Desperately seeking cancer drugs: Explaining the emergence and outcomes of accelerated pharmaceutical regulation

Sociology of Health and Illness

Volumn 33, Issue 5, 2011, Pages 731-747

  Davis, Courtney ^a   Abraham, John ^a  

^a UNIVERSITY OF SUSSEX   (United Kingdom)

Author keywords

Corporate bias; Disease politics; FDA; Iressa; Regulatory capture

Indexed keywords

ANTI HUMAN IMMUNODEFICIENCY VIRUS AGENT; ANTINEOPLASTIC AGENT; GEFITINIB; QUINAZOLINE DERIVATIVE;

ACQUIRED IMMUNE DEFICIENCY SYNDROME; ARTICLE; DRUG APPROVAL; DRUG DEVELOPMENT; DRUG INDUSTRY; FOOD AND DRUG ADMINISTRATION; HUMAN; LEGAL ASPECT; LUNG NON SMALL CELL CANCER; LUNG TUMOR; ORGANIZATION AND MANAGEMENT; POLITICS; PSYCHOLOGICAL ASPECT; UNITED STATES;

ACQUIRED IMMUNODEFICIENCY SYNDROME; ANTI-HIV AGENTS; ANTINEOPLASTIC AGENTS; CARCINOMA, NON-SMALL-CELL LUNG; DRUG APPROVAL; DRUG DISCOVERY; DRUG INDUSTRY; HUMANS; LUNG NEOPLASMS; POLITICS; QUINAZOLINES; UNITED STATES; UNITED STATES FOOD AND DRUG ADMINISTRATION;

EID: 79960498401     PISSN: 01419889     EISSN: 14679566     Source Type: Journal    
DOI: 10.1111/j.1467-9566.2010.01310.x     Document Type: Article

References (93)

