Торговец смертью: Торговец смертью. Большие гонки. Плейбой и его убийца
Шрифт:
87. This is a vast story, told well elsewhere. Start with Curfman GD, Morrissey S, Drazen JM. Expression of concern reaffirmed. N. Engl. J. Med. 2006 Mar 16;354(11):1193.
88. Opinion: Misleading Drug Trials. The Scientist [Internet]. [cited 2012 May 15]. Available from:com/2012/05/14/opinion-misleading-drug-trials/
89. The Yale Open Data Archive project, or YODA, is one good example of how this might look in the future.Глава 2. Откуда берутся лекарства?
1. I recommend the classic medical student textbook ‘Rang and Dale’: Rang& Dale’s Pharmacology. 6th ed. Churchill Livingstone; 2007. But also this, on the regulatory process around early drug development: Friedhoff LT. New Drugs: An Insider’s Guide to the FDA’s New Drug Approval Process for Scientists, Investors and Patients. 1st ed. PSPG Publishing, 2009.
2. Elliott C, Abadie R. Exploiting a research underclass in phase 1 clinical trials. New England Tournal of Medicine. 2008;358(22):2316.
3. Cohen LP. To screen new drugs for safety, Lilly pays homeless alcoholics: it’s ‘quick cash’ to habitues of Indianapolis shelters; it vanishes quickly, too. Wall St J (East Ed). 1996 Nov 14;A1, A10.
4. Abadie R. The Professional Guinea Pig: Big Pharma and the Risky World of Human Subjects. 1st ed. Duke University Press, 2010.
5. Helms R, editor. Guinea Pig Zero: An Anthology of the Journal for Human Research Subjects. 1st ed. Garrett County Press; 2006.
6. Tucker T. Great Starvation Experiment: Ancel Keys and the Men Who Starved for Science. 1st University of Minnesota Press Ed. University of Minnesota Press; 2008.
7. Gorkin L, Schron EB, Handshaw K, Shea S, Kinney MR, Branyon M, et al. Clinical trial enrollers vs. nonenrollers: The Cardiac Arrhythmia Suppression Trial (CAST) Recruitment and Enrollment Assessment in Clinical Trials (REACT) project. Controlled Clinical Trials. 1996 Feb;17(1):46–59.
8. Sheppard VB, Cox LS, Kanamori MJ, Canar J, Rodriguez Y, Goodman M, et al. BRIEF REPORT: If You Build It, They Will Come. J Gen Intern Med. 2005 May;20(5):444-7.
9. ACRO CRO Market [Internet]. [cited 2012 Feb 11].Available from: http://www.acrohealth.org/cro-market1.html.
10. MacDonald T, Hawkey C, Ford I. Time to treat as independent. BMJ. 2010 Nov 30;341(nov30 2):c6837-c6837.
11. Kassirer T. On the Take: How Medicine’s Complicity with Big Business Can Endanger Your Health. Ch 8. 1st ed. Oxford University Press, USA; 2004.
12. Pharmaceutical CSO — Pharmaceutical Commercialization — Quintiles [Internet.] Available from:commercial-services/
13. DRUG TESTING GOES OFFSHORE August 8, 2005 [Internet]. [cited 2012 Feb 11]. Available from:magazines/fortune/fortune_archive/200 5/08/08/8267653/index. htm
14. Thiers FA, Sinskey AJ, Berndt ER. Trends in the globalization of clinical trials. Nature Reviews Drug Discovery. 2008 Jan;7(1):13-4.
15. All of the issues around trials in developing countries are well covered in two books, Shah S. BODY HUNTERS, THE: Testing New Drugs on the World’s Poorest Patients. SCIE. THE NEW PRESS; 2007. And Petryna A. When Experiments Travel: Clinical Trials and the Global Search for Human Subjects. 1st ed. Princeton University Press; 2009.
16. Ethical and Scientific Implications of the Globalization of Clinical Research Seth W. Glickman, M.D., M.B.A., John G. McHutchison, M.D., Eric D. Peterson, M.D., M.P.H., Charles B. Cairns, M.D., Robert A. Harrington, M.D., Robert M. Califf, M.D., and Kevin A. Schulman, M.D. N Engl J Med 2009; 360:816–823. February 19, 2009.
17. Bansal N. The opportunities and challenges in conducting clinical trials globally. Clinical Research and Regulatory Affairs. 2012 Feb 9;1–6.
18. Ethical and Scientific Implications of the Globalization of Clinical Research Seth W. Glickman, M.D., M.B.A., John G. McHutchison, M.D., Eric D. Peterson, M.D., M.P.H., Charles B. Cairns, M.D., Robert A. Harrington, M.D., Robert M. Califf, M.D., and Kevin A. Schulman, M.D. N Engl J Med 2009; 360:816–823. February 19, 2009
19. Hyder AA, Wali SA, Khan AN, Teoh NB, Kass NE, Dawson L. Ethical review of health research: a perspective from developing country researchers. J Med Eth’cs. 2004 Feb;30(1):68–72.
20. Zhang D, Yin P, Freemantle N, Jordan R, Zhong N, Cheng KK. An assessment of the quality of randomised controlled trials conducted in China. Trials. 2008;9:22.
21. FDA Requires Foreign Clinical Studies be in Accordance with Good Clinical Practice to Better Protect Human Subjects by W. Thomas Smith American Bar Association Health eSource October 2008 Volume 5 Number 2 [Internet]. [cited 2012 Feb 11]. Available from:newsletter/ publications/aba_health_esource_home/Volume5_0 2_smith. html
22. WikiLeaks cables: Pfizer ‘used dirty tricks to avoid clinical trial payout’ Business The Guardian [Internet]. [cited 2012 Feb 11]. Available from:dec/09/wikileaks-cables-pfizer-nigeria
23. US embassy cable Monday 20 April 2009, 16:00, Abuja 000671 ‘Pfizer reaches preliminary agreement for $75m settlement’ [cited 2012 Feb 11]. Available from:world/us-embassy-cablesdocuments/203205
24. WikiLeaks cables: Pfizer ‘used dirty tricks to avoid clinical trial payout’ Business The Guardian [Internet]. [cited 2012 Feb 11]. Available from:2010/ dec/09/wikileaks-cables-pfizer-nigeria
25. Jonathan Kimmelman, Charles Weijer, and Eric M Meslin, ‘Helsinki discords: FDA, ethics, and international drug trials,’ The Lancet 373, no. 9657 (January 3, 2009): 13–14.
26. Goodyear MDE, Lemmens T, Sprumont D, Tangwa G. Does the FDA have the authority to trump the Declaration of Helsinki? BMJ. 2009 Apr 21;338(apr21 1):b1559-b1559.Глава 3.
1. Royal College of Physicians, London UK. INNOVATING FOR HEALTH. Patients, physicians, the pharmaceutical industry and the NHS. February 2009. Report of a Working Party.
2. If you’re very confused about the European Medicines Agency, and the UK MHRA, and how they relate to each other, it’s fairly simple. The MHRA used to approve drugs, now the EMA do, but they farm out some of the local work to the old national regulators, especially monitoring and communication, as well as some of the approval stuff.
3. I recommend the work of John Abraham, collected here: (http://www.sussex.ac.uk/profiles/6
4. Owen BM, Braeutigam R. The Regulation Game: Strategic Use of the Administrative Process. Ballinger Pub Co; 1978. Via Abraham J. On the prohibition of conflicts of interest in pharmaceutical regulation: Precautionary limits and permissive challenges. A commentary on Sismondo (66:9, 2008, 1909-14)and O’Donovan and Lexchin. Social Science& Medicine. 2010 Mar;70(5):648-51.