertise and public health. London: Routledge, 2000
7. Abraham J. Regulatory science as culture. Science Culture 2002; 11: 309-36
8. Abraham J. Bias in science and medical knowledge. Sociology 1984; 28: 717-36
9. Abraham J. The production and reception of science papers in the academic-industrial complex. Br J Sociol 1995; 46 (2): 167-90
10. Abraham J. 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. Soc Sci Med 2002; 55 (9): 1671-90
11. Abraham J. Distributing the benefit of the douht: scientific, regulatory and drug safety. Sci Technol Human Values 1994; 19: 493-522
12. Abraham J. Science, politics and the pharmaceutical industry: controversy and bias in drug regulation. London: UCL Press/Taylor and Francis, 1995
13. Abraham J, Sheppard J. The therapeutic nightmare: the battle over the world's most controversial sleeping pill. London: Earthscan, 1999
14. Abraham J, Sheppard J. The therapeutic nightmare. The therapeutic nightmare: the battle over the world's most controversial sleeping pill. London: Earthscan, 1999: 139
15. Abraham J, Sheppard J. Democracy, technocracy and the secret state of medicine control: expert and non-expert perspectives. Sci Technol Human Values 1997; 22: 139-67
16. Abraham J. Drug safety and the safety of patients: the challenge to medicine and health from permissive expert risk assessments. Health, Risk Soc 2002; 4: 19-29
17. International Federation of Pharmaceutical Manufacturers Associations (IFPMA). The value and benefits of ICH to industry. IFPMA; 2000
18. McIntyre A. Key issues in the pharmaceutical industry. Chichester: John Wiley & Sons, 1999
19. International Conference on Harmonisation (ICH). Progress on single dossier. Scrip 2000; 2522: 17
20. Garutti RJ. Clinical safety data management: definitions and standards for expedited reporting. In: D'Arcy PF, Harron DWG, editors. Proceedings of the Second International Conference on Harmonisation. Belfast: International Federation of Pharmaceutical Manufacturers Associations (IFPMA). 1994; 373-74
21. Gordon AJ. Clinical safety data management ICH guideline recommendations and reasoning. In: D'Arcy PF, Harron DWG, editors. Proceedings of the Second International Conference on Harmonisation. Belfast: International Federation of Pharmaceutical Manufacturers Associations (IFPMA). 1994; 380-88
22. International Conference on Harmonisation 2 (ICH2). Status of tripartite harmonisation initiatives. Scrip 1993; 1872: 19
23. Brown JS, Kaitin KI, McAuslane N, et al. Population exposure required to assess clinical safety: report to the ICH working group. Drug Inf J 1996; 30: 17-27
24. International Conference on Harmonisation (ICH). Guideline on the need for carcinogenicity studies of pharmaceuticals. 1995 Nov 29
25. International Conference on Harmonisation (ICH). Guideline on the extent of population exposure to assess clinical safety for drugs intended for long-term treatment of non-life-threatening conditions. 1994 Oct 27
26. Sjoberg P. Data to support the extension of clinical trials. In: D'Arcy PF, Harron DWG, editors. Proceedings of the Third International Conference on Harmonisation. Belfast: International Federation of Pharmaceutical Manufacturers Associations (IFPMA), 1996: 343-45
27. Abraham J. Scientific standards and institutional interests: carcinogenic risk assessment in the UK and US. Soc Stud Sci 1993; 23: 387-444
28. Abraham J. Regulating the cancer-inducing potential of non-steroidal anti-inflammatory drugs. Soc Sci Med 1998; 46: 39-51
29. Contrera JF, Jacobs AC, DeGeorge JJ. Carcinogenicity testing and the evaluation of regulatory requirements for pharmaceuticals. Regul Toxicol Pharmacol 1997; 25: 130-45
30. MacDonald JS. Evaluation of mew models II. In: D'Arcy PF, Harron DWG, editors. Proceedings of the Fourth International Conference on Harmonisation. Belfast: International Federation of Pharmaceutical Manufacturers Associations (IFPMA), 1998: 272-77
31. Mitsumori K. Evaluation of new models 1: initiation and promotion models and the Hras 2 mouse model. In: D'Arcy PF, Harron DWG, editors. Proceedings of the Fourth International Conference on Harmonisation. Belfast: International Federation of Pharmaceutical Manufacturers Associations (IFPMA), 1998: 263-71
32. International Conference on Harmonisation (ICH) of Technical Requirements for Registration of Pharmaceuticals for Human Use. Duration of chronic toxicity testing in animals. 1997 Jul 16
33. Abraham J, Reed T. Trading risks for markets: the international harmonisation of pharmaceutical regulation. Health Risk Society 1998; 3: 113-28