1. Abraham, J. (1994) Bias in science and medical knowledge, Sociology, 28, 717-36.
2. Abraham, J. (1995) Science, Politics and the Pharmaceutical Industry. London/New York: UCL/St. Martins Press.
3. Abraham, J. (2008) Sociology of pharmaceuticals development and regulation: a realist empirical research programme, Sociology of Health and Illness, 30, 869-85.
4. Abraham, J. (2009) Partial progress: governing the pharmaceutical industry and NHS, 1948-2008, Journal of Health, Politics, Policy and Law, 34, 931-77.
5. Abraham, J. (2010) Pharmaceuticalization of society in context, Sociology, 44, 603-22.
6. Abraham, J. and Davis, C. (2005a) Risking public safety, Health, Risk and Society, 7, 379-95.
7. Abraham, J. and Davis, C. (2005b) Comparative analysis of drug safety withdrawals in UK and US, 1971-1992, Social Science and Medicine, 61, 881-92.
8. Abraham, J. and Davis, C. (2006) Testing times: the emergence of the Practolol disaster and its challenge to British drug regulation, Social History of Medicine, 19, 127-47.
9. Abraham, J. and Davis, C. (2007) Deficits, expectations and paradigms in British and American drug safety assessments, Science, Technology & Human Values, 32, 399-431.
10. Abraham, J. and Davis, C. (2009) Drug evaluation and the permissive principle: continuities and contradictions in antidepressant regulation, Social Studies of Science, 39, 569-98.
11. Abraham, J. and Lewis, G. (1999) Harmonising and competing for medicines regulation: how healthy are the EU's systems of drug approval? Social Science and Medicine, 48, 1655-67.
12. Abraham, J. and Lewis, G. (2000) Regulating Medicines in Europe. London: Routledge.
13. Abraham, J. and Lewis, G. (2002) Citizenship, medical expertise, and the capitalist regulatory state in Europe, Sociology, 36, 67-88.
14. Abraham, J. and Sheppard, J. (1999) The Therapeutic Nightmare: The Battle over the World's most Controversial Sleeping Pill. London: Earthscan.
15. Anglin M.K. (1997) Working from the inside out: implications of breast cancer activism for biomedical policies and practices, Social Science and Medicine, 44, 1403-1415.
16. Anon. (1981a) Change of attitude at FDA called 'essential' by Reagan advisor, Scrip, 558, 12.
17. Anon. (1981b) US 'drug lag' Commission starts work, Scrip, 611, 10.
18. Anon. (1981c) Pressure affects BuDrugs morale, Scrip, 642, 7.
19. Anon. (1982a) US NDA rewrite published, Scrip, 739, 8.
20. Anon. (1982b) Deregulation hurts FDA morale, Scrip, 685, 10.
21. Anon. (1985) FDA's willingness to help, Scrip, 993, 17.
22. Anon. (1986a) Dr Young outlines Action Plan progress, Scrip, 1074, 16.
23. Anon. (1986b) PMA/FDA co-operation, Scrip, 1096, 19.
24. Anon. (1987) 'US PMA meeting's hidden concerns', Scrip, 1213, 19.
25. Anon. (1988a) FDA discussing new proposals, Scrip, 1336, 16.
26. Anon. (1988b) Bush calls for speedier US approvals, Scrip, 1335, 16.
27. Anon. (1988c) FDA's expedited drug plan unveiled, Scrip, 1356, 18.
28. Anon. (1988d) US PMA comments on expedited drug plan, Scrip, 1346, 17.
29. Anon. (1989a) FDA battles NIAID on AIDS, Scrip, 1450, 19.
30. Anon. (1989b) FDA and drug approval, Scrip, 1378, 17.
31. Anon. (1989c) NCI/FDA clash on cancer approvals, Scrip, 1382, 16.
32. Anon. (1990a) Mixed review for AIDS/cancer panel report, Scrip, 1546, 18.
33. Anon. (1990b) AIDS activists urge ddI/ddC approval, Scrip, 1557, 30.
34. Anon. (1991a) FDA discusses conditional approvals, Scrip, 1598, 17.
35. Anon. (1991b) PMA on conditional approvals, Scrip, 1624, 18.
36. Anon. (1994) Change afoot for FDA, Scrip, 1983, 18.
37. Anon. (1995a) BIO's proposals for FDA reform, Scrip, 2006, 17.
38. Anon. (1995b) PhRMA's FDA reform plan, Scrip, 2040, 16.
39. Anon. (1995c) FDA bill reflects industry views, Scrip, 2043, 14.
40. Anon. (1997) Senate approves FDA reform bill, Scrip, 2272, 15.
41. Anon. (2002) More Iressa ADRs in Japan, Scrip, 2794, 23.
42. Anon. (2009) Iressa set to make it as second asking, Cancer Drug News, 30 April, 1-2.
43. Apolone, G., Joppi, R., Bertele, V. and Garattini, S. (2005) Ten years of marketing approvals of anticancer drugs in Europe, British Journal of Cancer, 93, 504-9.
44. Baldwin, J. (2002) Demand grows for early access to promising cancer drugs, Journal of National Cancer Institute, 94, 1668-70.
45. Brown, N. and Webster, A. (2004) New Medical Technologies and Society. Cambridge: Polity.
46. Busfield, J. (2004) Mental health problems, psychotropic drug technologies and risk, Health, Risk and Society, 6, 361-75.
47. Carpenter, D.P. (2004) Political economy of FDA, Health Affairs, 23, 52-63.
48. Clinton, B. and Gore, A. (1996) Reinventing the Regulation of Cancer Drugs. Washington DC: National Performance Review.
49. Cohen, M.H. (2002) 'Briefing document, NDA-21399' FDA Oncology Division Medical Review. Rockville, Maryland: FDA. US FOIA request.
50. Conrad, P. (2007) Medicalization of society. Baltimore, MD: Johns Hopkins University Press.
51. Daemmrich, A. (2004) Pharmacopolitics. Chapel Hill, NC: University of North Carolina Press.
52. Daemmrich, A. and Krucken, G. (2000) Risk versus risk, Science as Culture, 9, 505-34.
53. Edgar, H. and Rothman, D.J. (1990) The challenge of AIDS to the regulatory process, Milbank Quarterly, 68, 111-42.
54. Epstein, S. (1996) Impure Science: AIDS Activism, and the Politics of Knowledge. Berkeley, CA: University of California Press.
55. Epstein, S. (1997) Activism, drug regulation and the politics of therapeutic evaluation in the AIDS era, Social Studies of Science, 27, 691-726.
56. European Commission (EC) (1993) Article 13(2), Regulation 2309/93. Brussels: EC.
57. FDA (1998a) Guidance for Industry: Fast-track Drug Development Programs. Rockville, MD: HHS.
58. FDA (1998b) Guidance for Industry: Approval of New Cancer Treatment Uses. Rockville, MD: HHS.
59. FDA (2002) Transcript, Oncological Drugs Advisory Committee (ODAC) Meeting, 24 September. Silver Spring, MD.
60. FDA (2003) Approval Package, Iressa, 1 April. Rockville: HHS.
61. FDA (2005) Transcript, ODAC Meeting, 4 March. Gaithersburg, MD.
62. Federal Register (FR) (1985) New drug and antibiotic regulations, 50, FR, 7452. Washington DC: GPO.
63. Federal Register (FR) (1987) New drug, antibiotic and biologic drug product regulations, 52, FR, 8798. Washington DC: GPO.
64. Federal Register (FR) (1988) Procedures for drugs intended to treat life-threatening and severely debilitating illnesses, 53, FR, 41516. Washington DC: GPO.
65. Federal Register (FR) (1992) Accelerated approval, 57, FR, 58958. Washington DC: GPO.
66. Francis, J. (1998) Resurgent regulation in the US. In Doern, G.B. and Wilks, S. (eds) Changing Regulatory Institutions in Britain and North America. Toronto: University of Toronto Press.
67. Fleming, T.R. (2005) Surrogate endpoints and FDA's accelerated approval process, Health Affairs, 24, 67-78.
68. Frasier, S., Valentine, K. and Roberts, C. (2009) Living drugs, Science as Culture, 18, 123-31.
69. Gabe, J. and Bury, M. (1988) Tranquillisers as a social problem, Sociological Review, 36, 320-52.
70. Gabe, J. and Bury, M. (1996) Halcyon nights: a sociological account of medical controversy, Sociology, 30, 447-69.
71. Garattini, S. and Bertele, V. (2001) Adjusting Europe's drug regulation to public health needs, Lancet, 358, 66.
72. Goldberg, P. (2005) An 'insurgency' targets randomized trials, The Cancer Letter, 31, 10-15.
73. Hilts, P.J. (2003) Protecting America's Health. New York: Knopf.
74. Johnson, J.R. and Temple, R. (1985) FDA requirements for approval of anti-cancer drugs, Cancer Treatment Reports, 69, 1155-59.
75. Johnson, J.R., Williams, G. and Pazdur, R. (2003) Endpoints and FDA approval of oncology drugs, Journal of Clinical Oncology, 21, 1404-11.
76. Kawachi, I. and Conrad, P. (1996) Medicalization and pharmacological treatment of blood pressure. In Davis, P. (ed) Contested Ground. Oxford: Oxford University Press.
77. National Academy of Sciences (NAS) (1983) Competitive Status of the US Pharmaceutical Industry. Washington DC: National Academy Press.
78. Navarro, V. (1994) The Politics of US Health Policy. Oxford: Blackwell.
79. Office of Technology Assessment (OTA) (1993) Costs, Risks and Rewards, Washington DC: GPO.
80. Official Journal of the European Union (OJEU) (2004) OJL13630.4.2004 of European Parliament and Council, Community procedures for authorisation and supervision of medicinal products, paragraph 33. Brussels: EU.
81. Patients' Coalition (1996) Issues of Concern to Patients in Debate over FDA Reform, 20 March. Washington, DC: Patients Coalition.
82. Patients' Coalition (1997) Testimony, Jeff Bloom, Patients Coalition, Commerce Committee and Health and Environment SubCommittee, House of Representatives, 12 April. Washington, DC: Patients Coalition.
83. Pearce, N. (1996) Adverse reactions, social responses: two asthma mortality epidemics. In Davis, P. (ed) Contested Ground. Oxford: Oxford University Press.
84. Rafalovich, A. (2005) Exploring clinician uncertainty in diagnosis and treatment of ADHD, Sociology of Health and Illness, 27, 305-23.
85. Roberts, T.G. and Chabner, B.A. (2004) Beyond fast-track for drug approvals, New England Journal of Medicine, 351, 502.
86. Salter, B. and Jones, M. (2006) Change in the policy community of human genetics, Policy and Politics, 34, 347-66.
87. Sklair, L. (2001) The Transnational Capitalist Class. Oxford: Blackwell.
88. Stahel, R., Rossi, A., Petruzelka, L., et al. (2003) Lessons from 'Iressa': expanded access programme, British Journal of Cancer, 89, 19-23.
89. US Government Accountability Office (US GAO) (2009) New Drug Approval: Report to Committee on Finance, US Senate. GAO-09-866: GPO. Washington, DC: GAO.
90. Williams, G. (2002) Team Leader Comments (Iressa), FDA Oncology Drugs Division, 24 September. Rockville, Maryland: FDA. US FOIA request.
91. Williams, S.J., Gabe, J. and Davis, P. (eds) (2009) Pharmaceuticals and Society. Chichester: Wiley-Blackwell.
92. Williams, S.J., Seale, C., Boden, S., Lowe, P. and Steinberg, D.L. (2008) Modafinil, the media and pharmaceuticalisation of everyday/night life, Sociology of Health and Illness, 30, 839-55.
93. Willman, D. (2000) How a new policy led to seven deadly drugs, Los Angeles Times, 20 December, 6.